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MenABCWY Noninferiority Study in Healthy Participants ≥10 to <26 Years of Age

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04440163
Recruitment Status : Completed
First Posted : June 19, 2020
Results First Posted : April 18, 2023
Last Update Posted : April 18, 2023
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Meningococcal Vaccine
Interventions Biological: MenABCWY
Biological: Saline
Biological: Trumenba
Biological: MenACWY-CRM
Enrollment 2431
Recruitment Details  
Pre-assignment Details A total of 2431 participants were enrolled and randomized in the study of which 18 participants did not receive any vaccination. Out of 2431 participants, 2413 participants received at least 1 dose of vaccination.
Arm/Group Title ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) ACWY-Experienced: Group 3 MenABCWY + Saline (Immunogenicity and Safety Set) ACWY-Experienced: Group 4 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) ACWY-Naive: Group 5 MenABCWY + Saline (Safety Set) ACWY-Naive: Group 6 Trumenba+ MenACWY - CRM (Safety Set) ACWY-Experienced: Group 7 MenABCWY + Saline (Safety Set) ACWY-Experienced: Group 8 Trumenba+ MenACWY - CRM (Safety Set)
Hide Arm/Group Description On Day 1 (Visit 1), Neisseria meningitidis group A, C, W, and Y (ACWY) naive participants received a single dose of 0.5 milliliter (mL) Neisseria meningitidis serogroup A, B, C, W, Y (MenABCWY) intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to both safety and immunogenicity analyses. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2. On Day 1 (Visit 1), ACWY naive participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of meningococcal (groups A, C, Y, and W-135) oligosaccharide diphtheria conjugate vaccine (MenACWY-CRM) intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3,participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to both safety and immunogenicity analyses. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2. On Day 1 (Visit 1), ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to both safety and immunogenicity analyses. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2. On Day 1 (Visit 1), ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to both safety and immunogenicity analyses. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2. On Day 1 (Visit 1), ACWY naive participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2). and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to safety analyses only. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2. On Day 1 (Visit 1), ACWY naive participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to safety analyses only. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2. On Day 1 (Visit 1), ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to safety analyses only. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2. On Day 1 (Visit 1), ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to safety analyses only. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
Period Title: Vaccination Phase (Approx. 7 Months)
Started 552 276 528 261 [1] 544 57 154 59
Vaccination 1 547 274 526 261 537 56 153 59
Vaccination 2 500 254 453 218 481 46 123 45
Completed 490 248 440 209 476 45 122 44
Not Completed 62 28 88 52 68 12 32 15
Reason Not Completed
Lost to Follow-up             26             15             42             22             30             3             18             5
Medication error without associated adverse event             0             0             0             1             1             0             0             0
No longer met eligibility criteria             5             1             5             2             3             0             2             3
Pregnancy             1             0             2             0             1             0             0             0
Protocol Violation             1             0             5             3             0             0             3             0
Other             0             0             3             2             0             1             0             1
Adverse Event             3             1             0             1             0             0             0             0
Withdrawal by Subject             11             5             18             14             10             3             5             4
Withdrawal by parent/guardian             10             4             11             7             16             4             3             2
Withdrawn before vaccination             5             2             2             0             7             1             1             0
[1]
One participant initially randomized to group 3 was included in group 4 as participant received the wrong vaccination (Trumenba + saline).
Period Title: Follow-up Phase (Approx. 5 Months)
Started 490 248 440 209 476 45 122 44
Completed 487 243 440 208 475 45 120 43
Not Completed 3 5 0 1 1 0 2 1
Reason Not Completed
Lost to Follow-up             3             5             0             0             1             0             2             1
Protocol Violation             0             0             0             1             0             0             0             0
Arm/Group Title ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) ACWY-Experienced: Group 3 MenABCWY + Saline (Immunogenicity and Safety Set) ACWY-Experienced: Group 4 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) ACWY-Naive: Group 5 MenABCWY + Saline (Safety Set) ACWY-Naive: Group 6 Trumenba+ MenACWY - CRM (Safety Set) ACWY-Experienced: Group 7 MenABCWY + Saline (Safety Set) ACWY-Experienced: Group 8 Trumenba+ MenACWY - CRM (Safety Set) Total
Hide Arm/Group Description On Day 1 (Visit 1), ACWY naive participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to both safety and immunogenicity analyses. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2. On Day 1 (Visit 1), ACWY naive participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to both safety and immunogenicity analyses. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2. On Day 1 (Visit 1), ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to both safety and immunogenicity analyses. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2. On Day 1 (Visit 1), ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to both safety and immunogenicity analyses. . Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2. On Day 1 (Visit 1), ACWY naive participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to safety analyses only. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2. On Day 1 (Visit 1), ACWY naive participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to safety analyses only. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2. On Day 1 (Visit 1), ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to safety analyses only. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2. On Day 1 (Visit 1), ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to safety analyses only. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2. Total of all reporting groups
Overall Number of Baseline Participants 547 274 526 260 537 56 153 59 2412
Hide Baseline Analysis Population Description
Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination. One participant initially randomized to group 3 was excluded from safety population set as the participant received the wrong vaccination (Trumenba + saline).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 547 participants 274 participants 526 participants 260 participants 537 participants 56 participants 153 participants 59 participants 2412 participants
16.7  (5.49) 16.7  (5.39) 17.3  (3.17) 17.4  (3.28) 13.5  (4.05) 13.5  (4.50) 17.1  (3.04) 16.0  (2.75) 16.1  (4.55)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 547 participants 274 participants 526 participants 260 participants 537 participants 56 participants 153 participants 59 participants 2412 participants
Female
289
  52.8%
140
  51.1%
279
  53.0%
131
  50.4%
253
  47.1%
20
  35.7%
96
  62.7%
28
  47.5%
1236
  51.2%
Male
258
  47.2%
134
  48.9%
247
  47.0%
129
  49.6%
284
  52.9%
36
  64.3%
57
  37.3%
31
  52.5%
1176
  48.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 547 participants 274 participants 526 participants 260 participants 537 participants 56 participants 153 participants 59 participants 2412 participants
Hispanic or Latino
93
  17.0%
53
  19.3%
156
  29.7%
86
  33.1%
131
  24.4%
15
  26.8%
58
  37.9%
29
  49.2%
621
  25.7%
Not Hispanic or Latino
450
  82.3%
217
  79.2%
366
  69.6%
173
  66.5%
405
  75.4%
41
  73.2%
93
  60.8%
30
  50.8%
1775
  73.6%
Unknown or Not Reported
4
   0.7%
4
   1.5%
4
   0.8%
1
   0.4%
1
   0.2%
0
   0.0%
2
   1.3%
0
   0.0%
16
   0.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 547 participants 274 participants 526 participants 260 participants 537 participants 56 participants 153 participants 59 participants 2412 participants
American Indian or Alaska Native
2
   0.4%
2
   0.7%
2
   0.4%
2
   0.8%
4
   0.7%
1
   1.8%
2
   1.3%
1
   1.7%
16
   0.7%
Asian
19
   3.5%
4
   1.5%
18
   3.4%
6
   2.3%
7
   1.3%
1
   1.8%
1
   0.7%
1
   1.7%
57
   2.4%
Native Hawaiian or Other Pacific Islander
1
   0.2%
0
   0.0%
2
   0.4%
0
   0.0%
1
   0.2%
0
   0.0%
0
   0.0%
0
   0.0%
4
   0.2%
Black or African American
26
   4.8%
19
   6.9%
74
  14.1%
32
  12.3%
57
  10.6%
5
   8.9%
27
  17.6%
5
   8.5%
245
  10.2%
White
467
  85.4%
239
  87.2%
370
  70.3%
195
  75.0%
419
  78.0%
46
  82.1%
103
  67.3%
42
  71.2%
1881
  78.0%
More than one race
9
   1.6%
3
   1.1%
12
   2.3%
3
   1.2%
7
   1.3%
2
   3.6%
2
   1.3%
0
   0.0%
38
   1.6%
Unknown or Not Reported
23
   4.2%
7
   2.6%
48
   9.1%
22
   8.5%
42
   7.8%
1
   1.8%
18
  11.8%
10
  16.9%
171
   7.1%
1.Primary Outcome
Title Percentage of Participants Achieving At Least 4-Fold Rise in Serum Bactericidal Assay Using Human Complement (hSBA) Titer From Baseline for Each MenACWY Strains: 1 Month After Vaccination 2 in Group 1 Compared to 1 Month After Vaccination 1 in Group 2
Hide Description 4-fold increase was defined as: 1) for participants with baseline hSBA titer below limit of detection (LOD) (or hSBA titer less than [<] 1:4), 4-fold rise was defined as hSBA titer greater than or equal to (>=) 1:16; 2) baseline hSBA titer >=LOD and < lower limit of quantitation (LLOQ) (i.e. hSBA titer of 1:8), 4-fold rise was defined as hSBA titer >=4 times LLOQ; 3) baseline hSBA titer >=LLOQ, 4-fold rise was defined as hSBA titer >=4 times baseline titer. Exact 2-sided confidence interval (CI) using Clopper and Pearson method was presented. Analysis was performed on post-vaccination (PV) 1 evaluable immunogenicity population (EIP) for Group 2 and PV2 evaluable immunogenicity population for Group 1. Here, 'Overall Number of Participants Analyzed' represented as 'N' and 'Number Analyzed' represented as 'n'.
Time Frame Baseline (pre-vaccination on Day 1), 1 month after Vaccination 2 in Group 1 and 1 month after Vaccination 1 in Group 2
Hide Outcome Measure Data
Hide Analysis Population Description
PV1 EIP and PV2 EIP: randomized to study group of interest; eligible at visit (V) 2 and 4 respectively; received vaccine at V1 or V1 and V3, respectively; blood drawn for assay testing at specified time points; at least 1 valid, determinate MenACWY or MenACWY/MenB assay result; no prohibited vaccine/treatment, no protocol deviations through V2 and V4, respectively. N=participants evaluable for outcome measure; n=participants evaluable for rows.
Arm/Group Title ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set)
Hide Arm/Group Description:
On Day 1 (Visit 1), ACWY naive participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to both safety and immunogenicity analyses. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
On Day 1 (Visit 1), ACWY naive participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to both safety and immunogenicity analyses. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
Overall Number of Participants Analyzed 451 254
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
MenA Number Analyzed 447 participants 254 participants
97.8
(95.9 to 98.9)
95.3
(91.9 to 97.5)
MenC Number Analyzed 451 participants 252 participants
93.3
(90.6 to 95.5)
52.4
(46.0 to 58.7)
MenW Number Analyzed 439 participants 244 participants
97.3
(95.3 to 98.6)
73.0
(66.9 to 78.4)
MenY Number Analyzed 446 participants 248 participants
94.4
(91.8 to 96.3)
70.6
(64.5 to 76.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set), ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set)
Comments MenA
Type of Statistical Test Non-Inferiority
Comments 95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was greater than (>) minus (-)10 percent (%), the non-inferiority was concluded.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Based on Miettinen and Nurminen method.
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage of participants
Estimated Value 2.5
Confidence Interval (2-Sided) 95%
-0.2 to 6.0
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set), ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set)
Comments MenC
Type of Statistical Test Non-Inferiority
Comments 95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was > -10%, the non-inferiority was concluded.
Method of Estimation Estimation Parameter Difference in percentage of participants
Estimated Value 41.0
Confidence Interval (2-Sided) 95%
34.4 to 47.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set), ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set)
Comments MenW
Type of Statistical Test Non-Inferiority
Comments 95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was > -10%, the non-inferiority was concluded.
Method of Estimation Estimation Parameter Difference in percentage of participants
Estimated Value 24.3
Confidence Interval (2-Sided) 95%
18.8 to 30.4
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set), ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set)
Comments MenY
Type of Statistical Test Non-Inferiority
Comments 95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was > -10%, the non-inferiority was concluded.
Method of Estimation Estimation Parameter Difference in percentage of participants
Estimated Value 23.8
Confidence Interval (2-Sided) 95%
18.0 to 30.1
Estimation Comments [Not Specified]
2.Primary Outcome
Title Percentage of Participants Achieving At Least 4-Fold Rise in hSBA Titer From Baseline for Each of the MenACWY Strains: 1 Month After Vaccination 2 in Group 3 Compared to 1 Month After Vaccination 1 in Group 4
Hide Description 4-fold increase was defined as: 1) for participants with baseline hSBA titer below LOD (or hSBA titer <1:4), 4-fold rise was defined as hSBA titer >=1:16; 2) baseline hSBA titer >=LOD (i.e., hSBA titer of >=1:4) and < LLOQ (i.e., hSBA titer of 1:8), 4-fold rise was defined as hSBA titer >=4times LLOQ; 3) baseline hSBA titer >=LLOQ, 4-fold rise was defined as hSBA titer >=4 times baseline titer. Exact 2-sided CI using Clopper and Pearson method was presented. Here, 'Overall Number of Participants Analyzed' represented as 'N' and 'Number Analyzed' represented as 'n'.
Time Frame Baseline (pre-vaccination on Day 1), 1 month after Vaccination 2 in Group 3 and 1 month after Vaccination 1 in Group 4
Hide Outcome Measure Data
Hide Analysis Population Description
PV1 and PV2 EIP for Group 4 and Group 3, respectively: randomized to study group of interest; eligible at V2 and V4, respectively; received vaccine at V1 or V1 and V3, respectively; blood drawn for assay testing at specified time points; at least 1 valid, determinate MenACWY or MenACWY/MenB assay result, no prohibited vaccines/treatment, no protocol deviations through V2 and V4 respectively. N=participants evaluable for outcome measure; n=participants evaluable for rows.
Arm/Group Title ACWY-Experienced: Group 3 MenABCWY + Saline (Immunogenicity and Safety Set) ACWY-Experienced: Group 4 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set)
Hide Arm/Group Description:
On Day 1 (Visit 1), ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to both safety and immunogenicity analyses. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
On Day 1 (Visit 1), ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to both safety and immunogenicity analyses. . Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
Overall Number of Participants Analyzed 387 227
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
MenA Number Analyzed 385 participants 227 participants
93.8
(90.9 to 96.0)
96.9
(93.7 to 98.8)
MenC Number Analyzed 386 participants 226 participants
93.8
(90.9 to 96.0)
94.7
(90.9 to 97.2)
MenW Number Analyzed 386 participants 222 participants
97.1
(94.8 to 98.5)
96.4
(93.0 to 98.4)
MenY Number Analyzed 387 participants 223 participants
93.0
(90.0 to 95.4)
93.7
(89.7 to 96.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ACWY-Experienced: Group 3 MenABCWY + Saline (Immunogenicity and Safety Set), ACWY-Experienced: Group 4 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set)
Comments MenA
Type of Statistical Test Non-Inferiority
Comments 95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was > -10%, the non-inferiority was concluded.
Method of Estimation Estimation Parameter Difference in percentage of participants
Estimated Value -3.2
Confidence Interval (2-Sided) 95%
-6.5 to 0.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection ACWY-Experienced: Group 3 MenABCWY + Saline (Immunogenicity and Safety Set), ACWY-Experienced: Group 4 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set)
Comments MenC
Type of Statistical Test Non-Inferiority
Comments 95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was > -10%, the non-inferiority was concluded.
Method of Estimation Estimation Parameter Difference in percentage of participants
Estimated Value -0.9
Confidence Interval (2-Sided) 95%
-4.6 to 3.3
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection ACWY-Experienced: Group 3 MenABCWY + Saline (Immunogenicity and Safety Set), ACWY-Experienced: Group 4 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set)
Comments MenW
Type of Statistical Test Non-Inferiority
Comments 95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was > -10%, the non-inferiority was concluded.
Method of Estimation Estimation Parameter Difference in percentage of participants
Estimated Value 0.7
Confidence Interval (2-Sided) 95%
-2.2 to 4.3
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection ACWY-Experienced: Group 3 MenABCWY + Saline (Immunogenicity and Safety Set), ACWY-Experienced: Group 4 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set)
Comments MenY
Type of Statistical Test Non-Inferiority
Comments 95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was > -10%, the non-inferiority was concluded.
Method of Estimation Estimation Parameter Difference in percentage of participants
Estimated Value -0.7
Confidence Interval (2-Sided) 95%
-4.6 to 3.8
Estimation Comments [Not Specified]
3.Primary Outcome
Title Percentage of Participants Achieving hSBA Titer Greater Than or Equal to (>=) LLOQ for All Primary Neisseria Meningitidis Group B (MenB) Test Strains Combined (Composite Response): Groups 1 and 3 Combined Versus Groups 2 and 4 Combined
Hide Description Percentage of participants achieving hSBA titer >= LLOQ (1:16 for strain A22 and 1:8 for strains A56, B24, and B44) for all MenB test strains (A22, A56, B24 and B44) combined were reported in this outcome measure. Exact 2-sided CI using the Clopper and Pearson method was presented.
Time Frame 1 month after Vaccination 2
Hide Outcome Measure Data
Hide Analysis Population Description
PV2 EIP: participants randomized to study group of interest; eligible at V4; received vaccine at V1 and V3; blood drawn for assay testing at specified time points; had at least 1 valid, determinate MenACWY or MenB assay result at V4; received no prohibited vaccines; no protocol deviations through V4. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for outcome measure.
Arm/Group Title Groups 1+3 Combined MenABCWY + Saline (Immunogenicity and Safety Set) Groups 2+4 Combined Trumenba + MenACWY-CRM (Immunogenicity and Safety Set)
Hide Arm/Group Description:
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to both safety and immunogenicity analyses. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to both safety and immunogenicity analyses. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
Overall Number of Participants Analyzed 755 383
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
78.3
(75.2 to 81.2)
68.7
(63.8 to 73.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Groups 1+3 Combined MenABCWY + Saline (Immunogenicity and Safety Set), Groups 2+4 Combined Trumenba + MenACWY-CRM (Immunogenicity and Safety Set)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments 95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was > -10%, the non-inferiority was concluded.
Method of Estimation Estimation Parameter Difference in percentage of participants
Estimated Value 9.6
Confidence Interval (2-Sided) 95%
4.2 to 15.2
Estimation Comments [Not Specified]
4.Primary Outcome
Title Percentage of Participants Achieving At Least a 4-Fold Rise in hSBA Titer From Baseline For Each Primary MenB Test Strains at 1 Month After Vaccination 2: Groups 1 and 3 Combined Versus Groups 2 and 4 Combined
Hide Description Percentage of participants achieving at least a 4-fold rise in hSBA titer for each primary MenB test strains (A22, A56, B24 and B44) were reported in this outcome measure. Exact 2-sided CI using the Clopper and Pearson method was presented.
Time Frame Baseline (pre-vaccination on Day 1), 1 month after Vaccination 2
Hide Outcome Measure Data
Hide Analysis Population Description
PV2 EIP: participants randomized to study group of interest; eligible at V4; received vaccine at V1 and V3; blood drawn for assay testing at specified time points; at least 1 valid, determinate MenACWY or MenB assay result at V4; no prohibited vaccines; no protocol deviations through V4. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for outcome measure and 'Number Analyzed' signifies number of participants evaluable for specified rows.
Arm/Group Title Groups 1+3 Combined MenABCWY + Saline (Immunogenicity and Safety Set) Groups 2+4 Combined Trumenba + MenACWY-CRM (Immunogenicity and Safety Set)
Hide Arm/Group Description:
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to both safety and immunogenicity analyses. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to both safety and immunogenicity analyses. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
Overall Number of Participants Analyzed 845 419
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
A22 Number Analyzed 778 participants 396 participants
83.0
(80.2 to 85.6)
79.0
(74.7 to 82.9)
A56 Number Analyzed 807 participants 400 participants
95.9
(94.3 to 97.2)
94.5
(91.8 to 96.5)
B24 Number Analyzed 833 participants 418 participants
68.1
(64.8 to 71.2)
57.2
(52.3 to 62.0)
B44 Number Analyzed 845 participants 419 participants
86.5
(84.0 to 88.7)
79.2
(75.0 to 83.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Groups 1+3 Combined MenABCWY + Saline (Immunogenicity and Safety Set), Groups 2+4 Combined Trumenba + MenACWY-CRM (Immunogenicity and Safety Set)
Comments A22
Type of Statistical Test Non-Inferiority
Comments 95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was > -10%, the non-inferiority was concluded.
Method of Estimation Estimation Parameter Difference in percentage of participants
Estimated Value 4.0
Confidence Interval (2-Sided) 95%
-0.7 to 8.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Groups 1+3 Combined MenABCWY + Saline (Immunogenicity and Safety Set), Groups 2+4 Combined Trumenba + MenACWY-CRM (Immunogenicity and Safety Set)
Comments A56
Type of Statistical Test Non-Inferiority
Comments 95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was > -10%, the non-inferiority was concluded.
Method of Estimation Estimation Parameter Difference in percentage of participants
Estimated Value 1.4
Confidence Interval (2-Sided) 95%
-1.0 to 4.3
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Groups 1+3 Combined MenABCWY + Saline (Immunogenicity and Safety Set), Groups 2+4 Combined Trumenba + MenACWY-CRM (Immunogenicity and Safety Set)
Comments B24
Type of Statistical Test Non-Inferiority
Comments 95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was > -10%, the non-inferiority was concluded.
Method of Estimation Estimation Parameter Difference in percentage of participants
Estimated Value 10.9
Confidence Interval (2-Sided) 95%
5.2 to 16.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Groups 1+3 Combined MenABCWY + Saline (Immunogenicity and Safety Set), Groups 2+4 Combined Trumenba + MenACWY-CRM (Immunogenicity and Safety Set)
Comments B44
Type of Statistical Test Non-Inferiority
Comments 95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was > -10%, the non-inferiority was concluded.
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 7.3
Confidence Interval (2-Sided) 95%
2.9 to 11.9
Estimation Comments [Not Specified]
5.Primary Outcome
Title Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
Hide Description Local reactions included pain at injection site, redness and swelling and were recorded by participants in an electronic diary (e-diary). Redness and swelling were measured and recorded in caliper units. 1 caliper unit =0.5 centimeter (cm) and graded as mild: >2.0 to 5.0 cm, moderate: >5.0 to 10.0 cm and severe: >10.0 cm. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity and severe: prevented daily activity. Percentage of participants with local reactions at injection site were reported in this outcome measure. Exact 2-sided CI was based on the Clopper and Pearson method.
Time Frame Within 7 days after Vaccination 1
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination. Here, "Overall Number of Participants Analyzed" (N) signifies participants evaluable for this outcome measure.
Arm/Group Title Groups 1+3+5+7 Combined MenABCWY + Saline Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM
Hide Arm/Group Description:
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
Overall Number of Participants Analyzed 1722 630
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Redness: Mild
8.8
(7.5 to 10.3)
7.3
(5.4 to 9.6)
Redness: Moderate
14.5
(12.8 to 16.2)
10.0
(7.8 to 12.6)
Redness: Severe
2.5
(1.8 to 3.3)
2.2
(1.2 to 3.7)
Swelling: Mild
10.5
(9.0 to 12.0)
8.3
(6.2 to 10.7)
Swelling: Moderate
13.3
(11.7 to 15.0)
12.4
(9.9 to 15.2)
Swelling: Severe
1.2
(0.7 to 1.8)
0.8
(0.3 to 1.8)
Pain at injection site: Mild
32.3
(30.1 to 34.6)
31.1
(27.5 to 34.9)
Pain at injection site: Moderate
49.5
(47.1 to 51.9)
47.6
(43.7 to 51.6)
Pain at injection site: Severe
7.5
(6.3 to 8.8)
6.3
(4.6 to 8.5)
6.Primary Outcome
Title Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
Hide Description Local reactions included pain at injection site, redness and swelling and were recorded by participants in an e-diary. Redness and swelling were measured and recorded in caliper units. 1 caliper unit =0.5 cm and graded as mild: >2.0 to 5.0 cm, moderate: >5.0 to 10.0 cm and severe: >10.0 cm. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity and severe: prevented daily activity. Percentage of participants with local reactions at injection site were reported in this outcome measure. Exact 2-sided CI was based on the Clopper and Pearson method.
Time Frame Within 7 days after Vaccination 2
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Arm/Group Title Groups 1+3+5+7 Combined MenABCWY + Saline Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM
Hide Arm/Group Description:
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
Overall Number of Participants Analyzed 1456 529
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Redness: Mild
7.7
(6.4 to 9.2)
6.6
(4.7 to 9.1)
Redness: Moderate
12.6
(10.9 to 14.4)
7.2
(5.1 to 9.7)
Redness: Severe
3.0
(2.1 to 4.0)
0.9
(0.3 to 2.2)
Swelling: Mild
10.4
(8.9 to 12.1)
6.4
(4.5 to 8.9)
Swelling: Moderate
12.8
(11.1 to 14.6)
8.1
(5.9 to 10.8)
Swelling: Severe
1.0
(0.5 to 1.6)
0.2
(0.0 to 1.0)
Pain at injection site: Mild
29.1
(26.7 to 31.5)
33.1
(29.1 to 37.3)
Pain at injection site: Moderate
48.8
(46.2 to 51.4)
40.3
(36.1 to 44.6)
Pain at injection site: Severe
6.5
(5.3 to 7.9)
5.3
(3.5 to 7.6)
7.Primary Outcome
Title Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
Hide Description Systemic events were recorded by participants in e-diary. Fever was defined as temperature >=38.0 degrees (deg) Celsius (C) and was categorized as 38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Fatigue, headache, chills, muscle pain and joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24 hours(h), moderate: >2 times in 24h and severe: required intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h. Exact 2-sided CI was based on the Clopper and Pearson method.
Time Frame Within 7 days after Vaccination 1
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Arm/Group Title Groups 1+3+5+7 Combined MenABCWY + Saline Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM
Hide Arm/Group Description:
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
Overall Number of Participants Analyzed 1739 638
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Fever: 38.0 deg C to 38.4 deg C
3.7
(2.8 to 4.7)
2.0
(1.1 to 3.5)
Fever: >38.4 deg C to 38.9 deg C
1.6
(1.0 to 2.3)
2.8
(1.7 to 4.4)
Fever: >38.9 deg C to 40.0 deg C
0.6
(0.3 to 1.1)
0.9
(0.3 to 2.0)
Fever: >40.0 deg C
0.0
(0.0 to 0.2)
0.0
(0.0 to 0.6)
Fatigue: Mild
23.5
(21.5 to 25.5)
25.7
(22.4 to 29.3)
Fatigue: Moderate
25.5
(23.4 to 27.6)
25.7
(22.4 to 29.3)
Fatigue: Severe
3.2
(2.4 to 4.1)
3.3
(2.0 to 5.0)
Headache: Mild
25.6
(23.6 to 27.8)
24.5
(21.2 to 28.0)
Headache: Moderate
19.2
(17.4 to 21.1)
20.4
(17.3 to 23.7)
Headache: Severe
1.9
(1.3 to 2.7)
2.0
(1.1 to 3.5)
Chills: Mild
12.6
(11.1 to 14.2)
10.2
(8.0 to 12.8)
Chills: Moderate
6.7
(5.5 to 7.9)
7.8
(5.9 to 10.2)
Chills: Severe
0.8
(0.4 to 1.3)
1.6
(0.8 to 2.9)
Vomiting: Mild
2.5
(1.8 to 3.4)
2.0
(1.1 to 3.5)
Vomiting: Moderate
0.6
(0.3 to 1.1)
0.9
(0.3 to 2.0)
Vomiting: Severe
0.0
(0.0 to 0.2)
0.0
(0.0 to 0.6)
Diarrhea: Mild
8.7
(7.5 to 10.2)
11.9
(9.5 to 14.7)
Diarrhea: Moderate
2.0
(1.4 to 2.7)
1.6
(0.8 to 2.9)
Diarrhea: Severe
0.3
(0.1 to 0.7)
0.0
(0.0 to 0.6)
Muscle Pain: Mild
13.6
(12.0 to 15.3)
13.5
(10.9 to 16.4)
Muscle Pain: Moderate
10.5
(9.1 to 12.1)
11.9
(9.5 to 14.7)
Muscle Pain: Severe
1.6
(1.1 to 2.3)
2.0
(1.1 to 3.5)
Joint Pain: Mild
10.7
(9.3 to 12.2)
12.9
(10.4 to 15.7)
Joint Pain: Moderate
8.6
(7.3 to 10.0)
8.6
(6.6 to 11.1)
Joint Pain: Severe
1.0
(0.6 to 1.6)
1.1
(0.4 to 2.2)
8.Primary Outcome
Title Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
Hide Description Systemic events were recorded by participants in e-diary. Fever was defined as temperature >=38.0 deg C and was categorized as 38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Fatigue, headache, chills, muscle pain and joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24h, moderate: >2 times in 24h and severe: required intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h. Exact 2-sided CI was based on the Clopper and Pearson method.
Time Frame Within 7 days after Vaccination 2
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Hide Analysis Population Description
Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Arm/Group Title Groups 1+3+5+7 Combined MenABCWY + Saline Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM
Hide Arm/Group Description:
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
Overall Number of Participants Analyzed 1459 532
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Fever: 38.0 deg C to 38.4 deg C
1.8
(1.2 to 2.6)
0.4
(0.0 to 1.4)
Fever: >38.4 deg C to 38.9 deg C
0.3
(0.1 to 0.7)
0.9
(0.3 to 2.2)
Fever: >38.9 deg C to 40.0 deg C
0.2
(0.0 to 0.6)
0.2
(0.0 to 1.0)
Fever: >40.0 deg C
0.0
(0.0 to 0.3)
0.0
(0.0 to 0.7)
Fatigue: Mild
22.8
(20.7 to 25.1)
22.0
(18.5 to 25.8)
Fatigue: Moderate
21.8
(19.7 to 24.0)
19.9
(16.6 to 23.6)
Fatigue: Severe
2.9
(2.1 to 3.9)
1.7
(0.8 to 3.2)
Headache: Mild
21.3
(19.2 to 23.5)
21.1
(17.7 to 24.8)
Headache: Moderate
16.8
(14.9 to 18.8)
16.2
(13.1 to 19.6)
Headache: Severe
1.7
(1.1 to 2.5)
0.6
(0.1 to 1.6)
Chills: Mild
9.9
(8.5 to 11.6)
8.8
(6.6 to 11.6)
Chills: Moderate
6.0
(4.9 to 7.4)
5.8
(4.0 to 8.2)
Chills: Severe
0.4
(0.2 to 0.9)
1.5
(0.7 to 2.9)
Vomiting: Mild
1.4
(0.8 to 2.1)
0.8
(0.2 to 1.9)
Vomiting: Moderate
0.1
(0.0 to 0.5)
0.2
(0.0 to 1.0)
Vomiting: Severe
0.0
(0.0 to 0.3)
0.0
(0.0 to 0.7)
Diarrhea: Mild
6.9
(5.6 to 8.3)
6.0
(4.2 to 8.4)
Diarrhea: Moderate
1.4
(0.8 to 2.1)
2.4
(1.3 to 4.1)
Diarrhea: Severe
0.0
(0.0 to 0.3)
0.0
(0.0 to 0.7)
Muscle Pain: Mild
10.0
(8.5 to 11.7)
10.0
(7.6 to 12.8)
Muscle Pain: Moderate
11.9
(10.3 to 13.7)
11.5
(8.9 to 14.5)
Muscle Pain: Severe
0.8
(0.4 to 1.4)
0.8
(0.2 to 1.9)
Joint Pain: Mild
9.6
(8.1 to 11.2)
7.9
(5.7 to 10.5)
Joint Pain: Moderate
8.3
(6.9 to 9.8)
6.8
(4.8 to 9.2)
Joint Pain: Severe
0.4
(0.2 to 0.9)
0.9
(0.3 to 2.2)
9.Primary Outcome
Title Percentage of Participants With Use of Antipyretic Medication Within 7 Days After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
Hide Description The use of antipyretic medication was recorded by participants in an e-diary for 7 days after vaccination. Exact 2-sided CI was based on the Clopper and Pearson method.
Time Frame Within 7 days after Vaccination 1
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Arm/Group Title Groups 1+3+5+7 Combined MenABCWY + Saline Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM
Hide Arm/Group Description:
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
Overall Number of Participants Analyzed 1739 638
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
29.5
(27.4 to 31.7)
28.1
(24.6 to 31.7)
10.Primary Outcome
Title Percentage of Participants With Use of Antipyretic Medication Within 7 Days After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
Hide Description The use of antipyretic medication recorded by participants in an e-diary for 7 days after vaccination. Exact 2-sided CI was based on the Clopper and Pearson method.
Time Frame Within 7 days after Vaccination 2
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Arm/Group Title Groups 1+3+5+7 Combined MenABCWY + Saline Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM
Hide Arm/Group Description:
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
Overall Number of Participants Analyzed 1459 532
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
25.1
(22.9 to 27.4)
20.5
(17.1 to 24.2)
11.Primary Outcome
Title Percentage of Participants With Adverse Events (AEs) Within 30 Days After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
Hide Description An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. Exact 2-sided CI was based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.
Time Frame Within 30 days after Vaccination 1
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination.
Arm/Group Title Groups 1+3+5+7 Combined MenABCWY + Saline Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM
Hide Arm/Group Description:
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
Overall Number of Participants Analyzed 1763 649
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
5.8
(4.7 to 7.0)
6.5
(4.7 to 8.6)
12.Primary Outcome
Title Percentage of Participants With AEs Within 30 Days After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
Hide Description An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. Exact 2-sided CI was based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.
Time Frame Within 30 days after Vaccination 2
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Arm/Group Title Groups 1+3+5+7 Combined MenABCWY + Saline Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM
Hide Arm/Group Description:
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
Overall Number of Participants Analyzed 1558 562
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
5.3
(4.3 to 6.6)
3.7
(2.3 to 5.7)
13.Primary Outcome
Title Percentage of Participants With AEs Within 30 Days After Any Vaccination: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
Hide Description An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. Exact 2-sided CI was based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.
Time Frame Within 30 days after any vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination.
Arm/Group Title Groups 1+3+5+7 Combined MenABCWY + Saline Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM
Hide Arm/Group Description:
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
Overall Number of Participants Analyzed 1763 649
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
9.7
(8.4 to 11.2)
9.1
(7.0 to 11.6)
14.Primary Outcome
Title Percentage of Participants With AEs During Vaccination Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
Hide Description An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. Exact 2-sided CI was based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.
Time Frame From day of Vaccination 1 (Day 1) up to 1 month after Vaccination 2 (approximately 7 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination.
Arm/Group Title Groups 1+3+5+7 Combined MenABCWY + Saline Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM
Hide Arm/Group Description:
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
Overall Number of Participants Analyzed 1763 649
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
20.9
(19.0 to 22.8)
20.3
(17.3 to 23.6)
15.Primary Outcome
Title Percentage of Participants With Serious Adverse Events (SAEs) Within 30 Days After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
Hide Description An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. Exact 2-sided CI was based on the Clopper and Pearson method.
Time Frame Within 30 days after Vaccination 1
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination.
Arm/Group Title Groups 1+3+5+7 Combined MenABCWY + Saline Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM
Hide Arm/Group Description:
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
Overall Number of Participants Analyzed 1763 649
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
0.06
(0.0 to 0.3)
0.0
(0.0 to 0.6)
16.Primary Outcome
Title Percentage of Participants With SAEs Within 30 Days After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
Hide Description An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. Exact 2-sided CI was based on the Clopper and Pearson method.
Time Frame Within 30 days after Vaccination 2
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Arm/Group Title Groups 1+3+5+7 Combined MenABCWY + Saline Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM
Hide Arm/Group Description:
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
Overall Number of Participants Analyzed 1558 562
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
0.1
(0.0 to 0.5)
0.0
(0.0 to 0.7)
17.Primary Outcome
Title Percentage of Participants With SAEs Within 30 Days After Any Vaccination: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
Hide Description An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/ incapacity; congenital anomaly/birth defect and other important medical events. Exact 2-sided CI was based on the Clopper and Pearson method.
Time Frame Within 30 days after any vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination.
Arm/Group Title Groups 1+3+5+7 Combined MenABCWY + Saline Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM
Hide Arm/Group Description:
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
Overall Number of Participants Analyzed 1763 649
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
0.2
(0.0 to 0.5)
0.0
(0.0 to 0.6)
18.Primary Outcome
Title Percentage of Participants With SAEs During Vaccination Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
Hide Description An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/ incapacity; congenital anomaly/birth defect and other important medical events. Exact 2-sided CI was based on the Clopper and Pearson method.
Time Frame From day of Vaccination 1 (Day 1) up to 1 month after Vaccination 2 (approximately 7 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination.
Arm/Group Title Groups 1+3+5+7 Combined MenABCWY + Saline Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM
Hide Arm/Group Description:
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
Overall Number of Participants Analyzed 1763 649
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
0.4
(0.2 to 0.8)
0.0
(0.0 to 0.6)
19.Primary Outcome
Title Percentage of Participants With SAEs During Follow-up Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
Hide Description An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/ incapacity; congenital anomaly/birth defect and other important medical events. Exact 2-sided CI was based on the Clopper and Pearson method.
Time Frame From 1 month after Vaccination 2 up to 6 months after Vaccination 2 (approximately 5 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Arm/Group Title Groups 1+3+5+7 Combined MenABCWY + Saline Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM
Hide Arm/Group Description:
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
Overall Number of Participants Analyzed 1390 509
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
0.3
(0.1 to 0.7)
0.8
(0.2 to 2.0)
20.Primary Outcome
Title Percentage of Participants With SAEs Throughout the Study: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
Hide Description An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/ incapacity; congenital anomaly/birth defect and other important medical events. Exact 2-sided CI was based on the Clopper and Pearson method.
Time Frame From day of Vaccination 1 (Day 1) up to 6 months after Vaccination 2 (approximately 12 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination.
Arm/Group Title Groups 1+3+5+7 Combined MenABCWY + Saline Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM
Hide Arm/Group Description:
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
Overall Number of Participants Analyzed 1763 649
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
0.6
(0.3 to 1.1)
0.6
(0.2 to 1.6)
21.Primary Outcome
Title Percentage of Participants With Medically Attended Adverse Events (MAEs) Within 30 Days After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
Hide Description MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. Exact 2-sided CI was based on the Clopper and Pearson method.
Time Frame Within 30 days after Vaccination 1
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination.
Arm/Group Title Groups 1+3+5+7 Combined MenABCWY + Saline Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM
Hide Arm/Group Description:
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
Overall Number of Participants Analyzed 1763 649
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
3.6
(2.8 to 4.5)
4.3
(2.9 to 6.2)
22.Primary Outcome
Title Percentage of Participants With MAEs Within 30 Days After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
Hide Description MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. Exact 2-sided CI was based on the Clopper and Pearson method.
Time Frame Within 30 days after Vaccination 2
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Arm/Group Title Groups 1+3+5+7 Combined MenABCWY + Saline Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM
Hide Arm/Group Description:
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
Overall Number of Participants Analyzed 1558 562
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
3.6
(2.7 to 4.6)
2.8
(1.6 to 4.6)
23.Primary Outcome
Title Percentage of Participants With MAEs Within 30 Days After Any Vaccination: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
Hide Description MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. Exact 2-sided CI was based on the Clopper and Pearson method.
Time Frame Within 30 days after any vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination.
Arm/Group Title Groups 1+3+5+7 Combined MenABCWY + Saline Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM
Hide Arm/Group Description:
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
Overall Number of Participants Analyzed 1763 649
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
6.3
(5.2 to 7.5)
6.3
(4.6 to 8.5)
24.Primary Outcome
Title Percentage of Participants With MAEs During Vaccination Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
Hide Description MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. Exact 2-sided CI was based on the Clopper and Pearson method.
Time Frame From day of Vaccination 1 (Day 1) up to 1 month after Vaccination 2 (approximately 7 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination.
Arm/Group Title Groups 1+3+5+7 Combined MenABCWY + Saline Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM
Hide Arm/Group Description:
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
Overall Number of Participants Analyzed 1763 649
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
14.9
(13.3 to 16.7)
14.3
(11.7 to 17.3)
25.Primary Outcome
Title Percentage of Participants With MAEs During Follow-up Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
Hide Description MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. Exact 2-sided CI was based on the Clopper and Pearson method.
Time Frame From 1 month after Vaccination 2 up to 6 months after Vaccination 2 (approximately 5 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Arm/Group Title Groups 1+3+5+7 Combined MenABCWY + Saline Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM
Hide Arm/Group Description:
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
Overall Number of Participants Analyzed 1390 509
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
9.3
(7.8 to 10.9)
7.5
(5.3 to 10.1)
26.Primary Outcome
Title Percentage of Participants With MAEs Throughout the Study: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
Hide Description MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. Exact 2-sided CI was based on the Clopper and Pearson method.
Time Frame From day of Vaccination 1 (Day 1) up to 6 months after Vaccination 2 (approximately 12 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination.
Arm/Group Title Groups 1+3+5+7 Combined MenABCWY + Saline Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM
Hide Arm/Group Description:
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
Overall Number of Participants Analyzed 1763 649
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
19.3
(17.5 to 21.2)
18.3
(15.4 to 21.5)
27.Primary Outcome
Title Percentage of Participants With Newly Diagnosed Chronic Medical Condition (NDCMC) Within 30 Days After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
Hide Description An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or otherwise long-lasting in its effects. Exact 2-sided CI was based on the Clopper and Pearson method.
Time Frame Within 30 days after Vaccination 1
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination.
Arm/Group Title Groups 1+3+5+7 Combined MenABCWY + Saline Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM
Hide Arm/Group Description:
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
Overall Number of Participants Analyzed 1763 649
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
0.2
(0.1 to 0.6)
0.0
(0.0 to 0.6)
28.Primary Outcome
Title Percentage of Participants With NDCMC Within 30 Days After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
Hide Description An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or otherwise long-lasting in its effects. Exact 2-sided CI was based on the Clopper and Pearson method.
Time Frame Within 30 days after Vaccination 2
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Arm/Group Title Groups 1+3+5+7 Combined MenABCWY + Saline Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM
Hide Arm/Group Description:
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
Overall Number of Participants Analyzed 1558 562
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
0.06
(0.0 to 0.4)
0.0
(0.0 to 0.7)
29.Primary Outcome
Title Percentage of Participants With NDCMC Within 30 Days After Any Vaccination: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
Hide Description An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or otherwise long-lasting in its effects. Exact 2-sided CI was based on the Clopper and Pearson method.
Time Frame Within 30 Days after any vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination.
Arm/Group Title Groups 1+3+5+7 Combined MenABCWY + Saline Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM
Hide Arm/Group Description:
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
Overall Number of Participants Analyzed 1763 649
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
0.3
(0.1 to 0.7)
0.0
(0.0 to 0.6)
30.Primary Outcome
Title Percentage of Participants With NDCMC During Vaccination Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
Hide Description An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or otherwise long-lasting in its effects. Exact 2-sided CI was based on the Clopper and Pearson method.
Time Frame From day of Vaccination 1 (Day 1) up to 1 month after Vaccination 2 (approximately 7 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination.
Arm/Group Title Groups 1+3+5+7 Combined MenABCWY + Saline Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM
Hide Arm/Group Description:
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
Overall Number of Participants Analyzed 1763 649
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
1.1
(0.7 to 1.7)
0.3
(0.0 to 1.1)
31.Primary Outcome
Title Percentage of Participants With NDCMC During Follow-up Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
Hide Description An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or otherwise long-lasting in its effects. Exact 2-sided CI was based on the Clopper and Pearson method.
Time Frame From 1 month after Vaccination 2 up to 6 months after Vaccination 2 (approximately 5 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Arm/Group Title Groups 1+3+5+7 Combined MenABCWY + Saline Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM
Hide Arm/Group Description:
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
Overall Number of Participants Analyzed 1390 509
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
0.4
(0.1 to 0.8)
0.0
(0.0 to 0.7)
32.Primary Outcome
Title Percentage of Participants With NDCMC Throughout the Study: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
Hide Description An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or otherwise long-lasting in its effects. Exact 2-sided CI was based on the Clopper and Pearson method.
Time Frame From day of Vaccination 1 (Day 1) up to 6 months after Vaccination 2 (approximately 12 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination.
Arm/Group Title Groups 1+3+5+7 Combined MenABCWY + Saline Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM
Hide Arm/Group Description:
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
Overall Number of Participants Analyzed 1763 649
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
1.4
(0.9 to 2.1)
0.3
(0.0 to 1.1)
33.Primary Outcome
Title Percentage of Participants With Immediate AE Within 30 Minutes After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
Hide Description Immediate AEs were defined as AEs occurring within the first 30 minutes after investigational product administration. Exact 2-sided CI was based on the Clopper and Pearson method.
Time Frame Within 30 minutes after Vaccination 1
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination.
Arm/Group Title Groups 1+3+5+7 Combined MenABCWY + Saline Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM
Hide Arm/Group Description:
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
Overall Number of Participants Analyzed 1763 649
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
0 [1] 
(NA to NA)
0 [1] 
(NA to NA)
[1]
Lower and upper limit of 95% CI could not be estimated, due to insufficient participants with event.
34.Primary Outcome
Title Percentage of Participants With Immediate AE Within 30 Minutes After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
Hide Description Immediate AEs were defined as AEs occurring within the first 30 minutes after investigational product administration. Exact 2-sided CI was based on the Clopper and Pearson method.
Time Frame Within 30 minutes after Vaccination 2
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Arm/Group Title Groups 1+3+5+7 Combined MenABCWY + Saline Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM
Hide Arm/Group Description:
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
Overall Number of Participants Analyzed 1558 562
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
0 [1] 
(NA to NA)
0 [1] 
(NA to NA)
[1]
Lower and upper limit of 95% CI could not be estimated, due to insufficient participants with event.
35.Primary Outcome
Title Percentage of Participants Who Missed Days of School or Work Due to AEs During Vaccination Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
Hide Description An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. Percentage of participants who missed days of school or work due to AEs during vaccination phase were reported in this outcome measure.
Time Frame From day of Vaccination 1 (Day 1) up to 1 month after Vaccination 2 (approximately 7 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination.
Arm/Group Title Groups 1+3+5+7 Combined MenABCWY + Saline Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM
Hide Arm/Group Description:
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
Overall Number of Participants Analyzed 1763 649
Measure Type: Number
Unit of Measure: Percentage of participants
5.0 4.5
36.Secondary Outcome
Title Percentage of Participants Achieving At Least 4-Fold Rise in hSBA Titer From Baseline for Each MenACWY Test Strains: 1 Month After Vaccination 1 in Group 1 Compared to Group 2
Hide Description 4-fold increase was defined as: 1) for participants with baseline hSBA titer below LOD (or hSBA titer <1:4), 4-fold rise was defined as hSBA titer >=1:16; 2) baseline hSBA titer >=LOD (i.e., hSBA titer of >=1:4) and < LLOQ (i.e. hSBA titer of 1:8), 4-fold rise was defined as hSBA titer >=4times LLOQ; 3) baseline hSBA titer >=LLOQ, 4-fold rise was defined as hSBA titer >=4 times baseline titer. Exact 2-sided CI using Clopper and Pearson method was presented.
Time Frame Baseline (pre-vaccination on Day 1), 1 month after Vaccination 1
Hide Outcome Measure Data
Hide Analysis Population Description
PV1 EIP: participants randomized to study group of interest; eligible at V2; received vaccine at V1; blood drawn for assay testing at specified time points; at least 1 valid, determinate MenACWY assay result at V2; no prohibited vaccines; no protocol deviations through V2. Here "Overall Number of Participants Analyzed" = participants evaluable for outcome measure and "Number Analyzed" = number of participants evaluable for specified rows.
Arm/Group Title ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set)
Hide Arm/Group Description:
On Day 1 (Visit 1), ACWY naive participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to both safety and immunogenicity analyses. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
On Day 1 (Visit 1), ACWY naive participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to both safety and immunogenicity analyses. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
Overall Number of Participants Analyzed 501 254
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
MenA Number Analyzed 499 participants 254 participants
97.0
(95.1 to 98.3)
95.3
(91.9 to 97.5)
MenC Number Analyzed 501 participants 252 participants
62.9
(58.5 to 67.1)
52.4
(46.0 to 58.7)
MenW Number Analyzed 492 participants 244 participants
79.3
(75.4 to 82.8)
73.0
(66.9 to 78.4)
MenY Number Analyzed 494 participants 248 participants
82.0
(78.3 to 85.3)
70.6
(64.5 to 76.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set), ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set)
Comments MenA
Type of Statistical Test Non-Inferiority
Comments 95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was > -10%, the non-inferiority was concluded.
Method of Estimation Estimation Parameter Difference in percentage of participants
Estimated Value 1.7
Confidence Interval (2-Sided) 95%
-1.0 to 5.3
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set), ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set)
Comments MenC
Type of Statistical Test Non-Inferiority
Comments 95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was > -10%, the non-inferiority was concluded.
Method of Estimation Estimation Parameter Difference in percentage of participants
Estimated Value 10.5
Confidence Interval (2-Sided) 95%
3.0 to 17.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set), ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set)
Comments MenW
Type of Statistical Test Non-Inferiority
Comments 95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was > -10%, the non-inferiority was concluded.
Method of Estimation Estimation Parameter Difference in percentage of participants
Estimated Value 6.3
Confidence Interval (2-Sided) 95%
-0.1 to 13.1
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set), ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set)
Comments MenY
Type of Statistical Test Non-Inferiority
Comments 95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was > -10%, the non-inferiority was concluded.
Method of Estimation Estimation Parameter Difference in percentage of participants
Estimated Value 11.4
Confidence Interval (2-Sided) 95%
5.0 to 18.2
Estimation Comments [Not Specified]
37.Secondary Outcome
Title Percentage of Participants Achieving At Least 4-Fold Rise in hSBA Titer From Baseline for Each MenACWY Test Strains: 1 Month After Vaccination 1 in Group 3 Compared to Group 4
Hide Description 4-fold increase was defined as: 1) for participants with baseline hSBA titer below LOD (or hSBA titer <1:4), 4-fold rise was defined as hSBA titer >=1:16; 2) baseline hSBA titer >=LOD (i.e., hSBA titer of >=1:4) and < LLOQ (i.e. hSBA titer of 1:8), 4-fold rise was defined as hSBA titer >=4 times LLOQ; 3) baseline hSBA titer > =LLOQ, 4-fold rise was defined as hSBA titer >=4 times baseline titer. Exact 2-sided CI using Clopper and Pearson method was presented.
Time Frame Baseline (pre-vaccination on Day 1), 1 month after Vaccination 1
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Hide Analysis Population Description
PV1 EIP: participants randomised to study group of interest; eligible at V 2; received vaccine at V1; blood drawn for assay testing at specified time points; at least 1 valid, determinate MenACWY assay result at V2; no prohibited vaccines and no protocol deviations through V2. Here "Overall Number of Participants Analyzed" = participants evaluable for outcome measure and "Number Analyzed" = number of participants evaluable for specified rows.
Arm/Group Title ACWY-Experienced: Group 3 MenABCWY + Saline (Immunogenicity and Safety Set) ACWY-Experienced: Group 4 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set)
Hide Arm/Group Description:
On Day 1 (Visit 1), ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to both safety and immunogenicity analyses. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
On Day 1 (Visit 1), ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to both safety and immunogenicity analyses. . Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
Overall Number of Participants Analyzed 442 227
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
MenA Number Analyzed 439 participants 227 participants
94.8
(92.2 to 96.7)
96.9
(93.7 to 98.8)
MenC Number Analyzed 439 participants 226 participants
93.4
(90.7 to 95.5)
94.7
(90.9 to 97.2)
MenW Number Analyzed 428 participants 222 participants
97.4
(95.4 to 98.7)
96.4
(93.0 to 98.4)
MenY Number Analyzed 442 participants 223 participants
94.3
(91.8 to 96.3)
93.7
(89.7 to 96.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ACWY-Experienced: Group 3 MenABCWY + Saline (Immunogenicity and Safety Set), ACWY-Experienced: Group 4 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set)
Comments MenA
Type of Statistical Test Non-Inferiority
Comments 95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was > -10%, the non-inferiority was concluded.
Method of Estimation Estimation Parameter Difference in percentage of participants
Estimated Value -2.2
Confidence Interval (2-Sided) 95%
-5.2 to 1.4
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection ACWY-Experienced: Group 3 MenABCWY + Saline (Immunogenicity and Safety Set), ACWY-Experienced: Group 4 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set)
Comments MenC
Type of Statistical Test Non-Inferiority
Comments 95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was > -10%, the non-inferiority was concluded.
Method of Estimation Estimation Parameter Difference in percentage of participants
Estimated Value -1.3
Confidence Interval (2-Sided) 95%
-4.9 to 2.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection ACWY-Experienced: Group 3 MenABCWY + Saline (Immunogenicity and Safety Set), ACWY-Experienced: Group 4 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set)
Comments MenW
Type of Statistical Test Non-Inferiority
Comments 95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was > -10%, the non-inferiority was concluded.
Method of Estimation Estimation Parameter Difference in percentage of participants
Estimated Value 1.0
Confidence Interval (2-Sided) 95%
-1.6 to 4.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection ACWY-Experienced: Group 3 MenABCWY + Saline (Immunogenicity and Safety Set), ACWY-Experienced: Group 4 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set)
Comments MenY
Type of Statistical Test Non-Inferiority
Comments 95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was > -10%, the non-inferiority was concluded.
Method of Estimation Estimation Parameter Difference in percentage of participants
Estimated Value 0.6
Confidence Interval (2-Sided) 95%
-3.0 to 5.0
Estimation Comments [Not Specified]
Time Frame Local reactions and systemic events recorded using systematic assessment within 7 days after Vaccination 1 and 2; SAEs and all-cause mortality recorded using non-systematic assessment from Day 1 up to 6 months after vaccination 2 (approximately 12 months) and other AEs recorded using non-systematic assessment from Day 1 up to 1 month after vaccination 2 (approximately 7 months)
Adverse Event Reporting Description Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination.
 
Arm/Group Title ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) ACWY-Experienced: Group 3 MenABCWY + Saline (Immunogenicity and Safety Set) ACWY-Experienced: Group 4 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) ACWY-Naive: Group 5 MenABCWY + Saline (Safety Set) ACWY-Naive: Group 6 Trumenba+ MenACWY - CRM (Safety Set) ACWY-Experienced: Group 7 MenABCWY + Saline (Safety Set) ACWY-Experienced: Group 8 Trumenba+ MenACWY - CRM (Safety Set)
Hide Arm/Group Description On Day 1 (Visit 1), ACWY naive participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to both safety and immunogenicity analyses. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2. On Day 1 (Visit 1), ACWY naive participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to both safety and immunogenicity analyses. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2. On Day 1 (Visit 1), ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to both safety and immunogenicity analyses. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2. On Day 1 (Visit 1), ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to both safety and immunogenicity analyses. . Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2. On Day 1 (Visit 1), ACWY naive participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to safety analyses only. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2. On Day 1 (Visit 1), ACWY naive participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to safety analyses only. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2. On Day 1 (Visit 1), ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to safety analyses only. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2. On Day 1 (Visit 1), ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to safety analyses only. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
All-Cause Mortality
ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) ACWY-Experienced: Group 3 MenABCWY + Saline (Immunogenicity and Safety Set) ACWY-Experienced: Group 4 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) ACWY-Naive: Group 5 MenABCWY + Saline (Safety Set) ACWY-Naive: Group 6 Trumenba+ MenACWY - CRM (Safety Set) ACWY-Experienced: Group 7 MenABCWY + Saline (Safety Set) ACWY-Experienced: Group 8 Trumenba+ MenACWY - CRM (Safety Set)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/547 (0.00%)   0/274 (0.00%)   0/526 (0.00%)   0/260 (0.00%)   0/537 (0.00%)   0/56 (0.00%)   0/153 (0.00%)   0/59 (0.00%) 
Hide Serious Adverse Events
ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) ACWY-Experienced: Group 3 MenABCWY + Saline (Immunogenicity and Safety Set) ACWY-Experienced: Group 4 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) ACWY-Naive: Group 5 MenABCWY + Saline (Safety Set) ACWY-Naive: Group 6 Trumenba+ MenACWY - CRM (Safety Set) ACWY-Experienced: Group 7 MenABCWY + Saline (Safety Set) ACWY-Experienced: Group 8 Trumenba+ MenACWY - CRM (Safety Set)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   6/547 (1.10%)   1/274 (0.36%)   3/526 (0.57%)   2/260 (0.77%)   2/537 (0.37%)   1/56 (1.79%)   0/153 (0.00%)   0/59 (0.00%) 
Cardiac disorders                 
Postural orthostatic tachycardia syndrome * 1  1/547 (0.18%)  0/274 (0.00%)  0/526 (0.00%)  0/260 (0.00%)  0/537 (0.00%)  0/56 (0.00%)  0/153 (0.00%)  0/59 (0.00%) 
Infections and infestations                 
Appendicitis * 1  0/547 (0.00%)  1/274 (0.36%)  0/526 (0.00%)  0/260 (0.00%)  0/537 (0.00%)  0/56 (0.00%)  0/153 (0.00%)  0/59 (0.00%) 
Escherichia urinary tract infection * 1  0/547 (0.00%)  0/274 (0.00%)  0/526 (0.00%)  1/260 (0.38%)  0/537 (0.00%)  0/56 (0.00%)  0/153 (0.00%)  0/59 (0.00%) 
Gastroenteritis salmonella * 1  0/547 (0.00%)  0/274 (0.00%)  1/526 (0.19%)  0/260 (0.00%)  0/537 (0.00%)  0/56 (0.00%)  0/153 (0.00%)  0/59 (0.00%) 
Injury, poisoning and procedural complications                 
Head injury * 1  1/547 (0.18%)  0/274 (0.00%)  0/526 (0.00%)  0/260 (0.00%)  0/537 (0.00%)  0/56 (0.00%)  0/153 (0.00%)  0/59 (0.00%) 
Overdose * 1  0/547 (0.00%)  0/274 (0.00%)  0/526 (0.00%)  0/260 (0.00%)  0/537 (0.00%)  1/56 (1.79%)  0/153 (0.00%)  0/59 (0.00%) 
Post procedural haemorrhage * 1  0/547 (0.00%)  0/274 (0.00%)  1/526 (0.19%)  0/260 (0.00%)  0/537 (0.00%)  0/56 (0.00%)  0/153 (0.00%)  0/59 (0.00%) 
Spinal cord injury * 1  0/547 (0.00%)  0/274 (0.00%)  0/526 (0.00%)  0/260 (0.00%)  1/537 (0.19%)  0/56 (0.00%)  0/153 (0.00%)  0/59 (0.00%) 
Tibia fracture * 1  0/547 (0.00%)  0/274 (0.00%)  0/526 (0.00%)  0/260 (0.00%)  1/537 (0.19%)  0/56 (0.00%)  0/153 (0.00%)  0/59 (0.00%) 
Metabolism and nutrition disorders                 
Food intolerance * 1  0/547 (0.00%)  0/274 (0.00%)  1/526 (0.19%)  0/260 (0.00%)  0/537 (0.00%)  0/56 (0.00%)  0/153 (0.00%)  0/59 (0.00%) 
Nervous system disorders                 
Status migrainosus * 1  0/547 (0.00%)  0/274 (0.00%)  0/526 (0.00%)  1/260 (0.38%)  0/537 (0.00%)  0/56 (0.00%)  0/153 (0.00%)  0/59 (0.00%) 
Psychiatric disorders                 
Anxiety * 1  1/547 (0.18%)  0/274 (0.00%)  0/526 (0.00%)  0/260 (0.00%)  0/537 (0.00%)  0/56 (0.00%)  0/153 (0.00%)  0/59 (0.00%) 
Depression * 1  2/547 (0.37%)  0/274 (0.00%)  0/526 (0.00%)  0/260 (0.00%)  0/537 (0.00%)  0/56 (0.00%)  0/153 (0.00%)  0/59 (0.00%) 
Depression suicidal * 1  0/547 (0.00%)  0/274 (0.00%)  1/526 (0.19%)  0/260 (0.00%)  0/537 (0.00%)  0/56 (0.00%)  0/153 (0.00%)  0/59 (0.00%) 
Disruptive mood dysregulation disorder * 1  1/547 (0.18%)  0/274 (0.00%)  0/526 (0.00%)  0/260 (0.00%)  0/537 (0.00%)  0/56 (0.00%)  0/153 (0.00%)  0/59 (0.00%) 
Suicide attempt * 1  1/547 (0.18%)  0/274 (0.00%)  0/526 (0.00%)  0/260 (0.00%)  0/537 (0.00%)  0/56 (0.00%)  0/153 (0.00%)  0/59 (0.00%) 
Respiratory, thoracic and mediastinal disorders                 
Dyspnoea * 1  1/547 (0.18%)  0/274 (0.00%)  0/526 (0.00%)  0/260 (0.00%)  0/537 (0.00%)  0/56 (0.00%)  0/153 (0.00%)  0/59 (0.00%) 
1
Term from vocabulary, MedDRA 25.0
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) ACWY-Experienced: Group 3 MenABCWY + Saline (Immunogenicity and Safety Set) ACWY-Experienced: Group 4 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) ACWY-Naive: Group 5 MenABCWY + Saline (Safety Set) ACWY-Naive: Group 6 Trumenba+ MenACWY - CRM (Safety Set) ACWY-Experienced: Group 7 MenABCWY + Saline (Safety Set) ACWY-Experienced: Group 8 Trumenba+ MenACWY - CRM (Safety Set)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   533/547 (97.44%)   262/274 (95.62%)   504/526 (95.82%)   244/260 (93.85%)   512/537 (95.34%)   53/56 (94.64%)   148/153 (96.73%)   58/59 (98.31%) 
Ear and labyrinth disorders                 
Cerumen impaction * 1  2/547 (0.37%)  1/274 (0.36%)  4/526 (0.76%)  2/260 (0.77%)  2/537 (0.37%)  0/56 (0.00%)  1/153 (0.65%)  2/59 (3.39%) 
Ear pain * 1  0/547 (0.00%)  0/274 (0.00%)  3/526 (0.57%)  0/260 (0.00%)  0/537 (0.00%)  1/56 (1.79%)  0/153 (0.00%)  0/59 (0.00%) 
Eye disorders                 
Conjunctivitis allergic * 1  0/547 (0.00%)  0/274 (0.00%)  2/526 (0.38%)  0/260 (0.00%)  0/537 (0.00%)  0/56 (0.00%)  2/153 (1.31%)  0/59 (0.00%) 
Gastrointestinal disorders                 
Abdominal pain * 1  2/547 (0.37%)  0/274 (0.00%)  5/526 (0.95%)  1/260 (0.38%)  2/537 (0.37%)  1/56 (1.79%)  0/153 (0.00%)  1/59 (1.69%) 
Abdominal pain lower * 1  0/547 (0.00%)  0/274 (0.00%)  2/526 (0.38%)  0/260 (0.00%)  1/537 (0.19%)  0/56 (0.00%)  2/153 (1.31%)  0/59 (0.00%) 
Constipation * 1  2/547 (0.37%)  0/274 (0.00%)  1/526 (0.19%)  0/260 (0.00%)  6/537 (1.12%)  0/56 (0.00%)  3/153 (1.96%)  0/59 (0.00%) 
Diarrhoea (DIARRHEA) † 1  69/547 (12.61%)  50/274 (18.25%)  116/526 (22.05%)  54/260 (20.77%)  72/537 (13.41%)  8/56 (14.29%)  23/153 (15.03%)  8/59 (13.56%) 
Gastrooesophageal reflux disease * 1  0/547 (0.00%)  0/274 (0.00%)  1/526 (0.19%)  0/260 (0.00%)  1/537 (0.19%)  0/56 (0.00%)  2/153 (1.31%)  0/59 (0.00%) 
Nausea * 1  3/547 (0.55%)  0/274 (0.00%)  2/526 (0.38%)  0/260 (0.00%)  0/537 (0.00%)  0/56 (0.00%)  3/153 (1.96%)  0/59 (0.00%) 
Vomiting (VOMITING) † 1  23/547 (4.20%)  13/274 (4.74%)  22/526 (4.18%)  4/260 (1.54%)  21/537 (3.91%)  3/56 (5.36%)  5/153 (3.27%)  3/59 (5.08%) 
General disorders                 
Chills (CHILLS) † 1  155/547 (28.34%)  78/274 (28.47%)  151/526 (28.71%)  59/260 (22.69%)  130/537 (24.21%)  14/56 (25.00%)  43/153 (28.10%)  19/59 (32.20%) 
Fatigue * 1  0/547 (0.00%)  0/274 (0.00%)  1/526 (0.19%)  0/260 (0.00%)  2/537 (0.37%)  0/56 (0.00%)  0/153 (0.00%)  1/59 (1.69%) 
Fatigue (FATIGUE) † 1  364/547 (66.54%)  183/274 (66.79%)  337/526 (64.07%)  160/260 (61.54%)  317/537 (59.03%)  30/56 (53.57%)  99/153 (64.71%)  43/59 (72.88%) 
Injection site pain (PAIN AT INJECTION SITE) † 1  522/547 (95.43%)  247/274 (90.15%)  486/526 (92.40%)  228/260 (87.69%)  493/537 (91.81%)  51/56 (91.07%)  144/153 (94.12%)  57/59 (96.61%) 
Pyrexia * 1  2/547 (0.37%)  0/274 (0.00%)  2/526 (0.38%)  0/260 (0.00%)  4/537 (0.74%)  0/56 (0.00%)  1/153 (0.65%)  1/59 (1.69%) 
Pyrexia (FEVER) † 1  44/547 (8.04%)  24/274 (8.76%)  29/526 (5.51%)  13/260 (5.00%)  42/537 (7.82%)  3/56 (5.36%)  8/153 (5.23%)  3/59 (5.08%) 
Swelling (SWELLING) † 1  186/547 (34.00%)  71/274 (25.91%)  158/526 (30.04%)  57/260 (21.92%)  200/537 (37.24%)  16/56 (28.57%)  49/153 (32.03%)  19/59 (32.20%) 
Infections and infestations                 
Acute sinusitis * 1  0/547 (0.00%)  0/274 (0.00%)  1/526 (0.19%)  2/260 (0.77%)  1/537 (0.19%)  1/56 (1.79%)  1/153 (0.65%)  0/59 (0.00%) 
COVID-19 * 1  22/547 (4.02%)  12/274 (4.38%)  24/526 (4.56%)  12/260 (4.62%)  36/537 (6.70%)  3/56 (5.36%)  10/153 (6.54%)  0/59 (0.00%) 
Conjunctivitis * 1  0/547 (0.00%)  0/274 (0.00%)  0/526 (0.00%)  0/260 (0.00%)  1/537 (0.19%)  1/56 (1.79%)  1/153 (0.65%)  0/59 (0.00%) 
Cytomegalovirus infection * 1  0/547 (0.00%)  0/274 (0.00%)  0/526 (0.00%)  0/260 (0.00%)  0/537 (0.00%)  1/56 (1.79%)  0/153 (0.00%)  0/59 (0.00%) 
Gastroenteritis * 1  2/547 (0.37%)  1/274 (0.36%)  1/526 (0.19%)  0/260 (0.00%)  2/537 (0.37%)  0/56 (0.00%)  2/153 (1.31%)  0/59 (0.00%) 
Impetigo * 1  0/547 (0.00%)  0/274 (0.00%)  1/526 (0.19%)  0/260 (0.00%)  0/537 (0.00%)  1/56 (1.79%)  0/153 (0.00%)  0/59 (0.00%) 
Influenza * 1  1/547 (0.18%)  0/274 (0.00%)  0/526 (0.00%)  0/260 (0.00%)  0/537 (0.00%)  0/56 (0.00%)  3/153 (1.96%)  0/59 (0.00%) 
Lice infestation * 1  0/547 (0.00%)  1/274 (0.36%)  0/526 (0.00%)  0/260 (0.00%)  1/537 (0.19%)  1/56 (1.79%)  0/153 (0.00%)  0/59 (0.00%) 
Nasopharyngitis * 1  3/547 (0.55%)  6/274 (2.19%)  1/526 (0.19%)  1/260 (0.38%)  0/537 (0.00%)  0/56 (0.00%)  0/153 (0.00%)  0/59 (0.00%) 
Otitis externa * 1  1/547 (0.18%)  2/274 (0.73%)  0/526 (0.00%)  1/260 (0.38%)  1/537 (0.19%)  0/56 (0.00%)  0/153 (0.00%)  1/59 (1.69%) 
Otitis media * 1  0/547 (0.00%)  2/274 (0.73%)  4/526 (0.76%)  1/260 (0.38%)  3/537 (0.56%)  0/56 (0.00%)  1/153 (0.65%)  1/59 (1.69%) 
Pharyngitis * 1  5/547 (0.91%)  4/274 (1.46%)  10/526 (1.90%)  2/260 (0.77%)  10/537 (1.86%)  2/56 (3.57%)  7/153 (4.58%)  1/59 (1.69%) 
Pharyngitis streptococcal * 1  0/547 (0.00%)  0/274 (0.00%)  0/526 (0.00%)  2/260 (0.77%)  3/537 (0.56%)  1/56 (1.79%)  2/153 (1.31%)  1/59 (1.69%) 
Respiratory tract infection viral * 1  3/547 (0.55%)  0/274 (0.00%)  1/526 (0.19%)  1/260 (0.38%)  1/537 (0.19%)  1/56 (1.79%)  2/153 (1.31%)  0/59 (0.00%) 
Sinusitis * 1  0/547 (0.00%)  2/274 (0.73%)  3/526 (0.57%)  0/260 (0.00%)  0/537 (0.00%)  0/56 (0.00%)  2/153 (1.31%)  0/59 (0.00%) 
Tonsillitis * 1  5/547 (0.91%)  4/274 (1.46%)  4/526 (0.76%)  0/260 (0.00%)  6/537 (1.12%)  0/56 (0.00%)  1/153 (0.65%)  0/59 (0.00%) 
Upper respiratory tract infection * 1  10/547 (1.83%)  7/274 (2.55%)  17/526 (3.23%)  7/260 (2.69%)  11/537 (2.05%)  4/56 (7.14%)  7/153 (4.58%)  1/59 (1.69%) 
Viral infection * 1  1/547 (0.18%)  2/274 (0.73%)  0/526 (0.00%)  3/260 (1.15%)  3/537 (0.56%)  0/56 (0.00%)  0/153 (0.00%)  0/59 (0.00%) 
Viral upper respiratory tract infection * 1  3/547 (0.55%)  2/274 (0.73%)  1/526 (0.19%)  0/260 (0.00%)  3/537 (0.56%)  0/56 (0.00%)  2/153 (1.31%)  0/59 (0.00%) 
Injury, poisoning and procedural complications                 
Contusion * 1  2/547 (0.37%)  1/274 (0.36%)  6/526 (1.14%)  0/260 (0.00%)  3/537 (0.56%)  1/56 (1.79%)  1/153 (0.65%)  0/59 (0.00%) 
Fall * 1  6/547 (1.10%)  2/274 (0.73%)  5/526 (0.95%)  4/260 (1.54%)  6/537 (1.12%)  1/56 (1.79%)  1/153 (0.65%)  0/59 (0.00%) 
Head injury * 1  0/547 (0.00%)  0/274 (0.00%)  0/526 (0.00%)  0/260 (0.00%)  1/537 (0.19%)  0/56 (0.00%)  2/153 (1.31%)  1/59 (1.69%) 
Joint injury * 1  1/547 (0.18%)  0/274 (0.00%)  1/526 (0.19%)  1/260 (0.38%)  1/537 (0.19%)  0/56 (0.00%)  0/153 (0.00%)  1/59 (1.69%) 
Ligament sprain * 1  2/547 (0.37%)  2/274 (0.73%)  0/526 (0.00%)  0/260 (0.00%)  1/537 (0.19%)  1/56 (1.79%)  1/153 (0.65%)  0/59 (0.00%) 
Radius fracture * 1  1/547 (0.18%)  1/274 (0.36%)  0/526 (0.00%)  0/260 (0.00%)  0/537 (0.00%)  1/56 (1.79%)  0/153 (0.00%)  0/59 (0.00%) 
Skin laceration * 1  6/547 (1.10%)  0/274 (0.00%)  1/526 (0.19%)  1/260 (0.38%)  1/537 (0.19%)  0/56 (0.00%)  0/153 (0.00%)  0/59 (0.00%) 
Investigations                 
SARS-CoV-2 test positive * 1  4/547 (0.73%)  2/274 (0.73%)  8/526 (1.52%)  3/260 (1.15%)  4/537 (0.74%)  0/56 (0.00%)  1/153 (0.65%)  1/59 (1.69%) 
Musculoskeletal and connective tissue disorders                 
Arthralgia * 1  1/547 (0.18%)  2/274 (0.73%)  4/526 (0.76%)  1/260 (0.38%)  1/537 (0.19%)  0/56 (0.00%)  2/153 (1.31%)  2/59 (3.39%) 
Arthralgia (JOINT PAIN) † 1  156/547 (28.52%)  75/274 (27.37%)  156/526 (29.66%)  83/260 (31.92%)  144/537 (26.82%)  12/56 (21.43%)  48/153 (31.37%)  19/59 (32.20%) 
Costochondritis * 1  1/547 (0.18%)  0/274 (0.00%)  0/526 (0.00%)  0/260 (0.00%)  1/537 (0.19%)  0/56 (0.00%)  2/153 (1.31%)  0/59 (0.00%) 
Myalgia * 1  0/547 (0.00%)  0/274 (0.00%)  0/526 (0.00%)  0/260 (0.00%)  0/537 (0.00%)  0/56 (0.00%)  0/153 (0.00%)  1/59 (1.69%) 
Myalgia (MUSCLE PAIN) † 1  198/547 (36.20%)  97/274 (35.40%)  207/526 (39.35%)  97/260 (37.31%)  167/537 (31.10%)  18/56 (32.14%)  57/153 (37.25%)  22/59 (37.29%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                 
Skin papilloma * 1  1/547 (0.18%)  1/274 (0.36%)  1/526 (0.19%)  1/260 (0.38%)  2/537 (0.37%)  0/56 (0.00%)  2/153 (1.31%)  1/59 (1.69%) 
Nervous system disorders                 
Headache * 1  1/547 (0.18%)  0/274 (0.00%)  1/526 (0.19%)  3/260 (1.15%)  3/537 (0.56%)  0/56 (0.00%)  2/153 (1.31%)  1/59 (1.69%) 
Headache (HEADACHE) † 1  330/547 (60.33%)  152/274 (55.47%)  312/526 (59.32%)  161/260 (61.92%)  282/537 (52.51%)  24/56 (42.86%)  86/153 (56.21%)  37/59 (62.71%) 
Migraine * 1  1/547 (0.18%)  0/274 (0.00%)  1/526 (0.19%)  0/260 (0.00%)  0/537 (0.00%)  0/56 (0.00%)  3/153 (1.96%)  0/59 (0.00%) 
Psychiatric disorders                 
Anxiety * 1  3/547 (0.55%)  1/274 (0.36%)  1/526 (0.19%)  2/260 (0.77%)  1/537 (0.19%)  1/56 (1.79%)  1/153 (0.65%)  0/59 (0.00%) 
Major depression * 1  0/547 (0.00%)  0/274 (0.00%)  1/526 (0.19%)  1/260 (0.38%)  0/537 (0.00%)  0/56 (0.00%)  0/153 (0.00%)  1/59 (1.69%) 
Reproductive system and breast disorders                 
Amenorrhoea * 1  0/547 (0.00%)  0/274 (0.00%)  1/526 (0.19%)  0/260 (0.00%)  0/537 (0.00%)  0/56 (0.00%)  2/153 (1.31%)  0/59 (0.00%) 
Dysmenorrhoea * 1  0/547 (0.00%)  1/274 (0.36%)  1/526 (0.19%)  1/260 (0.38%)  1/537 (0.19%)  0/56 (0.00%)  2/153 (1.31%)  0/59 (0.00%) 
Heavy menstrual bleeding * 1  0/547 (0.00%)  0/274 (0.00%)  0/526 (0.00%)  1/260 (0.38%)  0/537 (0.00%)  1/56 (1.79%)  0/153 (0.00%)  0/59 (0.00%) 
Respiratory, thoracic and mediastinal disorders                 
Asthma * 1  1/547 (0.18%)  0/274 (0.00%)  6/526 (1.14%)  0/260 (0.00%)  2/537 (0.37%)  0/56 (0.00%)  2/153 (1.31%)  0/59 (0.00%) 
Painful respiration * 1  0/547 (0.00%)  0/274 (0.00%)  2/526 (0.38%)  1/260 (0.38%)  1/537 (0.19%)  0/56 (0.00%)  0/153 (0.00%)  1/59 (1.69%) 
Rhinitis allergic * 1  3/547 (0.55%)  2/274 (0.73%)  3/526 (0.57%)  2/260 (0.77%)  3/537 (0.56%)  0/56 (0.00%)  4/153 (2.61%)  0/59 (0.00%) 
Skin and subcutaneous tissue disorders                 
Acne * 1  0/547 (0.00%)  1/274 (0.36%)  5/526 (0.95%)  3/260 (1.15%)  8/537 (1.49%)  0/56 (0.00%)  1/153 (0.65%)  0/59 (0.00%) 
Alopecia areata * 1  0/547 (0.00%)  1/274 (0.36%)  0/526 (0.00%)  0/260 (0.00%)  0/537 (0.00%)  1/56 (1.79%)  0/153 (0.00%)  0/59 (0.00%) 
Dermatitis atopic * 1  1/547 (0.18%)  1/274 (0.36%)  0/526 (0.00%)  0/260 (0.00%)  2/537 (0.37%)  1/56 (1.79%)  0/153 (0.00%)  0/59 (0.00%) 
Erythema (REDNESS) † 1  183/547 (33.46%)  75/274 (27.37%)  162/526 (30.80%)  58/260 (22.31%)  190/537 (35.38%)  15/56 (26.79%)  39/153 (25.49%)  16/59 (27.12%) 
Keratosis pilaris * 1  0/547 (0.00%)  0/274 (0.00%)  0/526 (0.00%)  0/260 (0.00%)  0/537 (0.00%)  1/56 (1.79%)  0/153 (0.00%)  0/59 (0.00%) 
1
Term from vocabulary, MedDRA 25.0
*
Indicates events were collected by non-systematic assessment
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT04440163    
Other Study ID Numbers: C3511001
2019-004313-13 ( EudraCT Number )
First Submitted: June 15, 2020
First Posted: June 19, 2020
Results First Submitted: March 22, 2023
Results First Posted: April 18, 2023
Last Update Posted: April 18, 2023