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Effectiveness of GlaxoSmithKline Biologicals S.A's Meningococcal Group B and Combined ABCWY Vaccines in Healthy Adolescents and Young Adults

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: NCT04502693
Recruitment Status : Completed
First Posted : August 6, 2020
Results First Posted : March 5, 2024
Last Update Posted : March 5, 2024
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Infections, Meningococcal
Interventions Combination Product: rMenB+OMV NZ vaccine
Biological: Meningococcal Groups A, C, W and Y Conjugate Vaccine (MenACWY)
Combination Product: Placebo
Combination Product: MenABCWY-1
Combination Product: MenABCWY-2
Combination Product: MenABCWY-3
Enrollment 3657
Recruitment Details

As pre-specified in protocol:

  • Participant flow, Baseline characteristics, Effectiveness and immunogenicity data are presented for MenB_0_2_6 group, MenB_0_6 group, ACWY group, ABCWY pooled group.
  • Lot-to-lot consistency analysis data are presented for individual ABCWY lot groups (ABCWY-1, ABCWY-2 and ABCWY-3) as Lot-to-Lot assessment was limited to the objective on lot-to-lot consistency only.
Pre-assignment Details Out of 3657 participants enrolled,19 participants did not receive vaccination as they did not meet the eligibility criteria, therefore only 3638 participants were included in the Exposed Set and started the study.
Arm/Group Title MenB_0_2_6 Group MenB_0_6 Group ABCWY_Pooled ACWY Group
Hide Arm/Group Description Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care. Participants received 2 doses of rMenB+OMV NZ vaccine on Day 1, and Day 181, 1 dose of MenACWY vaccine on Day 61. Participants received 1 dose of Placebo on Day 211 to maintain blinding.

Participants received 2 doses of either MenABCWY Lot 1, Lot 2, or Lot 3 vaccine on Day 1 and Day 181 and 1 dose of placebo on Day 61. Participants received 1 dose of placebo on Day 211 to maintain blinding.

To evaluate the effectiveness of 2 doses of the MenABCWY vaccines against rMenB+OMV and MenACWY vaccines, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.

Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.
Period Title: Overall Study
Started 897 906 1657 178
ABCWY-1 Group 0 0 549 0
ABCWY-2 Group 0 0 554 0
ABCWY-3 Group 0 0 554 0
Completed 797 811 1497 163
Not Completed 100 95 160 15
Reason Not Completed
Adverse Event             7             6             11             1
Lost to Follow-up             32             36             69             4
Protocol Violation             8             8             16             1
Withdrawal by Subject             46             38             54             7
MIGRATED / MOVED FROM THE STUDY AREA             6             7             9             1
Other             1             0             1             1
Arm/Group Title MenB_0_2_6 Group MenB_0_6 Group ABCWY_Pooled ACWY Group Total
Hide Arm/Group Description Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care. Participants received 2 doses of rMenB+OMV NZ vaccine on Day 1, and Day 181, 1 dose of MenACWY vaccine on Day 61. Participants received 1 dose of Placebo on Day 211 to maintain blinding.

Participants received 2 doses of either MenABCWY Lot 1, Lot 2, or Lot 3 vaccine on Day 1 and Day 181 and 1 dose of placebo on Day 61. Participants received 1 dose of placebo on Day 211 to maintain blinding.

To evaluate the effectiveness of 2 doses of the MenABCWY vaccines against rMenB+OMV and MenACWY vaccines, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.

Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care. Total of all reporting groups
Overall Number of Baseline Participants 897 906 1657 178 3638
Hide Baseline Analysis Population Description
As pre-specified in the protocol, data reported in the Baseline characteristics are presented for MenB_0_2_6 group, MenB_0_6 group, ACWY group, ABCWY pooled group.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 897 participants 906 participants 1657 participants 178 participants 3638 participants
16.5  (4.7) 16.5  (4.7) 16.5  (4.7) 16.9  (4.6) 16.5  (4.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 897 participants 906 participants 1657 participants 178 participants 3638 participants
Female
464
  51.7%
446
  49.2%
933
  56.3%
100
  56.2%
1943
  53.4%
Male
433
  48.3%
460
  50.8%
724
  43.7%
78
  43.8%
1695
  46.6%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 897 participants 906 participants 1657 participants 178 participants 3638 participants
American Indian or Alaska Native
5
   0.6%
5
   0.6%
3
   0.2%
0
   0.0%
13
   0.4%
Asian
43
   4.8%
60
   6.6%
71
   4.3%
9
   5.1%
183
   5.0%
Black or African American
33
   3.7%
29
   3.2%
59
   3.6%
6
   3.4%
127
   3.5%
Native Hawaiian or Other Pacific Islander
3
   0.3%
1
   0.1%
3
   0.2%
0
   0.0%
7
   0.2%
White
796
  88.7%
791
  87.3%
1492
  90.0%
162
  91.0%
3241
  89.1%
Other, Unspecified
17
   1.9%
20
   2.2%
29
   1.8%
1
   0.6%
67
   1.8%
1.Primary Outcome
Title Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic US N. Meningitidis Serogroup B Strains at 1 Month After the 3-dose (0,2,6-M), 2-dose(0,6-M) Vaccination Schedule of rMenB+OMV and 1 Dose of MenACWY
Hide Description

The effectiveness (test-based) of rMenB+OMV vaccine at 1 month after the 3 doses in MenB_0_2_6 group and 1 month after the 2 dose schedule in MenB_0_6 group when compared to one dose of MenACWY vaccination in ACWY group, against a panel of N. meningitidis serogroup B strains was measured in terms of percentage of samples without bactericidal activity using endogenous complement human Serum Bactericidal Assay (enc-hSBA), which provides a qualitative assessment (yes/no) of the presence of sufficient bactericidal antibodies in human sera to kill a meningococcal strain at a specific dilution of 1:4.

Participants were randomly selected for testing against each strain therefore only a subset of participants were tested for each of the strains.

Time Frame At 1 month after vaccination schedule (i.e., Day 211 for MenB_0_2_6 group [3-dose schedule] and MenB_0_6 group, and Day 31 for ACWY group)
Hide Outcome Measure Data
Hide Analysis Population Description

Analysis was performed on blood samples collected from Per Protocol Set (PPS) ,which included participants who received at least 1 dose of the study treatment to which they were randomized and have post-vaccination data for the specified analysis at the specified timepoints and did not have any protocol deviations that lead to exclusion from the PPS.

Number of Participants analyzed = Total number of participants included in PPS.

Arm/Group Title MenB_0_2_6 Group MenB_0_6 Group ACWY Group
Hide Arm/Group Description:
Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.
Participants received 2 doses of rMenB+OMV NZ vaccine on Day 1, and Day 181, 1 dose of MenACWY vaccine on Day 61. Participants received 1 dose of Placebo on Day 211 to maintain blinding.
Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.
Overall Number of Participants Analyzed 740 751 147
Overall Number of Units Analyzed
Type of Units Analyzed: Samples
25596 26142 4374
Measure Type: Number
Unit of Measure: Percentage of blood samples
13.3 14.4 79
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MenB_0_2_6 Group, ACWY Group
Comments To demonstrate the effectiveness of the rMenB+OMV NZ vaccine against a randomly selected panel of endemic US N. meningitidis serogroup B invasive disease strains as measured by bactericidal activity using enc-hSBA at 1 month after the 3-dose (0,2,6-months) schedule in MenB_0_2_6 group when compared to 1 month after the MenACWY dose in the ACWY group.
Type of Statistical Test Other
Comments Effectiveness of rMenB+OMV NZ vaccine is demonstrated if the LL of the 2-sided 97.5% CI for Vaccine Effectiveness (VE) against the selected strain panel between the MenB_0_2_6 and the ACWY groups is above 65%. VE is defined as 1- Risk Ratio (RR) = (1- percentage of samples without bactericidal serum activity at 1:4 dilution in MenB group / percentage of samples without bactericidal serum activity at 1:4 dilution in the ACWY group) x100 percentage.
Method of Estimation Estimation Parameter VE (Vaccine Effectiveness)
Estimated Value 83.2
Confidence Interval (2-Sided) 97.5%
81.9 to 84.4
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MenB_0_6 Group, ACWY Group
Comments To demonstrate the effectiveness of the rMenB+OMV NZ vaccine against a randomly selected panel of endemic US N. meningitidis serogroup B invasive disease strains as measured by bactericidal activity using enc-hSBA at 1 month after the 2-dose (0,6-M) schedule in MenB_0_6 group when compared to 1 month after the MenACWY dose in the ACWY group.
Type of Statistical Test Other
Comments

Effectiveness of rMenB+OMV NZ vaccine is demonstrated if the LL of the 2-sided 97.5% CI for VE against the selected strain panel between the MenB_0_ 6 and the ACWY groups is above 65%.

VE is defined as 1- RR = (1- percentage of samples without bactericidal serum activity at 1:4 dilution in MenB group / percentage of samples without bactericidal serum activity at 1:4 dilution in the ACWY group) x100 percentage.

Method of Estimation Estimation Parameter VE
Estimated Value 81.8
Confidence Interval (2-Sided) 97.5%
80.4 to 83.1
Estimation Comments [Not Specified]
2.Primary Outcome
Title Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic US N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose (0,2-M) Vaccination Schedule of rMenB+OMV and 1 Dose of MenACWY
Hide Description

The effectiveness (test-based) of rMenB+OMV vaccine at 1 month after the 2 doses in MenB_0_2_6 group when compared to one dose of MenACWY vaccination in ACWY group, against a panel of N. meningitidis serogroup B strains was measured in terms of percentage of samples without bactericidal activity using endogenous complement human Serum Bactericidal Assay (enc-hSBA), which provides a qualitative assessment (yes/no) of the presence of sufficient bactericidal antibodies in human sera to kill a meningococcal strain at a specific dilution of 1:4.

Participants were randomly selected for testing against each strain therefore only a subset of participants were tested for each of the strains.

Time Frame At 1 month after vaccination schedule (i.e., Day 91 for the MenB_0_2_6 group [2-dose schedule] and Day 31 for ACWY group)
Hide Outcome Measure Data
Hide Analysis Population Description

Analysis was performed on blood samples collected from Per Protocol Set (PPS) ,which included participants who received at least 1 dose of the study treatment to which they were randomized and have post-vaccination data for the specific analysis at specified timepoints and did not have any protocol deviations that lead to exclusion from the PPS.

Number of Participants analyzed = Total number of participants included in PPS.

Arm/Group Title MenB_0_2_6 Group ACWY Group
Hide Arm/Group Description:
Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.
Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.
Overall Number of Participants Analyzed 740 147
Overall Number of Units Analyzed
Type of Units Analyzed: Samples
27569 4374
Measure Type: Number
Unit of Measure: Percentage of blood samples
16.8 79
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MenB_0_2_6 Group, ACWY Group
Comments To demonstrate the effectiveness of the rMenB+OMV NZ vaccine against a randomly selected panel of endemic US N. meningitidis serogroup B invasive disease strains as measured by bactericidal activity using enc-hSBA at 1 month after the 2-dose (0,2-M) schedule in MenB_0_2_6 group when compared to 1 month after the MenACWY dose in the ACWY group.
Type of Statistical Test Other
Comments Effectiveness of rMenB+OMV NZ vaccine is demonstrated if the LL of the 2-sided 97.5% CI for VE against the selected strain panel between the MenB_0_2_6 and the ACWY groups is above 65%. VE is defined as 1- RR = (1- percentage of samples without bactericidal serum activity at 1:4 dilution in MenB group / percentage of samples without bactericidal serum activity at 1:4 dilution in the ACWY group) x100 percentage.
Method of Estimation Estimation Parameter VE
Estimated Value 78.7
Confidence Interval (2-Sided) 97.5%
77.2 to 80.1
Estimation Comments [Not Specified]
3.Primary Outcome
Title Percentage of Participants Whose Sera Kill Greater Than or Equal to (>=) 70% of the Strains Tested Using Enc-hSBA at 1 Month After the 3-dose (0,2,6-M) Schedule of rMenB+OMV and 2-dose(0,6-M) Schedule of rMenB+OMV
Hide Description The effectiveness (responder-based) of the rMenB+OMV NZ vaccine was measured in terms of percentage of participants whose sera kill >=70% of the strains tested using enc-hSBA, calculated based on Clopper Pearson method. Effectiveness is demonstrated if Lower Limit (LL) of the two-sided 97.5% CI for the percentages of participants whose sera kill ≥70% of strains is above 65%.
Time Frame At 1 month after vaccination schedule (i.e., Day 211 for MenB_0_2_6 group [3-dose schedule] and MenB_0_6 group)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Full Analysis Set, which included participants who were randomized, received at least 1 dose of the study treatment and had post-vaccination effectiveness available for the specified analysis at the specified timepoint.
Arm/Group Title MenB_0_2_6 Group MenB_0_6 Group
Hide Arm/Group Description:
Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.
Participants received 2 doses of rMenB+OMV NZ vaccine on Day 1, and Day 181, 1 dose of MenACWY vaccine on Day 61. Participants received 1 dose of Placebo on Day 211 to maintain blinding.
Overall Number of Participants Analyzed 790 813
Measure Type: Number
Number (97.5% Confidence Interval)
Unit of Measure: Percentage of participants
93.4
(91.2 to 95.2)
89.8
(87.2 to 92)
4.Primary Outcome
Title Percentage of Participants Whose Sera Kill >=70% of the Strains Tested Using Enc-hSBA at 1 Month After the 2-dose (0,2-M) Schedule of rMenB+OMV
Hide Description The effectiveness (responder-based) of the rMenB+OMV NZ vaccine was measured in terms of percentage of participants whose sera kill >=70% of the strains tested using enc-hSBA, calculated based on Clopper Pearson method. Effectiveness is demonstrated if Lower Limit (LL) of the two-sided 97.5% CI for the percentages of participants whose sera kill ≥70% of strains is above 65%.
Time Frame At 1 month after vaccination schedule (i.e., Day 91 for the MenB_0_2_6 group [2-dose schedule])
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Full Analysis Set, which included participants who were randomized, received at least 1 dose of the study treatment and had post-vaccination effectiveness available for the specified analysis at the specified timepoint.
Arm/Group Title MenB_0_2_6 Group
Hide Arm/Group Description:
Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.
Overall Number of Participants Analyzed 831
Measure Type: Number
Number (97.5% Confidence Interval)
Unit of Measure: Percentage of participants
84.8
(81.8 to 87.5)
5.Primary Outcome
Title Geometric Mean Titers (GMTs) Against Serogroups A, C, W and Y for Each Lot (ABCWY-1 Group, ABCWY-2 Group and ABCWY-3 Group) at 1 Month After the Last Vaccination of MenABCWY
Hide Description Immune response was measured in terms of hSBA GMTs directed against serogroups A, C, W and Y. As pre-specified in the protocol, the data reported in this outcome measures data were presented for individual lots to demonstrate the consistency of the immune response of 3 lots (ABCWY- 1 Group, ABCWY-2 Group, and ABCWY-3 Group) of the ACWY component of the MenABCWY vaccine.
Time Frame At 1 month after the last vaccination of MenABCWY (Day 211)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Per Protocol Set (PPS), which included participants who received at least 1 dose of the study treatment to which they were randomized and have post-vaccination data for the specified analysis at specified timepoints and did not have any protocol deviations that lead to exclusion from the PPS.
Arm/Group Title ABCWY-1 Group ABCWY-2 Group ABCWY-3 Group
Hide Arm/Group Description:
Participants received 2 doses of MenABCWY lot 1 vaccine at Day 1 and Day 181 and 2 doses of placebo at Day 61 and Day 211.
Participants received 2 doses of MenABCWY lot 2 vaccine at Day 1 and Day 181 and 2 doses of placebo at Day 61 and Day 211.
Participants received 2 doses of MenABCWY lot 3 vaccine at Day 1 and Day 181 and 2 doses of placebo at Day 61 and Day 211.
Overall Number of Participants Analyzed 452 449 458
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Men A Number Analyzed 448 participants 443 participants 454 participants
336.4
(299.3 to 378.0)
349.9
(311.5 to 393.0)
390.4
(347.4 to 438.8)
Men C Number Analyzed 448 participants 449 participants 456 participants
1036.7
(877.6 to 1224.5)
1130.2
(958.1 to 1333.4)
888.4
(752.1 to 1049.2)
Men W Number Analyzed 452 participants 449 participants 458 participants
564.5
(497.9 to 639.9)
635.5
(561.0 to 719.9)
640.1
(564.6 to 725.6)
Men Y Number Analyzed 451 participants 449 participants 457 participants
536.7
(464.5 to 620.2)
623.9
(540.4 to 720.2)
644.3
(557.6 to 744.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ABCWY-1 Group, ABCWY-2 Group
Comments To demonstrate lot-to-lot consistency of the immune responses of ABCWY-1 and ABCWY-2 lots of the MenACWY component of the MenABCWY vaccine, as measured by hSBA GMTs directed against serogroup A at 1 month after last vaccination (Day 211).
Type of Statistical Test Equivalence
Comments Lot-to-lot consistency is claimed if the 2-sided 95% CIs for the ratio of hSBA GMTs of antibodies against each of the serogroups A, C, W and Y are within the [0.5;2.0] equivalence interval for each pair of lots.
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 0.96
Confidence Interval (2-Sided) 95%
0.84 to 1.10
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection ABCWY-1 Group, ABCWY-3 Group
Comments To demonstrate lot-to-lot consistency of the immune responses of ABCWY-1 and ABCWY-3 lots of the MenACWY component of the MenABCWY vaccine, as measured by hSBA GMTs directed against serogroup A at 1 month after last vaccination (Day 211).
Type of Statistical Test Equivalence
Comments Lot-to-lot consistency is claimed if the 2-sided 95% CIs for the ratio of hSBA GMTs of antibodies against each of the serogroups A, C, W and Y is within the [0.5;2.0] equivalence interval for each pair of lots.
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 0.86
Confidence Interval (2-Sided) 95%
0.75 to 0.98
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection ABCWY-2 Group, ABCWY-3 Group
Comments To demonstrate lot-to-lot consistency of the immune responses of ABCWY-2 and ABCWY-3 lots of the MenACWY component of the MenABCWY vaccine, as measured by hSBA GMTs directed against serogroup A at 1 month after last vaccination (Day 211).
Type of Statistical Test Equivalence
Comments Lot-to-lot consistency is claimed if the 2-sided 95% CIs for the ratio of hSBA GMTs of antibodies against each of the serogroups A, C, W and Y is within the [0.5;2.0] equivalence interval for each pair of lots.
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 0.90
Confidence Interval (2-Sided) 95%
0.78 to 1.02
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection ABCWY-1 Group, ABCWY-2 Group
Comments To demonstrate lot-to-lot consistency of the immune responses of ABCWY-1 and ABCWY-2 lots of the MenACWY component of the MenABCWY vaccine, as measured by hSBA GMTs directed against serogroup C at 1 month after last vaccination (Day 211).
Type of Statistical Test Equivalence
Comments Lot-to-lot consistency is claimed if the 2-sided 95% CIs for the ratio of hSBA GMTs of antibodies against each of the serogroups A, C, W and Y are within the [0.5;2.0] equivalence interval for each pair of lots.
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 0.92
Confidence Interval (2-Sided) 95%
0.76 to 1.11
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection ABCWY-1 Group, ABCWY-3 Group
Comments To demonstrate lot-to-lot consistency of the immune responses of ABCWY-1 and ABCWY-3 lots of the MenACWY component of the MenABCWY vaccine, as measured by hSBA GMTs directed against serogroup C at 1 month after last vaccination (Day 211).
Type of Statistical Test Equivalence
Comments Lot-to-lot consistency is claimed if the 2-sided 95% CIs for the ratio of hSBA GMTs of antibodies against each of the serogroups A, C, W and Y is within the [0.5;2.0] equivalence interval for each pair of lots.
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 1.17
Confidence Interval (2-Sided) 95%
0.97 to 1.41
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection ABCWY-2 Group, ABCWY-3 Group
Comments To demonstrate lot-to-lot consistency of the immune responses of ABCWY-2 and ABCWY-3 lots of the MenACWY component of the MenABCWY vaccine, as measured by hSBA GMTs directed against serogroup C at 1 month after last vaccination (Day 211).
Type of Statistical Test Equivalence
Comments Lot-to-lot consistency is claimed if the 2-sided 95% CIs for the ratio of hSBA GMTs of antibodies against each of the serogroups A, C, W and Y is within the [0.5;2.0] equivalence interval for each pair of lots.
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 1.27
Confidence Interval (2-Sided) 95%
1.05 to 1.54
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection ABCWY-1 Group, ABCWY-2 Group
Comments To demonstrate lot-to-lot consistency of the immune responses of ABCWY-1 and ABCWY-2 lots of the MenACWY component of the MenABCWY vaccine, as measured by hSBA GMTs directed against serogroup W at 1 month after last vaccination (Day 211).
Type of Statistical Test Equivalence
Comments Lot-to-lot consistency is claimed if the 2-sided 95% CIs for the ratio of hSBA GMTs of antibodies against each of the serogroups A, C, W and Y are within the [0.5;2.0] equivalence interval for each pair of lots.
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 0.89
Confidence Interval (2-Sided) 95%
0.77 to 1.02
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection ABCWY-1 Group, ABCWY-3 Group
Comments To demonstrate lot-to-lot consistency of the immune responses of ABCWY-1 and ABCWY-3 lots of the MenACWY component of the MenABCWY vaccine, as measured by hSBA GMTs directed against serogroup W at 1 month after last vaccination (Day 211).
Type of Statistical Test Equivalence
Comments Lot-to-lot consistency is claimed if the 2-sided 95% CIs for the ratio of hSBA GMTs of antibodies against each of the serogroups A, C, W and Y is within the [0.5;2.0] equivalence interval for each pair of lots.
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 0.88
Confidence Interval (2-Sided) 95%
0.77 to 1.02
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection ABCWY-2 Group, ABCWY-3 Group
Comments To demonstrate lot-to-lot consistency of the immune responses of ABCWY-2 and ABCWY-3 lots of the MenACWY component of the MenABCWY vaccine, as measured by hSBA GMTs directed against serogroup W at 1 month after last vaccination (Day 211).
Type of Statistical Test Equivalence
Comments Lot-to-lot consistency is claimed if the 2-sided 95% CIs for the ratio of hSBA GMTs of antibodies against each of the serogroups A, C, W and Y is within the [0.5;2.0] equivalence interval for each pair of lots.
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 0.99
Confidence Interval (2-Sided) 95%
0.86 to 1.14
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection ABCWY-1 Group, ABCWY-2 Group
Comments To demonstrate lot-to-lot consistency of the immune responses of ABCWY-1 and ABCWY-2 lots of the MenACWY component of the MenABCWY vaccine, as measured by hSBA GMTs directed against serogroup Y at 1 month after last vaccination (Day 211).
Type of Statistical Test Equivalence
Comments Lot-to-lot consistency is claimed if the 2-sided 95% CIs for the ratio of hSBA GMTs of antibodies against each of the serogroups A, C, W and Y are within the [0.5;2.0] equivalence interval for each pair of lots.
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 0.86
Confidence Interval (2-Sided) 95%
0.73 to 1.01
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection ABCWY-1 Group, ABCWY-3 Group
Comments To demonstrate lot-to-lot consistency of the immune responses of ABCWY-1 and ABCWY-3 lots of the MenACWY component of the MenABCWY vaccine, as measured by hSBA GMTs directed against serogroup Y at 1 month after last vaccination (Day 211).
Type of Statistical Test Equivalence
Comments Lot-to-lot consistency is claimed if the 2-sided 95% CIs for the ratio of hSBA GMTs of antibodies against each of the serogroups A, C, W and Y is within the [0.5;2.0] equivalence interval for each pair of lots.
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 0.83
Confidence Interval (2-Sided) 95%
0.71 to 0.98
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection ABCWY-2 Group, ABCWY-3 Group
Comments To demonstrate lot-to-lot consistency of the immune responses of ABCWY-2 and ABCWY-3 lots of the MenACWY component of the MenABCWY vaccine, as measured by hSBA GMTs directed against serogroup Y at 1 month after last vaccination (Day 211).
Type of Statistical Test Equivalence
Comments Lot-to-lot consistency is claimed if the 2-sided 95% CIs for the ratio of hSBA GMTs of antibodies against each of the serogroups A, C, W and Y is within the [0.5;2.0] equivalence interval for each pair of lots.
Method of Estimation Estimation Parameter GMT ratio
Estimated Value 0.97
Confidence Interval (2-Sided) 95%
0.82 to 1.14
Estimation Comments [Not Specified]
6.Primary Outcome
Title Percentage of Participants With 4-fold Rise in hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y at 1 Month After Last MenABCWY Vaccination (Pooled Lots) and MenACWY Vaccination (for the ACWY Group), Relative to Baseline
Hide Description

Four-fold rise is defined as: If the pre-vaccination hSBA titer is < 4, then post-vaccination hSBA titer should be >= 16 . If the pre-vaccination hSBA titer is >= limit of detection (LOD) but < LL of quantification (LLOQ), then post-vaccination hSBA titer should be >= 4 times the LLOQ. If the pre-vaccination hSBA titer is >= LLOQ, then post-vaccination hSBA titer should be >= 4 times the pre-vaccination hSBA titer.

As pre-specified in the protocol, data reported in this outcome measure were presented for ACWY group, ABCWY pooled group to evaluate the immunological non-inferiority of 2 doses of the MenABCWY vaccines against MenACWY vaccines, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.

Time Frame At 1 month after vaccination schedule (i.e., Day 211 for the ABCWY_Pooled group and Day 31 for the ACWY Group) compared to Day 1 (baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Per Protocol Set, which included participants who received at least 1 dose of the study treatment to which they were randomized and have post-vaccination data for the specified analysis at specified timepoints and did not have any protocol deviations that lead to exclusion from the PPS.
Arm/Group Title ABCWY_Pooled ACWY Group
Hide Arm/Group Description:

Participants received 2 doses of either MenABCWY Lot 1, Lot 2, or Lot 3 vaccine on Day 1 and Day 181 and 1 dose of placebo on Day 61. Participants received 1 dose of placebo on Day 211 to maintain blinding.

To evaluate the effectiveness of 2 doses of the MenABCWY vaccines against rMenB+OMV and MenACWY vaccines, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.

Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.
Overall Number of Participants Analyzed 1196 119
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Men A Number Analyzed 1170 participants 112 participants
97.0
(95.9 to 97.9)
85.7
(77.8 to 91.6)
Men C Number Analyzed 1189 participants 114 participants
97.2
(96.1 to 98.1)
50.0
(40.5 to 59.5)
Men W Number Analyzed 1185 participants 115 participants
97.0
(95.9 to 97.9)
61.7
(52.2 to 70.6)
Men Y Number Analyzed 1196 participants 119 participants
96.7
(95.6 to 97.7)
69.7
(60.7 to 77.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ABCWY_Pooled, ACWY Group
Comments To demonstrate the immunological non-inferiority of the MenABCWY vaccine compared to the MenACWY vaccine in participants without a previous MenACWY vaccination (unprimed) as measured by the percentages of participants, achieving a 4-fold rise in hSBA titers against N. meningitidis serogroup A at 1 month after the last MenABCWY vaccination (Day 211) and 1 month after the MenACWY vaccination.
Type of Statistical Test Non-Inferiority
Comments Non-inferiority of MenABCWY vaccine is demonstrated if the LL of the 2-sided 95% CI for the difference in percentage of participants with 4-fold rise between the 2 groups is above -10%.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Difference in percentage of participants
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage of participants
Estimated Value 11.29
Confidence Interval (2-Sided) 95%
5.88 to 19.01
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection ABCWY_Pooled, ACWY Group
Comments To demonstrate the immunological non-inferiority of the MenABCWY vaccine compared to the MenACWY vaccine in participants without a previous MenACWY vaccination (unprimed) as measured by the percentages of participants, achieving a 4-fold rise in hSBA titers against N. meningitidis serogroup C at 1 month after the last MenABCWY vaccination (Day 211) and 1 month after the MenACWY vaccination.
Type of Statistical Test Non-Inferiority
Comments Non-inferiority of MenABCWY vaccine is demonstrated if the LL of the 2-sided 95% CI for the difference in percentage of participants with 4-fold rise between the 2 groups is above -10%.
Method of Estimation Estimation Parameter Difference in percentage of participants
Estimated Value 47.22
Confidence Interval (2-Sided) 95%
38.14 to 56.30
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection ABCWY_Pooled, ACWY Group
Comments To demonstrate the immunological non-inferiority of the MenABCWY vaccine compared to the MenACWY vaccine in participants without a previous MenACWY vaccination (unprimed) as measured by the percentages of participants, achieving a 4-fold rise in hSBA titers against N. meningitidis serogroup W at 1 month after the last MenABCWY vaccination (Day 211) and 1 month after the MenACWY vaccination.
Type of Statistical Test Non-Inferiority
Comments Non-inferiority of MenABCWY vaccine is demonstrated if the LL of the 2-sided 95% CI for the difference in percentage of participants with 4-fold rise between the 2 groups is above -10%.
Method of Estimation Estimation Parameter Difference in percentage of participants
Estimated Value 35.31
Confidence Interval (2-Sided) 95%
26.88 to 44.49
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection ABCWY_Pooled, ACWY Group
Comments To demonstrate the immunological non-inferiority of the MenABCWY vaccine compared to the MenACWY vaccine in participants without a previous MenACWY vaccination (unprimed) as measured by the percentages of participants, achieving a 4-fold rise in hSBA titers against N. meningitidis serogroup Y at 1 month after the last MenABCWY vaccination (Day 211) and 1 month after the MenACWY vaccination.
Type of Statistical Test Non-Inferiority
Comments Non-inferiority of MenABCWY vaccine is demonstrated if the LL of the 2-sided 95% CI for the difference in percentage of participants with 4-fold rise between the 2 groups is above -10%.
Method of Estimation Estimation Parameter Difference in percentage of participants
Estimated Value 26.99
Confidence Interval (2-Sided) 95%
19.38 to 35.81
Estimation Comments [Not Specified]
7.Primary Outcome
Title Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After Last MenABCWY Vaccination (Pooled Lots) and MenACWY Vaccination (for the ACWY Group)
Hide Description

The effectiveness (test-based) of 2 doses of MenABCWY vaccine when compared to 1 dose of MenACWY vaccine, against a panel of N. meningitidis serogroup B strains was measured in terms of percentage of samples without bactericidal activity using enc-hSBA, which provides a qualitative assessment (yes/no) of the presence of sufficient bactericidal antibodies in human sera to kill a meningococcal strain at a specific dilution of 1:4.

As pre-specified in the protocol, data reported in this outcome measure were presented for ACWY group and ABCWY pooled group to evaluate the effectiveness of 2 doses of the MenABCWY vaccines against MenACWY vaccines, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.

Time Frame At 1 month after the vaccination schedule (i.e., Day 211 for the ABCWY_Pooled group and Day 31 for the ACWY group)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on blood samples collected from Per Protocol Set (PPS), which included participants who received at least 1 dose of the study treatment to which they were randomized and have post-vaccination data for the specified analysis at specified timepoints and did not have any protocol deviations that lead to exclusion from the PPS.
Arm/Group Title ABCWY_Pooled ACWY Group
Hide Arm/Group Description:

Participants received 2 doses of either MenABCWY Lot 1, Lot 2, or Lot 3 vaccine on Day 1 and Day 181 and 1 dose of placebo on Day 61. Participants received 1 dose of placebo on Day 211 to maintain blinding.

To evaluate the effectiveness of 2 doses of the MenABCWY vaccines against rMenB+OMV and MenACWY vaccines, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.

Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.
Overall Number of Participants Analyzed 1356 147
Overall Number of Units Analyzed
Type of Units Analyzed: Samples
25715 4374
Measure Type: Number
Unit of Measure: Percentage of blood samples
17.4 79
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ABCWY_Pooled, ACWY Group
Comments To demonstrate the effectiveness of the MenABCWY vaccine against a randomly selected panel of endemic US N. meningitidis serogroup B invasive disease strains as measured by enc-hSBA at 1 month after the last MenABCWY vaccination (Day 211) when compared to 1 month after the MenACWY vaccination.
Type of Statistical Test Other
Comments Effectiveness of MenABCWY vaccine is demonstrated if the LL of the 2-sided 95% CI for VE against the selected strain panel between the ABCWY and the ACWY groups is above 65%. VE is defined as 1- RR = (1- percentage of samples without bactericidal serum activity at 1:4 dilution in ABCWY_Pooled group / percentage of samples without bactericidal serum activity at 1:4 dilution in the ACWY group) x100 percentage.
Method of Estimation Estimation Parameter VE
Estimated Value 77.9
Confidence Interval (2-Sided) 95%
76.6 to 79.2
Estimation Comments [Not Specified]
8.Primary Outcome
Title Percentage of Blood Samples With Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose (Pooled Lots) and 2-dose(0,2-M) Schedule of rMenB+OMV
Hide Description The effectiveness was measured in terms of percentage of samples with bactericidal activity using enc-hSBA, which provides a qualitative assessment (yes/no) of the presence of sufficient bactericidal antibodies in human sera to kill a meningococcal strain at a specific dilution of 1:4. As pre-specified in the protocol, data reported in this outcome measure were presented for MenB_0_2_6 Group and ABCWY pooled group to evaluate the effectiveness of 2 doses of the MenABCWY vaccines against MenACWY vaccines, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.
Time Frame At 1 month after the vaccination schedule (i.e., Day 211 for the ABCWY_Pooled group and Day 91 for the MenB_0_2_6 Group [2-dose schedule])
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on blood samples collected from PPS, which included participants who received at least 1 dose of the study treatment to which they were randomized and have post-vaccination data for the specified analysis at specified timepoints and did not have any protocol deviations that lead to exclusion from the PPS.
Arm/Group Title MenB_0_2_6 Group ABCWY_Pooled
Hide Arm/Group Description:
Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.

Participants received 2 doses of either MenABCWY Lot 1, Lot 2, or Lot 3 vaccine on Day 1 and Day 181 and 1 dose of placebo on Day 61. Participants received 1 dose of placebo on Day 211 to maintain blinding.

To evaluate the effectiveness of 2 doses of the MenABCWY vaccines against rMenB+OMV and MenACWY vaccines, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.

Overall Number of Participants Analyzed 740 1356
Overall Number of Units Analyzed
Type of Units Analyzed: Samples
27569 25715
Measure Type: Number
Unit of Measure: Percentage of blood samples
83.1 82.5
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MenB_0_2_6 Group, ABCWY_Pooled
Comments To demonstrate the non-inferiority of the effectiveness of the MenABCWY vaccine (0,6-months schedule) compared to the rMenB+OMV NZ vaccine (0,2-months) in terms of percentage of samples with bactericidal serum activity using enc-hSBA against a randomly selected panel of endemic US N. meningitidis serogroup B invasive disease strains.
Type of Statistical Test Non-Inferiority
Comments Non-inferiority of MenABCWY to rMenB+OMV NZ is demonstrated if LL of the 2-sided 95% CI for the difference in percentages of samples with bactericidal serum activity at 1:4 dilution is above -5%.
Method of Estimation Estimation Parameter Difference in percentage of participants
Estimated Value -0.61
Confidence Interval (2-Sided) 95%
-1.25 to 0.03
Estimation Comments [Not Specified]
9.Primary Outcome
Title Percentage of Participants Whose Sera Kill >=70% of the Strains Tested Using Enc-hSBA at 1 Month After the Last Vaccination in the ABCWY Group (Pooled Lots)
Hide Description The effectiveness (responder-based) of the MenABCWY vaccine is measured in terms of percentage of participants whose sera kill >=70% of the strains tested using enc-hSBA, being calculated based on Clopper Pearson method. Effectiveness is demonstrated Lower Limit (LL) of the two-sided 97.5% CI for the percentages of participants whose sera kill ≥70% of strains tested for MenABCWY is above 65%.
Time Frame At 1 month after the last vaccination of MenABCWY (Day 211)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the FAS, which included all participants who were randomized, received at least 1 dose of the study treatment, and had post-vaccination effectiveness data available for the specified analysis at the specified time points.
Arm/Group Title ABCWY_Pooled
Hide Arm/Group Description:

Participants received 2 doses of either MenABCWY Lot 1, Lot 2, or Lot 3 vaccine on Day 1 and Day 181 and 1 dose of placebo on Day 61. Participants received 1 dose of placebo on Day 211 to maintain blinding.

To evaluate the effectiveness of 2 doses of the MenABCWY vaccines against rMenB+OMV and MenACWY vaccines, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.

Overall Number of Participants Analyzed 817
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
84.1
(81.4 to 86.5)
10.Primary Outcome
Title Number of Participants With Any Solicited Local Adverse Events (AEs) After the First Study Intervention Administration
Hide Description Assessed solicited local adverse events were injection or administration site = pain, erythema, swelling, induration. Any = occurrence of the adverse event regardless of intensity grade. Any erythema and swelling = adverse event reported with a surface diameter greater than 0 millimeters. No solicited AEs were collected after vaccination on Day 211 because these vaccines were administered as part of standard of care and to maintain blinding. As pre- specified in the protocol, data reported in this outcome measure were presented for MenB_0_2_6 group, MenB_0_6 group, ACWY group, ABCWY pooled group.
Time Frame During 7 days after the first study intervention administration occurring at Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Solicited Safety Set (SSS), which included participants who received at least 1 dose of the study treatment and had solicited safety data during the specified period.
Arm/Group Title MenB_0_2_6 Group MenB_0_6 Group ABCWY_Pooled ACWY Group
Hide Arm/Group Description:
Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.
Participants received 2 doses of rMenB+OMV NZ vaccine on Day 1, and Day 181, 1 dose of MenACWY vaccine on Day 61. Participants received 1 dose of Placebo on Day 211 to maintain blinding.

Participants received 2 doses of either MenABCWY Lot 1, Lot 2, or Lot 3 vaccine on Day 1 and Day 181 and 1 dose of placebo on Day 61. Participants received 1 dose of placebo on Day 211 to maintain blinding.

To evaluate the effectiveness of 2 doses of the MenABCWY vaccines against rMenB+OMV and MenACWY vaccines, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.

Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.
Overall Number of Participants Analyzed 885 894 1638 178
Measure Type: Count of Participants
Unit of Measure: Participants
Pain
807
  91.2%
819
  91.6%
1503
  91.8%
67
  37.6%
Erythema
90
  10.2%
86
   9.6%
216
  13.2%
11
   6.2%
Swelling
87
   9.8%
89
  10.0%
217
  13.2%
11
   6.2%
Induration
60
   6.8%
64
   7.2%
150
   9.2%
7
   3.9%
11.Primary Outcome
Title Number of Participants With Any Solicited Local Adverse Events (AEs) After the Second Study Intervention Administration
Hide Description Assessed solicited local adverse events were injection or administration site pain, erythema, swelling, induration. Any = occurrence of the adverse event regardless of intensity grade. Any erythema and swelling = adverse event reported with a surface diameter greater than 0 millimeters. No solicited AEs were collected after vaccination on Day 211 because these vaccines were administered as part of standard of care and to maintain blinding. As pre- specified in the protocol, data reported in this outcome measure were presented for MenB_0_2_6 group, MenB_0_6 group, ACWY group, ABCWY pooled group.
Time Frame During 7 days after the second study intervention administration occurring at Day 61
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Solicited Safety Set (SSS), which included participants who received at least 1 dose of the study treatment and had solicited safety data during the specified period.
Arm/Group Title MenB_0_2_6 Group MenB_0_6 Group ABCWY_Pooled ACWY Group
Hide Arm/Group Description:
Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.
Participants received 2 doses of rMenB+OMV NZ vaccine on Day 1, and Day 181, 1 dose of MenACWY vaccine on Day 61. Participants received 1 dose of Placebo on Day 211 to maintain blinding.

Participants received 2 doses of either MenABCWY Lot 1, Lot 2, or Lot 3 vaccine on Day 1 and Day 181 and 1 dose of placebo on Day 61. Participants received 1 dose of placebo on Day 211 to maintain blinding.

To evaluate the effectiveness of 2 doses of the MenABCWY vaccines against rMenB+OMV and MenACWY vaccines, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.

Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.
Overall Number of Participants Analyzed 823 813 1511 161
Measure Type: Count of Participants
Unit of Measure: Participants
Pain
714
  86.8%
224
  27.6%
205
  13.6%
30
  18.6%
Erythema
89
  10.8%
26
   3.2%
5
   0.3%
1
   0.6%
Swelling
99
  12.0%
22
   2.7%
5
   0.3%
1
   0.6%
Induration
67
   8.1%
19
   2.3%
6
   0.4%
0
   0.0%
12.Primary Outcome
Title Number of Participants With Any Solicited Local Adverse Events (AEs) After the Third Study Intervention Administration
Hide Description Assessed solicited local adverse events were injection or administration site pain, erythema, swelling, induration. Any = occurrence of the adverse event regardless of intensity grade. Any erythema and swelling = adverse event reported with a surface diameter greater than 0 millimeters. No solicited AEs were collected after vaccination on Day 211 because these vaccines were administered as part of standard of care and to maintain blinding. As pre- specified in the protocol, data reported in this outcome measure were presented for MenB_0_2_6 group, MenB_0_6 group, ACWY group, ABCWY pooled group.
Time Frame During 7 days after the third study intervention administration occurring at Day 181
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Solicited Safety Set (SSS), which included participants who received at least 1 dose of the study treatment and had solicited safety data during the specified period.
Arm/Group Title MenB_0_2_6 Group MenB_0_6 Group ABCWY_Pooled ACWY Group
Hide Arm/Group Description:
Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.
Participants received 2 doses of rMenB+OMV NZ vaccine on Day 1, and Day 181, 1 dose of MenACWY vaccine on Day 61. Participants received 1 dose of Placebo on Day 211 to maintain blinding.

Participants received 2 doses of either MenABCWY Lot 1, Lot 2, or Lot 3 vaccine on Day 1 and Day 181 and 1 dose of placebo on Day 61. Participants received 1 dose of placebo on Day 211 to maintain blinding.

To evaluate the effectiveness of 2 doses of the MenABCWY vaccines against rMenB+OMV and MenACWY vaccines, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.

Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.
Overall Number of Participants Analyzed 765 759 1428 148
Measure Type: Count of Participants
Unit of Measure: Participants
Pain
677
  88.5%
676
  89.1%
1258
  88.1%
126
  85.1%
Erythema
118
  15.4%
87
  11.5%
168
  11.8%
11
   7.4%
Swelling
107
  14.0%
85
  11.2%
176
  12.3%
13
   8.8%
Induration
52
   6.8%
57
   7.5%
114
   8.0%
12
   8.1%
13.Primary Outcome
Title Number of Participants With Any Solicited Systemic AEs After the First Study Intervention Administration
Hide Description Assessed solicited systemic AEs were fatigue, nausea, myalgia, arthralgia, headache and fever [temperature >= 38.0°C]. Any = occurrence of the adverse event regardless of intensity grade or relation to study vaccination. No solicited AEs were collected after vaccination on Day 211 because these vaccines were administered as part of standard of care and to maintain blinding. As pre- specified in the protocol, data reported in this outcome measure were presented for MenB_0_2_6 group, MenB_0_6 group, ACWY group, ABCWY pooled group.
Time Frame During 7 days after the first study intervention administration occurring at Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Solicited Safety Set (SSS), which included participants who receive at least 1 dose of the study treatment and had solicited safety data during the specified period.
Arm/Group Title MenB_0_2_6 Group MenB_0_6 Group ABCWY_Pooled ACWY Group
Hide Arm/Group Description:
Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.
Participants received 2 doses of rMenB+OMV NZ vaccine on Day 1, and Day 181, 1 dose of MenACWY vaccine on Day 61. Participants received 1 dose of Placebo on Day 211 to maintain blinding.

Participants received 2 doses of either MenABCWY Lot 1, Lot 2, or Lot 3 vaccine on Day 1 and Day 181 and 1 dose of placebo on Day 61. Participants received 1 dose of placebo on Day 211 to maintain blinding.

To evaluate the effectiveness of 2 doses of the MenABCWY vaccines against rMenB+OMV and MenACWY vaccines, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.

Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.
Overall Number of Participants Analyzed 885 894 1638 178
Measure Type: Count of Participants
Unit of Measure: Participants
Fatigue
423
  47.8%
414
  46.3%
828
  50.5%
78
  43.8%
Nausea
112
  12.7%
111
  12.4%
242
  14.8%
27
  15.2%
Myalgia
92
  10.4%
106
  11.9%
242
  14.8%
13
   7.3%
Arthralgia
56
   6.3%
70
   7.8%
133
   8.1%
17
   9.6%
Headache
358
  40.5%
330
  36.9%
681
  41.6%
69
  38.8%
Fever (C)
19
   2.1%
17
   1.9%
55
   3.4%
3
   1.7%
14.Primary Outcome
Title Number of Participants With Any Solicited Systemic AEs After the Second Study Intervention Administration
Hide Description Assessed solicited systemic AEs were fatigue, nausea, myalgia, arthralgia, headache and fever [temperature >= 38.0°C]. Any = occurrence of the adverse event regardless of intensity grade or relation to study vaccination. No solicited AEs were collected after vaccination on Day 211 because these vaccines were administered as part of standard of care and to maintain blinding. As pre- specified in the protocol, data reported in this outcome measure were presented for MenB_0_2_6 group, MenB_0_6 group, ACWY group, ABCWY pooled group.
Time Frame During 7 days after the second study intervention administration occurring at Day 61
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Solicited Safety Set (SSS), which included participants who receive at least 1 dose of the study treatment and had solicited safety data during the specified period.
Arm/Group Title MenB_0_2_6 Group MenB_0_6 Group ABCWY_Pooled ACWY Group
Hide Arm/Group Description:
Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.
Participants received 2 doses of rMenB+OMV NZ vaccine on Day 1, and Day 181, 1 dose of MenACWY vaccine on Day 61. Participants received 1 dose of Placebo on Day 211 to maintain blinding.

Participants received 2 doses of either MenABCWY Lot 1, Lot 2, or Lot 3 vaccine on Day 1 and Day 181 and 1 dose of placebo on Day 61. Participants received 1 dose of placebo on Day 211 to maintain blinding.

To evaluate the effectiveness of 2 doses of the MenABCWY vaccines against rMenB+OMV and MenACWY vaccines, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.

Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.
Overall Number of Participants Analyzed 823 813 1511 161
Measure Type: Count of Participants
Unit of Measure: Participants
Fatigue
372
  45.2%
228
  28.0%
345
  22.8%
36
  22.4%
Nausea
104
  12.6%
56
   6.9%
85
   5.6%
18
  11.2%
Myalgia
110
  13.4%
46
   5.7%
55
   3.6%
3
   1.9%
Arthralgia
72
   8.7%
332.0
35
   2.3%
6
   3.7%
Headache
301
  36.6%
223
  27.4%
332
  22.0%
31
  19.3%
Fever (C)
22
   2.7%
12
   1.5%
18
   1.2%
1
   0.6%
15.Primary Outcome
Title Number of Participants With Any Solicited Systemic AEs After the Third Study Intervention Administration
Hide Description Assessed solicited systemic AEs were fatigue, nausea, myalgia, arthralgia, headache and fever [temperature >= 38.0°C]. Any = occurrence of the adverse event regardless of intensity grade or relation to study vaccination. No solicited AEs were collected after vaccination on Day 211 because these vaccines were administered as part of standard of care and to maintain blinding. As pre- specified in the protocol, data reported in this outcome measure were presented for MenB_0_2_6 group, MenB_0_6 group, ACWY group, ABCWY pooled group.
Time Frame During 7 days after the third study intervention administration occurring at Day 181
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Solicited Safety Set (SSS), which included participants who receive at least 1 dose of the study treatment and had solicited safety data during the specified period.
Arm/Group Title MenB_0_2_6 Group MenB_0_6 Group ABCWY_Pooled ACWY Group
Hide Arm/Group Description:
Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.
Participants received 2 doses of rMenB+OMV NZ vaccine on Day 1, and Day 181, 1 dose of MenACWY vaccine on Day 61. Participants received 1 dose of Placebo on Day 211 to maintain blinding.

Participants received 2 doses of either MenABCWY Lot 1, Lot 2, or Lot 3 vaccine on Day 1 and Day 181 and 1 dose of placebo on Day 61. Participants received 1 dose of placebo on Day 211 to maintain blinding.

To evaluate the effectiveness of 2 doses of the MenABCWY vaccines against rMenB+OMV and MenACWY vaccines, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.

Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.
Overall Number of Participants Analyzed 765 759 1428 148
Measure Type: Count of Participants
Unit of Measure: Participants
Fatigue
374
  48.9%
341
  44.9%
602
  42.2%
56
  37.8%
Nausea
94
  12.3%
84
  11.1%
147
  10.3%
14
   9.5%
Myalgia
106
  13.9%
109
  14.4%
168
  11.8%
17
  11.5%
Arthralgia
71
   9.3%
53
   7.0%
104
   7.3%
7
   4.7%
Headache
302
  39.5%
284
  37.4%
509
  35.6%
39
  26.4%
Fever (C)
21
   2.7%
23
   3.0%
27
   1.9%
2
   1.4%
16.Primary Outcome
Title Number of Participants With Any Unsolicited AEs After the First Study Intervention Administration
Hide Description Unsolicited AEs are defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms were reported as an unsolicited AE. Any Unsolicited AEs (including Serious adverse events (SAEs), AEs leading to withdrawal, Adverse event of special interest (AESIs) and medically attended AEs were collected during 30 days after vaccination 1-3. For vaccination on Day 211 (Vaccination 4), conducted as part of standard of care and to maintain blinding, no eDiary data or all unsolicited AEs were collected for the 30 days following vaccination. However, SAEs, AEs leading to withdrawal, AESIs and medically attended AEs were collected throughout study duration. As pre-specified in the protocol, data reported in this outcome measure were presented for MenB_0_2_6 group, MenB_0_6 group, ACWY group, ABCWY pooled group.
Time Frame During the 30 days after the first study intervention administration occurring at Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Unsolicited Safety Set (USS), which included participants who received at least 1 dose of the study treatment and had Unsolicited safety data during the specified period.
Arm/Group Title MenB_0_2_6 Group MenB_0_6 Group ABCWY_Pooled ACWY Group
Hide Arm/Group Description:
Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.
Participants received 2 doses of rMenB+OMV NZ vaccine on Day 1, and Day 181, 1 dose of MenACWY vaccine on Day 61. Participants received 1 dose of Placebo on Day 211 to maintain blinding.

Participants received 2 doses of either MenABCWY Lot 1, Lot 2, or Lot 3 vaccine on Day 1 and Day 181 and 1 dose of placebo on Day 61. Participants received 1 dose of placebo on Day 211 to maintain blinding.

To evaluate the effectiveness of 2 doses of the MenABCWY vaccines against rMenB+OMV and MenACWY vaccines, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.

Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.
Overall Number of Participants Analyzed 893 900 1648 178
Measure Type: Count of Participants
Unit of Measure: Participants
90
  10.1%
124
  13.8%
217
  13.2%
29
  16.3%
17.Primary Outcome
Title Number of Participants With Any Unsolicited AEs After the Second Study Intervention Administration
Hide Description Unsolicited AEs are defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms were reported as an unsolicited AE. Any Unsolicited AEs (including Serious adverse events (SAEs), AEs leading to withdrawal, Adverse event of special interest (AESIs) and medically attended AEs were collected during 30 days after vaccination 1-3. For vaccination on Day 211 (Vaccination 4), conducted as part of standard of care and to maintain blinding, no eDiary data or all unsolicited AEs were collected for the 30 days following vaccination. However, SAEs, AEs leading to withdrawal, AESIs and medically attended AEs were collected throughout study duration. As pre-specified in the protocol, data reported in this outcome measure were presented for MenB_0_2_6 group, MenB_0_6 group, ACWY group, ABCWY pooled group.
Time Frame During the 30 days after the second study intervention administration occurring at Day 61
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Unsolicited Safety Set (USS), which included participants who received at least 1 dose of the study treatment and had Unsolicited safety data during the specified period.
Arm/Group Title MenB_0_2_6 Group MenB_0_6 Group ABCWY_Pooled ACWY Group
Hide Arm/Group Description:
Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.
Participants received 2 doses of rMenB+OMV NZ vaccine on Day 1, and Day 181, 1 dose of MenACWY vaccine on Day 61. Participants received 1 dose of Placebo on Day 211 to maintain blinding.

Participants received 2 doses of either MenABCWY Lot 1, Lot 2, or Lot 3 vaccine on Day 1 and Day 181 and 1 dose of placebo on Day 61. Participants received 1 dose of placebo on Day 211 to maintain blinding.

To evaluate the effectiveness of 2 doses of the MenABCWY vaccines against rMenB+OMV and MenACWY vaccines, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.

Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.
Overall Number of Participants Analyzed 851 855 1579 170
Measure Type: Count of Participants
Unit of Measure: Participants
106
  12.5%
88
  10.3%
160
  10.1%
15
   8.8%
18.Primary Outcome
Title Number of Participants With Any Unsolicited AEs After the Third Study Intervention Administration
Hide Description Unsolicited AEs are defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms were reported as an unsolicited AE. Any Unsolicited AEs (including Serious adverse events (SAEs), AEs leading to withdrawal, Adverse event of special interest (AESIs) and medically attended AEs were collected during 30 days after vaccination 1-3. For vaccination on Day 211 (Vaccination 4), conducted as part of standard of care and to maintain blinding, no eDiary data or all unsolicited AEs were collected for the 30 days following vaccination. However, SAEs, AEs leading to withdrawal, AESIs and medically attended AEs were collected throughout study duration. As pre-specified in the protocol, data reported in this outcome measure were presented for MenB_0_2_6 group, MenB_0_6 group, ACWY group, ABCWY pooled group.
Time Frame During the 30 days after the third study intervention administration occurring at Day 181
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Unsolicited Safety Set (USS), which included all participants who received at least 1 dose of the study treatment and had Unsolicited safety data during the specified period.
Arm/Group Title MenB_0_2_6 Group MenB_0_6 Group ABCWY_Pooled ACWY Group
Hide Arm/Group Description:
Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.
Participants received 2 doses of rMenB+OMV NZ vaccine on Day 1, and Day 181, 1 dose of MenACWY vaccine on Day 61. Participants received 1 dose of Placebo on Day 211 to maintain blinding.

Participants received 2 doses of either MenABCWY Lot 1, Lot 2, or Lot 3 vaccine on Day 1 and Day 181 and 1 dose of placebo on Day 61. Participants received 1 dose of placebo on Day 211 to maintain blinding.

To evaluate the effectiveness of 2 doses of the MenABCWY vaccines against rMenB+OMV and MenACWY vaccines, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.

Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.
Overall Number of Participants Analyzed 815 823 1521 166
Measure Type: Count of Participants
Unit of Measure: Participants
96
  11.8%
94
  11.4%
183
  12.0%
19
  11.4%
19.Primary Outcome
Title Number of Participants With SAEs, AEs Leading to Withdrawal, AESIs and Medically Attended AEs
Hide Description A SAEs is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity and is a congenital anomaly/birth defect in the offspring of a study subject. AESIs are predefined (serious or non-serious) AEs of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation to characterize and understand it. Medically attended AEs are symptoms or illnesses requiring hospitalization, or emergency room visit, or visit to/by a health care provider. As pre-specified in the protocol, data reported in this outcome measure were presented for MenB_0_2_6 group, MenB_0_6 group, ACWY group, ABCWY pooled group.
Time Frame Throughout the study period (Day 1 to Day 361)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Unsolicited Safety Set (USS), which included participants who received at least 1 dose of the study treatment and report unsolicited AEs/report not having unsolicited AEs.
Arm/Group Title MenB_0_2_6 Group MenB_0_6 Group ABCWY_Pooled ACWY Group
Hide Arm/Group Description:
Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.
Participants received 2 doses of rMenB+OMV NZ vaccine on Day 1, and Day 181, 1 dose of MenACWY vaccine on Day 61. Participants received 1 dose of Placebo on Day 211 to maintain blinding.

Participants received 2 doses of either MenABCWY Lot 1, Lot 2, or Lot 3 vaccine on Day 1 and Day 181 and 1 dose of placebo on Day 61. Participants received 1 dose of placebo on Day 211 to maintain blinding.

To evaluate the effectiveness of 2 doses of the MenABCWY vaccines against rMenB+OMV and MenACWY vaccines, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.

Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.
Overall Number of Participants Analyzed 893 900 1648 178
Measure Type: Count of Participants
Unit of Measure: Participants
SAEs
20
   2.2%
22
   2.4%
25
   1.5%
5
   2.8%
AEs leading to withdrawal
6
   0.7%
4
   0.4%
4
   0.2%
1
   0.6%
AESIs
1
   0.1%
1
   0.1%
6
   0.4%
0
   0.0%
medically attended AEs
238
  26.7%
288
  32.0%
479
  29.1%
44
  24.7%
20.Secondary Outcome
Title Percentage of Participants With 4-fold Rise in hSBA Titers Against N.Meningitidis Group B Strains at 1 Month After Last MenABCWY Dose(ABCWY Group-pooled Lots) and 1 Month After 2-dose(0,2-M) Schedule of rMenB+OMV NZ Relative to Baseline
Hide Description The immunogenicity is measured as percentage of participants achieving a 4-fold rise in hSBA titers against N. meningitidis serogroup B indicator strains (M14459, 96217, M13520 and NZ98/254 for fHbp, NadA, NHBA and PorA P1.4 antigens, respectively). 4-fold rise per each indicator strain was defined as a post-vaccination hSBA titre ≥16 for participants with a pre-vaccination hSBA titre <4; a post-vaccination hSBA titre ≥4 times the LLOQ for participants with a pre-vaccination hSBA titre ≥LOD and <LLOQ; a post-vaccination hSBA titre ≥4 times the pre-vaccination hSBA titre for participants with a pre-vaccination hSBA titre ≥ LLOQ. As pre-specified in the protocol, data reported in this outcome measure were presented for MenB_0_2_6 Group and ABCWY pooled group to evaluate the effectiveness of 2 doses of the MenABCWY vaccines against MenACWY vaccines, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.
Time Frame At 1 month after the vaccination schedule (i.e., Day 211 for the ABCWY_Pooled group and Day 91 for the MenB_0_2_6 Group [2-dose schedule]) compared to Day 1 (Baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Per Protocol Set, which included participants who received at least 1 dose of the study treatment to which they were randomized and have post-vaccination data for the specified analysis at specified timepoints and did not have any protocol deviations that lead to exclusion from the PPS.
Arm/Group Title MenB_0_2_6 Group ABCWY_Pooled
Hide Arm/Group Description:
Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.

Participants received 2 doses of either MenABCWY Lot 1, Lot 2, or Lot 3 vaccine on Day 1 and Day 181 and 1 dose of placebo on Day 61. Participants received 1 dose of placebo on Day 211 to maintain blinding.

To evaluate the effectiveness of 2 doses of the MenABCWY vaccines against rMenB+OMV and MenACWY vaccines, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.

Overall Number of Participants Analyzed 719 678
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
fHbp (M14459) Ab Number Analyzed 719 participants 675 participants
74.7
(71.3 to 77.8)
79.7
(76.5 to 82.7)
NadA (96217) Ab Number Analyzed 717 participants 671 participants
96.4
(94.7 to 97.6)
92.7
(90.5 to 94.5)
NHBA (M13520) Ab Number Analyzed 718 participants 678 participants
58.6
(54.9 to 62.3)
61.9
(58.2 to 65.6)
PorA (NZ98/254) Ab Number Analyzed 704 participants 642 participants
53.3
(49.5 to 57.0)
42.2
(38.4 to 46.1)
21.Secondary Outcome
Title Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY
Hide Description The effectiveness of the 3 dose (0,2,6-M) and 2 dose (0,6-M ) schedule of rMenB+OMV NZ vaccine and 2 doses of MenABCWY vaccine when compared to 1 month after the MenACWY vaccination (Day 31), against a panel of N. meningitidis serogroup B strains is measured in terms of percentage of samples without bactericidal activity using enc-hSBA, which provides a qualitative assessment (yes/no) of the presence of sufficient bactericidal antibodies in human sera to kill a meningococcal strain at a specific dilution of 1:4. As pre-specified in the protocol, data reported in this outcome measure were presented for the MenB_0_2_6 group, MenB_0_6 group,ACWY group and ABCWY pooled group, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.
Time Frame At 1 month after the vaccination schedule (i.e., Day 211 for the MenB_0_2_6 group [3 dose schedule], MenB_0_6 group, ABCWY_Pooled group and Day 31 for the MenACWY group)
Hide Outcome Measure Data
Hide Analysis Population Description

Analysis was performed on blood samples collected from FAS, which included participants who were randomized, received at least one dose of the study treatment, and had post-vaccination effectiveness data available for the specified analysis at the specified time points. Participants were randomly selected for testing against each strain therefore only a subset of participants were tested for each of the strains.

Number of Participants analyzed = Total number of participants included in FAS.

Arm/Group Title MenB_0_2_6 Group MenB_0_6 Group ABCWY_Pooled ACWY Group
Hide Arm/Group Description:
Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.
Participants received 2 doses of rMenB+OMV NZ vaccine on Day 1, and Day 181, 1 dose of MenACWY vaccine on Day 61. Participants received 1 dose of Placebo on Day 211 to maintain blinding.

Participants received 2 doses of either MenABCWY Lot 1, Lot 2, or Lot 3 vaccine on Day 1 and Day 181 and 1 dose of placebo on Day 61. Participants received 1 dose of placebo on Day 211 to maintain blinding.

To evaluate the effectiveness of 2 doses of the MenABCWY vaccines against rMenB+OMV and MenACWY vaccines, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.

Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.
Overall Number of Participants Analyzed 790 813 817 136
Overall Number of Units Analyzed
Type of Units Analyzed: Samples
281 282 288 58
Measure Type: Number
Unit of Measure: Percentage of blood samples
Meningitis B M10713 Ab Number Analyzed 252 Samples 247 Samples 251 Samples 45 Samples
0.4 0.4 1.2 15.6
Meningitis B M08641 Ab Number Analyzed 229 Samples 259 Samples 237 Samples 29 Samples
6.6 6.2 8.0 96.6
Meningitis B M12898 Ab Number Analyzed 242 Samples 265 Samples 249 Samples 41 Samples
8.4 11.4 12.1 68.1
Meningitis B M09150 Ab Number Analyzed 249 Samples 222 Samples 273 Samples 36 Samples
5.2 8.5 12.6 73.0
Meningitis B M09401 Ab Number Analyzed 243 Samples 275 Samples 288 Samples 49 Samples
50.2 46.5 57 98.0
Meningitis B M07463 Ab Number Analyzed 259 Samples 274 Samples 256 Samples 49 Samples
1.5 1.8 3.5 49
Meningitis B M10496 Ab Number Analyzed 263 Samples 261 Samples 257 Samples 47 Samples
54.4 47.9 68.9 100.0
Meningitis B M14530 Ab Number Analyzed 241 Samples 257 Samples 284 Samples 37 Samples
2.1 1.6 3.2 100.0
Meningitis B M15668 Ab Number Analyzed 237 Samples 270 Samples 262 Samples 49 Samples
0.8 2.2 0.8 87.8
Meningitis B M14028 Ab Number Analyzed 246 Samples 282 Samples 283 Samples 37 Samples
2.8 5.7 4.9 100
Meningitis B M09909 Ab Number Analyzed 244 Samples 265 Samples 261 Samples 42 Samples
79.1 83.4 86.2 100.0
Meningitis B M14385 Ab Number Analyzed 235 Samples 237 Samples 259 Samples 43 Samples
0.9 0.8 0.0 16.3
Meningitis B M07992 Ab Number Analyzed 237 Samples 252 Samples 274 Samples 36 Samples
0.4 0.0 0.4 0.0
Meningitis B M09155 Ab Number Analyzed 234 Samples 255 Samples 230 Samples 45 Samples
1.7 2.0 1.3 97.8
Meningitis B M13085 Ab Number Analyzed 256 Samples 253 Samples 255 Samples 44 Samples
13.5 27.5 26.6 69.3
Meningitis B M18303 Ab Number Analyzed 241 Samples 252 Samples 264 Samples 40 Samples
2.9 4.0 9.5 100.0
Meningitis B M18711 Ab Number Analyzed 252 Samples 237 Samples 262 Samples 33 Samples
5.2 4.2 9.5 75.8
Meningitis B M15009 Ab Number Analyzed 262 Samples 254 Samples 242 Samples 37 Samples
11.8 20.5 31.8 86.5
Meningitis B M07773 Ab Number Analyzed 269 Samples 262 Samples 251 Samples 35 Samples
0.7 0.4 0.4 74.3
Meningitis B M09662 Ab Number Analyzed 267 Samples 266 Samples 255 Samples 48 Samples
61.4 50.8 66.3 95.8
Meningitis B M18483 Ab Number Analyzed 228 Samples 233 Samples 222 Samples 37 Samples
3.0 5.1 3.7 72.2
Meningitis B M11906 Ab Number Analyzed 264 Samples 271 Samples 260 Samples 39 Samples
23.7 30.3 39.9 84.7
Meningitis B M14987 Ab Number Analyzed 250 Samples 274 Samples 270 Samples 35 Samples
1.2 8.8 12.7 68.6
Meningitis B M12014 Ab Number Analyzed 249 Samples 270 Samples 254 Samples 46 Samples
0.4 0.7 1.2 67.4
Meningitis B M18200 Ab Number Analyzed 228 Samples 247 Samples 242 Samples 47 Samples
6.3 14.8 14.9 33.7
Meningitis B M08912 Ab Number Analyzed 225 Samples 247 Samples 237 Samples 40 Samples
0.4 0.0 0.0 0.0
Meningitis B M16748 Ab Number Analyzed 262 Samples 252 Samples 260 Samples 45 Samples
0.8 0.0 0 0.0
Meningitis B M08152 Ab Number Analyzed 208 Samples 215 Samples 223 Samples 35 Samples
22.4 25.3 32.8 66.8
Meningitis B M09973 Ab Number Analyzed 252 Samples 270 Samples 247 Samples 48 Samples
0.8 1.1 3.0 83.3
Meningitis B M15352 Ab Number Analyzed 237 Samples 249 Samples 245 Samples 33 Samples
8.9 8.4 17.8 97.0
Meningitis B M15165 Ab Number Analyzed 249 Samples 250 Samples 240 Samples 42 Samples
0.0 1.2 2.1 92.9
Meningitis B M08127 Ab Number Analyzed 269 Samples 250 Samples 287 Samples 51 Samples
0.7 0.4 0.7 84.3
Meningitis B M18347 Ab Number Analyzed 234 Samples 262 Samples 239 Samples 44 Samples
45.4 50.9 51.8 82.1
Meningitis B M12500 Ab Number Analyzed 223 Samples 253 Samples 241 Samples 43 Samples
0.9 2.4 2.5 95.3
Meningitis B M07499 Ab Number Analyzed 242 Samples 251 Samples 256 Samples 51 Samples
70.7 75.7 80.1 100.0
Meningitis B M09960 Ab Number Analyzed 243 Samples 247 Samples 251 Samples 33 Samples
1.2 0 0 3.0
Meningitis B M18045 Ab Number Analyzed 236 Samples 251 Samples 272 Samples 41 Samples
0 0.4 0 92.7
Meningitis B M10548 Ab Number Analyzed 234 Samples 243 Samples 261 Samples 58 Samples
8.1 11.9 12.5 74.1
Meningitis B M09354 Ab Number Analyzed 246 Samples 240 Samples 241 Samples 40 Samples
1.2 1.3 0 80.0
Meningitis B M11051 Ab Number Analyzed 246 Samples 282 Samples 247 Samples 46 Samples
61.0 64.2 66.7 97.8
Meningitis B M10104 Ab Number Analyzed 247 Samples 241 Samples 239 Samples 41 Samples
58.7 52.3 63.5 97.6
Meningitis B M13361 Ab Number Analyzed 258 Samples 268 Samples 250 Samples 34 Samples
0.8 0.4 0.4 85.3
Meningitis B M11042 Ab Number Analyzed 217 Samples 249 Samples 254 Samples 43 Samples
19.8 25.5 33.5 85.7
Meningitis B M18467 Ab Number Analyzed 255 Samples 223 Samples 250 Samples 47 Samples
1.2 0.4 0.8 78.7
Meningitis B M11113 Ab Number Analyzed 255 Samples 253 Samples 269 Samples 51 Samples
30.1 39.5 49.5 75.2
Meningitis B M07253 Ab Number Analyzed 260 Samples 245 Samples 255 Samples 40 Samples
34.7 33.8 50.2 86.4
Meningitis B M07356 Ab Number Analyzed 235 Samples 235 Samples 266 Samples 29 Samples
0.4 0 1.1 41.4
Meningitis B M10710 Ab Number Analyzed 254 Samples 253 Samples 270 Samples 40 Samples
1.6 2.0 1.4 92.5
Meningitis B M17147 Ab Number Analyzed 261 Samples 279 Samples 214 Samples 41 Samples
2.3 5.4 2.3 100
Meningitis B M14401 Ab Number Analyzed 241 Samples 266 Samples 253 Samples 43 Samples
1.7 0.4 1.2 83.7
Meningitis B M14293 Ab Number Analyzed 251 Samples 247 Samples 224 Samples 47 Samples
45.8 25.1 45.2 95.7
Meningitis B M08540 Ab Number Analyzed 258 Samples 261 Samples 222 Samples 34 Samples
1.6 0.8 0 38.2
Meningitis B M07960 Ab Number Analyzed 277 Samples 241 Samples 241 Samples 39 Samples
3.6 4.1 1.8 94.9
Meningitis B M16135 Ab Number Analyzed 254 Samples 230 Samples 257 Samples 41 Samples
0 1.7 0.8 95.1
Meningitis B M14548 Ab Number Analyzed 267 Samples 266 Samples 274 Samples 38 Samples
2.6 3.4 3.2 94.7
Meningitis B M09181 Ab Number Analyzed 228 Samples 276 Samples 240 Samples 43 Samples
0 0.4 0.4 72.1
Meningitis B M14224 Ab Number Analyzed 248 Samples 279 Samples 277 Samples 40 Samples
0.4 0.4 0 82.5
Meningitis B M07452 Ab Number Analyzed 260 Samples 260 Samples 245 Samples 47 Samples
2.7 8.1 17.1 85.1
Meningitis B M13520 Ab Number Analyzed 217 Samples 222 Samples 242 Samples 30 Samples
3.2 0.9 0 66.7
Meningitis B M09385 Ab Number Analyzed 228 Samples 252 Samples 265 Samples 32 Samples
0.4 1.6 0 46.9
Meningitis B M14881 Ab Number Analyzed 240 Samples 278 Samples 277 Samples 40 Samples
4.2 5.8 10 95
Meningitis B M13252 Ab Number Analyzed 279 Samples 241 Samples 262 Samples 50 Samples
0.7 1.2 0.4 98
Meningitis B M07818 Ab Number Analyzed 232 Samples 244 Samples 228 Samples 43 Samples
0.4 0.8 1.3 90.7
Meningitis B M09914 Ab Number Analyzed 281 Samples 257 Samples 258 Samples 49 Samples
85.4 86.8 88.3 98
Meningitis B M15083 Ab Number Analyzed 231 Samples 262 Samples 241 Samples 40 Samples
51.4 56.7 61 84.5
Meningitis B M11290 Ab Number Analyzed 264 Samples 266 Samples 221 Samples 34 Samples
61.4 61.7 67.4 100
Meningitis B M14988 Ab Number Analyzed 241 Samples 269 Samples 246 Samples 40 Samples
0.4 0 1.2 60
Meningitis B M10536 Ab Number Analyzed 228 Samples 223 Samples 260 Samples 36 Samples
19.7 14.3 14.3 91.7
Meningitis B M08959 Ab Number Analyzed 252 Samples 241 Samples 258 Samples 47 Samples
0.8 0.4 1.9 85.1
Meningitis B M08785 Ab Number Analyzed 251 Samples 249 Samples 260 Samples 39 Samples
0.8 0.4 0.4 53.8
Meningitis B M07245 Ab Number Analyzed 238 Samples 248 Samples 230 Samples 43 Samples
0 0 0.9 23.3
Meningitis B M19315 Ab Number Analyzed 262 Samples 254 Samples 255 Samples 34 Samples
3.8 3.1 9.5 79.4
Meningitis B M14376 Ab Number Analyzed 234 Samples 220 Samples 222 Samples 41 Samples
0 1.4 0 92.7
Meningitis B M08994 Ab Number Analyzed 226 Samples 253 Samples 233 Samples 31 Samples
2.5 7.6 6.9 62.7
Meningitis B M11646 Ab Number Analyzed 241 Samples 224 Samples 250 Samples 36 Samples
0 1.3 2 83.3
Meningitis B M13362 Ab Number Analyzed 259 Samples 228 Samples 231 Samples 49 Samples
0 0.4 0.4 81.6
Meningitis B M08080 Ab Number Analyzed 236 Samples 247 Samples 242 Samples 45 Samples
27.4 41 51.6 85.7
Meningitis B M08370 Ab Number Analyzed 265 Samples 262 Samples 251 Samples 43 Samples
2.3 1.5 3.7 97.7
Meningitis B M08129 Ab Number Analyzed 245 Samples 254 Samples 257 Samples 28 Samples
4.1 4.7 7 71.4
Meningitis B M07111 Ab Number Analyzed 231 Samples 254 Samples 270 Samples 33 Samples
0.4 1.2 0.7 90.9
Meningitis B M07537 Ab Number Analyzed 241 Samples 242 Samples 263 Samples 47 Samples
95.9 95.9 97.7 100
Meningitis B M13438 Ab Number Analyzed 255 Samples 262 Samples 282 Samples 50 Samples
1.2 0.8 0 16
Meningitis B M10661 Ab Number Analyzed 246 Samples 275 Samples 273 Samples 33 Samples
2 2.9 2.9 97
Meningitis B M10920 Ab Number Analyzed 247 Samples 252 Samples 275 Samples 34 Samples
29.1 27.8 37.8 91.2
Meningitis B M15564 Ab Number Analyzed 240 Samples 273 Samples 263 Samples 40 Samples
0.4 0.7 0.8 77.5
Meningitis B M10934 Ab Number Analyzed 273 Samples 241 Samples 256 Samples 36 Samples
0.4 0.8 0.8 100
Meningitis B M09400 Ab Number Analyzed 254 Samples 281 Samples 279 Samples 39 Samples
0.8 1.8 0.4 97.4
Meningitis B M08781 Ab Number Analyzed 221 Samples 258 Samples 229 Samples 28 Samples
71.9 74.4 78.2 100
Meningitis B M09173 Ab Number Analyzed 238 Samples 249 Samples 247 Samples 42 Samples
0.4 0.4 0.8 95.2
Meningitis B M14113 Ab Number Analyzed 228 Samples 255 Samples 264 Samples 42 Samples
15.4 21.2 22 100
Meningitis B M08389 Ab Number Analyzed 254 Samples 259 Samples 250 Samples 45 Samples
10.7 7 11.7 87.2
Meningitis B M16822 Ab Number Analyzed 239 Samples 233 Samples 264 Samples 34 Samples
67.8 76.4 82.2 100
Meningitis B M10995 Ab Number Analyzed 268 Samples 258 Samples 239 Samples 47 Samples
5.2 17.8 30.6 85.1
Meningitis B M08780 Ab Number Analyzed 236 Samples 259 Samples 260 Samples 40 Samples
1.3 0.8 1.5 92.5
Meningitis B M09910 Ab Number Analyzed 247 Samples 246 Samples 257 Samples 43 Samples
1.6 1.2 1.2 93
Meningitis B M08320 Ab Number Analyzed 262 Samples 238 Samples 253 Samples 45 Samples
33.6 39.7 43.3 87
Meningitis B M14879 Ab Number Analyzed 239 Samples 242 Samples 247 Samples 47 Samples
2.1 2.1 6.1 21.3
Meningitis B M09345 Ab Number Analyzed 251 Samples 257 Samples 282 Samples 48 Samples
19.3 20.1 33.4 81.2
Meningitis B M14594 Ab Number Analyzed 245 Samples 241 Samples 238 Samples 44 Samples
20.8 27.4 41.2 97.7
Meningitis B M07621 Ab Number Analyzed 251 Samples 260 Samples 263 Samples 40 Samples
1.2 1.2 1.1 77.5
Meningitis B M13568 Ab Number Analyzed 261 Samples 264 Samples 253 Samples 40 Samples
5.4 3.8 3.9 95
Meningitis B M18017 Ab Number Analyzed 246 Samples 247 Samples 258 Samples 31 Samples
0.4 0 1.6 96.8
Meningitis B M08420 Ab Number Analyzed 243 Samples 255 Samples 256 Samples 40 Samples
0.8 0.4 1.6 95
Meningitis B M07959 Ab Number Analyzed 236 Samples 237 Samples 254 Samples 35 Samples
1.7 2.5 1.7 97.1
Meningitis B M06970 Ab Number Analyzed 236 Samples 261 Samples 253 Samples 32 Samples
19.6 17.6 30.2 85.7
Meningitis B M10491 Ab Number Analyzed 239 Samples 262 Samples 227 Samples 39 Samples
5.4 8.4 17 82.1
Meningitis B M13569 Ab Number Analyzed 221 Samples 243 Samples 247 Samples 31 Samples
0.9 2.9 1.2 96.8
Meningitis B M10182 Ab Number Analyzed 229 Samples 234 Samples 256 Samples 44 Samples
0.4 0 0 0
Meningitis B M13547 Ab Number Analyzed 251 Samples 258 Samples 238 Samples 44 Samples
2.4 7 4.7 47.7
Meningitis B M15276 Ab Number Analyzed 231 Samples 231 Samples 259 Samples 41 Samples
0.4 0 1.5 87.8
22.Secondary Outcome
Title Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY
Hide Description The effectiveness of the 2 dose (0,2-M) schedule of rMenB+OMV NZ vaccine when compared to 1 month after the MenACWY vaccination (Day 31), against a panel of N. meningitidis serogroup B strains is measured in terms of percentage of samples without bactericidal activity using enc-hSBA, which provides a qualitative assessment (yes/no) of the presence of sufficient bactericidal antibodies in human sera to kill a meningococcal strain at a specific dilution of 1:4.
Time Frame At 1 month after the vaccination schedule (i.e., Day 91 for the MenB_0_2_6 group [2 dose schedule] and Day 31 for the MenACWY group)
Hide Outcome Measure Data
Hide Analysis Population Description

Analysis was performed on blood samples collected from FAS , which included all participants who were randomized, received at least 1 dose of the study treatment and had post-vaccination effectiveness data available for the specified analysis at the specified time points.

Participants were randomly selected for testing against each strain therefore only a subset of participants were tested for each of the strains.

Number of Participants analyzed = Total number of participants included in FAS.

Arm/Group Title MenB_0_2_6 Group ACWY Group
Hide Arm/Group Description:
Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.
Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.
Overall Number of Participants Analyzed 893 173
Overall Number of Units Analyzed
Type of Units Analyzed: Samples
293 58
Measure Type: Number
Unit of Measure: Percentage of blood samples
Meningitis B M10713 Ab Number Analyzed 266 Samples 45 Samples
1.9 15.6
Meningitis B M08641 Ab Number Analyzed 250 Samples 29 Samples
11.2 96.6
Meningitis B M12898 Ab Number Analyzed 260 Samples 41 Samples
12.4 69
Meningitis B M09150 Ab Number Analyzed 250 Samples 36 Samples
9.3 68.6
Meningitis B M09401 Ab Number Analyzed 253 Samples 49 Samples
47 98
Meningitis B M07463 Ab Number Analyzed 265 Samples 49 Samples
2.6 49
Meningitis B M10496 Ab Number Analyzed 277 Samples 47 Samples
50.5 100
Meningitis B M14530 Ab Number Analyzed 254 Samples 37 Samples
3.9 100
Meningitis B M15668 Ab Number Analyzed 252 Samples 49 Samples
0.4 87.8
Meningitis B M14028 Ab Number Analyzed 257 Samples 37 Samples
5.4 100
Meningitis B M09909 Ab Number Analyzed 266 Samples 42 Samples
82 100
Meningitis B M14385 Ab Number Analyzed 227 Samples 43 Samples
0 16.3
Meningitis B M07992 Ab Number Analyzed 249 Samples 36 Samples
0 0
Meningitis B M09155 Ab Number Analyzed 243 Samples 45 Samples
2.5 97.8
Meningitis B M13085 Ab Number Analyzed 271 Samples 44 Samples
21 66.4
Meningitis B M18303 Ab Number Analyzed 252 Samples 40 Samples
9.1 100
Meningitis B M18711 Ab Number Analyzed 261 Samples 33 Samples
7.7 75.8
Meningitis B M15009 Ab Number Analyzed 243 Samples 37 Samples
22.2 86.5
Meningitis B M07773 Ab Number Analyzed 281 Samples 35 Samples
1.1 74.3
Meningitis B M09662 Ab Number Analyzed 284 Samples 48 Samples
58.1 95.8
Meningitis B M18483 Ab Number Analyzed 234 Samples 37 Samples
4.3 77.3
Meningitis B M11906 Ab Number Analyzed 277 Samples 39 Samples
38.8 85.3
Meningitis B M14987 Ab Number Analyzed 264 Samples 35 Samples
10.7 62.3
Meningitis B M12014 Ab Number Analyzed 267 Samples 46 Samples
0.7 63.2
Meningitis B M18200 Ab Number Analyzed 241 Samples 47 Samples
12.1 34.4
Meningitis B M08912 Ab Number Analyzed 246 Samples 40 Samples
0 0
Meningitis B M16748 Ab Number Analyzed 281 Samples 45 Samples
0 0
Meningitis B M08152 Ab Number Analyzed 224 Samples 35 Samples
35.6 67.2
Meningitis B M09973 Ab Number Analyzed 271 Samples 48 Samples
1.5 83.3
Meningitis B M15352 Ab Number Analyzed 219 Samples 33 Samples
11.9 97
Meningitis B M15165 Ab Number Analyzed 265 Samples 42 Samples
0.8 92.9
Meningitis B M08127 Ab Number Analyzed 285 Samples 51 Samples
0.4 84.3
Meningitis B M18347 Ab Number Analyzed 249 Samples 44 Samples
60.5 80.4
Meningitis B M12500 Ab Number Analyzed 236 Samples 43 Samples
3.4 95.3
Meningitis B M07499 Ab Number Analyzed 259 Samples 51 Samples
81.1 100
Meningitis B M09960 Ab Number Analyzed 251 Samples 33 Samples
4.4 3
Meningitis B M18045 Ab Number Analyzed 247 Samples 41 Samples
0 92.7
Meningitis B M10548 Ab Number Analyzed 244 Samples 58 Samples
11.9 74.1
Meningitis B M09354 Ab Number Analyzed 258 Samples 40 Samples
0.4 80
Meningitis B M11051 Ab Number Analyzed 270 Samples 46 Samples
68.9 97.8
Meningitis B M10104 Ab Number Analyzed 249 Samples 41 Samples
61.8 97.6
Meningitis B M13361 Ab Number Analyzed 269 Samples 34 Samples
0.4 85.3
Meningitis B M11042 Ab Number Analyzed 210 Samples 43 Samples
30.1 84.2
Meningitis B M18467 Ab Number Analyzed 272 Samples 47 Samples
0.4 78.7
Meningitis B M11113 Ab Number Analyzed 273 Samples 51 Samples
43.1 75.6
Meningitis B M07253 Ab Number Analyzed 274 Samples 40 Samples
43.3 85.3
Meningitis B M07356 Ab Number Analyzed 247 Samples 29 Samples
0 41.4
Meningitis B M10710 Ab Number Analyzed 269 Samples 40 Samples
2.2 92.5
Meningitis B M17147 Ab Number Analyzed 274 Samples 41 Samples
5.1 100
Meningitis B M14401 Ab Number Analyzed 251 Samples 43 Samples
0.8 83.7
Meningitis B M14293 Ab Number Analyzed 264 Samples 47 Samples
36.4 95.7
Meningitis B M08540 Ab Number Analyzed 271 Samples 34 Samples
0.4 38.2
Meningitis B M07960 Ab Number Analyzed 292 Samples 39 Samples
4.1 94.9
Meningitis B M16135 Ab Number Analyzed 263 Samples 41 Samples
0.8 95.1
Meningitis B M14548 Ab Number Analyzed 286 Samples 38 Samples
2.8 94.7
Meningitis B M09181 Ab Number Analyzed 252 Samples 43 Samples
0 72.1
Meningitis B M14224 Ab Number Analyzed 268 Samples 40 Samples
0.7 82.5
Meningitis B M07452 Ab Number Analyzed 267 Samples 47 Samples
13.5 85.1
Meningitis B M13520 Ab Number Analyzed 234 Samples 30 Samples
0.9 66.7
Meningitis B M09385 Ab Number Analyzed 230 Samples 32 Samples
2.2 46.9
Meningitis B M14881 Ab Number Analyzed 258 Samples 40 Samples
14.7 95
Meningitis B M13252 Ab Number Analyzed 286 Samples 50 Samples
3.1 98
Meningitis B M07818 Ab Number Analyzed 249 Samples 43 Samples
0.4 90.7
Meningitis B M09914 Ab Number Analyzed 293 Samples 49 Samples
87.7 98
Meningitis B M15083 Ab Number Analyzed 260 Samples 40 Samples
63.7 78
Meningitis B M11290 Ab Number Analyzed 278 Samples 34 Samples
70.5 100
Meningitis B M14988 Ab Number Analyzed 251 Samples 40 Samples
0.4 60
Meningitis B M10536 Ab Number Analyzed 241 Samples 36 Samples
23.2 91.7
Meningitis B M08959 Ab Number Analyzed 267 Samples 47 Samples
0.4 85.1
Meningitis B M08785 Ab Number Analyzed 262 Samples 39 Samples
0.4 53.8
Meningitis B M07245 Ab Number Analyzed 254 Samples 43 Samples
0 23.3
Meningitis B M19315 Ab Number Analyzed 270 Samples 34 Samples
6.3 79.4
Meningitis B M14376 Ab Number Analyzed 269 Samples 41 Samples
0 92.7
Meningitis B M08994 Ab Number Analyzed 233 Samples 31 Samples
8.9 55.7
Meningitis B M11646 Ab Number Analyzed 252 Samples 36 Samples
1.6 83.3
Meningitis B M13362 Ab Number Analyzed 272 Samples 49 Samples
1.5 81.6
Meningitis B M08080 Ab Number Analyzed 244 Samples 45 Samples
46.8 87.1
Meningitis B M08370 Ab Number Analyzed 280 Samples 43 Samples
3.9 97.7
Meningitis B M08129 Ab Number Analyzed 242 Samples 28 Samples
7.4 71.4
Meningitis B M07111 Ab Number Analyzed 244 Samples 33 Samples
0.4 90.9
Meningitis B M07537 Ab Number Analyzed 253 Samples 47 Samples
96.4 100
Meningitis B M13438 Ab Number Analyzed 263 Samples 50 Samples
0.4 16
Meningitis B M10661 Ab Number Analyzed 259 Samples 33 Samples
2.7 97
Meningitis B M10920 Ab Number Analyzed 259 Samples 34 Samples
50.2 91.2
Meningitis B M15564 Ab Number Analyzed 258 Samples 40 Samples
0.8 77.5
Meningitis B M10934 Ab Number Analyzed 286 Samples 36 Samples
0 100
Meningitis B M09400 Ab Number Analyzed 261 Samples 39 Samples
1.1 97.4
Meningitis B M08781 Ab Number Analyzed 223 Samples 28 Samples
75.8 100
Meningitis B M09173 Ab Number Analyzed 244 Samples 42 Samples
0 95.2
Meningitis B M14113 Ab Number Analyzed 244 Samples 42 Samples
28.3 100
Meningitis B M08389 Ab Number Analyzed 258 Samples 45 Samples
1.9 86.7
Meningitis B M16822 Ab Number Analyzed 240 Samples 34 Samples
85 100
Meningitis B M10995 Ab Number Analyzed 282 Samples 47 Samples
16.3 85.1
Meningitis B M08780 Ab Number Analyzed 241 Samples 40 Samples
0.8 92.5
Meningitis B M09910 Ab Number Analyzed 256 Samples 43 Samples
1.2 93
Meningitis B M08320 Ab Number Analyzed 277 Samples 45 Samples
45.1 86.8
Meningitis B M14879 Ab Number Analyzed 252 Samples 47 Samples
3.3 23.2
Meningitis B M09345 Ab Number Analyzed 263 Samples 48 Samples
32.3 74.9
Meningitis B M14594 Ab Number Analyzed 254 Samples 44 Samples
35.8 97.7
Meningitis B M07621 Ab Number Analyzed 259 Samples 40 Samples
0.4 77.5
Meningitis B M13568 Ab Number Analyzed 268 Samples 40 Samples
9.7 95
Meningitis B M18017 Ab Number Analyzed 262 Samples 31 Samples
0 96.8
Meningitis B M08420 Ab Number Analyzed 260 Samples 40 Samples
0.8 95
Meningitis B M07959 Ab Number Analyzed 243 Samples 35 Samples
1.2 97.1
Meningitis B M06970 Ab Number Analyzed 243 Samples 32 Samples
28.8 90.6
Meningitis B M10491 Ab Number Analyzed 254 Samples 39 Samples
16.1 82.1
Meningitis B M13569 Ab Number Analyzed 233 Samples 31 Samples
0.4 96.8
Meningitis B M10182 Ab Number Analyzed 251 Samples 44 Samples
0 0
Meningitis B M13547 Ab Number Analyzed 260 Samples 44 Samples
5 47.7
Meningitis B M15276 Ab Number Analyzed 238 Samples 41 Samples
0.4 87.8
23.Secondary Outcome
Title Percentage of Participants Classified by Percentage of Serogroup B Invasive Disease Strains Killed Using Enc-hSBA in Each Subject at 1 Month After Vaccination Schedule for the MenB_0_2_6 Group [3 Dose], MenB_0_6 Group and Last MenABCWY Dose (Pooled Lots)
Hide Description The percentage of participants classified by percentage of N.meningitidis serogroup B invasive strains killed using enc-hSBA and the corresponding 2- sided 95% CI based on Clopper-Pearson method is calculated for each vaccine group. As pre-specified in the protocol, data reported in this outcome measure were presented for the MenB_0_2_6 group, MenB_0_6 group and ABCWY pooled group, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.
Time Frame At 1 month after the vaccination schedule (Day 211 for MenB_0_2_6 group (3 dose schedule), MenB_0_6 group and ABCWY_Pooled group)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the FAS, which included participants who were randomized, received at least 1 dose of the study treatment and had post-vaccination effectiveness data available for the specified analysis at the specified time points.
Arm/Group Title MenB_0_2_6 Group MenB_0_6 Group ABCWY_Pooled
Hide Arm/Group Description:
Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.
Participants received 2 doses of rMenB+OMV NZ vaccine on Day 1, and Day 181, 1 dose of MenACWY vaccine on Day 61. Participants received 1 dose of Placebo on Day 211 to maintain blinding.

Participants received 2 doses of either MenABCWY Lot 1, Lot 2, or Lot 3 vaccine on Day 1 and Day 181 and 1 dose of placebo on Day 61. Participants received 1 dose of placebo on Day 211 to maintain blinding.

To evaluate the effectiveness of 2 doses of the MenABCWY vaccines against rMenB+OMV and MenACWY vaccines, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.

Overall Number of Participants Analyzed 790 813 817
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
>=50% killed strains
98.7
(97.7 to 99.4)
98.5
(97.4 to 99.2)
98
(96.8 to 98.9)
>=55% killed strains
98.4
(97.2 to 99.1)
97.4
(96.1 to 98.4)
96.8
(95.4 to 97.9)
>=60% killed strains
97.8
(96.6 to 98.7)
96.8
(95.3 to 97.9)
95.2
(93.5 to 96.6)
>=65% killed strains
96.5
(94.9 to 97.6)
93.6
(91.7 to 95.2)
90.1
(87.8 to 92)
>=70% killed strains
93.4
(91.5 to 95)
89.8
(87.5 to 91.8)
84.1
(81.4 to 86.5)
>=75% killed strains
86.8
(84.3 to 89.1)
82.2
(79.4 to 84.7)
74.7
(71.5 to 77.6)
>=80% killed strains
79.2
(76.2 to 82)
75.5
(72.4 to 78.4)
66
(62.6 to 69.2)
>=85% killed strains
62.8
(59.3 to 66.2)
60.4
(56.9 to 63.8)
50.1
(46.6 to 53.5)
>=90% killed strains
43.7
(40.2 to 47.2)
41.3
(37.9 to 44.8)
32.1
(28.9 to 35.4)
>=95% killed strains
22.5
(19.7 to 25.6)
21
(18.3 to 24)
13.7
(11.4 to 16.3)
100% killed strains
10
(8 to 12.3)
8.4
(6.6 to 10.5)
6.1
(4.6 to 8)
24.Secondary Outcome
Title Percentage of Participants Classified by Percentage of Serogroup B Invasive Disease Strains Killed Using Enc-hSBA in Each Subject at 1 Month After Vaccination With rMenB+OMV NZ (0,2-months)
Hide Description The percentage of participants classified by percentage of N.meningitidis serogroup B invasive strains killed using enc-hSBA and the corresponding 2- sided 95% CI based on Clopper-Pearson method is calculated for each vaccine group.
Time Frame At 1 month after the vaccination schedule (Day 91 for MenB_0_2_6 group [2 dose schedule])
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the FAS, which included participants who were randomized, received at least 1 dose of the study treatment, and had post-vaccination effectiveness data available for the specified analysis at the specified time points.
Arm/Group Title MenB_0_2_6 Group
Hide Arm/Group Description:
Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.
Overall Number of Participants Analyzed 831
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
>=50% killed strains
98.6
(97.5 to 99.3)
>=55% killed strains
97.7
(96.5 to 98.6)
>=60% killed strains
96.5
(95 to 97.7)
>=65% killed strains
92.2
(90.1 to 93.9)
>=70% killed strains
84.8
(82.2 to 87.2)
>=75% killed strains
75.7
(72.6 to 78.6)
>=80% killed strains
66.7
(63.3 to 69.9)
>=85% killed strains
49.7
(46.2 to 53.2)
>=90% killed strains
33.8
(30.6 to 37.1)
>=95% killed strains
16.2
(13.8 to 18.9)
100% killed strains
7.7
(6 to 9.7)
25.Secondary Outcome
Title Percentage of Participants With hSBA Titers >= LLOQ for Each and All Serogroup B Indicator Strains at Day 1 and at 1 Month After Vaccination With rMenB+OMV NZ (0,2,6-months and 0,6-months) and Last Dose of MenABCWY (ABCWY Group-pooled Lots)
Hide Description The immune response to rMenB+OMV NZ and MenABCWY vaccine is evaluated by measuring bactericidal activity against each (individual response) and all (composite response) N. meningitidis serogroup B indicator strains(M14459, 96217, M13520 and NZ98/254 for fHbp, NadA, NHBA and PorA P1.4 antigens, respectively). As pre-specified in the protocol, data reported in this outcome measure were presented for the MenB_0_2_6 group, MenB_0_6 group and ABCWY pooled group, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.
Time Frame At Day 1 (pre-vaccination) and1 month after the vaccination schedule (i.e., Day 211 for MenB_0_2_6 group [3 dose schedule], MenB_0_6 group and ABCWY_Pooled group)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Full Analysis Set, which included participants who were randomized, received at least 1 dose of the study treatment, and had post-vaccination effectiveness data available for the specified analysis at the specified time point.
Arm/Group Title MenB_0_2_6 Group MenB_0_6 Group ABCWY_Pooled
Hide Arm/Group Description:
Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.
Participants received 2 doses of rMenB+OMV NZ vaccine on Day 1, and Day 181, 1 dose of MenACWY vaccine on Day 61. Participants received 1 dose of Placebo on Day 211 to maintain blinding.

Participants received 2 doses of either MenABCWY Lot 1, Lot 2, or Lot 3 vaccine on Day 1 and Day 181 and 1 dose of placebo on Day 61. Participants received 1 dose of placebo on Day 211 to maintain blinding.

To evaluate the effectiveness of 2 doses of the MenABCWY vaccines against rMenB+OMV and MenACWY vaccines, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.

Overall Number of Participants Analyzed 749 731 780
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
fHbp (M14459) Ab, Day 1 Number Analyzed 749 participants 730 participants 762 participants
4.9
(3.5 to 6.7)
3.4
(2.2 to 5)
5.4
(3.9 to 7.2)
fHbp (M14459) Ab, Day 211 Number Analyzed 690 participants 707 participants 738 participants
97.4
(95.9 to 98.4)
94.6
(92.7 to 96.2)
95.9
(94.2 to 97.2)
NadA (96217) Ab, Day 1 Number Analyzed 744 participants 731 participants 780 participants
6.2
(4.6 to 8.2)
4.4
(3.0 to 6.1)
6.2
(4.6 to 8.1)
NadA (96217) Ab, Day 211 Number Analyzed 691 participants 707 participants 734 participants
100
(99.5 to 100)
98
(96.7 to 98.9)
96.2
(94.5 to 97.5)
NHBA (M13520) Ab, Day 1 Number Analyzed 749 participants 731 participants 764 participants
23.2
(20.3 to 26.4)
20.9
(18 to 24.1)
18.5
(15.8 to 21.4)
NHBA (M13520) Ab, Day 211 Number Analyzed 695 participants 711 participants 738 participants
97.0
(95.4 to 98.1)
97.5
(96.0 to 98.5)
95.3
(93.5 to 96.7)
PorA (NZ98/254) Ab, Day 1 Number Analyzed 738 participants 716 participants 751 participants
2.3
(1.3 to 3.7)
1.4
(0.7 to 2.6)
2.1
(1.2 to 3.4)
PorA (NZ98/254) Ab, Day 211 Number Analyzed 657 participants 684 participants 709 participants
85.8
(82.9 to 88.4)
82.6
(79.5 to 85.4)
75.3
(72.0 to 78.5)
Composite Response, Day=1 Number Analyzed 727 participants 708 participants 747 participants
1.1
(0.5 to 2.2)
0.6
(0.2 to 1.4)
1.1
(0.5 to 2.1)
Composite Response, Day=211 Number Analyzed 654 participants 683 participants 707 participants
83.3
(80.3 to 86.1)
80.7
(77.5 to 83.6)
71.4
(67.9 to 74.7)
26.Secondary Outcome
Title Percentage of Participants With hSBA Titers >= LLOQ for Each and All Serogroup B Indicator Strains at Day 1 and at 1 Month After Vaccination With rMenB+OMV NZ (0,2-months)
Hide Description The immune response to rMenB+OMV NZ is evaluated by measuring bactericidal activity against each (individual response) and all (composite response) N. meningitidis serogroup B indicator strains (M14459, 96217, M13520 and NZ98/254 for fHbp, NadA, NHBA and PorA P1.4 antigens, respectively).
Time Frame At Day 1 (pre-vaccination) and1 month after the vaccination schedule (i.e., Day 91 for MenB_0_2_6 group [2 dose schedule])
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Full Analysis Set, which included participants who were randomized, received at least 1 dose of the study treatment, and had post-vaccination effectiveness data available for the specified analysis at the specified time points.
Arm/Group Title MenB_0_2_6 Group
Hide Arm/Group Description:
Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.
Overall Number of Participants Analyzed 753
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
fHbp (M14459) Ab, Day 1 Number Analyzed 749 participants
4.9
(3.5 to 6.7)
fHbp (M14459) Ab, Day 91 Number Analyzed 750 participants
92.9
(90.9 to 94.7)
NadA (96217) Ab, Day 1 Number Analyzed 744 participants
6.2
(4.6 to 8.2)
NadA (96217) Ab, Day 91 Number Analyzed 753 participants
99.5
(98.6 to 99.9)
NHBA, Day 1 Number Analyzed 749 participants
23.2
(20.3 to 26.4)
NHBA (M13520) Ab, Day 91 Number Analyzed 750 participants
96.1
(94.5 to 97.4)
PorA N (NZ98/254) Ab, Day 1 Number Analyzed 738 participants
2.3
(1.3 to 3.7)
PorA N (NZ98/254) Ab, Day 91 Number Analyzed 745 participants
80
(76.9 to 82.8)
Composite Response, Day=1 Number Analyzed 727 participants
1.1
(0.5 to 2.2)
Composite Response, Day=91 Number Analyzed 744 participants
75.5
(72.3 to 78.6)
27.Secondary Outcome
Title Percentage of Participants With 4-fold Rise in hSBA Titers for Each of the Serogroup B Strains at 1 Month After Vaccination With rMenB+OMV NZ (0,2,6-months and 0,6-months) and Last Dose of MenABCWY (ABCWY Group-pooled Lots)
Hide Description The immune response to 3 dose (0,2,6-M), 2 dose (0,6-M) schedule of rMenB+OMV NZ and 2 doses of MenABCWY vaccine was evaluated by measuring bactericidal activity against each of the N. meningitidis serogroup B test strains- M14459, 96217, NZ98/254 and M13520 for fHbp, NadA, NHBA and PorA P1.4 antigens, respectively compared to baseline. Four-fold rise per each indicator strain was defined as a post-vaccination hSBA titre ≥16 for subjects with a pre-vaccination hSBA titre <4 a post-vaccination hSBA titer ≥4 times the LLOQ for subjects with a pre-vaccination hSBA titre ≥LOD and <LLOQ a post-vaccination hSBA titre ≥4 times the pre-vaccination hSBA titre for participants with a pre-vaccination hSBA titre ≥ LLOQ. As pre-specified in the protocol, data reported in this outcome measure were presented for the MenB_0_2_6 group, MenB_0_6 group and ABCWY pooled group, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.
Time Frame At 1 month after the vaccination schedule (i.e., Day 211 for MenB_0_2_6 group [3 dose schedule], MenB_0_6 group and ABCWY_Pooled group) compared to Day 1 (baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Full Analysis Set, which included participants who were randomized, received at least 1 dose of the study treatment, and had post-vaccination effectiveness data available for the specified analysis at the specified time points.
Arm/Group Title MenB_0_2_6 Group MenB_0_6 Group ABCWY_Pooled
Hide Arm/Group Description:
Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.
Participants received 2 doses of rMenB+OMV NZ vaccine on Day 1, and Day 181, 1 dose of MenACWY vaccine on Day 61. Participants received 1 dose of Placebo on Day 211 to maintain blinding.

Participants received 2 doses of either MenABCWY Lot 1, Lot 2, or Lot 3 vaccine on Day 1 and Day 181 and 1 dose of placebo on Day 61. Participants received 1 dose of placebo on Day 211 to maintain blinding.

To evaluate the effectiveness of 2 doses of the MenABCWY vaccines against rMenB+OMV and MenACWY vaccines, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.

Overall Number of Participants Analyzed 685 704 731
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
fHbp (M14459) Ab Number Analyzed 679 participants 699 participants 729 participants
86.7
(84.0 to 89.2)
82.4
(79.4 to 85.2)
78.9
(75.7 to 81.8)
NadA (96217) Ab Number Analyzed 679 participants 700 participants 725 participants
98.7
(97.5 to 99.4)
95.3
(93.4 to 96.7)
92.3
(90.1 to 94.1)
NHBA (M13520) Ab Number Analyzed 685 participants 704 participants 731 participants
66.9
(63.2 to 70.4)
69.5
(65.9 to 72.8)
61.1
(57.5 to 64.7)
PorA (NZ98/254) Ab Number Analyzed 637 participants 664 participants 693 participants
56.5
(52.6 to 60.4)
57.2
(53.4 to 61.0)
42.4
(38.7 to 46.2)
28.Secondary Outcome
Title Percentage of Participants With 4-fold Rise in hSBA Titers for Each of the Serogroup B Strains at 1 Month After Vaccination With rMenB+OMV NZ (0,2 Months)
Hide Description The immune response to 2 dose (0,2-M) is evaluated by measuring bactericidal activity against each of the N. meningitidis serogroup B test strains- M14459, 96217, NZ98/254 and M13520 for fHbp, NadA, NHBA and PorA P1.4 antigens, respectively compared to baseline. Four-fold rise per each indicator strain was defined as a post-vaccination hSBA titre ≥16 for participants with a pre-vaccination hSBA titre <4 a post-vaccination hSBA titre ≥4 times the LLOQ for subjects with a pre-vaccination hSBA titre ≥LOD and <LLOQ a post-vaccination hSBA titre ≥4 times the pre-vaccination hSBA titre for subjects with a pre-vaccination hSBA titre ≥ LLOQ.
Time Frame At 1 month after the vaccination schedule (i.e., Day 91 for MenB_0_2_6 [2-dose schedule]) compared to Day 1 (baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Full Analysis Set, which included participants who were randomized, received at least 1 dose of the study treatment, and had post-vaccination effectiveness data available for the specified analysis at the specified time points.
Arm/Group Title MenB_0_2_6 Group
Hide Arm/Group Description:
Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.
Overall Number of Participants Analyzed 739
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
fHbp (M14459) Ab Number Analyzed 739 participants
74.6
(71.3 to 77.7)
NadA (96217) Ab Number Analyzed 738 participants
96.3
(94.7 to 97.6)
NHBA (M13520) Ab Number Analyzed 739 participants
58.5
(54.8 to 62.0)
PorA (NZ98/254) Ab Number Analyzed 724 participants
53.5
(49.7 to 57.1)
29.Secondary Outcome
Title hSBA Geometric Mean Titres (GMTs) Against Each of the N. Meningitidis Serogroup B Strains at Day 1 and at 1 Month After Vaccination With rMenB+OMV NZ (0,2,6-months, 0,6-months) and Last Dose of MenABCWY (ABCWY Group-pooled Lots)
Hide Description The immune response to rMenB+OMV NZ and MenABCWY vaccine was evaluated by measuring bactericidal activity against N. meningitidis serogroup B test strains in terms of GMTs after vaccination compared to baseline (Day 1). For each N. meningitidis serogroup B test strain (M14459, M13520, 96217 and NZ98/254 for fHbp, NadA, NHBA and PorA P1.4 antigens, respectively), The GMTs (After vaccination/baseline) are calculated, with their associated 2-sided 95% CIs. As pre-specified in the protocol, data reported in this outcome measure were presented for the MenB_0_2_6 group, MenB_0_6 group and ABCWY pooled group, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.
Time Frame At Day 1 (pre-vaccination) and at 1 month after the vaccination schedule (i.e., Day 211 for MenB_0_2_6 group (3 dose schedule), MenB_0_6 group and ABCWY_Pooled group)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Full Analysis Set, which included participants who were randomized, received at least 1 dose of the study treatment, and had post-vaccination effectiveness data available for the specified analysis at the specified time points.
Arm/Group Title MenB_0_2_6 Group MenB_0_6 Group ABCWY_Pooled
Hide Arm/Group Description:
Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.
Participants received 2 doses of rMenB+OMV NZ vaccine on Day 1, and Day 181, 1 dose of MenACWY vaccine on Day 61. Participants received 1 dose of Placebo on Day 211 to maintain blinding.

Participants received 2 doses of either MenABCWY Lot 1, Lot 2, or Lot 3 vaccine on Day 1 and Day 181 and 1 dose of placebo on Day 61. Participants received 1 dose of placebo on Day 211 to maintain blinding.

To evaluate the effectiveness of 2 doses of the MenABCWY vaccines against rMenB+OMV and MenACWY vaccines, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.

Overall Number of Participants Analyzed 749 731 780
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
fHbp (M14459) Ab, Day 1 Number Analyzed 749 participants 730 participants 762 participants
2.8
(2.7 to 2.8)
2.7
(2.6 to 2.8)
2.8
(2.7 to 2.9)
fHbp (M14459) Ab, Day 211 Number Analyzed 690 participants 707 participants 738 participants
30.8
(28.3 to 33.5)
28.1
(25.9 to 30.6)
25
(23 to 27.1)
NadA (96217) Ab, Day 1 Number Analyzed 744 participants 731 participants 780 participants
8.4
(8.1 to 8.6)
8.3
(8 to 8.6)
8.5
(8.2 to 8.8)
NadA (96217) Ab, Day 211 Number Analyzed 691 participants 707 participants 734 participants
267.2
(243.7 to 293)
215.1
(196.2 to 235.9)
150.6
(137.3 to 165.2)
NHBA (M13520) Ab, Day 1 Number Analyzed 749 participants 731 participants 764 participants
3.4
(3.1 to 3.7)
3.2
(3 to 3.5)
3.1
(2.8 to 3.4)
NHBA (M13520) Ab, Day 211 Number Analyzed 695 participants 711 participants 738 participants
30.6
(27.7 to 33.7)
33.2
(30.2 to 36.6)
25.2
(22.9 to 27.8)
PorA (NZ98/254) Ab, Day 1 Number Analyzed 738 participants 716 participants 751 participants
3.2
(3.1 to 3.2)
3.1
(3 to 3.2)
3.1
(3.1 to 3.2)
PorA (NZ98/254) Ab, Day 211 Number Analyzed 657 participants 684 participants 709 participants
18.1
(16.3 to 20.1)
17.7
(15.9 to 19.6)
12.9
(11.6 to 14.4)
30.Secondary Outcome
Title hSBA GMTs Against Each of the N. Meningitidis Serogroup B Strains at Day 1 and at 1 Month After Vaccination With rMenB+OMV NZ (0,2-months)
Hide Description The immune response to rMenB+OMV NZ and MenABCWY vaccine was evaluated by measuring bactericidal activity against N. meningitidis serogroup B test strains in terms of GMTs after vaccination compared to baseline (Day 1). For each N. meningitidis serogroup B test strain (M14459, M13520, 96217 and NZ98/254 for fHbp, NadA, NHBA and PorA P1.4 antigens, respectively), The GMTs (After vaccination/baseline) were calculated, with their associated 2-sided 95% CIs.
Time Frame At Day 1 (pre-vaccination) and at 1 month after the vaccination schedule (i.e., Day 91 for MenB_0_2_6 group[2-dose schedule])
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Full Analysis Set, which included all participants who were randomized, received at least 1 dose of the study treatment, and had post-vaccination effectiveness data available for the specified analysis at the specified time points.
Arm/Group Title MenB_0_2_6 Group
Hide Arm/Group Description:
Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.
Overall Number of Participants Analyzed 753
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
fHbp (M14459) Ab, Day 1 Number Analyzed 749 participants
2.8
(2.7 to 2.8)
fHbp (M14459) Ab, Day 91 Number Analyzed 750 participants
20.9
(18.9 to 23.1)
NadA (96217) Ab, Day 1 Number Analyzed 744 participants
8.4
(8.1 to 8.6)
NadA (96217) Ab, Day 91 Number Analyzed 753 participants
178.5
(161.7 to 197.2)
NHBA (M13520) Ab, Day 1 Number Analyzed 749 participants
3.4
(3.1 to 3.7)
NHBA (M13520) Ab, Day 91 Number Analyzed 750 participants
27.2
(24.1 to 30.6)
PorA (NZ98/254) Ab, Day 1 Number Analyzed 738 participants
3.2
(3.1 to 3.2)
PorA (NZ98/254) Ab, Day 91 Number Analyzed 745 participants
17.1
(15.2 to 19.3)
31.Secondary Outcome
Title hSBA Geometric Mean Ratios (GMRs) for Each of the N. Meningitidis Serogroup B Strains at 1 Month After Vaccination With rMenB+OMV NZ (0,2,6-months, 0,6-months) and Last Dose of MenABCWY (ABCWY Group-pooled Lots)
Hide Description The immune response to rMenB+OMV NZ vaccine was evaluated by measuring bactericidal activity against N. meningitidis serogroup B test strains after vaccination compared to baseline (Day 1). For each N. meningitidis serogroup B test strain (M14459, M13520, 96217 and NZ98/254 for fHbp, NadA, NHBA and PorA P1.4 antigens, respectively), the GMRs (after vaccination/baseline) are calculated, with their associated 2-sided 95% CIs. As pre-specified in the protocol, data reported in this outcome measure were presented for the MenB_0_2_6 group, MenB_0_6 group and ABCWY pooled group, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.
Time Frame At 1 month after the vaccination schedule (i.e., Day 211 for MenB_0_2_6 group (3 dose schedule), MenB_0_6 group and ABCWY_Pooled group) compared to Day 1 (baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Full Analysis Set, which included participants who were randomized, received at least 1 dose of the study treatment, and had post-vaccination effectiveness data available for the specified analysis at the specified time points.
Arm/Group Title MenB_0_2_6 Group MenB_0_6 Group ABCWY_Pooled
Hide Arm/Group Description:
Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.
Participants received 2 doses of rMenB+OMV NZ vaccine on Day 1, and Day 181, 1 dose of MenACWY vaccine on Day 61. Participants received 1 dose of Placebo on Day 211 to maintain blinding.

Participants received 2 doses of either MenABCWY Lot 1, Lot 2, or Lot 3 vaccine on Day 1 and Day 181 and 1 dose of placebo on Day 61. Participants received 1 dose of placebo on Day 211 to maintain blinding.

To evaluate the effectiveness of 2 doses of the MenABCWY vaccines against rMenB+OMV and MenACWY vaccines, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.

Overall Number of Participants Analyzed 685 704 731
Geometric Mean (95% Confidence Interval)
Unit of Measure: Ratio
fHbp (M14459) Ab Number Analyzed 679 participants 699 participants 729 participants
11.2
(10.3 to 12.2)
10.5
(9.6 to 11.4)
9
(8.2 to 9.8)
NadA (96217) Ab Number Analyzed 679 participants 700 participants 725 participants
32.1
(29.1 to 35.3)
25.8
(23.5 to 28.4)
17.7
(16 to 19.4)
NHBA (M13520) Ab Number Analyzed 685 participants 704 participants 731 participants
9.1
(8.2 to 10.1)
10.6
(9.5 to 11.7)
8.2
(7.4 to 9.1)
PorA (NZ98/254) Ab Number Analyzed 637 participants 664 participants 693 participants
5.8
(5.2 to 6.5)
5.8
(5.2 to 6.4)
4.1
(3.7 to 4.6)
32.Secondary Outcome
Title hSBA GMRs for Each of the N. Meningitidis Serogroup B Strains at 1 Month After Vaccination With rMenB+OMV NZ (0,2-months)
Hide Description The immune response to rMenB+OMV NZ vaccine was evaluated by measuring bactericidal activity against N. meningitidis serogroup B test strains after vaccination compared to baseline (Day 1). For each N. meningitidis serogroup B test strain (M14459, M13520, 96217 and NZ98/254 for fHbp, NadA, NHBA and PorA P1.4 antigens, respectively), the GMRs (after vaccination/baseline) are calculated, with their associated 2-sided 95% CIs.
Time Frame At 1 month after the vaccination schedule (i.e., Day 91 for MenB_0_2_6 group [2-dose schedule]) compared to Day 1 (baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Full Analysis Set, which included participants who were randomized, received at least 1 dose of the study treatment, and had post-vaccination effectiveness data available for the specified analysis at the specified time points.
Arm/Group Title MenB_0_2_6 Group
Hide Arm/Group Description:
Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.
Overall Number of Participants Analyzed 739
Geometric Mean (95% Confidence Interval)
Unit of Measure: Ratio
fHbp (M14459) Ab Number Analyzed 739 participants
7.7
(6.9 to 8.5)
NadA (96217) Ab Number Analyzed 738 participants
21.7
(19.5 to 24)
NHBA (M13520) Ab Number Analyzed 739 participants
8
(7.1 to 9)
PorA (NZ98/254) Ab Number Analyzed 724 participants
5.5
(4.9 to 6.2)
33.Secondary Outcome
Title Percentage of Participants With hSBA Titers >= LLOQ for Each of the N. Meningitidis Serogroups A,C,W,Y at Day 1 and at 1 Month After the First and the Last MenABCWY Vaccination for ABCWY_Pooled Group and 1 Month After the MenACWY Vaccine for ACWY Group
Hide Description The immune responses to MenABCWY and MenACWY vaccines were evaluated by measuring bactericidal activity against N. meningitidis serogroups A, C, W and Y after vaccination compared to baseline (Day 1) and expressed as the percentage of participants with hSBA titers >= LLOQ for serogroups A, C, W and Y at baseline and 1 month after vaccination schedule of MenABCWY and MenACWY vaccines. As pre-specified in the protocol, data reported in this outcome measure were presented for the ACWY group and ABCWY pooled group, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.
Time Frame At Day 1, and 1 month after vaccination schedule (i.e, at Day 31 for ABCWY group [pooled lots -first dose] and for ACWY Group, and at Day 211 for ABCWY group [pooled lots - second dose])
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Full Analysis Set, which included participants who were randomized, received at least 1 dose of the study treatment, and had post-vaccination effectiveness data available for the specified analysis at the specified time points.
Arm/Group Title ABCWY_Pooled ACWY Group
Hide Arm/Group Description:

Participants received 2 doses of either MenABCWY Lot 1, Lot 2, or Lot 3 vaccine on Day 1 and Day 181 and 1 dose of placebo on Day 61. Participants received 1 dose of placebo on Day 211 to maintain blinding.

To evaluate the effectiveness of 2 doses of the MenABCWY vaccines against rMenB+OMV and MenACWY vaccines, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.

Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.
Overall Number of Participants Analyzed 1489 141
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Men A, Day 1 Number Analyzed 1452 participants 137 participants
9.2
(7.7 to 10.8)
11.7
(6.8 to 18.3)
Men A, Day 31 Number Analyzed 132 participants 133 participants
79.5
(71.7 to 86.1)
90.2
(83.9 to 94.7)
Men A, Day 211 Number Analyzed 1446 participants 0 participants
98.6
(97.9 to 99.2)
Men C, Day 1 Number Analyzed 1487 participants 139 participants
29.8
(27.5 to 32.2)
28.8
(21.4 to 37.1)
Men C, Day 31 Number Analyzed 139 participants 136 participants
74.8
(66.8 to 81.8)
64.0
(55.3 to 72.0)
Men C, Day 211 Number Analyzed 1457 participants 0 participants
99.6
(99.1 to 99.8)
Men W, Day 1 Number Analyzed 1473 participants 140 participants
12.6
(10.9 to 14.4)
12.9
(7.8 to 19.6)
Men W, Day 31 Number Analyzed 142 participants 137 participants
80.3
(72.8 to 86.5)
69.3
(60.9 to 76.9)
Men W, Day 211 Number Analyzed 1463 participants 0 participants
99.2
(98.7 to 99.6)
Men Y, Day 1 Number Analyzed 1489 participants 141 participants
12.2
(10.6 to 14.0)
13.5
(8.3 to 20.2)
Men Y, Day 31 Number Analyzed 146 participants 140 participants
82.2
(75.0 to 88.0)
80.0
(72.4 to 86.3)
Men Y, Day 211 Number Analyzed 1461 participants 0 participants
99.2
(98.7 to 99.6)
34.Secondary Outcome
Title Percentage of Participants With 4-fold Rise in hSBA Titers for Each of the N. Meningitidis Serogroups A, C, W and Y at 1 Month After the First MenABCWY Dose for ABCWY_Pooled Group Compared to the MenACWY Vaccine for ACWY Group Relative to Baseline (Day 1)
Hide Description

The immune response to MenABCWY vaccine compared to MenACWY vaccine was evaluated by measuring bactericidal activity against each of the N. meningitidis serogroups A, C, W and Y at Day 31 compared to baseline (Day 1).

Four-fold rise is defined as:

- If the pre-vaccination hSBA titer is < 4, then post-vaccination hSBA titer should be ≥ 16. - If the pre-vaccination hSBA titer is ≥ LOD but < LLOQ, then post-vaccination hSBA titer should be ≥ 4 times the LLOQ. - If the pre-vaccination hSBA titer is ≥ LLOQ, then post-vaccination hSBA titer should be ≥ 4 times the pre-vaccination hSBA titer. The corresponding 2- sided 95% CI based on Clopper-Pearson method is calculated for each vaccine group. As pre-specified in the protocol, data reported in this outcome measure were presented for the ACWY group and ABCWY pooled group, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.

Time Frame At 1 month after vaccination schedule (i.e, at Day 31 for ABCWY group [pooled group] and for ACWY Group) relative to baseline (Day 1)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Full Analysis Set, which included participants who were randomized, received at least 1 dose of the study treatment, and had post-vaccination effectiveness available for the specified analysis at the specified time points.
Arm/Group Title ABCWY_Pooled ACWY Group
Hide Arm/Group Description:

Participants received 2 doses of either MenABCWY Lot 1, Lot 2, or Lot 3 vaccine on Day 1 and Day 181 and 1 dose of placebo on Day 61. Participants received 1 dose of placebo on Day 211 to maintain blinding.

To evaluate the effectiveness of 2 doses of the MenABCWY vaccines against rMenB+OMV and MenACWY vaccines, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.

Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.
Overall Number of Participants Analyzed 146 140
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Men A Number Analyzed 127 participants 129 participants
74.0
(65.5 to 81.4)
86.0
(78.8 to 91.5)
Men C Number Analyzed 139 participants 134 participants
66.9
(58.4 to 74.6)
56.7
(47.9 to 65.2)
Men W Number Analyzed 139 participants 136 participants
74.1
(66.0 to 81.2)
66.2
(57.6 to 74.1)
Men Y Number Analyzed 146 participants 140 participants
76.0
(68.3 to 82.7)
72.1
(63.9 to 79.4)
35.Secondary Outcome
Title hSBA GMTs Against Each of the N. Meningitidis Serogroups A, C, W and Y at Day 1 and 1 Month After the First and the Last MenABCWY Vaccination for the ABCWY_Pooled Group and at 1 Month After the MenACWY Vaccination for ACWY Group
Hide Description The immune responses to MenABCWY and MenACWY vaccines are evaluated by measuring bactericidal activity against N. meningitidis serogroups A, C, W and Y in terms of GMTs after vaccination compared to baseline (Day 1). For each N. meningitidis serogroups A, C, W and Y, the GMTs (after vaccination/baseline) are calculated, with their associated 2-sided 95% CIs. As pre-specified in the protocol, data reported in this outcome measure were presented for the ACWY group and ABCWY pooled group, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.
Time Frame At Day 1, and 1 month after vaccination schedule (i.e, at Day 31 for ABCWY group [pooled lots -first dose] and for ACWY Group, and at Day 211 for ABCWY group [pooled lots - second dose])
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Hide Analysis Population Description
Analysis was performed on the Full Analysis Set, which included participants who were randomized, received at least 1 dose of the study treatment, and had post-vaccination effectiveness data available for the specified analysis at the specified time points.
Arm/Group Title ABCWY_Pooled ACWY Group
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Participants received 2 doses of either MenABCWY Lot 1, Lot 2, or Lot 3 vaccine on Day 1 and Day 181 and 1 dose of placebo on Day 61. Participants received 1 dose of placebo on Day 211 to maintain blinding.

To evaluate the effectiveness of 2 doses of the MenABCWY vaccines against rMenB+OMV and MenACWY vaccines, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.

Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.
Overall Number of Participants Analyzed 1489 141
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Men A, Day 1 Number Analyzed 1452 participants 137 participants
11.1
(10.3 to 11.9)
12.7
(10.9 to 14.8)
Men A, Day 31 Number Analyzed 132 participants 133 participants
175.3
(121.2 to 253.3)
474.8
(331.3 to 680.3)
Men A, Day 211 Number Analyzed 1446 participants 0 participants
352.0
(322.0 to 384.7)
Men C, Day 1 Number Analyzed 1487 participants 139 participants
12.0
(10.9 to 13.3)
11.4
(9.1 to 14.3)
Men C, Day 31 Number Analyzed 139 participants 136 participants
674.8
(355.9 to 1279.4)
379.0
(204.4 to 703.0)
Men C, Day 211 Number Analyzed 1457 participants 0 participants
1162.5
(1015.7 to 1330.5)
Men W, Day 1 Number Analyzed 1473 participants 140 participants
8.0
(7.4 to 8.7)
7.4
(6.2 to 8.9)
Men W, Day 31 Number Analyzed 142 participants 137 participants
374.0
(243.4 to 574.8)
194.3
(128.3 to 294.2)
Men W, Day 211 Number Analyzed 1463 participants 0 participants
666.5
(603.2 to 736.3)
Men Y, Day 1 Number Analyzed 1489 participants 141 participants
9.3
(8.7 to 10.0)
9.9
(8.6 to 11.5)
Men Y, Day 31 Number Analyzed 146 participants 140 participants
375.4
(246.9 to 570.7)
320.9
(213.8 to 481.7)
Men Y, Day 211 Number Analyzed 1461 participants 0 participants
655.9
(587.0 to 733.0)
36.Secondary Outcome
Title GMRs for Each of the N. Meningitidis Serogroups A, C, W and Y at 1 Month After the First and the Last MenABCWY Vaccination for the ABCWY _Pooled Group and at 1 Month After the MenACWY Vaccination for ACWY Group
Hide Description The immune responses to MenABCWY and MenACWY vaccines are evaluated by measuring bactericidal activity against N. meningitidis serogroups A, C, W and Y. For each N. meningitidis serogroups A, C, W and Y, the GMRs (after vaccination/baseline) are calculated, with their associated 2-sided 95% CIs. As pre-specified in the protocol, data reported in this outcome measure were presented for the ACWY group and ABCWY pooled group, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.
Time Frame 1 month after vaccination schedule (i.e, at Day 31 for ABCWY group [pooled lots -first dose] and for ACWY Group, and at Day 211 for ABCWY group [pooled lots - second dose]) compared to baseline (Day 1)
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Hide Analysis Population Description
Analysis was performed on the Full Analysis Set, which included participants who were randomized, received at least 1 dose of the study treatment, and had post-vaccination effectiveness data available for the specified analysis at the specified time points.
Arm/Group Title ABCWY_Pooled ACWY Group
Hide Arm/Group Description:

Participants received 2 doses of either MenABCWY Lot 1, Lot 2, or Lot 3 vaccine on Day 1 and Day 181 and 1 dose of placebo on Day 61. Participants received 1 dose of placebo on Day 211 to maintain blinding.

To evaluate the effectiveness of 2 doses of the MenABCWY vaccines against rMenB+OMV and MenACWY vaccines, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.

Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.
Overall Number of Participants Analyzed 1446 140
Geometric Mean (95% Confidence Interval)
Unit of Measure: Ratio
Men A, Day 31 Number Analyzed 127 participants 129 participants
11.8
(7.9 to 17.7)
31.8
(21.4 to 47.1)
Men A, Day 211 Number Analyzed 1397 participants 0 participants
31.2
(28.3 to 34.5)
Men C, Day 31 Number Analyzed 139 participants 134 participants
30.9
(16.9 to 56.2)
22.9
(12.8 to 41.1)
Men C, Day 211 Number Analyzed 1439 participants 0 participants
96.9
(84.5 to 111.1)
Men W, Day 31 Number Analyzed 139 participants 136 participants
32.9
(21.7 to 50.0)
23.2
(15.5 to 34.7)
Men W, Day 211 Number Analyzed 1432 participants 0 participants
83.8
(74.9 to 93.8)
Men Y, Day 31 Number Analyzed 146 participants 140 participants
28.1
(18.3 to 43.2)
25.6
(16.9 to 38.8)
Men Y, Day 211 Number Analyzed 1446 participants 0 participants
70.2
(62.3 to 79.1)
37.Secondary Outcome
Title Total Immunoglobulin G (IgG) Antibodies Concentrations Against N. Meningitidis Serogroups A, C, W and Y at Day 1 and 1 Month After the First and the Last MenABCWY Vaccination for ABCWY _Pooled Group and 1 Month After the MenACWY Vaccination for ACWY Group
Hide Description The immune responses to MenABCWY and MenACWY vaccines were evaluated by measuring the total IgG in terms of electrochemiluminescence-based multiplex (ECL) geometric mean concentrations (GMCs) which was an alternative assay to Enzyme-Linked Immunosorbent Assay (ELISA). ECL (validated assay) was used because ELISA is not validated. As pre- specified in the protocol, data reported in this outcome measure were presented for the ACWY group and ABCWY pooled group, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.
Time Frame At Day 1, and 1 month after vaccination schedule (i.e, at Day 31 for ABCWY group [pooled lots -first dose] and for ACWY Group, and at Day 211 for ABCWY group [pooled lots - second dose])
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Hide Analysis Population Description
Analysis was performed on the Full Analysis Set, which included participants who were randomized, received at least 1 dose of the study treatment, and had post-vaccination effectiveness data available for the specified analysis at the specified time points.
Arm/Group Title ACWY Group ABCWY_Pooled
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Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.

Participants received 2 doses of either MenABCWY Lot 1, Lot 2, or Lot 3 vaccine on Day 1 and Day 181 and 1 dose of placebo on Day 61. Participants received 1 dose of placebo on Day 211 to maintain blinding.

To evaluate the effectiveness of 2 doses of the MenABCWY vaccines against rMenB+OMV and MenACWY vaccines, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.

Overall Number of Participants Analyzed 172 179
Geometric Mean (95% Confidence Interval)
Unit of Measure: microgram per milliliter(µg/mL)
Men A, Day 1 Number Analyzed 170 participants 179 participants
2.3
(2.0 to 2.7)
1.9
(1.6 to 2.2)
Men A, Day 31 Number Analyzed 168 participants 177 participants
53.7
(40.8 to 70.7)
18.1
(13.8 to 23.8)
Men A, Day 211 Number Analyzed 0 participants 164 participants
30.2
(23.3 to 39.2)
Men C, Day 1 Number Analyzed 170 participants 179 participants
0.8
(0.7 to 1.0)
0.7
(0.6 to 0.8)
Men C, Day 31 Number Analyzed 170 participants 175 participants
13.8
(10.4 to 18.4)
15.5
(11.6 to 20.7)
Men C, Day 211 Number Analyzed 0 participants 163 participants
17.0
(13.1 to 22.0)
Men W, Day 1 Number Analyzed 170 participants 179 participants
0.6
(0.5 to 0.7)
0.5
(0.4 to 0.6)
Men W, Day 31 Number Analyzed 172 participants 178 participants
8.4
(6.0 to 11.6)
9.1
(6.5 to 12.8)
Men W, Day 211 Number Analyzed 0 participants 164 participants
21.7
(16.0 to 29.5)
Men Y, Day 1 Number Analyzed 170 participants 179 participants
0.9
(0.8 to 1.0)
0.9
(0.7 to 1.0)
Men Y, Day 31 Number Analyzed 172 participants 178 participants
14.3
(10.2 to 19.8)
12.9
(9.2 to 18.0)
Men Y, Day 211 Number Analyzed 0 participants 164 participants
26.3
(19.6 to 35.4)
Time Frame SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title MenB_0_2_6 Group MenB_0_6 Group ACWY Group ABCWY-1 Group ABCWY-2 Group ABCWY-3 Group
Hide Arm/Group Description Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care. Participants received 2 doses of rMenB+OMV NZ vaccine on Day 1, and Day 181, 1 dose of MenACWY vaccine on Day 61. Participants received 1 dose of Placebo on Day 211 to maintain blinding. Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care. Participants received 2 doses of MenABCWY lot 1 vaccine at Day 1 and Day 181 and 2 doses of placebo at Day 61 and Day 211. Participants received 2 doses of MenABCWY lot 2 vaccine at Day 1 and Day 181 and 2 doses of placebo at Day 61 and Day 211 Participants received 2 doses of MenABCWY lot 3 vaccine at Day 1 and Day 181 and 2 doses of placebo at Day 61 and Day 211.
All-Cause Mortality
MenB_0_2_6 Group MenB_0_6 Group ACWY Group ABCWY-1 Group ABCWY-2 Group ABCWY-3 Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/897 (0.11%)      1/906 (0.11%)      0/178 (0.00%)      0/549 (0.00%)      0/554 (0.00%)      0/554 (0.00%)    
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MenB_0_2_6 Group MenB_0_6 Group ACWY Group ABCWY-1 Group ABCWY-2 Group ABCWY-3 Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   20/897 (2.23%)      22/906 (2.43%)      5/178 (2.81%)      8/549 (1.46%)      9/554 (1.62%)      8/554 (1.44%)    
Blood and lymphatic system disorders             
Lymphadenitis  1  0/897 (0.00%)  0 0/906 (0.00%)  0 0/178 (0.00%)  0 0/549 (0.00%)  0 0/554 (0.00%)  0 1/554 (0.18%)  1
Congenital, familial and genetic disorders             
Urachal abnormality  1  1/897 (0.11%)  1 0/906 (0.00%)  0 0/178 (0.00%)  0 0/549 (0.00%)  0 0/554 (0.00%)  0 0/554 (0.00%)  0
Eye disorders             
Hypermetropia  1  1/897 (0.11%)  1 0/906 (0.00%)  0 0/178 (0.00%)  0 0/549 (0.00%)  0 0/554 (0.00%)  0 0/554 (0.00%)  0
Gastrointestinal disorders             
Abdominal pain  1  1/897 (0.11%)  1 0/906 (0.00%)  0 0/178 (0.00%)  0 0/549 (0.00%)  0 0/554 (0.00%)  0 0/554 (0.00%)  0
Colitis ulcerative  1  0/897 (0.00%)  0 1/906 (0.11%)  1 0/178 (0.00%)  0 0/549 (0.00%)  0 0/554 (0.00%)  0 0/554 (0.00%)  0
Nausea  1  0/897 (0.00%)  0 1/906 (0.11%)  1 0/178 (0.00%)  0 0/549 (0.00%)  0 0/554 (0.00%)  0 0/554 (0.00%)  0
Vomiting  1  0/897 (0.00%)  0 1/906 (0.11%)  1 0/178 (0.00%)  0 0/549 (0.00%)  0 0/554 (0.00%)  0 0/554 (0.00%)  0
General disorders             
Chest pain  1  0/897 (0.00%)  0 0/906 (0.00%)  0 1/178 (0.56%)  1 0/549 (0.00%)  0 0/554 (0.00%)  0 0/554 (0.00%)  0
Pyrexia