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Phase 2 Study Of VLA15, A Vaccine Candidate Against Lyme Borreliosis, In A Healthy Pediatric And Adult Study Population

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: NCT04801420
Recruitment Status : Active, not recruiting
First Posted : March 17, 2021
Results First Posted : June 7, 2023
Last Update Posted : April 10, 2024
Sponsor:
Collaborator:
Valneva Austria GmbH
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Lyme Borreliosis
Interventions Biological: VLA15
Biological: Placebo
Enrollment 625
Recruitment Details  
Pre-assignment Details A total of 714 participants were screened of which 89 failed screening and 625 participants were randomized into the study.
Arm/Group Title Group 1: VLA15 Group 2: VLA15 + Placebo Group 3: Placebo
Hide Arm/Group Description Participants aged 5 to 65 years received three intramuscular vaccinations of 180 microgram (mcg) VLA15 at Month 0, 2 and 6 during the Main Study Phase. Eligible participants will receive booster dose of VLA15 at Month 18 during the Booster Phase. Participants aged 5 to 65 years received two intramuscular vaccinations of 180 mcg VLA15 at Month 0 and 6 and a placebo injection at Month 2 during the Main Study Phase. Eligible participants will receive booster dose of VLA15 at Month 18 during the Booster Phase. Participants aged 5 to 65 years received three intramuscular vaccinations of placebo at Month 0, 2 and 6 during the Main Study Phase. Eligible participants will receive placebo injection at Month 18 during the Booster Phase.
Period Title: Overall Study
Started 208 209 208
Completed 0 0 0
Not Completed 208 209 208
Reason Not Completed
Other             1             2             1
Lost to Follow-up             7             9             10
Moved from study area             0             1             1
Withdrawal by Subject             5             1             4
Individual stopping criteria reached             0             1             0
Ongoing in the study             195             195             192
Arm/Group Title Group 1: VLA15 Group 2: VLA15 + Placebo Group 3: Placebo Total
Hide Arm/Group Description Participants aged 5 to 65 years received three intramuscular vaccinations of 180 microgram (mcg) VLA15 at Month 0, 2 and 6 during the Main Study Phase. Eligible participants will receive booster dose of VLA15 at Month 18 during the Booster Phase. Participants aged 5 to 65 years received two intramuscular vaccinations of 180 mcg VLA15 at Month 0 and 6 and a placebo injection at Month 2 during the Main Study Phase. Eligible participants will receive booster dose of VLA15 at Month 18 during the Booster Phase. Participants aged 5 to 65 years received three intramuscular vaccinations of placebo at Month 0, 2 and 6 during the Main Study Phase. Eligible participants will receive placebo injection at Month 18 during the Booster Phase. Total of all reporting groups
Overall Number of Baseline Participants 208 209 208 625
Hide Baseline Analysis Population Description
Full Analysis Set included all participants enrolled who received at least one vaccination. Participants were analyzed according to the study group they were allocated to, rather than by the actual treatment they received.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 208 participants 209 participants 208 participants 625 participants
28.7  (19.08) 28.9  (19.56) 29.0  (19.72) 28.9  (19.42)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 208 participants 209 participants 208 participants 625 participants
Female
112
  53.8%
108
  51.7%
101
  48.6%
321
  51.4%
Male
96
  46.2%
101
  48.3%
107
  51.4%
304
  48.6%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 208 participants 209 participants 208 participants 625 participants
American Indian or Alaska Native
1
   0.5%
0
   0.0%
0
   0.0%
1
   0.2%
Asian
4
   1.9%
3
   1.4%
6
   2.9%
13
   2.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
27
  13.0%
17
   8.1%
24
  11.5%
68
  10.9%
White
172
  82.7%
184
  88.0%
176
  84.6%
532
  85.1%
Unknown or Not Reported
4
   1.9%
5
   2.4%
2
   1.0%
11
   1.8%
1.Primary Outcome
Title Percentage of Participants With Solicited Local and Solicited Systemic Adverse Events (AEs) Within 7 Days After Vaccination 1
Hide Description Participants or their legal guardians were required to record any solicited local and systemic adverse events in the electronic diary. Solicited symptoms were pre-defined symptoms which were collected via an electronic diary. Solicited local AEs included pain, tenderness, erythema (redness), swelling and induration (hardening). Solicited systemic AEs included headache, muscle pain, joint pain, nausea, vomiting, fatigue and fever. Two-sided 95% confidence intervals were calculated according to Altman method.
Time Frame From Day 1 to Day 7 after vaccination 1 at Month 0
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set (SAS) included all participants who entered into the study and received at least one vaccination. Participants were analyzed according to the actual treatment received. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row. Here, "Number Analyzed" signifies participants evaluable for specified rows.
Arm/Group Title Group 1: VLA15 Group 2: VLA15 + Placebo Group 3: Placebo Any VLA15 All Participants
Hide Arm/Group Description:
Participants aged 5 to 65 years received three intramuscular vaccinations of 180 microgram (mcg) VLA15 at Month 0, 2 and 6 during the Main Study Phase. Eligible participants will receive booster dose of VLA15 at Month 18 during the Booster Phase.
Participants aged 5 to 65 years received two intramuscular vaccinations of 180 mcg VLA15 at Month 0 and 6 and a placebo injection at Month 2 during the Main Study Phase. Eligible participants will receive booster dose of VLA15 at Month 18 during the Booster Phase.
Participants aged 5 to 65 years received three intramuscular vaccinations of placebo at Month 0, 2 and 6 during the Main Study Phase. Eligible participants will receive placebo injection at Month 18 during the Booster Phase.
Participants aged 5 to 65 years who received intramuscular vaccinations of 180 mcg VLA15 at either Month 0, 2 or 6 during the Main Study Phase were included. This arm also included participants who received wrong vaccination or missed a vaccination and could not be assigned to Group 1 or 2.
Participants aged 5 to 65 years who received intramuscular vaccination of either 180 mcg VLA15 or placebo during the Main Study Phase were included. This arm also included participants who received wrong vaccination or missed a vaccination.
Overall Number of Participants Analyzed 190 187 208 417 625
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Pain Number Analyzed 184 participants 182 participants 200 participants 402 participants 602 participants
63.0
(55.9 to 69.7)
59.3
(52.1 to 66.2)
12.5
(8.6 to 17.8)
60.4
(55.6 to 65.1)
44.5
(40.6 to 48.5)
Tenderness Number Analyzed 185 participants 184 participants 200 participants 406 participants 606 participants
81.6
(75.4 to 86.5)
84.8
(78.9 to 89.3)
19.5
(14.6 to 25.5)
81.8
(77.7 to 85.2)
61.2
(57.3 to 65.0)
Erythema/redness Number Analyzed 181 participants 181 participants 199 participants 397 participants 596 participants
12.2
(8.2 to 17.7)
14.9
(10.5 to 20.8)
2.5
(1.1 to 5.7)
13.1
(10.1 to 16.8)
9.6
(7.5 to 12.2)
Swelling Number Analyzed 179 participants 181 participants 200 participants 394 participants 594 participants
8.9
(5.6 to 14.0)
8.8
(5.5 to 13.9)
0.5
(0.1 to 2.8)
9.1
(6.7 to 12.4)
6.2
(4.6 to 8.5)
Induration/Hardening Number Analyzed 180 participants 181 participants 199 participants 395 participants 594 participants
10.0
(6.4 to 15.3)
6.6
(3.8 to 11.2)
1.0
(0.3 to 3.6)
8.9
(6.4 to 12.1)
6.2
(4.6 to 8.5)
Headache Number Analyzed 181 participants 180 participants 200 participants 396 participants 596 participants
24.9
(19.1 to 31.6)
21.1
(15.8 to 27.6)
19.5
(14.6 to 25.5)
23.5
(19.6 to 27.9)
22.1
(19.0 to 25.7)
Muscle pain Number Analyzed 183 participants 182 participants 200 participants 401 participants 601 participants
36.1
(29.5 to 43.2)
34.6
(28.1 to 41.8)
11.0
(7.4 to 16.1)
35.7
(31.1 to 40.5)
27.5
(24.0 to 31.2)
Joint pain Number Analyzed 181 participants 180 participants 201 participants 395 participants 596 participants
9.9
(6.4 to 15.2)
3.9
(1.9 to 7.8)
6.5
(3.8 to 10.7)
7.6
(5.4 to 10.6)
7.2
(5.4 to 9.6)
Nausea Number Analyzed 178 participants 180 participants 200 participants 392 participants 592 participants
3.9
(1.9 to 7.9)
6.1
(3.4 to 10.6)
6.0
(3.5 to 10.2)
5.4
(3.5 to 8.1)
5.6
(4.0 to 7.7)
Vomiting Number Analyzed 178 participants 180 participants 199 participants 392 participants 591 participants
1.1
(0.3 to 4.0)
0.6
(0.1 to 3.1)
1.0
(0.3 to 3.6)
0.8
(0.3 to 2.2)
0.8
(0.4 to 2.0)
Fatigue Number Analyzed 179 participants 181 participants 201 participants 395 participants 596 participants
20.7
(15.4 to 27.2)
17.1
(12.3 to 23.3)
16.4
(11.9 to 22.2)
19.7
(16.1 to 24.0)
18.6
(15.7 to 21.9)
Fever Number Analyzed 167 participants 163 participants 188 participants 363 participants 551 participants
1.8
(0.6 to 5.1)
0.0
(0.0 to 2.3)
0.5
(0.1 to 3.0)
1.1
(0.4 to 2.8)
0.9
(0.4 to 2.1)
2.Primary Outcome
Title Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 2
Hide Description Participants or their legal guardians were required to record any solicited local and systemic adverse events in the electronic diary. Solicited symptoms were pre-defined symptoms which were collected via an electronic diary. Solicited local AEs included pain, tenderness, erythema (redness), swelling and induration (hardening). Solicited systemic AEs included headache, muscle pain, joint pain, nausea, vomiting, fatigue and fever. Two-sided 95% confidence intervals were calculated according to Altman method.
Time Frame From Day 1 to Day 7 after vaccination 2 at Month 2
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set (SAS) included all participants who entered into the study and received at least one vaccination. Participants were analyzed according to the actual treatment received. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row. Here, "Number Analyzed" signifies participants evaluable for specified rows.
Arm/Group Title Group 1: VLA15 Group 2: VLA15 + Placebo Group 3: Placebo Any VLA15 All Participants
Hide Arm/Group Description:
Participants aged 5 to 65 years received three intramuscular vaccinations of 180 microgram (mcg) VLA15 at Month 0, 2 and 6 during the Main Study Phase. Eligible participants will receive booster dose of VLA15 at Month 18 during the Booster Phase.
Participants aged 5 to 65 years received two intramuscular vaccinations of 180 mcg VLA15 at Month 0 and 6 and a placebo injection at Month 2 during the Main Study Phase. Eligible participants will receive booster dose of VLA15 at Month 18 during the Booster Phase.
Participants aged 5 to 65 years received three intramuscular vaccinations of placebo at Month 0, 2 and 6 during the Main Study Phase. Eligible participants will receive placebo injection at Month 18 during the Booster Phase.
Participants aged 5 to 65 years who received intramuscular vaccinations of 180 mcg VLA15 at either Month 0, 2 or 6 during the Main Study Phase were included. This arm also included participants who received wrong vaccination or missed a vaccination and could not be assigned to Group 1 or 2.
Participants aged 5 to 65 years who received intramuscular vaccination of either 180 mcg VLA15 or placebo during the Main Study Phase were included. This arm also included participants who received wrong vaccination or missed a vaccination.
Overall Number of Participants Analyzed 190 181 203 399 602
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Pain Number Analyzed 185 participants 177 participants 191 participants 390 participants 581 participants
56.8
(49.6 to 63.7)
7.9
(4.8 to 12.8)
8.4
(5.2 to 13.2)
32.1
(27.6 to 36.8)
24.3
(21.0 to 27.9)
Tenderness Number Analyzed 188 participants 177 participants 193 participants 393 participants 586 participants
81.4
(75.2 to 86.3)
14.7
(10.2 to 20.7)
14.5
(10.2 to 20.2)
47.6
(42.7 to 52.5)
36.7
(32.9 to 40.7)
Erythema/redness Number Analyzed 184 participants 177 participants 191 participants 388 participants 579 participants
15.8
(11.2 to 21.7)
0.0
(0.0 to 2.1)
1.6
(0.5 to 4.5)
7.5
(5.3 to 10.5)
5.5
(3.9 to 7.7)
Swelling Number Analyzed 184 participants 177 participants 191 participants 387 participants 578 participants
11.4
(7.6 to 16.8)
0.0
(0.0 to 2.1)
0.5
(0.1 to 2.9)
5.4
(3.6 to 8.2)
3.8
(2.5 to 5.7)
Induration/Hardening Number Analyzed 185 participants 177 participants 191 participants 390 participants 581 participants
9.2
(5.8 to 14.2)
1.1
(0.3 to 4.0)
0.0
(0.0 to 2.0)
5.4
(3.5 to 8.1)
3.6
(2.4 to 5.5)
Headache Number Analyzed 184 participants 176 participants 192 participants 386 participants 578 participants
16.8
(12.1 to 22.9)
12.5
(8.4 to 18.2)
13.0
(9.0 to 18.5)
15.3
(12.0 to 19.2)
14.5
(11.9 to 17.6)
Muscle pain Number Analyzed 185 participants 176 participants 191 participants 388 participants 579 participants
23.8
(18.2 to 30.4)
4.0
(1.9 to 8.0)
3.7
(1.8 to 7.4)
14.2
(11.1 to 18.0)
10.7
(8.4 to 13.5)
Joint pain Number Analyzed 184 participants 176 participants 191 participants 386 participants 577 participants
4.9
(2.6 to 9.0)
3.4
(1.6 to 7.2)
1.6
(0.5 to 4.5)
4.7
(3.0 to 7.3)
3.6
(2.4 to 5.5)
Nausea Number Analyzed 184 participants 176 participants 193 participants 385 participants 578 participants
4.3
(2.2 to 8.3)
3.4
(1.6 to 7.2)
5.7
(3.2 to 9.9)
3.6
(2.2 to 6.0)
4.3
(2.9 to 6.3)
Vomiting Number Analyzed 184 participants 176 participants 191 participants 385 participants 576 participants
1.1
(0.3 to 3.9)
1.7
(0.6 to 4.9)
0.0
(0.0 to 2.0)
1.3
(0.6 to 3.0)
0.9
(0.4 to 2.0)
Fatigue Number Analyzed 184 participants 176 participants 192 participants 385 participants 577 participants
13.6
(9.4 to 19.3)
9.1
(5.7 to 14.3)
12.0
(8.1 to 17.3)
11.9
(9.1 to 15.6)
12.0
(9.6 to 14.9)
Fever Number Analyzed 176 participants 167 participants 182 participants 368 participants 550 participants
1.7
(0.6 to 4.9)
0.0
(0.0 to 2.2)
0.0
(0.0 to 2.1)
0.8
(0.3 to 2.4)
0.5
(0.2 to 1.6)
3.Primary Outcome
Title Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 3
Hide Description Participants or their legal guardians were required to record any solicited local and systemic adverse events in the electronic diary. Solicited symptoms were pre-defined symptoms which were collected via an electronic diary. Solicited local AEs included pain, tenderness, erythema (redness), swelling and induration (hardening). Solicited systemic AEs included headache, muscle pain, joint pain, nausea, vomiting, fatigue and fever. Two-sided 95% confidence intervals were calculated according to Altman method.
Time Frame From Day 1 to Day 7 after vaccination 3 at Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set (SAS) included all participants who entered into the study and received at least one vaccination. Participants were analyzed according to the actual treatment received. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row. Here, "Number Analyzed" signifies participants evaluable for specified rows.
Arm/Group Title Group 1: VLA15 Group 2: VLA15 + Placebo Group 3: Placebo Any VLA15 All Participants
Hide Arm/Group Description:
Participants aged 5 to 65 years received three intramuscular vaccinations of 180 microgram (mcg) VLA15 at Month 0, 2 and 6 during the Main Study Phase. Eligible participants will receive booster dose of VLA15 at Month 18 during the Booster Phase.
Participants aged 5 to 65 years received two intramuscular vaccinations of 180 mcg VLA15 at Month 0 and 6 and a placebo injection at Month 2 during the Main Study Phase. Eligible participants will receive booster dose of VLA15 at Month 18 during the Booster Phase.
Participants aged 5 to 65 years received three intramuscular vaccinations of placebo at Month 0, 2 and 6 during the Main Study Phase. Eligible participants will receive placebo injection at Month 18 during the Booster Phase.
Participants aged 5 to 65 years who received intramuscular vaccinations of 180 mcg VLA15 at either Month 0, 2 or 6 during the Main Study Phase were included. This arm also included participants who received wrong vaccination or missed a vaccination and could not be assigned to Group 1 or 2.
Participants aged 5 to 65 years who received intramuscular vaccination of either 180 mcg VLA15 or placebo during the Main Study Phase were included. This arm also included participants who received wrong vaccination or missed a vaccination.
Overall Number of Participants Analyzed 190 187 191 384 575
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Pain Number Analyzed 178 participants 178 participants 179 participants 363 participants 542 participants
57.3
(50.0 to 64.3)
62.4
(55.1 to 69.1)
5.6
(3.1 to 10.0)
59.5
(54.4 to 64.4)
41.7
(37.6 to 45.9)
Tenderness Number Analyzed 179 participants 179 participants 179 participants 365 participants 544 participants
74.3
(67.4 to 80.1)
83.2
(77.1 to 88.0)
12.8
(8.7 to 18.5)
78.6
(74.1 to 82.5)
57.0
(52.8 to 61.1)
Erythema/redness Number Analyzed 178 participants 177 participants 179 participants 362 participants 541 participants
10.7
(6.9 to 16.1)
7.9
(4.8 to 12.8)
1.1
(0.3 to 4.0)
9.7
(7.0 to 13.1)
6.8
(5.0 to 9.3)
Swelling Number Analyzed 177 participants 177 participants 179 participants 361 participants 540 participants
7.9
(4.8 to 12.8)
10.2
(6.5 to 15.5)
0.6
(0.1 to 3.1)
9.1
(6.6 to 12.6)
6.3
(4.5 to 8.7)
Induration/Hardening Number Analyzed 177 participants 178 participants 179 participants 362 participants 541 participants
7.9
(4.8 to 12.8)
9.0
(5.6 to 14.1)
0.6
(0.1 to 3.1)
8.3
(5.9 to 11.6)
5.7
(4.1 to 8.0)
Headache Number Analyzed 175 participants 178 participants 180 participants 360 participants 540 participants
16.6
(11.8 to 22.8)
20.8
(15.5 to 27.3)
8.9
(5.5 to 14.0)
18.6
(14.9 to 23.0)
15.4
(12.6 to 18.7)
Muscle pain Number Analyzed 176 participants 179 participants 179 participants 362 participants 541 participants
26.7
(20.7 to 33.7)
29.6
(23.4 to 36.7)
7.8
(4.7 to 12.7)
28.2
(23.8 to 33.0)
21.4
(18.2 to 25.1)
Joint pain Number Analyzed 175 participants 178 participants 180 participants 360 participants 540 participants
6.3
(3.5 to 10.9)
3.9
(1.9 to 7.9)
3.3
(1.5 to 7.1)
5.0
(3.2 to 7.8)
4.4
(3.0 to 6.5)
Nausea Number Analyzed 175 participants 177 participants 179 participants 359 participants 538 participants
2.3
(0.9 to 5.7)
4.0
(1.9 to 7.9)
2.2
(0.9 to 5.6)
3.1
(1.7 to 5.4)
2.8
(1.7 to 4.5)
Vomiting Number Analyzed 175 participants 177 participants 179 participants 359 participants 538 participants
1.1
(0.3 to 4.1)
1.1
(0.3 to 4.0)
0.0
(0.0 to 2.1)
1.1
(0.4 to 2.8)
0.7
(0.3 to 1.9)
Fatigue Number Analyzed 175 participants 178 participants 180 participants 360 participants 540 participants
17.7
(12.8 to 24.0)
16.9
(12.1 to 23.0)
11.7
(7.8 to 17.2)
17.2
(13.7 to 21.5)
15.4
(12.6 to 18.7)
Fever Number Analyzed 169 participants 170 participants 173 participants 346 participants 519 participants
0.0
(0.0 to 2.2)
1.8
(0.6 to 5.1)
0.6
(0.1 to 3.2)
0.9
(0.3 to 2.5)
0.8
(0.3 to 2.0)
4.Primary Outcome
Title Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Any Vaccination During the Main Study Phase
Hide Description Participants or their legal guardians were required to record any solicited local and systemic adverse events in the electronic diary. Solicited symptoms were pre-defined symptoms which were collected via an electronic diary. Solicited local AEs included pain, tenderness, erythema (redness), swelling and induration (hardening). Solicited systemic AEs included headache, muscle pain, joint pain, nausea, vomiting, fatigue and fever. Two-sided 95% confidence intervals were calculated according to Altman method.
Time Frame From Day 1 to Day 7 after vaccination 1, 2 or 3 at Month 0, 2 and 6 respectively
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set (SAS) included all participants who entered into the study and received at least one vaccination. Participants were analyzed according to the actual treatment received. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table and for each specified row.
Arm/Group Title Group 1: VLA15 Group 2: VLA15 + Placebo Group 3: Placebo Any VLA15 All Participants
Hide Arm/Group Description:
Participants aged 5 to 65 years received three intramuscular vaccinations of 180 microgram (mcg) VLA15 at Month 0, 2 and 6 during the Main Study Phase. Eligible participants will receive booster dose of VLA15 at Month 18 during the Booster Phase.
Participants aged 5 to 65 years received two intramuscular vaccinations of 180 mcg VLA15 at Month 0 and 6 and a placebo injection at Month 2 during the Main Study Phase. Eligible participants will receive booster dose of VLA15 at Month 18 during the Booster Phase.
Participants aged 5 to 65 years received three intramuscular vaccinations of placebo at Month 0, 2 and 6 during the Main Study Phase. Eligible participants will receive placebo injection at Month 18 during the Booster Phase.
Participants aged 5 to 65 years who received intramuscular vaccinations of 180 mcg VLA15 at either Month 0, 2 or 6 during the Main Study Phase were included. This arm also included participants who received wrong vaccination or missed a vaccination and could not be assigned to Group 1 or 2.
Participants aged 5 to 65 years who received intramuscular vaccination of either 180 mcg VLA15 or placebo during the Main Study Phase were included. This arm also included participants who received wrong vaccination or missed a vaccination.
Overall Number of Participants Analyzed 190 187 208 417 625
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Pain
80.5
(74.3 to 85.5)
77.0
(70.5 to 82.5)
16.8
(12.4 to 22.5)
77.0
(72.7 to 80.8)
57.0
(53.0 to 60.8)
Tenderness
92.6
(88.0 to 95.6)
92.5
(87.8 to 95.5)
28.4
(22.7 to 34.8)
90.6
(87.5 to 93.1)
69.9
(66.2 to 73.4)
Erythema/Redness
26.8
(21.0 to 33.6)
18.7
(13.8 to 24.9)
3.4
(1.6 to 6.8)
21.8
(18.1 to 26.0)
15.7
(13.0 to 18.7)
Swelling
20.5
(15.4 to 26.8)
16.6
(11.9 to 22.6)
1.4
(0.5 to 4.2)
18.0
(14.6 to 22.0)
12.5
(10.1 to 15.3)
Induration/Hardening
19.5
(14.5 to 25.7)
14.4
(10.1 to 20.2)
1.4
(0.5 to 4.2)
16.5
(13.3 to 20.4)
11.5
(9.2 to 14.3)
Headache
38.4
(31.8 to 45.5)
36.4
(29.8 to 43.5)
28.8
(23.1 to 35.3)
37.4
(32.9 to 42.1)
34.6
(30.9 to 38.4)
Muscle pain
45.8
(38.9 to 52.9)
48.1
(41.1 to 55.3)
17.8
(13.2 to 23.6)
46.8
(42.0 to 51.6)
37.1
(33.4 to 41.0)
Joint pain
15.3
(10.8 to 21.1)
9.6
(6.2 to 14.7)
8.2
(5.2 to 12.7)
13.2
(10.3 to 16.8)
11.5
(9.2 to 14.3)
Nausea
8.4
(5.2 to 13.2)
11.2
(7.5 to 16.6)
9.6
(6.3 to 14.4)
9.6
(7.1 to 12.8)
9.6
(7.5 to 12.2)
Vomiting
3.2
(1.5 to 6.7)
3.2
(1.5 to 6.8)
1.0
(0.3 to 3.4)
2.9
(1.7 to 5.0)
2.2
(1.3 to 3.7)
Fatigue
33.2
(26.9 to 40.1)
29.9
(23.8 to 36.9)
28.4
(22.7 to 34.8)
31.4
(27.1 to 36.0)
30.4
(26.9 to 34.1)
Fever
3.2
(1.5 to 6.7)
1.6
(0.5 to 4.6)
1.0
(0.3 to 3.4)
2.4
(1.3 to 4.4)
1.9
(1.1 to 3.3)
5.Primary Outcome
Title Geometric Mean Titers (GMTs) for Immunoglobulin G (IgG) Against Each Outer Surface Protein A (OspA) Serotype (ST1 to ST6) at Day 208 During the Main Study Phase
Hide Description GMTs for IgG against each OspA serotype ST1 to ST6, determined by an IgG binding assay at Day 208 is presented in this outcome measure.
Time Frame Day 208 (Month 7)
Hide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol Analysis Set (PPAS) consisted of the FAS population excluding those participants with at least one relevant protocol deviation (i.e., a protocol deviation with possible impact on immunogenicity). All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row. Here, "Number Analyzed" signifies participants with available results for each serotype.
Arm/Group Title Group 1: VLA15 Group 2: VLA15 + Placebo Group 3: Placebo
Hide Arm/Group Description:
Participants aged 5 to 65 years received three intramuscular vaccinations of 180 microgram (mcg) VLA15 at Month 0, 2 and 6 during the Main Study Phase. Eligible participants will receive booster dose of VLA15 at Month 18 during the Booster Phase.
Participants aged 5 to 65 years received two intramuscular vaccinations of 180 mcg VLA15 at Month 0 and 6 and a placebo injection at Month 2 during the Main Study Phase. Eligible participants will receive booster dose of VLA15 at Month 18 during the Booster Phase.
Participants aged 5 to 65 years received three intramuscular vaccinations of placebo at Month 0, 2 and 6 during the Main Study Phase. Eligible participants will receive placebo injection at Month 18 during the Booster Phase.
Overall Number of Participants Analyzed 177 162 177
Geometric Mean (95% Confidence Interval)
Unit of Measure: Units per milliliter
ST1 Number Analyzed 172 participants 158 participants 166 participants
333.2
(275.2 to 403.4)
197.3
(156.2 to 249.3)
23.8
(21.6 to 26.2)
ST2 Number Analyzed 172 participants 158 participants 166 participants
656.0
(560.2 to 768.2)
460.3
(370.6 to 571.8)
21.9
(20.2 to 23.7)
ST3 Number Analyzed 172 participants 158 participants 166 participants
586.4
(497.4 to 691.4)
436.2
(344.8 to 551.8)
21.9
(20.2 to 23.8)
ST4 Number Analyzed 172 participants 158 participants 166 participants
422.8
(355.3 to 503.1)
245.8
(196.1 to 308.2)
23.5
(21.3 to 25.8)
ST5 Number Analyzed 172 participants 158 participants 166 participants
443.4
(375.5 to 523.6)
239.4
(190.5 to 301.0)
22.4
(20.6 to 24.4)
ST6 Number Analyzed 172 participants 158 participants 166 participants
429.7
(360.2 to 512.8)
222.0
(177.4 to 277.8)
24.3
(22.1 to 26.7)
6.Secondary Outcome
Title Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Booster Dose
Hide Description Participants or their legal guardians were required to record any solicited local and systemic adverse events in the electronic diary. Solicited local AEs included pain, tenderness, erythema (redness), swelling and induration (hardening). Solicited systemic AEs included headache, muscle pain, joint pain, nausea, vomiting, fatigue and fever.
Time Frame Within 7 days after booster dose
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Percentage of Participants With Serious Adverse Events (SAEs)
Hide Description SAE was any untoward medical occurrence that at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect; was another medically important condition. Two-sided 95% confidence intervals were calculated according to Altman method.
Time Frame From Day 1 of vaccination up to Day 208 (Month 7)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set (SAS) included all participants who entered into the study and received at least one vaccination. Participants were analyzed according to the actual treatment received.
Arm/Group Title Group 1: VLA15 Group 2: VLA15 + Placebo Group 3: Placebo Any VLA15 All Participants
Hide Arm/Group Description:
Participants aged 5 to 65 years received three intramuscular vaccinations of 180 microgram (mcg) VLA15 at Month 0, 2 and 6 during the Main Study Phase. Eligible participants will receive booster dose of VLA15 at Month 18 during the Booster Phase.
Participants aged 5 to 65 years received two intramuscular vaccinations of 180 mcg VLA15 at Month 0 and 6 and a placebo injection at Month 2 during the Main Study Phase. Eligible participants will receive booster dose of VLA15 at Month 18 during the Booster Phase.
Participants aged 5 to 65 years received three intramuscular vaccinations of placebo at Month 0, 2 and 6 during the Main Study Phase. Eligible participants will receive placebo injection at Month 18 during the Booster Phase.
Participants aged 5 to 65 years who received intramuscular vaccinations of 180 mcg VLA15 at either Month 0, 2 or 6 during the Main Study Phase were included. This arm also included participants who received wrong vaccination or missed a vaccination and could not be assigned to Group 1 or 2.
Participants aged 5 to 65 years who received intramuscular vaccination of either 180 mcg VLA15 or placebo during the Main Study Phase were included. This arm also included participants who received wrong vaccination or missed a vaccination.
Overall Number of Participants Analyzed 190 187 208 417 625
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
0.0
(0.0 to 2.0)
1.1
(0.3 to 3.8)
1.9
(0.8 to 4.8)
0.7
(0.2 to 2.1)
1.1
(0.5 to 2.3)
8.Secondary Outcome
Title Percentage of Participants With Adverse Events of Special Interest (AESIs)
Hide Description An AESI (serious or non-serious) was one of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor were appropriate. Two-sided 95% confidence intervals were calculated according to Altman method.
Time Frame From Day 1 of vaccination up to Day 208 (Month 7)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set (SAS) included all participants who entered into the study and received at least one vaccination. Participants were analyzed according to the actual treatment received.
Arm/Group Title Group 1: VLA15 Group 2: VLA15 + Placebo Group 3: Placebo Any VLA15 All Participants
Hide Arm/Group Description:
Participants aged 5 to 65 years received three intramuscular vaccinations of 180 microgram (mcg) VLA15 at Month 0, 2 and 6 during the Main Study Phase. Eligible participants will receive booster dose of VLA15 at Month 18 during the Booster Phase.
Participants aged 5 to 65 years received two intramuscular vaccinations of 180 mcg VLA15 at Month 0 and 6 and a placebo injection at Month 2 during the Main Study Phase. Eligible participants will receive booster dose of VLA15 at Month 18 during the Booster Phase.
Participants aged 5 to 65 years received three intramuscular vaccinations of placebo at Month 0, 2 and 6 during the Main Study Phase. Eligible participants will receive placebo injection at Month 18 during the Booster Phase.
Participants aged 5 to 65 years who received intramuscular vaccinations of 180 mcg VLA15 at either Month 0, 2 or 6 during the Main Study Phase were included. This arm also included participants who received wrong vaccination or missed a vaccination and could not be assigned to Group 1 or 2.
Participants aged 5 to 65 years who received intramuscular vaccination of either 180 mcg VLA15 or placebo during the Main Study Phase were included. This arm also included participants who received wrong vaccination or missed a vaccination.
Overall Number of Participants Analyzed 190 187 208 417 625
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
0.0
(0.0 to 2.0)
0.5
(0.1 to 3.0)
0.0
(0.0 to 1.8)
1.2
(0.5 to 2.8)
0.8
(0.3 to 1.9)
9.Secondary Outcome
Title Percentage of Participants With Unsolicited Adverse Events
Hide Description An AE was any untoward medical occurrence in a participant administered an investigational product, whether or not related to this treatment. Unsolicited AEs were defined as any solicited local or systemic AE if it had an onset date more than 6 days after vaccination or any other symptom or untoward medical event. Two-sided 95% confidence intervals were calculated according to Altman method.
Time Frame From Day 1 to Day 28 after vaccination 1, 2 and 3 at Month 0, 2 and 6, respectively
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set (SAS) included all participants who entered into the study and received at least one vaccination.
Arm/Group Title Group 1: VLA15 Group 2: VLA15 + Placebo Group 3: Placebo Any VLA15 All Participants
Hide Arm/Group Description:
Participants aged 5 to 65 years received three intramuscular vaccinations of 180 microgram (mcg) VLA15 at Month 0, 2 and 6 during the Main Study Phase. Eligible participants will receive booster dose of VLA15 at Month 18 during the Booster Phase.
Participants aged 5 to 65 years received two intramuscular vaccinations of 180 mcg VLA15 at Month 0 and 6 and a placebo injection at Month 2 during the Main Study Phase. Eligible participants will receive booster dose of VLA15 at Month 18 during the Booster Phase.
Participants aged 5 to 65 years received three intramuscular vaccinations of placebo at Month 0, 2 and 6 during the Main Study Phase. Eligible participants will receive placebo injection at Month 18 during the Booster Phase.
Participants aged 5 to 65 years who received intramuscular vaccinations of 180 mcg VLA15 at either Month 0, 2 or 6 during the Main Study Phase were included. This arm also included participants who received wrong vaccination or missed a vaccination and could not be assigned to Group 1 or 2.
Participants aged 5 to 65 years who received intramuscular vaccination of either 180 mcg VLA15 or placebo during the Main Study Phase were included. This arm also included participants who received wrong vaccination or missed a vaccination.
Overall Number of Participants Analyzed 190 187 208 417 625
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
16.8
(12.2 to 22.8)
25.1
(19.5 to 31.8)
24.5
(19.2 to 30.8)
20.9
(17.2 to 25.0)
22.1
(19.0 to 25.5)
10.Secondary Outcome
Title Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group
Hide Description Percentage of participants with SAEs, AESIs, solicited and unsolicited AEs stratified by age group 18 to 65, 12 to 17 and 5 to 11 years were reported. SAE: any untoward medical occurrence that at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect; was another medically important condition. AESI: scientific and medical concern specific to the sponsor's product or program. Solicited AE: predefined reactions at injection site or systemic reactions after each vaccination. Unsolicited AEs: any solicited local or systemic AE if it had an onset date more than 6 days after vaccination or any other symptom or untoward medical event. Unsolicited AEs were collected only up to 28 days after any vaccination. Two-sided 95% confidence intervals were calculated according to Altman method.
Time Frame SAEs, AESIs: From Day 1 of vaccination (vac) up to Day 208 (Month 7), Solicited AEs: From Day 1 to Day 7 after vac 1, 2 and 3 at Month 0, 2 and 6, respectively; Unsolicited AEs: From Day 1 to Day 28 after vac 1, 2 and 3 at Month 0, 2 and 6, respectively
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set (SAS) included all participants who entered into the study and received at least one vaccination. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row. Here, "Number Analyzed" signifies participants evaluable for specified rows.
Arm/Group Title Group 1: VLA15 Group 2: VLA15 + Placebo Group 3: Placebo Any VLA15 All Participants
Hide Arm/Group Description:
Participants aged 5 to 65 years received three intramuscular vaccinations of 180 microgram (mcg) VLA15 at Month 0, 2 and 6 during the Main Study Phase. Eligible participants will receive booster dose of VLA15 at Month 18 during the Booster Phase.
Participants aged 5 to 65 years received two intramuscular vaccinations of 180 mcg VLA15 at Month 0 and 6 and a placebo injection at Month 2 during the Main Study Phase. Eligible participants will receive booster dose of VLA15 at Month 18 during the Booster Phase.
Participants aged 5 to 65 years received three intramuscular vaccinations of placebo at Month 0, 2 and 6 during the Main Study Phase. Eligible participants will receive placebo injection at Month 18 during the Booster Phase.
Participants aged 5 to 65 years who received intramuscular vaccinations of 180 mcg VLA15 at either Month 0, 2 or 6 during the Main Study Phase were included. This arm also included participants who received wrong vaccination or missed a vaccination and could not be assigned to Group 1 or 2.
Participants aged 5 to 65 years who received intramuscular vaccination of either 180 mcg VLA15 or placebo during the Main Study Phase were included. This arm also included participants who received wrong vaccination or missed a vaccination.
Overall Number of Participants Analyzed 190 187 208 417 625
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
SAE: 18 to 65 years Number Analyzed 97 participants 90 participants 107 participants 213 participants 320 participants
0.0
(0.0 to 3.8)
1.1
(0.2 to 6.0)
1.9
(0.5 to 6.6)
0.5
(0.1 to 2.6)
0.9
(0.3 to 2.7)
SAE: 12 to 17 years Number Analyzed 44 participants 48 participants 50 participants 100 participants 150 participants
0.0
(0.0 to 8.0)
0.0
(0.0 to 7.4)
4.0
(1.1 to 13.5)
1.0
(0.2 to 5.4)
2.0
(0.7 to 5.7)
SAE: 5 to 11 years Number Analyzed 49 participants 49 participants 51 participants 104 participants 155 participants
0.0
(0.0 to 7.3)
2.0
(0.4 to 10.7)
0.0
(0.0 to 7.0)
1.0
(0.2 to 5.2)
0.6
(0.1 to 3.6)
AESI: 18 to 65 years Number Analyzed 97 participants 90 participants 107 participants 213 participants 320 participants
0.0
(0.0 to 3.8)
0.0
(0.0 to 4.1)
0.0
(0.0 to 3.5)
0.9
(0.3 to 3.4)
0.6
(0.2 to 2.2)
AESI: 12 to 17 years Number Analyzed 44 participants 48 participants 50 participants 100 participants 150 participants
0.0
(0.0 to 8.0)
0.0
(0.0 to 7.4)
0.0
(0.0 to 7.1)
1.0
(0.2 to 5.4)
0.7
(0.1 to 3.7)
AESI: 5 to 11 years Number Analyzed 49 participants 49 participants 51 participants 104 participants 155 participants
0.0
(0.0 to 7.3)
2.0
(0.4 to 10.7)
0.0
(0.0 to 7.0)
1.9
(0.5 to 6.7)
1.3
(0.4 to 4.6)
Solicited AE: 18 to 65 years Number Analyzed 97 participants 90 participants 107 participants 213 participants 320 participants
94.8
(88.5 to 97.8)
95.6
(89.1 to 98.3)
62.6
(53.2 to 71.2)
93.9
(89.8 to 96.4)
83.4
(79.0 to 87.1)
Solicited AE: 12 to 17 years Number Analyzed 44 participants 48 participants 50 participants 100 participants 150 participants
97.7
(88.2 to 99.6)
93.8
(83.2 to 97.9)
60.0
(46.2 to 72.4)
95.0
(88.8 to 97.8)
83.3
(76.6 to 88.4)
Solicited AE: 5 to 11 years Number Analyzed 49 participants 49 participants 51 participants 104 participants 155 participants
87.8
(75.8 to 94.3)
98.0
(89.3 to 99.6)
64.7
(51.0 to 76.4)
93.3
(86.8 to 96.7)
83.9
(77.3 to 88.8)
Unsolicited AE: 18 to 65 years Number Analyzed 97 participants 90 participants 107 participants 213 participants 320 participants
23.7
(16.4 to 33.1)
30.0
(21.5 to 40.1)
29.0
(21.2 to 38.2)
26.3
(20.8 to 32.6)
27.2
(22.6 to 32.3)
Unsolicited AE: 12 to 17 years Number Analyzed 44 participants 48 participants 50 participants 100 participants 150 participants
18.2
(9.5 to 32.0)
20.8
(11.7 to 34.3)
22.0
(12.8 to 35.2)
19.0
(12.5 to 27.8)
20.0
(14.4 to 27.1)
Unsolicited AE: 5 to 11 years Number Analyzed 49 participants 49 participants 51 participants 104 participants 155 participants
2.0
(0.4 to 10.7)
20.4
(11.5 to 33.6)
17.6
(9.6 to 30.3)
11.5
(6.7 to 19.1)
13.5
(9.0 to 19.8)
11.Secondary Outcome
Title GMTs for IgG Against Each OspA Serotype (ST1 to ST6) at Baseline, Day 85, Day 180 and Day 194 During the Main Study Phase
Hide Description GMTs for IgG against each OspA serotype ST1 to ST6, determined by an IgG binding assay.
Time Frame Baseline, Day 85, Day 180 and Day 194
Outcome Measure Data Not Reported
12.Secondary Outcome
Title Seroconversion Rate for Each OspA Serotype (ST1 to ST6) Specific IgG at Day 85, 180, 194 and 208
Hide Description Seroconversion Rate (SCR) for each OspA serotype specific IgG ST1 to ST6, determined by enzyme linked immunosorbent assay (ELISA). Seroconversion for ELISA was defined as: 1) For participants who were seronegative at screening: percentage of participants with a change from seronegative at screening to seropositive (i.e. antibody titer of >=40 Units per milliliter [U/mL]) at a certain time point. 2) For participants who were seropositive at screening: percentage of participants with a >= 4-fold rise in OspA IgG antibody titer from screening.
Time Frame Day 85, Day 180, Day 194 and Day 208
Outcome Measure Data Not Reported
13.Secondary Outcome
Title Geometric Mean of the Fold Rise (GMFR) for IgG Against Each OspA Serotype (ST1 to ST6) at Day 85 and Day 208 During the Main Study Phase
Hide Description GMFR as compared to baseline for IgG against each OspA serotype ST1 to ST6, determined by IgG binding assay at Day 85 and Day 208.
Time Frame Baseline, Day 85 and 208
Outcome Measure Data Not Reported
14.Secondary Outcome
Title GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group at Baseline, Day 85, Day 180, Day 194 and Day 208 During the Main Study Phase
Hide Description GMTs for IgG against each OspA serotype ST1 to ST6, determined by an IgG binding assay stratified by age group (18 to 65, 12 to 17 and 5 to 11 years).
Time Frame Baseline, Day 85, Day 180, Day 194 (18 to 65 years only) and Day 208
Outcome Measure Data Not Reported
15.Secondary Outcome
Title Seroconversion Rate for Each OspA Serotype (ST1 to ST6) Specific IgG at Day 85, 180, 194 and 208 Stratified by Age Group During the Main Study Phase
Hide Description SCR for each OspA serotype specific IgG ST1 to ST6, determined by ELISA stratified by age group (18 to 65, 12 to 17 and 5 to 11 years). Seroconversion for ELISA was defined as: 1) For participants who were seronegative at screening: percentage of participants with a change from seronegative at screening to seropositive (i.e. antibody titer of >=40 Units per milliliter [U/mL]) at a certain time point. 2) For participants who were seropositive at screening: percentage of participants with a >= 4-fold rise in OspA IgG antibody titer from screening.
Time Frame Day 85, Day 180, Day 194 (18 to 65 years only) and Day 208
Outcome Measure Data Not Reported
16.Secondary Outcome
Title Geometric Mean of the Fold Rise (GMFR) for IgG Against Each OspA Serotype (ST1 to ST6) at Day 85, Day 180, Day 194 and Day 208 Stratified by Age Group During the Main Study Phase
Hide Description GMFR as compared to baseline for IgG against each OspA serotype ST1 to ST6, stratified by age group (18 to 65, 12 to 17 and 5 to 11 years) determined by IgG binding assay at Day 85, Day 180, Day 194 (18 to 65 years only) and Day 208.
Time Frame Baseline, Day 85, Day 180, Day 194 (18 to 65 years only) and Day 208
Outcome Measure Data Not Reported
17.Secondary Outcome
Title GMTs for IgG Against Each OspA Serotype (ST1 to ST6) During the Booster Phase
Hide Description [Not Specified]
Time Frame Up to Month 54
Outcome Measure Data Not Reported
18.Secondary Outcome
Title SCR for Each OspA Serotype (ST1 to ST6) IgG During the Booster Phase
Hide Description Seroconversion for ELISA was defined as: 1) For participants who were seronegative at screening: a change from seronegative at screening to seropositive (i.e. antibody titer of >=40 U/mL) at a certain time point. 2) For participants who were seropositive at screening: a >= 4-fold rise in OspA IgG antibody titer from screening.
Time Frame Up to Month 54
Outcome Measure Data Not Reported
19.Secondary Outcome
Title GMFR for IgG Against Each OspA Serotype (ST1 to ST6) at Month 19 During the Booster Phase
Hide Description [Not Specified]
Time Frame Month 19
Outcome Measure Data Not Reported
20.Secondary Outcome
Title GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Cohort During the Booster Phase
Hide Description [Not Specified]
Time Frame Up to Month 54
Outcome Measure Data Not Reported
21.Secondary Outcome
Title SCR for Each OspA Serotype (ST1 to ST6) IgG Stratified by Age Cohort During the Booster Phase
Hide Description Seroconversion for ELISA was defined as: 1) For participants who were seronegative at screening: a change from seronegative at screening to seropositive (i.e. antibody titer of >=40 U/mL) at a certain time point. 2) For participants who were seropositive at screening: a >= 4-fold rise in OspA IgG antibody titer from screening.
Time Frame Up to Month 54
Outcome Measure Data Not Reported
22.Secondary Outcome
Title GMFR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Cohort During the Booster Phase
Hide Description [Not Specified]
Time Frame Up to Month 54
Outcome Measure Data Not Reported
Time Frame Solicited AEs (systematic assessment): From Day 1 to Day 7 after vaccination 1, 2 and 3 at Month 0, 2 and 6, respectively; unsolicited AEs (non-systematic assessment): From Day 1 to Day 28 after vaccination 1, 2 and 3, at Month 0, 2 and 6, respectively, all-cause mortality, AESIs and serious AEs (non-systematic assessment): From Day 1 of vaccination up to Day 208 (Month 7).
Adverse Event Reporting Description Solicited AEs comprised injection site reactions (pain, tenderness, erythema [redness]), induration [hardening], swelling, or systemic reactions (headache, muscle pain, joint pain, fever, nausea, vomiting, fatigue). Solicited AEs were collected by systematic assessment through participant e-diaries. Safety Analysis Set: participants who entered into study and received at least 1 dose of vaccination. Participants were analyzed according to the actual treatment received.
 
Arm/Group Title Group 1: VLA15 Group 2: VLA15 + Placebo Group 3: Placebo Any VLA15 All Participants
Hide Arm/Group Description Participants aged 5 to 65 years received three intramuscular vaccinations of 180 microgram (mcg) VLA15 at Month 0, 2 and 6 during the Main Study Phase. Eligible participants received booster dose of VLA15 at Month 18 during the Booster Phase. Participants aged 5 to 65 years received two intramuscular vaccinations of 180 mcg VLA15 at Month 0 and 6 and a placebo injection at Month 2 during the Main Study Phase. Eligible participants will receive booster dose of VLA15 at Month 18 during the Booster Phase. Participants aged 5 to 65 years received three intramuscular vaccinations of placebo at Month 0, 2 and 6 during the Main Study Phase. Eligible participants will receive placebo injection at Month 18 during the Booster Phase. Participants aged 5 to 65 years who received intramuscular vaccinations of 180 mcg VLA15 at either Month 0, 2 or 6 during the Main Study Phase were included. This arm also included participants who received wrong vaccination or missed a vaccination and could not be assigned to Group 1 or 2. Participants aged 5 to 65 years who received intramuscular vaccination of either 180 mcg VLA15 or placebo during the Main Study Phase were included. This arm also included participants who received wrong vaccination or missed a vaccination.
All-Cause Mortality
Group 1: VLA15 Group 2: VLA15 + Placebo Group 3: Placebo Any VLA15 All Participants
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/190 (0.00%)      0/187 (0.00%)      0/208 (0.00%)      0/417 (0.00%)      0/625 (0.00%)    
Hide Serious Adverse Events
Group 1: VLA15 Group 2: VLA15 + Placebo Group 3: Placebo Any VLA15 All Participants
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/190 (0.00%)      2/187 (1.07%)      4/208 (1.92%)      3/417 (0.72%)      7/625 (1.12%)    
Infections and infestations           
Cellulitis * 1  0/190 (0.00%)  0 0/187 (0.00%)  0 1/208 (0.48%)  1 0/417 (0.00%)  0 1/625 (0.16%)  1
Injury, poisoning and procedural complications           
Concussion * 1  0/190 (0.00%)  0 1/187 (0.53%)  1 0/208 (0.00%)  0 1/417 (0.24%)  1 1/625 (0.16%)  1
Metabolism and nutrition disorders           
Type 1 diabetes mellitus * 1  0/190 (0.00%)  0 0/187 (0.00%)  0 0/208 (0.00%)  0 1/417 (0.24%)  1 1/625 (0.16%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Prostate cancer * 1  0/190 (0.00%)  0 0/187 (0.00%)  0 1/208 (0.48%)  1 0/417 (0.00%)  0 1/625 (0.16%)  1
Psychiatric disorders           
Major depression * 1  0/190 (0.00%)  0 1/187 (0.53%)  1 0/208 (0.00%)  0 1/417 (0.24%)  1 1/625 (0.16%)  1
Reactive attachment disorder of infancy or early childhood * 1  0/190 (0.00%)  0 0/187 (0.00%)  0 1/208 (0.48%)  1 0/417 (0.00%)  0 1/625 (0.16%)  1
Suicidal ideation * 1  0/190 (0.00%)  0 0/187 (0.00%)  0 1/208 (0.48%)  2 0/417 (0.00%)  0 1/625 (0.16%)  2
1
Term from vocabulary, MedDRA 25.0
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Group 1: VLA15 Group 2: VLA15 + Placebo Group 3: Placebo Any VLA15 All Participants
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   178/190 (93.68%)      179/187 (95.72%)      133/208 (63.94%)      391/417 (93.76%)      524/625 (83.84%)    
Gastrointestinal disorders           
Nausea † 1  16/190 (8.42%)  19 21/187 (11.23%)  25 20/208 (9.62%)  27 40/417 (9.59%)  47 60/625 (9.60%)  74
General disorders           
Injection site pain † 1  177/190 (93.16%)  760 176/187 (94.12%)  561 67/208 (32.21%)  141 384/417 (92.09%)  1385 451/625 (72.16%)  1526
Fatigue † 1  63/190 (33.16%)  93 55/187 (29.41%)  77 59/208 (28.37%)  78 129/417 (30.94%)  186 188/625 (30.08%)  264
Injection site erythema † 1  74/190 (38.95%)  118 62/187 (33.16%)  86 18/208 (8.65%)  23 147/417 (35.25%)  215 165/625 (26.40%)  238
Injection site swelling † 1  64/190 (33.68%)  89 55/187 (29.41%)  67 13/208 (6.25%)  14 125/417 (29.98%)  162 138/625 (22.08%)  176
Injection site induration † 1  56/190 (29.47%)  86 50/187 (26.74%)  61 10/208 (4.81%)  12 113/417 (27.10%)  158 123/625 (19.68%)  170
Musculoskeletal and connective tissue disorders           
Myalgia † 1  87/190 (45.79%)  158 90/187 (48.13%)  122 37/208 (17.79%)  43 195/417 (46.76%)  300 232/625 (37.12%)  343
Arthralgia † 1  29/190 (15.26%)  38 19/187 (10.16%)  22 18/208 (8.65%)  23 57/417 (13.67%)  71 75/625 (12.00%)  94
Nervous system disorders           
Headache † 1  74/190 (38.95%)  106 68/187 (36.36%)  98 63/208 (30.29%)  83 157/417 (37.65%)  220 220/625 (35.20%)  303
1
Term from vocabulary, MedDRA 25.0
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
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Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer Inc.
Phone: 1-800-718-1021 ext 0
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT04801420    
Other Study ID Numbers: VLA15-221
C4601008 ( Other Identifier: Alias Study Number )
First Submitted: March 8, 2021
First Posted: March 17, 2021
Results First Submitted: March 24, 2023
Results First Posted: June 7, 2023
Last Update Posted: April 10, 2024