Trial Outcomes & Findings for Safety and Immunogenicity of Catch-up Vaccination Regimens of V114 (V114-024) (NCT NCT03885934)
NCT ID: NCT03885934
Last Updated: 2023-01-13
Results Overview
The geometric mean concentration (GMC) of immunoglobulin G (IgG) serotype-specific antibodies to the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13®; and two serotypes (22F and 33F) which are unique to V114 was determined. Sera from participants was used to measure vaccine-induced anti-pneumococcal polysaccharides (PnPs) serotype-specific IgG for all the 15 serotypes using pneumococcal electrochemiluminescence (PnECL) assay. The within-group 95% confidence intervals (CIs) were derived by exponentiating the CIs of the mean of the natural log values based on the t-distribution.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
606 participants
Primary outcome timeframe
30 days post last vaccination
Results posted on
2023-01-13
Participant Flow
A total of approximately 600 participants were planned for enrollment. Randomization was stratified by age and pneumococcal conjugate vaccine (PCV) history.
Participant milestones
| Measure |
V114, Schedule A: Participants 7-11 Months
Each participant received a 0.5 mL intramuscular (IM) injection for 7 to 11 months of age (Pneumococcal conjugate vaccine \[PCV\]-naïve)(3 doses). Dose 1: at randomization, Dose 2: 4 to 8 weeks after Dose 1, and Dose 3: 8 to 12 weeks after Dose 2 and ≥12 months of age.
|
Prevnar 13®, Schedule A: Participants 7-11 Months
Each participant received a 0.5 mL IM injection for 7 to 11 months of age (PCV-naïve)(3 doses). Dose 1: at randomization, Dose 2: 4 to 8 weeks after Dose 1, and Dose 3: 8 to 12 weeks after Dose 2 and ≥12 months of age.
|
V114, Schedule B: Participants 12-23 Months
Each participant received a 0.5 mL IM injection for 12 to 23 months of age (PCV-naïve)(2 doses). Dose 1: at randomization, and Dose 2: 8 to 12 weeks after Dose 1.
|
Prevnar 13®, Schedule B: Participants 12-23 Months
Each participant received a 0.5 mL IM injection for 12 to 23 months of age (PCV-naïve)(2 doses). Dose 1: at randomization, and Dose 2: 8 to 12 weeks after Dose 1.
|
V114, Schedule C: Participants 2-17 Years
Each participant received a 0.5 mL IM injection for 2 to 17 years of age (PCV-naïve or PCV-experienced) (1 dose). Single dose administered at randomization and at least 8 weeks after previous PCV for participants who were PCV-experienced.
|
Prevnar 13®, Schedule C: Participants 2-17 Years
Each participant received a 0.5 mL IM injection for 2 to 17 years of age (PCV-naïve or PCV-experienced)(1 dose). Single dose administered at randomization and at least 8 weeks after previous PCV for participants who were PCV-experienced.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
64
|
64
|
62
|
64
|
177
|
175
|
|
Overall Study
PCV Dose 1
|
64
|
64
|
62
|
64
|
177
|
175
|
|
Overall Study
PCV Dose 2
|
63
|
64
|
62
|
64
|
0
|
0
|
|
Overall Study
PCV Dose 3
|
63
|
64
|
0
|
0
|
0
|
0
|
|
Overall Study
COMPLETED
|
63
|
64
|
62
|
64
|
177
|
175
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
V114, Schedule A: Participants 7-11 Months
Each participant received a 0.5 mL intramuscular (IM) injection for 7 to 11 months of age (Pneumococcal conjugate vaccine \[PCV\]-naïve)(3 doses). Dose 1: at randomization, Dose 2: 4 to 8 weeks after Dose 1, and Dose 3: 8 to 12 weeks after Dose 2 and ≥12 months of age.
|
Prevnar 13®, Schedule A: Participants 7-11 Months
Each participant received a 0.5 mL IM injection for 7 to 11 months of age (PCV-naïve)(3 doses). Dose 1: at randomization, Dose 2: 4 to 8 weeks after Dose 1, and Dose 3: 8 to 12 weeks after Dose 2 and ≥12 months of age.
|
V114, Schedule B: Participants 12-23 Months
Each participant received a 0.5 mL IM injection for 12 to 23 months of age (PCV-naïve)(2 doses). Dose 1: at randomization, and Dose 2: 8 to 12 weeks after Dose 1.
|
Prevnar 13®, Schedule B: Participants 12-23 Months
Each participant received a 0.5 mL IM injection for 12 to 23 months of age (PCV-naïve)(2 doses). Dose 1: at randomization, and Dose 2: 8 to 12 weeks after Dose 1.
|
V114, Schedule C: Participants 2-17 Years
Each participant received a 0.5 mL IM injection for 2 to 17 years of age (PCV-naïve or PCV-experienced) (1 dose). Single dose administered at randomization and at least 8 weeks after previous PCV for participants who were PCV-experienced.
|
Prevnar 13®, Schedule C: Participants 2-17 Years
Each participant received a 0.5 mL IM injection for 2 to 17 years of age (PCV-naïve or PCV-experienced)(1 dose). Single dose administered at randomization and at least 8 weeks after previous PCV for participants who were PCV-experienced.
|
|---|---|---|---|---|---|---|
|
Overall Study
Withdrawn by Parent/Guardian
|
1
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Safety and Immunogenicity of Catch-up Vaccination Regimens of V114 (V114-024)
Baseline characteristics by cohort
| Measure |
V114, Schedule A: Participants 7-11 Months
n=64 Participants
Each participant received a 0.5 mL intramuscular (IM) injection for 7 to 11 months of age (Pneumococcal conjugate vaccine \[PCV\]-naïve)(3 doses). Dose 1: at randomization, Dose 2: 4 to 8 weeks after Dose 1, and Dose 3: 8 to 12 weeks after Dose 2 and ≥12 months of age.
|
Prevnar 13®, Schedule A: Participants 7-11 Months
n=64 Participants
Each participant received a 0.5 mL IM injection for 7 to 11 months of age (PCV-naïve)(3 doses). Dose 1: at randomization, Dose 2: 4 to 8 weeks after Dose 1, and Dose 3: 8 to 12 weeks after Dose 2 and ≥12 months of age.
|
V114, Schedule B: Participants 12-23 Months
n=62 Participants
Each participant received a 0.5 mL IM injection for 12 to 23 months of age (PCV-naïve)(2 doses). Dose 1: at randomization, and Dose 2: 8 to 12 weeks after Dose 1.
|
Prevnar 13®, Schedule B: Participants 12-23 Months
n=64 Participants
Each participant received a 0.5 mL IM injection for 12 to 23 months of age (PCV-naïve)(2 doses). Dose 1: at randomization, and Dose 2: 8 to 12 weeks after Dose 1.
|
V114, Schedule C: Participants 2-17 Years
n=177 Participants
Each participant received a 0.5 mL IM injection for 2 to 17 years of age (PCV-naïve or PCV-experienced) (1 dose). Single dose administered at randomization and at least 8 weeks after previous PCV for participants who were PCV-experienced.
|
Prevnar 13®, Schedule C: Participants 2-17 Years
n=175 Participants
Each participant received a 0.5 mL IM injection for 2 to 17 years of age (PCV-naïve or PCV-experienced)(1 dose). Single dose administered at randomization and at least 8 weeks after previous PCV for participants who were PCV-experienced.
|
Total
n=606 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Customized
7-11 Months
|
64 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
128 Participants
n=115 Participants
|
|
Age, Customized
12-23 Months
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
64 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
126 Participants
n=115 Participants
|
|
Age, Customized
≥2 to <6 Years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
114 Participants
n=21 Participants
|
112 Participants
n=10 Participants
|
226 Participants
n=115 Participants
|
|
Age, Customized
≥6 to 17 Years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
63 Participants
n=21 Participants
|
63 Participants
n=10 Participants
|
126 Participants
n=115 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
85 Participants
n=21 Participants
|
83 Participants
n=10 Participants
|
298 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
92 Participants
n=21 Participants
|
92 Participants
n=10 Participants
|
308 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
64 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
63 Participants
n=4 Participants
|
176 Participants
n=21 Participants
|
174 Participants
n=10 Participants
|
603 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Asian
|
53 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
53 Participants
n=4 Participants
|
60 Participants
n=21 Participants
|
56 Participants
n=10 Participants
|
327 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
117 Participants
n=21 Participants
|
118 Participants
n=10 Participants
|
278 Participants
n=115 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: 30 days post last vaccinationPopulation: The analysis population included all randomized participants without deviations from the protocol that may substantially affect the results of the immunogenicity endpoint.
The geometric mean concentration (GMC) of immunoglobulin G (IgG) serotype-specific antibodies to the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13®; and two serotypes (22F and 33F) which are unique to V114 was determined. Sera from participants was used to measure vaccine-induced anti-pneumococcal polysaccharides (PnPs) serotype-specific IgG for all the 15 serotypes using pneumococcal electrochemiluminescence (PnECL) assay. The within-group 95% confidence intervals (CIs) were derived by exponentiating the CIs of the mean of the natural log values based on the t-distribution.
Outcome measures
| Measure |
Prevnar 13®, Schedule C: Participants 2-17 Years
n=64 Participants
Each participant received a 0.5 mL IM injection for 2 to 17 years of age (PCV-naïve or PCV-experienced)(1 dose). Single dose administered at randomization and at least 8 weeks after previous PCV for participants who were PCV-experienced.
|
V114, Schedule A: Participants 7-11 Months
n=64 Participants
Each participant received a 0.5 mL intramuscular (IM) injection for 7 to 11 months of age (Pneumococcal conjugate vaccine \[PCV\]-naïve)(3 doses). Dose 1: at randomization, Dose 2: 4 to 8 weeks after Dose 1, and Dose 3: 8 to 12 weeks after Dose 2 and ≥12 months of age.
|
|---|---|---|
|
Geometric Mean Concentration of Serotype-specific Immunoglobulin G - Schedule A: 7-11 Months
Serotype 1
|
3.66 μg/mL
Interval 2.98 to 4.5
|
2.47 μg/mL
Interval 2.09 to 2.92
|
|
Geometric Mean Concentration of Serotype-specific Immunoglobulin G - Schedule A: 7-11 Months
Serotype 3
|
1.71 μg/mL
Interval 1.4 to 2.08
|
2.65 μg/mL
Interval 2.3 to 3.05
|
|
Geometric Mean Concentration of Serotype-specific Immunoglobulin G - Schedule A: 7-11 Months
Serotype 4
|
3.85 μg/mL
Interval 3.12 to 4.76
|
2.21 μg/mL
Interval 1.82 to 2.68
|
|
Geometric Mean Concentration of Serotype-specific Immunoglobulin G - Schedule A: 7-11 Months
Serotype 5
|
4.56 μg/mL
Interval 3.58 to 5.8
|
3.82 μg/mL
Interval 3.14 to 4.63
|
|
Geometric Mean Concentration of Serotype-specific Immunoglobulin G - Schedule A: 7-11 Months
Serotype 6A
|
4.30 μg/mL
Interval 3.28 to 5.65
|
2.23 μg/mL
Interval 1.71 to 2.91
|
|
Geometric Mean Concentration of Serotype-specific Immunoglobulin G - Schedule A: 7-11 Months
Serotype 6B
|
4.17 μg/mL
Interval 3.25 to 5.36
|
3.03 μg/mL
Interval 2.41 to 3.82
|
|
Geometric Mean Concentration of Serotype-specific Immunoglobulin G - Schedule A: 7-11 Months
Serotype 7F
|
6.42 μg/mL
Interval 5.25 to 7.85
|
5.16 μg/mL
Interval 4.27 to 6.23
|
|
Geometric Mean Concentration of Serotype-specific Immunoglobulin G - Schedule A: 7-11 Months
Serotype 9V
|
3.59 μg/mL
Interval 2.86 to 4.51
|
2.61 μg/mL
Interval 2.09 to 3.26
|
|
Geometric Mean Concentration of Serotype-specific Immunoglobulin G - Schedule A: 7-11 Months
Serotype 14
|
13.07 μg/mL
Interval 10.4 to 16.42
|
9.62 μg/mL
Interval 7.94 to 11.67
|
|
Geometric Mean Concentration of Serotype-specific Immunoglobulin G - Schedule A: 7-11 Months
Serotype 18C
|
3.50 μg/mL
Interval 2.75 to 4.45
|
3.45 μg/mL
Interval 2.8 to 4.24
|
|
Geometric Mean Concentration of Serotype-specific Immunoglobulin G - Schedule A: 7-11 Months
Serotype 19A
|
5.81 μg/mL
Interval 4.92 to 6.85
|
4.59 μg/mL
Interval 3.95 to 5.33
|
|
Geometric Mean Concentration of Serotype-specific Immunoglobulin G - Schedule A: 7-11 Months
Serotype 19F
|
4.83 μg/mL
Interval 4.03 to 5.79
|
3.49 μg/mL
Interval 2.94 to 4.15
|
|
Geometric Mean Concentration of Serotype-specific Immunoglobulin G - Schedule A: 7-11 Months
Serotype 23F
|
2.79 μg/mL
Interval 2.1 to 3.69
|
2.62 μg/mL
Interval 2.02 to 3.39
|
|
Geometric Mean Concentration of Serotype-specific Immunoglobulin G - Schedule A: 7-11 Months
Serotype 22F
|
0.14 μg/mL
Interval 0.1 to 0.19
|
9.04 μg/mL
Interval 7.48 to 10.93
|
|
Geometric Mean Concentration of Serotype-specific Immunoglobulin G - Schedule A: 7-11 Months
Serotype 33F
|
0.13 μg/mL
Interval 0.1 to 0.16
|
3.37 μg/mL
Interval 2.78 to 4.1
|
PRIMARY outcome
Timeframe: 30 days post last vaccinationPopulation: The analysis population included all randomized participants without deviations from the protocol that may substantially affect the results of the immunogenicity endpoint.
The GMC of IgG serotype-specific antibodies to the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13®; and two serotypes (22F and 33F) which are unique to V114 was determined. Sera from participants was used to measure vaccine-induced anti-PnPs serotype-specific IgG for all the 15 serotypes using pneumococcal electrochemiluminescence (PnECL) assay. The within-group 95% CIs were derived by exponentiating the CIs of the mean of the natural log values based on the t-distribution.
Outcome measures
| Measure |
Prevnar 13®, Schedule C: Participants 2-17 Years
n=64 Participants
Each participant received a 0.5 mL IM injection for 2 to 17 years of age (PCV-naïve or PCV-experienced)(1 dose). Single dose administered at randomization and at least 8 weeks after previous PCV for participants who were PCV-experienced.
|
V114, Schedule A: Participants 7-11 Months
n=62 Participants
Each participant received a 0.5 mL intramuscular (IM) injection for 7 to 11 months of age (Pneumococcal conjugate vaccine \[PCV\]-naïve)(3 doses). Dose 1: at randomization, Dose 2: 4 to 8 weeks after Dose 1, and Dose 3: 8 to 12 weeks after Dose 2 and ≥12 months of age.
|
|---|---|---|
|
GMC of Serotype-specific IgG - Schedule B: 12-23 Months
Serotype 1
|
4.20 μg/mL
Interval 3.3 to 5.34
|
3.83 μg/mL
Interval 3.07 to 4.77
|
|
GMC of Serotype-specific IgG - Schedule B: 12-23 Months
Serotype 3
|
1.68 μg/mL
Interval 1.29 to 2.2
|
2.96 μg/mL
Interval 2.44 to 3.58
|
|
GMC of Serotype-specific IgG - Schedule B: 12-23 Months
Serotype 4
|
4.89 μg/mL
Interval 3.76 to 6.36
|
3.46 μg/mL
Interval 2.67 to 4.5
|
|
GMC of Serotype-specific IgG - Schedule B: 12-23 Months
Serotype 5
|
3.12 μg/mL
Interval 2.52 to 3.88
|
3.39 μg/mL
Interval 2.65 to 4.34
|
|
GMC of Serotype-specific IgG - Schedule B: 12-23 Months
Serotype 6A
|
3.73 μg/mL
Interval 2.64 to 5.29
|
2.05 μg/mL
Interval 1.3 to 3.23
|
|
GMC of Serotype-specific IgG - Schedule B: 12-23 Months
Serotype 6B
|
2.87 μg/mL
Interval 1.92 to 4.3
|
2.69 μg/mL
Interval 1.7 to 4.25
|
|
GMC of Serotype-specific IgG - Schedule B: 12-23 Months
Serotype 7F
|
5.42 μg/mL
Interval 4.3 to 6.82
|
4.80 μg/mL
Interval 3.63 to 6.34
|
|
GMC of Serotype-specific IgG - Schedule B: 12-23 Months
Serotype 9V
|
2.89 μg/mL
Interval 2.21 to 3.78
|
2.48 μg/mL
Interval 1.97 to 3.11
|
|
GMC of Serotype-specific IgG - Schedule B: 12-23 Months
Serotype 14
|
8.30 μg/mL
Interval 6.56 to 10.51
|
8.23 μg/mL
Interval 6.19 to 10.94
|
|
GMC of Serotype-specific IgG - Schedule B: 12-23 Months
Serotype 18C
|
3.68 μg/mL
Interval 2.85 to 4.75
|
5.09 μg/mL
Interval 3.98 to 6.52
|
|
GMC of Serotype-specific IgG - Schedule B: 12-23 Months
Serotype 19A
|
5.87 μg/mL
Interval 4.85 to 7.11
|
6.74 μg/mL
Interval 5.29 to 8.6
|
|
GMC of Serotype-specific IgG - Schedule B: 12-23 Months
Serotype 19F
|
5.92 μg/mL
Interval 4.93 to 7.11
|
5.90 μg/mL
Interval 4.69 to 7.43
|
|
GMC of Serotype-specific IgG - Schedule B: 12-23 Months
Serotype 23F
|
2.18 μg/mL
Interval 1.54 to 3.07
|
2.85 μg/mL
Interval 1.99 to 4.07
|
|
GMC of Serotype-specific IgG - Schedule B: 12-23 Months
Serotype 22F
|
0.12 μg/mL
Interval 0.09 to 0.16
|
15.90 μg/mL
Interval 12.16 to 20.78
|
|
GMC of Serotype-specific IgG - Schedule B: 12-23 Months
Serotype 33F
|
0.15 μg/mL
Interval 0.12 to 0.19
|
5.17 μg/mL
Interval 3.96 to 6.74
|
PRIMARY outcome
Timeframe: 30 days post vaccinationPopulation: The analysis population included all randomized participants without deviations from the protocol that may substantially affect the results of the immunogenicity endpoint.
The GMC of IgG serotype-specific antibodies to the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13®; and two serotypes (22F and 33F) which are unique to V114 was determined. Sera from participants was used to measure vaccine-induced anti-PnPs serotype-specific IgG for all the 15 serotypes using pneumococcal electrochemiluminescence (PnECL) assay. The within-group 95% CIs were derived by exponentiating the CIs of the mean of the natural log values based on the t-distribution.
Outcome measures
| Measure |
Prevnar 13®, Schedule C: Participants 2-17 Years
n=175 Participants
Each participant received a 0.5 mL IM injection for 2 to 17 years of age (PCV-naïve or PCV-experienced)(1 dose). Single dose administered at randomization and at least 8 weeks after previous PCV for participants who were PCV-experienced.
|
V114, Schedule A: Participants 7-11 Months
n=177 Participants
Each participant received a 0.5 mL intramuscular (IM) injection for 7 to 11 months of age (Pneumococcal conjugate vaccine \[PCV\]-naïve)(3 doses). Dose 1: at randomization, Dose 2: 4 to 8 weeks after Dose 1, and Dose 3: 8 to 12 weeks after Dose 2 and ≥12 months of age.
|
|---|---|---|
|
GMC of Serotype-specific IgG - Schedule C: 2-17 Years
Serotype 1
|
3.99 μg/mL
Interval 3.48 to 4.58
|
3.00 μg/mL
Interval 2.6 to 3.46
|
|
GMC of Serotype-specific IgG - Schedule C: 2-17 Years
Serotype 3
|
1.03 μg/mL
Interval 0.88 to 1.21
|
1.37 μg/mL
Interval 1.19 to 1.58
|
|
GMC of Serotype-specific IgG - Schedule C: 2-17 Years
Serotype 4
|
5.22 μg/mL
Interval 4.52 to 6.03
|
2.53 μg/mL
Interval 2.17 to 2.96
|
|
GMC of Serotype-specific IgG - Schedule C: 2-17 Years
Serotype 5
|
4.24 μg/mL
Interval 3.46 to 5.2
|
3.43 μg/mL
Interval 2.89 to 4.07
|
|
GMC of Serotype-specific IgG - Schedule C: 2-17 Years
Serotype 6A
|
8.81 μg/mL
Interval 6.96 to 11.14
|
9.03 μg/mL
Interval 7.07 to 11.53
|
|
GMC of Serotype-specific IgG - Schedule C: 2-17 Years
Serotype 6B
|
10.51 μg/mL
Interval 8.01 to 13.78
|
13.55 μg/mL
Interval 10.52 to 17.46
|
|
GMC of Serotype-specific IgG - Schedule C: 2-17 Years
Serotype 7F
|
4.63 μg/mL
Interval 3.92 to 5.46
|
4.03 μg/mL
Interval 3.46 to 4.7
|
|
GMC of Serotype-specific IgG - Schedule C: 2-17 Years
Serotype 9V
|
4.35 μg/mL
Interval 3.65 to 5.2
|
3.60 μg/mL
Interval 3.06 to 4.24
|
|
GMC of Serotype-specific IgG - Schedule C: 2-17 Years
Serotype 14
|
8.04 μg/mL
Interval 6.24 to 10.36
|
9.21 μg/mL
Interval 7.11 to 11.92
|
|
GMC of Serotype-specific IgG - Schedule C: 2-17 Years
Serotype 18C
|
4.46 μg/mL
Interval 3.76 to 5.3
|
7.16 μg/mL
Interval 6.03 to 8.52
|
|
GMC of Serotype-specific IgG - Schedule C: 2-17 Years
Serotype 19A
|
14.90 μg/mL
Interval 12.23 to 18.16
|
10.99 μg/mL
Interval 9.12 to 13.26
|
|
GMC of Serotype-specific IgG - Schedule C: 2-17 Years
Serotype 19F
|
12.28 μg/mL
Interval 10.07 to 14.97
|
8.95 μg/mL
Interval 7.45 to 10.76
|
|
GMC of Serotype-specific IgG - Schedule C: 2-17 Years
Serotype 23F
|
5.12 μg/mL
Interval 4.12 to 6.37
|
5.36 μg/mL
Interval 4.41 to 6.5
|
|
GMC of Serotype-specific IgG - Schedule C: 2-17 Years
Serotype 22F
|
0.31 μg/mL
Interval 0.24 to 0.38
|
14.99 μg/mL
Interval 12.73 to 17.66
|
|
GMC of Serotype-specific IgG - Schedule C: 2-17 Years
Serotype 33F
|
0.27 μg/mL
Interval 0.22 to 0.32
|
4.89 μg/mL
Interval 4.12 to 5.8
|
PRIMARY outcome
Timeframe: Up to 14 days post any vaccinationPopulation: The analysis population included all randomized participants who received at least 1 dose of study intervention.
An adverse event (AE) is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. The parent/guardian of the participant recorded the presence of any vaccination report card (VRC)-prompted injection-site AEs that occurred in the 14 days after any vaccination. The percentage of participants with an injection-site AE prompted on the VRC (redness/erythema, hardness/induration, swelling, and pain) was summarized.
Outcome measures
| Measure |
Prevnar 13®, Schedule C: Participants 2-17 Years
n=64 Participants
Each participant received a 0.5 mL IM injection for 2 to 17 years of age (PCV-naïve or PCV-experienced)(1 dose). Single dose administered at randomization and at least 8 weeks after previous PCV for participants who were PCV-experienced.
|
V114, Schedule A: Participants 7-11 Months
n=64 Participants
Each participant received a 0.5 mL intramuscular (IM) injection for 7 to 11 months of age (Pneumococcal conjugate vaccine \[PCV\]-naïve)(3 doses). Dose 1: at randomization, Dose 2: 4 to 8 weeks after Dose 1, and Dose 3: 8 to 12 weeks after Dose 2 and ≥12 months of age.
|
|---|---|---|
|
Percentage of Participants With Solicited Injection-site Adverse Events - Schedule A: 7-11 Months
Redness/Erythema
|
34.4 Percentage of Participants
Interval 22.9 to 47.3
|
28.1 Percentage of Participants
Interval 17.6 to 40.8
|
|
Percentage of Participants With Solicited Injection-site Adverse Events - Schedule A: 7-11 Months
Hardness/Induration
|
14.1 Percentage of Participants
Interval 6.6 to 25.0
|
17.2 Percentage of Participants
Interval 8.9 to 28.7
|
|
Percentage of Participants With Solicited Injection-site Adverse Events - Schedule A: 7-11 Months
Pain
|
7.8 Percentage of Participants
Interval 2.6 to 17.3
|
18.8 Percentage of Participants
Interval 10.1 to 30.5
|
|
Percentage of Participants With Solicited Injection-site Adverse Events - Schedule A: 7-11 Months
Swelling
|
15.6 Percentage of Participants
Interval 7.8 to 26.9
|
18.8 Percentage of Participants
Interval 10.1 to 30.5
|
PRIMARY outcome
Timeframe: Up to 14 days post any vaccinationPopulation: The analysis population included all randomized participants who received at least 1 dose of study intervention.
An AE is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. The parent/guardian of the participant recorded the presence of any vaccination report card (VRC)-prompted injection-site AEs that occurred in the 14 days after any vaccination. The percentage of participants with an injection-site AE prompted on the VRC (redness/erythema, hardness/induration, swelling, and pain) was summarized.
Outcome measures
| Measure |
Prevnar 13®, Schedule C: Participants 2-17 Years
n=64 Participants
Each participant received a 0.5 mL IM injection for 2 to 17 years of age (PCV-naïve or PCV-experienced)(1 dose). Single dose administered at randomization and at least 8 weeks after previous PCV for participants who were PCV-experienced.
|
V114, Schedule A: Participants 7-11 Months
n=62 Participants
Each participant received a 0.5 mL intramuscular (IM) injection for 7 to 11 months of age (Pneumococcal conjugate vaccine \[PCV\]-naïve)(3 doses). Dose 1: at randomization, Dose 2: 4 to 8 weeks after Dose 1, and Dose 3: 8 to 12 weeks after Dose 2 and ≥12 months of age.
|
|---|---|---|
|
Percentage of Participants With Solicited Injection-site AEs - Schedule B: 12-23 Months
Redness/Erythema
|
21.9 Percentage of Participants
Interval 12.5 to 34.0
|
21.0 Percentage of Participants
Interval 11.7 to 33.2
|
|
Percentage of Participants With Solicited Injection-site AEs - Schedule B: 12-23 Months
Hardness/Induration
|
9.4 Percentage of Participants
Interval 3.5 to 19.3
|
8.1 Percentage of Participants
Interval 2.7 to 17.8
|
|
Percentage of Participants With Solicited Injection-site AEs - Schedule B: 12-23 Months
Pain
|
23.4 Percentage of Participants
Interval 13.8 to 35.7
|
33.9 Percentage of Participants
Interval 22.3 to 47.0
|
|
Percentage of Participants With Solicited Injection-site AEs - Schedule B: 12-23 Months
Swelling
|
12.5 Percentage of Participants
Interval 5.6 to 23.2
|
14.5 Percentage of Participants
Interval 6.9 to 25.8
|
PRIMARY outcome
Timeframe: Up to 14 days post vaccinationPopulation: The analysis population included all randomized participants who received 1 dose of study intervention.
An AE is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. The parent/guardian of the participant recorded the presence of any vaccination report card (VRC)-prompted injection-site AEs that occurred in the 14 days after any vaccination. The percentage of participants with an injection-site AE prompted on the VRC (redness/erythema, hardness/induration, swelling, and pain) was summarized.
Outcome measures
| Measure |
Prevnar 13®, Schedule C: Participants 2-17 Years
n=175 Participants
Each participant received a 0.5 mL IM injection for 2 to 17 years of age (PCV-naïve or PCV-experienced)(1 dose). Single dose administered at randomization and at least 8 weeks after previous PCV for participants who were PCV-experienced.
|
V114, Schedule A: Participants 7-11 Months
n=177 Participants
Each participant received a 0.5 mL intramuscular (IM) injection for 7 to 11 months of age (Pneumococcal conjugate vaccine \[PCV\]-naïve)(3 doses). Dose 1: at randomization, Dose 2: 4 to 8 weeks after Dose 1, and Dose 3: 8 to 12 weeks after Dose 2 and ≥12 months of age.
|
|---|---|---|
|
Percentage of Participants With Solicited Injection-site AEs - Schedule C: 2-17 Years
Redness/Erythema
|
21.1 Percentage of Participants
Interval 15.3 to 27.9
|
19.2 Percentage of Participants
Interval 13.7 to 25.8
|
|
Percentage of Participants With Solicited Injection-site AEs - Schedule C: 2-17 Years
Hardness/Induration
|
14.9 Percentage of Participants
Interval 9.9 to 21.0
|
6.8 Percentage of Participants
Interval 3.6 to 11.5
|
|
Percentage of Participants With Solicited Injection-site AEs - Schedule C: 2-17 Years
Pain
|
56.6 Percentage of Participants
Interval 48.9 to 64.0
|
54.8 Percentage of Participants
Interval 47.2 to 62.3
|
|
Percentage of Participants With Solicited Injection-site AEs - Schedule C: 2-17 Years
Swelling
|
24.0 Percentage of Participants
Interval 17.9 to 31.0
|
20.9 Percentage of Participants
Interval 15.2 to 27.6
|
PRIMARY outcome
Timeframe: Up to 14 days post any vaccinationPopulation: The analysis population included all randomized participants who received at least 1 dose of study intervention.
An AE is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. The parent/guardian of the participant recorded the presence of any VRC-prompted systemic AEs that occurred in the 14 days after any vaccination. For participants 7 months to \<3 years of age at enrollment, solicited systemic AEs include irritability, drowsiness/somnolence, appetite lost/decreased appetite, and hives or welts/urticaria. The percentage of participants with a systemic AE was summarized.
Outcome measures
| Measure |
Prevnar 13®, Schedule C: Participants 2-17 Years
n=64 Participants
Each participant received a 0.5 mL IM injection for 2 to 17 years of age (PCV-naïve or PCV-experienced)(1 dose). Single dose administered at randomization and at least 8 weeks after previous PCV for participants who were PCV-experienced.
|
V114, Schedule A: Participants 7-11 Months
n=64 Participants
Each participant received a 0.5 mL intramuscular (IM) injection for 7 to 11 months of age (Pneumococcal conjugate vaccine \[PCV\]-naïve)(3 doses). Dose 1: at randomization, Dose 2: 4 to 8 weeks after Dose 1, and Dose 3: 8 to 12 weeks after Dose 2 and ≥12 months of age.
|
|---|---|---|
|
Percentage of Participants With Solicited Systemic AEs - Schedule A: 7-11 Months
Appetite lost/Decreased appetite
|
18.8 Percentage of Participants
Interval 10.1 to 30.5
|
15.6 Percentage of Participants
Interval 7.8 to 26.9
|
|
Percentage of Participants With Solicited Systemic AEs - Schedule A: 7-11 Months
Irritability
|
43.8 Percentage of Participants
Interval 31.4 to 56.7
|
32.8 Percentage of Participants
Interval 21.6 to 45.7
|
|
Percentage of Participants With Solicited Systemic AEs - Schedule A: 7-11 Months
Drowsiness/Somnolence
|
15.6 Percentage of Participants
Interval 7.8 to 26.9
|
21.9 Percentage of Participants
Interval 12.5 to 34.0
|
|
Percentage of Participants With Solicited Systemic AEs - Schedule A: 7-11 Months
Hives or Welts/Urticaria
|
4.7 Percentage of Participants
Interval 1.0 to 13.1
|
1.6 Percentage of Participants
Interval 0.0 to 8.4
|
PRIMARY outcome
Timeframe: Up to 14 days post any vaccinationPopulation: The analysis population included all randomized participants who received at least 1 dose of study intervention.
An AE is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. The parent/guardian of the participant recorded the presence of any VRC-prompted systemic AEs that occurred in the 14 days after any vaccination. For participants 7 months to \<3 years of age at enrollment, solicited systemic AEs include irritability, drowsiness/somnolence, appetite lost/decreased appetite, and hives or welts/urticaria. The percentage of participants with a systemic AE was summarized.
Outcome measures
| Measure |
Prevnar 13®, Schedule C: Participants 2-17 Years
n=64 Participants
Each participant received a 0.5 mL IM injection for 2 to 17 years of age (PCV-naïve or PCV-experienced)(1 dose). Single dose administered at randomization and at least 8 weeks after previous PCV for participants who were PCV-experienced.
|
V114, Schedule A: Participants 7-11 Months
n=62 Participants
Each participant received a 0.5 mL intramuscular (IM) injection for 7 to 11 months of age (Pneumococcal conjugate vaccine \[PCV\]-naïve)(3 doses). Dose 1: at randomization, Dose 2: 4 to 8 weeks after Dose 1, and Dose 3: 8 to 12 weeks after Dose 2 and ≥12 months of age.
|
|---|---|---|
|
Percentage of Participants With Solicited Systemic AEs - Schedule B: 12-23 Months
Appetite lost/Decreased appetite
|
18.8 Percentage of Participants
Interval 10.1 to 30.5
|
22.6 Percentage of Participants
Interval 12.9 to 35.0
|
|
Percentage of Participants With Solicited Systemic AEs - Schedule B: 12-23 Months
Irritability
|
21.9 Percentage of Participants
Interval 12.5 to 34.0
|
35.5 Percentage of Participants
Interval 23.7 to 48.7
|
|
Percentage of Participants With Solicited Systemic AEs - Schedule B: 12-23 Months
Drowsiness/Somnolence
|
17.2 Percentage of Participants
Interval 8.9 to 28.7
|
24.2 Percentage of Participants
Interval 14.2 to 36.7
|
|
Percentage of Participants With Solicited Systemic AEs - Schedule B: 12-23 Months
Hives or Welts/Urticaria
|
0.0 Percentage of Participants
Interval 0.0 to 0.0
|
0.0 Percentage of Participants
Interval 0.0 to 0.0
|
PRIMARY outcome
Timeframe: Up to 14 days post vaccinationPopulation: The analysis population included all randomized participants who received 1 dose of study intervention.
An AE is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. The parent/guardian of the participant recorded the presence of any VRC-prompted systemic AEs that occurred in the 14 days after any vaccination. For participants 7 months to \<3 years of age at enrollment, solicited systemic AEs include irritability, drowsiness/somnolence, appetite lost/decreased appetite, and hives or welts/urticaria. For participants ≥3 years of age at enrollment, solicited systemic AEs include muscle pain/ myalgia, joint pain/arthralgia, headache, tiredness/fatigue, and hives or welts/urticaria. The percentage of participants with a systemic AE was summarized.
Outcome measures
| Measure |
Prevnar 13®, Schedule C: Participants 2-17 Years
n=175 Participants
Each participant received a 0.5 mL IM injection for 2 to 17 years of age (PCV-naïve or PCV-experienced)(1 dose). Single dose administered at randomization and at least 8 weeks after previous PCV for participants who were PCV-experienced.
|
V114, Schedule A: Participants 7-11 Months
n=177 Participants
Each participant received a 0.5 mL intramuscular (IM) injection for 7 to 11 months of age (Pneumococcal conjugate vaccine \[PCV\]-naïve)(3 doses). Dose 1: at randomization, Dose 2: 4 to 8 weeks after Dose 1, and Dose 3: 8 to 12 weeks after Dose 2 and ≥12 months of age.
|
|---|---|---|
|
Percentage of Participants With Solicited Systemic AEs - Schedule C: 2-17 Years
Joint pain/arthralgia
|
1.7 Percentage of Participants
Interval 0.4 to 4.9
|
0.0 Percentage of Participants
Interval 0.0 to 2.1
|
|
Percentage of Participants With Solicited Systemic AEs - Schedule C: 2-17 Years
Appetite lost/Decreased appetite
|
2.9 Percentage of Participants
Interval 0.9 to 6.5
|
2.3 Percentage of Participants
Interval 0.6 to 5.7
|
|
Percentage of Participants With Solicited Systemic AEs - Schedule C: 2-17 Years
Tiredness/Fatigue
|
17.1 Percentage of Participants
Interval 11.9 to 23.6
|
15.8 Percentage of Participants
Interval 10.8 to 22.0
|
|
Percentage of Participants With Solicited Systemic AEs - Schedule C: 2-17 Years
Headache
|
13.7 Percentage of Participants
Interval 9.0 to 19.7
|
11.9 Percentage of Participants
Interval 7.5 to 17.6
|
|
Percentage of Participants With Solicited Systemic AEs - Schedule C: 2-17 Years
Irritability
|
4.0 Percentage of Participants
Interval 1.6 to 8.1
|
2.8 Percentage of Participants
Interval 0.9 to 6.5
|
|
Percentage of Participants With Solicited Systemic AEs - Schedule C: 2-17 Years
Muscle pain/Myalgia
|
16.6 Percentage of Participants
Interval 11.4 to 22.9
|
23.7 Percentage of Participants
Interval 17.7 to 30.7
|
|
Percentage of Participants With Solicited Systemic AEs - Schedule C: 2-17 Years
Drowsiness/Somnolence
|
2.9 Percentage of Participants
Interval 0.9 to 6.5
|
2.8 Percentage of Participants
Interval 0.9 to 6.5
|
|
Percentage of Participants With Solicited Systemic AEs - Schedule C: 2-17 Years
Hives or Welts/Urticaria
|
1.1 Percentage of Participants
Interval 0.1 to 4.1
|
1.1 Percentage of Participants
Interval 0.1 to 4.0
|
PRIMARY outcome
Timeframe: Up to ~6 months post final vaccinationPopulation: The analysis population included all randomized participants who received at least 1 dose of study intervention.
A serious adverse event (SAE) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is another important medical event. SAEs that are reported to be at least possibly related by the investigator to study vaccination will be summarized. Estimated within-group CIs are calculated based on the exact binomial method proposed by Clopper and Pearson and are provided in accordance with the statistical analysis plan.
Outcome measures
| Measure |
Prevnar 13®, Schedule C: Participants 2-17 Years
n=64 Participants
Each participant received a 0.5 mL IM injection for 2 to 17 years of age (PCV-naïve or PCV-experienced)(1 dose). Single dose administered at randomization and at least 8 weeks after previous PCV for participants who were PCV-experienced.
|
V114, Schedule A: Participants 7-11 Months
n=64 Participants
Each participant received a 0.5 mL intramuscular (IM) injection for 7 to 11 months of age (Pneumococcal conjugate vaccine \[PCV\]-naïve)(3 doses). Dose 1: at randomization, Dose 2: 4 to 8 weeks after Dose 1, and Dose 3: 8 to 12 weeks after Dose 2 and ≥12 months of age.
|
|---|---|---|
|
Percentage of Participants With at Least 1 Vaccine-related Serious Adverse Event - Schedule A: 7-11 Months
|
0.0 Percentage of Participants
95% Confidence Interval 0.0 • Interval 0.0 to 5.6
|
0.0 Percentage of Participants
95% Confidence Interval 0.0 • Interval 0.0 to 5.6
|
PRIMARY outcome
Timeframe: Up to ~6 months post final vaccinationPopulation: The analysis population included all randomized participants who received at least 1 dose of study intervention.
A serious adverse event (SAE) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is another important medical event. SAEs that are reported to be at least possibly related by the investigator to study vaccination will be summarized. Estimated within-group CIs are calculated based on the exact binomial method proposed by Clopper and Pearson and are provided in accordance with the statistical analysis plan.
Outcome measures
| Measure |
Prevnar 13®, Schedule C: Participants 2-17 Years
n=64 Participants
Each participant received a 0.5 mL IM injection for 2 to 17 years of age (PCV-naïve or PCV-experienced)(1 dose). Single dose administered at randomization and at least 8 weeks after previous PCV for participants who were PCV-experienced.
|
V114, Schedule A: Participants 7-11 Months
n=62 Participants
Each participant received a 0.5 mL intramuscular (IM) injection for 7 to 11 months of age (Pneumococcal conjugate vaccine \[PCV\]-naïve)(3 doses). Dose 1: at randomization, Dose 2: 4 to 8 weeks after Dose 1, and Dose 3: 8 to 12 weeks after Dose 2 and ≥12 months of age.
|
|---|---|---|
|
Percentage of Participants With at Least 1 Vaccine-related SAE - Schedule B: 12-23 Months
|
0.0 Percentage of Participants
95% Confidence Interval 0.0 • Interval 0.0 to 5.6
|
0.0 Percentage of Participants
95% Confidence Interval 0.0 • Interval 0.0 to 5.8
|
PRIMARY outcome
Timeframe: Up to ~6 months post vaccinationPopulation: The analysis population included all randomized participants who received at least 1 dose of study intervention.
A serious adverse event (SAE) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is another important medical event. SAEs that are reported to be at least possibly related by the investigator to study vaccination will be summarized.
Outcome measures
| Measure |
Prevnar 13®, Schedule C: Participants 2-17 Years
n=175 Participants
Each participant received a 0.5 mL IM injection for 2 to 17 years of age (PCV-naïve or PCV-experienced)(1 dose). Single dose administered at randomization and at least 8 weeks after previous PCV for participants who were PCV-experienced.
|
V114, Schedule A: Participants 7-11 Months
n=177 Participants
Each participant received a 0.5 mL intramuscular (IM) injection for 7 to 11 months of age (Pneumococcal conjugate vaccine \[PCV\]-naïve)(3 doses). Dose 1: at randomization, Dose 2: 4 to 8 weeks after Dose 1, and Dose 3: 8 to 12 weeks after Dose 2 and ≥12 months of age.
|
|---|---|---|
|
Percentage of Participants With at Least 1 Vaccine-related SAE - Schedule C: 2-17 Years
|
0.0 Percentage of Participants
95% Confidence Interval 0.0 • Interval 0.0 to 2.1
|
0.0 Percentage of Participants
95% Confidence Interval 0.0 • Interval 0.0 to 2.1
|
SECONDARY outcome
Timeframe: 30 days post final vaccinationPopulation: The analysis population included all randomized participants without deviations from the protocol that may substantially affect the results of the immunogenicity endpoint.
Sera from participants was used to measure vaccine-induced anti-PnPs serotype-specific IgG for all the 15 serotypes using PnECL assay. The percentage that achieved the IgG threshold value of ≥0.35 μg/mL was summarized. Estimated within-group CIs are calculated based on the exact binomial method proposed by Clopper and Pearson and are provided in accordance with the statistical analysis plan.
Outcome measures
| Measure |
Prevnar 13®, Schedule C: Participants 2-17 Years
n=64 Participants
Each participant received a 0.5 mL IM injection for 2 to 17 years of age (PCV-naïve or PCV-experienced)(1 dose). Single dose administered at randomization and at least 8 weeks after previous PCV for participants who were PCV-experienced.
|
V114, Schedule A: Participants 7-11 Months
n=64 Participants
Each participant received a 0.5 mL intramuscular (IM) injection for 7 to 11 months of age (Pneumococcal conjugate vaccine \[PCV\]-naïve)(3 doses). Dose 1: at randomization, Dose 2: 4 to 8 weeks after Dose 1, and Dose 3: 8 to 12 weeks after Dose 2 and ≥12 months of age.
|
|---|---|---|
|
Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each of the 15 Serotypes - Schedule A: 7-11 Months
Serotype 1
|
100.0 Percentage of Participants
Interval 93.9 to 100.0
|
100.0 Percentage of Participants
Interval 94.0 to 100.0
|
|
Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each of the 15 Serotypes - Schedule A: 7-11 Months
Serotype 3
|
96.6 Percentage of Participants
Interval 88.3 to 99.6
|
100.0 Percentage of Participants
Interval 94.0 to 100.0
|
|
Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each of the 15 Serotypes - Schedule A: 7-11 Months
Serotype 4
|
100.0 Percentage of Participants
Interval 93.9 to 100.0
|
100.0 Percentage of Participants
Interval 94.0 to 100.0
|
|
Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each of the 15 Serotypes - Schedule A: 7-11 Months
Serotype 5
|
100.0 Percentage of Participants
Interval 93.9 to 100.0
|
100.0 Percentage of Participants
Interval 94.0 to 100.0
|
|
Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each of the 15 Serotypes - Schedule A: 7-11 Months
Serotype 6A
|
98.3 Percentage of Participants
Interval 90.9 to 100.0
|
95.0 Percentage of Participants
Interval 86.1 to 99.0
|
|
Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each of the 15 Serotypes - Schedule A: 7-11 Months
Serotype 6B
|
100.0 Percentage of Participants
Interval 93.9 to 100.0
|
96.7 Percentage of Participants
Interval 88.5 to 99.6
|
|
Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each of the 15 Serotypes - Schedule A: 7-11 Months
Serotype 7F
|
100.0 Percentage of Participants
Interval 93.9 to 100.0
|
100.0 Percentage of Participants
Interval 94.0 to 100.0
|
|
Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each of the 15 Serotypes - Schedule A: 7-11 Months
Serotype 9V
|
100.0 Percentage of Participants
Interval 93.9 to 100.0
|
98.3 Percentage of Participants
Interval 91.1 to 100.0
|
|
Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each of the 15 Serotypes - Schedule A: 7-11 Months
Serotype 14
|
100.0 Percentage of Participants
Interval 93.9 to 100.0
|
100.0 Percentage of Participants
Interval 94.0 to 100.0
|
|
Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each of the 15 Serotypes - Schedule A: 7-11 Months
Serotype 18C
|
100.0 Percentage of Participants
Interval 93.9 to 100.0
|
100.0 Percentage of Participants
Interval 94.0 to 100.0
|
|
Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each of the 15 Serotypes - Schedule A: 7-11 Months
Serotype 19A
|
100.0 Percentage of Participants
Interval 93.9 to 100.0
|
100.0 Percentage of Participants
Interval 94.0 to 100.0
|
|
Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each of the 15 Serotypes - Schedule A: 7-11 Months
Serotype 19F
|
100.0 Percentage of Participants
Interval 93.9 to 100.0
|
100.0 Percentage of Participants
Interval 94.0 to 100.0
|
|
Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each of the 15 Serotypes - Schedule A: 7-11 Months
Serotype 23F
|
100.0 Percentage of Participants
Interval 93.9 to 100.0
|
98.3 Percentage of Participants
Interval 91.1 to 100.0
|
|
Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each of the 15 Serotypes - Schedule A: 7-11 Months
Serotype 22F
|
13.8 Percentage of Participants
Interval 6.1 to 25.4
|
100.0 Percentage of Participants
Interval 94.0 to 100.0
|
|
Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each of the 15 Serotypes - Schedule A: 7-11 Months
Serotype 33F
|
11.9 Percentage of Participants
Interval 4.9 to 22.9
|
100.0 Percentage of Participants
Interval 94.0 to 100.0
|
SECONDARY outcome
Timeframe: 30 days post final vaccinationPopulation: The analysis population included all randomized participants without deviations from the protocol that may substantially affect the results of the immunogenicity endpoint.
Sera from participants was used to measure vaccine-induced anti-PnPs serotype-specific IgG for all the 15 serotypes using PnECL assay. The percentage that achieved the IgG threshold value of ≥0.35 μg/mL was summarized. Estimated within-group CIs are calculated based on the exact binomial method proposed by Clopper and Pearson and are provided in accordance with the statistical analysis plan. The analysis population included all randomized participants without deviations from the protocol that may substantially affect the results of the immunogenicity endpoint.
Outcome measures
| Measure |
Prevnar 13®, Schedule C: Participants 2-17 Years
n=64 Participants
Each participant received a 0.5 mL IM injection for 2 to 17 years of age (PCV-naïve or PCV-experienced)(1 dose). Single dose administered at randomization and at least 8 weeks after previous PCV for participants who were PCV-experienced.
|
V114, Schedule A: Participants 7-11 Months
n=62 Participants
Each participant received a 0.5 mL intramuscular (IM) injection for 7 to 11 months of age (Pneumococcal conjugate vaccine \[PCV\]-naïve)(3 doses). Dose 1: at randomization, Dose 2: 4 to 8 weeks after Dose 1, and Dose 3: 8 to 12 weeks after Dose 2 and ≥12 months of age.
|
|---|---|---|
|
Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each of the 15 Serotypes - Schedule B: 12-23 Months
Serotype 1
|
98.3 Percentage of Participants
Interval 91.1 to 100.0
|
100.0 Percentage of Participants
Interval 93.6 to 100.0
|
|
Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each of the 15 Serotypes - Schedule B: 12-23 Months
Serotype 3 (n=56,60)
|
90.0 Percentage of Participants
Interval 79.5 to 96.2
|
98.2 Percentage of Participants
Interval 90.4 to 100.0
|
|
Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each of the 15 Serotypes - Schedule B: 12-23 Months
Serotype 4 (n=56,60)
|
96.7 Percentage of Participants
Interval 88.5 to 99.6
|
100.0 Percentage of Participants
Interval 93.6 to 100.0
|
|
Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each of the 15 Serotypes - Schedule B: 12-23 Months
Serotype 5 (n=56,60)
|
98.3 Percentage of Participants
Interval 91.1 to 100.0
|
98.2 Percentage of Participants
Interval 90.4 to 100.0
|
|
Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each of the 15 Serotypes - Schedule B: 12-23 Months
Serotype 6A (n=56,60)
|
95.0 Percentage of Participants
Interval 86.1 to 99.0
|
83.9 Percentage of Participants
Interval 71.7 to 92.4
|
|
Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each of the 15 Serotypes - Schedule B: 12-23 Months
Serotype 6B (n=56,60)
|
88.3 Percentage of Participants
Interval 77.4 to 95.2
|
89.3 Percentage of Participants
Interval 78.1 to 96.0
|
|
Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each of the 15 Serotypes - Schedule B: 12-23 Months
Serotype 7F (n=56,60)
|
100.0 Percentage of Participants
Interval 94.0 to 100.0
|
98.2 Percentage of Participants
Interval 90.4 to 100.0
|
|
Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each of the 15 Serotypes - Schedule B: 12-23 Months
Serotype 9V (n=56,60)
|
96.7 Percentage of Participants
Interval 88.5 to 99.6
|
98.2 Percentage of Participants
Interval 90.4 to 100.0
|
|
Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each of the 15 Serotypes - Schedule B: 12-23 Months
Serotype 14 (n=56,60)
|
100.0 Percentage of Participants
Interval 94.0 to 100.0
|
98.2 Percentage of Participants
Interval 90.4 to 100.0
|
|
Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each of the 15 Serotypes - Schedule B: 12-23 Months
Serotype 18C (n=56,60)
|
98.3 Percentage of Participants
Interval 91.1 to 100.0
|
96.4 Percentage of Participants
Interval 87.7 to 99.6
|
|
Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each of the 15 Serotypes - Schedule B: 12-23 Months
Serotype 19A (n=56,60)
|
100.0 Percentage of Participants
Interval 94.0 to 100.0
|
98.2 Percentage of Participants
Interval 90.4 to 100.0
|
|
Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each of the 15 Serotypes - Schedule B: 12-23 Months
Serotype 19F (n=56,60)
|
100.0 Percentage of Participants
Interval 94.0 to 100.0
|
100.0 Percentage of Participants
Interval 93.6 to 100.0
|
|
Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each of the 15 Serotypes - Schedule B: 12-23 Months
Serotype 23F (n=56,60)
|
88.3 Percentage of Participants
Interval 77.4 to 95.2
|
94.6 Percentage of Participants
Interval 85.1 to 98.9
|
|
Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each of the 15 Serotypes - Schedule B: 12-23 Months
Serotype 22F (n=56,60)
|
6.7 Percentage of Participants
Interval 1.8 to 16.2
|
100.0 Percentage of Participants
Interval 93.6 to 100.0
|
|
Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each of the 15 Serotypes - Schedule B: 12-23 Months
Serotype 33F (n=56,60)
|
15.0 Percentage of Participants
Interval 7.1 to 26.6
|
94.6 Percentage of Participants
Interval 85.1 to 98.9
|
SECONDARY outcome
Timeframe: 30 days post vaccinationPopulation: The analysis population included all randomized participants without deviations from the protocol that may substantially affect the results of the immunogenicity endpoint.
Sera from participants was used to measure vaccine-induced anti-PnPs serotype-specific IgG for all the 15 serotypes using PnECL assay. The percentage that achieved the IgG threshold value of ≥0.35 μg/mL was summarized. Estimated within-group CIs are calculated based on the exact binomial method proposed by Clopper and Pearson and are provided in accordance with the statistical analysis plan.
Outcome measures
| Measure |
Prevnar 13®, Schedule C: Participants 2-17 Years
n=175 Participants
Each participant received a 0.5 mL IM injection for 2 to 17 years of age (PCV-naïve or PCV-experienced)(1 dose). Single dose administered at randomization and at least 8 weeks after previous PCV for participants who were PCV-experienced.
|
V114, Schedule A: Participants 7-11 Months
n=177 Participants
Each participant received a 0.5 mL intramuscular (IM) injection for 7 to 11 months of age (Pneumococcal conjugate vaccine \[PCV\]-naïve)(3 doses). Dose 1: at randomization, Dose 2: 4 to 8 weeks after Dose 1, and Dose 3: 8 to 12 weeks after Dose 2 and ≥12 months of age.
|
|---|---|---|
|
Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each of the 15 Serotypes - Schedule C: 2-17 Years
Serotype 1
|
100.0 Percentage of Participants
Interval 97.7 to 100.0
|
99.4 Percentage of Participants
Interval 96.6 to 100.0
|
|
Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each of the 15 Serotypes - Schedule C: 2-17 Years
Serotype 3
|
87.7 Percentage of Participants
Interval 81.6 to 92.3
|
95.7 Percentage of Participants
Interval 91.3 to 98.2
|
|
Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each of the 15 Serotypes - Schedule C: 2-17 Years
Serotype 4
|
100.0 Percentage of Participants
Interval 97.7 to 100.0
|
98.8 Percentage of Participants
Interval 95.6 to 99.9
|
|
Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each of the 15 Serotypes - Schedule C: 2-17 Years
Serotype 5
|
99.4 Percentage of Participants
Interval 96.6 to 100.0
|
99.4 Percentage of Participants
Interval 96.6 to 100.0
|
|
Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each of the 15 Serotypes - Schedule C: 2-17 Years
Serotype 6A
|
98.1 Percentage of Participants
Interval 94.7 to 99.6
|
98.1 Percentage of Participants
Interval 94.7 to 99.6
|
|
Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each of the 15 Serotypes - Schedule C: 2-17 Years
Serotype 6B
|
96.9 Percentage of Participants
Interval 92.9 to 99.0
|
98.1 Percentage of Participants
Interval 94.7 to 99.6
|
|
Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each of the 15 Serotypes - Schedule C: 2-17 Years
Serotype 7F
|
100.0 Percentage of Participants
Interval 97.7 to 100.0
|
99.4 Percentage of Participants
Interval 96.6 to 100.0
|
|
Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each of the 15 Serotypes - Schedule C: 2-17 Years
Serotype 9V
|
98.8 Percentage of Participants
Interval 95.6 to 99.9
|
100.0 Percentage of Participants
Interval 97.7 to 100.0
|
|
Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each of the 15 Serotypes - Schedule C: 2-17 Years
Serotype 14
|
98.1 Percentage of Participants
Interval 94.7 to 99.6
|
99.4 Percentage of Participants
Interval 96.6 to 100.0
|
|
Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each of the 15 Serotypes - Schedule C: 2-17 Years
Serotype 18C
|
100.0 Percentage of Participants
Interval 97.7 to 100.0
|
100.0 Percentage of Participants
Interval 97.7 to 100.0
|
|
Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each of the 15 Serotypes - Schedule C: 2-17 Years
Serotype 19A
|
100.0 Percentage of Participants
Interval 97.7 to 100.0
|
100.0 Percentage of Participants
Interval 97.7 to 100.0
|
|
Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each of the 15 Serotypes - Schedule C: 2-17 Years
Serotype 19F
|
100.0 Percentage of Participants
Interval 97.7 to 100.0
|
99.4 Percentage of Participants
Interval 96.6 to 100.0
|
|
Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each of the 15 Serotypes - Schedule C: 2-17 Years
Serotype 23F
|
95.7 Percentage of Participants
Interval 91.3 to 98.2
|
99.4 Percentage of Participants
Interval 96.6 to 100.0
|
|
Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each of the 15 Serotypes - Schedule C: 2-17 Years
Serotype 22F
|
37.7 Percentage of Participants
Interval 30.2 to 45.8
|
100.0 Percentage of Participants
Interval 97.7 to 100.0
|
|
Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each of the 15 Serotypes - Schedule C: 2-17 Years
Serotype 33F
|
37.5 Percentage of Participants
Interval 30.0 to 45.5
|
99.4 Percentage of Participants
Interval 96.6 to 100.0
|
Adverse Events
V114 (7-11 Months)
Serious events: 7 serious events
Other events: 44 other events
Deaths: 0 deaths
Prevnar (7-11 Months)
Serious events: 5 serious events
Other events: 47 other events
Deaths: 0 deaths
V114 (12-23 Months)
Serious events: 4 serious events
Other events: 46 other events
Deaths: 0 deaths
Prevnar (12-23 Months)
Serious events: 4 serious events
Other events: 36 other events
Deaths: 0 deaths
V114 (2-17 Years)
Serious events: 4 serious events
Other events: 125 other events
Deaths: 0 deaths
Prevnar (2-17 Years)
Serious events: 4 serious events
Other events: 125 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
V114 (7-11 Months)
n=64 participants at risk
Each participant received a 0.5 mL intramuscular (IM) injection for 7 to 11 months of age (Pneumococcal conjugate vaccine \[PCV\]-naïve). 3 doses. Dose 1: at randomization, Dose 2: 4 to 8 weeks after Dose 1, and Dose 3: 8 to 12 weeks after Dose 2 and ≥12 months of age.
|
Prevnar (7-11 Months)
n=64 participants at risk
Each participant received a 0.5 mL IM injection for 7 to 11 months of age (PCV-naïve). 3 doses. Dose 1: at randomization, Dose 2: 4 to 8 weeks after Dose 1, and Dose 3: 8 to 12 weeks after Dose 2 and ≥12 months of age.
|
V114 (12-23 Months)
n=62 participants at risk
Each participant received a 0.5 mL IM injection for 12 to 23 months of age (PCV-naïve), 2 doses: Dose 1: at randomization, and Dose 2: 8 to 12 weeks after Dose 1.
|
Prevnar (12-23 Months)
n=64 participants at risk
Each participant received a 0.5 mL IM injection for 12 to 23 months of age (PCV-naïve), 2 doses: Dose 1: at randomization, and Dose 2: 8 to 12 weeks after Dose 1.
|
V114 (2-17 Years)
n=177 participants at risk
Each participant received a 0.5 mL IM injection for 2 to 17 years of age (PCV-naïve or PCV experienced): Single dose administered at randomization and at least 8 weeks after previous PCV for participants who were PCV-experienced.
|
Prevnar (2-17 Years)
n=175 participants at risk
Each participant received a 0.5 mL IM injection for 2 to 17 years of age (PCV-naïve or PCV-experienced): Single dose administered at randomization and at least 8 weeks after previous PCV for participants who were PCV-experienced.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Bronchiolitis
|
1.6%
1/64 • Number of events 1 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
1.6%
1/64 • Number of events 1 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/62 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
1.6%
1/64 • Number of events 1 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/177 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/175 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
|
Infections and infestations
Croup infectious
|
1.6%
1/64 • Number of events 1 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/64 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/62 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/64 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/177 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/175 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
|
Infections and infestations
Gastroenteritis
|
3.1%
2/64 • Number of events 2 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/64 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/62 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
1.6%
1/64 • Number of events 1 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.56%
1/177 • Number of events 1 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.57%
1/175 • Number of events 1 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
|
Infections and infestations
Gastroenteritis salmonella
|
1.6%
1/64 • Number of events 1 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/64 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/62 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/64 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/177 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/175 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
|
Infections and infestations
Pharyngitis
|
1.6%
1/64 • Number of events 1 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/64 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/62 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
1.6%
1/64 • Number of events 1 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/177 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/175 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
|
Infections and infestations
Pneumonia bacterial
|
1.6%
1/64 • Number of events 1 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/64 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/62 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/64 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/177 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/175 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
|
Infections and infestations
Exanthema subitum
|
0.00%
0/64 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
1.6%
1/64 • Number of events 1 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/62 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/64 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/177 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/175 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
|
Infections and infestations
Tracheobronchitis
|
0.00%
0/64 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
1.6%
1/64 • Number of events 1 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/62 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/64 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/177 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/175 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
|
Infections and infestations
Pneumonia respiratory syncytial viral
|
0.00%
0/64 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
1.6%
1/64 • Number of events 1 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/62 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/64 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/177 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/175 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
|
Infections and infestations
Chikungunya virus infection
|
0.00%
0/64 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/64 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
1.6%
1/62 • Number of events 1 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/64 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/177 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/175 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/64 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/64 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/62 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
1.6%
1/64 • Number of events 1 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/177 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/175 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/64 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/64 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/62 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
1.6%
1/64 • Number of events 1 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/177 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/175 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
|
Infections and infestations
Influenza
|
0.00%
0/64 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/64 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/62 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/64 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.56%
1/177 • Number of events 1 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/175 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/64 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/64 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/62 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/64 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.56%
1/177 • Number of events 1 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.57%
1/175 • Number of events 1 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/64 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/64 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/62 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/64 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/177 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.57%
1/175 • Number of events 1 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
|
Infections and infestations
Wound abscess
|
0.00%
0/64 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/64 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/62 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/64 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/177 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.57%
1/175 • Number of events 1 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/64 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/64 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
1.6%
1/62 • Number of events 1 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/64 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/177 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/175 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/64 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/64 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/62 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/64 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/177 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.57%
1/175 • Number of events 1 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/64 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/64 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
1.6%
1/62 • Number of events 1 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/64 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/177 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/175 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/64 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
1.6%
1/64 • Number of events 1 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/62 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/64 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/177 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/175 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/64 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/64 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
1.6%
1/62 • Number of events 1 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/64 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/177 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/175 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
|
Infections and infestations
Tuberculosis
|
0.00%
0/64 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/64 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/62 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/64 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.56%
1/177 • Number of events 1 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/175 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
Other adverse events
| Measure |
V114 (7-11 Months)
n=64 participants at risk
Each participant received a 0.5 mL intramuscular (IM) injection for 7 to 11 months of age (Pneumococcal conjugate vaccine \[PCV\]-naïve). 3 doses. Dose 1: at randomization, Dose 2: 4 to 8 weeks after Dose 1, and Dose 3: 8 to 12 weeks after Dose 2 and ≥12 months of age.
|
Prevnar (7-11 Months)
n=64 participants at risk
Each participant received a 0.5 mL IM injection for 7 to 11 months of age (PCV-naïve). 3 doses. Dose 1: at randomization, Dose 2: 4 to 8 weeks after Dose 1, and Dose 3: 8 to 12 weeks after Dose 2 and ≥12 months of age.
|
V114 (12-23 Months)
n=62 participants at risk
Each participant received a 0.5 mL IM injection for 12 to 23 months of age (PCV-naïve), 2 doses: Dose 1: at randomization, and Dose 2: 8 to 12 weeks after Dose 1.
|
Prevnar (12-23 Months)
n=64 participants at risk
Each participant received a 0.5 mL IM injection for 12 to 23 months of age (PCV-naïve), 2 doses: Dose 1: at randomization, and Dose 2: 8 to 12 weeks after Dose 1.
|
V114 (2-17 Years)
n=177 participants at risk
Each participant received a 0.5 mL IM injection for 2 to 17 years of age (PCV-naïve or PCV experienced): Single dose administered at randomization and at least 8 weeks after previous PCV for participants who were PCV-experienced.
|
Prevnar (2-17 Years)
n=175 participants at risk
Each participant received a 0.5 mL IM injection for 2 to 17 years of age (PCV-naïve or PCV-experienced): Single dose administered at randomization and at least 8 weeks after previous PCV for participants who were PCV-experienced.
|
|---|---|---|---|---|---|---|
|
General disorders
Injection site erythema
|
28.1%
18/64 • Number of events 29 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
34.4%
22/64 • Number of events 36 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
21.0%
13/62 • Number of events 14 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
21.9%
14/64 • Number of events 16 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
19.2%
34/177 • Number of events 37 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
21.1%
37/175 • Number of events 37 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
|
General disorders
Injection site induration
|
17.2%
11/64 • Number of events 20 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
14.1%
9/64 • Number of events 16 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
8.1%
5/62 • Number of events 8 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
9.4%
6/64 • Number of events 9 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
6.8%
12/177 • Number of events 13 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
14.9%
26/175 • Number of events 28 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.2%
4/64 • Number of events 4 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
4.7%
3/64 • Number of events 3 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/62 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/64 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/177 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/175 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
|
General disorders
Injection site swelling
|
18.8%
12/64 • Number of events 23 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
15.6%
10/64 • Number of events 17 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
14.5%
9/62 • Number of events 11 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
12.5%
8/64 • Number of events 8 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
20.9%
37/177 • Number of events 39 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
24.0%
42/175 • Number of events 43 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
|
General disorders
Pyrexia
|
31.2%
20/64 • Number of events 26 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
21.9%
14/64 • Number of events 16 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
14.5%
9/62 • Number of events 11 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
10.9%
7/64 • Number of events 7 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
7.3%
13/177 • Number of events 14 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
7.4%
13/175 • Number of events 14 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
|
General disorders
Injection site pain
|
18.8%
12/64 • Number of events 19 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
7.8%
5/64 • Number of events 6 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
33.9%
21/62 • Number of events 27 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
23.4%
15/64 • Number of events 17 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
54.8%
97/177 • Number of events 111 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
56.6%
99/175 • Number of events 106 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
|
Nervous system disorders
Somnolence
|
21.9%
14/64 • Number of events 22 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
15.6%
10/64 • Number of events 15 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
24.2%
15/62 • Number of events 29 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
17.2%
11/64 • Number of events 11 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/177 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/175 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
|
General disorders
Fatigue
|
0.00%
0/64 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/64 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/62 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/64 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
15.8%
28/177 • Number of events 42 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
17.1%
30/175 • Number of events 38 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/64 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/64 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/62 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/64 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
23.7%
42/177 • Number of events 46 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
17.1%
30/175 • Number of events 34 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
|
Nervous system disorders
Headache
|
0.00%
0/64 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/64 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/62 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/64 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
11.9%
21/177 • Number of events 32 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
13.7%
24/175 • Number of events 33 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
|
Infections and infestations
Nasopharyngitis
|
3.1%
2/64 • Number of events 2 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
9.4%
6/64 • Number of events 7 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
12.9%
8/62 • Number of events 11 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
10.9%
7/64 • Number of events 7 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/177 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/175 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/64 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/64 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
6.5%
4/62 • Number of events 5 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
1.6%
1/64 • Number of events 1 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/177 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/175 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
15.6%
10/64 • Number of events 15 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
18.8%
12/64 • Number of events 17 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
22.6%
14/62 • Number of events 21 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
18.8%
12/64 • Number of events 19 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/177 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/175 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
|
Psychiatric disorders
Irritability
|
32.8%
21/64 • Number of events 39 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
43.8%
28/64 • Number of events 41 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
35.5%
22/62 • Number of events 33 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
21.9%
14/64 • Number of events 18 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/177 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/175 • Non-serious adverse events: Up to 14 days after any vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
The analysis population included all randomized participants who received at least 1 dose of study intervention.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments. Authorship will be determined by mutual agreement and in line with International Committee of Medical Journal Editors authorship requirements.
- Publication restrictions are in place
Restriction type: OTHER