Trial Outcomes & Findings for Safety, Tolerability, and Immunogenicity of V114 in Healthy Infants (V114-029) (NCT NCT03893448)
NCT ID: NCT03893448
Last Updated: 2023-07-28
Results Overview
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs consisted of swelling, redness, pain or tenderness, and hard lump.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1720 participants
Primary outcome timeframe
Up to 14 days after each vaccination with either V114 or Prevnar 13™
Results posted on
2023-07-28
Participant Flow
This study recruited healthy infants approximately 2 months (42 to 90 days, inclusive) of age, without a history of invasive pneumococcal disease or prior administration of any pneumococcal vaccine.
1720 participants were randomized in a 1:1 ratio to receive a 4-dose regimen of either V114 or Prevnar 13™. One participant randomized to the Prevnar 13™ arm was inadvertently treated with Prevnar 13™ and V114.
Participant milestones
| Measure |
V114
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
|
Prevnar 13™
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
|
|---|---|---|
|
Overall Study
STARTED
|
860
|
860
|
|
Overall Study
Treated
|
858
|
856
|
|
Overall Study
COMPLETED
|
758
|
734
|
|
Overall Study
NOT COMPLETED
|
102
|
126
|
Reasons for withdrawal
| Measure |
V114
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
|
Prevnar 13™
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
|
|---|---|---|
|
Overall Study
Withdrawal by Parent/Guardian
|
59
|
85
|
|
Overall Study
Physician Decision
|
8
|
14
|
|
Overall Study
Lost to Follow-up
|
34
|
27
|
|
Overall Study
Death
|
1
|
0
|
Baseline Characteristics
Safety, Tolerability, and Immunogenicity of V114 in Healthy Infants (V114-029)
Baseline characteristics by cohort
| Measure |
V114
n=860 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
|
Prevnar 13™
n=860 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 between 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
|
Total
n=1720 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
8.4 weeks
STANDARD_DEVIATION 1.2 • n=5 Participants
|
8.4 weeks
STANDARD_DEVIATION 1.3 • n=7 Participants
|
8.4 weeks
STANDARD_DEVIATION 1.2 • n=5 Participants
|
|
Age, Customized
In utero
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Customized
Preterm newborn infants (gestational age < 37 weeks)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Customized
Newborns (0-27 days)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Customized
Infants and toddlers (28 days-23 months)
|
860 Participants
n=5 Participants
|
860 Participants
n=7 Participants
|
1720 Participants
n=5 Participants
|
|
Age, Customized
Children (2-11 years)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Customized
Adolescents (12-17 years)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Customized
Adults (18-64 years)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Customized
From 65-84 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Customized
85 years and over
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
397 Participants
n=5 Participants
|
428 Participants
n=7 Participants
|
825 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
463 Participants
n=5 Participants
|
432 Participants
n=7 Participants
|
895 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
207 Participants
n=5 Participants
|
204 Participants
n=7 Participants
|
411 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
640 Participants
n=5 Participants
|
645 Participants
n=7 Participants
|
1285 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
6 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
223 Participants
n=5 Participants
|
227 Participants
n=7 Participants
|
450 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
52 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
105 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
474 Participants
n=5 Participants
|
483 Participants
n=7 Participants
|
957 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
98 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
178 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 14 days after each vaccination with either V114 or Prevnar 13™Population: All randomized participants who received at least 1 dose of either V114 or Prevnar 13™. One participant in the Prevnar 13™ group inadvertently received both V114 and Prevnar 13™ and was excluded from the analysis population.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs consisted of swelling, redness, pain or tenderness, and hard lump.
Outcome measures
| Measure |
V114
n=858 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
|
Prevnar 13™
n=855 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
|
|---|---|---|
|
Percentage of Participants With Solicited Injection-Site Adverse Events (AEs) in V114 Versus Prevnar 13™
Solicited injection site AEs
|
69.0 Percentage of participants
|
69.2 Percentage of participants
|
|
Percentage of Participants With Solicited Injection-Site Adverse Events (AEs) in V114 Versus Prevnar 13™
Injection site erythema (redness)
|
33.7 Percentage of participants
|
38.5 Percentage of participants
|
|
Percentage of Participants With Solicited Injection-Site Adverse Events (AEs) in V114 Versus Prevnar 13™
Injection site induration (hard lump)
|
26.3 Percentage of participants
|
26.8 Percentage of participants
|
|
Percentage of Participants With Solicited Injection-Site Adverse Events (AEs) in V114 Versus Prevnar 13™
Injection site pain (pain)
|
49.8 Percentage of participants
|
46.9 Percentage of participants
|
|
Percentage of Participants With Solicited Injection-Site Adverse Events (AEs) in V114 Versus Prevnar 13™
Injection site swelling (swelling)
|
26.3 Percentage of participants
|
24.0 Percentage of participants
|
PRIMARY outcome
Timeframe: Up to 14 days after each vaccination with either V114 or Prevnar 13™Population: All randomized participants who received at least 1 dose of either V114 or Prevnar 13™. One participant in the Prevnar 13™ group inadvertently received both V114 and Prevnar 13™ and was excluded from the analysis population.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited systemic AEs consisted of irritability, drowsiness, appetite lost, and hives or welts.
Outcome measures
| Measure |
V114
n=858 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
|
Prevnar 13™
n=855 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
|
|---|---|---|
|
Percentage of Participants With Solicited Systemic AEs
Solicited systemic adverse events
|
84.4 Percentage of participants
|
84.8 Percentage of participants
|
|
Percentage of Participants With Solicited Systemic AEs
Decreased appetite
|
34.3 Percentage of participants
|
36.0 Percentage of participants
|
|
Percentage of Participants With Solicited Systemic AEs
Irritability
|
76.5 Percentage of participants
|
75.4 Percentage of participants
|
|
Percentage of Participants With Solicited Systemic AEs
Somnolence (drowsiness)
|
59.0 Percentage of participants
|
62.0 Percentage of participants
|
|
Percentage of Participants With Solicited Systemic AEs
Urticaria (hives)
|
6.5 Percentage of participants
|
6.5 Percentage of participants
|
PRIMARY outcome
Timeframe: From Day 1 up to 6 months after Vaccination 4 (up to 21 months)Population: All randomized participants who received at least 1 dose of either V114 or Prevnar 13™. One participant in the Prevnar 13™ group inadvertently received both V114 and Prevnar 13™ and was excluded from the analysis population.
An 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 an other important medical event. Any SAEs that are at least possibly related to vaccination are summarized.
Outcome measures
| Measure |
V114
n=858 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
|
Prevnar 13™
n=855 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
|
|---|---|---|
|
Percentage of Participants With Vaccine-Related Serious Adverse Events (SAEs)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
PRIMARY outcome
Timeframe: One month after Vaccination 3 (Month 7)Population: All randomized participants who did not have protocol deviations that could have substantially affected the results of the immunogenicity analysis and who had sufficient blood volume to perform the analysis.
Anti-PnP serotype-specific IgG response rates for the 15 serotypes contained in V114 were measured with pneumococcal electrochemiluminescence (PnECL). The percentage of participants with IgG Ab ≥0.35 ug/mL are reported for each serotype.
Outcome measures
| Measure |
V114
n=858 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
|
Prevnar 13™
n=856 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
|
|---|---|---|
|
Percentage of Participants With Anti-Pneumococcal Polysaccharide (Anti-PnP) Immunoglobulin G (IgG) Antibody (Ab) ≥0.35 ug/mL One Month After Vaccination 3
Serotype 1
|
95.7 Percentage of participants
|
99.1 Percentage of participants
|
|
Percentage of Participants With Anti-Pneumococcal Polysaccharide (Anti-PnP) Immunoglobulin G (IgG) Antibody (Ab) ≥0.35 ug/mL One Month After Vaccination 3
Serotype 3
|
94.7 Percentage of participants
|
79.2 Percentage of participants
|
|
Percentage of Participants With Anti-Pneumococcal Polysaccharide (Anti-PnP) Immunoglobulin G (IgG) Antibody (Ab) ≥0.35 ug/mL One Month After Vaccination 3
Serotype 4
|
96.4 Percentage of participants
|
98.6 Percentage of participants
|
|
Percentage of Participants With Anti-Pneumococcal Polysaccharide (Anti-PnP) Immunoglobulin G (IgG) Antibody (Ab) ≥0.35 ug/mL One Month After Vaccination 3
Serotype 5
|
95.3 Percentage of participants
|
97.4 Percentage of participants
|
|
Percentage of Participants With Anti-Pneumococcal Polysaccharide (Anti-PnP) Immunoglobulin G (IgG) Antibody (Ab) ≥0.35 ug/mL One Month After Vaccination 3
Serotype 6A
|
93.7 Percentage of participants
|
98.6 Percentage of participants
|
|
Percentage of Participants With Anti-Pneumococcal Polysaccharide (Anti-PnP) Immunoglobulin G (IgG) Antibody (Ab) ≥0.35 ug/mL One Month After Vaccination 3
Serotype 6B
|
88.6 Percentage of participants
|
92.0 Percentage of participants
|
|
Percentage of Participants With Anti-Pneumococcal Polysaccharide (Anti-PnP) Immunoglobulin G (IgG) Antibody (Ab) ≥0.35 ug/mL One Month After Vaccination 3
Serotype 7F
|
99.0 Percentage of participants
|
99.8 Percentage of participants
|
|
Percentage of Participants With Anti-Pneumococcal Polysaccharide (Anti-PnP) Immunoglobulin G (IgG) Antibody (Ab) ≥0.35 ug/mL One Month After Vaccination 3
Serotype 9V
|
97.1 Percentage of participants
|
98.2 Percentage of participants
|
|
Percentage of Participants With Anti-Pneumococcal Polysaccharide (Anti-PnP) Immunoglobulin G (IgG) Antibody (Ab) ≥0.35 ug/mL One Month After Vaccination 3
Serotype 14
|
97.9 Percentage of participants
|
97.9 Percentage of participants
|
|
Percentage of Participants With Anti-Pneumococcal Polysaccharide (Anti-PnP) Immunoglobulin G (IgG) Antibody (Ab) ≥0.35 ug/mL One Month After Vaccination 3
Serotype 18C
|
97.4 Percentage of participants
|
98.3 Percentage of participants
|
|
Percentage of Participants With Anti-Pneumococcal Polysaccharide (Anti-PnP) Immunoglobulin G (IgG) Antibody (Ab) ≥0.35 ug/mL One Month After Vaccination 3
Serotype 19A
|
97.9 Percentage of participants
|
99.7 Percentage of participants
|
|
Percentage of Participants With Anti-Pneumococcal Polysaccharide (Anti-PnP) Immunoglobulin G (IgG) Antibody (Ab) ≥0.35 ug/mL One Month After Vaccination 3
Serotype 19F
|
99.0 Percentage of participants
|
100.0 Percentage of participants
|
|
Percentage of Participants With Anti-Pneumococcal Polysaccharide (Anti-PnP) Immunoglobulin G (IgG) Antibody (Ab) ≥0.35 ug/mL One Month After Vaccination 3
Serotype 23F
|
91.5 Percentage of participants
|
91.8 Percentage of participants
|
|
Percentage of Participants With Anti-Pneumococcal Polysaccharide (Anti-PnP) Immunoglobulin G (IgG) Antibody (Ab) ≥0.35 ug/mL One Month After Vaccination 3
Serotype 22F
|
98.6 Percentage of participants
|
91.8 Percentage of participants
|
|
Percentage of Participants With Anti-Pneumococcal Polysaccharide (Anti-PnP) Immunoglobulin G (IgG) Antibody (Ab) ≥0.35 ug/mL One Month After Vaccination 3
Serotype 33F
|
87.3 Percentage of participants
|
91.8 Percentage of participants
|
PRIMARY outcome
Timeframe: One month after Vaccination 3 (Month 7)Population: All randomized participants who did not have protocol deviations that could have substantially affected the results of the immunogenicity analysis and who had sufficient blood volume to perform the analysis.
The GMC of anti-PnP IgG Ab were measured with PnECL one month after vaccination 3 and reported for the 15 serotypes contained in V114. IgG GMCs were compared to the lowest in recipients of Prevnar 13™ excluding serotype 3 for the 2 serotypes unique to V114, and compared to the same serotypes for the 13 shared serotypes.
Outcome measures
| Measure |
V114
n=858 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
|
Prevnar 13™
n=856 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
|
|---|---|---|
|
Geometric Mean Concentration (GMC) of Anti-PnP IgG Ab One Month After Vaccination 3
Serotype 33F
|
1.67 ug/mL
Interval 1.51 to 1.85
|
0.06 ug/mL
Interval 0.05 to 0.06
|
|
Geometric Mean Concentration (GMC) of Anti-PnP IgG Ab One Month After Vaccination 3
Serotype 1
|
1.21 ug/mL
Interval 1.15 to 1.27
|
1.89 ug/mL
Interval 1.79 to 2.0
|
|
Geometric Mean Concentration (GMC) of Anti-PnP IgG Ab One Month After Vaccination 3
Serotype 3
|
1.08 ug/mL
Interval 1.03 to 1.14
|
0.62 ug/mL
Interval 0.59 to 0.66
|
|
Geometric Mean Concentration (GMC) of Anti-PnP IgG Ab One Month After Vaccination 3
Serotype 4
|
1.29 ug/mL
Interval 1.22 to 1.36
|
1.35 ug/mL
Interval 1.28 to 1.43
|
|
Geometric Mean Concentration (GMC) of Anti-PnP IgG Ab One Month After Vaccination 3
Serotype 5
|
1.63 ug/mL
Interval 1.52 to 1.74
|
2.25 ug/mL
Interval 2.09 to 2.41
|
|
Geometric Mean Concentration (GMC) of Anti-PnP IgG Ab One Month After Vaccination 3
Serotype 6A
|
1.55 ug/mL
Interval 1.44 to 1.66
|
2.95 ug/mL
Interval 2.76 to 3.15
|
|
Geometric Mean Concentration (GMC) of Anti-PnP IgG Ab One Month After Vaccination 3
Serotype 6B
|
1.60 ug/mL
Interval 1.45 to 1.76
|
1.97 ug/mL
Interval 1.8 to 2.16
|
|
Geometric Mean Concentration (GMC) of Anti-PnP IgG Ab One Month After Vaccination 3
Serotype 7F
|
2.48 ug/mL
Interval 2.35 to 2.61
|
3.23 ug/mL
Interval 3.06 to 3.4
|
|
Geometric Mean Concentration (GMC) of Anti-PnP IgG Ab One Month After Vaccination 3
Serotype 9V
|
1.73 ug/mL
Interval 1.63 to 1.83
|
1.89 ug/mL
Interval 1.77 to 2.01
|
|
Geometric Mean Concentration (GMC) of Anti-PnP IgG Ab One Month After Vaccination 3
Serotype 14
|
4.78 ug/mL
Interval 4.44 to 5.16
|
6.80 ug/mL
Interval 6.3 to 7.33
|
|
Geometric Mean Concentration (GMC) of Anti-PnP IgG Ab One Month After Vaccination 3
Serotype 18C
|
1.53 ug/mL
Interval 1.44 to 1.61
|
2.00 ug/mL
Interval 1.88 to 2.13
|
|
Geometric Mean Concentration (GMC) of Anti-PnP IgG Ab One Month After Vaccination 3
Serotype 19A
|
1.63 ug/mL
Interval 1.54 to 1.73
|
2.29 ug/mL
Interval 2.16 to 2.44
|
|
Geometric Mean Concentration (GMC) of Anti-PnP IgG Ab One Month After Vaccination 3
Serotype 19F
|
2.01 ug/mL
Interval 1.91 to 2.11
|
2.72 ug/mL
Interval 2.59 to 2.86
|
|
Geometric Mean Concentration (GMC) of Anti-PnP IgG Ab One Month After Vaccination 3
Serotype 23F
|
1.31 ug/mL
Interval 1.22 to 1.41
|
1.47 ug/mL
Interval 1.36 to 1.59
|
|
Geometric Mean Concentration (GMC) of Anti-PnP IgG Ab One Month After Vaccination 3
Serotype 22F
|
4.91 ug/mL
Interval 4.58 to 5.26
|
0.05 ug/mL
Interval 0.05 to 0.06
|
PRIMARY outcome
Timeframe: One month after Vaccination 4 (Month 13 to Month 16)Population: All randomized participants who did not have protocol deviations that could have substantially affected the results of the immunogenicity analysis and who had sufficient blood volume to perform the analysis.
The GMC of anti-PnP IgG Ab were measured with PnECL one month after vaccination 4 and reported for the 15 serotypes contained in V114. IgG GMCs were compared to the lowest in recipients of Prevnar 13™ excluding serotype 3 for the 2 serotypes unique to V114, and compared to the same serotypes for the 13 shared serotypes.
Outcome measures
| Measure |
V114
n=858 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
|
Prevnar 13™
n=856 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
|
|---|---|---|
|
GMC of Anti-PnP IgG Ab One Month After Vaccination 4
Serotype 3
|
0.96 ug/mL
Interval 0.91 to 1.01
|
0.71 ug/mL
Interval 0.67 to 0.75
|
|
GMC of Anti-PnP IgG Ab One Month After Vaccination 4
Serotype 1
|
1.35 ug/mL
Interval 1.27 to 1.42
|
2.03 ug/mL
Interval 1.92 to 2.14
|
|
GMC of Anti-PnP IgG Ab One Month After Vaccination 4
Serotype 4
|
1.23 ug/mL
Interval 1.16 to 1.31
|
1.60 ug/mL
Interval 1.51 to 1.71
|
|
GMC of Anti-PnP IgG Ab One Month After Vaccination 4
Serotype 5
|
2.49 ug/mL
Interval 2.34 to 2.64
|
3.95 ug/mL
Interval 3.71 to 4.2
|
|
GMC of Anti-PnP IgG Ab One Month After Vaccination 4
Serotype 6A
|
3.70 ug/mL
Interval 3.46 to 3.97
|
6.21 ug/mL
Interval 5.83 to 6.62
|
|
GMC of Anti-PnP IgG Ab One Month After Vaccination 4
Serotype 6B
|
4.76 ug/mL
Interval 4.43 to 5.1
|
6.43 ug/mL
Interval 6.02 to 6.88
|
|
GMC of Anti-PnP IgG Ab One Month After Vaccination 4
Serotype 7F
|
3.42 ug/mL
Interval 3.22 to 3.64
|
4.85 ug/mL
Interval 4.56 to 5.16
|
|
GMC of Anti-PnP IgG Ab One Month After Vaccination 4
Serotype 9V
|
2.40 ug/mL
Interval 2.27 to 2.55
|
3.29 ug/mL
Interval 3.1 to 3.49
|
|
GMC of Anti-PnP IgG Ab One Month After Vaccination 4
Serotype 14
|
5.61 ug/mL
Interval 5.21 to 6.04
|
6.95 ug/mL
Interval 6.51 to 7.43
|
|
GMC of Anti-PnP IgG Ab One Month After Vaccination 4
Serotype 18C
|
2.62 ug/mL
Interval 2.46 to 2.78
|
3.08 ug/mL
Interval 2.88 to 3.29
|
|
GMC of Anti-PnP IgG Ab One Month After Vaccination 4
Serotype 19A
|
4.10 ug/mL
Interval 3.88 to 4.33
|
5.53 ug/mL
Interval 5.21 to 5.87
|
|
GMC of Anti-PnP IgG Ab One Month After Vaccination 4
Serotype 19F
|
3.55 ug/mL
Interval 3.37 to 3.75
|
4.47 ug/mL
Interval 4.23 to 4.73
|
|
GMC of Anti-PnP IgG Ab One Month After Vaccination 4
Serotype 23F
|
2.04 ug/mL
Interval 1.91 to 2.18
|
3.32 ug/mL
Interval 3.08 to 3.58
|
|
GMC of Anti-PnP IgG Ab One Month After Vaccination 4
Serotype 22F
|
7.52 ug/mL
Interval 7.09 to 7.98
|
0.11 ug/mL
Interval 0.1 to 0.12
|
|
GMC of Anti-PnP IgG Ab One Month After Vaccination 4
Serotype 33F
|
4.15 ug/mL
Interval 3.89 to 4.42
|
0.09 ug/mL
Interval 0.09 to 0.1
|
SECONDARY outcome
Timeframe: One month after Vaccination 3 (Month 7)Population: All randomized participants who did not have protocol deviations that could have substantially affected the results of the immunogenicity analysis and who had sufficient blood volume to perform the analysis.
Antibody responses to diphtheria toxoid, tetanus toxoid, and pertussis antigens were measured using Luminex Assay. The percentage of participants meeting specific criteria are summarized for each serotype. The serotype-specific response rate criteria are as follows: diphtheria toxoid: % ≥0.1 IU/mL; tetanus toxoid: % ≥0.1 IU/mL; pertussis toxin (PT): % ≥ 5 EU/mL; pertussis filamentous hemagglutinin (FHA): % ≥5 EU/mL; pertussis fimbrae types 2/3 (FIM 2/3): % ≥20 EU/mL; pertussis pertactin (PRN): % ≥5 EU/mL; poliovirus 1: % neutralizing antibody (NAb) ≥1:8 dilution; poliovirus 2: % NAb ≥1:8 dilution, poliovirus 3: % NAb ≥1:8 dilution; and Haemophilus influenzae Type B polyribosylribitol phosphate (Hib-PRP): % ≥0.15 ug/mL.
Outcome measures
| Measure |
V114
n=858 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
|
Prevnar 13™
n=856 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
|
|---|---|---|
|
Percentage of Participants Meeting Response Rate Criteria for Pentacel™-Specific (Anti-Diptheria Toxoid, Tetanus Toxoid, and Pertussis Antigens) Immunoglobulin G (IgG) Antibody (Ab) Geometric Mean Concentration (GMC) One Month After Vaccination 3
Diphtheria toxoid
|
96.9 Percentage of participants
|
97.6 Percentage of participants
|
|
Percentage of Participants Meeting Response Rate Criteria for Pentacel™-Specific (Anti-Diptheria Toxoid, Tetanus Toxoid, and Pertussis Antigens) Immunoglobulin G (IgG) Antibody (Ab) Geometric Mean Concentration (GMC) One Month After Vaccination 3
Tetanus toxoid
|
100.0 Percentage of participants
|
99.8 Percentage of participants
|
|
Percentage of Participants Meeting Response Rate Criteria for Pentacel™-Specific (Anti-Diptheria Toxoid, Tetanus Toxoid, and Pertussis Antigens) Immunoglobulin G (IgG) Antibody (Ab) Geometric Mean Concentration (GMC) One Month After Vaccination 3
Pertussis toxin
|
99.0 Percentage of participants
|
98.5 Percentage of participants
|
|
Percentage of Participants Meeting Response Rate Criteria for Pentacel™-Specific (Anti-Diptheria Toxoid, Tetanus Toxoid, and Pertussis Antigens) Immunoglobulin G (IgG) Antibody (Ab) Geometric Mean Concentration (GMC) One Month After Vaccination 3
Pertussis filamentous hemagglutinin
|
99.1 Percentage of participants
|
99.4 Percentage of participants
|
|
Percentage of Participants Meeting Response Rate Criteria for Pentacel™-Specific (Anti-Diptheria Toxoid, Tetanus Toxoid, and Pertussis Antigens) Immunoglobulin G (IgG) Antibody (Ab) Geometric Mean Concentration (GMC) One Month After Vaccination 3
Pertussis fimbrae types 2/3
|
63.7 Percentage of participants
|
61.7 Percentage of participants
|
|
Percentage of Participants Meeting Response Rate Criteria for Pentacel™-Specific (Anti-Diptheria Toxoid, Tetanus Toxoid, and Pertussis Antigens) Immunoglobulin G (IgG) Antibody (Ab) Geometric Mean Concentration (GMC) One Month After Vaccination 3
Pertussis pertactin
|
67.3 Percentage of participants
|
65.5 Percentage of participants
|
|
Percentage of Participants Meeting Response Rate Criteria for Pentacel™-Specific (Anti-Diptheria Toxoid, Tetanus Toxoid, and Pertussis Antigens) Immunoglobulin G (IgG) Antibody (Ab) Geometric Mean Concentration (GMC) One Month After Vaccination 3
Poliovirus 1
|
99.8 Percentage of participants
|
99.8 Percentage of participants
|
|
Percentage of Participants Meeting Response Rate Criteria for Pentacel™-Specific (Anti-Diptheria Toxoid, Tetanus Toxoid, and Pertussis Antigens) Immunoglobulin G (IgG) Antibody (Ab) Geometric Mean Concentration (GMC) One Month After Vaccination 3
Poliovirus 2
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
|
Percentage of Participants Meeting Response Rate Criteria for Pentacel™-Specific (Anti-Diptheria Toxoid, Tetanus Toxoid, and Pertussis Antigens) Immunoglobulin G (IgG) Antibody (Ab) Geometric Mean Concentration (GMC) One Month After Vaccination 3
Poliovirus 3
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
|
Percentage of Participants Meeting Response Rate Criteria for Pentacel™-Specific (Anti-Diptheria Toxoid, Tetanus Toxoid, and Pertussis Antigens) Immunoglobulin G (IgG) Antibody (Ab) Geometric Mean Concentration (GMC) One Month After Vaccination 3
Hib-PRP
|
92.1 Percentage of participants
|
93.5 Percentage of participants
|
SECONDARY outcome
Timeframe: One month after Vaccination 3 (Month 7)Population: All randomized participants who did not have protocol deviations that could have substantially affected the results of the immunogenicity analysis and who had sufficient blood volume to perform the analysis.
Pertussis antibody GMCs were measured using Luminex Assay.
Outcome measures
| Measure |
V114
n=858 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
|
Prevnar 13™
n=856 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
|
|---|---|---|
|
Pertussis Antigen Immunoglobulin G (IgG) Antibody (Ab) Geometric Mean Concentration (GMC) One Month After Vaccination 3
Pertussis - PT
|
43.73 ug/mL
Within-group confidence intervals (CIs) were not calculated, per protocol.
|
44.35 ug/mL
Within-group CIs were not calculated, per protocol.
|
|
Pertussis Antigen Immunoglobulin G (IgG) Antibody (Ab) Geometric Mean Concentration (GMC) One Month After Vaccination 3
Pertussis - FHA
|
67.51 ug/mL
Within-group CIs were not calculated, per protocol.
|
69.18 ug/mL
Within-group CIs were not calculated, per protocol.
|
|
Pertussis Antigen Immunoglobulin G (IgG) Antibody (Ab) Geometric Mean Concentration (GMC) One Month After Vaccination 3
Pertussis - FIM 2/3
|
39.79 ug/mL
Within-group CIs were not calculated, per protocol.
|
36.87 ug/mL
Within-group CIs were not calculated, per protocol.
|
|
Pertussis Antigen Immunoglobulin G (IgG) Antibody (Ab) Geometric Mean Concentration (GMC) One Month After Vaccination 3
Pertussis - PRN
|
13.16 ug/mL
Within-group CIs were not calculated, per protocol.
|
13.17 ug/mL
Within-group CIs were not calculated, per protocol.
|
SECONDARY outcome
Timeframe: One month after Vaccination 4 (Month 13 to Month 16)Population: All randomized participants who did not have protocol deviations that could have substantially affected the results of the immunogenicity analysis, who had sufficient blood volume to perform the analysis, and who had available HAV EIA data.
Antibody response rates to hepatitis A were measured with hepatitis A virus enzyme immunoassay (HAV EIA). The percentage of participants with hepatitis A antigen ≥10 mIU/mL are reported.
Outcome measures
| Measure |
V114
n=649 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
|
Prevnar 13™
n=626 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
|
|---|---|---|
|
Hepatitis A Antibody Response Rate One Month After Vaccination 4
|
97.4 Percentage of participants
|
97.1 Percentage of participants
|
SECONDARY outcome
Timeframe: One month after Vaccination 4 (Month 13 to Month 16)Population: All randomized participants who did not have protocol deviations that could have substantially affected the results of the immunogenicity analysis and who had sufficient blood volume to perform the analysis.
Antibody responses to measles were measured with the bulk measles IgG enzyme immunoassay (EIA). Antibody responses to mumps were measured with enzyme-linked immunosorbent assay (ELISA). Antibody responses to rubella were measured with Bulk Rubella IgG EIA. The percentage of participants with measles antigen ≥255 mIU/ML; mumps antigen ≥10 mumps Ab units/mL; and rubella antigen ≥10 IU/mL, are reported.
Outcome measures
| Measure |
V114
n=858 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
|
Prevnar 13™
n=856 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
|
|---|---|---|
|
Measles, Mumps, and Rubella Antibody Response Rate One Month After Vaccination 4
Measles antigen ≥255 mIU/ML
|
98.1 Percentage of participants
|
98.3 Percentage of participants
|
|
Measles, Mumps, and Rubella Antibody Response Rate One Month After Vaccination 4
Mumps antigen ≥10 mumps Ab units/mL
|
95.8 Percentage of participants
|
97.5 Percentage of participants
|
|
Measles, Mumps, and Rubella Antibody Response Rate One Month After Vaccination 4
Rubella antigen ≥10 IU/mL
|
98.1 Percentage of participants
|
98.9 Percentage of participants
|
SECONDARY outcome
Timeframe: One month after Vaccination 4 (Month 13 to Month 16)Population: All randomized participants who did not have protocol deviations that could have substantially affected the results of the immunogenicity analysis, who had sufficient blood volume to perform the analysis, and who had available VZV gpELISA data.
Antibody responses to varicella-zoster virus were measured with glycoprotein enzyme-linked immunosorbent assay (gpELISA). The percentage of participants with VZV antigen ≥5 gpELISA units/mL are reported.
Outcome measures
| Measure |
V114
n=715 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
|
Prevnar 13™
n=685 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
|
|---|---|---|
|
Varicella-Zoster Virus (VZV) Antibody Response Rate One Month After Vaccination 4
|
96.4 Percentage of participants
|
97.7 Percentage of participants
|
SECONDARY outcome
Timeframe: One month after Vaccination 4 (Month 13 to Month 16)Population: All randomized participants who did not have protocol deviations that could have substantially affected the results of the immunogenicity, who had sufficient blood volume to perform the analysis, and who had available Hib PRP ELISA data.
Antibody responses to Haemophilus influenzae Type B polyribosylribitol phosphate (Hib PRP) were measured with ELISA. The percentage of participants with anti-HiB PRP antigen ≥0.15 ug/mL are reported.
Outcome measures
| Measure |
V114
n=650 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
|
Prevnar 13™
n=626 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
|
|---|---|---|
|
Haemophilus Influenzae Type B Antibody Response Rate One Month After Vaccination 4
|
98.9 Percentage of participants
|
100.0 Percentage of participants
|
SECONDARY outcome
Timeframe: One month after Vaccination 3 (Month 7)Population: All randomized participants who did not have protocol deviations that could have substantially affected the results of the immunogenicity analysis and who had sufficient blood volume to perform the analysis.
Serotype-specific anti-PnP IgG GMCs for the 2 unique V114 serotypes were measured with PnECL. The GMCs for each serotype are reported.
Outcome measures
| Measure |
V114
n=858 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
|
Prevnar 13™
n=856 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
|
|---|---|---|
|
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) One Month After Vaccination 3 for 2 Unique V114 Seroptypes
22F
|
4.91 ug/mL
Interval 4.58 to 5.26
|
0.05 ug/mL
Interval 0.05 to 0.06
|
|
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) One Month After Vaccination 3 for 2 Unique V114 Seroptypes
33F
|
1.67 ug/mL
Interval 1.51 to 1.85
|
0.06 ug/mL
Interval 0.05 to 0.06
|
SECONDARY outcome
Timeframe: One month after Vaccination 3 (Month 7)Population: All randomized participants who did not have protocol deviations that could have substantially affected the results of the immunogenicity analysis and who had sufficient blood volume to perform the analysis.
Serotype-specific anti-PnP IgG response rates for the 2 unique V114 serotypes were measured with PnECL. The percentage of participants with IgG Ab ≥0.35 ug/mL are reported for each serotype.
Outcome measures
| Measure |
V114
n=858 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
|
Prevnar 13™
n=856 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
|
|---|---|---|
|
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Immunoglobulin G (IgG) Response Rates One Month After Vaccination 3 for 2 Unique V114 Seroptypes
Serotype 22F
|
98.6 Percentage of participants
|
3.5 Percentage of participants
|
|
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Immunoglobulin G (IgG) Response Rates One Month After Vaccination 3 for 2 Unique V114 Seroptypes
Serotype 33F
|
87.3 Percentage of participants
|
2.1 Percentage of participants
|
SECONDARY outcome
Timeframe: One month after Vaccination 4 (Month 13 to Month 16)Population: All randomized participants who did not have protocol deviations that could have substantially affected the results of the immunogenicity analysis and who had sufficient blood volume to perform the analysis.
Serotype-specific anti-PnP GMCs were measured with PnECL. The GMC for each serotype is reported.
Outcome measures
| Measure |
V114
n=858 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
|
Prevnar 13™
n=856 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
|
|---|---|---|
|
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMC) One Month After Vaccination 4 for 2 Unique V114 Seroptypes
22F
|
7.52 ug/mL
Interval 7.09 to 7.98
|
0.11 ug/mL
Interval 0.1 to 0.12
|
|
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMC) One Month After Vaccination 4 for 2 Unique V114 Seroptypes
33F
|
4.15 ug/mL
Interval 3.89 to 4.42
|
0.09 ug/mL
Interval 0.09 to 0.1
|
SECONDARY outcome
Timeframe: One month after Vaccination 3 (Month 7)Population: Due to the large serum volume required for MOPA, the analysis population for OPA testing was performed on a subset of participants, which included the first 20% of all participants with sufficient serum volume at 30 days post-dose 3.
Serotype-specific anti-PnP OPA GMTs were measured with multiplex opsonophagocytic assay (MOPA). The GMTs for each serotype are summarized.
Outcome measures
| Measure |
V114
n=176 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
|
Prevnar 13™
n=168 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
|
|---|---|---|
|
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) One Month After Vaccination 3
Serotype 1
|
56.9 Titers
Interval 46.1 to 70.3
|
78.3 Titers
Interval 61.5 to 99.5
|
|
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) One Month After Vaccination 3
Serotype 3
|
284.7 Titers
Interval 253.5 to 319.8
|
210.6 Titers
Interval 188.2 to 235.7
|
|
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) One Month After Vaccination 3
Serotype 4
|
1304.8 Titers
Interval 1139.6 to 1494.0
|
1566.7 Titers
Interval 1381.8 to 1776.4
|
|
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) One Month After Vaccination 3
Serotype 5
|
387.4 Titers
Interval 315.0 to 476.3
|
510.8 Titers
Interval 415.9 to 627.2
|
|
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) One Month After Vaccination 3
Serotype 6A
|
2072.1 Titers
Interval 1787.5 to 2401.9
|
2743.4 Titers
Interval 2368.1 to 3178.2
|
|
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) One Month After Vaccination 3
Serotype 6B
|
1932.5 Titers
Interval 1612.1 to 2316.6
|
1963.7 Titers
Interval 1604.9 to 2402.8
|
|
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) One Month After Vaccination 3
Serotype 7F
|
4973.2 Titers
Interval 4277.6 to 5781.8
|
7335.1 Titers
Interval 6181.8 to 8703.5
|
|
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) One Month After Vaccination 3
Serotype 9V
|
1217.3 Titers
Interval 1040.2 to 1424.6
|
1534.1 Titers
Interval 1305.5 to 1802.8
|
|
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) One Month After Vaccination 3
Serotype 14
|
2400.7 Titers
Interval 1980.8 to 2909.6
|
1853.1 Titers
Interval 1511.2 to 2272.5
|
|
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) One Month After Vaccination 3
Serotype 18C
|
1171.2 Titers
Interval 1022.7 to 1341.4
|
1330.2 Titers
Interval 1158.3 to 1527.5
|
|
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) One Month After Vaccination 3
Serotype 19A
|
841.3 Titers
Interval 716.0 to 988.6
|
1400.7 Titers
Interval 1205.5 to 1627.4
|
|
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) One Month After Vaccination 3
Serotype 19F
|
703.9 Titers
Interval 614.2 to 806.6
|
850.6 Titers
Interval 744.5 to 971.9
|
|
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) One Month After Vaccination 3
Serotype 23F
|
2078.9 Titers
Interval 1779.2 to 2428.9
|
3668.8 Titers
Interval 3069.2 to 4385.6
|
|
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) One Month After Vaccination 3
Serotype 22F
|
1849.3 Titers
Interval 1606.9 to 2128.2
|
9.1 Titers
Interval 7.9 to 10.4
|
|
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) One Month After Vaccination 3
Serotype 33F
|
8262.6 Titers
Interval 6585.3 to 10367.1
|
119.6 Titers
Interval 83.2 to 171.8
|
SECONDARY outcome
Timeframe: One month after Vaccination 3 (Month 7)Population: Due to the large serum volume required for MOPA, the analysis population for OPA testing was performed on a subset of participants, which included the first 20% of all participants with sufficient serum volume at 30 days post-dose 3.
Serotype-specific anti-PnP OPA GMTs were measured with MOPA. The percentage of participants meeting ≥0.35 ug/mL are reported for each serotype.
Outcome measures
| Measure |
V114
n=176 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
|
Prevnar 13™
n=168 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
|
|---|---|---|
|
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Response Rates One Month After Vaccination 3
Serotype 1
|
86.5 Percentage of participants
Interval 80.4 to 91.2
|
87.7 Percentage of participants
Interval 81.6 to 92.3
|
|
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Response Rates One Month After Vaccination 3
Serotype 3
|
100.0 Percentage of participants
Interval 97.8 to 100.0
|
100.0 Percentage of participants
Interval 97.7 to 100.0
|
|
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Response Rates One Month After Vaccination 3
Serotype 4
|
99.4 Percentage of participants
Interval 96.7 to 100.0
|
100.0 Percentage of participants
Interval 97.7 to 100.0
|
|
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Response Rates One Month After Vaccination 3
Serotype 5
|
96.5 Percentage of participants
Interval 92.5 to 98.7
|
98.1 Percentage of participants
Interval 94.7 to 99.6
|
|
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Response Rates One Month After Vaccination 3
Serotype 6A
|
97.1 Percentage of participants
Interval 93.3 to 99.0
|
98.1 Percentage of participants
Interval 94.6 to 99.6
|
|
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Response Rates One Month After Vaccination 3
Serotype 6B
|
98.2 Percentage of participants
Interval 94.9 to 99.6
|
98.1 Percentage of participants
Interval 94.6 to 99.6
|
|
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Response Rates One Month After Vaccination 3
Serotype 7F
|
100.0 Percentage of participants
Interval 97.9 to 100.0
|
100.0 Percentage of participants
Interval 97.7 to 100.0
|
|
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Response Rates One Month After Vaccination 3
Serotype 9V
|
98.2 Percentage of participants
Interval 94.9 to 99.6
|
97.5 Percentage of participants
Interval 93.8 to 99.3
|
|
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Response Rates One Month After Vaccination 3
Serotype 14
|
98.8 Percentage of participants
Interval 95.7 to 99.9
|
98.8 Percentage of participants
Interval 95.6 to 99.8
|
|
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Response Rates One Month After Vaccination 3
Serotype 18C
|
98.8 Percentage of participants
Interval 95.8 to 99.9
|
99.4 Percentage of participants
Interval 96.6 to 100.0
|
|
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Response Rates One Month After Vaccination 3
Serotype 19A
|
98.2 Percentage of participants
Interval 95.0 to 99.6
|
99.4 Percentage of participants
Interval 96.6 to 100.0
|
|
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Response Rates One Month After Vaccination 3
Serotype 19F
|
95.9 Percentage of participants
Interval 91.7 to 98.3
|
98.8 Percentage of participants
Interval 95.6 to 99.9
|
|
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Response Rates One Month After Vaccination 3
Serotype 23F
|
99.4 Percentage of participants
Interval 96.7 to 100.0
|
100.0 Percentage of participants
Interval 97.7 to 100.0
|
|
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Response Rates One Month After Vaccination 3
Serotype 22F
|
99.4 Percentage of participants
Interval 96.8 to 100.0
|
5.8 Percentage of participants
Interval 2.7 to 10.7
|
|
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Response Rates One Month After Vaccination 3
Serotype 33F
|
98.8 Percentage of participants
Interval 95.8 to 99.9
|
56.8 Percentage of participants
Interval 48.6 to 64.7
|
SECONDARY outcome
Timeframe: One month after Vaccination 3 (Month 7)Population: All randomized participants who did not have protocol deviations that could have substantially affected the results of the immunogenicity analysis, who had sufficient blood volume to perform the analysis, and who had available serotype 3-specific IgG data.
Serotype 3-specific anti-PnP IgG response rates were measured with PnECL. The percentage of participants with IgG Ab ≥0.35 ug/mL are reported for Serotype 3.
Outcome measures
| Measure |
V114
n=699 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
|
Prevnar 13™
n=662 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
|
|---|---|---|
|
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype 3-Specific Immunoglobulin G (IgG) Response Rate One Month After Vaccination 3
|
94.7 Percentage of participants
|
79.2 Percentage of participants
|
SECONDARY outcome
Timeframe: One month after Vaccination 3 (Month 7)Population: All randomized participants who did not have protocol deviations that could have substantially affected the results of the immunogenicity analysis, who had sufficient blood volume to perform the analysis, and who had available serotype 3-specific IgG data.
Serotype 3-specific anti-PnP GMC was measured with PnECL.
Outcome measures
| Measure |
V114
n=699 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
|
Prevnar 13™
n=662 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
|
|---|---|---|
|
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype 3-Specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) One Month After Vaccination 3
|
1.08 ug/mL
Interval 1.03 to 1.14
|
0.62 ug/mL
Interval 0.59 to 0.66
|
SECONDARY outcome
Timeframe: One month after Vaccination 4 (Month 13 to Month 16)Population: All randomized participants who did not have protocol deviations that could have substantially affected the results of the immunogenicity analysis who had sufficient blood volume to perform the analysis, and who had available serotype 3-specific IgG data.
Serotype 3-specific anti-PnP GMC were measured with PnECL.
Outcome measures
| Measure |
V114
n=712 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
|
Prevnar 13™
n=686 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
|
|---|---|---|
|
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype 3-Specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) One Month After Vaccination 4
|
0.96 ug/mL
Interval 0.91 to 1.01
|
0.71 ug/mL
Interval 0.67 to 0.75
|
Adverse Events
V114
Serious events: 88 serious events
Other events: 790 other events
Deaths: 1 deaths
Prevnar 13™
Serious events: 81 serious events
Other events: 778 other events
Deaths: 1 deaths
Cross-treated Participants
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
V114
n=858 participants at risk
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
|
Prevnar 13™
n=855 participants at risk
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 between 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
|
Cross-treated Participants
n=1 participants at risk
One participant assigned to the Prevnar 13™ arm who inadvertently received both V114 and Prevnar 13™. The participant received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 between 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and a single 0.5 mL IM injection of V114 Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). The participant concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.12%
1/858 • Number of events 1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.00%
0/855 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.00%
0/1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
|
Congenital, familial and genetic disorders
Heart disease congenital
|
0.12%
1/858 • Number of events 1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.00%
0/855 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.00%
0/1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.23%
2/858 • Number of events 2 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.12%
1/855 • Number of events 1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.00%
0/1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/858 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.12%
1/855 • Number of events 1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.00%
0/1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/858 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.12%
1/855 • Number of events 1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.00%
0/1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
|
Gastrointestinal disorders
Gastritis
|
0.12%
1/858 • Number of events 1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.12%
1/855 • Number of events 1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.00%
0/1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/858 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.12%
1/855 • Number of events 1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.00%
0/1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
|
Gastrointestinal disorders
Haematochezia
|
0.12%
1/858 • Number of events 1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.00%
0/855 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.00%
0/1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.12%
1/858 • Number of events 1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.00%
0/855 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.00%
0/1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
|
General disorders
Pyrexia
|
0.23%
2/858 • Number of events 2 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.35%
3/855 • Number of events 3 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.00%
0/1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
|
Immune system disorders
Anaphylactic reaction
|
0.23%
2/858 • Number of events 2 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.00%
0/855 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.00%
0/1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
|
Infections and infestations
Abscess limb
|
0.12%
1/858 • Number of events 1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.12%
1/855 • Number of events 1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.00%
0/1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
|
Infections and infestations
Bacteraemia
|
0.23%
2/858 • Number of events 2 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.12%
1/855 • Number of events 1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.00%
0/1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
|
Infections and infestations
Bronchiolitis
|
1.3%
11/858 • Number of events 12 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.70%
6/855 • Number of events 6 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
100.0%
1/1 • Number of events 1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
|
Infections and infestations
Bronchitis
|
0.58%
5/858 • Number of events 5 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.23%
2/855 • Number of events 2 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.00%
0/1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
|
Infections and infestations
Bronchitis viral
|
0.12%
1/858 • Number of events 1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.00%
0/855 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.00%
0/1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
|
Infections and infestations
COVID-19
|
0.23%
2/858 • Number of events 2 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.12%
1/855 • Number of events 1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.00%
0/1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
|
Infections and infestations
Croup infectious
|
0.23%
2/858 • Number of events 2 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.12%
1/855 • Number of events 1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.00%
0/1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
|
Infections and infestations
Cystitis
|
0.12%
1/858 • Number of events 1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.00%
0/855 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.00%
0/1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
|
Infections and infestations
Dengue fever
|
0.12%
1/858 • Number of events 1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.12%
1/855 • Number of events 1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.00%
0/1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
|
Infections and infestations
Diarrhoea infectious
|
0.12%
1/858 • Number of events 1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.12%
1/855 • Number of events 1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.00%
0/1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
|
Infections and infestations
Enterovirus infection
|
0.12%
1/858 • Number of events 1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.00%
0/855 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.00%
0/1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.12%
1/858 • Number of events 1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.12%
1/855 • Number of events 1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.00%
0/1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
|
Infections and infestations
Exanthema subitum
|
0.35%
3/858 • Number of events 3 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.35%
3/855 • Number of events 3 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.00%
0/1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
|
Infections and infestations
Gastroenteritis
|
0.82%
7/858 • Number of events 7 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
1.3%
11/855 • Number of events 13 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.00%
0/1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
|
Infections and infestations
Gastroenteritis bacterial
|
0.00%
0/858 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.12%
1/855 • Number of events 1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.00%
0/1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
|
Infections and infestations
Gastroenteritis viral
|
0.70%
6/858 • Number of events 6 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.23%
2/855 • Number of events 2 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.00%
0/1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
0.00%
0/858 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.12%
1/855 • Number of events 1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.00%
0/1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
|
Infections and infestations
Herpangina
|
0.12%
1/858 • Number of events 1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.00%
0/855 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.00%
0/1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
|
Infections and infestations
Influenza
|
0.23%
2/858 • Number of events 2 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.12%
1/855 • Number of events 1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.00%
0/1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
|
Infections and infestations
Nasopharyngitis
|
0.12%
1/858 • Number of events 1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.12%
1/855 • Number of events 1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.00%
0/1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/858 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.12%
1/855 • Number of events 1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.00%
0/1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
|
Infections and infestations
Oral viral infection
|
0.00%
0/858 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.12%
1/855 • Number of events 1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.00%
0/1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
|
Infections and infestations
Otitis media
|
0.12%
1/858 • Number of events 1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.00%
0/855 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.00%
0/1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
|
Infections and infestations
Periorbital cellulitis
|
0.12%
1/858 • Number of events 1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.00%
0/855 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.00%
0/1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
|
Infections and infestations
Pharyngitis
|
0.23%
2/858 • Number of events 2 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.00%
0/855 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.00%
0/1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
|
Infections and infestations
Pneumonia
|
0.58%
5/858 • Number of events 5 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.58%
5/855 • Number of events 5 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.00%
0/1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
|
Infections and infestations
Pneumonia influenzal
|
0.00%
0/858 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.12%
1/855 • Number of events 1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.00%
0/1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
|
Infections and infestations
Pneumonia respiratory syncytial viral
|
0.47%
4/858 • Number of events 4 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.12%
1/855 • Number of events 1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.00%
0/1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
|
Infections and infestations
Pneumonia viral
|
0.12%
1/858 • Number of events 1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.23%
2/855 • Number of events 2 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.00%
0/1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/858 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.12%
1/855 • Number of events 1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.00%
0/1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
|
Infections and infestations
Respiratory syncytial virus bronchiolitis
|
0.82%
7/858 • Number of events 7 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
1.4%
12/855 • Number of events 12 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.00%
0/1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.12%
1/858 • Number of events 1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.35%
3/855 • Number of events 3 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.00%
0/1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
|
Infections and infestations
Scarlet fever
|
0.00%
0/858 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.12%
1/855 • Number of events 1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.00%
0/1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
|
Infections and infestations
Sepsis
|
0.12%
1/858 • Number of events 1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.12%
1/855 • Number of events 1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.00%
0/1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
|
Infections and infestations
Septic shock
|
0.00%
0/858 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.12%
1/855 • Number of events 1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.00%
0/1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.23%
2/858 • Number of events 2 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.23%
2/855 • Number of events 2 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.00%
0/1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
|
Infections and infestations
Urinary tract infection
|
0.35%
3/858 • Number of events 3 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.35%
3/855 • Number of events 3 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.00%
0/1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
|
Infections and infestations
Varicella
|
0.00%
0/858 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.12%
1/855 • Number of events 1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.00%
0/1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
|
Infections and infestations
Viral diarrhoea
|
0.00%
0/858 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.12%
1/855 • Number of events 1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.00%
0/1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
|
Infections and infestations
Viral infection
|
0.47%
4/858 • Number of events 4 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.23%
2/855 • Number of events 2 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.00%
0/1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
|
Infections and infestations
Viral rash
|
0.23%
2/858 • Number of events 2 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.23%
2/855 • Number of events 2 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.00%
0/1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
|
Infections and infestations
Viral rhinitis
|
0.00%
0/858 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.12%
1/855 • Number of events 1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.00%
0/1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.23%
2/858 • Number of events 2 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.12%
1/855 • Number of events 1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.00%
0/1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
|
Injury, poisoning and procedural complications
Brain contusion
|
0.12%
1/858 • Number of events 1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.00%
0/855 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.00%
0/1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
|
Injury, poisoning and procedural complications
Foreign body in gastrointestinal tract
|
0.12%
1/858 • Number of events 1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.00%
0/855 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.00%
0/1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/858 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.23%
2/855 • Number of events 2 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.00%
0/1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/858 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.12%
1/855 • Number of events 1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.00%
0/1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.12%
1/858 • Number of events 1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.00%
0/855 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.00%
0/1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
|
Nervous system disorders
Altered state of consciousness
|
0.00%
0/858 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.12%
1/855 • Number of events 1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.00%
0/1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/858 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.12%
1/855 • Number of events 1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.00%
0/1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
|
Nervous system disorders
Febrile convulsion
|
0.35%
3/858 • Number of events 4 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.23%
2/855 • Number of events 2 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.00%
0/1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
|
Nervous system disorders
Idiopathic generalised epilepsy
|
0.00%
0/858 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.12%
1/855 • Number of events 1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.00%
0/1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
|
Nervous system disorders
Infantile spasms
|
0.12%
1/858 • Number of events 1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.00%
0/855 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.00%
0/1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
|
Nervous system disorders
Seizure
|
0.12%
1/858 • Number of events 1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.00%
0/855 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.00%
0/1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
|
Reproductive system and breast disorders
Penile haemorrhage
|
0.00%
0/858 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.12%
1/855 • Number of events 1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.00%
0/1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.23%
2/858 • Number of events 2 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.00%
0/855 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.00%
0/1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.12%
1/858 • Number of events 1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.00%
0/855 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.00%
0/1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
|
Vascular disorders
Kawasaki's disease
|
0.12%
1/858 • Number of events 1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.12%
1/855 • Number of events 1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.00%
0/1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
Other adverse events
| Measure |
V114
n=858 participants at risk
Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
|
Prevnar 13™
n=855 participants at risk
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 between 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
|
Cross-treated Participants
n=1 participants at risk
One participant assigned to the Prevnar 13™ arm who inadvertently received both V114 and Prevnar 13™. The participant received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 between 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and a single 0.5 mL IM injection of V114 Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). The participant concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
5.4%
46/858 • Number of events 62 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
7.3%
62/855 • Number of events 76 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.00%
0/1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
|
Gastrointestinal disorders
Vomiting
|
4.9%
42/858 • Number of events 54 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
5.4%
46/855 • Number of events 52 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.00%
0/1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
|
General disorders
Injection site erythema
|
33.7%
289/858 • Number of events 488 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
38.5%
329/855 • Number of events 584 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
100.0%
1/1 • Number of events 1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
|
General disorders
Injection site induration
|
26.3%
226/858 • Number of events 385 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
26.8%
229/855 • Number of events 404 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
100.0%
1/1 • Number of events 1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
|
General disorders
Injection site pain
|
49.8%
427/858 • Number of events 903 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
46.9%
401/855 • Number of events 832 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
100.0%
1/1 • Number of events 2 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
|
General disorders
Injection site swelling
|
26.3%
226/858 • Number of events 360 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
24.0%
205/855 • Number of events 348 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.00%
0/1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
|
General disorders
Pyrexia
|
30.9%
265/858 • Number of events 431 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
31.6%
270/855 • Number of events 464 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.00%
0/1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.4%
55/858 • Number of events 55 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
4.9%
42/855 • Number of events 44 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.00%
0/1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
34.3%
294/858 • Number of events 579 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
36.0%
308/855 • Number of events 606 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.00%
0/1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
|
Nervous system disorders
Somnolence
|
59.0%
506/858 • Number of events 1257 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
62.0%
530/855 • Number of events 1309 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.00%
0/1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
|
Psychiatric disorders
Irritability
|
76.5%
656/858 • Number of events 2514 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
75.4%
645/855 • Number of events 2435 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
100.0%
1/1 • Number of events 3 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.1%
35/858 • Number of events 39 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
5.3%
45/855 • Number of events 48 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.00%
0/1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
4.2%
36/858 • Number of events 40 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
5.5%
47/855 • Number of events 49 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.00%
0/1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
6.5%
56/858 • Number of events 69 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
6.5%
56/855 • Number of events 69 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
0.00%
0/1 • Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
|
Additional Information
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