Trial Outcomes & Findings for A Study to Evaluate the Interchangeability of V114 and Prevnar 13™ in Healthy Infants (V114-027/PNEU-DIRECTION) (NCT NCT03620162)
NCT ID: NCT03620162
Last Updated: 2023-01-17
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. Per protocol, the percentage of participants with solicited injection-site AEs was assessed for up to \~14 days after each vaccination. The solicited injection-site AEs assessed were erythema/redness, induration/hard lump, tenderness/pain and swelling.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
900 participants
Primary outcome timeframe
Up to ~14 days after each vaccination
Results posted on
2023-01-17
Participant Flow
Participants were screened at Study Day 1, prior to randomization.
Participant milestones
| Measure |
Group 1: Prevnar 13™-Prevnar 13™-Prevnar 13™-Prevnar 13™
Participants received a single 0.5 mL intramuscular (IM) injection of Prevnar 13™ on Day 1 (Vaccination 1), Month 2 (Vaccination 2), Month 4 (Vaccination 3) and Months 10-13 (Vaccination 4). Participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
|
Group 2: Prevnar 13™-Prevnar 13™-Prevnar 13™-V114
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1), Month 2 (Vaccination 2), Month 4 (Vaccination 3) and a single 0.5 mL IM injection of V114 on Months 10-13 (Vaccination 4). Participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
|
Group 3: Prevnar 13™-Prevnar 13™-V114-V114
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1), Month 2 (Vaccination 2) and a single 0.5 mL IM injection of V114 on Month 4 (Vaccination 3) and Months 10-13 (Vaccination 4). Participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
|
Group 4: Prevnar 13™-V114-V114-V114
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of V114 on Month 2 (Vaccination 2), Month 4 (Vaccination 3) and Months 10-13 (Vaccination 4). Participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
|
Group 5: V114-V114-V114-V114
Participants received a single 0.5 mL IM injection of V114 on Day 1 (Vaccination 1), Month 2 (Vaccination 2), Month 4 (Vaccination 3) and Months 10-13 (Vaccination 4). Participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
179
|
181
|
180
|
180
|
180
|
|
Overall Study
Vaccination 1 (V114 or Prevnar 13™)
|
179
|
181
|
178
|
179
|
179
|
|
Overall Study
Vaccination 2 (V114 or Prevnar 13™)
|
176
|
175
|
166
|
169
|
173
|
|
Overall Study
Vaccination 3 (V114 or Prevnar 13™)
|
175
|
174
|
161
|
167
|
173
|
|
Overall Study
Vaccination 4 (V114 or Prevnar 13™)
|
165
|
168
|
150
|
162
|
168
|
|
Overall Study
COMPLETED
|
164
|
167
|
147
|
160
|
167
|
|
Overall Study
NOT COMPLETED
|
15
|
14
|
33
|
20
|
13
|
Reasons for withdrawal
| Measure |
Group 1: Prevnar 13™-Prevnar 13™-Prevnar 13™-Prevnar 13™
Participants received a single 0.5 mL intramuscular (IM) injection of Prevnar 13™ on Day 1 (Vaccination 1), Month 2 (Vaccination 2), Month 4 (Vaccination 3) and Months 10-13 (Vaccination 4). Participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
|
Group 2: Prevnar 13™-Prevnar 13™-Prevnar 13™-V114
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1), Month 2 (Vaccination 2), Month 4 (Vaccination 3) and a single 0.5 mL IM injection of V114 on Months 10-13 (Vaccination 4). Participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
|
Group 3: Prevnar 13™-Prevnar 13™-V114-V114
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1), Month 2 (Vaccination 2) and a single 0.5 mL IM injection of V114 on Month 4 (Vaccination 3) and Months 10-13 (Vaccination 4). Participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
|
Group 4: Prevnar 13™-V114-V114-V114
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of V114 on Month 2 (Vaccination 2), Month 4 (Vaccination 3) and Months 10-13 (Vaccination 4). Participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
|
Group 5: V114-V114-V114-V114
Participants received a single 0.5 mL IM injection of V114 on Day 1 (Vaccination 1), Month 2 (Vaccination 2), Month 4 (Vaccination 3) and Months 10-13 (Vaccination 4). Participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
|
|---|---|---|---|---|---|
|
Overall Study
Physician Decision
|
4
|
0
|
1
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
2
|
6
|
7
|
3
|
2
|
|
Overall Study
Consent withdrawn by parent/guardian
|
9
|
8
|
25
|
17
|
9
|
Baseline Characteristics
A Study to Evaluate the Interchangeability of V114 and Prevnar 13™ in Healthy Infants (V114-027/PNEU-DIRECTION)
Baseline characteristics by cohort
| Measure |
Group 1: Prevnar 13™-Prevnar 13™-Prevnar 13™-Prevnar 13™
n=179 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of Prevnar 13™ on Day 1 (Vaccination 1), Month 2 (Vaccination 2), Month 4 (Vaccination 3) and Months 10-13 (Vaccination 4). Participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
|
Group 2: Prevnar 13™-Prevnar 13™-Prevnar 13™-V114
n=181 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1), Month 2 (Vaccination 2), Month 4 (Vaccination 3) and a single 0.5 mL IM injection of V114 on Months 10-13 (Vaccination 4). Participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
|
Group 3: Prevnar 13™-Prevnar 13™-V114-V114
n=180 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1), Month 2 (Vaccination 2) and a single 0.5 mL IM injection of V114 on Month 4 (Vaccination 3) and Months 10-13 (Vaccination 4). Participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
|
Group 4: Prevnar 13™-V114-V114-V114
n=180 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of V114 on Month 2 (Vaccination 2), Month 4 (Vaccination 3) and Months 10-13 (Vaccination 4). Participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
|
Group 5: V114-V114-V114-V114
n=180 Participants
Participants received a single 0.5 mL IM injection of V114 on Day 1 (Vaccination 1), Month 2 (Vaccination 2), Month 4 (Vaccination 3) and Months 10-13 (Vaccination 4). Participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
|
Total
n=900 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
63.0 days
STANDARD_DEVIATION 7.8 • n=5 Participants
|
63.6 days
STANDARD_DEVIATION 8.4 • n=7 Participants
|
62.7 days
STANDARD_DEVIATION 9.1 • n=5 Participants
|
63.4 days
STANDARD_DEVIATION 9.3 • n=4 Participants
|
64.0 days
STANDARD_DEVIATION 9.3 • n=21 Participants
|
63.3 days
STANDARD_DEVIATION 8.8 • n=10 Participants
|
|
Sex: Female, Male
Female
|
76 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
86 Participants
n=4 Participants
|
88 Participants
n=21 Participants
|
426 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
103 Participants
n=5 Participants
|
90 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
94 Participants
n=4 Participants
|
92 Participants
n=21 Participants
|
474 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
33 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
43 Participants
n=21 Participants
|
213 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
146 Participants
n=5 Participants
|
134 Participants
n=7 Participants
|
133 Participants
n=5 Participants
|
136 Participants
n=4 Participants
|
137 Participants
n=21 Participants
|
686 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
36 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
38 Participants
n=21 Participants
|
177 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
34 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
115 Participants
n=5 Participants
|
106 Participants
n=7 Participants
|
114 Participants
n=5 Participants
|
114 Participants
n=4 Participants
|
104 Participants
n=21 Participants
|
553 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
19 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
133 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Up to ~14 days after each vaccinationPopulation: All randomized participants who got ≥1 dose of V114 or Prevnar 13™.
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. Per protocol, the percentage of participants with solicited injection-site AEs was assessed for up to \~14 days after each vaccination. The solicited injection-site AEs assessed were erythema/redness, induration/hard lump, tenderness/pain and swelling.
Outcome measures
| Measure |
Group 1: Prevnar 13™-Prevnar 13™-Prevnar 13™-Prevnar 13™
n=179 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of Prevnar 13™ on Day 1 (Vaccination 1), Month 2 (Vaccination 2), Month 4 (Vaccination 3) and Months 10-13 (Vaccination 4). Participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
|
Group 2: Prevnar 13™-Prevnar 13™-Prevnar 13™-V114
n=181 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1), Month 2 (Vaccination 2), Month 4 (Vaccination 3) and a single 0.5 mL IM injection of V114 on Months 10-13 (Vaccination 4). Participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
|
Group 3: Prevnar 13™-Prevnar 13™-V114-V114
n=178 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1), Month 2 (Vaccination 2) and a single 0.5 mL IM injection of V114 on Month 4 (Vaccination 3) and Months 10-13 (Vaccination 4). Participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
|
Group 4: Prevnar 13™-V114-V114-V114
n=179 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of V114 on Month 2 (Vaccination 2), Month 4 (Vaccination 3) and Months 10-13 (Vaccination 4). Participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
|
Group 5: V114-V114-V114-V114
n=179 Participants
Participants received a single 0.5 mL IM injection of V114 on Day 1 (Vaccination 1), Month 2 (Vaccination 2), Month 4 (Vaccination 3) and Months 10-13 (Vaccination 4). Participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
|
Group 1: Prevnar 13™(Vaccinations 1-4) + Group 2: Prevnar 13™(Vaccinations 1-3)-V114 (Vaccination 4)
Group 1 participants who received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1), Month 2 (Vaccination 2), Month 4 (Vaccination 3), Months 10-13 (Vaccination 4) and Group 2 participants who received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1), Month 2 (Vaccination 2), Month 4 (Vaccination 3) and a single 0.5 mL IM injection of V114 on Months 10-13 (Vaccination 4), were combined across vaccination schedule. Group 1 plus Group 2 participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With a Solicited Injection-site Adverse Event (AE)
Tenderness/Pain
|
44.1 Percentage of Participants
|
43.6 Percentage of Participants
|
46.1 Percentage of Participants
|
43.6 Percentage of Participants
|
47.5 Percentage of Participants
|
—
|
|
Percentage of Participants With a Solicited Injection-site Adverse Event (AE)
Induration/Hard lump
|
34.6 Percentage of Participants
|
26.0 Percentage of Participants
|
28.1 Percentage of Participants
|
25.1 Percentage of Participants
|
26.3 Percentage of Participants
|
—
|
|
Percentage of Participants With a Solicited Injection-site Adverse Event (AE)
Erythema/Redness
|
47.5 Percentage of Participants
|
37.6 Percentage of Participants
|
38.8 Percentage of Participants
|
43.0 Percentage of Participants
|
44.1 Percentage of Participants
|
—
|
|
Percentage of Participants With a Solicited Injection-site Adverse Event (AE)
Swelling
|
22.9 Percentage of Participants
|
18.8 Percentage of Participants
|
24.7 Percentage of Participants
|
20.7 Percentage of Participants
|
22.9 Percentage of Participants
|
—
|
PRIMARY outcome
Timeframe: Up to ~14 days after each vaccinationPopulation: All randomized participants who got ≥1 dose of V114 or Prevnar 13™.
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. Per protocol, the percentage of participants with solicited systemic AEs was assessed for up to \~14 days after each vaccination. The solicited systemic AEs assessed were appetite lost/decreased appetite, irritability, drowsiness/somnolence and hives or welts/urticaria.
Outcome measures
| Measure |
Group 1: Prevnar 13™-Prevnar 13™-Prevnar 13™-Prevnar 13™
n=179 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of Prevnar 13™ on Day 1 (Vaccination 1), Month 2 (Vaccination 2), Month 4 (Vaccination 3) and Months 10-13 (Vaccination 4). Participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
|
Group 2: Prevnar 13™-Prevnar 13™-Prevnar 13™-V114
n=181 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1), Month 2 (Vaccination 2), Month 4 (Vaccination 3) and a single 0.5 mL IM injection of V114 on Months 10-13 (Vaccination 4). Participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
|
Group 3: Prevnar 13™-Prevnar 13™-V114-V114
n=178 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1), Month 2 (Vaccination 2) and a single 0.5 mL IM injection of V114 on Month 4 (Vaccination 3) and Months 10-13 (Vaccination 4). Participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
|
Group 4: Prevnar 13™-V114-V114-V114
n=179 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of V114 on Month 2 (Vaccination 2), Month 4 (Vaccination 3) and Months 10-13 (Vaccination 4). Participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
|
Group 5: V114-V114-V114-V114
n=179 Participants
Participants received a single 0.5 mL IM injection of V114 on Day 1 (Vaccination 1), Month 2 (Vaccination 2), Month 4 (Vaccination 3) and Months 10-13 (Vaccination 4). Participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
|
Group 1: Prevnar 13™(Vaccinations 1-4) + Group 2: Prevnar 13™(Vaccinations 1-3)-V114 (Vaccination 4)
Group 1 participants who received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1), Month 2 (Vaccination 2), Month 4 (Vaccination 3), Months 10-13 (Vaccination 4) and Group 2 participants who received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1), Month 2 (Vaccination 2), Month 4 (Vaccination 3) and a single 0.5 mL IM injection of V114 on Months 10-13 (Vaccination 4), were combined across vaccination schedule. Group 1 plus Group 2 participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With a Solicited Systemic AE
Hives/Urticaria
|
7.3 Percentage of Participants
|
3.9 Percentage of Participants
|
5.6 Percentage of Participants
|
8.9 Percentage of Participants
|
6.7 Percentage of Participants
|
—
|
|
Percentage of Participants With a Solicited Systemic AE
Appetite lost/Decreased Appetite
|
35.8 Percentage of Participants
|
32.0 Percentage of Participants
|
27.0 Percentage of Participants
|
35.2 Percentage of Participants
|
34.6 Percentage of Participants
|
—
|
|
Percentage of Participants With a Solicited Systemic AE
Irritability
|
67.6 Percentage of Participants
|
60.8 Percentage of Participants
|
62.9 Percentage of Participants
|
68.2 Percentage of Participants
|
70.4 Percentage of Participants
|
—
|
|
Percentage of Participants With a Solicited Systemic AE
Drowsiness/Somnolence
|
57.0 Percentage of Participants
|
55.8 Percentage of Participants
|
56.7 Percentage of Participants
|
57.0 Percentage of Participants
|
60.3 Percentage of Participants
|
—
|
PRIMARY outcome
Timeframe: Up to ~6 months after Vaccination 4 (up to ~19 months)Population: All randomized participants who got ≥1 dose of V114 or Prevnar 13™.
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgement. Relatedness of an SAE to the study vaccine was determined by the investigator. Per protocol, the percentage of participants with vaccine-related SAEs was assessed through 6 months following Vaccination 4.
Outcome measures
| Measure |
Group 1: Prevnar 13™-Prevnar 13™-Prevnar 13™-Prevnar 13™
n=179 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of Prevnar 13™ on Day 1 (Vaccination 1), Month 2 (Vaccination 2), Month 4 (Vaccination 3) and Months 10-13 (Vaccination 4). Participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
|
Group 2: Prevnar 13™-Prevnar 13™-Prevnar 13™-V114
n=181 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1), Month 2 (Vaccination 2), Month 4 (Vaccination 3) and a single 0.5 mL IM injection of V114 on Months 10-13 (Vaccination 4). Participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
|
Group 3: Prevnar 13™-Prevnar 13™-V114-V114
n=178 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1), Month 2 (Vaccination 2) and a single 0.5 mL IM injection of V114 on Month 4 (Vaccination 3) and Months 10-13 (Vaccination 4). Participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
|
Group 4: Prevnar 13™-V114-V114-V114
n=179 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of V114 on Month 2 (Vaccination 2), Month 4 (Vaccination 3) and Months 10-13 (Vaccination 4). Participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
|
Group 5: V114-V114-V114-V114
n=179 Participants
Participants received a single 0.5 mL IM injection of V114 on Day 1 (Vaccination 1), Month 2 (Vaccination 2), Month 4 (Vaccination 3) and Months 10-13 (Vaccination 4). Participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
|
Group 1: Prevnar 13™(Vaccinations 1-4) + Group 2: Prevnar 13™(Vaccinations 1-3)-V114 (Vaccination 4)
Group 1 participants who received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1), Month 2 (Vaccination 2), Month 4 (Vaccination 3), Months 10-13 (Vaccination 4) and Group 2 participants who received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1), Month 2 (Vaccination 2), Month 4 (Vaccination 3) and a single 0.5 mL IM injection of V114 on Months 10-13 (Vaccination 4), were combined across vaccination schedule. Group 1 plus Group 2 participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With a Vaccine-related Serious Adverse Event (SAE)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0.6 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
PRIMARY outcome
Timeframe: 30 Days after Vaccination 4 (Months 11-14)Population: All randomized participants who were compliant with the protocol, got scheduled dosing of V114 or Prevnar 13™ and had IgG GMC data for serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F or 23F in Groups 1, 2, 3, 4 or 5 at 30 Days post Vaccination 4. 13 IgG serotypes in Groups 2, 3, 4 were compared to Group 1 as a protocol-specified primary outcome analysis; 13 IgG serotypes in Group 5 were compared to Group 1 as a separate protocol-specified secondary outcome analysis and reported later.
The GMC of anti-PnP serotype-specific IgG for 13 shared serotypes contained in V114 and Prevnar 13™ (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) was assessed using a pneumococcal electrochemiluminescence (PnECL) assay. Per protocol, 13 IgG serotypes in Groups 2, 3, 4 (experimental arms) were compared to Group 1 (comparator arm) at 30 days post Vaccination 4 as a pre-specified primary outcome analysis; 13 IgG serotypes in Group 5 (experimental arm) were compared to Group 1 (comparator arm) at 30 days post Vaccination 4, as a separate protocol-specified secondary outcome analysis and reported later in the record.
Outcome measures
| Measure |
Group 1: Prevnar 13™-Prevnar 13™-Prevnar 13™-Prevnar 13™
n=179 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of Prevnar 13™ on Day 1 (Vaccination 1), Month 2 (Vaccination 2), Month 4 (Vaccination 3) and Months 10-13 (Vaccination 4). Participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
|
Group 2: Prevnar 13™-Prevnar 13™-Prevnar 13™-V114
n=181 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1), Month 2 (Vaccination 2), Month 4 (Vaccination 3) and a single 0.5 mL IM injection of V114 on Months 10-13 (Vaccination 4). Participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
|
Group 3: Prevnar 13™-Prevnar 13™-V114-V114
n=178 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1), Month 2 (Vaccination 2) and a single 0.5 mL IM injection of V114 on Month 4 (Vaccination 3) and Months 10-13 (Vaccination 4). Participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
|
Group 4: Prevnar 13™-V114-V114-V114
n=179 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of V114 on Month 2 (Vaccination 2), Month 4 (Vaccination 3) and Months 10-13 (Vaccination 4). Participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
|
Group 5: V114-V114-V114-V114
n=179 Participants
Participants received a single 0.5 mL IM injection of V114 on Day 1 (Vaccination 1), Month 2 (Vaccination 2), Month 4 (Vaccination 3) and Months 10-13 (Vaccination 4). Participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
|
Group 1: Prevnar 13™(Vaccinations 1-4) + Group 2: Prevnar 13™(Vaccinations 1-3)-V114 (Vaccination 4)
Group 1 participants who received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1), Month 2 (Vaccination 2), Month 4 (Vaccination 3), Months 10-13 (Vaccination 4) and Group 2 participants who received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1), Month 2 (Vaccination 2), Month 4 (Vaccination 3) and a single 0.5 mL IM injection of V114 on Months 10-13 (Vaccination 4), were combined across vaccination schedule. Group 1 plus Group 2 participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
|
|---|---|---|---|---|---|---|
|
Geometric Mean Concentration (GMC) of Anti-Pneumococcal Polysaccharide (PnP) Immunoglobulin G (IgG) For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4
Serotype 1
|
2.02 µg/mL
Interval 1.78 to 2.3
|
1.69 µg/mL
Interval 1.48 to 1.93
|
1.89 µg/mL
Interval 1.63 to 2.18
|
1.68 µg/mL
Interval 1.48 to 1.91
|
1.46 µg/mL
Interval 1.3 to 1.63
|
—
|
|
Geometric Mean Concentration (GMC) of Anti-Pneumococcal Polysaccharide (PnP) Immunoglobulin G (IgG) For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4
Serotype 3
|
0.72 µg/mL
Interval 0.64 to 0.82
|
0.77 µg/mL
Interval 0.68 to 0.87
|
0.68 µg/mL
Interval 0.61 to 0.77
|
0.73 µg/mL
Interval 0.66 to 0.82
|
0.89 µg/mL
Interval 0.79 to 0.99
|
—
|
|
Geometric Mean Concentration (GMC) of Anti-Pneumococcal Polysaccharide (PnP) Immunoglobulin G (IgG) For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4
Serotype 4
|
1.51 µg/mL
Interval 1.3 to 1.76
|
1.33 µg/mL
Interval 1.14 to 1.56
|
1.27 µg/mL
Interval 1.1 to 1.46
|
1.23 µg/mL
Interval 1.08 to 1.41
|
1.35 µg/mL
Interval 1.17 to 1.57
|
—
|
|
Geometric Mean Concentration (GMC) of Anti-Pneumococcal Polysaccharide (PnP) Immunoglobulin G (IgG) For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4
Serotype 5
|
3.66 µg/mL
Interval 3.18 to 4.2
|
3.39 µg/mL
Interval 2.91 to 3.94
|
3.82 µg/mL
Interval 3.23 to 4.51
|
2.90 µg/mL
Interval 2.5 to 3.38
|
2.90 µg/mL
Interval 2.5 to 3.35
|
—
|
|
Geometric Mean Concentration (GMC) of Anti-Pneumococcal Polysaccharide (PnP) Immunoglobulin G (IgG) For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4
Serotype 6A
|
6.42 µg/mL
Interval 5.56 to 7.42
|
7.16 µg/mL
Interval 6.3 to 8.15
|
7.16 µg/mL
Interval 6.17 to 8.3
|
5.17 µg/mL
Interval 4.43 to 6.03
|
4.43 µg/mL
Interval 3.86 to 5.09
|
—
|
|
Geometric Mean Concentration (GMC) of Anti-Pneumococcal Polysaccharide (PnP) Immunoglobulin G (IgG) For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4
Serotype 6B
|
6.15 µg/mL
Interval 5.36 to 7.07
|
7.58 µg/mL
Interval 6.61 to 8.68
|
6.64 µg/mL
Interval 5.73 to 7.69
|
6.62 µg/mL
Interval 5.75 to 7.62
|
5.83 µg/mL
Interval 5.09 to 6.68
|
—
|
|
Geometric Mean Concentration (GMC) of Anti-Pneumococcal Polysaccharide (PnP) Immunoglobulin G (IgG) For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4
Serotype 7F
|
5.10 µg/mL
Interval 4.43 to 5.88
|
5.69 µg/mL
Interval 4.93 to 6.56
|
5.06 µg/mL
Interval 4.33 to 5.92
|
3.98 µg/mL
Interval 3.47 to 4.57
|
3.43 µg/mL
Interval 3.02 to 3.91
|
—
|
|
Geometric Mean Concentration (GMC) of Anti-Pneumococcal Polysaccharide (PnP) Immunoglobulin G (IgG) For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4
Serotype 9V
|
2.93 µg/mL
Interval 2.56 to 3.34
|
2.76 µg/mL
Interval 2.41 to 3.16
|
2.57 µg/mL
Interval 2.22 to 2.97
|
2.46 µg/mL
Interval 2.19 to 2.78
|
2.89 µg/mL
Interval 2.56 to 3.26
|
—
|
|
Geometric Mean Concentration (GMC) of Anti-Pneumococcal Polysaccharide (PnP) Immunoglobulin G (IgG) For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4
Serotype 14
|
7.62 µg/mL
Interval 6.55 to 8.86
|
10.59 µg/mL
Interval 9.01 to 12.44
|
10.91 µg/mL
Interval 9.29 to 12.81
|
7.87 µg/mL
Interval 6.77 to 9.16
|
6.57 µg/mL
Interval 5.73 to 7.55
|
—
|
|
Geometric Mean Concentration (GMC) of Anti-Pneumococcal Polysaccharide (PnP) Immunoglobulin G (IgG) For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4
Serotype 18C
|
2.57 µg/mL
Interval 2.21 to 2.99
|
3.88 µg/mL
Interval 3.38 to 4.45
|
3.70 µg/mL
Interval 3.2 to 4.29
|
2.76 µg/mL
Interval 2.42 to 3.15
|
2.65 µg/mL
Interval 2.34 to 3.01
|
—
|
|
Geometric Mean Concentration (GMC) of Anti-Pneumococcal Polysaccharide (PnP) Immunoglobulin G (IgG) For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4
Serotype 19A
|
5.92 µg/mL
Interval 5.15 to 6.8
|
5.52 µg/mL
Interval 4.88 to 6.25
|
5.20 µg/mL
Interval 4.42 to 6.12
|
4.95 µg/mL
Interval 4.27 to 5.73
|
4.66 µg/mL
Interval 4.15 to 5.24
|
—
|
|
Geometric Mean Concentration (GMC) of Anti-Pneumococcal Polysaccharide (PnP) Immunoglobulin G (IgG) For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4
Serotype 19F
|
4.78 µg/mL
Interval 4.22 to 5.42
|
4.88 µg/mL
Interval 4.33 to 5.51
|
5.02 µg/mL
Interval 4.4 to 5.73
|
4.60 µg/mL
Interval 4.0 to 5.28
|
4.10 µg/mL
Interval 3.66 to 4.59
|
—
|
|
Geometric Mean Concentration (GMC) of Anti-Pneumococcal Polysaccharide (PnP) Immunoglobulin G (IgG) For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4
Serotype 23F
|
2.89 µg/mL
Interval 2.42 to 3.44
|
2.72 µg/mL
Interval 2.33 to 3.18
|
2.29 µg/mL
Interval 1.93 to 2.7
|
2.22 µg/mL
Interval 1.92 to 2.56
|
2.11 µg/mL
Interval 1.81 to 2.46
|
—
|
SECONDARY outcome
Timeframe: 30 Days after Vaccination 3 (Month 5)Population: All randomized participants who were protocol compliant, got scheduled dosing of V114, Prevnar 13™ or background RECOMBIVAX HB™, had anti-HBsAg data at 30 days post Vaccination 3. Per protocol anti-HBsAg analysis was done in participants combined across dosing schedules (Group 1 + 2) and separated across dosing schedules (Group 1, 2). Per protocol Group 5 was compared to Group 1 + 2 as a secondary outcome analysis. Per protocol anti-HBsAg analysis was not planned to be reported in Groups 3, 4.
The concentration of anti-HBsAg was assessed using an enhanced chemiluminescence assay. The protocol-specified analysis of the percentage of participants with anti-HBsAg ≥10 mIU/mL at 30 days post vaccination 3 was conducted in participants combined across vaccine dosing schedules (Group 1 + Group 2) as well as in participants separated across vaccine dosing schedules (Group 1, Group 2). Per protocol, participants with anti-HBsAg ≥10 mIU/mL in Group 5 were compared to Group 1 + Group 2 at 30 days post Vaccination 3, as a pre-specified secondary outcome analysis. Analysis of participants with anti-HBsAg ≥10 mIU/mL was not planned to be reported in Group 3 and Group 4, per protocol.
Outcome measures
| Measure |
Group 1: Prevnar 13™-Prevnar 13™-Prevnar 13™-Prevnar 13™
n=142 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of Prevnar 13™ on Day 1 (Vaccination 1), Month 2 (Vaccination 2), Month 4 (Vaccination 3) and Months 10-13 (Vaccination 4). Participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
|
Group 2: Prevnar 13™-Prevnar 13™-Prevnar 13™-V114
n=142 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1), Month 2 (Vaccination 2), Month 4 (Vaccination 3) and a single 0.5 mL IM injection of V114 on Months 10-13 (Vaccination 4). Participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
|
Group 3: Prevnar 13™-Prevnar 13™-V114-V114
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1), Month 2 (Vaccination 2) and a single 0.5 mL IM injection of V114 on Month 4 (Vaccination 3) and Months 10-13 (Vaccination 4). Participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
|
Group 4: Prevnar 13™-V114-V114-V114
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of V114 on Month 2 (Vaccination 2), Month 4 (Vaccination 3) and Months 10-13 (Vaccination 4). Participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
|
Group 5: V114-V114-V114-V114
n=153 Participants
Participants received a single 0.5 mL IM injection of V114 on Day 1 (Vaccination 1), Month 2 (Vaccination 2), Month 4 (Vaccination 3) and Months 10-13 (Vaccination 4). Participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
|
Group 1: Prevnar 13™(Vaccinations 1-4) + Group 2: Prevnar 13™(Vaccinations 1-3)-V114 (Vaccination 4)
n=284 Participants
Group 1 participants who received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1), Month 2 (Vaccination 2), Month 4 (Vaccination 3), Months 10-13 (Vaccination 4) and Group 2 participants who received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1), Month 2 (Vaccination 2), Month 4 (Vaccination 3) and a single 0.5 mL IM injection of V114 on Months 10-13 (Vaccination 4), were combined across vaccination schedule. Group 1 plus Group 2 participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
|
|---|---|---|---|---|---|---|
|
Group 5 Versus Group 1 + Group 2: Percentage of Participants With Anti-Hepatitis B Surface Antigen (HBsAg) ≥10 mIU/mL at 30 Days Post Vaccination 3
|
98.6 Percentage of Participants
|
99.3 Percentage of Participants
|
—
|
—
|
98.7 Percentage of Participants
|
98.9 Percentage of Participants
|
SECONDARY outcome
Timeframe: 30 Days after Vaccination 3 (Month 5)Population: All randomized participants who were protocol compliant, got scheduled dosing of V114, Prevnar 13™ or background RotaTeq™, had anti-rotavirus data at 30 days post Vaccination 3. Per protocol anti-rotavirus analysis was done in participants combined across dosing schedules (Group 1 + 2) and separated across dosing schedules (Group 1, 2). Per protocol Group 5 was compared to Group 1 + 2 as a secondary outcome analysis. Per protocol anti-rotavirus analysis was not planned or reported in Group 3, 4
The GMT of anti-rotavirus IgA was assessed using a serum IgA enzyme linked immunosorbent assay. The protocol specified analysis of anti-rotavirus IgA GMT at 30 days post vaccination 3 was conducted in participants combined across vaccine dosing schedules (Group 1 + Group 2) as well as in participants separated across vaccine dosing schedules (Group 1, Group 2). Per protocol, GMT of anti-rotavirus IgA in Group 5 was compared to Group 1 + Group 2 at 30 days post Vaccination 3, as a pre-specified secondary outcome analysis. Anti-rotavirus IgA GMT analysis was not planned to be reported in Group 3 and Group 4, per protocol.
Outcome measures
| Measure |
Group 1: Prevnar 13™-Prevnar 13™-Prevnar 13™-Prevnar 13™
n=147 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of Prevnar 13™ on Day 1 (Vaccination 1), Month 2 (Vaccination 2), Month 4 (Vaccination 3) and Months 10-13 (Vaccination 4). Participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
|
Group 2: Prevnar 13™-Prevnar 13™-Prevnar 13™-V114
n=143 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1), Month 2 (Vaccination 2), Month 4 (Vaccination 3) and a single 0.5 mL IM injection of V114 on Months 10-13 (Vaccination 4). Participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
|
Group 3: Prevnar 13™-Prevnar 13™-V114-V114
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1), Month 2 (Vaccination 2) and a single 0.5 mL IM injection of V114 on Month 4 (Vaccination 3) and Months 10-13 (Vaccination 4). Participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
|
Group 4: Prevnar 13™-V114-V114-V114
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of V114 on Month 2 (Vaccination 2), Month 4 (Vaccination 3) and Months 10-13 (Vaccination 4). Participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
|
Group 5: V114-V114-V114-V114
n=152 Participants
Participants received a single 0.5 mL IM injection of V114 on Day 1 (Vaccination 1), Month 2 (Vaccination 2), Month 4 (Vaccination 3) and Months 10-13 (Vaccination 4). Participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
|
Group 1: Prevnar 13™(Vaccinations 1-4) + Group 2: Prevnar 13™(Vaccinations 1-3)-V114 (Vaccination 4)
n=290 Participants
Group 1 participants who received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1), Month 2 (Vaccination 2), Month 4 (Vaccination 3), Months 10-13 (Vaccination 4) and Group 2 participants who received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1), Month 2 (Vaccination 2), Month 4 (Vaccination 3) and a single 0.5 mL IM injection of V114 on Months 10-13 (Vaccination 4), were combined across vaccination schedule. Group 1 plus Group 2 participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
|
|---|---|---|---|---|---|---|
|
Group 5 Versus Group 1 + Group 2: Geometric Mean Titer (GMT) of Anti-Rotavirus Immunoglobulin A (IgA) at 30 Days Post Vaccination 3
|
286.5 Titers
Interval 218.1 to 376.2
|
329.5 Titers
Interval 254.9 to 426.1
|
—
|
—
|
298.3 Titers
Interval 228.2 to 390.0
|
307.0 Titers
Interval 254.7 to 369.9
|
SECONDARY outcome
Timeframe: 30 Days after Vaccination 3 (Month 5)Population: All randomized participants who were compliant with the protocol, got scheduled dosing of V114 or Prevnar 13™, had IgG GMC data available for serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 22F or 33F in Groups 1, 2, 3, 4 or 5 at 30 Days post Vaccination 3.
The concentration of anti-PnP serotype-specific IgG for 15 serotypes contained in V114 (13 serotypes shared with Prevnar 13™ \[1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F\] and 2 unique serotypes \[22F, 33F\]) was assessed using a PnECL assay. Per protocol, GMC of 15 IgG serotypes was assessed at 30 days post Vaccination 3.
Outcome measures
| Measure |
Group 1: Prevnar 13™-Prevnar 13™-Prevnar 13™-Prevnar 13™
n=179 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of Prevnar 13™ on Day 1 (Vaccination 1), Month 2 (Vaccination 2), Month 4 (Vaccination 3) and Months 10-13 (Vaccination 4). Participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
|
Group 2: Prevnar 13™-Prevnar 13™-Prevnar 13™-V114
n=181 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1), Month 2 (Vaccination 2), Month 4 (Vaccination 3) and a single 0.5 mL IM injection of V114 on Months 10-13 (Vaccination 4). Participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
|
Group 3: Prevnar 13™-Prevnar 13™-V114-V114
n=178 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1), Month 2 (Vaccination 2) and a single 0.5 mL IM injection of V114 on Month 4 (Vaccination 3) and Months 10-13 (Vaccination 4). Participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
|
Group 4: Prevnar 13™-V114-V114-V114
n=179 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of V114 on Month 2 (Vaccination 2), Month 4 (Vaccination 3) and Months 10-13 (Vaccination 4). Participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
|
Group 5: V114-V114-V114-V114
n=179 Participants
Participants received a single 0.5 mL IM injection of V114 on Day 1 (Vaccination 1), Month 2 (Vaccination 2), Month 4 (Vaccination 3) and Months 10-13 (Vaccination 4). Participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
|
Group 1: Prevnar 13™(Vaccinations 1-4) + Group 2: Prevnar 13™(Vaccinations 1-3)-V114 (Vaccination 4)
Group 1 participants who received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1), Month 2 (Vaccination 2), Month 4 (Vaccination 3), Months 10-13 (Vaccination 4) and Group 2 participants who received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1), Month 2 (Vaccination 2), Month 4 (Vaccination 3) and a single 0.5 mL IM injection of V114 on Months 10-13 (Vaccination 4), were combined across vaccination schedule. Group 1 plus Group 2 participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
|
|---|---|---|---|---|---|---|
|
GMC of Anti-PnP IgG for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3
Serotype 1
|
1.93 µg/mL
Interval 1.69 to 2.2
|
1.99 µg/mL
Interval 1.78 to 2.21
|
1.86 µg/mL
Interval 1.64 to 2.1
|
1.35 µg/mL
Interval 1.19 to 1.53
|
1.27 µg/mL
Interval 1.14 to 1.41
|
—
|
|
GMC of Anti-PnP IgG for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3
Serotype 3
|
0.54 µg/mL
Interval 0.47 to 0.61
|
0.64 µg/mL
Interval 0.56 to 0.73
|
0.56 µg/mL
Interval 0.49 to 0.63
|
0.67 µg/mL
Interval 0.6 to 0.76
|
1.01 µg/mL
Interval 0.91 to 1.12
|
—
|
|
GMC of Anti-PnP IgG for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3
Serotype 4
|
1.39 µg/mL
Interval 1.22 to 1.57
|
1.47 µg/mL
Interval 1.3 to 1.66
|
1.34 µg/mL
Interval 1.14 to 1.56
|
1.07 µg/mL
Interval 0.93 to 1.22
|
1.40 µg/mL
Interval 1.24 to 1.57
|
—
|
|
GMC of Anti-PnP IgG for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3
Serotype 5
|
1.99 µg/mL
Interval 1.69 to 2.34
|
2.16 µg/mL
Interval 1.87 to 2.49
|
2.15 µg/mL
Interval 1.83 to 2.52
|
1.73 µg/mL
Interval 1.5 to 1.99
|
1.91 µg/mL
Interval 1.67 to 2.18
|
—
|
|
GMC of Anti-PnP IgG for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3
Serotype 6A
|
3.07 µg/mL
Interval 2.66 to 3.54
|
3.22 µg/mL
Interval 2.83 to 3.67
|
3.26 µg/mL
Interval 2.79 to 3.82
|
2.05 µg/mL
Interval 1.76 to 2.38
|
1.82 µg/mL
Interval 1.59 to 2.09
|
—
|
|
GMC of Anti-PnP IgG for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3
Serotype 6B
|
2.03 µg/mL
Interval 1.66 to 2.49
|
2.50 µg/mL
Interval 2.1 to 2.99
|
2.43 µg/mL
Interval 2.05 to 2.88
|
2.29 µg/mL
Interval 1.91 to 2.76
|
2.26 µg/mL
Interval 1.87 to 2.73
|
—
|
|
GMC of Anti-PnP IgG for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3
Serotype 7F
|
3.36 µg/mL
Interval 2.99 to 3.77
|
3.54 µg/mL
Interval 3.16 to 3.96
|
3.52 µg/mL
Interval 3.1 to 3.99
|
2.61 µg/mL
Interval 2.33 to 2.94
|
2.41 µg/mL
Interval 2.17 to 2.67
|
—
|
|
GMC of Anti-PnP IgG for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3
Serotype 9V
|
1.69 µg/mL
Interval 1.48 to 1.94
|
1.81 µg/mL
Interval 1.6 to 2.05
|
1.68 µg/mL
Interval 1.44 to 1.97
|
1.47 µg/mL
Interval 1.28 to 1.67
|
2.01 µg/mL
Interval 1.8 to 2.24
|
—
|
|
GMC of Anti-PnP IgG for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3
Serotype 14
|
6.57 µg/mL
Interval 5.55 to 7.79
|
6.18 µg/mL
Interval 5.22 to 7.31
|
9.32 µg/mL
Interval 7.45 to 11.67
|
6.71 µg/mL
Interval 5.76 to 7.83
|
5.50 µg/mL
Interval 4.79 to 6.31
|
—
|
|
GMC of Anti-PnP IgG for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3
Serotype 18C
|
1.69 µg/mL
Interval 1.46 to 1.95
|
2.03 µg/mL
Interval 1.81 to 2.28
|
2.08 µg/mL
Interval 1.81 to 2.38
|
1.50 µg/mL
Interval 1.33 to 1.71
|
1.51 µg/mL
Interval 1.34 to 1.72
|
—
|
|
GMC of Anti-PnP IgG for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3
Serotype 19A
|
2.17 µg/mL
Interval 1.92 to 2.47
|
2.46 µg/mL
Interval 2.21 to 2.74
|
2.25 µg/mL
Interval 1.95 to 2.6
|
1.64 µg/mL
Interval 1.43 to 1.87
|
1.63 µg/mL
Interval 1.47 to 1.82
|
—
|
|
GMC of Anti-PnP IgG for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3
Serotype 19F
|
2.83 µg/mL
Interval 2.51 to 3.18
|
2.90 µg/mL
Interval 2.61 to 3.23
|
3.08 µg/mL
Interval 2.72 to 3.48
|
2.32 µg/mL
Interval 2.06 to 2.62
|
2.21 µg/mL
Interval 2.0 to 2.46
|
—
|
|
GMC of Anti-PnP IgG for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3
Serotype 23F
|
1.32 µg/mL
Interval 1.09 to 1.59
|
1.72 µg/mL
Interval 1.49 to 1.99
|
1.22 µg/mL
Interval 1.02 to 1.45
|
1.33 µg/mL
Interval 1.14 to 1.57
|
1.46 µg/mL
Interval 1.25 to 1.69
|
—
|
|
GMC of Anti-PnP IgG for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3
Serotype 22F
|
0.05 µg/mL
Interval 0.04 to 0.05
|
0.05 µg/mL
Interval 0.04 to 0.06
|
3.63 µg/mL
Interval 2.91 to 4.52
|
5.94 µg/mL
Interval 5.13 to 6.88
|
5.15 µg/mL
Interval 4.52 to 5.87
|
—
|
|
GMC of Anti-PnP IgG for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3
Serotype 33F
|
0.05 µg/mL
Interval 0.05 to 0.06
|
0.05 µg/mL
Interval 0.05 to 0.06
|
0.28 µg/mL
Interval 0.21 to 0.36
|
0.89 µg/mL
Interval 0.7 to 1.14
|
2.22 µg/mL
Interval 1.86 to 2.66
|
—
|
SECONDARY outcome
Timeframe: 30 Days after Vaccination 3 (Month 5)Population: All randomized participants who were compliant with the protocol, got scheduled dosing of V114 or Prevnar 13™, had IgG concentration ≥0.35µg/mL data available for serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 22F or 33F in Groups 1, 2, 3, 4 or 5 at 30 Days post Vaccination 3.
The concentration of anti-PnP serotype-specific IgG for 15 serotypes contained in V114 (13 serotypes shared with Prevnar 13™ \[1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F\] and 2 unique serotypes \[22F, 33F\]) was assessed using a PnECL assay. Per protocol, percentage of participants with anti-PnP IgG concentrations ≥0.35 µg/mL was assessed at 30 days post Vaccination 3.
Outcome measures
| Measure |
Group 1: Prevnar 13™-Prevnar 13™-Prevnar 13™-Prevnar 13™
n=179 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of Prevnar 13™ on Day 1 (Vaccination 1), Month 2 (Vaccination 2), Month 4 (Vaccination 3) and Months 10-13 (Vaccination 4). Participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
|
Group 2: Prevnar 13™-Prevnar 13™-Prevnar 13™-V114
n=181 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1), Month 2 (Vaccination 2), Month 4 (Vaccination 3) and a single 0.5 mL IM injection of V114 on Months 10-13 (Vaccination 4). Participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
|
Group 3: Prevnar 13™-Prevnar 13™-V114-V114
n=178 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1), Month 2 (Vaccination 2) and a single 0.5 mL IM injection of V114 on Month 4 (Vaccination 3) and Months 10-13 (Vaccination 4). Participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
|
Group 4: Prevnar 13™-V114-V114-V114
n=179 Participants
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of V114 on Month 2 (Vaccination 2), Month 4 (Vaccination 3) and Months 10-13 (Vaccination 4). Participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
|
Group 5: V114-V114-V114-V114
n=179 Participants
Participants received a single 0.5 mL IM injection of V114 on Day 1 (Vaccination 1), Month 2 (Vaccination 2), Month 4 (Vaccination 3) and Months 10-13 (Vaccination 4). Participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
|
Group 1: Prevnar 13™(Vaccinations 1-4) + Group 2: Prevnar 13™(Vaccinations 1-3)-V114 (Vaccination 4)
Group 1 participants who received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1), Month 2 (Vaccination 2), Month 4 (Vaccination 3), Months 10-13 (Vaccination 4) and Group 2 participants who received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1), Month 2 (Vaccination 2), Month 4 (Vaccination 3) and a single 0.5 mL IM injection of V114 on Months 10-13 (Vaccination 4), were combined across vaccination schedule. Group 1 plus Group 2 participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Anti-PnP IgG Concentration ≥0.35 µg/mL for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3
Serotype 1
|
97.9 Percentage of Participants
Interval 94.0 to 99.6
|
100 Percentage of Participants
Interval 97.4 to 100.0
|
99.2 Percentage of Participants
Interval 95.8 to 100.0
|
97.8 Percentage of Participants
Interval 93.8 to 99.5
|
96.6 Percentage of Participants
Interval 92.3 to 98.9
|
—
|
|
Percentage of Participants With Anti-PnP IgG Concentration ≥0.35 µg/mL for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3
Serotype 3
|
73.2 Percentage of Participants
Interval 65.2 to 80.3
|
73.9 Percentage of Participants
Interval 65.9 to 80.9
|
79.1 Percentage of Participants
Interval 71.0 to 85.7
|
81.9 Percentage of Participants
Interval 74.4 to 87.9
|
93.9 Percentage of Participants
Interval 88.7 to 97.2
|
—
|
|
Percentage of Participants With Anti-PnP IgG Concentration ≥0.35 µg/mL for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3
Serotype 4
|
97.9 Percentage of Participants
Interval 93.9 to 99.6
|
98.6 Percentage of Participants
Interval 94.9 to 99.8
|
93.0 Percentage of Participants
Interval 87.1 to 96.7
|
94.2 Percentage of Participants
Interval 88.8 to 97.4
|
96.6 Percentage of Participants
Interval 92.2 to 98.9
|
—
|
|
Percentage of Participants With Anti-PnP IgG Concentration ≥0.35 µg/mL for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3
Serotype 5
|
97.9 Percentage of Participants
Interval 93.9 to 99.6
|
99.3 Percentage of Participants
Interval 96.1 to 100.0
|
97.7 Percentage of Participants
Interval 93.3 to 99.5
|
97.1 Percentage of Participants
Interval 92.7 to 99.2
|
98.0 Percentage of Participants
Interval 94.2 to 99.6
|
—
|
|
Percentage of Participants With Anti-PnP IgG Concentration ≥0.35 µg/mL for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3
Serotype 6A
|
99.3 Percentage of Participants
Interval 96.1 to 100.0
|
99.3 Percentage of Participants
Interval 96.1 to 100.0
|
99.2 Percentage of Participants
Interval 95.7 to 100.0
|
97.1 Percentage of Participants
Interval 92.7 to 99.2
|
98.6 Percentage of Participants
Interval 95.2 to 99.8
|
—
|
|
Percentage of Participants With Anti-PnP IgG Concentration ≥0.35 µg/mL for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3
Serotype 6B
|
91.3 Percentage of Participants
Interval 85.3 to 95.4
|
94.3 Percentage of Participants
Interval 89.1 to 97.5
|
96.1 Percentage of Participants
Interval 91.1 to 98.7
|
95.7 Percentage of Participants
Interval 90.8 to 98.4
|
95.2 Percentage of Participants
Interval 90.4 to 98.1
|
—
|
|
Percentage of Participants With Anti-PnP IgG Concentration ≥0.35 µg/mL for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3
Serotype 7F
|
100 Percentage of Participants
Interval 97.4 to 100.0
|
100 Percentage of Participants
Interval 97.4 to 100.0
|
100 Percentage of Participants
Interval 97.2 to 100.0
|
100 Percentage of Participants
Interval 97.4 to 100.0
|
100 Percentage of Participants
Interval 97.5 to 100.0
|
—
|
|
Percentage of Participants With Anti-PnP IgG Concentration ≥0.35 µg/mL for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3
Serotype 9V
|
96.5 Percentage of Participants
Interval 92.0 to 98.9
|
96.5 Percentage of Participants
Interval 92.0 to 98.8
|
96.1 Percentage of Participants
Interval 91.1 to 98.7
|
95.7 Percentage of Participants
Interval 90.8 to 98.4
|
98.6 Percentage of Participants
Interval 95.2 to 99.8
|
—
|
|
Percentage of Participants With Anti-PnP IgG Concentration ≥0.35 µg/mL for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3
Serotype 14
|
98.6 Percentage of Participants
Interval 95.0 to 99.8
|
98.6 Percentage of Participants
Interval 95.0 to 99.8
|
96.9 Percentage of Participants
Interval 92.2 to 99.1
|
100 Percentage of Participants
Interval 97.4 to 100.0
|
98.6 Percentage of Participants
Interval 95.2 to 99.8
|
—
|
|
Percentage of Participants With Anti-PnP IgG Concentration ≥0.35 µg/mL for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3
Serotype 18C
|
95.8 Percentage of Participants
Interval 91.0 to 98.4
|
100 Percentage of Participants
Interval 97.4 to 100.0
|
99.2 Percentage of Participants
Interval 95.8 to 100.0
|
97.8 Percentage of Participants
Interval 93.8 to 99.5
|
98.0 Percentage of Participants
Interval 94.2 to 99.6
|
—
|
|
Percentage of Participants With Anti-PnP IgG Concentration ≥0.35 µg/mL for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3
Serotype 19A
|
99.3 Percentage of Participants
Interval 96.2 to 100.0
|
100 Percentage of Participants
Interval 97.4 to 100.0
|
98.4 Percentage of Participants
Interval 94.5 to 99.8
|
97.1 Percentage of Participants
Interval 92.7 to 99.2
|
97.3 Percentage of Participants
Interval 93.2 to 99.3
|
—
|
|
Percentage of Participants With Anti-PnP IgG Concentration ≥0.35 µg/mL for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3
Serotype 19F
|
99.3 Percentage of Participants
Interval 96.2 to 100.0
|
99.3 Percentage of Participants
Interval 96.1 to 100.0
|
99.2 Percentage of Participants
Interval 95.7 to 100.0
|
100 Percentage of Participants
Interval 97.4 to 100.0
|
100 Percentage of Participants
Interval 97.5 to 100.0
|
—
|
|
Percentage of Participants With Anti-PnP IgG Concentration ≥0.35 µg/mL for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3
Serotype 23F
|
91.4 Percentage of Participants
Interval 85.5 to 95.5
|
97.9 Percentage of Participants
Interval 93.9 to 99.6
|
90.6 Percentage of Participants
Interval 84.2 to 95.1
|
92.6 Percentage of Participants
Interval 86.8 to 96.4
|
94.6 Percentage of Participants
Interval 89.6 to 97.6
|
—
|
|
Percentage of Participants With Anti-PnP IgG Concentration ≥0.35 µg/mL for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3
Serotype 22F
|
2.9 Percentage of Participants
Interval 0.8 to 7.3
|
1.4 Percentage of Participants
Interval 0.2 to 5.1
|
93.8 Percentage of Participants
Interval 88.1 to 97.3
|
99.3 Percentage of Participants
Interval 96.0 to 100.0
|
98.6 Percentage of Participants
Interval 95.2 to 99.8
|
—
|
|
Percentage of Participants With Anti-PnP IgG Concentration ≥0.35 µg/mL for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3
Serotype 33F
|
2.1 Percentage of Participants
Interval 0.4 to 6.1
|
2.2 Percentage of Participants
Interval 0.4 to 6.2
|
39.4 Percentage of Participants
Interval 30.8 to 48.4
|
75.9 Percentage of Participants
Interval 67.9 to 82.8
|
93.2 Percentage of Participants
Interval 87.9 to 96.7
|
—
|
SECONDARY outcome
Timeframe: 30 Days after Vaccination 4 (Months 11-14)Population: All randomized participants who were compliant with the protocol, got scheduled dosing of V114 or Prevnar 13™, had IgG GMC data available for serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F or 23F in Groups 5 or 1 at 30 Days post Vaccination 4. 13 IgG serotypes in Group 5 were compared to Group 1 as a protocol-specified secondary outcome analysis; 13 IgG serotypes in Groups 2, 3, 4 were compared to Group 1 as a separate protocol-specified primary outcome analysis and reported earlier.
The GMC of anti-PnP serotype-specific IgG for 13 shared serotypes contained in V114 and Prevnar 13™ (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) was assessed using a PnECL assay. Per protocol, GMC of 13 IgG serotypes was analysed by vaccine dosing schedules (Groups 1, 5). Per protocol, 13 IgG serotypes in Group 5 (experimental arm) were compared to Group 1 (comparator arm) at 30 days post Vaccination 4 as a pre-specified secondary outcome analysis; 13 IgG serotypes in Groups 2, 3, 4 (experimental arms) were compared to Group 1 (comparator arm) at 30 days post Vaccination 4, as a separate protocol-specified primary outcome analysis and reported earlier in the record.
Outcome measures
| Measure |
Group 1: Prevnar 13™-Prevnar 13™-Prevnar 13™-Prevnar 13™
n=179 Participants
Participants received a single 0.5 mL intramuscular (IM) injection of Prevnar 13™ on Day 1 (Vaccination 1), Month 2 (Vaccination 2), Month 4 (Vaccination 3) and Months 10-13 (Vaccination 4). Participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
|
Group 2: Prevnar 13™-Prevnar 13™-Prevnar 13™-V114
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1), Month 2 (Vaccination 2), Month 4 (Vaccination 3) and a single 0.5 mL IM injection of V114 on Months 10-13 (Vaccination 4). Participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
|
Group 3: Prevnar 13™-Prevnar 13™-V114-V114
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1), Month 2 (Vaccination 2) and a single 0.5 mL IM injection of V114 on Month 4 (Vaccination 3) and Months 10-13 (Vaccination 4). Participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
|
Group 4: Prevnar 13™-V114-V114-V114
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of V114 on Month 2 (Vaccination 2), Month 4 (Vaccination 3) and Months 10-13 (Vaccination 4). Participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
|
Group 5: V114-V114-V114-V114
n=179 Participants
Participants received a single 0.5 mL IM injection of V114 on Day 1 (Vaccination 1), Month 2 (Vaccination 2), Month 4 (Vaccination 3) and Months 10-13 (Vaccination 4). Participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
|
Group 1: Prevnar 13™(Vaccinations 1-4) + Group 2: Prevnar 13™(Vaccinations 1-3)-V114 (Vaccination 4)
Group 1 participants who received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1), Month 2 (Vaccination 2), Month 4 (Vaccination 3), Months 10-13 (Vaccination 4) and Group 2 participants who received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1), Month 2 (Vaccination 2), Month 4 (Vaccination 3) and a single 0.5 mL IM injection of V114 on Months 10-13 (Vaccination 4), were combined across vaccination schedule. Group 1 plus Group 2 participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
|
|---|---|---|---|---|---|---|
|
Group 5 Versus Group 1: GMC of Anti-PnP IgG For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4
Serotype 1
|
2.02 µg/mL
Interval 1.78 to 2.3
|
—
|
—
|
—
|
1.46 µg/mL
Interval 1.3 to 1.63
|
—
|
|
Group 5 Versus Group 1: GMC of Anti-PnP IgG For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4
Serotype 3
|
0.72 µg/mL
Interval 0.64 to 0.82
|
—
|
—
|
—
|
0.89 µg/mL
Interval 0.79 to 0.99
|
—
|
|
Group 5 Versus Group 1: GMC of Anti-PnP IgG For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4
Serotype 4
|
1.51 µg/mL
Interval 1.3 to 1.76
|
—
|
—
|
—
|
1.35 µg/mL
Interval 1.17 to 1.57
|
—
|
|
Group 5 Versus Group 1: GMC of Anti-PnP IgG For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4
Serotype 5
|
3.66 µg/mL
Interval 3.18 to 4.2
|
—
|
—
|
—
|
2.90 µg/mL
Interval 2.5 to 3.35
|
—
|
|
Group 5 Versus Group 1: GMC of Anti-PnP IgG For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4
Serotype 6A
|
6.42 µg/mL
Interval 5.56 to 7.42
|
—
|
—
|
—
|
4.43 µg/mL
Interval 3.86 to 5.09
|
—
|
|
Group 5 Versus Group 1: GMC of Anti-PnP IgG For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4
Serotype 6B
|
6.15 µg/mL
Interval 5.36 to 7.07
|
—
|
—
|
—
|
5.83 µg/mL
Interval 5.09 to 6.68
|
—
|
|
Group 5 Versus Group 1: GMC of Anti-PnP IgG For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4
Serotype 7F
|
5.10 µg/mL
Interval 4.43 to 5.88
|
—
|
—
|
—
|
3.43 µg/mL
Interval 3.02 to 3.91
|
—
|
|
Group 5 Versus Group 1: GMC of Anti-PnP IgG For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4
Serotype 9V
|
2.93 µg/mL
Interval 2.56 to 3.34
|
—
|
—
|
—
|
2.89 µg/mL
Interval 2.56 to 3.26
|
—
|
|
Group 5 Versus Group 1: GMC of Anti-PnP IgG For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4
Serotype 14
|
7.62 µg/mL
Interval 6.55 to 8.86
|
—
|
—
|
—
|
6.57 µg/mL
Interval 5.73 to 7.55
|
—
|
|
Group 5 Versus Group 1: GMC of Anti-PnP IgG For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4
Serotype 18C
|
2.57 µg/mL
Interval 2.21 to 2.99
|
—
|
—
|
—
|
2.65 µg/mL
Interval 2.34 to 3.01
|
—
|
|
Group 5 Versus Group 1: GMC of Anti-PnP IgG For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4
Serotype 19A
|
5.92 µg/mL
Interval 5.15 to 6.8
|
—
|
—
|
—
|
4.66 µg/mL
Interval 4.15 to 5.24
|
—
|
|
Group 5 Versus Group 1: GMC of Anti-PnP IgG For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4
Serotype 19F
|
4.78 µg/mL
Interval 4.22 to 5.42
|
—
|
—
|
—
|
4.10 µg/mL
Interval 3.66 to 4.59
|
—
|
|
Group 5 Versus Group 1: GMC of Anti-PnP IgG For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4
Serotype 23F
|
2.89 µg/mL
Interval 2.42 to 3.44
|
—
|
—
|
—
|
2.11 µg/mL
Interval 1.81 to 2.46
|
—
|
Adverse Events
Group 1: Prevnar 13™-Prevnar 13™-Prevnar 13™-Prevnar 13™
Serious events: 21 serious events
Other events: 164 other events
Deaths: 0 deaths
Group 2: Prevnar 13™-Prevnar 13™-Prevnar 13™-V114
Serious events: 24 serious events
Other events: 161 other events
Deaths: 0 deaths
Group 3: Prevnar 13™-Prevnar 13™-V114-V114
Serious events: 15 serious events
Other events: 160 other events
Deaths: 0 deaths
Group 4: Prevnar 13™-V114-V114-V114
Serious events: 18 serious events
Other events: 163 other events
Deaths: 0 deaths
Group 5: V114-V114-V114-V114
Serious events: 21 serious events
Other events: 160 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1: Prevnar 13™-Prevnar 13™-Prevnar 13™-Prevnar 13™
n=179 participants at risk
Participants received a single 0.5 mL intramuscular (IM) injection of Prevnar 13™ on Day 1 (Vaccination 1), Month 2 (Vaccination 2), Month 4 (Vaccination 3) and Months 10-13 (Vaccination 4). Participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
|
Group 2: Prevnar 13™-Prevnar 13™-Prevnar 13™-V114
n=181 participants at risk
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1), Month 2 (Vaccination 2), Month 4 (Vaccination 3) and a single 0.5 mL IM injection of V114 on Months 10-13 (Vaccination 4). Participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
|
Group 3: Prevnar 13™-Prevnar 13™-V114-V114
n=178 participants at risk
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1), Month 2 (Vaccination 2) and a single 0.5 mL IM injection of V114 on Month 4 (Vaccination 3) and Months 10-13 (Vaccination 4). Participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
|
Group 4: Prevnar 13™-V114-V114-V114
n=179 participants at risk
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of V114 on Month 2 (Vaccination 2), Month 4 (Vaccination 3) and Months 10-13 (Vaccination 4). Participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
|
Group 5: V114-V114-V114-V114
n=179 participants at risk
Participants received a single 0.5 mL IM injection of V114 on Day 1 (Vaccination 1), Month 2 (Vaccination 2), Month 4 (Vaccination 3) and Months 10-13 (Vaccination 4). Participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
|
|---|---|---|---|---|---|
|
General disorders
Pyrexia
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.55%
1/181 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/178 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
|
Infections and infestations
Pneumonia influenzal
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/181 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/178 • 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 ~19 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 V114 or Prevnar 13™.
|
0.56%
1/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
|
Infections and infestations
Pneumonia respiratory syncytial viral
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/181 • 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 ~19 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 V114 or Prevnar 13™.
|
0.56%
1/178 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.55%
1/181 • 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 ~19 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 V114 or Prevnar 13™.
|
0.56%
1/178 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
|
Infections and infestations
Respiratory syncytial virus bronchiolitis
|
1.1%
2/179 • 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 ~19 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 V114 or Prevnar 13™.
|
1.1%
2/181 • 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 ~19 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 V114 or Prevnar 13™.
|
0.56%
1/178 • 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 ~19 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 V114 or Prevnar 13™.
|
1.7%
3/179 • 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 ~19 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 V114 or Prevnar 13™.
|
1.7%
3/179 • 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 ~19 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 V114 or Prevnar 13™.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.56%
1/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.55%
1/181 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/178 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
|
Infections and infestations
Respiratory tract infection
|
0.56%
1/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/181 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/178 • 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 ~19 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 V114 or Prevnar 13™.
|
0.56%
1/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
|
Infections and infestations
Sepsis
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/181 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/178 • 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 ~19 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 V114 or Prevnar 13™.
|
0.56%
1/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
|
Infections and infestations
Skin bacterial infection
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.55%
1/181 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/178 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.55%
1/181 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/178 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
|
Infections and infestations
Urinary tract infection
|
0.56%
1/179 • 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 ~19 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 V114 or Prevnar 13™.
|
1.1%
2/181 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/178 • 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 ~19 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 V114 or Prevnar 13™.
|
1.1%
2/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.56%
1/179 • 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 ~19 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 V114 or Prevnar 13™.
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/181 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/178 • 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 ~19 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 V114 or Prevnar 13™.
|
0.56%
1/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
|
Nervous system disorders
Seizure
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
1.1%
2/181 • 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 ~19 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 V114 or Prevnar 13™.
|
0.56%
1/178 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
|
Infections and infestations
Viral infection
|
0.56%
1/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.55%
1/181 • 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 ~19 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 V114 or Prevnar 13™.
|
0.56%
1/178 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
|
Infections and infestations
Viral pharyngitis
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.55%
1/181 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/178 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
|
Infections and infestations
Viral rash
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/181 • 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 ~19 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 V114 or Prevnar 13™.
|
0.56%
1/178 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/181 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/178 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.56%
1/179 • 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 ~19 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 V114 or Prevnar 13™.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.56%
1/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/181 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/178 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
|
Injury, poisoning and procedural complications
Foreign body ingestion
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.55%
1/181 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/178 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/181 • 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 ~19 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 V114 or Prevnar 13™.
|
0.56%
1/178 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/181 • 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 ~19 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 V114 or Prevnar 13™.
|
0.56%
1/178 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.56%
1/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/181 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/178 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/181 • 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 ~19 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 V114 or Prevnar 13™.
|
0.56%
1/178 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hair follicle tumour benign
|
0.56%
1/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/181 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/178 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/181 • 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 ~19 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 V114 or Prevnar 13™.
|
0.56%
1/178 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
|
Nervous system disorders
Febrile convulsion
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.55%
1/181 • 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 ~19 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 V114 or Prevnar 13™.
|
0.56%
1/178 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.56%
1/179 • 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 ~19 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 V114 or Prevnar 13™.
|
|
Nervous system disorders
Syncope
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/181 • 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 ~19 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 V114 or Prevnar 13™.
|
0.56%
1/178 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
|
Respiratory, thoracic and mediastinal disorders
Asphyxia
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/181 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/178 • 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 ~19 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 V114 or Prevnar 13™.
|
0.56%
1/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.56%
1/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/181 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/178 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.55%
1/181 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/178 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/181 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/178 • 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 ~19 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 V114 or Prevnar 13™.
|
0.56%
1/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
|
Respiratory, thoracic and mediastinal disorders
Upper airway obstruction
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/181 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/178 • 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 ~19 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 V114 or Prevnar 13™.
|
0.56%
1/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/181 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/178 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.56%
1/179 • 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 ~19 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 V114 or Prevnar 13™.
|
|
General disorders
Complication associated with device
|
0.56%
1/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/181 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/178 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.55%
1/181 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/178 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
|
Infections and infestations
Adenoviral upper respiratory infection
|
0.56%
1/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/181 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/178 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
|
Infections and infestations
Adenovirus infection
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/181 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/178 • 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 ~19 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 V114 or Prevnar 13™.
|
0.56%
1/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/181 • 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 ~19 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 V114 or Prevnar 13™.
|
0.56%
1/178 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
|
Infections and infestations
Bacteraemia
|
0.56%
1/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/181 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/178 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/181 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/178 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.56%
1/179 • 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 ~19 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 V114 or Prevnar 13™.
|
|
Infections and infestations
Bronchiolitis
|
3.4%
6/179 • 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 ~19 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 V114 or Prevnar 13™.
|
3.3%
6/181 • 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 ~19 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 V114 or Prevnar 13™.
|
1.7%
3/178 • 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 ~19 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 V114 or Prevnar 13™.
|
1.7%
3/179 • 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 ~19 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 V114 or Prevnar 13™.
|
4.5%
8/179 • Number of events 8 • 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 ~19 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 V114 or Prevnar 13™.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.55%
1/181 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/178 • 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 ~19 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 V114 or Prevnar 13™.
|
1.1%
2/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.56%
1/179 • 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 ~19 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 V114 or Prevnar 13™.
|
|
Infections and infestations
Conjunctivitis
|
0.56%
1/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/181 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/178 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
|
Infections and infestations
Croup infectious
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/181 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/178 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.56%
1/179 • 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 ~19 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 V114 or Prevnar 13™.
|
|
Infections and infestations
Exanthema subitum
|
0.56%
1/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.55%
1/181 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/178 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
|
Infections and infestations
Gastroenteritis
|
2.2%
4/179 • 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 ~19 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 V114 or Prevnar 13™.
|
1.1%
2/181 • 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 ~19 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 V114 or Prevnar 13™.
|
0.56%
1/178 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.56%
1/179 • 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 ~19 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 V114 or Prevnar 13™.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.55%
1/181 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/178 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
|
Infections and infestations
Herpangina
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/181 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/178 • 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 ~19 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 V114 or Prevnar 13™.
|
0.56%
1/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
|
Infections and infestations
Influenza
|
0.56%
1/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.55%
1/181 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/178 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
1.7%
3/179 • 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 ~19 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 V114 or Prevnar 13™.
|
|
Infections and infestations
Mycoplasma infection
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/181 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/178 • 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 ~19 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 V114 or Prevnar 13™.
|
0.56%
1/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/181 • 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 ~19 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 V114 or Prevnar 13™.
|
0.56%
1/178 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.55%
1/181 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/178 • 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 ~19 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 V114 or Prevnar 13™.
|
0.56%
1/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
|
Infections and infestations
Periorbital cellulitis
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/181 • 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 ~19 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 V114 or Prevnar 13™.
|
0.56%
1/178 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
|
Infections and infestations
Pharyngitis
|
0.56%
1/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/181 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/178 • 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 ~19 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 V114 or Prevnar 13™.
|
0.56%
1/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.56%
1/179 • 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 ~19 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 V114 or Prevnar 13™.
|
|
Infections and infestations
Pharyngotonsillitis
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/181 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/178 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.56%
1/179 • 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 ~19 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 V114 or Prevnar 13™.
|
|
Infections and infestations
Pneumonia
|
1.1%
2/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/181 • 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 ~19 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 V114 or Prevnar 13™.
|
0.56%
1/178 • 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 ~19 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 V114 or Prevnar 13™.
|
1.1%
2/179 • 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 ~19 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 V114 or Prevnar 13™.
|
1.1%
2/179 • 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 ~19 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 V114 or Prevnar 13™.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.55%
1/181 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/178 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
0.00%
0/179 • 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 ~19 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 V114 or Prevnar 13™.
|
Other adverse events
| Measure |
Group 1: Prevnar 13™-Prevnar 13™-Prevnar 13™-Prevnar 13™
n=179 participants at risk
Participants received a single 0.5 mL intramuscular (IM) injection of Prevnar 13™ on Day 1 (Vaccination 1), Month 2 (Vaccination 2), Month 4 (Vaccination 3) and Months 10-13 (Vaccination 4). Participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
|
Group 2: Prevnar 13™-Prevnar 13™-Prevnar 13™-V114
n=181 participants at risk
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1), Month 2 (Vaccination 2), Month 4 (Vaccination 3) and a single 0.5 mL IM injection of V114 on Months 10-13 (Vaccination 4). Participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
|
Group 3: Prevnar 13™-Prevnar 13™-V114-V114
n=178 participants at risk
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1), Month 2 (Vaccination 2) and a single 0.5 mL IM injection of V114 on Month 4 (Vaccination 3) and Months 10-13 (Vaccination 4). Participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
|
Group 4: Prevnar 13™-V114-V114-V114
n=179 participants at risk
Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of V114 on Month 2 (Vaccination 2), Month 4 (Vaccination 3) and Months 10-13 (Vaccination 4). Participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
|
Group 5: V114-V114-V114-V114
n=179 participants at risk
Participants received a single 0.5 mL IM injection of V114 on Day 1 (Vaccination 1), Month 2 (Vaccination 2), Month 4 (Vaccination 3) and Months 10-13 (Vaccination 4). Participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
8.4%
15/179 • Number of events 20 • 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 ~19 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 V114 or Prevnar 13™.
|
6.1%
11/181 • 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 ~19 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 V114 or Prevnar 13™.
|
6.2%
11/178 • 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 ~19 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 V114 or Prevnar 13™.
|
5.6%
10/179 • Number of events 10 • 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 ~19 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 V114 or Prevnar 13™.
|
5.6%
10/179 • 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 ~19 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 V114 or Prevnar 13™.
|
|
Gastrointestinal disorders
Vomiting
|
4.5%
8/179 • Number of events 11 • 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 ~19 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 V114 or Prevnar 13™.
|
6.1%
11/181 • 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 ~19 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 V114 or Prevnar 13™.
|
2.2%
4/178 • 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 ~19 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 V114 or Prevnar 13™.
|
6.1%
11/179 • 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 ~19 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 V114 or Prevnar 13™.
|
6.1%
11/179 • Number of events 11 • 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 ~19 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 V114 or Prevnar 13™.
|
|
General disorders
Injection site erythema
|
47.5%
85/179 • Number of events 137 • 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 ~19 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 V114 or Prevnar 13™.
|
37.6%
68/181 • Number of events 108 • 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 ~19 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 V114 or Prevnar 13™.
|
38.8%
69/178 • Number of events 109 • 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 ~19 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 V114 or Prevnar 13™.
|
43.0%
77/179 • Number of events 130 • 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 ~19 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 V114 or Prevnar 13™.
|
44.1%
79/179 • Number of events 142 • 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 ~19 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 V114 or Prevnar 13™.
|
|
General disorders
Injection site induration
|
34.6%
62/179 • Number of events 106 • 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 ~19 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 V114 or Prevnar 13™.
|
26.0%
47/181 • Number of events 83 • 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 ~19 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 V114 or Prevnar 13™.
|
28.1%
50/178 • Number of events 84 • 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 ~19 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 V114 or Prevnar 13™.
|
25.1%
45/179 • Number of events 75 • 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 ~19 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 V114 or Prevnar 13™.
|
26.3%
47/179 • Number of events 86 • 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 ~19 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 V114 or Prevnar 13™.
|
|
General disorders
Injection site pain
|
44.1%
79/179 • Number of events 158 • 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 ~19 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 V114 or Prevnar 13™.
|
43.6%
79/181 • Number of events 140 • 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 ~19 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 V114 or Prevnar 13™.
|
46.1%
82/178 • Number of events 165 • 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 ~19 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 V114 or Prevnar 13™.
|
43.6%
78/179 • Number of events 156 • 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 ~19 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 V114 or Prevnar 13™.
|
47.5%
85/179 • Number of events 170 • 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 ~19 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 V114 or Prevnar 13™.
|
|
General disorders
Injection site swelling
|
22.9%
41/179 • Number of events 58 • 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 ~19 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 V114 or Prevnar 13™.
|
18.8%
34/181 • 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 ~19 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 V114 or Prevnar 13™.
|
24.7%
44/178 • Number of events 63 • 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 ~19 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 V114 or Prevnar 13™.
|
20.7%
37/179 • Number of events 59 • 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 ~19 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 V114 or Prevnar 13™.
|
22.9%
41/179 • Number of events 71 • 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 ~19 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 V114 or Prevnar 13™.
|
|
General disorders
Pyrexia
|
29.6%
53/179 • Number of events 83 • 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 ~19 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 V114 or Prevnar 13™.
|
36.5%
66/181 • Number of events 94 • 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 ~19 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 V114 or Prevnar 13™.
|
29.2%
52/178 • Number of events 77 • 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 ~19 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 V114 or Prevnar 13™.
|
27.4%
49/179 • Number of events 78 • 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 ~19 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 V114 or Prevnar 13™.
|
27.4%
49/179 • Number of events 68 • 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 ~19 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 V114 or Prevnar 13™.
|
|
Infections and infestations
Nasopharyngitis
|
5.6%
10/179 • 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 ~19 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 V114 or Prevnar 13™.
|
6.1%
11/181 • 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 ~19 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 V114 or Prevnar 13™.
|
7.3%
13/178 • Number of events 14 • 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 ~19 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 V114 or Prevnar 13™.
|
4.5%
8/179 • Number of events 8 • 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 ~19 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 V114 or Prevnar 13™.
|
5.6%
10/179 • 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 ~19 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 V114 or Prevnar 13™.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.8%
14/179 • Number of events 14 • 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 ~19 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 V114 or Prevnar 13™.
|
5.0%
9/181 • Number of events 10 • 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 ~19 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 V114 or Prevnar 13™.
|
5.1%
9/178 • Number of events 11 • 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 ~19 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 V114 or Prevnar 13™.
|
6.7%
12/179 • 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 ~19 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 V114 or Prevnar 13™.
|
7.8%
14/179 • Number of events 14 • 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 ~19 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 V114 or Prevnar 13™.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
35.8%
64/179 • Number of events 150 • 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 ~19 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 V114 or Prevnar 13™.
|
32.0%
58/181 • Number of events 95 • 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 ~19 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 V114 or Prevnar 13™.
|
27.0%
48/178 • Number of events 77 • 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 ~19 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 V114 or Prevnar 13™.
|
35.2%
63/179 • Number of events 90 • 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 ~19 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 V114 or Prevnar 13™.
|
34.6%
62/179 • Number of events 121 • 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 ~19 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 V114 or Prevnar 13™.
|
|
Nervous system disorders
Somnolence
|
57.0%
102/179 • Number of events 285 • 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 ~19 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 V114 or Prevnar 13™.
|
55.8%
101/181 • Number of events 241 • 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 ~19 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 V114 or Prevnar 13™.
|
56.7%
101/178 • Number of events 207 • 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 ~19 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 V114 or Prevnar 13™.
|
57.0%
102/179 • Number of events 248 • 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 ~19 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 V114 or Prevnar 13™.
|
60.3%
108/179 • Number of events 237 • 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 ~19 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 V114 or Prevnar 13™.
|
|
Psychiatric disorders
Irritability
|
67.6%
121/179 • Number of events 430 • 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 ~19 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 V114 or Prevnar 13™.
|
60.8%
110/181 • Number of events 362 • 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 ~19 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 V114 or Prevnar 13™.
|
62.9%
112/178 • Number of events 378 • 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 ~19 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 V114 or Prevnar 13™.
|
68.2%
122/179 • Number of events 376 • 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 ~19 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 V114 or Prevnar 13™.
|
70.4%
126/179 • Number of events 434 • 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 ~19 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 V114 or Prevnar 13™.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.5%
17/179 • Number of events 17 • 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 ~19 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 V114 or Prevnar 13™.
|
6.6%
12/181 • Number of events 14 • 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 ~19 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 V114 or Prevnar 13™.
|
5.6%
10/178 • 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 ~19 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 V114 or Prevnar 13™.
|
10.1%
18/179 • Number of events 20 • 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 ~19 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 V114 or Prevnar 13™.
|
9.5%
17/179 • Number of events 17 • 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 ~19 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 V114 or Prevnar 13™.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
13.4%
24/179 • Number of events 25 • 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 ~19 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 V114 or Prevnar 13™.
|
8.3%
15/181 • Number of events 18 • 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 ~19 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 V114 or Prevnar 13™.
|
6.7%
12/178 • Number of events 14 • 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 ~19 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 V114 or Prevnar 13™.
|
6.7%
12/179 • Number of events 16 • 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 ~19 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 V114 or Prevnar 13™.
|
7.8%
14/179 • Number of events 15 • 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 ~19 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 V114 or Prevnar 13™.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
3.4%
6/179 • 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 ~19 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 V114 or Prevnar 13™.
|
1.7%
3/181 • 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 ~19 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 V114 or Prevnar 13™.
|
2.2%
4/178 • 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 ~19 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 V114 or Prevnar 13™.
|
8.9%
16/179 • Number of events 16 • 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 ~19 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 V114 or Prevnar 13™.
|
3.4%
6/179 • 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 ~19 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 V114 or Prevnar 13™.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
7.3%
13/179 • Number of events 16 • 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 ~19 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 V114 or Prevnar 13™.
|
3.9%
7/181 • Number of events 9 • 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 ~19 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 V114 or Prevnar 13™.
|
5.6%
10/178 • Number of events 14 • 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 ~19 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 V114 or Prevnar 13™.
|
8.9%
16/179 • Number of events 20 • 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 ~19 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 V114 or Prevnar 13™.
|
6.7%
12/179 • Number of events 20 • 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 ~19 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 V114 or Prevnar 13™.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
- Publication restrictions are in place
Restriction type: OTHER