Trial Outcomes & Findings for A Study of Pneumococcal Conjugate Vaccine (V114) Compared to a Marketed Vaccine (V114-003) (NCT NCT01215188)

Last Updated: 2019-04-30

Results Overview

Percentage of participants meeting the serotype-specific IgG reference level (an antibody concentration measured by the pneumococcal polysaccharide electrochemiluminescence \[Pn ECL\] assay corresponding to the World Health Organization enzyme-linked immunosorbent assay \[WHO ELISA\] ≥ 0.35 μg/mL) (post-dose 3) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

1152 participants

Primary outcome timeframe

One month postvaccination 3

Results posted on

2019-04-30

Participant Flow

This trial was conducted in 58 trial centers: 4 in Canada, 8 in Finland, 3 in Israel, 1 in Puerto Rico, 3 in Spain and 39 in the United States.

There were 1152 participants randomized into the study. The 1142 participants included in this study excluded 4 subjects who each received a combination of vaccines and who each had a final disposition of completed and excludes an additional 6 subjects who were randomized but never vaccinated.

Participant milestones

Participant milestones
Measure	V114 Adjuvanted Participants received four intramuscular (IM) doses at 0.5 mL of aluminum-adjuvanted V114 pneumococcal conjugate vaccine at 2, 4, 6, and 12 to 15 months of age.	V114 Nonadjuvanted Participants received four IM doses at 0.5 mL of non-adjuvanted V114 pneumococcal conjugate vaccine at 2, 4, 6, and 12 to 15 months of age.	PREVNAR 13® Participants received four 0.5 mL IM doses of PREVNAR 13® at 2, 4, 6, and 12 to 15 months of age.
Overall Study STARTED	378	386	378
Overall Study COMPLETED	320	327	326
Overall Study NOT COMPLETED	58	59	52

Reasons for withdrawal

Reasons for withdrawal
Measure	V114 Adjuvanted Participants received four intramuscular (IM) doses at 0.5 mL of aluminum-adjuvanted V114 pneumococcal conjugate vaccine at 2, 4, 6, and 12 to 15 months of age.	V114 Nonadjuvanted Participants received four IM doses at 0.5 mL of non-adjuvanted V114 pneumococcal conjugate vaccine at 2, 4, 6, and 12 to 15 months of age.	PREVNAR 13® Participants received four 0.5 mL IM doses of PREVNAR 13® at 2, 4, 6, and 12 to 15 months of age.
Overall Study Lost to Follow-up	22	22	16
Overall Study Adverse Event	1	1	3
Overall Study Physician Decision	2	1	0
Overall Study Lack of Efficacy	0	0	1
Overall Study Protocol Violation	1	1	1
Overall Study Withdrawal by Subject	32	34	31

Baseline Characteristics

A Study of Pneumococcal Conjugate Vaccine (V114) Compared to a Marketed Vaccine (V114-003)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	V114 Adjuvanted n=378 Participants Participants received four intramuscular (IM) doses at 0.5 mL of aluminum-adjuvanted V114 pneumococcal conjugate vaccine at 2, 4, 6, and 12 to 15 months of age.	V114 Nonadjuvanted n=386 Participants Participants received four IM doses at 0.5 mL of non-adjuvanted V114 pneumococcal conjugate vaccine at 2, 4, 6, and 12 to 15 months of age.	PREVNAR 13® n=378 Participants Participants received four 0.5 mL IM doses of PREVNAR 13® at 2, 4, 6, and 12 to 15 months of age.	Total n=1142 Participants Total of all reporting groups
Age, Customized	8.9 Weeks STANDARD_DEVIATION 1.2 • n=5 Participants	8.8 Weeks STANDARD_DEVIATION 1.2 • n=7 Participants	8.7 Weeks STANDARD_DEVIATION 1.1 • n=5 Participants	8.8 Weeks STANDARD_DEVIATION 1.2 • n=4 Participants
Sex: Female, Male Female	177 Participants n=5 Participants	189 Participants n=7 Participants	179 Participants n=5 Participants	545 Participants n=4 Participants
Sex: Female, Male Male	201 Participants n=5 Participants	197 Participants n=7 Participants	199 Participants n=5 Participants	597 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	70 Participants n=5 Participants	77 Participants n=7 Participants	79 Participants n=5 Participants	226 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	308 Participants n=5 Participants	309 Participants n=7 Participants	299 Participants n=5 Participants	916 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	28 Participants n=5 Participants	31 Participants n=7 Participants	25 Participants n=5 Participants	84 Participants n=4 Participants
Race (NIH/OMB) Asian	10 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants	22 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Black or African American	44 Participants n=5 Participants	43 Participants n=7 Participants	40 Participants n=5 Participants	127 Participants n=4 Participants
Race (NIH/OMB) White	268 Participants n=5 Participants	288 Participants n=7 Participants	275 Participants n=5 Participants	831 Participants n=4 Participants
Race (NIH/OMB) More than one race	27 Participants n=5 Participants	18 Participants n=7 Participants	31 Participants n=5 Participants	76 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants

PRIMARY outcome

Timeframe: One month postvaccination 3

Population: The analysis population included all infant participants who did not have a protocol violation that could have impacted the validity of the antibody responses.

Outcome measures

Outcome measures
Measure	V114 Adjuvanted n=300 Participants Participants received four intramuscular (IM) doses at 0.5 mL of aluminum-adjuvanted V114 pneumococcal conjugate vaccine at 2, 4, 6, and 12 to 15 months of age.	V114 Nonadjuvanted n=315 Participants Participants received four IM doses at 0.5 mL of non-adjuvanted V114 pneumococcal conjugate vaccine at 2, 4, 6, and 12 to 15 months of age.	PREVNAR 13® n=315 Participants Participants received four 0.5 mL IM doses of PREVNAR 13® at 2, 4, 6, and 12 to 15 months of age.
Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific ≥0.35 μg/mLThreshold Value for Postvaccination 3 Serotype 7F	99.0 Percentage of Participants Interval 97.1 to 100.0	99.4 Percentage of Participants Interval 97.7 to 100.0	99.4 Percentage of Participants Interval 97.7 to 100.0
Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific ≥0.35 μg/mLThreshold Value for Postvaccination 3 Serotype 22F (non-PREVNAR 13® serotype)	99.0 Percentage of Participants Interval 97.1 to 100.0	99.4 Percentage of Participants Interval 97.7 to 100.0	1.9 Percentage of Participants Interval 0.7 to 4.1
Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific ≥0.35 μg/mLThreshold Value for Postvaccination 3 Serotype 23F	87.7 Percentage of Participants Interval 83.4 to 91.2	81.6 Percentage of Participants Interval 76.9 to 85.7	90.8 Percentage of Participants Interval 87.0 to 93.7
Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific ≥0.35 μg/mLThreshold Value for Postvaccination 3 Serotype 33F (non-PREVNAR 13® serotype)	83.3 Percentage of Participants Interval 78.6 to 87.4	84.8 Percentage of Participants Interval 80.3 to 88.5	1.0 Percentage of Participants Interval 0.0 to 2.8
Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific ≥0.35 μg/mLThreshold Value for Postvaccination 3 Serotype 1	98.0 Percentage of Participants Interval 95.7 to 99.3	96.2 Percentage of Participants Interval 93.4 to 98.0	97.5 Percentage of Participants Interval 95.1 to 98.9
Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific ≥0.35 μg/mLThreshold Value for Postvaccination 3 Serotype 3	93.3 Percentage of Participants Interval 89.9 to 95.9	89.8 Percentage of Participants Interval 86.0 to 92.9	69.2 Percentage of Participants Interval 63.8 to 74.3
Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific ≥0.35 μg/mLThreshold Value for Postvaccination 3 Serotype 4	97.0 Percentage of Participants Interval 94.4 to 98.6	94.0 Percentage of Participants Interval 90.7 to 96.3	96.5 Percentage of Participants Interval 93.8 to 98.2
Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific ≥0.35 μg/mLThreshold Value for Postvaccination 3 Serotype 5	95.7 Percentage of Participants Interval 92.7 to 97.7	92.4 Percentage of Participants Interval 88.9 to 95.1	96.2 Percentage of Participants Interval 93.4 to 98.0
Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific ≥0.35 μg/mLThreshold Value for Postvaccination 3 Serotype 6A	77.0 Percentage of Participants Interval 71.8 to 81.6	78.4 Percentage of Participants Interval 73.5 to 82.8	96.8 Percentage of Participants Interval 94.2 to 98.5
Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific ≥0.35 μg/mLThreshold Value for Postvaccination 3 Serotype 6B	73.7 Percentage of Participants Interval 68.3 to 78.6	65.4 Percentage of Participants Interval 59.9 to 70.6	87.6 Percentage of Participants Interval 83.5 to 91.0
Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific ≥0.35 μg/mLThreshold Value for Postvaccination 3 Serotype 9V	95.0 Percentage of Participants Interval 91.9 to 97.2	92.4 Percentage of Participants Interval 88.9 to 95.1	97.5 Percentage of Participants Interval 95.1 to 98.9
Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific ≥0.35 μg/mLThreshold Value for Postvaccination 3 Serotype 14	98.7 Percentage of Participants Interval 96.6 to 100.0	98.4 Percentage of Participants Interval 96.3 to 99.5	97.8 Percentage of Participants Interval 95.5 to 99.1
Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific ≥0.35 μg/mLThreshold Value for Postvaccination 3 Serotype 18C	96.7 Percentage of Participants Interval 94.0 to 98.4	89.8 Percentage of Participants Interval 86.0 to 92.9	97.5 Percentage of Participants Interval 95.1 to 98.9
Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific ≥0.35 μg/mLThreshold Value for Postvaccination 3 Serotype 19A	82.7 Percentage of Participants Interval 77.9 to 86.8	84.4 Percentage of Participants Interval 80.0 to 88.3	96.5 Percentage of Participants Interval 93.8 to 98.2
Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific ≥0.35 μg/mLThreshold Value for Postvaccination 3 Serotype 19F	91.3 Percentage of Participants Interval 87.6 to 94.3	91.1 Percentage of Participants Interval 87.4 to 94.0	99.4 Percentage of Participants Interval 97.7 to 100.0

PRIMARY outcome

Timeframe: One month postvaccination 3

Population: The analysis population included all infant participants who did not have a protocol violation that could have impacted the validity of the antibody responses.

The IgG GMCs were evaluated as measured in the Pn ECL assay, for recipients of adjuvanted V114, non-adjuvanted V114, and Prevnar 13® (post-dose 3) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®.

Outcome measures

Outcome measures
Measure	V114 Adjuvanted n=300 Participants Participants received four intramuscular (IM) doses at 0.5 mL of aluminum-adjuvanted V114 pneumococcal conjugate vaccine at 2, 4, 6, and 12 to 15 months of age.	V114 Nonadjuvanted n=315 Participants Participants received four IM doses at 0.5 mL of non-adjuvanted V114 pneumococcal conjugate vaccine at 2, 4, 6, and 12 to 15 months of age.	PREVNAR 13® n=315 Participants Participants received four 0.5 mL IM doses of PREVNAR 13® at 2, 4, 6, and 12 to 15 months of age.
IgG Geometric Mean Concentrations (GMCs) for Postvaccination 3 Serotype 1	1.34 µg/mL Interval 1.24 to 1.45	1.38 µg/mL Interval 1.27 to 1.51	1.84 µg/mL Interval 1.69 to 2.01
IgG Geometric Mean Concentrations (GMCs) for Postvaccination 3 Serotype 6B	0.95 µg/mL Interval 0.78 to 1.15	0.69 µg/mL Interval 0.57 to 0.84	1.47 µg/mL Interval 1.27 to 1.69
IgG Geometric Mean Concentrations (GMCs) for Postvaccination 3 Serotype 14	4.17 µg/mL Interval 3.76 to 4.63	3.84 µg/mL Interval 3.43 to 4.29	5.62 µg/mL Interval 5.02 to 6.28
IgG Geometric Mean Concentrations (GMCs) for Postvaccination 3 Serotype 18C	1.27 µg/mL Interval 1.17 to 1.39	1.08 µg/mL Interval 0.97 to 1.2	1.99 µg/mL Interval 1.81 to 2.19
IgG Geometric Mean Concentrations (GMCs) for Postvaccination 3 Serotype 33F (non-PREVNAR 13® serotype)	1.47 µg/mL Interval 1.24 to 1.73	1.50 µg/mL Interval 1.29 to 1.74	0.06 µg/mL Interval 0.06 to 0.07
IgG Geometric Mean Concentrations (GMCs) for Postvaccination 3 Serotype 3	0.95 µg/mL Interval 0.88 to 1.03	0.88 µg/mL Interval 0.81 to 0.96	0.50 µg/mL Interval 0.46 to 0.55
IgG Geometric Mean Concentrations (GMCs) for Postvaccination 3 Serotype 4	1.28 µg/mL Interval 1.18 to 1.39	1.26 µg/mL Interval 1.16 to 1.37	1.32 µg/mL Interval 1.22 to 1.43
IgG Geometric Mean Concentrations (GMCs) for Postvaccination 3 Serotype 5	1.61 µg/mL Interval 1.46 to 1.77	1.53 µg/mL Interval 1.38 to 1.71	1.83 µg/mL Interval 1.65 to 2.02
IgG Geometric Mean Concentrations (GMCs) for Postvaccination 3 Serotype 6A	0.93 µg/mL Interval 0.8 to 1.08	0.93 µg/mL Interval 0.8 to 1.07	2.91 µg/mL Interval 2.62 to 3.24
IgG Geometric Mean Concentrations (GMCs) for Postvaccination 3 Serotype 7F	2.63 µg/mL Interval 2.41 to 2.87	2.66 µg/mL Interval 2.44 to 2.9	3.67 µg/mL Interval 3.4 to 3.97
IgG Geometric Mean Concentrations (GMCs) for Postvaccination 3 Serotype 9V	1.49 µg/mL Interval 1.35 to 1.64	1.29 µg/mL Interval 1.16 to 1.44	1.79 µg/mL Interval 1.63 to 1.97
IgG Geometric Mean Concentrations (GMCs) for Postvaccination 3 Serotype 19A	0.90 µg/mL Interval 0.8 to 1.0	0.94 µg/mL Interval 0.84 to 1.05	2.05 µg/mL Interval 1.85 to 2.27
IgG Geometric Mean Concentrations (GMCs) for Postvaccination 3 Serotype 19F	1.50 µg/mL Interval 1.33 to 1.69	1.71 µg/mL Interval 1.52 to 1.93	2.54 µg/mL Interval 2.35 to 2.75
IgG Geometric Mean Concentrations (GMCs) for Postvaccination 3 Serotype 22F (non-PREVNAR 13® serotype)	5.24 µg/mL Interval 4.74 to 5.79	4.86 µg/mL Interval 4.4 to 5.37	0.07 µg/mL Interval 0.06 to 0.07
IgG Geometric Mean Concentrations (GMCs) for Postvaccination 3 Serotype 23F	1.05 µg/mL Interval 0.94 to 1.17	0.79 µg/mL Interval 0.69 to 0.89	1.41 µg/mL Interval 1.25 to 1.58

PRIMARY outcome

Timeframe: One month postvaccination 4

Population: The analysis population included all infant participants who did not have a protocol violation that could have impacted the validity of the antibody responses.

The IgG GMCs were evaluated as measured in the Pn ECL assay, for recipients of adjuvanted V114, non-adjuvanted V114, and Prevnar 13® (post-dose 4) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®.

Outcome measures

Outcome measures
Measure	V114 Adjuvanted n=275 Participants Participants received four intramuscular (IM) doses at 0.5 mL of aluminum-adjuvanted V114 pneumococcal conjugate vaccine at 2, 4, 6, and 12 to 15 months of age.	V114 Nonadjuvanted n=298 Participants Participants received four IM doses at 0.5 mL of non-adjuvanted V114 pneumococcal conjugate vaccine at 2, 4, 6, and 12 to 15 months of age.	PREVNAR 13® n=283 Participants Participants received four 0.5 mL IM doses of PREVNAR 13® at 2, 4, 6, and 12 to 15 months of age.
IgG GMCs for Postvaccination 4 Serotype 3	1.26 µg/mL Interval 1.15 to 1.39	1.12 µg/mL Interval 1.04 to 1.22	0.69 µg/mL Interval 0.63 to 0.75
IgG GMCs for Postvaccination 4 Serotype 5	1.93 µg/mL Interval 1.74 to 2.14	1.79 µg/mL Interval 1.63 to 1.97	2.53 µg/mL Interval 2.28 to 2.81
IgG GMCs for Postvaccination 4 Serotype 6A	3.78 µg/mL Interval 3.37 to 4.26	3.17 µg/mL Interval 2.81 to 3.57	6.55 µg/mL Interval 5.89 to 7.28
IgG GMCs for Postvaccination 4 Serotype 19A	3.04 µg/mL Interval 2.72 to 3.4	3.42 µg/mL Interval 3.03 to 3.87	6.14 µg/mL Interval 5.57 to 6.78
IgG GMCs for Postvaccination 4 Serotype 19F	5.56 µg/mL Interval 4.99 to 6.2	6.35 µg/mL Interval 5.68 to 7.09	4.51 µg/mL Interval 4.07 to 5.0
IgG GMCs for Postvaccination 4 Serotype 22F (non-PREVNAR 13® serotype)	9.64 µg/mL Interval 8.74 to 10.62	7.73 µg/mL Interval 7.08 to 8.45	0.12 µg/mL Interval 0.11 to 0.14
IgG GMCs for Postvaccination 4 Serotype 33F (non-PREVNAR 13® serotype)	6.29 µg/mL Interval 5.62 to 7.05	4.95 µg/mL Interval 4.46 to 5.51	0.08 µg/mL Interval 0.08 to 0.09
IgG GMCs for Postvaccination 4 Serotype 1	1.91 µg/mL Interval 1.73 to 2.1	1.81 µg/mL Interval 1.65 to 2.0	2.18 µg/mL Interval 1.99 to 2.38
IgG GMCs for Postvaccination 4 Serotype 4	1.46 µg/mL Interval 1.3 to 1.65	1.40 µg/mL Interval 1.27 to 1.53	1.68 µg/mL Interval 1.52 to 1.86
IgG GMCs for Postvaccination 4 Serotype 6B	5.24 µg/mL Interval 4.68 to 5.86	3.98 µg/mL Interval 3.52 to 4.51	5.51 µg/mL Interval 4.9 to 6.2
IgG GMCs for Postvaccination 4 Serotype 7F	4.18 µg/mL Interval 3.76 to 4.64	3.43 µg/mL Interval 3.14 to 3.75	5.73 µg/mL Interval 5.24 to 6.28
IgG GMCs for Postvaccination 4 Serotype 9V	2.82 µg/mL Interval 2.52 to 3.15	2.50 µg/mL Interval 2.28 to 2.75	3.37 µg/mL Interval 3.04 to 3.72
IgG GMCs for Postvaccination 4 Serotype 14	6.05 µg/mL Interval 5.37 to 6.82	5.55 µg/mL Interval 4.99 to 6.17	7.57 µg/mL Interval 6.81 to 8.42
IgG GMCs for Postvaccination 4 Serotype 18C	2.14 µg/mL Interval 1.94 to 2.37	1.68 µg/mL Interval 1.54 to 1.83	3.37 µg/mL Interval 3.06 to 3.71
IgG GMCs for Postvaccination 4 Serotype 23F	1.99 µg/mL Interval 1.75 to 2.26	1.61 µg/mL Interval 1.43 to 1.8	3.14 µg/mL Interval 2.78 to 3.54

PRIMARY outcome

Timeframe: Up to Day 14 postvaccination

Population: The analysis population included all randomized participants who received at least one dose of study vaccination.

An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the Sponsor's product, is also an adverse experience.

Outcome measures

Outcome measures
Measure	V114 Adjuvanted n=368 Participants Participants received four intramuscular (IM) doses at 0.5 mL of aluminum-adjuvanted V114 pneumococcal conjugate vaccine at 2, 4, 6, and 12 to 15 months of age.	V114 Nonadjuvanted n=382 Participants Participants received four IM doses at 0.5 mL of non-adjuvanted V114 pneumococcal conjugate vaccine at 2, 4, 6, and 12 to 15 months of age.	PREVNAR 13® n=376 Participants Participants received four 0.5 mL IM doses of PREVNAR 13® at 2, 4, 6, and 12 to 15 months of age.
Number of Participants With an Adverse Event (AE)	349 Participants	359 Participants	354 Participants

PRIMARY outcome

Timeframe: Up to Day 14 postvaccination

Population: The analysis population included all randomized participants who received at least one dose of study vaccination.

Injection-site AEs reported by \> 0% of participants in one or more vaccination groups were assessed.

Outcome measures

Outcome measures
Measure	V114 Adjuvanted n=368 Participants Participants received four intramuscular (IM) doses at 0.5 mL of aluminum-adjuvanted V114 pneumococcal conjugate vaccine at 2, 4, 6, and 12 to 15 months of age.	V114 Nonadjuvanted n=382 Participants Participants received four IM doses at 0.5 mL of non-adjuvanted V114 pneumococcal conjugate vaccine at 2, 4, 6, and 12 to 15 months of age.	PREVNAR 13® n=376 Participants Participants received four 0.5 mL IM doses of PREVNAR 13® at 2, 4, 6, and 12 to 15 months of age.
Number of Participants With an Injection-site AE	307 Participants	302 Participants	304 Participants

PRIMARY outcome

Timeframe: Up to Day 14 postvaccination

Systemic AEs reported by \> 0% of participants in one or more vaccination groups were assessed.

Outcome measures

Outcome measures
Measure	V114 Adjuvanted n=368 Participants Participants received four intramuscular (IM) doses at 0.5 mL of aluminum-adjuvanted V114 pneumococcal conjugate vaccine at 2, 4, 6, and 12 to 15 months of age.	V114 Nonadjuvanted n=382 Participants Participants received four IM doses at 0.5 mL of non-adjuvanted V114 pneumococcal conjugate vaccine at 2, 4, 6, and 12 to 15 months of age.	PREVNAR 13® n=376 Participants Participants received four 0.5 mL IM doses of PREVNAR 13® at 2, 4, 6, and 12 to 15 months of age.
Number of Participants With a Systemic AE	342 Participants	352 Participants	347 Participants

PRIMARY outcome

Timeframe: Up to one month after last dose of study vaccine

Population: The analysis population included all randomized participants who received at least one dose of study vaccination.

An SAE is an AE that results in death, is life threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment.

Outcome measures

Outcome measures
Measure	V114 Adjuvanted n=368 Participants Participants received four intramuscular (IM) doses at 0.5 mL of aluminum-adjuvanted V114 pneumococcal conjugate vaccine at 2, 4, 6, and 12 to 15 months of age.	V114 Nonadjuvanted n=382 Participants Participants received four IM doses at 0.5 mL of non-adjuvanted V114 pneumococcal conjugate vaccine at 2, 4, 6, and 12 to 15 months of age.	PREVNAR 13® n=376 Participants Participants received four 0.5 mL IM doses of PREVNAR 13® at 2, 4, 6, and 12 to 15 months of age.
Number of Participants With a Serious Adverse Event (SAE)	25 Participants	27 Participants	29 Participants

PRIMARY outcome

Timeframe: Up to Day 14 postvaccination

Population: The analysis population included all randomized participants who received at least one dose of study vaccination.

Outcome measures

Outcome measures
Measure	V114 Adjuvanted n=368 Participants Participants received four intramuscular (IM) doses at 0.5 mL of aluminum-adjuvanted V114 pneumococcal conjugate vaccine at 2, 4, 6, and 12 to 15 months of age.	V114 Nonadjuvanted n=382 Participants Participants received four IM doses at 0.5 mL of non-adjuvanted V114 pneumococcal conjugate vaccine at 2, 4, 6, and 12 to 15 months of age.	PREVNAR 13® n=376 Participants Participants received four 0.5 mL IM doses of PREVNAR 13® at 2, 4, 6, and 12 to 15 months of age.
Number of Participants Who Discontinued the Study Due to an AE	1 Participants	1 Participants	2 Participants

SECONDARY outcome

Timeframe: One month postvaccination 3

Population: The analysis population included all infant participants who did not have a protocol violation that could have impacted the validity of the antibody responses.

The antibody responses as measured by MOPA4 (post-dose 3) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®. Functional antibody activity was assessed only in a subset of the vaccinated participants, thus the study was not powered for assessing non-inferiority with respect to the OPA antibody responses.

Outcome measures

Outcome measures
Measure	V114 Adjuvanted n=120 Participants Participants received four intramuscular (IM) doses at 0.5 mL of aluminum-adjuvanted V114 pneumococcal conjugate vaccine at 2, 4, 6, and 12 to 15 months of age.	V114 Nonadjuvanted n=120 Participants Participants received four IM doses at 0.5 mL of non-adjuvanted V114 pneumococcal conjugate vaccine at 2, 4, 6, and 12 to 15 months of age.	PREVNAR 13® n=122 Participants Participants received four 0.5 mL IM doses of PREVNAR 13® at 2, 4, 6, and 12 to 15 months of age.
Percentage of Participants With Opsonophagocytic Killing Activity (OPA) Titer ≥ 8 as Measured by Fourfold Multiplexed Opsonization Assay (MOPA4) for Postvaccination 3 Serotype 22F (non-PREVNAR 13® serotype)	99.2 Percentage of Participants Interval 95.4 to 100.0	100.0 Percentage of Participants Interval 97.0 to 100.0	11.6 Percentage of Participants Interval 6.5 to 18.7
Percentage of Participants With Opsonophagocytic Killing Activity (OPA) Titer ≥ 8 as Measured by Fourfold Multiplexed Opsonization Assay (MOPA4) for Postvaccination 3 Serotype 33F (non-PREVNAR 13® serotype)	97.5 Percentage of Participants Interval 92.9 to 99.5	99.2 Percentage of Participants Interval 95.4 to 100.0	60.7 Percentage of Participants Interval 51.4 to 69.4
Percentage of Participants With Opsonophagocytic Killing Activity (OPA) Titer ≥ 8 as Measured by Fourfold Multiplexed Opsonization Assay (MOPA4) for Postvaccination 3 Serotype 1	80.0 Percentage of Participants Interval 71.7 to 86.7	73.3 Percentage of Participants Interval 64.5 to 81.0	77.7 Percentage of Participants Interval 69.2 to 84.8
Percentage of Participants With Opsonophagocytic Killing Activity (OPA) Titer ≥ 8 as Measured by Fourfold Multiplexed Opsonization Assay (MOPA4) for Postvaccination 3 Serotype 4	100.0 Percentage of Participants Interval 97.0 to 100.0	100.0 Percentage of Participants Interval 96.9 to 100.0	100.0 Percentage of Participants Interval 97.0 to 100.0
Percentage of Participants With Opsonophagocytic Killing Activity (OPA) Titer ≥ 8 as Measured by Fourfold Multiplexed Opsonization Assay (MOPA4) for Postvaccination 3 Serotype 5	99.2 Percentage of Participants Interval 95.4 to 100.0	95.8 Percentage of Participants Interval 90.5 to 98.6	97.5 Percentage of Participants Interval 93.0 to 99.5
Percentage of Participants With Opsonophagocytic Killing Activity (OPA) Titer ≥ 8 as Measured by Fourfold Multiplexed Opsonization Assay (MOPA4) for Postvaccination 3 Serotype 6B	84.0 Percentage of Participants Interval 76.2 to 90.1	80.0 Percentage of Participants Interval 71.7 to 86.7	96.7 Percentage of Participants Interval 91.8 to 99.1
Percentage of Participants With Opsonophagocytic Killing Activity (OPA) Titer ≥ 8 as Measured by Fourfold Multiplexed Opsonization Assay (MOPA4) for Postvaccination 3 Serotype 9V	100.0 Percentage of Participants Interval 97.0 to 100.0	98.3 Percentage of Participants Interval 94.1 to 100.0	99.2 Percentage of Participants Interval 95.5 to 100.0
Percentage of Participants With Opsonophagocytic Killing Activity (OPA) Titer ≥ 8 as Measured by Fourfold Multiplexed Opsonization Assay (MOPA4) for Postvaccination 3 Serotype 14	100.0 Percentage of Participants Interval 97.0 to 100.0	99.2 Percentage of Participants Interval 95.4 to 100.0	100.0 Percentage of Participants Interval 97.0 to 100.0
Percentage of Participants With Opsonophagocytic Killing Activity (OPA) Titer ≥ 8 as Measured by Fourfold Multiplexed Opsonization Assay (MOPA4) for Postvaccination 3 Serotype 18C	99.2 Percentage of Participants Interval 95.4 to 100.0	96.7 Percentage of Participants Interval 91.7 to 99.1	100.0 Percentage of Participants Interval 97.0 to 100.0
Percentage of Participants With Opsonophagocytic Killing Activity (OPA) Titer ≥ 8 as Measured by Fourfold Multiplexed Opsonization Assay (MOPA4) for Postvaccination 3 Serotype 19A	92.5 Percentage of Participants Interval 86.2 to 96.5	95.0 Percentage of Participants Interval 89.3 to 98.1	95.9 Percentage of Participants Interval 90.7 to 98.7
Percentage of Participants With Opsonophagocytic Killing Activity (OPA) Titer ≥ 8 as Measured by Fourfold Multiplexed Opsonization Assay (MOPA4) for Postvaccination 3 Serotype 3	99.2 Percentage of Participants Interval 95.4 to 100.0	100.0 Percentage of Participants Interval 97.0 to 100.0	100.0 Percentage of Participants Interval 97.0 to 100.0
Percentage of Participants With Opsonophagocytic Killing Activity (OPA) Titer ≥ 8 as Measured by Fourfold Multiplexed Opsonization Assay (MOPA4) for Postvaccination 3 Serotype 6A	89.2 Percentage of Participants Interval 82.2 to 94.1	85.8 Percentage of Participants Interval 78.3 to 91.5	100.0 Percentage of Participants Interval 97.0 to 100.0
Percentage of Participants With Opsonophagocytic Killing Activity (OPA) Titer ≥ 8 as Measured by Fourfold Multiplexed Opsonization Assay (MOPA4) for Postvaccination 3 Serotype 7F	100.0 Percentage of Participants Interval 97.0 to 100.0	100.0 Percentage of Participants Interval 97.0 to 100.0	100.0 Percentage of Participants Interval 97.0 to 100.0
Percentage of Participants With Opsonophagocytic Killing Activity (OPA) Titer ≥ 8 as Measured by Fourfold Multiplexed Opsonization Assay (MOPA4) for Postvaccination 3 Serotype 19F	95.0 Percentage of Participants Interval 89.4 to 98.1	95.8 Percentage of Participants Interval 90.5 to 98.6	99.2 Percentage of Participants Interval 95.5 to 100.0
Percentage of Participants With Opsonophagocytic Killing Activity (OPA) Titer ≥ 8 as Measured by Fourfold Multiplexed Opsonization Assay (MOPA4) for Postvaccination 3 Serotype 23F	97.5 Percentage of Participants Interval 92.9 to 99.5	96.6 Percentage of Participants Interval 91.6 to 99.1	96.7 Percentage of Participants Interval 91.8 to 99.1

SECONDARY outcome

Timeframe: One month postvaccination 4

Population: The analysis population included all infant participants who did not have a protocol violation that could have impacted the validity of the antibody responses.

The antibody responses as measured by MOPA4 (post-dose 4) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®. Functional antibody activity was assessed only in a subset of the vaccinated participants, thus the study was not powered for assessing non-inferiority with respect to the OPA antibody responses.

Outcome measures

SECONDARY outcome

Timeframe: One month postvaccination 3

Population: The analysis population included all infant participants who did not have a protocol violation that could have impacted the validity of the antibody responses.

The antibody responses as measured by MOPA4 (post-dose 3) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®. The OPA antibody responses included the percentage of participants with OPA titer and the GMTs. Functional antibody activity was assessed only in a subset of the vaccinated participants, thus the study was not powered for assessing non-inferiority with respect to the OPA antibody responses.

Outcome measures

Outcome measures
Measure	V114 Adjuvanted n=120 Participants Participants received four intramuscular (IM) doses at 0.5 mL of aluminum-adjuvanted V114 pneumococcal conjugate vaccine at 2, 4, 6, and 12 to 15 months of age.	V114 Nonadjuvanted n=120 Participants Participants received four IM doses at 0.5 mL of non-adjuvanted V114 pneumococcal conjugate vaccine at 2, 4, 6, and 12 to 15 months of age.	PREVNAR 13® n=122 Participants Participants received four 0.5 mL IM doses of PREVNAR 13® at 2, 4, 6, and 12 to 15 months of age.
OPA Geometric Mean Titers (GMTs) as Measured by MOPA4 for Postvaccination 3 Serotype 33F (non-PREVNAR 13® serotype)	25075.2 μg/mL Interval 16645.2 to 37774.5	28262.3 μg/mL Interval 20745.0 to 38503.5	66.6 μg/mL Interval 39.0 to 113.7
OPA Geometric Mean Titers (GMTs) as Measured by MOPA4 for Postvaccination 3 Serotype 1	35.4 μg/mL Interval 25.4 to 49.3	32.4 μg/mL Interval 22.5 to 46.5	44.6 μg/mL Interval 31.2 to 63.7
OPA Geometric Mean Titers (GMTs) as Measured by MOPA4 for Postvaccination 3 Serotype 3	296.7 μg/mL Interval 246.9 to 356.6	254.3 μg/mL Interval 215.9 to 299.6	209.9 μg/mL Interval 178.6 to 246.7
OPA Geometric Mean Titers (GMTs) as Measured by MOPA4 for Postvaccination 3 Serotype 4	1672.9 μg/mL Interval 1414.3 to 1978.7	1633.1 μg/mL Interval 1384.3 to 1926.6	1911.6 μg/mL Interval 1608.0 to 2272.4
OPA Geometric Mean Titers (GMTs) as Measured by MOPA4 for Postvaccination 3 Serotype 6A	1273.6 μg/mL Interval 807.3 to 2009.1	703.3 μg/mL Interval 435.4 to 1136.1	4009.7 μg/mL Interval 3316.0 to 4848.4
OPA Geometric Mean Titers (GMTs) as Measured by MOPA4 for Postvaccination 3 Serotype 6B	765.5 μg/mL Interval 463.2 to 1265.2	419.5 μg/mL Interval 244.8 to 719.0	1597.5 μg/mL Interval 1145.7 to 2227.4
OPA Geometric Mean Titers (GMTs) as Measured by MOPA4 for Postvaccination 3 Serotype 9V	2227.4 μg/mL Interval 1791.0 to 2770.1	1927.3 μg/mL Interval 1493.8 to 2486.5	2685.5 μg/mL Interval 2110.5 to 3417.1
OPA Geometric Mean Titers (GMTs) as Measured by MOPA4 for Postvaccination 3 Serotype 14	2266.2 μg/mL Interval 1835.9 to 2797.2	1574.8 μg/mL Interval 1232.4 to 2012.3	2786.5 μg/mL Interval 2244.3 to 3459.7
OPA Geometric Mean Titers (GMTs) as Measured by MOPA4 for Postvaccination 3 Serotype 18C	1263.7 μg/mL Interval 1035.4 to 1542.2	846.6 μg/mL Interval 652.4 to 1098.8	2209.0 μg/mL Interval 1833.1 to 2662.0
OPA Geometric Mean Titers (GMTs) as Measured by MOPA4 for Postvaccination 3 Serotype 19A	551.7 μg/mL Interval 383.3 to 794.1	457.9 μg/mL Interval 331.1 to 633.3	1292.1 μg/mL Interval 921.9 to 1810.9
OPA Geometric Mean Titers (GMTs) as Measured by MOPA4 for Postvaccination 3 Serotype 19F	986.2 μg/mL Interval 714.0 to 1362.2	933.7 μg/mL Interval 665.8 to 1309.5	1417.1 μg/mL Interval 1145.4 to 1753.3
OPA Geometric Mean Titers (GMTs) as Measured by MOPA4 for Postvaccination 3 Serotype 22F (non-PREVNAR 13® serotype)	3048.8 μg/mL Interval 2484.3 to 3741.5	2714.4 μg/mL Interval 2302.6 to 3199.9	3.9 μg/mL Interval 2.8 to 5.5
OPA Geometric Mean Titers (GMTs) as Measured by MOPA4 for Postvaccination 3 Serotype 23F	1087.7 μg/mL Interval 821.8 to 1439.8	726.4 μg/mL Interval 530.3 to 995.1	3040.3 μg/mL Interval 2249.0 to 4110.1
OPA Geometric Mean Titers (GMTs) as Measured by MOPA4 for Postvaccination 3 Serotype 5	467.6 μg/mL Interval 369.4 to 591.7	337.0 μg/mL Interval 259.5 to 437.7	542.8 μg/mL Interval 416.8 to 706.7
OPA Geometric Mean Titers (GMTs) as Measured by MOPA4 for Postvaccination 3 Serotype 7F	5818.1 μg/mL Interval 4945.3 to 6844.8	5791.3 μg/mL Interval 4816.9 to 6962.9	10454.1 μg/mL Interval 8614.1 to 12687.0

SECONDARY outcome

Timeframe: One month postvaccination 4

Population: The analysis population included all infant participants who did not have a protocol violation that could have impacted the validity of the antibody responses.

Outcome measures

Outcome measures
Measure	V114 Adjuvanted n=58 Participants Participants received four intramuscular (IM) doses at 0.5 mL of aluminum-adjuvanted V114 pneumococcal conjugate vaccine at 2, 4, 6, and 12 to 15 months of age.	V114 Nonadjuvanted n=59 Participants Participants received four IM doses at 0.5 mL of non-adjuvanted V114 pneumococcal conjugate vaccine at 2, 4, 6, and 12 to 15 months of age.	PREVNAR 13® n=50 Participants Participants received four 0.5 mL IM doses of PREVNAR 13® at 2, 4, 6, and 12 to 15 months of age.
OPA GMTs as Measured by MOPA4 for Postvaccination 4 Serotype 4	1674.3 μg/mL Interval 1171.5 to 2392.9	1752.9 μg/mL Interval 1394.0 to 2204.0	2456.5 μg/mL Interval 1895.1 to 3184.2
OPA GMTs as Measured by MOPA4 for Postvaccination 4 Serotype 5	680.8 μg/mL Interval 474.7 to 976.6	866.5 μg/mL Interval 648.5 to 1157.9	830.3 μg/mL Interval 602.1 to 1144.8
OPA GMTs as Measured by MOPA4 for Postvaccination 4 Serotype 6A	2583.6 μg/mL Interval 1667.0 to 4004.2	2835.9 μg/mL Interval 2171.6 to 3703.5	7382.0 μg/mL Interval 5445.2 to 10007.6
OPA GMTs as Measured by MOPA4 for Postvaccination 4 Serotype 7F	10205.9 μg/mL Interval 7487.6 to 13911.2	8543.2 μg/mL Interval 6622.6 to 11020.6	19147.5 μg/mL Interval 13725.9 to 26710.7
OPA GMTs as Measured by MOPA4 for Postvaccination 4 Serotype 9V	2888.0 μg/mL Interval 1985.0 to 4201.7	3339.1 μg/mL Interval 2457.9 to 4536.2	4901.5 μg/mL Interval 3740.3 to 6423.2
OPA GMTs as Measured by MOPA4 for Postvaccination 4 Serotype 19F	1885.8 μg/mL Interval 1226.6 to 2899.2	2949.8 μg/mL Interval 2273.6 to 3827.0	2624.6 μg/mL Interval 1866.0 to 3691.5
OPA GMTs as Measured by MOPA4 for Postvaccination 4 Serotype 33F (non-PREVNAR 13® serotype)	59179.6 μg/mL Interval 43706.0 to 80131.4	54562.2 μg/mL Interval 38760.3 to 76806.2	815.8 μg/mL Interval 408.0 to 1631.3
OPA GMTs as Measured by MOPA4 for Postvaccination 4 Serotype 1	139.1 μg/mL Interval 90.0 to 215.0	124.0 μg/mL Interval 79.6 to 192.9	133.1 μg/mL Interval 86.3 to 205.1
OPA GMTs as Measured by MOPA4 for Postvaccination 4 Serotype 3	438.6 μg/mL Interval 344.8 to 557.9	405.2 μg/mL Interval 330.0 to 497.4	369.7 μg/mL Interval 293.8 to 465.0
OPA GMTs as Measured by MOPA4 for Postvaccination 4 Serotype 6B	3866.8 μg/mL Interval 2723.7 to 5489.7	2265.1 μg/mL Interval 1559.4 to 3290.2	4686.1 μg/mL Interval 3058.7 to 7179.3
OPA GMTs as Measured by MOPA4 for Postvaccination 4 Serotype 14	3543.1 μg/mL Interval 2508.3 to 5005.0	2877.7 μg/mL Interval 2088.7 to 3964.7	3872.9 μg/mL Interval 2762.1 to 5430.5
OPA GMTs as Measured by MOPA4 for Postvaccination 4 Serotype 18C	1327.0 μg/mL Interval 945.3 to 1862.8	1171.1 μg/mL Interval 928.6 to 1476.9	3214.7 μg/mL Interval 2438.0 to 4238.9
OPA GMTs as Measured by MOPA4 for Postvaccination 4 Serotype 19A	1871.0 μg/mL Interval 1282.1 to 2730.4	2260.8 μg/mL Interval 1604.8 to 3185.0	4519.7 μg/mL Interval 3028.7 to 6744.7
OPA GMTs as Measured by MOPA4 for Postvaccination 4 Serotype 22F (non-PREVNAR 13® serotype)	4586.5 μg/mL Interval 3406.2 to 6175.7	4497.0 μg/mL Interval 3594.5 to 5626.1	4.8 μg/mL Interval 2.6 to 8.8
OPA GMTs as Measured by MOPA4 for Postvaccination 4 Serotype 23F	3118.0 μg/mL Interval 2203.2 to 4412.6	2469.2 μg/mL Interval 1904.5 to 3201.4	11490.0 μg/mL Interval 7815.4 to 16892.4

SECONDARY outcome

Timeframe: One month postvaccination 4

Population: The analysis population included all infant participants who did not have a protocol violation that could have impacted the validity of the antibody responses.

Percentage of participants achieving World Health Organization (WHO) predefined antibody threshold as measured by the pneumococcal polysaccharide electrochemiluminescence (Pn ECL) assay corresponding to the WHO enzyme-linked immunosorbent assay (ELISA) value of ≥ 0.35μg/mL (post-dose 4) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®.

Outcome measures

Outcome measures
Measure	V114 Adjuvanted n=300 Participants Participants received four intramuscular (IM) doses at 0.5 mL of aluminum-adjuvanted V114 pneumococcal conjugate vaccine at 2, 4, 6, and 12 to 15 months of age.	V114 Nonadjuvanted n=315 Participants Participants received four IM doses at 0.5 mL of non-adjuvanted V114 pneumococcal conjugate vaccine at 2, 4, 6, and 12 to 15 months of age.	PREVNAR 13® n=315 Participants Participants received four 0.5 mL IM doses of PREVNAR 13® at 2, 4, 6, and 12 to 15 months of age.
Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥0.35 μg/mL for Postvaccination 4 Serotype 1	98.2 Percentage of Participants Interval 95.8 to 99.4	98.0 Percentage of Participants Interval 95.7 to 99.3	100.0 Percentage of Participants Interval 98.7 to 100.0
Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥0.35 μg/mL for Postvaccination 4 Serotype 3	96.0 Percentage of Participants Interval 92.9 to 98.0	95.9 Percentage of Participants Interval 93.0 to 97.9	80.9 Percentage of Participants Interval 75.8 to 85.3
Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥0.35 μg/mL for Postvaccination 4 Serotype 6A	98.5 Percentage of Participants Interval 96.3 to 100.0	97.3 Percentage of Participants Interval 94.8 to 98.8	99.6 Percentage of Participants Interval 98.0 to 100.0
Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥0.35 μg/mL for Postvaccination 4 Serotype 6B	99.3 Percentage of Participants Interval 97.4 to 100.0	97.7 Percentage of Participants Interval 95.2 to 99.1	98.9 Percentage of Participants Interval 96.9 to 100.0
Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥0.35 μg/mL for Postvaccination 4 Serotype 7F	100.0 Percentage of Participants Interval 98.7 to 100.0	99.0 Percentage of Participants Interval 97.1 to 100.0	99.6 Percentage of Participants Interval 98.0 to 100.0
Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥0.35 μg/mL for Postvaccination 4 Serotype 9V	98.9 Percentage of Participants Interval 96.8 to 100.0	99.0 Percentage of Participants Interval 97.1 to 100.0	99.6 Percentage of Participants Interval 98.0 to 100.0
Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥0.35 μg/mL for Postvaccination 4 Serotype 18C	98.5 Percentage of Participants Interval 96.3 to 100.0	99.0 Percentage of Participants Interval 97.1 to 100.0	100.0 Percentage of Participants Interval 98.7 to 100.0
Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥0.35 μg/mL for Postvaccination 4 Serotype 19A	97.5 Percentage of Participants Interval 94.8 to 99.0	98.7 Percentage of Participants Interval 96.6 to 100.0	100.0 Percentage of Participants Interval 98.7 to 100.0
Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥0.35 μg/mL for Postvaccination 4 Serotype 19F	99.3 Percentage of Participants Interval 97.4 to 100.0	99.0 Percentage of Participants Interval 97.1 to 100.0	99.3 Percentage of Participants Interval 97.5 to 100.0
Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥0.35 μg/mL for Postvaccination 4 Serotype 22F (non-PREVNAR 13® serotype)	100.0 Percentage of Participants Interval 98.7 to 100.0	99.7 Percentage of Participants Interval 98.1 to 100.0	7.4 Percentage of Participants Interval 4.7 to 11.1
Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥0.35 μg/mL for Postvaccination 4 Serotype 23F	95.6 Percentage of Participants Interval 92.5 to 97.7	95.0 Percentage of Participants Interval 91.8 to 97.2	98.9 Percentage of Participants Interval 96.9 to 100.0
Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥0.35 μg/mL for Postvaccination 4 Serotype 33F (non-PREVNAR 13® serotype)	98.9 Percentage of Participants Interval 96.8 to 100.0	98.3 Percentage of Participants Interval 96.1 to 99.5	4.9 Percentage of Participants Interval 2.7 to 8.2
Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥0.35 μg/mL for Postvaccination 4 Serotype 4	95.6 Percentage of Participants Interval 92.5 to 97.7	96.3 Percentage of Participants Interval 93.5 to 98.1	96.8 Percentage of Participants Interval 94.0 to 98.5
Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥0.35 μg/mL for Postvaccination 4 Serotype 5	99.3 Percentage of Participants Interval 97.4 to 100.0	99.0 Percentage of Participants Interval 97.1 to 100.0	98.9 Percentage of Participants Interval 96.9 to 100.0
Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥0.35 μg/mL for Postvaccination 4 Serotype 14	99.6 Percentage of Participants Interval 98.0 to 100.0	99.7 Percentage of Participants Interval 98.1 to 100.0	100.0 Percentage of Participants Interval 98.7 to 100.0

SECONDARY outcome

Timeframe: One month postvaccination 4

Population: The analysis population included all infant participants who did not have a protocol violation that could have impacted the validity of the antibody responses.

Percentage of participants achieving WHO predefined antibody threshold as measured by the Pn ECL assay corresponding to the WHO enzyme-linked immunosorbent assay (ELISA) value of ≥ 1.0 μg/mL (post-dose 4) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®.

Outcome measures

Outcome measures
Measure	V114 Adjuvanted n=275 Participants Participants received four intramuscular (IM) doses at 0.5 mL of aluminum-adjuvanted V114 pneumococcal conjugate vaccine at 2, 4, 6, and 12 to 15 months of age.	V114 Nonadjuvanted n=298 Participants Participants received four IM doses at 0.5 mL of non-adjuvanted V114 pneumococcal conjugate vaccine at 2, 4, 6, and 12 to 15 months of age.	PREVNAR 13® n=283 Participants Participants received four 0.5 mL IM doses of PREVNAR 13® at 2, 4, 6, and 12 to 15 months of age.
Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥1.0 μg/mL for Postvaccination 4 Serotype 1	77.5 Percentage of Participants Interval 72.1 to 82.3	76.5 Percentage of Participants Interval 71.3 to 81.2	84.1 Percentage of Participants Interval 79.3 to 88.2
Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥1.0 μg/mL for Postvaccination 4 Serotype 3	63.6 Percentage of Participants Interval 57.6 to 69.3	56.8 Percentage of Participants Interval 50.9 to 62.5	30.9 Percentage of Participants Interval 25.5 to 36.6
Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥1.0 μg/mL for Postvaccination 4 Serotype 4	62.0 Percentage of Participants Interval 56.0 to 67.8	65.1 Percentage of Participants Interval 59.4 to 70.5	73.3 Percentage of Participants Interval 67.7 to 78.4
Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥1.0 μg/mL for Postvaccination 4 Serotype 5	79.6 Percentage of Participants Interval 74.4 to 84.2	75.8 Percentage of Participants Interval 70.6 to 80.6	85.1 Percentage of Participants Interval 80.4 to 89.1
Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥1.0 μg/mL for Postvaccination 4 Serotype 6B	97.1 Percentage of Participants Interval 94.3 to 98.7	92.6 Percentage of Participants Interval 89.0 to 95.3	95.4 Percentage of Participants Interval 92.2 to 97.5
Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥1.0 μg/mL for Postvaccination 4 Serotype 9V	88.6 Percentage of Participants Interval 84.3 to 92.2	87.9 Percentage of Participants Interval 83.7 to 91.4	91.5 Percentage of Participants Interval 87.6 to 94.5
Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥1.0 μg/mL for Postvaccination 4 Serotype 14	95.3 Percentage of Participants Interval 92.1 to 97.5	97.0 Percentage of Participants Interval 94.3 to 98.6	98.2 Percentage of Participants Interval 95.9 to 99.4
Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥1.0 μg/mL for Postvaccination 4 Serotype 18C	83.6 Percentage of Participants Interval 78.7 to 87.8	74.5 Percentage of Participants Interval 69.2 to 79.3	95.0 Percentage of Participants Interval 91.8 to 97.2
Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥1.0 μg/mL for Postvaccination 4 Serotype 19A	87.6 Percentage of Participants Interval 83.2 to 91.3	87.9 Percentage of Participants Interval 83.7 to 91.4	96.4 Percentage of Participants Interval 93.6 to 98.3
Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥1.0 μg/mL for Postvaccination 4 Serotype 19F	95.3 Percentage of Participants Interval 92.1 to 97.5	97.0 Percentage of Participants Interval 94.3 to 98.6	95.7 Percentage of Participants Interval 92.7 to 97.8
Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥1.0 μg/mL for Postvaccination 4 Serotype 22F (non-PREVNAR 13® serotype)	99.6 Percentage of Participants Interval 98.0 to 100.0	98.7 Percentage of Participants Interval 96.6 to 100.0	2.8 Percentage of Participants Interval 1.2 to 5.5
Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥1.0 μg/mL for Postvaccination 4 Serotype 23F	76.4 Percentage of Participants Interval 70.9 to 81.3	70.5 Percentage of Participants Interval 64.9 to 75.6	86.4 Percentage of Participants Interval 81.9 to 90.2
Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥1.0 μg/mL for Postvaccination 4 Serotype 33F (non-PREVNAR 13® serotype)	96.0 Percentage of Participants Interval 92.9 to 98.0	96.6 Percentage of Participants Interval 93.9 to 98.4	1.4 Percentage of Participants Interval 0.0 to 3.6
Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥1.0 μg/mL for Postvaccination 4 Serotype 6A	89.8 Percentage of Participants Interval 85.6 to 93.1	89.2 Percentage of Participants Interval 85.1 to 92.5	97.5 Percentage of Participants Interval 94.9 to 99.0
Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥1.0 μg/mL for Postvaccination 4 Serotype 7F	96.4 Percentage of Participants Interval 93.4 to 98.2	97.0 Percentage of Participants Interval 94.3 to 98.6	99.3 Percentage of Participants Interval 97.5 to 100.0

Adverse Events

V114

Serious events: 25 serious events

Other events: 345 other events

Deaths: 1 deaths

V114 Non-Adjuvanted

Serious events: 27 serious events

Other events: 348 other events

Deaths: 1 deaths

Prevnar

Serious events: 29 serious events

Other events: 347 other events

Deaths: 2 deaths

Serious adverse events

Other adverse events

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 The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission.
Publication restrictions are in place

Restriction type: OTHER

Measure	V114 Adjuvanted n=58 Participants Participants received four intramuscular (IM) doses at 0.5 mL of aluminum-adjuvanted V114 pneumococcal conjugate vaccine at 2, 4, 6, and 12 to 15 months of age.	V114 Nonadjuvanted n=59 Participants Participants received four IM doses at 0.5 mL of non-adjuvanted V114 pneumococcal conjugate vaccine at 2, 4, 6, and 12 to 15 months of age.	PREVNAR 13® n=50 Participants Participants received four 0.5 mL IM doses of PREVNAR 13® at 2, 4, 6, and 12 to 15 months of age.
Percentage of Participants With OPA Titer ≥ 8 as Measured by MOPA4 for Postvaccination 4 Serotype 5	98.3 Percentage of Participants Interval 90.8 to 100.0	100.0 Percentage of Participants Interval 93.9 to 100.0	100.0 Percentage of Participants Interval 92.9 to 100.0
Percentage of Participants With OPA Titer ≥ 8 as Measured by MOPA4 for Postvaccination 4 Serotype 6A	98.3 Percentage of Participants Interval 90.8 to 100.0	100.0 Percentage of Participants Interval 93.9 to 100.0	100.0 Percentage of Participants Interval 92.9 to 100.0
Percentage of Participants With OPA Titer ≥ 8 as Measured by MOPA4 for Postvaccination 4 Serotype 6B	98.3 Percentage of Participants Interval 90.8 to 100.0	100.0 Percentage of Participants Interval 93.9 to 100.0	100.0 Percentage of Participants Interval 92.9 to 100.0
Percentage of Participants With OPA Titer ≥ 8 as Measured by MOPA4 for Postvaccination 4 Serotype 9V	98.3 Percentage of Participants Interval 90.8 to 100.0	100.0 Percentage of Participants Interval 93.9 to 100.0	100.0 Percentage of Participants Interval 92.9 to 100.0
Percentage of Participants With OPA Titer ≥ 8 as Measured by MOPA4 for Postvaccination 4 Serotype 14	100.0 Percentage of Participants Interval 93.8 to 100.0	100.0 Percentage of Participants Interval 93.9 to 100.0	100.0 Percentage of Participants Interval 92.9 to 100.0
Percentage of Participants With OPA Titer ≥ 8 as Measured by MOPA4 for Postvaccination 4 Serotype 19F	96.6 Percentage of Participants Interval 88.1 to 100.0	100.0 Percentage of Participants Interval 93.9 to 100.0	100.0 Percentage of Participants Interval 92.9 to 100.0
Percentage of Participants With OPA Titer ≥ 8 as Measured by MOPA4 for Postvaccination 4 Serotype 22F (non-PREVNAR 13® serotype)	100.0 Percentage of Participants Interval 93.8 to 100.0	100.0 Percentage of Participants Interval 93.8 to 100.0	17.0 Percentage of Participants Interval 7.6 to 30.8
Percentage of Participants With OPA Titer ≥ 8 as Measured by MOPA4 for Postvaccination 4 Serotype 23F	100.0 Percentage of Participants Interval 93.8 to 100.0	100.0 Percentage of Participants Interval 93.9 to 100.0	100.0 Percentage of Participants Interval 92.9 to 100.0
Percentage of Participants With OPA Titer ≥ 8 as Measured by MOPA4 for Postvaccination 4 Serotype 33F (non-PREVNAR 13® serotype)	100.0 Percentage of Participants Interval 93.8 to 100.0	100.0 Percentage of Participants Interval 93.9 to 100.0	88.0 Percentage of Participants Interval 75.7 to 95.5
Percentage of Participants With OPA Titer ≥ 8 as Measured by MOPA4 for Postvaccination 4 Serotype 1	96.6 Percentage of Participants Interval 88.1 to 100.0	94.9 Percentage of Participants Interval 85.9 to 98.9	96.0 Percentage of Participants Interval 86.3 to 100.0
Percentage of Participants With OPA Titer ≥ 8 as Measured by MOPA4 for Postvaccination 4 Serotype 3	100.0 Percentage of Participants Interval 93.8 to 100.0	100.0 Percentage of Participants Interval 93.9 to 100.0	100.0 Percentage of Participants Interval 92.9 to 100.0
Percentage of Participants With OPA Titer ≥ 8 as Measured by MOPA4 for Postvaccination 4 Serotype 4	98.3 Percentage of Participants Interval 90.8 to 100.0	100.0 Percentage of Participants Interval 93.9 to 100.0	100.0 Percentage of Participants Interval 92.9 to 100.0
Percentage of Participants With OPA Titer ≥ 8 as Measured by MOPA4 for Postvaccination 4 Serotype 7F	100.0 Percentage of Participants Interval 93.8 to 100.0	100.0 Percentage of Participants Interval 93.9 to 100.0	100.0 Percentage of Participants Interval 92.9 to 100.0
Percentage of Participants With OPA Titer ≥ 8 as Measured by MOPA4 for Postvaccination 4 Serotype 18C	98.3 Percentage of Participants Interval 90.8 to 100.0	100.0 Percentage of Participants Interval 93.9 to 100.0	100.0 Percentage of Participants Interval 92.9 to 100.0
Percentage of Participants With OPA Titer ≥ 8 as Measured by MOPA4 for Postvaccination 4 Serotype 19A	98.3 Percentage of Participants Interval 90.8 to 100.0	98.3 Percentage of Participants Interval 90.9 to 100.0	100.0 Percentage of Participants Interval 92.9 to 100.0

Measure	V114 n=368 participants at risk Participants received four intramuscular (IM) doses at 0.5 mL of aluminum-adjuvanted V114 pneumococcal conjugate vaccine at 2, 4, 6, and 12 to 15 months of age.	V114 Non-Adjuvanted n=382 participants at risk Participants received four IM doses at 0.5 mL of non-adjuvanted V114 pneumococcal conjugate vaccine at 2, 4, 6, and 12 to 15 months of age.	Prevnar n=376 participants at risk Participants received four 0.5 mL IM doses of PREVNAR 13® at 2, 4, 6, and 12 to 15 months of age.
Gastrointestinal disorders Constipation	5.2% 19/368 • Number of events 19 • Up to 1 month after final vaccination The safety population consisted of all randomized participants who received study vaccine.	0.79% 3/382 • Number of events 3 • Up to 1 month after final vaccination The safety population consisted of all randomized participants who received study vaccine.	3.7% 14/376 • Number of events 15 • Up to 1 month after final vaccination The safety population consisted of all randomized participants who received study vaccine.
Gastrointestinal disorders Diarrhoea	9.8% 36/368 • Number of events 38 • Up to 1 month after final vaccination The safety population consisted of all randomized participants who received study vaccine.	6.8% 26/382 • Number of events 29 • Up to 1 month after final vaccination The safety population consisted of all randomized participants who received study vaccine.	9.6% 36/376 • Number of events 39 • Up to 1 month after final vaccination The safety population consisted of all randomized participants who received study vaccine.
Gastrointestinal disorders Vomiting	4.6% 17/368 • Number of events 20 • Up to 1 month after final vaccination The safety population consisted of all randomized participants who received study vaccine.	6.5% 25/382 • Number of events 28 • Up to 1 month after final vaccination The safety population consisted of all randomized participants who received study vaccine.	6.6% 25/376 • Number of events 27 • Up to 1 month after final vaccination The safety population consisted of all randomized participants who received study vaccine.
General disorders Injection site erythema	59.0% 217/368 • Number of events 475 • Up to 1 month after final vaccination The safety population consisted of all randomized participants who received study vaccine.	46.9% 179/382 • Number of events 348 • Up to 1 month after final vaccination The safety population consisted of all randomized participants who received study vaccine.	53.5% 201/376 • Number of events 400 • Up to 1 month after final vaccination The safety population consisted of all randomized participants who received study vaccine.
General disorders Injection site induration	44.3% 163/368 • Number of events 314 • Up to 1 month after final vaccination The safety population consisted of all randomized participants who received study vaccine.	29.3% 112/382 • Number of events 180 • Up to 1 month after final vaccination The safety population consisted of all randomized participants who received study vaccine.	42.6% 160/376 • Number of events 324 • Up to 1 month after final vaccination The safety population consisted of all randomized participants who received study vaccine.
General disorders Injection site pain	71.7% 264/368 • Number of events 687 • Up to 1 month after final vaccination The safety population consisted of all randomized participants who received study vaccine.	73.3% 280/382 • Number of events 632 • Up to 1 month after final vaccination The safety population consisted of all randomized participants who received study vaccine.	72.1% 271/376 • Number of events 647 • Up to 1 month after final vaccination The safety population consisted of all randomized participants who received study vaccine.
General disorders Injection site swelling	49.2% 181/368 • Number of events 378 • Up to 1 month after final vaccination The safety population consisted of all randomized participants who received study vaccine.	34.6% 132/382 • Number of events 235 • Up to 1 month after final vaccination The safety population consisted of all randomized participants who received study vaccine.	43.9% 165/376 • Number of events 332 • Up to 1 month after final vaccination The safety population consisted of all randomized participants who received study vaccine.
General disorders Irritability	85.6% 315/368 • Number of events 1072 • Up to 1 month after final vaccination The safety population consisted of all randomized participants who received study vaccine.	81.4% 311/382 • Number of events 1005 • Up to 1 month after final vaccination The safety population consisted of all randomized participants who received study vaccine.	81.4% 306/376 • Number of events 988 • Up to 1 month after final vaccination The safety population consisted of all randomized participants who received study vaccine.
General disorders Pyrexia	33.4% 123/368 • Number of events 197 • Up to 1 month after final vaccination The safety population consisted of all randomized participants who received study vaccine.	22.5% 86/382 • Number of events 147 • Up to 1 month after final vaccination The safety population consisted of all randomized participants who received study vaccine.	29.3% 110/376 • Number of events 186 • Up to 1 month after final vaccination The safety population consisted of all randomized participants who received study vaccine.
Infections and infestations Nasopharyngitis	6.0% 22/368 • Number of events 22 • Up to 1 month after final vaccination The safety population consisted of all randomized participants who received study vaccine.	5.8% 22/382 • Number of events 27 • Up to 1 month after final vaccination The safety population consisted of all randomized participants who received study vaccine.	5.6% 21/376 • Number of events 22 • Up to 1 month after final vaccination The safety population consisted of all randomized participants who received study vaccine.
Infections and infestations Otitis media	7.9% 29/368 • Number of events 29 • Up to 1 month after final vaccination The safety population consisted of all randomized participants who received study vaccine.	7.3% 28/382 • Number of events 28 • Up to 1 month after final vaccination The safety population consisted of all randomized participants who received study vaccine.	5.9% 22/376 • Number of events 23 • Up to 1 month after final vaccination The safety population consisted of all randomized participants who received study vaccine.
Infections and infestations Upper respiratory tract infection	8.2% 30/368 • Number of events 32 • Up to 1 month after final vaccination The safety population consisted of all randomized participants who received study vaccine.	10.7% 41/382 • Number of events 44 • Up to 1 month after final vaccination The safety population consisted of all randomized participants who received study vaccine.	6.9% 26/376 • Number of events 32 • Up to 1 month after final vaccination The safety population consisted of all randomized participants who received study vaccine.
Metabolism and nutrition disorders Decreased appetite	57.6% 212/368 • Number of events 492 • Up to 1 month after final vaccination The safety population consisted of all randomized participants who received study vaccine.	51.0% 195/382 • Number of events 405 • Up to 1 month after final vaccination The safety population consisted of all randomized participants who received study vaccine.	52.1% 196/376 • Number of events 397 • Up to 1 month after final vaccination The safety population consisted of all randomized participants who received study vaccine.
Nervous system disorders Somnolence	71.5% 263/368 • Number of events 743 • Up to 1 month after final vaccination The safety population consisted of all randomized participants who received study vaccine.	73.6% 281/382 • Number of events 756 • Up to 1 month after final vaccination The safety population consisted of all randomized participants who received study vaccine.	70.5% 265/376 • Number of events 689 • Up to 1 month after final vaccination The safety population consisted of all randomized participants who received study vaccine.
Respiratory, thoracic and mediastinal disorders Cough	7.6% 28/368 • Number of events 30 • Up to 1 month after final vaccination The safety population consisted of all randomized participants who received study vaccine.	6.5% 25/382 • Number of events 28 • Up to 1 month after final vaccination The safety population consisted of all randomized participants who received study vaccine.	5.1% 19/376 • Number of events 19 • Up to 1 month after final vaccination The safety population consisted of all randomized participants who received study vaccine.