Trial Outcomes & Findings for A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Two Lots of V114 in Healthy Infants (V114-008) (NCT NCT02987972)

Last Updated: 2019-10-23

Results Overview

Serotype-specific pneumococcal IgG antibody was measured using the Meso-Scale Discovery (MSD) Pneumococcal electrochemiluminescence assay (Pn ECL). The percentage of participants with serotype-specific IgG ≥0.35 µg/mL was summarized for each serotype.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

1051 participants

Primary outcome timeframe

1 month post vaccination 3 (Month 5)

Results posted on

2019-10-23

Participant Flow

Participant milestones

Participant milestones
Measure	V114 Lot 1 Infants received a 0.5 mL intramuscular injection of V114 Lot 1 at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)	V114 Lot 2 Infants received a 0.5 mL intramuscular injection of V114 Lot 2 at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)	Prevnar 13™ Infants received a 0.5 mL intramuscular injection of Prevnar 13™ at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)
Overall Study STARTED	351	350	350
Overall Study Vaccination 1	350	347	347
Overall Study Vaccination 2	333	335	335
Overall Study Vaccination 3	330	331	332
Overall Study Vaccination 4	310	306	311
Overall Study COMPLETED	308	305	308
Overall Study NOT COMPLETED	43	45	42

Reasons for withdrawal

Reasons for withdrawal
Measure	V114 Lot 1 Infants received a 0.5 mL intramuscular injection of V114 Lot 1 at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)	V114 Lot 2 Infants received a 0.5 mL intramuscular injection of V114 Lot 2 at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)	Prevnar 13™ Infants received a 0.5 mL intramuscular injection of Prevnar 13™ at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)
Overall Study Adverse Event	1	1	0
Overall Study Death	1	0	0
Overall Study Lack of Efficacy	9	12	12
Overall Study Lost to Follow-up	7	8	4
Overall Study Physician Decision	1	6	0
Overall Study Protocol Violation	2	1	5
Overall Study Withdrawal by Subject	22	17	21

Baseline Characteristics

A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Two Lots of V114 in Healthy Infants (V114-008)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	V114 Lot 1 n=351 Participants Infants received a 0.5 mL intramuscular injection of V114 Lot 1 at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)	V114 Lot 2 n=350 Participants Infants received a 0.5 mL intramuscular injection of V114 Lot 2 at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)	Prevnar 13™ n=350 Participants Infants received a 0.5 mL intramuscular injection of Prevnar 13™ at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)	Total n=1051 Participants Total of all reporting groups
Age, Customized Infants and toddlers (28 days-23 months)	351 Participants n=5 Participants	350 Participants n=7 Participants	350 Participants n=5 Participants	1051 Participants n=4 Participants
Sex: Female, Male Female	164 Participants n=5 Participants	186 Participants n=7 Participants	173 Participants n=5 Participants	523 Participants n=4 Participants
Sex: Female, Male Male	187 Participants n=5 Participants	164 Participants n=7 Participants	177 Participants n=5 Participants	528 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	3 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	6 Participants n=4 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	7 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	3 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	6 Participants n=4 Participants
Race (NIH/OMB) Black or African American	34 Participants n=5 Participants	24 Participants n=7 Participants	33 Participants n=5 Participants	91 Participants n=4 Participants
Race (NIH/OMB) White	290 Participants n=5 Participants	296 Participants n=7 Participants	289 Participants n=5 Participants	875 Participants n=4 Participants
Race (NIH/OMB) More than one race	18 Participants n=5 Participants	25 Participants n=7 Participants	22 Participants n=5 Participants	65 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
Ethnicity Hispanic Or Latino	49 Participants n=5 Participants	36 Participants n=7 Participants	53 Participants n=5 Participants	138 Participants n=4 Participants
Ethnicity Not Hispanic Or Latino	300 Participants n=5 Participants	313 Participants n=7 Participants	294 Participants n=5 Participants	907 Participants n=4 Participants
Ethnicity Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants
Ethnicity Unknown	2 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants

PRIMARY outcome

Timeframe: 1 month post vaccination 3 (Month 5)

Population: Participants not considered as protocol violators and had data available for endpoint. Violations could include but were not limited to: failure to receive the scheduled correct doses within scheduled timeframe and lack of valid serology results available from 28 to 42 days following the dose being analyzed.

Outcome measures

Outcome measures
Measure	V114 Lot 1 n=329 Participants Infants received a 0.5 mL intramuscular injection of V114 Lot 1 at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)	V114 Lot 2 n=330 Participants Infants received a 0.5 mL intramuscular injection of V114 Lot 2 at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)	Prevnar 13™ n=332 Participants Infants received a 0.5 mL intramuscular injection of Prevnar 13™ at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)
Percentage of Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 µg/mL for the 13 Common Serotypes in V114 and Prevnar 13™: 1 Month Post Vaccination 3 Type 1	96.8 Percentage of Participants Interval 93.94 to 98.51	97.8 Percentage of Participants Interval 95.28 to 99.19	96.9 Percentage of Participants Interval 94.21 to 98.58
Percentage of Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 µg/mL for the 13 Common Serotypes in V114 and Prevnar 13™: 1 Month Post Vaccination 3 Type 3	96.0 Percentage of Participants Interval 93.01 to 98.0	94.1 Percentage of Participants Interval 90.66 to 96.61	71.8 Percentage of Participants Interval 66.28 to 76.92
Percentage of Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 µg/mL for the 13 Common Serotypes in V114 and Prevnar 13™: 1 Month Post Vaccination 3 Type 4	98.2 Percentage of Participants Interval 95.78 to 99.4	97.1 Percentage of Participants Interval 94.29 to 98.72	95.1 Percentage of Participants Interval 91.98 to 97.32
Percentage of Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 µg/mL for the 13 Common Serotypes in V114 and Prevnar 13™: 1 Month Post Vaccination 3 Type 5	96.0 Percentage of Participants Interval 93.03 to 98.01	96.0 Percentage of Participants Interval 92.88 to 97.96	96.6 Percentage of Participants Interval 93.75 to 98.33
Percentage of Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 µg/mL for the 13 Common Serotypes in V114 and Prevnar 13™: 1 Month Post Vaccination 3 Type 6A	90.6 Percentage of Participants Interval 86.6 to 93.8	95.6 Percentage of Participants Interval 92.45 to 97.71	96.2 Percentage of Participants Interval 93.31 to 98.09
Percentage of Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 µg/mL for the 13 Common Serotypes in V114 and Prevnar 13™: 1 Month Post Vaccination 3 Type 6B	90.6 Percentage of Participants Interval 86.5 to 93.75	92.3 Percentage of Participants Interval 88.48 to 95.18	91.4 Percentage of Participants Interval 87.54 to 94.34
Percentage of Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 µg/mL for the 13 Common Serotypes in V114 and Prevnar 13™: 1 Month Post Vaccination 3 Type 7F	99.6 Percentage of Participants Interval 98.01 to 99.99	99.3 Percentage of Participants Interval 97.38 to 99.91	99.0 Percentage of Participants Interval 97.01 to 99.79
Percentage of Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 µg/mL for the 13 Common Serotypes in V114 and Prevnar 13™: 1 Month Post Vaccination 3 Type 9V	97.1 Percentage of Participants Interval 94.41 to 98.75	97.8 Percentage of Participants Interval 95.28 to 99.19	95.8 Percentage of Participants Interval 92.86 to 97.84
Percentage of Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 µg/mL for the 13 Common Serotypes in V114 and Prevnar 13™: 1 Month Post Vaccination 3 Type 14	99.3 Percentage of Participants Interval 97.42 to 99.91	97.4 Percentage of Participants Interval 94.79 to 98.96	97.2 Percentage of Participants Interval 94.62 to 98.8
Percentage of Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 µg/mL for the 13 Common Serotypes in V114 and Prevnar 13™: 1 Month Post Vaccination 3 Type 18C	96.8 Percentage of Participants Interval 93.94 to 98.51	98.2 Percentage of Participants Interval 95.78 to 99.4	95.5 Percentage of Participants Interval 92.48 to 97.6
Percentage of Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 µg/mL for the 13 Common Serotypes in V114 and Prevnar 13™: 1 Month Post Vaccination 3 Type 19A	98.9 Percentage of Participants Interval 96.88 to 99.78	98.5 Percentage of Participants Interval 96.29 to 99.6	98.6 Percentage of Participants Interval 96.51 to 99.62
Percentage of Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 µg/mL for the 13 Common Serotypes in V114 and Prevnar 13™: 1 Month Post Vaccination 3 Type 19F	100.0 Percentage of Participants Interval 98.68 to 100.0	98.9 Percentage of Participants Interval 96.82 to 99.77	99.7 Percentage of Participants Interval 98.09 to 99.99
Percentage of Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 µg/mL for the 13 Common Serotypes in V114 and Prevnar 13™: 1 Month Post Vaccination 3 Type 23F	92.4 Percentage of Participants Interval 88.68 to 95.26	94.9 Percentage of Participants Interval 91.55 to 97.17	90.7 Percentage of Participants Interval 86.74 to 93.77

PRIMARY outcome

Timeframe: 1 month post Vaccination 3 (Month 5)

Serotype-specific pneumococcal IgG antibody will be assayed using the Meso-Scale Discovery (MSD) Pn electrochemiluminescence assay. The geometric mean concentration (GMC) of serotype-specific IgG will be assessed.

Outcome measures

Outcome measures
Measure	V114 Lot 1 n=329 Participants Infants received a 0.5 mL intramuscular injection of V114 Lot 1 at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)	V114 Lot 2 n=330 Participants Infants received a 0.5 mL intramuscular injection of V114 Lot 2 at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)	Prevnar 13™ n=332 Participants Infants received a 0.5 mL intramuscular injection of Prevnar 13™ at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)
Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar 13™ and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 3 Type 33F	1.58 µg/mL Interval 1.34 to 1.86	1.51 µg/mL Interval 1.3 to 1.75	0.05 µg/mL Interval 0.04 to 0.05
Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar 13™ and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 3 Type 19A	1.63 µg/mL Interval 1.52 to 1.76	1.64 µg/mL Interval 1.51 to 1.78	1.99 µg/mL Interval 1.83 to 2.18
Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar 13™ and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 3 Type 1	1.19 µg/mL Interval 1.1 to 1.27	1.37 µg/mL Interval 1.26 to 1.49	1.65 µg/mL Interval 1.5 to 1.82
Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar 13™ and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 3 Type 3	1.04 µg/mL Interval 0.97 to 1.12	1.02 µg/mL Interval 0.93 to 1.11	0.53 µg/mL Interval 0.48 to 0.58
Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar 13™ and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 3 Type 4	1.30 µg/mL Interval 1.21 to 1.4	1.27 µg/mL Interval 1.17 to 1.37	1.26 µg/mL Interval 1.14 to 1.38
Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar 13™ and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 3 Type 5	1.37 µg/mL Interval 1.25 to 1.5	1.45 µg/mL Interval 1.32 to 1.59	1.75 µg/mL Interval 1.58 to 1.94
Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar 13™ and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 3 Type 6A	1.42 µg/mL Interval 1.27 to 1.59	1.48 µg/mL Interval 1.34 to 1.63	2.62 µg/mL Interval 2.35 to 2.92
Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar 13™ and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 3 Type 6B	1.95 µg/mL Interval 1.68 to 2.28	1.71 µg/mL Interval 1.49 to 1.96	1.89 µg/mL Interval 1.64 to 2.18
Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar 13™ and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 3 Type 7F	2.43 µg/mL Interval 2.26 to 2.62	2.42 µg/mL Interval 2.23 to 2.62	2.98 µg/mL Interval 2.72 to 3.26
Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar 13™ and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 3 Type 9V	1.40 µg/mL Interval 1.28 to 1.52	1.70 µg/mL Interval 1.56 to 1.86	1.59 µg/mL Interval 1.44 to 1.76
Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar 13™ and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 3 Type 14	5.08 µg/mL Interval 4.63 to 5.58	4.78 µg/mL Interval 4.27 to 5.34	5.79 µg/mL Interval 5.11 to 6.55
Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar 13™ and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 3 Type 18C	1.24 µg/mL Interval 1.15 to 1.35	1.65 µg/mL Interval 1.52 to 1.79	1.67 µg/mL Interval 1.52 to 1.82
Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar 13™ and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 3 Type 19F	2.26 µg/mL Interval 2.1 to 2.43	2.33 µg/mL Interval 2.15 to 2.53	2.57 µg/mL Interval 2.38 to 2.78
Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar 13™ and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 3 Type 23F	1.22 µg/mL Interval 1.1 to 1.35	1.47 µg/mL Interval 1.32 to 1.63	1.25 µg/mL Interval 1.11 to 1.4
Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar 13™ and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 3 Type 22F	4.80 µg/mL Interval 4.4 to 5.24	4.18 µg/mL Interval 3.76 to 4.63	0.05 µg/mL Interval 0.05 to 0.06

PRIMARY outcome

Timeframe: Up to 1 month post Vaccination 4 (up to 14 months)

Population: All participants that received at least 1 vaccination and had data available for endpoint.

An adverse event (AE) is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The percentage of participants with one or more AEs was assessed.

Outcome measures

Outcome measures
Measure	V114 Lot 1 n=350 Participants Infants received a 0.5 mL intramuscular injection of V114 Lot 1 at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)	V114 Lot 2 n=347 Participants Infants received a 0.5 mL intramuscular injection of V114 Lot 2 at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)	Prevnar 13™ n=347 Participants Infants received a 0.5 mL intramuscular injection of Prevnar 13™ at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)
Percentage of Participants Who Experience at Least 1 Adverse Event	95.7 Percentage of Participants	97.7 Percentage of Participants	95.7 Percentage of Participants

PRIMARY outcome

Timeframe: Up to 1 month post Vaccination 4 (up to 14 months)

Population: All participants that received at least 1 vaccination and had data available for endpoint.

The percentage of participants who discontinued the study because of an AE (as defined above) was assessed.

Outcome measures

Outcome measures
Measure	V114 Lot 1 n=350 Participants Infants received a 0.5 mL intramuscular injection of V114 Lot 1 at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)	V114 Lot 2 n=347 Participants Infants received a 0.5 mL intramuscular injection of V114 Lot 2 at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)	Prevnar 13™ n=347 Participants Infants received a 0.5 mL intramuscular injection of Prevnar 13™ at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)
Percentage of Participants Who Discontinued From the Study Due to an Adverse Event	0.3 Percentage of Participants	0.3 Percentage of Participants	0.0 Percentage of Participants

PRIMARY outcome

Timeframe: Up to 14 days post any vaccination

Population: All participants that received at least 1 vaccination and had data available for endpoint.

Injection-site AEs solicited on the Vaccine Report Card were redness, swelling, hard lump, and pain/tenderness. The percentage of participants with 1 or more solicited injection-site AEs was assessed.

Outcome measures

Outcome measures
Measure	V114 Lot 1 n=350 Participants Infants received a 0.5 mL intramuscular injection of V114 Lot 1 at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)	V114 Lot 2 n=347 Participants Infants received a 0.5 mL intramuscular injection of V114 Lot 2 at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)	Prevnar 13™ n=347 Participants Infants received a 0.5 mL intramuscular injection of Prevnar 13™ at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)
Percentage of Participants With a Solicited Injection-site Adverse Event	76.6 Percentage of Participants	76.7 Percentage of Participants	70.3 Percentage of Participants

PRIMARY outcome

Timeframe: Up to 14 days post any vaccination

Population: All participants that received at least 1 vaccination and had data available for endpoint.

Systemic AEs solicited on the Vaccine Report Card were fever, irritability, drowsiness, hive/welts, and appetite loss. The percentage of participants with 1 or more solicited systemic AEs was assessed.

Outcome measures

Outcome measures
Measure	V114 Lot 1 n=350 Participants Infants received a 0.5 mL intramuscular injection of V114 Lot 1 at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)	V114 Lot 2 n=347 Participants Infants received a 0.5 mL intramuscular injection of V114 Lot 2 at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)	Prevnar 13™ n=347 Participants Infants received a 0.5 mL intramuscular injection of Prevnar 13™ at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)
Percentage of Participants With a Solicited Systemic Adverse Event	90.3 Percentage of Participants	92.2 Percentage of Participants	89.6 Percentage of Participants

SECONDARY outcome

Timeframe: Before Vaccination 4 (Month 10 to 13)

Serotype-specific pneumococcal IgG antibody was assayed using the MSD Pn electrochemiluminescence assay.

Outcome measures

Outcome measures
Measure	V114 Lot 1 n=329 Participants Infants received a 0.5 mL intramuscular injection of V114 Lot 1 at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)	V114 Lot 2 n=330 Participants Infants received a 0.5 mL intramuscular injection of V114 Lot 2 at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)	Prevnar 13™ n=332 Participants Infants received a 0.5 mL intramuscular injection of Prevnar 13™ at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)
Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: Pre-vaccination 4 Type 1	0.32 µg/mL Interval 0.29 to 0.34	0.35 µg/mL Interval 0.33 to 0.38	0.46 µg/mL Interval 0.43 to 0.5
Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: Pre-vaccination 4 Type 3	0.25 µg/mL Interval 0.23 to 0.27	0.26 µg/mL Interval 0.24 to 0.29	0.12 µg/mL Interval 0.11 to 0.14
Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: Pre-vaccination 4 Type 4	0.26 µg/mL Interval 0.24 to 0.28	0.26 µg/mL Interval 0.24 to 0.27	0.27 µg/mL Interval 0.25 to 0.29
Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: Pre-vaccination 4 Type 5	0.74 µg/mL Interval 0.69 to 0.8	0.74 µg/mL Interval 0.68 to 0.79	0.86 µg/mL Interval 0.8 to 0.92
Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: Pre-vaccination 4 Type 6A	0.33 µg/mL Interval 0.3 to 0.37	0.38 µg/mL Interval 0.35 to 0.41	0.58 µg/mL Interval 0.54 to 0.64
Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: Pre-vaccination 4 Type 6B	0.61 µg/mL Interval 0.55 to 0.67	0.56 µg/mL Interval 0.51 to 0.62	0.50 µg/mL Interval 0.46 to 0.55
Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: Pre-vaccination 4 Type 7F	0.77 µg/mL Interval 0.72 to 0.83	0.81 µg/mL Interval 0.76 to 0.88	1.05 µg/mL Interval 0.98 to 1.12
Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: Pre-vaccination 4 Type 9V	0.40 µg/mL Interval 0.37 to 0.44	0.41 µg/mL Interval 0.38 to 0.44	0.48 µg/mL Interval 0.44 to 0.52
Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: Pre-vaccination 4 Type 14	1.34 µg/mL Interval 1.22 to 1.48	1.24 µg/mL Interval 1.12 to 1.37	2.03 µg/mL Interval 1.83 to 2.24
Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: Pre-vaccination 4 Type 18C	0.28 µg/mL Interval 0.25 to 0.3	0.41 µg/mL Interval 0.38 to 0.44	0.34 µg/mL Interval 0.32 to 0.37
Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: Pre-vaccination 4 Type 19A	0.40 µg/mL Interval 0.36 to 0.44	0.41 µg/mL Interval 0.37 to 0.45	0.50 µg/mL Interval 0.45 to 0.55
Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: Pre-vaccination 4 Type 19F	0.43 µg/mL Interval 0.39 to 0.46	0.47 µg/mL Interval 0.43 to 0.52	0.57 µg/mL Interval 0.52 to 0.63
Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: Pre-vaccination 4 Type 23F	0.29 µg/mL Interval 0.26 to 0.32	0.37 µg/mL Interval 0.33 to 0.4	0.32 µg/mL Interval 0.28 to 0.36
Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: Pre-vaccination 4 Type 22F	1.30 µg/mL Interval 1.2 to 1.4	1.23 µg/mL Interval 1.14 to 1.32	0.05 µg/mL Interval 0.04 to 0.05
Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: Pre-vaccination 4 Type 33F	1.01 µg/mL Interval 0.92 to 1.11	0.95 µg/mL Interval 0.87 to 1.04	0.04 µg/mL Interval 0.04 to 0.04

SECONDARY outcome

Timeframe: 1 month post vaccination 4 (Month 11-14)

Serotype-specific pneumococcal IgG antibody was assayed using the MSD Pn electrochemiluminescence assay.

Outcome measures

Outcome measures
Measure	V114 Lot 1 n=329 Participants Infants received a 0.5 mL intramuscular injection of V114 Lot 1 at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)	V114 Lot 2 n=330 Participants Infants received a 0.5 mL intramuscular injection of V114 Lot 2 at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)	Prevnar 13™ n=332 Participants Infants received a 0.5 mL intramuscular injection of Prevnar 13™ at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)
Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 4 Type 1	1.75 µg/mL Interval 1.6 to 1.92	2.00 µg/mL Interval 1.84 to 2.19	2.47 µg/mL Interval 2.24 to 2.72
Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 4 Type 3	1.12 µg/mL Interval 1.03 to 1.22	1.16 µg/mL Interval 1.06 to 1.26	0.78 µg/mL Interval 0.71 to 0.85
Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 4 Type 4	1.66 µg/mL Interval 1.49 to 1.85	1.53 µg/mL Interval 1.37 to 1.7	1.88 µg/mL Interval 1.69 to 2.1
Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 4 Type 5	3.43 µg/mL Interval 3.09 to 3.8	3.24 µg/mL Interval 2.94 to 3.57	4.72 µg/mL Interval 4.27 to 5.21
Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 4 Type 6A	4.97 µg/mL Interval 4.49 to 5.51	4.60 µg/mL Interval 4.21 to 5.04	6.94 µg/mL Interval 6.27 to 7.69
Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 4 Type 6B	7.38 µg/mL Interval 6.68 to 8.15	5.74 µg/mL Interval 5.24 to 6.28	6.91 µg/mL Interval 6.25 to 7.63
Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 4 Type 7F	4.25 µg/mL Interval 3.87 to 4.66	4.47 µg/mL Interval 4.07 to 4.91	6.29 µg/mL Interval 5.73 to 6.91
Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 4 Type 9V	2.43 µg/mL Interval 2.2 to 2.69	2.71 µg/mL Interval 2.47 to 2.96	3.53 µg/mL Interval 3.2 to 3.89
Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 4 Type 14	7.29 µg/mL Interval 6.54 to 8.14	7.01 µg/mL Interval 6.3 to 7.8	8.28 µg/mL Interval 7.47 to 9.19
Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 4 Type 18C	2.75 µg/mL Interval 2.47 to 3.05	3.15 µg/mL Interval 2.88 to 3.45	2.94 µg/mL Interval 2.65 to 3.26
Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 4 Type 19A	5.80 µg/mL Interval 5.33 to 6.31	5.35 µg/mL Interval 4.89 to 5.87	6.53 µg/mL Interval 5.93 to 7.18
Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 4 Type 19F	5.29 µg/mL Interval 4.81 to 5.82	4.94 µg/mL Interval 4.53 to 5.39	5.47 µg/mL Interval 4.97 to 6.01
Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 4 Type 23F	2.52 µg/mL Interval 2.25 to 2.83	3.12 µg/mL Interval 2.82 to 3.44	3.38 µg/mL Interval 3.02 to 3.78
Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 4 Type 22F	8.60 µg/mL Interval 7.85 to 9.42	7.54 µg/mL Interval 6.91 to 8.23	0.06 µg/mL Interval 0.05 to 0.06
Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 4 Type 33F	5.02 µg/mL Interval 4.59 to 5.49	4.39 µg/mL Interval 4.06 to 4.73	0.06 µg/mL Interval 0.05 to 0.06

Adverse Events

V114 Lot 1

Serious events: 18 serious events

Other events: 333 other events

Deaths: 1 deaths

V114 Lot 2

Serious events: 19 serious events

Other events: 337 other events

Deaths: 0 deaths

Prevnar 13™

Serious events: 15 serious events

Other events: 330 other events

Deaths: 0 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 trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.
Publication restrictions are in place

Restriction type: OTHER

Measure	V114 Lot 1 n=350 participants at risk Infants received a 0.5 mL intramuscular injection of V114 Lot 1 at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)	V114 Lot 2 n=347 participants at risk Infants received a 0.5 mL intramuscular injection of V114 Lot 2 at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)	Prevnar 13™ n=347 participants at risk Infants received a 0.5 mL intramuscular injection of Prevnar 13™ at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)
Gastrointestinal disorders Diarrhoea	11.1% 39/350 • Number of events 54 • Up to approximately 1-month (28 to 42 days) post Vaccination 4 (up to 15 months) All enrolled participants that received at least 1 vaccination	12.7% 44/347 • Number of events 61 • Up to approximately 1-month (28 to 42 days) post Vaccination 4 (up to 15 months) All enrolled participants that received at least 1 vaccination	15.0% 52/347 • Number of events 59 • Up to approximately 1-month (28 to 42 days) post Vaccination 4 (up to 15 months) All enrolled participants that received at least 1 vaccination
Gastrointestinal disorders Teething	4.9% 17/350 • Number of events 23 • Up to approximately 1-month (28 to 42 days) post Vaccination 4 (up to 15 months) All enrolled participants that received at least 1 vaccination	7.5% 26/347 • Number of events 38 • Up to approximately 1-month (28 to 42 days) post Vaccination 4 (up to 15 months) All enrolled participants that received at least 1 vaccination	5.5% 19/347 • Number of events 22 • Up to approximately 1-month (28 to 42 days) post Vaccination 4 (up to 15 months) All enrolled participants that received at least 1 vaccination
Gastrointestinal disorders Vomiting	7.7% 27/350 • Number of events 31 • Up to approximately 1-month (28 to 42 days) post Vaccination 4 (up to 15 months) All enrolled participants that received at least 1 vaccination	6.6% 23/347 • Number of events 24 • Up to approximately 1-month (28 to 42 days) post Vaccination 4 (up to 15 months) All enrolled participants that received at least 1 vaccination	9.8% 34/347 • Number of events 45 • Up to approximately 1-month (28 to 42 days) post Vaccination 4 (up to 15 months) All enrolled participants that received at least 1 vaccination
General disorders Injection site erythema	43.1% 151/350 • Number of events 256 • Up to approximately 1-month (28 to 42 days) post Vaccination 4 (up to 15 months) All enrolled participants that received at least 1 vaccination	47.3% 164/347 • Number of events 280 • Up to approximately 1-month (28 to 42 days) post Vaccination 4 (up to 15 months) All enrolled participants that received at least 1 vaccination	44.1% 153/347 • Number of events 259 • Up to approximately 1-month (28 to 42 days) post Vaccination 4 (up to 15 months) All enrolled participants that received at least 1 vaccination
General disorders Injection site induration	33.4% 117/350 • Number of events 206 • Up to approximately 1-month (28 to 42 days) post Vaccination 4 (up to 15 months) All enrolled participants that received at least 1 vaccination	31.4% 109/347 • Number of events 195 • Up to approximately 1-month (28 to 42 days) post Vaccination 4 (up to 15 months) All enrolled participants that received at least 1 vaccination	32.6% 113/347 • Number of events 200 • Up to approximately 1-month (28 to 42 days) post Vaccination 4 (up to 15 months) All enrolled participants that received at least 1 vaccination
General disorders Injection site pain	56.6% 198/350 • Number of events 385 • Up to approximately 1-month (28 to 42 days) post Vaccination 4 (up to 15 months) All enrolled participants that received at least 1 vaccination	57.6% 200/347 • Number of events 393 • Up to approximately 1-month (28 to 42 days) post Vaccination 4 (up to 15 months) All enrolled participants that received at least 1 vaccination	46.7% 162/347 • Number of events 327 • Up to approximately 1-month (28 to 42 days) post Vaccination 4 (up to 15 months) All enrolled participants that received at least 1 vaccination
General disorders Injection site swelling	28.0% 98/350 • Number of events 157 • Up to approximately 1-month (28 to 42 days) post Vaccination 4 (up to 15 months) All enrolled participants that received at least 1 vaccination	28.8% 100/347 • Number of events 176 • Up to approximately 1-month (28 to 42 days) post Vaccination 4 (up to 15 months) All enrolled participants that received at least 1 vaccination	26.2% 91/347 • Number of events 142 • Up to approximately 1-month (28 to 42 days) post Vaccination 4 (up to 15 months) All enrolled participants that received at least 1 vaccination
General disorders Pyrexia	32.9% 115/350 • Number of events 199 • Up to approximately 1-month (28 to 42 days) post Vaccination 4 (up to 15 months) All enrolled participants that received at least 1 vaccination	36.9% 128/347 • Number of events 221 • Up to approximately 1-month (28 to 42 days) post Vaccination 4 (up to 15 months) All enrolled participants that received at least 1 vaccination	40.6% 141/347 • Number of events 252 • Up to approximately 1-month (28 to 42 days) post Vaccination 4 (up to 15 months) All enrolled participants that received at least 1 vaccination
Infections and infestations Nasopharyngitis	7.1% 25/350 • Number of events 27 • Up to approximately 1-month (28 to 42 days) post Vaccination 4 (up to 15 months) All enrolled participants that received at least 1 vaccination	5.8% 20/347 • Number of events 23 • Up to approximately 1-month (28 to 42 days) post Vaccination 4 (up to 15 months) All enrolled participants that received at least 1 vaccination	5.5% 19/347 • Number of events 22 • Up to approximately 1-month (28 to 42 days) post Vaccination 4 (up to 15 months) All enrolled participants that received at least 1 vaccination
Infections and infestations Otitis media	4.6% 16/350 • Number of events 16 • Up to approximately 1-month (28 to 42 days) post Vaccination 4 (up to 15 months) All enrolled participants that received at least 1 vaccination	4.6% 16/347 • Number of events 16 • Up to approximately 1-month (28 to 42 days) post Vaccination 4 (up to 15 months) All enrolled participants that received at least 1 vaccination	5.2% 18/347 • Number of events 18 • Up to approximately 1-month (28 to 42 days) post Vaccination 4 (up to 15 months) All enrolled participants that received at least 1 vaccination
Infections and infestations Upper respiratory tract infection	7.4% 26/350 • Number of events 27 • Up to approximately 1-month (28 to 42 days) post Vaccination 4 (up to 15 months) All enrolled participants that received at least 1 vaccination	6.9% 24/347 • Number of events 29 • Up to approximately 1-month (28 to 42 days) post Vaccination 4 (up to 15 months) All enrolled participants that received at least 1 vaccination	9.8% 34/347 • Number of events 42 • Up to approximately 1-month (28 to 42 days) post Vaccination 4 (up to 15 months) All enrolled participants that received at least 1 vaccination
Metabolism and nutrition disorders Decreased appetite	45.1% 158/350 • Number of events 303 • Up to approximately 1-month (28 to 42 days) post Vaccination 4 (up to 15 months) All enrolled participants that received at least 1 vaccination	50.4% 175/347 • Number of events 332 • Up to approximately 1-month (28 to 42 days) post Vaccination 4 (up to 15 months) All enrolled participants that received at least 1 vaccination	44.4% 154/347 • Number of events 289 • Up to approximately 1-month (28 to 42 days) post Vaccination 4 (up to 15 months) All enrolled participants that received at least 1 vaccination
Nervous system disorders Somnolence	63.1% 221/350 • Number of events 564 • Up to approximately 1-month (28 to 42 days) post Vaccination 4 (up to 15 months) All enrolled participants that received at least 1 vaccination	69.5% 241/347 • Number of events 661 • Up to approximately 1-month (28 to 42 days) post Vaccination 4 (up to 15 months) All enrolled participants that received at least 1 vaccination	67.1% 233/347 • Number of events 573 • Up to approximately 1-month (28 to 42 days) post Vaccination 4 (up to 15 months) All enrolled participants that received at least 1 vaccination
Psychiatric disorders Irritability	84.3% 295/350 • Number of events 1118 • Up to approximately 1-month (28 to 42 days) post Vaccination 4 (up to 15 months) All enrolled participants that received at least 1 vaccination	86.7% 301/347 • Number of events 1255 • Up to approximately 1-month (28 to 42 days) post Vaccination 4 (up to 15 months) All enrolled participants that received at least 1 vaccination	84.7% 294/347 • Number of events 1113 • Up to approximately 1-month (28 to 42 days) post Vaccination 4 (up to 15 months) All enrolled participants that received at least 1 vaccination
Respiratory, thoracic and mediastinal disorders Cough	7.4% 26/350 • Number of events 31 • Up to approximately 1-month (28 to 42 days) post Vaccination 4 (up to 15 months) All enrolled participants that received at least 1 vaccination	5.5% 19/347 • Number of events 23 • Up to approximately 1-month (28 to 42 days) post Vaccination 4 (up to 15 months) All enrolled participants that received at least 1 vaccination	5.5% 19/347 • Number of events 19 • Up to approximately 1-month (28 to 42 days) post Vaccination 4 (up to 15 months) All enrolled participants that received at least 1 vaccination
Respiratory, thoracic and mediastinal disorders Nasal congestion	6.0% 21/350 • Number of events 28 • Up to approximately 1-month (28 to 42 days) post Vaccination 4 (up to 15 months) All enrolled participants that received at least 1 vaccination	4.3% 15/347 • Number of events 15 • Up to approximately 1-month (28 to 42 days) post Vaccination 4 (up to 15 months) All enrolled participants that received at least 1 vaccination	2.6% 9/347 • Number of events 10 • Up to approximately 1-month (28 to 42 days) post Vaccination 4 (up to 15 months) All enrolled participants that received at least 1 vaccination
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	4.3% 15/350 • Number of events 16 • Up to approximately 1-month (28 to 42 days) post Vaccination 4 (up to 15 months) All enrolled participants that received at least 1 vaccination	6.1% 21/347 • Number of events 29 • Up to approximately 1-month (28 to 42 days) post Vaccination 4 (up to 15 months) All enrolled participants that received at least 1 vaccination	4.6% 16/347 • Number of events 16 • Up to approximately 1-month (28 to 42 days) post Vaccination 4 (up to 15 months) All enrolled participants that received at least 1 vaccination