Trial Outcomes & Findings for A Study to Evaluate the Safety and Tolerability of V114 and Prevnar 13™ in Healthy Infants (V114-031/PNEU-LINK) (NCT NCT03692871)

Last Updated: 2023-07-28

Results Overview

An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited injection-site AEs included injection-site erythema (redness), injection-site induration (hard lump), injection-site pain (tenderness), and injection-site swelling.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

2409 participants

Primary outcome timeframe

Up to Day 14 after each study vaccination

Results posted on

2023-07-28

Participant Flow

This study enrolled healthy infants. Other inclusion criteria applied.

Participant milestones

Participant milestones
Measure	V114 Participants received a single 0.5 mL intramuscular (IM) injection of V114 at approximately 2 months of age (Vaccination 1); approximately 4 months of age (Vaccination 2); approximately 6 months of age (Vaccination 3); and approximately 12-15 months of age (Vaccination 4).	Prevnar 13™ Participants received a single 0.5 mL IM injection of Prevnar 13™ at approximately 2 months of age (Vaccination 1); approximately 4 months of age (Vaccination 2); approximately 6 months of age (Vaccination 3); and approximately 12-15 months of age (Vaccination 4).
Overall Study STARTED	1972	437
Overall Study COMPLETED	1847	400
Overall Study NOT COMPLETED	125	37

Reasons for withdrawal

Reasons for withdrawal
Measure	V114 Participants received a single 0.5 mL intramuscular (IM) injection of V114 at approximately 2 months of age (Vaccination 1); approximately 4 months of age (Vaccination 2); approximately 6 months of age (Vaccination 3); and approximately 12-15 months of age (Vaccination 4).	Prevnar 13™ Participants received a single 0.5 mL IM injection of Prevnar 13™ at approximately 2 months of age (Vaccination 1); approximately 4 months of age (Vaccination 2); approximately 6 months of age (Vaccination 3); and approximately 12-15 months of age (Vaccination 4).
Overall Study Death	1	1
Overall Study Lost to Follow-up	24	9
Overall Study Physician Decision	22	7
Overall Study Protocol Deviation	1	0
Overall Study Withdrawal by Parent/Guardian	77	20

Baseline Characteristics

A Study to Evaluate the Safety and Tolerability of V114 and Prevnar 13™ in Healthy Infants (V114-031/PNEU-LINK)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	V114 n=1972 Participants Participants received a single 0.5 mL intramuscular (IM) injection of V114 at approximately 2 months of age (Vaccination 1); approximately 4 months of age (Vaccination 2); approximately 6 months of age (Vaccination 3); and approximately 12-15 months of age (Vaccination 4).	Prevnar 13™ n=437 Participants Participants received a single 0.5 mL IM injection of Prevnar 13™ at approximately 2 months of age (Vaccination 1); approximately 4 months of age (Vaccination 2); approximately 6 months of age (Vaccination 3); and approximately 12-15 months of age (Vaccination 4).	Total n=2409 Participants Total of all reporting groups
Age, Continuous	8.7 weeks STANDARD_DEVIATION 1.5 • n=5 Participants	8.8 weeks STANDARD_DEVIATION 1.5 • n=7 Participants	8.7 weeks STANDARD_DEVIATION 1.5 • n=5 Participants
Sex: Female, Male Female	948 Participants n=5 Participants	227 Participants n=7 Participants	1175 Participants n=5 Participants
Sex: Female, Male Male	1024 Participants n=5 Participants	210 Participants n=7 Participants	1234 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	293 Participants n=5 Participants	74 Participants n=7 Participants	367 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1678 Participants n=5 Participants	362 Participants n=7 Participants	2040 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	64 Participants n=5 Participants	20 Participants n=7 Participants	84 Participants n=5 Participants
Race (NIH/OMB) Asian	730 Participants n=5 Participants	152 Participants n=7 Participants	882 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Black or African American	54 Participants n=5 Participants	19 Participants n=7 Participants	73 Participants n=5 Participants
Race (NIH/OMB) White	966 Participants n=5 Participants	214 Participants n=7 Participants	1180 Participants n=5 Participants
Race (NIH/OMB) More than one race	154 Participants n=5 Participants	31 Participants n=7 Participants	185 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to Day 14 after each study vaccination

Population: All randomized participants who received at least 1 dose of study vaccination

Outcome measures

Outcome measures
Measure	V114 n=1965 Participants Participants received a single 0.5 mL intramuscular (IM) injection of V114 at approximately 2 months of age (Vaccination 1); approximately 4 months of age (Vaccination 2); approximately 6 months of age (Vaccination 3); and approximately 12-15 months of age (Vaccination 4).	Prevnar 13™ n=433 Participants Participants received a single 0.5 mL IM injection of Prevnar 13™ at approximately 2 months of age (Vaccination 1); approximately 4 months of age (Vaccination 2); approximately 6 months of age (Vaccination 3); and approximately 12-15 months of age (Vaccination 4).
Percentage of Participants With a Solicited Injection-site Adverse Event Injection-site pain	42.9 Percentage of participants	36.5 Percentage of participants
Percentage of Participants With a Solicited Injection-site Adverse Event Injection-site erythema	43.9 Percentage of participants	36.0 Percentage of participants
Percentage of Participants With a Solicited Injection-site Adverse Event Injection-site induration	25.3 Percentage of participants	25.6 Percentage of participants
Percentage of Participants With a Solicited Injection-site Adverse Event Injection-site swelling	27.9 Percentage of participants	23.3 Percentage of participants

PRIMARY outcome

Timeframe: Up to Day 14 after each study vaccination

Population: All randomized participants who received at least 1 dose of study vaccination

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited systemic AEs included decreased appetite, irritability, somnolence (drowsiness), and urticaria (hives or welts).

Outcome measures

Outcome measures
Measure	V114 n=1965 Participants Participants received a single 0.5 mL intramuscular (IM) injection of V114 at approximately 2 months of age (Vaccination 1); approximately 4 months of age (Vaccination 2); approximately 6 months of age (Vaccination 3); and approximately 12-15 months of age (Vaccination 4).	Prevnar 13™ n=433 Participants Participants received a single 0.5 mL IM injection of Prevnar 13™ at approximately 2 months of age (Vaccination 1); approximately 4 months of age (Vaccination 2); approximately 6 months of age (Vaccination 3); and approximately 12-15 months of age (Vaccination 4).
Percentage of Participants With a Solicited Systemic Adverse Event Decreased appetite	41.6 Percentage of participants	36.0 Percentage of participants
Percentage of Participants With a Solicited Systemic Adverse Event Irritability	74.9 Percentage of participants	69.3 Percentage of participants
Percentage of Participants With a Solicited Systemic Adverse Event Somnolence	55.4 Percentage of participants	55.0 Percentage of participants
Percentage of Participants With a Solicited Systemic Adverse Event Urticaria	5.9 Percentage of participants	6.7 Percentage of participants

PRIMARY outcome

Timeframe: Up to 6 months after Vaccination 4 (up to 19 months after Vaccination 1)

Population: All randomized participants who received at least 1 dose of study vaccination

A serious adverse event (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. SAEs that were reported by the investigator to be at least possibly related to the study vaccination were summarized.

Outcome measures

Outcome measures
Measure	V114 n=1965 Participants Participants received a single 0.5 mL intramuscular (IM) injection of V114 at approximately 2 months of age (Vaccination 1); approximately 4 months of age (Vaccination 2); approximately 6 months of age (Vaccination 3); and approximately 12-15 months of age (Vaccination 4).	Prevnar 13™ n=433 Participants Participants received a single 0.5 mL IM injection of Prevnar 13™ at approximately 2 months of age (Vaccination 1); approximately 4 months of age (Vaccination 2); approximately 6 months of age (Vaccination 3); and approximately 12-15 months of age (Vaccination 4).
Percentage of Participants With a Vaccine-related Serious Adverse Event	0.1 Percentage of participants	0 Percentage of participants

SECONDARY outcome

Timeframe: 30 days after Vaccination 3 (approximately 5 months after Vaccination 1)

Population: All randomized participants in the Premature Infant Immunogenicity Substudy who did not have protocol deviations that could have substantially affected the results of the immunogenicity analysis and who had sufficient data to perform the analysis for each serotype

The GMC of IgG serotype-specific antibodies to the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™ and 2 serotypes (22F and 33F) unique to V114 were quantitated from participants' sera by a multiplex electrochemiluminescence (ECL) assay. This endpoint was part of a Premature Infant Immunogenicity Substudy.

Outcome measures

Outcome measures
Measure	V114 n=38 Participants Participants received a single 0.5 mL intramuscular (IM) injection of V114 at approximately 2 months of age (Vaccination 1); approximately 4 months of age (Vaccination 2); approximately 6 months of age (Vaccination 3); and approximately 12-15 months of age (Vaccination 4).	Prevnar 13™ n=35 Participants Participants received a single 0.5 mL IM injection of Prevnar 13™ at approximately 2 months of age (Vaccination 1); approximately 4 months of age (Vaccination 2); approximately 6 months of age (Vaccination 3); and approximately 12-15 months of age (Vaccination 4).
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days After Vaccination 3 (Premature Infants Only) Serotype 5	1.48 μg/mL Interval 1.04 to 2.1	1.66 μg/mL Interval 1.09 to 2.53
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days After Vaccination 3 (Premature Infants Only) Serotype 6A	1.37 μg/mL Interval 0.95 to 1.96	3.19 μg/mL Interval 2.31 to 4.43
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days After Vaccination 3 (Premature Infants Only) Serotype 6B	1.69 μg/mL Interval 1.15 to 2.48	2.53 μg/mL Interval 1.64 to 3.89
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days After Vaccination 3 (Premature Infants Only) Serotype 3	0.86 μg/mL Interval 0.65 to 1.13	0.58 μg/mL Interval 0.45 to 0.76
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days After Vaccination 3 (Premature Infants Only) Serotype 7F	1.95 μg/mL Interval 1.46 to 2.62	2.92 μg/mL Interval 2.21 to 3.87
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days After Vaccination 3 (Premature Infants Only) Serotype 18C	1.46 μg/mL Interval 1.08 to 1.96	1.54 μg/mL Interval 1.16 to 2.04
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days After Vaccination 3 (Premature Infants Only) Serotype 22F	4.33 μg/mL Interval 3.18 to 5.9	0.05 μg/mL Interval 0.03 to 0.07
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days After Vaccination 3 (Premature Infants Only) Serotype 9V	1.47 μg/mL Interval 1.08 to 2.0	1.50 μg/mL Interval 1.07 to 2.12
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days After Vaccination 3 (Premature Infants Only) Serotype 14	4.38 μg/mL Interval 3.18 to 6.03	6.52 μg/mL Interval 4.35 to 9.77
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days After Vaccination 3 (Premature Infants Only) Serotype 19A	1.63 μg/mL Interval 1.25 to 2.13	3.00 μg/mL Interval 2.18 to 4.11
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days After Vaccination 3 (Premature Infants Only) Serotype 1	1.15 μg/mL Interval 0.88 to 1.52	1.61 μg/mL Interval 1.25 to 2.09
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days After Vaccination 3 (Premature Infants Only) Serotype 4	1.41 μg/mL Interval 1.01 to 1.99	1.27 μg/mL Interval 0.96 to 1.68
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days After Vaccination 3 (Premature Infants Only) Serotype 19F	2.03 μg/mL Interval 1.53 to 2.68	2.78 μg/mL Interval 2.17 to 3.58
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days After Vaccination 3 (Premature Infants Only) Serotype 23F	1.17 μg/mL Interval 0.81 to 1.7	1.18 μg/mL Interval 0.82 to 1.68
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days After Vaccination 3 (Premature Infants Only) Serotype 33F	1.58 μg/mL Interval 0.93 to 2.69	0.05 μg/mL Interval 0.04 to 0.08

SECONDARY outcome

Timeframe: Before Vaccination 4 (10-13 months after Vaccination 1)

Outcome measures

Outcome measures
Measure	V114 n=38 Participants Participants received a single 0.5 mL intramuscular (IM) injection of V114 at approximately 2 months of age (Vaccination 1); approximately 4 months of age (Vaccination 2); approximately 6 months of age (Vaccination 3); and approximately 12-15 months of age (Vaccination 4).	Prevnar 13™ n=40 Participants Participants received a single 0.5 mL IM injection of Prevnar 13™ at approximately 2 months of age (Vaccination 1); approximately 4 months of age (Vaccination 2); approximately 6 months of age (Vaccination 3); and approximately 12-15 months of age (Vaccination 4).
GMC of Serotype-specific IgG Before Vaccination 4 (Premature Infants Only) Serotype 5	0.77 μg/mL Interval 0.6 to 1.01	0.89 μg/mL Interval 0.65 to 1.22
GMC of Serotype-specific IgG Before Vaccination 4 (Premature Infants Only) Serotype 6B	0.59 μg/mL Interval 0.47 to 0.75	0.61 μg/mL Interval 0.43 to 0.87
GMC of Serotype-specific IgG Before Vaccination 4 (Premature Infants Only) Serotype 1	0.30 μg/mL Interval 0.24 to 0.38	0.47 μg/mL Interval 0.38 to 0.59
GMC of Serotype-specific IgG Before Vaccination 4 (Premature Infants Only) Serotype 3	0.22 μg/mL Interval 0.16 to 0.29	0.13 μg/mL Interval 0.1 to 0.17
GMC of Serotype-specific IgG Before Vaccination 4 (Premature Infants Only) Serotype 4	0.24 μg/mL Interval 0.19 to 0.31	0.31 μg/mL Interval 0.24 to 0.38
GMC of Serotype-specific IgG Before Vaccination 4 (Premature Infants Only) Serotype 6A	0.32 μg/mL Interval 0.24 to 0.43	0.72 μg/mL Interval 0.52 to 0.99
GMC of Serotype-specific IgG Before Vaccination 4 (Premature Infants Only) Serotype 7F	0.57 μg/mL Interval 0.44 to 0.73	0.95 μg/mL Interval 0.74 to 1.21
GMC of Serotype-specific IgG Before Vaccination 4 (Premature Infants Only) Serotype 9V	0.40 μg/mL Interval 0.32 to 0.51	0.46 μg/mL Interval 0.35 to 0.62
GMC of Serotype-specific IgG Before Vaccination 4 (Premature Infants Only) Serotype 14	1.14 μg/mL Interval 0.84 to 1.54	2.22 μg/mL Interval 1.73 to 2.84
GMC of Serotype-specific IgG Before Vaccination 4 (Premature Infants Only) Serotype 18C	0.35 μg/mL Interval 0.28 to 0.45	0.36 μg/mL Interval 0.27 to 0.49
GMC of Serotype-specific IgG Before Vaccination 4 (Premature Infants Only) Serotype 19A	0.38 μg/mL Interval 0.29 to 0.51	0.81 μg/mL Interval 0.52 to 1.24
GMC of Serotype-specific IgG Before Vaccination 4 (Premature Infants Only) Serotype 19F	0.41 μg/mL Interval 0.31 to 0.53	0.69 μg/mL Interval 0.52 to 0.9
GMC of Serotype-specific IgG Before Vaccination 4 (Premature Infants Only) Serotype 23F	0.33 μg/mL Interval 0.24 to 0.45	0.37 μg/mL Interval 0.26 to 0.52
GMC of Serotype-specific IgG Before Vaccination 4 (Premature Infants Only) Serotype 22F	1.24 μg/mL Interval 0.98 to 1.58	0.05 μg/mL Interval 0.04 to 0.07
GMC of Serotype-specific IgG Before Vaccination 4 (Premature Infants Only) Serotype 33F	1.09 μg/mL Interval 0.82 to 1.45	0.05 μg/mL Interval 0.04 to 0.07

SECONDARY outcome

Timeframe: 30 days after Vaccination 4 (11-14 months after Vaccination 1)

Outcome measures

Outcome measures
Measure	V114 n=34 Participants Participants received a single 0.5 mL intramuscular (IM) injection of V114 at approximately 2 months of age (Vaccination 1); approximately 4 months of age (Vaccination 2); approximately 6 months of age (Vaccination 3); and approximately 12-15 months of age (Vaccination 4).	Prevnar 13™ n=39 Participants Participants received a single 0.5 mL IM injection of Prevnar 13™ at approximately 2 months of age (Vaccination 1); approximately 4 months of age (Vaccination 2); approximately 6 months of age (Vaccination 3); and approximately 12-15 months of age (Vaccination 4).
GMC of Serotype-specific IgG at 30 Days After Vaccination 4 (Premature Infants Only) Serotype 7F	4.01 μg/mL Interval 2.98 to 5.4	5.10 μg/mL Interval 3.76 to 6.9
GMC of Serotype-specific IgG at 30 Days After Vaccination 4 (Premature Infants Only) Serotype 9V	3.10 μg/mL Interval 2.36 to 4.08	3.09 μg/mL Interval 2.31 to 4.12
GMC of Serotype-specific IgG at 30 Days After Vaccination 4 (Premature Infants Only) Serotype 1	1.56 μg/mL Interval 1.19 to 2.06	1.96 μg/mL Interval 1.54 to 2.5
GMC of Serotype-specific IgG at 30 Days After Vaccination 4 (Premature Infants Only) Serotype 3	1.04 μg/mL Interval 0.8 to 1.36	0.79 μg/mL Interval 0.6 to 1.06
GMC of Serotype-specific IgG at 30 Days After Vaccination 4 (Premature Infants Only) Serotype 4	1.55 μg/mL Interval 1.11 to 2.16	1.61 μg/mL Interval 1.21 to 2.15
GMC of Serotype-specific IgG at 30 Days After Vaccination 4 (Premature Infants Only) Serotype 5	3.30 μg/mL Interval 2.34 to 4.65	3.60 μg/mL Interval 2.53 to 5.13
GMC of Serotype-specific IgG at 30 Days After Vaccination 4 (Premature Infants Only) Serotype 6A	4.18 μg/mL Interval 3.17 to 5.49	6.38 μg/mL Interval 4.69 to 8.68
GMC of Serotype-specific IgG at 30 Days After Vaccination 4 (Premature Infants Only) Serotype 6B	6.62 μg/mL Interval 5.24 to 8.37	6.75 μg/mL Interval 4.43 to 10.28
GMC of Serotype-specific IgG at 30 Days After Vaccination 4 (Premature Infants Only) Serotype 14	5.40 μg/mL Interval 3.89 to 7.49	7.15 μg/mL Interval 5.33 to 9.61
GMC of Serotype-specific IgG at 30 Days After Vaccination 4 (Premature Infants Only) Serotype 18C	3.21 μg/mL Interval 2.32 to 4.45	2.77 μg/mL Interval 1.99 to 3.85
GMC of Serotype-specific IgG at 30 Days After Vaccination 4 (Premature Infants Only) Serotype 19A	4.96 μg/mL Interval 3.85 to 6.39	6.47 μg/mL Interval 4.46 to 9.4
GMC of Serotype-specific IgG at 30 Days After Vaccination 4 (Premature Infants Only) Serotype 19F	4.48 μg/mL Interval 3.51 to 5.73	4.83 μg/mL Interval 3.66 to 6.38
GMC of Serotype-specific IgG at 30 Days After Vaccination 4 (Premature Infants Only) Serotype 23F	2.38 μg/mL Interval 1.76 to 3.2	3.04 μg/mL Interval 2.16 to 4.27
GMC of Serotype-specific IgG at 30 Days After Vaccination 4 (Premature Infants Only) Serotype 22F	9.83 μg/mL Interval 7.47 to 12.92	0.08 μg/mL Interval 0.07 to 0.11
GMC of Serotype-specific IgG at 30 Days After Vaccination 4 (Premature Infants Only) Serotype 33F	5.46 μg/mL Interval 4.29 to 6.96	0.10 μg/mL Interval 0.07 to 0.13

SECONDARY outcome

Timeframe: 30 days after Vaccination 3 (approximately 5 months after Vaccination 1)

The GMC of IgG serotype-specific antibodies to the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™ and 2 serotypes (22F and 33F) unique to V114 were quantitated from participants' sera by a multiplex electrochemiluminescence (ECL) assay. Immunoglobulin G for the 15 serotypes contained in V114 vaccine was determined using a pneumococcal electrochemiluminescence (PnECL) assay. This endpoint was part of a Premature Infant Immunogenicity Substudy.

Outcome measures

Outcome measures
Measure	V114 n=38 Participants Participants received a single 0.5 mL intramuscular (IM) injection of V114 at approximately 2 months of age (Vaccination 1); approximately 4 months of age (Vaccination 2); approximately 6 months of age (Vaccination 3); and approximately 12-15 months of age (Vaccination 4).	Prevnar 13™ n=35 Participants Participants received a single 0.5 mL IM injection of Prevnar 13™ at approximately 2 months of age (Vaccination 1); approximately 4 months of age (Vaccination 2); approximately 6 months of age (Vaccination 3); and approximately 12-15 months of age (Vaccination 4).
Percentage of Participants Meeting Serotype-specific IgG Threshold of ≥0.35 μg/mL 30 Days After Vaccination 3 (Premature Infants Only) Serotype 1	97.4 Percentage of participants Interval 86.2 to 99.9	97.1 Percentage of participants Interval 85.1 to 99.9
Percentage of Participants Meeting Serotype-specific IgG Threshold of ≥0.35 μg/mL 30 Days After Vaccination 3 (Premature Infants Only) Serotype 5	97.4 Percentage of participants Interval 86.2 to 99.9	88.6 Percentage of participants Interval 73.3 to 96.8
Percentage of Participants Meeting Serotype-specific IgG Threshold of ≥0.35 μg/mL 30 Days After Vaccination 3 (Premature Infants Only) Serotype 18C	97.4 Percentage of participants Interval 86.2 to 99.9	94.3 Percentage of participants Interval 80.8 to 99.3
Percentage of Participants Meeting Serotype-specific IgG Threshold of ≥0.35 μg/mL 30 Days After Vaccination 3 (Premature Infants Only) Serotype 3	89.5 Percentage of participants Interval 75.2 to 97.1	74.3 Percentage of participants Interval 56.7 to 87.5
Percentage of Participants Meeting Serotype-specific IgG Threshold of ≥0.35 μg/mL 30 Days After Vaccination 3 (Premature Infants Only) Serotype 4	94.7 Percentage of participants Interval 82.3 to 99.4	97.1 Percentage of participants Interval 85.1 to 99.9
Percentage of Participants Meeting Serotype-specific IgG Threshold of ≥0.35 μg/mL 30 Days After Vaccination 3 (Premature Infants Only) Serotype 6A	97.4 Percentage of participants Interval 86.2 to 99.9	97.1 Percentage of participants Interval 85.1 to 99.9
Percentage of Participants Meeting Serotype-specific IgG Threshold of ≥0.35 μg/mL 30 Days After Vaccination 3 (Premature Infants Only) Serotype 6B	92.1 Percentage of participants Interval 78.6 to 98.3	94.3 Percentage of participants Interval 80.8 to 99.3
Percentage of Participants Meeting Serotype-specific IgG Threshold of ≥0.35 μg/mL 30 Days After Vaccination 3 (Premature Infants Only) Serotype 7F	97.4 Percentage of participants Interval 86.2 to 99.9	100 Percentage of participants Interval 90.0 to 100.0
Percentage of Participants Meeting Serotype-specific IgG Threshold of ≥0.35 μg/mL 30 Days After Vaccination 3 (Premature Infants Only) Serotype 9V	97.4 Percentage of participants Interval 86.2 to 99.9	94.3 Percentage of participants Interval 80.8 to 99.3
Percentage of Participants Meeting Serotype-specific IgG Threshold of ≥0.35 μg/mL 30 Days After Vaccination 3 (Premature Infants Only) Serotype 14	100 Percentage of participants Interval 90.7 to 100.0	97.1 Percentage of participants Interval 85.1 to 99.9
Percentage of Participants Meeting Serotype-specific IgG Threshold of ≥0.35 μg/mL 30 Days After Vaccination 3 (Premature Infants Only) Serotype 19A	94.7 Percentage of participants Interval 82.3 to 99.4	97.1 Percentage of participants Interval 85.1 to 99.9
Percentage of Participants Meeting Serotype-specific IgG Threshold of ≥0.35 μg/mL 30 Days After Vaccination 3 (Premature Infants Only) Serotype 19F	97.4 Percentage of participants Interval 86.2 to 99.9	100 Percentage of participants Interval 90.0 to 100.0
Percentage of Participants Meeting Serotype-specific IgG Threshold of ≥0.35 μg/mL 30 Days After Vaccination 3 (Premature Infants Only) Serotype 23F	89.5 Percentage of participants Interval 75.2 to 97.1	94.3 Percentage of participants Interval 80.8 to 99.3
Percentage of Participants Meeting Serotype-specific IgG Threshold of ≥0.35 μg/mL 30 Days After Vaccination 3 (Premature Infants Only) Serotype 22F	97.4 Percentage of participants Interval 86.2 to 99.9	2.9 Percentage of participants Interval 0.1 to 14.9
Percentage of Participants Meeting Serotype-specific IgG Threshold of ≥0.35 μg/mL 30 Days After Vaccination 3 (Premature Infants Only) Serotype 33F	86.8 Percentage of participants Interval 71.9 to 95.6	2.9 Percentage of participants Interval 0.1 to 14.9

Adverse Events

V114

Serious events: 192 serious events

Other events: 1807 other events

Deaths: 1 deaths

Prevnar 13™

Serious events: 45 serious events

Other events: 395 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	V114 n=1965 participants at risk Participants received a single 0.5 mL intramuscular (IM) injection of V114 at approximately 2 months of age (Vaccination 1); approximately 4 months of age (Vaccination 2); approximately 6 months of age (Vaccination 3); and approximately 12-15 months of age (Vaccination 4).	Prevnar 13™ n=433 participants at risk Participants received a single 0.5 mL IM injection of Prevnar 13™ at approximately 2 months of age (Vaccination 1); approximately 4 months of age (Vaccination 2); approximately 6 months of age (Vaccination 3); and approximately 12-15 months of age (Vaccination 4).
Gastrointestinal disorders Diarrhoea	9.6% 188/1965 • Number of events 235 • Non-serious AEs: up to 14 days after each vaccination dose; serious AEs and deaths (all causes): up to 6 months after Vaccination 4 (up to 19 months after Vaccination 1) The safety analysis population included all randomized participants who received at least 1 dose of study vaccination. The analysis population for All-Cause Mortality included all randomized participants.	9.2% 40/433 • Number of events 49 • Non-serious AEs: up to 14 days after each vaccination dose; serious AEs and deaths (all causes): up to 6 months after Vaccination 4 (up to 19 months after Vaccination 1) The safety analysis population included all randomized participants who received at least 1 dose of study vaccination. The analysis population for All-Cause Mortality included all randomized participants.
Gastrointestinal disorders Vomiting	5.9% 116/1965 • Number of events 135 • Non-serious AEs: up to 14 days after each vaccination dose; serious AEs and deaths (all causes): up to 6 months after Vaccination 4 (up to 19 months after Vaccination 1) The safety analysis population included all randomized participants who received at least 1 dose of study vaccination. The analysis population for All-Cause Mortality included all randomized participants.	4.4% 19/433 • Number of events 20 • Non-serious AEs: up to 14 days after each vaccination dose; serious AEs and deaths (all causes): up to 6 months after Vaccination 4 (up to 19 months after Vaccination 1) The safety analysis population included all randomized participants who received at least 1 dose of study vaccination. The analysis population for All-Cause Mortality included all randomized participants.
General disorders Injection site erythema	43.9% 863/1965 • Number of events 1528 • Non-serious AEs: up to 14 days after each vaccination dose; serious AEs and deaths (all causes): up to 6 months after Vaccination 4 (up to 19 months after Vaccination 1) The safety analysis population included all randomized participants who received at least 1 dose of study vaccination. The analysis population for All-Cause Mortality included all randomized participants.	36.0% 156/433 • Number of events 272 • Non-serious AEs: up to 14 days after each vaccination dose; serious AEs and deaths (all causes): up to 6 months after Vaccination 4 (up to 19 months after Vaccination 1) The safety analysis population included all randomized participants who received at least 1 dose of study vaccination. The analysis population for All-Cause Mortality included all randomized participants.
General disorders Injection site induration	25.3% 497/1965 • Number of events 885 • Non-serious AEs: up to 14 days after each vaccination dose; serious AEs and deaths (all causes): up to 6 months after Vaccination 4 (up to 19 months after Vaccination 1) The safety analysis population included all randomized participants who received at least 1 dose of study vaccination. The analysis population for All-Cause Mortality included all randomized participants.	25.6% 111/433 • Number of events 205 • Non-serious AEs: up to 14 days after each vaccination dose; serious AEs and deaths (all causes): up to 6 months after Vaccination 4 (up to 19 months after Vaccination 1) The safety analysis population included all randomized participants who received at least 1 dose of study vaccination. The analysis population for All-Cause Mortality included all randomized participants.
General disorders Injection site pain	42.9% 843/1965 • Number of events 1580 • Non-serious AEs: up to 14 days after each vaccination dose; serious AEs and deaths (all causes): up to 6 months after Vaccination 4 (up to 19 months after Vaccination 1) The safety analysis population included all randomized participants who received at least 1 dose of study vaccination. The analysis population for All-Cause Mortality included all randomized participants.	36.5% 158/433 • Number of events 288 • Non-serious AEs: up to 14 days after each vaccination dose; serious AEs and deaths (all causes): up to 6 months after Vaccination 4 (up to 19 months after Vaccination 1) The safety analysis population included all randomized participants who received at least 1 dose of study vaccination. The analysis population for All-Cause Mortality included all randomized participants.
General disorders Injection site swelling	27.9% 549/1965 • Number of events 929 • Non-serious AEs: up to 14 days after each vaccination dose; serious AEs and deaths (all causes): up to 6 months after Vaccination 4 (up to 19 months after Vaccination 1) The safety analysis population included all randomized participants who received at least 1 dose of study vaccination. The analysis population for All-Cause Mortality included all randomized participants.	23.3% 101/433 • Number of events 163 • Non-serious AEs: up to 14 days after each vaccination dose; serious AEs and deaths (all causes): up to 6 months after Vaccination 4 (up to 19 months after Vaccination 1) The safety analysis population included all randomized participants who received at least 1 dose of study vaccination. The analysis population for All-Cause Mortality included all randomized participants.
General disorders Pyrexia	39.4% 775/1965 • Number of events 1533 • Non-serious AEs: up to 14 days after each vaccination dose; serious AEs and deaths (all causes): up to 6 months after Vaccination 4 (up to 19 months after Vaccination 1) The safety analysis population included all randomized participants who received at least 1 dose of study vaccination. The analysis population for All-Cause Mortality included all randomized participants.	40.6% 176/433 • Number of events 329 • Non-serious AEs: up to 14 days after each vaccination dose; serious AEs and deaths (all causes): up to 6 months after Vaccination 4 (up to 19 months after Vaccination 1) The safety analysis population included all randomized participants who received at least 1 dose of study vaccination. The analysis population for All-Cause Mortality included all randomized participants.
Infections and infestations Nasopharyngitis	8.0% 158/1965 • Number of events 182 • Non-serious AEs: up to 14 days after each vaccination dose; serious AEs and deaths (all causes): up to 6 months after Vaccination 4 (up to 19 months after Vaccination 1) The safety analysis population included all randomized participants who received at least 1 dose of study vaccination. The analysis population for All-Cause Mortality included all randomized participants.	8.5% 37/433 • Number of events 41 • Non-serious AEs: up to 14 days after each vaccination dose; serious AEs and deaths (all causes): up to 6 months after Vaccination 4 (up to 19 months after Vaccination 1) The safety analysis population included all randomized participants who received at least 1 dose of study vaccination. The analysis population for All-Cause Mortality included all randomized participants.
Infections and infestations Upper respiratory tract infection	6.6% 129/1965 • Number of events 139 • Non-serious AEs: up to 14 days after each vaccination dose; serious AEs and deaths (all causes): up to 6 months after Vaccination 4 (up to 19 months after Vaccination 1) The safety analysis population included all randomized participants who received at least 1 dose of study vaccination. The analysis population for All-Cause Mortality included all randomized participants.	6.9% 30/433 • Number of events 32 • Non-serious AEs: up to 14 days after each vaccination dose; serious AEs and deaths (all causes): up to 6 months after Vaccination 4 (up to 19 months after Vaccination 1) The safety analysis population included all randomized participants who received at least 1 dose of study vaccination. The analysis population for All-Cause Mortality included all randomized participants.
Metabolism and nutrition disorders Decreased appetite	41.6% 817/1965 • Number of events 1664 • Non-serious AEs: up to 14 days after each vaccination dose; serious AEs and deaths (all causes): up to 6 months after Vaccination 4 (up to 19 months after Vaccination 1) The safety analysis population included all randomized participants who received at least 1 dose of study vaccination. The analysis population for All-Cause Mortality included all randomized participants.	36.0% 156/433 • Number of events 302 • Non-serious AEs: up to 14 days after each vaccination dose; serious AEs and deaths (all causes): up to 6 months after Vaccination 4 (up to 19 months after Vaccination 1) The safety analysis population included all randomized participants who received at least 1 dose of study vaccination. The analysis population for All-Cause Mortality included all randomized participants.
Nervous system disorders Somnolence	55.4% 1088/1965 • Number of events 2696 • Non-serious AEs: up to 14 days after each vaccination dose; serious AEs and deaths (all causes): up to 6 months after Vaccination 4 (up to 19 months after Vaccination 1) The safety analysis population included all randomized participants who received at least 1 dose of study vaccination. The analysis population for All-Cause Mortality included all randomized participants.	55.0% 238/433 • Number of events 590 • Non-serious AEs: up to 14 days after each vaccination dose; serious AEs and deaths (all causes): up to 6 months after Vaccination 4 (up to 19 months after Vaccination 1) The safety analysis population included all randomized participants who received at least 1 dose of study vaccination. The analysis population for All-Cause Mortality included all randomized participants.
Psychiatric disorders Irritability	74.9% 1472/1965 • Number of events 5402 • Non-serious AEs: up to 14 days after each vaccination dose; serious AEs and deaths (all causes): up to 6 months after Vaccination 4 (up to 19 months after Vaccination 1) The safety analysis population included all randomized participants who received at least 1 dose of study vaccination. The analysis population for All-Cause Mortality included all randomized participants.	69.3% 300/433 • Number of events 1053 • Non-serious AEs: up to 14 days after each vaccination dose; serious AEs and deaths (all causes): up to 6 months after Vaccination 4 (up to 19 months after Vaccination 1) The safety analysis population included all randomized participants who received at least 1 dose of study vaccination. The analysis population for All-Cause Mortality included all randomized participants.
Skin and subcutaneous tissue disorders Urticaria	5.9% 115/1965 • Number of events 139 • Non-serious AEs: up to 14 days after each vaccination dose; serious AEs and deaths (all causes): up to 6 months after Vaccination 4 (up to 19 months after Vaccination 1) The safety analysis population included all randomized participants who received at least 1 dose of study vaccination. The analysis population for All-Cause Mortality included all randomized participants.	6.7% 29/433 • Number of events 40 • Non-serious AEs: up to 14 days after each vaccination dose; serious AEs and deaths (all causes): up to 6 months after Vaccination 4 (up to 19 months after Vaccination 1) The safety analysis population included all randomized participants who received at least 1 dose of study vaccination. The analysis population for All-Cause Mortality included all randomized participants.

Additional Information

Clinical Trials Disclosure

Merck Sharp & Dohme LLC

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The investigators agree to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
Publication restrictions are in place

Restriction type: OTHER