Trial Outcomes & Findings for Safety, Tolerability, and Immunogenicity of a 3-dose Regimen of V114 in Healthy Infants (PNEU-PED-EU-2/V114-026) (NCT NCT04016714)

Last Updated: 2023-05-06

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

1191 participants

Primary outcome timeframe

Day 1 to Day 14 after each vaccination

Results posted on

2023-05-06

Participant Flow

Participant milestones

Participant milestones
Measure	V114 Participants received a single 0.5 mL intramuscular (IM) injection of V114 at Visit 1, 2, and 4 (approximately 3, 5, and 12 months of age). As part of the study design, participants also received other pediatric vaccines, including Vaxelis™ (0.5 mL single dose at Visits 1, 2, and 4); M-M-R™II (0.5 mL single dose at Visit 4); and VARIVAX™ (0.5 mL single dose at Visit 4, except participants in Norway and Denmark, who received a second dose of VARIVAX™ at Visit 5, according to local vaccination requirements).	Prevenar 13™ Participants received a single 0.5 mL IM injection of Prevenar 13™ at Visit 1, 2, and 4 (approximately 3, 5, and 12 months of age). As part of the study design, participants also received other pediatric vaccines, including Vaxelis™ (0.5 mL single dose at Visits 1, 2, and 4); M-M-R™II (0.5 mL single dose at Visit 4); and VARIVAX™ (0.5 mL single dose at Visit 4, except participants in Norway and Denmark, who received a second dose of VARIVAX™ at Visit 5, according to local vaccination requirements).
Overall Study STARTED	595	596
Overall Study Vaccination 1 (V114 or Prevenar 13™)	595	596
Overall Study Vaccination 2 (V114 or Prevenar 13™)	585	588
Overall Study Vaccination 3 (V114 or Prevenar 13™)	573	581
Overall Study COMPLETED	572	580
Overall Study NOT COMPLETED	23	16

Reasons for withdrawal

Reasons for withdrawal
Measure	V114 Participants received a single 0.5 mL intramuscular (IM) injection of V114 at Visit 1, 2, and 4 (approximately 3, 5, and 12 months of age). As part of the study design, participants also received other pediatric vaccines, including Vaxelis™ (0.5 mL single dose at Visits 1, 2, and 4); M-M-R™II (0.5 mL single dose at Visit 4); and VARIVAX™ (0.5 mL single dose at Visit 4, except participants in Norway and Denmark, who received a second dose of VARIVAX™ at Visit 5, according to local vaccination requirements).	Prevenar 13™ Participants received a single 0.5 mL IM injection of Prevenar 13™ at Visit 1, 2, and 4 (approximately 3, 5, and 12 months of age). As part of the study design, participants also received other pediatric vaccines, including Vaxelis™ (0.5 mL single dose at Visits 1, 2, and 4); M-M-R™II (0.5 mL single dose at Visit 4); and VARIVAX™ (0.5 mL single dose at Visit 4, except participants in Norway and Denmark, who received a second dose of VARIVAX™ at Visit 5, according to local vaccination requirements).
Overall Study Death	1	0
Overall Study Lost to Follow-up	3	1
Overall Study Physician Decision	3	3
Overall Study Withdrawal by Parent/Guardian	16	12

Baseline Characteristics

Safety, Tolerability, and Immunogenicity of a 3-dose Regimen of V114 in Healthy Infants (PNEU-PED-EU-2/V114-026)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	V114 n=595 Participants Participants received a single 0.5 mL intramuscular (IM) injection of V114 at Visit 1, 2 and 4 (approximately 3, 5, and 12 months of age). As part of the study design, participants also received other pediatric vaccines, including Vaxelis™ (0.5 mL single dose at Visits 1, 2, and 4); M-M-R™II (0.5 mL single dose at Visit 4); and VARIVAX™ (0.5 mL single dose at Visit 4, except participants in Norway and Denmark, who received a second dose of VARIVAX™ at Visit 5, according to local vaccination requirements).	Prevenar 13™ n=596 Participants Participants received a single 0.5 mL IM injection of Prevenar 13™ at Visit 1, 2 and 4 (approximately 3, 5, and 12 months of age). As part of the study design, participants also received other pediatric vaccines, including Vaxelis™ (0.5 mL single dose at Visits 1, 2, and 4); M-M-R™II (0.5 mL single dose at Visit 4); and VARIVAX™ (0.5 mL single dose at Visit 4, except participants in Norway and Denmark, who received a second dose of VARIVAX™ at Visit 5, according to local vaccination requirements).	Total n=1191 Participants Total of all reporting groups
Age, Continuous	12.4 weeks STANDARD_DEVIATION 1.4 • n=5 Participants	12.5 weeks STANDARD_DEVIATION 1.4 • n=7 Participants	12.4 weeks STANDARD_DEVIATION 1.4 • n=5 Participants
Age, Customized In utero	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Customized Preterm newborn infants (gestational age < 37 wks)	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Customized Newborns (0-27 days)	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Customized Infants and toddlers (28 days-23 months)	595 Participants n=5 Participants	596 Participants n=7 Participants	1191 Participants n=5 Participants
Age, Customized Children (2-11 years)	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Customized Adolescents (12-17 years)	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Customized Adults (18-64 years)	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Customized From 65-84 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Customized 85 years and over	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	272 Participants n=5 Participants	289 Participants n=7 Participants	561 Participants n=5 Participants
Sex: Female, Male Male	323 Participants n=5 Participants	307 Participants n=7 Participants	630 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	579 Participants n=5 Participants	579 Participants n=7 Participants	1158 Participants n=5 Participants
Race (NIH/OMB) More than one race	13 Participants n=5 Participants	12 Participants n=7 Participants	25 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity Hispanic or Latino	26 Participants n=5 Participants	22 Participants n=7 Participants	48 Participants n=5 Participants
Ethnicity Not Hispanic or Latino	564 Participants n=5 Participants	570 Participants n=7 Participants	1134 Participants n=5 Participants
Ethnicity Not Reported	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Ethnicity Unknown	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1 to Day 14 after each vaccination

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

Outcome measures

Outcome measures
Measure	V114 n=595 Participants Participants received a single 0.5 mL intramuscular (IM) injection of V114 at Visit 1, 2, and 4 (approximately 3, 5, and 12 months of age). As part of the study design, participants also received other pediatric vaccines, including Vaxelis™ (0.5 mL single dose at Visits 1, 2, and 4); M-M-R™II (0.5 mL single dose at Visit 4); and VARIVAX™ (0.5 mL single dose at Visit 4, except participants in Norway and Denmark, who received a second dose of VARIVAX™ at Visit 5, according to local vaccination requirements).	Prevenar 13™ n=594 Participants Participants received a single 0.5 mL IM injection of Prevenar 13™ at Visit 1, 2, and 4 (approximately 3, 5, and 12 months of age). As part of the study design, participants also received other pediatric vaccines, including Vaxelis™ (0.5 mL single dose at Visits 1, 2, and 4); M-M-R™II (0.5 mL single dose at Visit 4); and VARIVAX™ (0.5 mL single dose at Visit 4, except participants in Norway and Denmark, who received a second dose of VARIVAX™ at Visit 5, according to local vaccination requirements).
Percentage of Participants With a Solicited Injection-site Adverse Event Injection-site erythema	60.0 Percentage of participants	65.5 Percentage of participants
Percentage of Participants With a Solicited Injection-site Adverse Event Injection-site induration	57.0 Percentage of participants	59.1 Percentage of participants
Percentage of Participants With a Solicited Injection-site Adverse Event Injection-site pain	63.0 Percentage of participants	59.6 Percentage of participants
Percentage of Participants With a Solicited Injection-site Adverse Event Injection-site swelling	46.4 Percentage of participants	44.1 Percentage of participants

PRIMARY outcome

Timeframe: Day 1 to Day 14 after each 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=595 Participants Participants received a single 0.5 mL intramuscular (IM) injection of V114 at Visit 1, 2, and 4 (approximately 3, 5, and 12 months of age). As part of the study design, participants also received other pediatric vaccines, including Vaxelis™ (0.5 mL single dose at Visits 1, 2, and 4); M-M-R™II (0.5 mL single dose at Visit 4); and VARIVAX™ (0.5 mL single dose at Visit 4, except participants in Norway and Denmark, who received a second dose of VARIVAX™ at Visit 5, according to local vaccination requirements).	Prevenar 13™ n=594 Participants Participants received a single 0.5 mL IM injection of Prevenar 13™ at Visit 1, 2, and 4 (approximately 3, 5, and 12 months of age). As part of the study design, participants also received other pediatric vaccines, including Vaxelis™ (0.5 mL single dose at Visits 1, 2, and 4); M-M-R™II (0.5 mL single dose at Visit 4); and VARIVAX™ (0.5 mL single dose at Visit 4, except participants in Norway and Denmark, who received a second dose of VARIVAX™ at Visit 5, according to local vaccination requirements).
Percentage of Participants With a Solicited Systemic Adverse Event Decreased appetite	54.8 Percentage of participants	58.2 Percentage of participants
Percentage of Participants With a Solicited Systemic Adverse Event Irritability	96.3 Percentage of participants	94.1 Percentage of participants
Percentage of Participants With a Solicited Systemic Adverse Event Somnolence	77.3 Percentage of participants	77.9 Percentage of participants
Percentage of Participants With a Solicited Systemic Adverse Event Urticaria	16.8 Percentage of participants	21.4 Percentage of participants

PRIMARY outcome

Timeframe: Up to approximately 6 months after Dose 3 (up to approximately 16 months)

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=595 Participants Participants received a single 0.5 mL intramuscular (IM) injection of V114 at Visit 1, 2, and 4 (approximately 3, 5, and 12 months of age). As part of the study design, participants also received other pediatric vaccines, including Vaxelis™ (0.5 mL single dose at Visits 1, 2, and 4); M-M-R™II (0.5 mL single dose at Visit 4); and VARIVAX™ (0.5 mL single dose at Visit 4, except participants in Norway and Denmark, who received a second dose of VARIVAX™ at Visit 5, according to local vaccination requirements).	Prevenar 13™ n=594 Participants Participants received a single 0.5 mL IM injection of Prevenar 13™ at Visit 1, 2, and 4 (approximately 3, 5, and 12 months of age). As part of the study design, participants also received other pediatric vaccines, including Vaxelis™ (0.5 mL single dose at Visits 1, 2, and 4); M-M-R™II (0.5 mL single dose at Visit 4); and VARIVAX™ (0.5 mL single dose at Visit 4, except participants in Norway and Denmark, who received a second dose of VARIVAX™ at Visit 5, according to local vaccination requirements).
Percentage of Participants With a Vaccine-related Serious Adverse Event	0.3 Percentage of participants	0.3 Percentage of participants

PRIMARY outcome

Timeframe: 30 days after Dose 3

Population: All randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and who had sufficient data to perform the analysis for each serotype

The geometric mean concentration (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 Prevenar 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.

Outcome measures

Outcome measures
Measure	V114 n=500 Participants Participants received a single 0.5 mL intramuscular (IM) injection of V114 at Visit 1, 2, and 4 (approximately 3, 5, and 12 months of age). As part of the study design, participants also received other pediatric vaccines, including Vaxelis™ (0.5 mL single dose at Visits 1, 2, and 4); M-M-R™II (0.5 mL single dose at Visit 4); and VARIVAX™ (0.5 mL single dose at Visit 4, except participants in Norway and Denmark, who received a second dose of VARIVAX™ at Visit 5, according to local vaccination requirements).	Prevenar 13™ n=525 Participants Participants received a single 0.5 mL IM injection of Prevenar 13™ at Visit 1, 2, and 4 (approximately 3, 5, and 12 months of age). As part of the study design, participants also received other pediatric vaccines, including Vaxelis™ (0.5 mL single dose at Visits 1, 2, and 4); M-M-R™II (0.5 mL single dose at Visit 4); and VARIVAX™ (0.5 mL single dose at Visit 4, except participants in Norway and Denmark, who received a second dose of VARIVAX™ at Visit 5, according to local vaccination requirements).
Percentage of Participants Meeting Serotype-specific Immunoglobulin G (IgG) Threshold Value of ≥0.35 μg/mL 30 Days After Dose 3 Serotype 1	96.8 Percentage of participants	99.0 Percentage of participants
Percentage of Participants Meeting Serotype-specific Immunoglobulin G (IgG) Threshold Value of ≥0.35 μg/mL 30 Days After Dose 3 Serotype 3	92.8 Percentage of participants	82.3 Percentage of participants
Percentage of Participants Meeting Serotype-specific Immunoglobulin G (IgG) Threshold Value of ≥0.35 μg/mL 30 Days After Dose 3 Serotype 4	96.6 Percentage of participants	98.5 Percentage of participants
Percentage of Participants Meeting Serotype-specific Immunoglobulin G (IgG) Threshold Value of ≥0.35 μg/mL 30 Days After Dose 3 Serotype 5	99.4 Percentage of participants	99.6 Percentage of participants
Percentage of Participants Meeting Serotype-specific Immunoglobulin G (IgG) Threshold Value of ≥0.35 μg/mL 30 Days After Dose 3 Serotype 6A	99.2 Percentage of participants	99.4 Percentage of participants
Percentage of Participants Meeting Serotype-specific Immunoglobulin G (IgG) Threshold Value of ≥0.35 μg/mL 30 Days After Dose 3 Serotype 6B	99.2 Percentage of participants	99.0 Percentage of participants
Percentage of Participants Meeting Serotype-specific Immunoglobulin G (IgG) Threshold Value of ≥0.35 μg/mL 30 Days After Dose 3 Serotype 7F	100.0 Percentage of participants	99.6 Percentage of participants
Percentage of Participants Meeting Serotype-specific Immunoglobulin G (IgG) Threshold Value of ≥0.35 μg/mL 30 Days After Dose 3 Serotype 9V	99.8 Percentage of participants	99.6 Percentage of participants
Percentage of Participants Meeting Serotype-specific Immunoglobulin G (IgG) Threshold Value of ≥0.35 μg/mL 30 Days After Dose 3 Serotype 14	99.2 Percentage of participants	99.6 Percentage of participants
Percentage of Participants Meeting Serotype-specific Immunoglobulin G (IgG) Threshold Value of ≥0.35 μg/mL 30 Days After Dose 3 Serotype 18C	99.8 Percentage of participants	99.4 Percentage of participants
Percentage of Participants Meeting Serotype-specific Immunoglobulin G (IgG) Threshold Value of ≥0.35 μg/mL 30 Days After Dose 3 Serotype 19A	99.6 Percentage of participants	99.8 Percentage of participants
Percentage of Participants Meeting Serotype-specific Immunoglobulin G (IgG) Threshold Value of ≥0.35 μg/mL 30 Days After Dose 3 Serotype 19F	99.8 Percentage of participants	99.6 Percentage of participants
Percentage of Participants Meeting Serotype-specific Immunoglobulin G (IgG) Threshold Value of ≥0.35 μg/mL 30 Days After Dose 3 Serotype 23F	97.8 Percentage of participants	96.9 Percentage of participants
Percentage of Participants Meeting Serotype-specific Immunoglobulin G (IgG) Threshold Value of ≥0.35 μg/mL 30 Days After Dose 3 Serotype 22F	99.4 Percentage of participants	5.4 Percentage of participants
Percentage of Participants Meeting Serotype-specific Immunoglobulin G (IgG) Threshold Value of ≥0.35 μg/mL 30 Days After Dose 3 Serotype 33F	99.2 Percentage of participants	2.0 Percentage of participants

PRIMARY outcome

Timeframe: 30 days after Dose 3

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 Prevenar 13™ and 2 serotypes (22F and 33F) unique to V114 were quantitated from participants' sera by a multiplex electrochemiluminescence (ECL) assay.

Outcome measures

Outcome measures
Measure	V114 n=500 Participants Participants received a single 0.5 mL intramuscular (IM) injection of V114 at Visit 1, 2, and 4 (approximately 3, 5, and 12 months of age). As part of the study design, participants also received other pediatric vaccines, including Vaxelis™ (0.5 mL single dose at Visits 1, 2, and 4); M-M-R™II (0.5 mL single dose at Visit 4); and VARIVAX™ (0.5 mL single dose at Visit 4, except participants in Norway and Denmark, who received a second dose of VARIVAX™ at Visit 5, according to local vaccination requirements).	Prevenar 13™ n=525 Participants Participants received a single 0.5 mL IM injection of Prevenar 13™ at Visit 1, 2, and 4 (approximately 3, 5, and 12 months of age). As part of the study design, participants also received other pediatric vaccines, including Vaxelis™ (0.5 mL single dose at Visits 1, 2, and 4); M-M-R™II (0.5 mL single dose at Visit 4); and VARIVAX™ (0.5 mL single dose at Visit 4, except participants in Norway and Denmark, who received a second dose of VARIVAX™ at Visit 5, according to local vaccination requirements).
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) 30 Days After Dose 3 Serotype 22F	6.06 µg/mL Interval 5.68 to 6.46	0.09 µg/mL Interval 0.08 to 0.1
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) 30 Days After Dose 3 Serotype 1	1.28 µg/mL Interval 1.21 to 1.36	2.20 µg/mL Interval 2.08 to 2.34
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) 30 Days After Dose 3 Serotype 3	0.85 µg/mL Interval 0.79 to 0.9	0.65 µg/mL Interval 0.61 to 0.69
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) 30 Days After Dose 3 Serotype 4	1.41 µg/mL Interval 1.31 to 1.51	2.00 µg/mL Interval 1.86 to 2.16
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) 30 Days After Dose 3 Serotype 5	2.08 µg/mL Interval 1.95 to 2.21	3.35 µg/mL Interval 3.11 to 3.6
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) 30 Days After Dose 3 Serotype 6A	3.21 µg/mL Interval 2.97 to 3.47	5.36 µg/mL Interval 4.98 to 5.78
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) 30 Days After Dose 3 Serotype 6B	4.56 µg/mL Interval 4.2 to 4.94	5.12 µg/mL Interval 4.71 to 5.57
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) 30 Days After Dose 3 Serotype 7F	2.78 µg/mL Interval 2.64 to 2.94	3.74 µg/mL Interval 3.53 to 3.97
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) 30 Days After Dose 3 Serotype 9V	2.14 µg/mL Interval 2.02 to 2.27	3.07 µg/mL Interval 2.89 to 3.26
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) 30 Days After Dose 3 Serotype 14	5.35 µg/mL Interval 4.93 to 5.8	6.83 µg/mL Interval 6.33 to 7.37
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) 30 Days After Dose 3 Serotype 18C	2.10 µg/mL Interval 1.98 to 2.23	2.48 µg/mL Interval 2.33 to 2.65
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) 30 Days After Dose 3 Serotype 19A	4.74 µg/mL Interval 4.43 to 5.08	6.38 µg/mL Interval 5.96 to 6.83
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) 30 Days After Dose 3 Serotype 19F	4.08 µg/mL Interval 3.82 to 4.36	5.18 µg/mL Interval 4.85 to 5.53
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) 30 Days After Dose 3 Serotype 23F	1.58 µg/mL Interval 1.47 to 1.7	1.77 µg/mL Interval 1.64 to 1.91
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) 30 Days After Dose 3 Serotype 33F	3.28 µg/mL Interval 3.06 to 3.51	0.07 µg/mL Interval 0.06 to 0.07

SECONDARY outcome

Timeframe: 30 days after Dose 3

Antigen-specific response rates in participants administered V114 concomitantly with Vaxelis™ were compared with response rates in participants administered Prevenar 13™ concomitantly with Vaxelis™, and the percentages of participants meeting specified Vaxelis™ antigen responses recorded. Antigens in Vaxelis™ include: diphtheria toxoid, tetanus toxoid, pertussis toxin (PT), pertussis filamentous hemagglutinin (FHA), pertussis fimbriae 2/3 (FIM 2/3), pertussis pertactin (PRN), Haemophilus influenzae type b polyribosylribitol phosphate (Hib-PRP), hepatitis B surface antigen (HBsAg), and poliovirus serotypes 1, 2, and 3.

Outcome measures

Outcome measures
Measure	V114 n=514 Participants Participants received a single 0.5 mL intramuscular (IM) injection of V114 at Visit 1, 2, and 4 (approximately 3, 5, and 12 months of age). As part of the study design, participants also received other pediatric vaccines, including Vaxelis™ (0.5 mL single dose at Visits 1, 2, and 4); M-M-R™II (0.5 mL single dose at Visit 4); and VARIVAX™ (0.5 mL single dose at Visit 4, except participants in Norway and Denmark, who received a second dose of VARIVAX™ at Visit 5, according to local vaccination requirements).	Prevenar 13™ n=543 Participants Participants received a single 0.5 mL IM injection of Prevenar 13™ at Visit 1, 2, and 4 (approximately 3, 5, and 12 months of age). As part of the study design, participants also received other pediatric vaccines, including Vaxelis™ (0.5 mL single dose at Visits 1, 2, and 4); M-M-R™II (0.5 mL single dose at Visit 4); and VARIVAX™ (0.5 mL single dose at Visit 4, except participants in Norway and Denmark, who received a second dose of VARIVAX™ at Visit 5, according to local vaccination requirements).
Percentage of Participants Meeting Specified Vaxelis™ Antigen Reponses 30 Days After Dose 3 Diphtheria toxoid: % ≥0.1 IU/mL	100.0 Percentage of participants	99.8 Percentage of participants
Percentage of Participants Meeting Specified Vaxelis™ Antigen Reponses 30 Days After Dose 3 Tetanus toxoid: % ≥0.1 IU/mL	100.0 Percentage of participants	99.8 Percentage of participants
Percentage of Participants Meeting Specified Vaxelis™ Antigen Reponses 30 Days After Dose 3 Pertussis - PT: % ≥5 EU/mL	100.0 Percentage of participants	99.8 Percentage of participants
Percentage of Participants Meeting Specified Vaxelis™ Antigen Reponses 30 Days After Dose 3 Pertussis - FHA: % ≥5 EU/mL	100.0 Percentage of participants	99.8 Percentage of participants
Percentage of Participants Meeting Specified Vaxelis™ Antigen Reponses 30 Days After Dose 3 Pertussis - FIM 2/3: % ≥20 EU/m L	99.8 Percentage of participants	99.6 Percentage of participants
Percentage of Participants Meeting Specified Vaxelis™ Antigen Reponses 30 Days After Dose 3 Pertussis - PRN: % ≥5 EU/mL	99.8 Percentage of participants	99.6 Percentage of participants
Percentage of Participants Meeting Specified Vaxelis™ Antigen Reponses 30 Days After Dose 3 Hib-PRP: % ≥0.15 μg/mL	96.8 Percentage of participants	97.9 Percentage of participants
Percentage of Participants Meeting Specified Vaxelis™ Antigen Reponses 30 Days After Dose 3 HBsAg: % ≥10 mIU/mL	99.0 Percentage of participants	99.6 Percentage of participants
Percentage of Participants Meeting Specified Vaxelis™ Antigen Reponses 30 Days After Dose 3 Poliovirus 1: % w/ Nab ≥1:8 dilution	99.8 Percentage of participants	99.8 Percentage of participants
Percentage of Participants Meeting Specified Vaxelis™ Antigen Reponses 30 Days After Dose 3 Poliovirus 2: % w/ Nab ≥1:8 dilution	100.0 Percentage of participants	99.8 Percentage of participants
Percentage of Participants Meeting Specified Vaxelis™ Antigen Reponses 30 Days After Dose 3 Poliovirus 3: % w/ Nab ≥1:8 dilution	100.0 Percentage of participants	100.0 Percentage of participants

SECONDARY outcome

Timeframe: 30 days after Dose 2

Outcome measures

Outcome measures
Measure	V114 n=505 Participants Participants received a single 0.5 mL intramuscular (IM) injection of V114 at Visit 1, 2, and 4 (approximately 3, 5, and 12 months of age). As part of the study design, participants also received other pediatric vaccines, including Vaxelis™ (0.5 mL single dose at Visits 1, 2, and 4); M-M-R™II (0.5 mL single dose at Visit 4); and VARIVAX™ (0.5 mL single dose at Visit 4, except participants in Norway and Denmark, who received a second dose of VARIVAX™ at Visit 5, according to local vaccination requirements).	Prevenar 13™ n=499 Participants Participants received a single 0.5 mL IM injection of Prevenar 13™ at Visit 1, 2, and 4 (approximately 3, 5, and 12 months of age). As part of the study design, participants also received other pediatric vaccines, including Vaxelis™ (0.5 mL single dose at Visits 1, 2, and 4); M-M-R™II (0.5 mL single dose at Visit 4); and VARIVAX™ (0.5 mL single dose at Visit 4, except participants in Norway and Denmark, who received a second dose of VARIVAX™ at Visit 5, according to local vaccination requirements).
Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL 30 Days After Dose 2 Serotype 7F	98.6 Percentage of participants	99.8 Percentage of participants
Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL 30 Days After Dose 2 Serotype 9V	94.0 Percentage of participants	94.8 Percentage of participants
Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL 30 Days After Dose 2 Serotype 18C	93.1 Percentage of participants	94.4 Percentage of participants
Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL 30 Days After Dose 2 Serotype 1	97.2 Percentage of participants	98.2 Percentage of participants
Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL 30 Days After Dose 2 Serotype 3	96.8 Percentage of participants	78.0 Percentage of participants
Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL 30 Days After Dose 2 Serotype 4	97.6 Percentage of participants	98.2 Percentage of participants
Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL 30 Days After Dose 2 Serotype 5	92.1 Percentage of participants	91.2 Percentage of participants
Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL 30 Days After Dose 2 Serotype 6A	77.2 Percentage of participants	91.4 Percentage of participants
Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL 30 Days After Dose 2 Serotype 6B	59.0 Percentage of participants	40.3 Percentage of participants
Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL 30 Days After Dose 2 Serotype 14	96.6 Percentage of participants	96.0 Percentage of participants
Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL 30 Days After Dose 2 Serotype 19A	94.1 Percentage of participants	96.6 Percentage of participants
Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL 30 Days After Dose 2 Serotype 19F	98.0 Percentage of participants	99.4 Percentage of participants
Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL 30 Days After Dose 2 Serotype 23F	75.4 Percentage of participants	66.7 Percentage of participants
Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL 30 Days After Dose 2 Serotype 22F	97.8 Percentage of participants	2.0 Percentage of participants
Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL 30 Days After Dose 2 Serotype 33F	49.5 Percentage of participants	1.6 Percentage of participants

SECONDARY outcome

Timeframe: 30 days after Dose 2

Outcome measures

Outcome measures
Measure	V114 n=505 Participants Participants received a single 0.5 mL intramuscular (IM) injection of V114 at Visit 1, 2, and 4 (approximately 3, 5, and 12 months of age). As part of the study design, participants also received other pediatric vaccines, including Vaxelis™ (0.5 mL single dose at Visits 1, 2, and 4); M-M-R™II (0.5 mL single dose at Visit 4); and VARIVAX™ (0.5 mL single dose at Visit 4, except participants in Norway and Denmark, who received a second dose of VARIVAX™ at Visit 5, according to local vaccination requirements).	Prevenar 13™ n=499 Participants Participants received a single 0.5 mL IM injection of Prevenar 13™ at Visit 1, 2, and 4 (approximately 3, 5, and 12 months of age). As part of the study design, participants also received other pediatric vaccines, including Vaxelis™ (0.5 mL single dose at Visits 1, 2, and 4); M-M-R™II (0.5 mL single dose at Visit 4); and VARIVAX™ (0.5 mL single dose at Visit 4, except participants in Norway and Denmark, who received a second dose of VARIVAX™ at Visit 5, according to local vaccination requirements).
GMC of Serotype-specific IgG 30 Days After Dose 2 Serotype 6B	0.42 μg/mL Interval 0.37 to 0.48	0.24 μg/mL Interval 0.22 to 0.27
GMC of Serotype-specific IgG 30 Days After Dose 2 Serotype 14	5.59 μg/mL Interval 5.09 to 6.13	5.48 μg/mL Interval 4.92 to 6.1
GMC of Serotype-specific IgG 30 Days After Dose 2 Serotype 1	1.39 μg/mL Interval 1.3 to 1.48	1.70 μg/mL Interval 1.6 to 1.81
GMC of Serotype-specific IgG 30 Days After Dose 2 Serotype 3	1.10 μg/mL Interval 1.04 to 1.17	0.61 μg/mL Interval 0.57 to 0.65
GMC of Serotype-specific IgG 30 Days After Dose 2 Serotype 4	1.74 μg/mL Interval 1.62 to 1.86	1.59 μg/mL Interval 1.48 to 1.7
GMC of Serotype-specific IgG 30 Days After Dose 2 Serotype 5	1.14 μg/mL Interval 1.05 to 1.23	1.26 μg/mL Interval 1.16 to 1.37
GMC of Serotype-specific IgG 30 Days After Dose 2 Serotype 6A	0.67 μg/mL Interval 0.61 to 0.73	1.53 μg/mL Interval 1.4 to 1.68
GMC of Serotype-specific IgG 30 Days After Dose 2 Serotype 7F	1.69 μg/mL Interval 1.59 to 1.8	2.18 μg/mL Interval 2.06 to 2.31
GMC of Serotype-specific IgG 30 Days After Dose 2 Serotype 9V	1.55 μg/mL Interval 1.43 to 1.68	1.55 μg/mL Interval 1.43 to 1.67
GMC of Serotype-specific IgG 30 Days After Dose 2 Serotype 18C	1.18 μg/mL Interval 1.11 to 1.26	1.58 μg/mL Interval 1.46 to 1.7
GMC of Serotype-specific IgG 30 Days After Dose 2 Serotype 19A	1.70 μg/mL Interval 1.56 to 1.84	2.35 μg/mL Interval 2.15 to 2.56
GMC of Serotype-specific IgG 30 Days After Dose 2 Serotype 19F	2.79 μg/mL Interval 2.59 to 3.01	4.04 μg/mL Interval 3.76 to 4.34
GMC of Serotype-specific IgG 30 Days After Dose 2 Serotype 23F	0.71 μg/mL Interval 0.65 to 0.78	0.54 μg/mL Interval 0.49 to 0.59
GMC of Serotype-specific IgG 30 Days After Dose 2 Serotype 22F	3.16 μg/mL Interval 2.92 to 3.42	0.04 μg/mL Interval 0.04 to 0.04
GMC of Serotype-specific IgG 30 Days After Dose 2 Serotype 33F	0.30 μg/mL Interval 0.27 to 0.34	0.04 μg/mL Interval 0.04 to 0.04

SECONDARY outcome

Timeframe: 30 days after Dose 3

Population: All randomized participants in the OPA Subset without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and who had sufficient data to perform the analysis for each serotype

OPA for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevenar 13™ and 2 serotypes unique to V114 (22F and 33F) was measured using a multiplex opsonophagocytic assay (MOPA).

Outcome measures

SECONDARY outcome

Timeframe: 30 days after Dose 3

Sera from participants was used to measure GMT of the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevenar 13™ and 2 serotypes unique to V114 (22F and 33F) was determined using a MOPA.

Outcome measures

Outcome measures
Measure	V114 n=108 Participants Participants received a single 0.5 mL intramuscular (IM) injection of V114 at Visit 1, 2, and 4 (approximately 3, 5, and 12 months of age). As part of the study design, participants also received other pediatric vaccines, including Vaxelis™ (0.5 mL single dose at Visits 1, 2, and 4); M-M-R™II (0.5 mL single dose at Visit 4); and VARIVAX™ (0.5 mL single dose at Visit 4, except participants in Norway and Denmark, who received a second dose of VARIVAX™ at Visit 5, according to local vaccination requirements).	Prevenar 13™ n=95 Participants Participants received a single 0.5 mL IM injection of Prevenar 13™ at Visit 1, 2, and 4 (approximately 3, 5, and 12 months of age). As part of the study design, participants also received other pediatric vaccines, including Vaxelis™ (0.5 mL single dose at Visits 1, 2, and 4); M-M-R™II (0.5 mL single dose at Visit 4); and VARIVAX™ (0.5 mL single dose at Visit 4, except participants in Norway and Denmark, who received a second dose of VARIVAX™ at Visit 5, according to local vaccination requirements).
Geometric Mean Titers (GMTs) of Serotype-specific OPA 30 Days After Dose 3 Serotype 1	152.2 Titer Interval 122.6 to 189.0	184.0 Titer Interval 147.2 to 230.0
Geometric Mean Titers (GMTs) of Serotype-specific OPA 30 Days After Dose 3 Serotype 3	320.4 Titer Interval 266.9 to 384.8	296.2 Titer Interval 245.5 to 357.3
Geometric Mean Titers (GMTs) of Serotype-specific OPA 30 Days After Dose 3 Serotype 4	2290.8 Titer Interval 1856.9 to 2826.1	2842.0 Titer Interval 2404.6 to 3359.0
Geometric Mean Titers (GMTs) of Serotype-specific OPA 30 Days After Dose 3 Serotype 5	855.5 Titer Interval 699.9 to 1045.7	1024.5 Titer Interval 850.5 to 1234.0
Geometric Mean Titers (GMTs) of Serotype-specific OPA 30 Days After Dose 3 Serotype 6A	3316.8 Titer Interval 2828.4 to 3889.5	4649.1 Titer Interval 3951.6 to 5469.7
Geometric Mean Titers (GMTs) of Serotype-specific OPA 30 Days After Dose 3 Serotype 6B	2691.6 Titer Interval 2244.4 to 3227.8	2658.7 Titer Interval 2234.2 to 3163.8
Geometric Mean Titers (GMTs) of Serotype-specific OPA 30 Days After Dose 3 Serotype 7F	5819.2 Titer Interval 4985.3 to 6792.7	7839.0 Titer Interval 6786.9 to 9054.2
Geometric Mean Titers (GMTs) of Serotype-specific OPA 30 Days After Dose 3 Serotype 9V	2192.1 Titer Interval 1807.8 to 2658.1	2745.1 Titer Interval 2284.2 to 3298.9
Geometric Mean Titers (GMTs) of Serotype-specific OPA 30 Days After Dose 3 Serotype 14	3449.4 Titer Interval 2803.1 to 4244.7	2360.2 Titer Interval 1972.4 to 2824.3
Geometric Mean Titers (GMTs) of Serotype-specific OPA 30 Days After Dose 3 Serotype 18C	2203.1 Titer Interval 1872.6 to 2592.1	2003.4 Titer Interval 1725.7 to 2325.7
Geometric Mean Titers (GMTs) of Serotype-specific OPA 30 Days After Dose 3 Serotype 19A	2839.1 Titer Interval 2455.2 to 3282.9	3843.6 Titer Interval 3366.9 to 4387.8
Geometric Mean Titers (GMTs) of Serotype-specific OPA 30 Days After Dose 3 Serotype 19F	1748.4 Titer Interval 1469.8 to 2079.7	2067.0 Titer Interval 1800.1 to 2373.4
Geometric Mean Titers (GMTs) of Serotype-specific OPA 30 Days After Dose 3 Serotype 23F	3650.2 Titer Interval 3041.3 to 4381.0	6776.2 Titer Interval 5344.0 to 8592.3
Geometric Mean Titers (GMTs) of Serotype-specific OPA 30 Days After Dose 3 Serotype 22F	2927.9 Titer Interval 2547.0 to 3365.7	29.3 Titer Interval 17.8 to 48.4
Geometric Mean Titers (GMTs) of Serotype-specific OPA 30 Days After Dose 3 Serotype 33F	13334.7 Titer Interval 11334.6 to 15687.7	1557.9 Titer Interval 1227.3 to 1977.5

Adverse Events

V114

Serious events: 30 serious events

Other events: 590 other events

Deaths: 1 deaths

Prevenar 13™

Serious events: 28 serious events

Other events: 592 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	V114 n=595 participants at risk Participants received a single 0.5 mL intramuscular (IM) injection of V114 at Visit 1, 2, and 4 (approximately 3, 5, and 12 months of age). As part of the study design, participants also received other pediatric vaccines, including Vaxelis™ (0.5 mL single dose at Visits 1, 2, and 4); M-M-R™II (0.5 mL single dose at Visit 4); and VARIVAX™ (0.5 mL single dose at Visit 4, except participants in Norway and Denmark, who received a second dose of VARIVAX™ at Visit 5, according to local vaccination requirements).	Prevenar 13™ n=594 participants at risk Participants received a single 0.5 mL IM injection of Prevenar 13™ at Visit 1, 2 and 4 (approximately 3, 5, and 12 months of age). As part of the study design, participants also received other pediatric vaccines, including Vaxelis™ (0.5 mL single dose at Visits 1, 2, and 4); M-M-R™II (0.5 mL single dose at Visit 4); and VARIVAX™ (0.5 mL single dose at Visit 4, except participants in Norway and Denmark, who received a second dose of VARIVAX™ at Visit 5, according to local vaccination requirements).
Gastrointestinal disorders Diarrhoea	11.6% 69/595 • Number of events 82 • Non-serious AEs: up to 14 days after each vaccination dose; serious AEs and deaths (all causes): up to approximately 6 months after Dose 3 (up to approximately 16 months) 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.	11.8% 70/594 • Number of events 89 • Non-serious AEs: up to 14 days after each vaccination dose; serious AEs and deaths (all causes): up to approximately 6 months after Dose 3 (up to approximately 16 months) 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 Teething	7.9% 47/595 • Number of events 60 • Non-serious AEs: up to 14 days after each vaccination dose; serious AEs and deaths (all causes): up to approximately 6 months after Dose 3 (up to approximately 16 months) 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.	8.4% 50/594 • Number of events 67 • Non-serious AEs: up to 14 days after each vaccination dose; serious AEs and deaths (all causes): up to approximately 6 months after Dose 3 (up to approximately 16 months) 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	5.2% 31/595 • Number of events 38 • Non-serious AEs: up to 14 days after each vaccination dose; serious AEs and deaths (all causes): up to approximately 6 months after Dose 3 (up to approximately 16 months) 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.	6.4% 38/594 • Number of events 41 • Non-serious AEs: up to 14 days after each vaccination dose; serious AEs and deaths (all causes): up to approximately 6 months after Dose 3 (up to approximately 16 months) 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	60.0% 357/595 • Number of events 613 • Non-serious AEs: up to 14 days after each vaccination dose; serious AEs and deaths (all causes): up to approximately 6 months after Dose 3 (up to approximately 16 months) 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.	65.5% 389/594 • Number of events 658 • Non-serious AEs: up to 14 days after each vaccination dose; serious AEs and deaths (all causes): up to approximately 6 months after Dose 3 (up to approximately 16 months) 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	57.0% 339/595 • Number of events 658 • Non-serious AEs: up to 14 days after each vaccination dose; serious AEs and deaths (all causes): up to approximately 6 months after Dose 3 (up to approximately 16 months) 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.	59.1% 351/594 • Number of events 679 • Non-serious AEs: up to 14 days after each vaccination dose; serious AEs and deaths (all causes): up to approximately 6 months after Dose 3 (up to approximately 16 months) 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	63.0% 375/595 • Number of events 646 • Non-serious AEs: up to 14 days after each vaccination dose; serious AEs and deaths (all causes): up to approximately 6 months after Dose 3 (up to approximately 16 months) 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.	59.6% 354/594 • Number of events 595 • Non-serious AEs: up to 14 days after each vaccination dose; serious AEs and deaths (all causes): up to approximately 6 months after Dose 3 (up to approximately 16 months) 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	46.4% 276/595 • Number of events 444 • Non-serious AEs: up to 14 days after each vaccination dose; serious AEs and deaths (all causes): up to approximately 6 months after Dose 3 (up to approximately 16 months) 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.	44.1% 262/594 • Number of events 417 • Non-serious AEs: up to 14 days after each vaccination dose; serious AEs and deaths (all causes): up to approximately 6 months after Dose 3 (up to approximately 16 months) 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	53.4% 318/595 • Number of events 728 • Non-serious AEs: up to 14 days after each vaccination dose; serious AEs and deaths (all causes): up to approximately 6 months after Dose 3 (up to approximately 16 months) 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.	55.6% 330/594 • Number of events 762 • Non-serious AEs: up to 14 days after each vaccination dose; serious AEs and deaths (all causes): up to approximately 6 months after Dose 3 (up to approximately 16 months) 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	11.8% 70/595 • Number of events 80 • Non-serious AEs: up to 14 days after each vaccination dose; serious AEs and deaths (all causes): up to approximately 6 months after Dose 3 (up to approximately 16 months) 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.	14.1% 84/594 • Number of events 101 • Non-serious AEs: up to 14 days after each vaccination dose; serious AEs and deaths (all causes): up to approximately 6 months after Dose 3 (up to approximately 16 months) 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.
Investigations Body temperature increased	8.6% 51/595 • Number of events 74 • Non-serious AEs: up to 14 days after each vaccination dose; serious AEs and deaths (all causes): up to approximately 6 months after Dose 3 (up to approximately 16 months) 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.	10.3% 61/594 • Number of events 91 • Non-serious AEs: up to 14 days after each vaccination dose; serious AEs and deaths (all causes): up to approximately 6 months after Dose 3 (up to approximately 16 months) 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	54.8% 326/595 • Number of events 632 • Non-serious AEs: up to 14 days after each vaccination dose; serious AEs and deaths (all causes): up to approximately 6 months after Dose 3 (up to approximately 16 months) 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.	58.2% 346/594 • Number of events 686 • Non-serious AEs: up to 14 days after each vaccination dose; serious AEs and deaths (all causes): up to approximately 6 months after Dose 3 (up to approximately 16 months) 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	77.3% 460/595 • Number of events 1118 • Non-serious AEs: up to 14 days after each vaccination dose; serious AEs and deaths (all causes): up to approximately 6 months after Dose 3 (up to approximately 16 months) 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.	77.9% 463/594 • Number of events 1085 • Non-serious AEs: up to 14 days after each vaccination dose; serious AEs and deaths (all causes): up to approximately 6 months after Dose 3 (up to approximately 16 months) 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	96.3% 573/595 • Number of events 2266 • Non-serious AEs: up to 14 days after each vaccination dose; serious AEs and deaths (all causes): up to approximately 6 months after Dose 3 (up to approximately 16 months) 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.	94.1% 559/594 • Number of events 2304 • Non-serious AEs: up to 14 days after each vaccination dose; serious AEs and deaths (all causes): up to approximately 6 months after Dose 3 (up to approximately 16 months) 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	16.8% 100/595 • Number of events 130 • Non-serious AEs: up to 14 days after each vaccination dose; serious AEs and deaths (all causes): up to approximately 6 months after Dose 3 (up to approximately 16 months) 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.	21.4% 127/594 • Number of events 173 • Non-serious AEs: up to 14 days after each vaccination dose; serious AEs and deaths (all causes): up to approximately 6 months after Dose 3 (up to approximately 16 months) 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

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme LLC

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

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

Restriction type: OTHER

Measure	V114 n=108 Participants Participants received a single 0.5 mL intramuscular (IM) injection of V114 at Visit 1, 2, and 4 (approximately 3, 5, and 12 months of age). As part of the study design, participants also received other pediatric vaccines, including Vaxelis™ (0.5 mL single dose at Visits 1, 2, and 4); M-M-R™II (0.5 mL single dose at Visit 4); and VARIVAX™ (0.5 mL single dose at Visit 4, except participants in Norway and Denmark, who received a second dose of VARIVAX™ at Visit 5, according to local vaccination requirements).	Prevenar 13™ n=95 Participants Participants received a single 0.5 mL IM injection of Prevenar 13™ at Visit 1, 2, and 4 (approximately 3, 5, and 12 months of age). As part of the study design, participants also received other pediatric vaccines, including Vaxelis™ (0.5 mL single dose at Visits 1, 2, and 4); M-M-R™II (0.5 mL single dose at Visit 4); and VARIVAX™ (0.5 mL single dose at Visit 4, except participants in Norway and Denmark, who received a second dose of VARIVAX™ at Visit 5, according to local vaccination requirements).
Percentage of Participants Meeting Specified Opsonophagocytic Activity (OPA) Responses 30 Days After Dose 3 Serotype 6A: % ≥1:232 dilution	100.0 Percentage of participants Interval 96.4 to 100.0	100.0 Percentage of participants Interval 96.1 to 100.0
Percentage of Participants Meeting Specified Opsonophagocytic Activity (OPA) Responses 30 Days After Dose 3 Serotype 14: % ≥1:62 dilution	100.0 Percentage of participants Interval 96.5 to 100.0	100.0 Percentage of participants Interval 96.1 to 100.0
Percentage of Participants Meeting Specified Opsonophagocytic Activity (OPA) Responses 30 Days After Dose 3 Serotype 1: % ≥1:9 dilution	98.1 Percentage of participants Interval 93.5 to 99.8	97.9 Percentage of participants Interval 92.5 to 99.7
Percentage of Participants Meeting Specified Opsonophagocytic Activity (OPA) Responses 30 Days After Dose 3 Serotype 3: % ≥1:19 dilution	99.0 Percentage of participants Interval 94.7 to 100.0	97.8 Percentage of participants Interval 92.4 to 99.7
Percentage of Participants Meeting Specified Opsonophagocytic Activity (OPA) Responses 30 Days After Dose 3 Serotype 4: % ≥1:34 dilution	100.0 Percentage of participants Interval 96.5 to 100.0	100.0 Percentage of participants Interval 96.1 to 100.0
Percentage of Participants Meeting Specified Opsonophagocytic Activity (OPA) Responses 30 Days After Dose 3 Serotype 5: % ≥1:27 dilution	100.0 Percentage of participants Interval 96.6 to 100.0	100.0 Percentage of participants Interval 96.2 to 100.0
Percentage of Participants Meeting Specified Opsonophagocytic Activity (OPA) Responses 30 Days After Dose 3 Serotype 6B: % ≥1:40 dilution	100.0 Percentage of participants Interval 96.6 to 100.0	100.0 Percentage of participants Interval 96.1 to 100.0
Percentage of Participants Meeting Specified Opsonophagocytic Activity (OPA) Responses 30 Days After Dose 3 Serotype 7F: % ≥1:61 dilution	100.0 Percentage of participants Interval 96.6 to 100.0	100.0 Percentage of participants Interval 96.2 to 100.0
Percentage of Participants Meeting Specified Opsonophagocytic Activity (OPA) Responses 30 Days After Dose 3 Serotype 9V: % ≥1:151 dilution	99.0 Percentage of participants Interval 94.7 to 100.0	100.0 Percentage of participants Interval 96.0 to 100.0
Percentage of Participants Meeting Specified Opsonophagocytic Activity (OPA) Responses 30 Days After Dose 3 Serotype 18C: % ≥1:115 dilution	99.0 Percentage of participants Interval 94.8 to 100.0	100.0 Percentage of participants Interval 96.1 to 100.0
Percentage of Participants Meeting Specified Opsonophagocytic Activity (OPA) Responses 30 Days After Dose 3 Serotype 19A : % ≥1:31 dilution	100.0 Percentage of participants Interval 96.6 to 100.0	100.0 Percentage of participants Interval 96.1 to 100.0
Percentage of Participants Meeting Specified Opsonophagocytic Activity (OPA) Responses 30 Days After Dose 3 Serotype 19F: % ≥1:113 dilution	100.0 Percentage of participants Interval 96.5 to 100.0	100.0 Percentage of participants Interval 96.1 to 100.0
Percentage of Participants Meeting Specified Opsonophagocytic Activity (OPA) Responses 30 Days After Dose 3 Serotype 23F: % ≥1:55 dilution	100.0 Percentage of participants Interval 96.5 to 100.0	100.0 Percentage of participants Interval 96.0 to 100.0
Percentage of Participants Meeting Specified Opsonophagocytic Activity (OPA) Responses 30 Days After Dose 3 Serotype 22F: % ≥1:15 dilution	100.0 Percentage of participants Interval 96.5 to 100.0	26.4 Percentage of participants Interval 17.7 to 36.7
Percentage of Participants Meeting Specified Opsonophagocytic Activity (OPA) Responses 30 Days After Dose 3 Serotype 33F: % ≥1:20 dilution	100.0 Percentage of participants Interval 96.5 to 100.0	98.9 Percentage of participants Interval 94.3 to 100.0