Trial Outcomes & Findings for Safety, Tolerability, and Immunogenicity of V114 in Healthy Infants (V114-025) (NCT NCT04031846)

Last Updated: 2023-07-28

Results Overview

An AE is any untoward medical occurrence in a participant temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of a study intervention. Injection-site AEs solicited on the Vaccine Report Card (VRC) consisted of erythema (redness), induration (hard lump), pain (tenderness) and swelling.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1184 participants

Primary outcome timeframe

Up to 14 days post any vaccination (up to approximately study month 13)

Results posted on

2023-07-28

Participant Flow

Healthy males and females aged 42 to 90 days (inclusive) were enrolled. One participant randomized to the V114 group, who was cross-treated with both pneumococcal conjugate vaccines (PCVs), V114 and Prevenar 13™, was excluded from the all participants as treated (APaT) i.e. the safety endpoints population; but was included in the AE module as a separate treatment group.

Participant milestones

Participant milestones
Measure	V114 Full-term infants received a 0.5 mL intramuscular injection of V114 at approximately 2, 4, and 11-15 months of age (Study Day 1, Month 2, and Month 9-13). Preterm infants received a 0.5 mL intramuscular injection of V114 at approximately 2, 3, 4,and 11-15 months of age (Study Day 1, Month 1, Month 2, and Month 9-13). All infants also received licensed background intramuscular injections of 0.5 mL Infanrix™ hexa at approximately 2, 3, 4, and 11-15 months of age (Study Day 1, Months 1, 2, and Month 9-13); and also 1.5 mL oral dose of Rotarix™ at 2 and 4 months of age (Study Day 1 and Month 2).	Prevenar 13™ Full-term infants received a 0.5 mL intramuscular injection of Prevenar 13™ at approximately 2, 4, and 11-15 months of age (Study Day 1, Month 2, and Month 9-13). Preterm infants received a 0.5 mL intramuscular injection of Prevenar 13™ at approximately 2, 3, 4, and 11-15 months of age (Study Day 1, Month 1, Month 2, and Month 9-13). All infants also received licensed background intramuscular injections of 0.5 mL Infanrix™ hexa at approximately 2, 3, 4, and 11-15 months of age (Study Day 1, Months 1, 2, and Month 9-13); and also 1.5 mL oral dose of Rotarix™ at 2 and 4 months of age (Study Day 1 and Month 2).
Overall Study STARTED	591	593
Overall Study Vaccinated	588	591
Overall Study All Participants As Treated	587	591
Overall Study PCV Dose at Age 2 Months	588	591
Overall Study PCV Dose at Age 3 Months	32	35
Overall Study PCV Dose at Age 4 Months	582	584
Overall Study PCV Dose at Age 11-15 Months	571	574
Overall Study COMPLETED	569	570
Overall Study NOT COMPLETED	22	23

Reasons for withdrawal

Reasons for withdrawal
Measure	V114 Full-term infants received a 0.5 mL intramuscular injection of V114 at approximately 2, 4, and 11-15 months of age (Study Day 1, Month 2, and Month 9-13). Preterm infants received a 0.5 mL intramuscular injection of V114 at approximately 2, 3, 4,and 11-15 months of age (Study Day 1, Month 1, Month 2, and Month 9-13). All infants also received licensed background intramuscular injections of 0.5 mL Infanrix™ hexa at approximately 2, 3, 4, and 11-15 months of age (Study Day 1, Months 1, 2, and Month 9-13); and also 1.5 mL oral dose of Rotarix™ at 2 and 4 months of age (Study Day 1 and Month 2).	Prevenar 13™ Full-term infants received a 0.5 mL intramuscular injection of Prevenar 13™ at approximately 2, 4, and 11-15 months of age (Study Day 1, Month 2, and Month 9-13). Preterm infants received a 0.5 mL intramuscular injection of Prevenar 13™ at approximately 2, 3, 4, and 11-15 months of age (Study Day 1, Month 1, Month 2, and Month 9-13). All infants also received licensed background intramuscular injections of 0.5 mL Infanrix™ hexa at approximately 2, 3, 4, and 11-15 months of age (Study Day 1, Months 1, 2, and Month 9-13); and also 1.5 mL oral dose of Rotarix™ at 2 and 4 months of age (Study Day 1 and Month 2).
Overall Study Lost to Follow-up	4	4
Overall Study Physician Decision	0	1
Overall Study Protocol Violation	1	1
Overall Study Withdrawal By Parent/Guardian	17	17

Baseline Characteristics

Safety, Tolerability, and Immunogenicity of V114 in Healthy Infants (V114-025)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	V114 n=591 Participants Full-term infants received a 0.5 mL intramuscular injection of V114 at approximately 2, 4, and 11-15 months of age (Study Day 1, Month 2, and Month 9-13). Preterm infants received a 0.5 mL intramuscular injection of V114 at approximately 2, 3, 4,and 11-15 months of age (Study Day 1, Month 1, Month 2, and Month 9-13). All infants also received licensed background intramuscular injections of 0.5 mL Infanrix™ hexa at approximately 2, 3, 4, and 11-15 months of age (Study Day 1, Months 1, 2, and Month 9-13); and also 1.5 mL oral dose of Rotarix™ at 2 and 4 months of age (Study Day 1 and Month 2).	Prevenar 13™ n=593 Participants Full-term infants received a 0.5 mL intramuscular injection of Prevenar 13™ at approximately 2, 4, and 11-15 months of age (Study Day 1, Month 2, and Month 9-13). Preterm infants received a 0.5 mL intramuscular injection of Prevenar 13™ at approximately 2, 3, 4, and 11-15 months of age (Study Day 1, Month 1, Month 2, and Month 9-13). All infants also received licensed background intramuscular injections of 0.5 mL Infanrix™ hexa at approximately 2, 3, 4, and 11-15 months of age (Study Day 1, Months 1, 2, and Month 9-13); and also 1.5 mL oral dose of Rotarix™ at 2 and 4 months of age (Study Day 1 and Month 2).	Total n=1184 Participants Total of all reporting groups
Age, Continuous	8.4 Weeks STANDARD_DEVIATION 1.5 • n=5 Participants	8.5 Weeks STANDARD_DEVIATION 1.5 • n=7 Participants	8.5 Weeks STANDARD_DEVIATION 1.5 • 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)	591 Participants n=5 Participants	593 Participants n=7 Participants	1184 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	283 Participants n=5 Participants	286 Participants n=7 Participants	569 Participants n=5 Participants
Sex: Female, Male Male	308 Participants n=5 Participants	307 Participants n=7 Participants	615 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	66 Participants n=5 Participants	65 Participants n=7 Participants	131 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	525 Participants n=5 Participants	526 Participants n=7 Participants	1051 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants	5 Participants n=7 Participants	9 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	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) White	574 Participants n=5 Participants	573 Participants n=7 Participants	1147 Participants n=5 Participants
Race (NIH/OMB) More than one race	5 Participants n=5 Participants	7 Participants n=7 Participants	12 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

PRIMARY outcome

Timeframe: Up to 14 days post any vaccination (up to approximately study month 13)

Population: Participants who received at least 1 dose of study vaccination based on the group to which they were randomized, and corresponding to the study vaccination they actually received. One participant randomized to V114, who inadvertently received both V114 and Prevenar 13™, was excluded from this analysis.

Outcome measures

Outcome measures
Measure	V114 n=587 Participants Full-term infants received a 0.5 mL intramuscular injection of V114 at approximately 2, 4, and 11-15 months of age (Study Day 1, Month 2, and Month 9-13). Preterm infants received a 0.5 mL intramuscular injection of V114 at approximately 2, 3, 4,and 11-15 months of age (Study Day 1, Month 1, Month 2, and Month 9-13). All infants also received licensed background intramuscular injections of 0.5 mL Infanrix™ hexa at approximately 2, 3, 4, and 11-15 months of age (Study Day 1, Months 1, 2, and Month 9-13); and also 1.5 mL oral dose of Rotarix™ at 2 and 4 months of age (Study Day 1 and Month 2).	Prevenar 13™ n=591 Participants Full-term infants received a 0.5 mL intramuscular injection of Prevenar 13™ at approximately 2, 4, and 11-15 months of age (Study Day 1, Month 2, and Month 9-13). Preterm infants received a 0.5 mL intramuscular injection of Prevenar 13™ at approximately 2, 3, 4, and 11-15 months of age (Study Day 1, Month 1, Month 2, and Month 9-13). All infants also received licensed background intramuscular injections of 0.5 mL Infanrix™ hexa at approximately 2, 3, 4, and 11-15 months of age (Study Day 1, Months 1, 2, and Month 9-13); and also 1.5 mL oral dose of Rotarix™ at 2 and 4 months of age (Study Day 1 and Month 2).
Percentage of Participants That Report at Least 1 Solicited Injection-site Adverse Event (AE) Injection site erythema	45.3 Percentage of Participants	44.7 Percentage of Participants
Percentage of Participants That Report at Least 1 Solicited Injection-site Adverse Event (AE) Injection site induration	41.9 Percentage of Participants	39.1 Percentage of Participants
Percentage of Participants That Report at Least 1 Solicited Injection-site Adverse Event (AE) Injection site pain	40.5 Percentage of Participants	29.3 Percentage of Participants
Percentage of Participants That Report at Least 1 Solicited Injection-site Adverse Event (AE) Injection site swelling	33.6 Percentage of Participants	29.4 Percentage of Participants

PRIMARY outcome

Timeframe: Up to 14 days post any vaccination (up to approximately study month 13)

An AE is any untoward medical occurrence in a participant temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of a study intervention. Systemic AEs solicited on the VRC consisted of decreased appetite (loss of appetite), irritability, somnolence (drowsiness) and urticaria (hive/welts).

Outcome measures

Outcome measures
Measure	V114 n=587 Participants Full-term infants received a 0.5 mL intramuscular injection of V114 at approximately 2, 4, and 11-15 months of age (Study Day 1, Month 2, and Month 9-13). Preterm infants received a 0.5 mL intramuscular injection of V114 at approximately 2, 3, 4,and 11-15 months of age (Study Day 1, Month 1, Month 2, and Month 9-13). All infants also received licensed background intramuscular injections of 0.5 mL Infanrix™ hexa at approximately 2, 3, 4, and 11-15 months of age (Study Day 1, Months 1, 2, and Month 9-13); and also 1.5 mL oral dose of Rotarix™ at 2 and 4 months of age (Study Day 1 and Month 2).	Prevenar 13™ n=591 Participants Full-term infants received a 0.5 mL intramuscular injection of Prevenar 13™ at approximately 2, 4, and 11-15 months of age (Study Day 1, Month 2, and Month 9-13). Preterm infants received a 0.5 mL intramuscular injection of Prevenar 13™ at approximately 2, 3, 4, and 11-15 months of age (Study Day 1, Month 1, Month 2, and Month 9-13). All infants also received licensed background intramuscular injections of 0.5 mL Infanrix™ hexa at approximately 2, 3, 4, and 11-15 months of age (Study Day 1, Months 1, 2, and Month 9-13); and also 1.5 mL oral dose of Rotarix™ at 2 and 4 months of age (Study Day 1 and Month 2).
Percentage of Participants That Report at Least 1 Solicited Systemic AE Decreased appetite	33.9 Percentage of Participants	33.5 Percentage of Participants
Percentage of Participants That Report at Least 1 Solicited Systemic AE Irritability	71.7 Percentage of Participants	66.3 Percentage of Participants
Percentage of Participants That Report at Least 1 Solicited Systemic AE Somnolence	46.2 Percentage of Participants	41.8 Percentage of Participants
Percentage of Participants That Report at Least 1 Solicited Systemic AE Urticaria	3.7 Percentage of Participants	3.9 Percentage of Participants

PRIMARY outcome

Timeframe: Up to 6 months post last vaccination (up to approximately study month 20)

A serious adverse event (SAE) is an AE that results in death, is life threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, is a cancer, is an overdose, or is another important medical event. The relatedness of a vaccine to a SAE is determined by an investigator who is a qualified physician.

Outcome measures

Outcome measures
Measure	V114 n=587 Participants Full-term infants received a 0.5 mL intramuscular injection of V114 at approximately 2, 4, and 11-15 months of age (Study Day 1, Month 2, and Month 9-13). Preterm infants received a 0.5 mL intramuscular injection of V114 at approximately 2, 3, 4,and 11-15 months of age (Study Day 1, Month 1, Month 2, and Month 9-13). All infants also received licensed background intramuscular injections of 0.5 mL Infanrix™ hexa at approximately 2, 3, 4, and 11-15 months of age (Study Day 1, Months 1, 2, and Month 9-13); and also 1.5 mL oral dose of Rotarix™ at 2 and 4 months of age (Study Day 1 and Month 2).	Prevenar 13™ n=591 Participants Full-term infants received a 0.5 mL intramuscular injection of Prevenar 13™ at approximately 2, 4, and 11-15 months of age (Study Day 1, Month 2, and Month 9-13). Preterm infants received a 0.5 mL intramuscular injection of Prevenar 13™ at approximately 2, 3, 4, and 11-15 months of age (Study Day 1, Month 1, Month 2, and Month 9-13). All infants also received licensed background intramuscular injections of 0.5 mL Infanrix™ hexa at approximately 2, 3, 4, and 11-15 months of age (Study Day 1, Months 1, 2, and Month 9-13); and also 1.5 mL oral dose of Rotarix™ at 2 and 4 months of age (Study Day 1 and Month 2).
Percentage of Participants That Report at Least 1 Vaccine-related Serious Adverse Event (SAE)	0.0 Percentage of Participants	0.2 Percentage of Participants

PRIMARY outcome

Timeframe: 30 days PTD (Up to approximately study month 14)

Population: All randomized participants without deviations from the protocol that may substantially affect the results. Deviations include, but are not limited to, failure to receive vaccination; receipt of prohibited medication or vaccine; failure to receive vaccination at the required time point; failure to receive the required vaccination dose; and collection of blood sample at a time point outside of the prespecified time window.

Sera from participants was used to measure vaccine-induced anti-PnPs serotype-specific IgG for each serotype using pneumococcal electrochemiluminescence (PnECL). The Geometric Mean Concentration (GMC) for each of the 13 serotypes shared by both V114 and Prevenar 13™ (Serotypes 1 to 23F); and the 2 serotypes unique to V114 (Serotypes 22F and 33F) was assessed. Per protocol, within-group CIs were not calculated.

Outcome measures

PRIMARY outcome

Timeframe: 30 days PTD (Up to approximately study month 14)

Sera from participants was used to measure vaccine-induced anti-PnPs serotype-specific IgG for the 15 serotypes using pneumococcal electrochemiluminescence (PnECL). The percentage of participants that achieve the threshold value of ≥0.35 μg/mL for each of the 13 serotypes shared by both V114 and Prevenar 13™ (Serotypes 1 to 23F); and the 2 serotypes unique to V114 (Serotypes 22F and 33F) was assessed.

Outcome measures

Outcome measures
Measure	V114 n=588 Participants Full-term infants received a 0.5 mL intramuscular injection of V114 at approximately 2, 4, and 11-15 months of age (Study Day 1, Month 2, and Month 9-13). Preterm infants received a 0.5 mL intramuscular injection of V114 at approximately 2, 3, 4,and 11-15 months of age (Study Day 1, Month 1, Month 2, and Month 9-13). All infants also received licensed background intramuscular injections of 0.5 mL Infanrix™ hexa at approximately 2, 3, 4, and 11-15 months of age (Study Day 1, Months 1, 2, and Month 9-13); and also 1.5 mL oral dose of Rotarix™ at 2 and 4 months of age (Study Day 1 and Month 2).	Prevenar 13™ n=591 Participants Full-term infants received a 0.5 mL intramuscular injection of Prevenar 13™ at approximately 2, 4, and 11-15 months of age (Study Day 1, Month 2, and Month 9-13). Preterm infants received a 0.5 mL intramuscular injection of Prevenar 13™ at approximately 2, 3, 4, and 11-15 months of age (Study Day 1, Month 1, Month 2, and Month 9-13). All infants also received licensed background intramuscular injections of 0.5 mL Infanrix™ hexa at approximately 2, 3, 4, and 11-15 months of age (Study Day 1, Months 1, 2, and Month 9-13); and also 1.5 mL oral dose of Rotarix™ at 2 and 4 months of age (Study Day 1 and Month 2).
Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PTD Serotype 1	96.7 Percentage of Participants	99.4 Percentage of Participants
Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PTD Serotype 3	92.0 Percentage of Participants	83.8 Percentage of Participants
Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PTD Serotype 4	95.7 Percentage of Participants	97.9 Percentage of Participants
Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PTD Serotype 5	99.1 Percentage of Participants	100.0 Percentage of Participants
Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PTD Serotype 6A	98.5 Percentage of Participants	98.9 Percentage of Participants
Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PTD Serotype 6B	97.4 Percentage of Participants	99.1 Percentage of Participants
Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PTD Serotype 7F	99.8 Percentage of Participants	99.8 Percentage of Participants
Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PTD Serotype 9V	98.9 Percentage of Participants	100.0 Percentage of Participants
Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PTD Serotype 14	99.8 Percentage of Participants	100.0 Percentage of Participants
Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PTD Serotype 18C	98.9 Percentage of Participants	99.3 Percentage of Participants
Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PTD Serotype 19A	99.1 Percentage of Participants	100.0 Percentage of Participants
Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PTD Serotype 19F	99.6 Percentage of Participants	100.0 Percentage of Participants
Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PTD Serotype 23F	96.8 Percentage of Participants	97.4 Percentage of Participants
Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PTD Serotype 22F	99.6 Percentage of Participants	5.8 Percentage of Participants
Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PTD Serotype 33F	99.1 Percentage of Participants	4.2 Percentage of Participants

SECONDARY outcome

Timeframe: 30 days PTD (Up to approximately study month 14)

Sera from participants was used to measure vaccine-induced responses to 10 pre-specified Infanrix™ hexa antigens with the following threshold (% ≥) values: Diphtheria toxoid-0.1 international unit (IU)/mL;Tetanus toxoid-0.1 IU/mL; Pertussis pertussis toxin (PT)-5 endotoxin unit (EU)/mL; Pertussis filamentous hemagglutinin (FHA)-5 EU/mL; Pertussis pertactin (PRN)-5 EU/mL; Haemophilus influenzae type b (Hib) polyribosylribitol phosphate (PRP)-0.15 μg/mL; hepatitis B surface antigen (HBsAg)-10 mIU/mL; Poliovirus 1,2 and 3-1:8 neutralizing antibodies (NAb) dilution.

Outcome measures

Outcome measures
Measure	V114 n=588 Participants Full-term infants received a 0.5 mL intramuscular injection of V114 at approximately 2, 4, and 11-15 months of age (Study Day 1, Month 2, and Month 9-13). Preterm infants received a 0.5 mL intramuscular injection of V114 at approximately 2, 3, 4,and 11-15 months of age (Study Day 1, Month 1, Month 2, and Month 9-13). All infants also received licensed background intramuscular injections of 0.5 mL Infanrix™ hexa at approximately 2, 3, 4, and 11-15 months of age (Study Day 1, Months 1, 2, and Month 9-13); and also 1.5 mL oral dose of Rotarix™ at 2 and 4 months of age (Study Day 1 and Month 2).	Prevenar 13™ n=591 Participants Full-term infants received a 0.5 mL intramuscular injection of Prevenar 13™ at approximately 2, 4, and 11-15 months of age (Study Day 1, Month 2, and Month 9-13). Preterm infants received a 0.5 mL intramuscular injection of Prevenar 13™ at approximately 2, 3, 4, and 11-15 months of age (Study Day 1, Month 1, Month 2, and Month 9-13). All infants also received licensed background intramuscular injections of 0.5 mL Infanrix™ hexa at approximately 2, 3, 4, and 11-15 months of age (Study Day 1, Months 1, 2, and Month 9-13); and also 1.5 mL oral dose of Rotarix™ at 2 and 4 months of age (Study Day 1 and Month 2).
Percentage of Participants Who Meet Antigen-Specific Threshold Value for Each Antigen in Infanrix™ Hexa at 30 Days PTD Diphtheria toxoid	99.3 Percentage of Participants	99.8 Percentage of Participants
Percentage of Participants Who Meet Antigen-Specific Threshold Value for Each Antigen in Infanrix™ Hexa at 30 Days PTD Tetanus toxoid	99.6 Percentage of Participants	100.0 Percentage of Participants
Percentage of Participants Who Meet Antigen-Specific Threshold Value for Each Antigen in Infanrix™ Hexa at 30 Days PTD Pertussis PT	99.4 Percentage of Participants	99.6 Percentage of Participants
Percentage of Participants Who Meet Antigen-Specific Threshold Value for Each Antigen in Infanrix™ Hexa at 30 Days PTD Pertussis FHA	99.8 Percentage of Participants	100.0 Percentage of Participants
Percentage of Participants Who Meet Antigen-Specific Threshold Value for Each Antigen in Infanrix™ Hexa at 30 Days PTD Pertussis PRN	99.6 Percentage of Participants	100.0 Percentage of Participants
Percentage of Participants Who Meet Antigen-Specific Threshold Value for Each Antigen in Infanrix™ Hexa at 30 Days PTD Hib PRP	98.5 Percentage of Participants	98.1 Percentage of Participants
Percentage of Participants Who Meet Antigen-Specific Threshold Value for Each Antigen in Infanrix™ Hexa at 30 Days PTD HBsAg	99.2 Percentage of Participants	100.0 Percentage of Participants
Percentage of Participants Who Meet Antigen-Specific Threshold Value for Each Antigen in Infanrix™ Hexa at 30 Days PTD Poliovirus 1	100.0 Percentage of Participants	100.0 Percentage of Participants
Percentage of Participants Who Meet Antigen-Specific Threshold Value for Each Antigen in Infanrix™ Hexa at 30 Days PTD Poliovirus 2	100.0 Percentage of Participants	100.0 Percentage of Participants
Percentage of Participants Who Meet Antigen-Specific Threshold Value for Each Antigen in Infanrix™ Hexa at 30 Days PTD Poliovirus 3	100.0 Percentage of Participants	99.8 Percentage of Participants

SECONDARY outcome

Timeframe: 30 days PPS (Up to approximately study month 3)

Sera from participants was used to measure vaccine-induced antibodies in response to vaccination with Rotarix™ by assessing the GMT for IgA. Per protocol, within-group CIs were not calculated.

Outcome measures

Outcome measures
Measure	V114 n=520 Participants Full-term infants received a 0.5 mL intramuscular injection of V114 at approximately 2, 4, and 11-15 months of age (Study Day 1, Month 2, and Month 9-13). Preterm infants received a 0.5 mL intramuscular injection of V114 at approximately 2, 3, 4,and 11-15 months of age (Study Day 1, Month 1, Month 2, and Month 9-13). All infants also received licensed background intramuscular injections of 0.5 mL Infanrix™ hexa at approximately 2, 3, 4, and 11-15 months of age (Study Day 1, Months 1, 2, and Month 9-13); and also 1.5 mL oral dose of Rotarix™ at 2 and 4 months of age (Study Day 1 and Month 2).	Prevenar 13™ n=503 Participants Full-term infants received a 0.5 mL intramuscular injection of Prevenar 13™ at approximately 2, 4, and 11-15 months of age (Study Day 1, Month 2, and Month 9-13). Preterm infants received a 0.5 mL intramuscular injection of Prevenar 13™ at approximately 2, 3, 4, and 11-15 months of age (Study Day 1, Month 1, Month 2, and Month 9-13). All infants also received licensed background intramuscular injections of 0.5 mL Infanrix™ hexa at approximately 2, 3, 4, and 11-15 months of age (Study Day 1, Months 1, 2, and Month 9-13); and also 1.5 mL oral dose of Rotarix™ at 2 and 4 months of age (Study Day 1 and Month 2).
Anti-rotavirus Immunoglobulin A (IgA) Geometric Mean Titers (GMTs) at 30 Days Post Primary Series (PPS) of Rotarix™	45.39 Titer NA means that per protocol, no within-group measures of dispersion (MOD) were planned or calculated.	47.07 Titer NA means that per protocol, no within-group MOD were planned or calculated.

SECONDARY outcome

Timeframe: 30 days PPS (Up to approximately study month 3)

Sera from participants was used to measure vaccine-induced anti-PnPs serotype-specific IgG for each serotype using PnECL. The GMC for each of the 13 serotypes shared by both V114 and Prevenar 13™ (Serotypes 1 to 23F); and the 2 serotypes unique to V114 (Serotypes 22F and 33F) was assessed. Per protocol, within-group CIs were not calculated.

Outcome measures

SECONDARY outcome

Timeframe: 30 days PPS (Up to approximately study month 3)

Sera from participants was used to measure vaccine-induced anti-PnPs serotype-specific IgG for the 15 serotypes using PnECL. The percentage of participants that achieve the threshold value of ≥0.35 μg/mL for each of the 13 serotypes shared by both V114 and Prevenar 13™ (Serotypes 1 to 23F); and the 2 serotypes unique to V114 (Serotypes 22F and 33F) was assessed.

Outcome measures

Outcome measures
Measure	V114 n=588 Participants Full-term infants received a 0.5 mL intramuscular injection of V114 at approximately 2, 4, and 11-15 months of age (Study Day 1, Month 2, and Month 9-13). Preterm infants received a 0.5 mL intramuscular injection of V114 at approximately 2, 3, 4,and 11-15 months of age (Study Day 1, Month 1, Month 2, and Month 9-13). All infants also received licensed background intramuscular injections of 0.5 mL Infanrix™ hexa at approximately 2, 3, 4, and 11-15 months of age (Study Day 1, Months 1, 2, and Month 9-13); and also 1.5 mL oral dose of Rotarix™ at 2 and 4 months of age (Study Day 1 and Month 2).	Prevenar 13™ n=591 Participants Full-term infants received a 0.5 mL intramuscular injection of Prevenar 13™ at approximately 2, 4, and 11-15 months of age (Study Day 1, Month 2, and Month 9-13). Preterm infants received a 0.5 mL intramuscular injection of Prevenar 13™ at approximately 2, 3, 4, and 11-15 months of age (Study Day 1, Month 1, Month 2, and Month 9-13). All infants also received licensed background intramuscular injections of 0.5 mL Infanrix™ hexa at approximately 2, 3, 4, and 11-15 months of age (Study Day 1, Months 1, 2, and Month 9-13); and also 1.5 mL oral dose of Rotarix™ at 2 and 4 months of age (Study Day 1 and Month 2).
Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PPS Serotype 1	95.4 Percentage of Participants	97.4 Percentage of Participants
Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PPS Serotype 3	93.5 Percentage of Participants	67.8 Percentage of Participants
Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PPS Serotype 4	93.9 Percentage of Participants	96.8 Percentage of Participants
Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PPS Serotype 5	84.5 Percentage of Participants	88.4 Percentage of Participants
Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PPS Serotype 6A	73.2 Percentage of Participants	92.6 Percentage of Participants
Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PPS Serotype 6B	57.3 Percentage of Participants	52.7 Percentage of Participants
Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PPS Serotype 7F	97.9 Percentage of Participants	99.0 Percentage of Participants
Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PPS Serotype 9V	88.7 Percentage of Participants	95.4 Percentage of Participants
Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PPS Serotype 14	96.9 Percentage of Participants	97.4 Percentage of Participants
Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PPS Serotype 18C	92.3 Percentage of Participants	93.0 Percentage of Participants
Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PPS Serotype 19A	96.2 Percentage of Participants	97.4 Percentage of Participants
Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PPS Serotype 19F	98.9 Percentage of Participants	99.4 Percentage of Participants
Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PPS Serotype 23F	78.5 Percentage of Participants	71.9 Percentage of Participants
Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PPS Serotype 22F	95.6 Percentage of Participants	5.2 Percentage of Participants
Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PPS Serotype 33F	48.7 Percentage of Participants	2.8 Percentage of Participants

SECONDARY outcome

Timeframe: 30 days PTD (Up to approximately study month 14)

Sera from participants was used to measure vaccine-induced anti-PnPs serotype-specific OPA using the multiplexed opsonophagocytic assay (MOPA). The GMT for each of the 13 serotypes shared by both V114 and Prevenar 13™ (Serotypes 1 to 23F); and the 2 serotypes unique to V114 (Serotypes 22F and 33F) was assessed. The within-group CIs were obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution.

Outcome measures

Outcome measures
Measure	V114 n=116 Participants Full-term infants received a 0.5 mL intramuscular injection of V114 at approximately 2, 4, and 11-15 months of age (Study Day 1, Month 2, and Month 9-13). Preterm infants received a 0.5 mL intramuscular injection of V114 at approximately 2, 3, 4,and 11-15 months of age (Study Day 1, Month 1, Month 2, and Month 9-13). All infants also received licensed background intramuscular injections of 0.5 mL Infanrix™ hexa at approximately 2, 3, 4, and 11-15 months of age (Study Day 1, Months 1, 2, and Month 9-13); and also 1.5 mL oral dose of Rotarix™ at 2 and 4 months of age (Study Day 1 and Month 2).	Prevenar 13™ n=122 Participants Full-term infants received a 0.5 mL intramuscular injection of Prevenar 13™ at approximately 2, 4, and 11-15 months of age (Study Day 1, Month 2, and Month 9-13). Preterm infants received a 0.5 mL intramuscular injection of Prevenar 13™ at approximately 2, 3, 4, and 11-15 months of age (Study Day 1, Month 1, Month 2, and Month 9-13). All infants also received licensed background intramuscular injections of 0.5 mL Infanrix™ hexa at approximately 2, 3, 4, and 11-15 months of age (Study Day 1, Months 1, 2, and Month 9-13); and also 1.5 mL oral dose of Rotarix™ at 2 and 4 months of age (Study Day 1 and Month 2).
Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) GMTs for Each Serotype at 30 Days PTD Serotype 1	136.8 Titer Interval 107.2 to 174.6	164.6 Titer Interval 127.9 to 211.8
Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) GMTs for Each Serotype at 30 Days PTD Serotype 3	321.5 Titer Interval 277.2 to 372.9	303.0 Titer Interval 253.2 to 362.6
Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) GMTs for Each Serotype at 30 Days PTD Serotype 4	2231.7 Titer Interval 1770.5 to 2813.1	3206.4 Titer Interval 2626.6 to 3914.1
Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) GMTs for Each Serotype at 30 Days PTD Serotype 5	791.6 Titer Interval 640.9 to 977.8	947.9 Titer Interval 784.3 to 1145.7
Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) GMTs for Each Serotype at 30 Days PTD Serotype 6	3274.9 Titer Interval 2734.5 to 3921.9	5387.2 Titer Interval 4388.9 to 6612.5
Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) GMTs for Each Serotype at 30 Days PTD Serotype 6B	2439.9 Titer Interval 1936.1 to 3074.7	3182.4 Titer Interval 2500.9 to 4049.7
Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) GMTs for Each Serotype at 30 Days PTD Serotype 7F	6300.9 Titer Interval 5363.9 to 7401.7	10071.4 Titer Interval 8327.2 to 12181.0
Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) GMTs for Each Serotype at 30 Days PTD Serotype 9V	1904.4 Titer Interval 1584.8 to 2288.4	2616.6 Titer Interval 2133.3 to 3209.4
Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) GMTs for Each Serotype at 30 Days PTD Serotype 14	2633.8 Titer Interval 2102.6 to 3299.2	2582.1 Titer Interval 2089.5 to 3190.9
Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) GMTs for Each Serotype at 30 Days PTD Serotype 18C	1968.6 Titer Interval 1676.4 to 2311.7	2091.8 Titer Interval 1789.1 to 2445.7
Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) GMTs for Each Serotype at 30 Days PTD Serotype 19A	2995.6 Titer Interval 2556.5 to 3510.0	4254.3 Titer Interval 3649.3 to 4959.5
Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) GMTs for Each Serotype at 30 Days PTD Serotype 19F	1793.9 Titer Interval 1535.3 to 2096.1	2012.3 Titer Interval 1677.0 to 2414.6
Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) GMTs for Each Serotype at 30 Days PTD Serotype 23F	4517.8 Titer Interval 3685.1 to 5538.8	7987.6 Titer Interval 6149.3 to 10375.5
Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) GMTs for Each Serotype at 30 Days PTD Serotype 22F	2405.2 Titer Interval 1980.5 to 2921.0	24.5 Titer Interval 16.0 to 37.7
Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) GMTs for Each Serotype at 30 Days PTD Serotype 33F	14268.4 Titer Interval 11680.1 to 17430.2	1875.6 Titer Interval 1477.4 to 2381.3

SECONDARY outcome

Timeframe: 30 days PTD (Up to approximately study month 14)

Sera from participants was used to measure vaccine-induced anti-PnPs serotype-specific OPA using the MOPA. The threshold dilution (% ≥) for each of the 13 serotypes shared by both V114 and Prevenar 13™ (Serotypes 1 to 23F) were as follows: 1:9, 1:19, 1:34, 1:27, 1:232, 1:40, 1:61, 1:151, 1:62, 1:115, 1:31, 1:113, 1:55. For Serotypes 22F and 33F the threshold dilution was 1:15 and 1:20 respectively. The within-group CIs were based on the exact binomial method of Clopper and Pearson.

Outcome measures

Outcome measures
Measure	V114 n=116 Participants Full-term infants received a 0.5 mL intramuscular injection of V114 at approximately 2, 4, and 11-15 months of age (Study Day 1, Month 2, and Month 9-13). Preterm infants received a 0.5 mL intramuscular injection of V114 at approximately 2, 3, 4,and 11-15 months of age (Study Day 1, Month 1, Month 2, and Month 9-13). All infants also received licensed background intramuscular injections of 0.5 mL Infanrix™ hexa at approximately 2, 3, 4, and 11-15 months of age (Study Day 1, Months 1, 2, and Month 9-13); and also 1.5 mL oral dose of Rotarix™ at 2 and 4 months of age (Study Day 1 and Month 2).	Prevenar 13™ n=122 Participants Full-term infants received a 0.5 mL intramuscular injection of Prevenar 13™ at approximately 2, 4, and 11-15 months of age (Study Day 1, Month 2, and Month 9-13). Preterm infants received a 0.5 mL intramuscular injection of Prevenar 13™ at approximately 2, 3, 4, and 11-15 months of age (Study Day 1, Month 1, Month 2, and Month 9-13). All infants also received licensed background intramuscular injections of 0.5 mL Infanrix™ hexa at approximately 2, 3, 4, and 11-15 months of age (Study Day 1, Months 1, 2, and Month 9-13); and also 1.5 mL oral dose of Rotarix™ at 2 and 4 months of age (Study Day 1 and Month 2).
Percentage of Participants Who Meet Serotype-specific OPA Threshold Value for Each Serotype at 30 Days PTD Serotype 18C	100.0 Percentage of Participants Interval 96.3 to 100.0	100.0 Percentage of Participants Interval 96.5 to 100.0
Percentage of Participants Who Meet Serotype-specific OPA Threshold Value for Each Serotype at 30 Days PTD Serotype 19A	100.0 Percentage of Participants Interval 96.4 to 100.0	100.0 Percentage of Participants Interval 96.5 to 100.0
Percentage of Participants Who Meet Serotype-specific OPA Threshold Value for Each Serotype at 30 Days PTD Serotype 19F	100.0 Percentage of Participants Interval 96.3 to 100.0	99.0 Percentage of Participants Interval 94.7 to 100.0
Percentage of Participants Who Meet Serotype-specific OPA Threshold Value for Each Serotype at 30 Days PTD Serotype 1	95.0 Percentage of Participants Interval 88.8 to 98.4	98.1 Percentage of Participants Interval 93.5 to 99.8
Percentage of Participants Who Meet Serotype-specific OPA Threshold Value for Each Serotype at 30 Days PTD Serotype 3	100.0 Percentage of Participants Interval 96.3 to 100.0	98.1 Percentage of Participants Interval 93.2 to 99.8
Percentage of Participants Who Meet Serotype-specific OPA Threshold Value for Each Serotype at 30 Days PTD Serotype 4	100.0 Percentage of Participants Interval 96.3 to 100.0	100.0 Percentage of Participants Interval 96.3 to 100.0
Percentage of Participants Who Meet Serotype-specific OPA Threshold Value for Each Serotype at 30 Days PTD Serotype 5	100.0 Percentage of Participants Interval 96.4 to 100.0	100.0 Percentage of Participants Interval 96.6 to 100.0
Percentage of Participants Who Meet Serotype-specific OPA Threshold Value for Each Serotype at 30 Days PTD Serotype 6A	99.0 Percentage of Participants Interval 94.4 to 100.0	100.0 Percentage of Participants Interval 96.3 to 100.0
Percentage of Participants Who Meet Serotype-specific OPA Threshold Value for Each Serotype at 30 Days PTD Serotype 6B	100.0 Percentage of Participants Interval 96.2 to 100.0	100.0 Percentage of Participants Interval 96.2 to 100.0
Percentage of Participants Who Meet Serotype-specific OPA Threshold Value for Each Serotype at 30 Days PTD Serotype 7F	100.0 Percentage of Participants Interval 96.3 to 100.0	100.0 Percentage of Participants Interval 96.4 to 100.0
Percentage of Participants Who Meet Serotype-specific OPA Threshold Value for Each Serotype at 30 Days PTD Serotype 9V	97.9 Percentage of Participants Interval 92.7 to 99.7	100.0 Percentage of Participants Interval 96.5 to 100.0
Percentage of Participants Who Meet Serotype-specific OPA Threshold Value for Each Serotype at 30 Days PTD Serotype 14	100.0 Percentage of Participants Interval 96.3 to 100.0	99.0 Percentage of Participants Interval 94.6 to 100.0
Percentage of Participants Who Meet Serotype-specific OPA Threshold Value for Each Serotype at 30 Days PTD Serotype 23F	100.0 Percentage of Participants Interval 96.3 to 100.0	100.0 Percentage of Participants Interval 96.3 to 100.0
Percentage of Participants Who Meet Serotype-specific OPA Threshold Value for Each Serotype at 30 Days PTD Serotype 22F	99.0 Percentage of Participants Interval 94.4 to 100.0	28.1 Percentage of Participants Interval 19.4 to 38.2
Percentage of Participants Who Meet Serotype-specific OPA Threshold Value for Each Serotype at 30 Days PTD Serotype 33F	100.0 Percentage of Participants Interval 96.2 to 100.0	98.0 Percentage of Participants Interval 93.0 to 99.8

SECONDARY outcome

Timeframe: 30 days PTD (Up to approximately study month 14)

Population: All randomized participants without deviations from the protocol that may substantially affect the results. For each pre-specified serotype, participants were only analyzed for the treatment group that they were randomized to.

Sera from participants was used to measure vaccine-induced anti-PnPs serotype-specific IgG for the 15 serotypes using PnECL. As pre-specified in the protocol the percentage of participants from the two serotypes unique to V114 (Serotypes 22F and 33F) are presented, as well as the percentage of participants with the lowest response rate from any of the 13 shared serotypes randomized to Prevenar 13™ (Serotype 3).

Outcome measures

Outcome measures
Measure	V114 n=588 Participants Full-term infants received a 0.5 mL intramuscular injection of V114 at approximately 2, 4, and 11-15 months of age (Study Day 1, Month 2, and Month 9-13). Preterm infants received a 0.5 mL intramuscular injection of V114 at approximately 2, 3, 4,and 11-15 months of age (Study Day 1, Month 1, Month 2, and Month 9-13). All infants also received licensed background intramuscular injections of 0.5 mL Infanrix™ hexa at approximately 2, 3, 4, and 11-15 months of age (Study Day 1, Months 1, 2, and Month 9-13); and also 1.5 mL oral dose of Rotarix™ at 2 and 4 months of age (Study Day 1 and Month 2).	Prevenar 13™ n=591 Participants Full-term infants received a 0.5 mL intramuscular injection of Prevenar 13™ at approximately 2, 4, and 11-15 months of age (Study Day 1, Month 2, and Month 9-13). Preterm infants received a 0.5 mL intramuscular injection of Prevenar 13™ at approximately 2, 3, 4, and 11-15 months of age (Study Day 1, Month 1, Month 2, and Month 9-13). All infants also received licensed background intramuscular injections of 0.5 mL Infanrix™ hexa at approximately 2, 3, 4, and 11-15 months of age (Study Day 1, Months 1, 2, and Month 9-13); and also 1.5 mL oral dose of Rotarix™ at 2 and 4 months of age (Study Day 1 and Month 2).
Percentage of Participants Who Achieved the IgG Serotype-Specific Threshold Value of ≥0.35 μg/mL For Protocol Pre-Specified Serotypes at 30 Days PTD Serotype 22F	99.6 Percentage of Participants	—
Percentage of Participants Who Achieved the IgG Serotype-Specific Threshold Value of ≥0.35 μg/mL For Protocol Pre-Specified Serotypes at 30 Days PTD Serotype 33F	99.1 Percentage of Participants	—
Percentage of Participants Who Achieved the IgG Serotype-Specific Threshold Value of ≥0.35 μg/mL For Protocol Pre-Specified Serotypes at 30 Days PTD Serotype 3	—	83.8 Percentage of Participants

Adverse Events

V114

Serious events: 57 serious events

Other events: 548 other events

Deaths: 0 deaths

Prevenar 13™

Serious events: 70 serious events

Other events: 540 other events

Deaths: 0 deaths

V114 + Prevenar 13™

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	V114 n=587 participants at risk Full-term infants received a 0.5 mL intramuscular injection of V114 at approximately 2, 4, and 11-15 months of age (Study Day 1, Month 2, and Month 9-13). Preterm infants received a 0.5 mL intramuscular injection of V114 at approximately 2, 3, 4,and 11-15 months of age (Study Day 1, Month 1, Month 2, and Month 9-13). All infants also received licensed background intramuscular injections of 0.5 mL Infanrix™ hexa at approximately 2, 3, 4, and 11-15 months of age (Study Day 1, Months 1, 2, and Month 9-13); and also 1.5 mL oral dose of Rotarix™ at 2 and 4 months of age (Study Day 1 and Month 2).	Prevenar 13™ n=591 participants at risk Full-term infants received a 0.5 mL intramuscular injection of Prevenar 13™ at approximately 2, 4, and 11-15 months of age (Study Day 1, Month 2, and Month 9-13). Preterm infants received a 0.5 mL intramuscular injection of Prevenar 13™ at approximately 2, 3, 4, and 11-15 months of age (Study Day 1, Month 1, Month 2, and Month 9-13). All infants also received licensed background intramuscular injections of 0.5 mL Infanrix™ hexa at approximately 2, 3, 4, and 11-15 months of age (Study Day 1, Months 1, 2, and Month 9-13); and also 1.5 mL oral dose of Rotarix™ at 2 and 4 months of age (Study Day 1 and Month 2).	V114 + Prevenar 13™ n=1 participants at risk Participants inadvertently vaccinated with both V114 and Prevenar 13™
Gastrointestinal disorders Diarrhoea	6.6% 39/587 • Number of events 48 • Non-serious AEs reported from Day 1 through 14 days following each vaccination. Serious AEs reported from Day 1 up to approximately study month 20. All-cause mortality (ACM) reported from randomization up to approximately study month 20. The ACM population was all randomized participants. For AEs the population was APaT, which consisted of participants who received at least 1 dose of study vaccination. The ACM and AEs for participants inadvertently vaccinated with both V114 and Prevenar 13™were reported separately from other participants.	7.6% 45/591 • Number of events 66 • Non-serious AEs reported from Day 1 through 14 days following each vaccination. Serious AEs reported from Day 1 up to approximately study month 20. All-cause mortality (ACM) reported from randomization up to approximately study month 20. The ACM population was all randomized participants. For AEs the population was APaT, which consisted of participants who received at least 1 dose of study vaccination. The ACM and AEs for participants inadvertently vaccinated with both V114 and Prevenar 13™were reported separately from other participants.	0.00% 0/1 • Non-serious AEs reported from Day 1 through 14 days following each vaccination. Serious AEs reported from Day 1 up to approximately study month 20. All-cause mortality (ACM) reported from randomization up to approximately study month 20. The ACM population was all randomized participants. For AEs the population was APaT, which consisted of participants who received at least 1 dose of study vaccination. The ACM and AEs for participants inadvertently vaccinated with both V114 and Prevenar 13™were reported separately from other participants.
General disorders Injection site erythema	45.3% 266/587 • Number of events 455 • Non-serious AEs reported from Day 1 through 14 days following each vaccination. Serious AEs reported from Day 1 up to approximately study month 20. All-cause mortality (ACM) reported from randomization up to approximately study month 20. The ACM population was all randomized participants. For AEs the population was APaT, which consisted of participants who received at least 1 dose of study vaccination. The ACM and AEs for participants inadvertently vaccinated with both V114 and Prevenar 13™were reported separately from other participants.	44.7% 264/591 • Number of events 443 • Non-serious AEs reported from Day 1 through 14 days following each vaccination. Serious AEs reported from Day 1 up to approximately study month 20. All-cause mortality (ACM) reported from randomization up to approximately study month 20. The ACM population was all randomized participants. For AEs the population was APaT, which consisted of participants who received at least 1 dose of study vaccination. The ACM and AEs for participants inadvertently vaccinated with both V114 and Prevenar 13™were reported separately from other participants.	100.0% 1/1 • Number of events 1 • Non-serious AEs reported from Day 1 through 14 days following each vaccination. Serious AEs reported from Day 1 up to approximately study month 20. All-cause mortality (ACM) reported from randomization up to approximately study month 20. The ACM population was all randomized participants. For AEs the population was APaT, which consisted of participants who received at least 1 dose of study vaccination. The ACM and AEs for participants inadvertently vaccinated with both V114 and Prevenar 13™were reported separately from other participants.
General disorders Injection site induration	41.9% 246/587 • Number of events 418 • Non-serious AEs reported from Day 1 through 14 days following each vaccination. Serious AEs reported from Day 1 up to approximately study month 20. All-cause mortality (ACM) reported from randomization up to approximately study month 20. The ACM population was all randomized participants. For AEs the population was APaT, which consisted of participants who received at least 1 dose of study vaccination. The ACM and AEs for participants inadvertently vaccinated with both V114 and Prevenar 13™were reported separately from other participants.	39.1% 231/591 • Number of events 392 • Non-serious AEs reported from Day 1 through 14 days following each vaccination. Serious AEs reported from Day 1 up to approximately study month 20. All-cause mortality (ACM) reported from randomization up to approximately study month 20. The ACM population was all randomized participants. For AEs the population was APaT, which consisted of participants who received at least 1 dose of study vaccination. The ACM and AEs for participants inadvertently vaccinated with both V114 and Prevenar 13™were reported separately from other participants.	0.00% 0/1 • Non-serious AEs reported from Day 1 through 14 days following each vaccination. Serious AEs reported from Day 1 up to approximately study month 20. All-cause mortality (ACM) reported from randomization up to approximately study month 20. The ACM population was all randomized participants. For AEs the population was APaT, which consisted of participants who received at least 1 dose of study vaccination. The ACM and AEs for participants inadvertently vaccinated with both V114 and Prevenar 13™were reported separately from other participants.
General disorders Injection site pain	40.5% 238/587 • Number of events 370 • Non-serious AEs reported from Day 1 through 14 days following each vaccination. Serious AEs reported from Day 1 up to approximately study month 20. All-cause mortality (ACM) reported from randomization up to approximately study month 20. The ACM population was all randomized participants. For AEs the population was APaT, which consisted of participants who received at least 1 dose of study vaccination. The ACM and AEs for participants inadvertently vaccinated with both V114 and Prevenar 13™were reported separately from other participants.	29.3% 173/591 • Number of events 257 • Non-serious AEs reported from Day 1 through 14 days following each vaccination. Serious AEs reported from Day 1 up to approximately study month 20. All-cause mortality (ACM) reported from randomization up to approximately study month 20. The ACM population was all randomized participants. For AEs the population was APaT, which consisted of participants who received at least 1 dose of study vaccination. The ACM and AEs for participants inadvertently vaccinated with both V114 and Prevenar 13™were reported separately from other participants.	0.00% 0/1 • Non-serious AEs reported from Day 1 through 14 days following each vaccination. Serious AEs reported from Day 1 up to approximately study month 20. All-cause mortality (ACM) reported from randomization up to approximately study month 20. The ACM population was all randomized participants. For AEs the population was APaT, which consisted of participants who received at least 1 dose of study vaccination. The ACM and AEs for participants inadvertently vaccinated with both V114 and Prevenar 13™were reported separately from other participants.
General disorders Injection site swelling	33.6% 197/587 • Number of events 315 • Non-serious AEs reported from Day 1 through 14 days following each vaccination. Serious AEs reported from Day 1 up to approximately study month 20. All-cause mortality (ACM) reported from randomization up to approximately study month 20. The ACM population was all randomized participants. For AEs the population was APaT, which consisted of participants who received at least 1 dose of study vaccination. The ACM and AEs for participants inadvertently vaccinated with both V114 and Prevenar 13™were reported separately from other participants.	29.4% 174/591 • Number of events 263 • Non-serious AEs reported from Day 1 through 14 days following each vaccination. Serious AEs reported from Day 1 up to approximately study month 20. All-cause mortality (ACM) reported from randomization up to approximately study month 20. The ACM population was all randomized participants. For AEs the population was APaT, which consisted of participants who received at least 1 dose of study vaccination. The ACM and AEs for participants inadvertently vaccinated with both V114 and Prevenar 13™were reported separately from other participants.	0.00% 0/1 • Non-serious AEs reported from Day 1 through 14 days following each vaccination. Serious AEs reported from Day 1 up to approximately study month 20. All-cause mortality (ACM) reported from randomization up to approximately study month 20. The ACM population was all randomized participants. For AEs the population was APaT, which consisted of participants who received at least 1 dose of study vaccination. The ACM and AEs for participants inadvertently vaccinated with both V114 and Prevenar 13™were reported separately from other participants.
General disorders Pyrexia	44.5% 261/587 • Number of events 447 • Non-serious AEs reported from Day 1 through 14 days following each vaccination. Serious AEs reported from Day 1 up to approximately study month 20. All-cause mortality (ACM) reported from randomization up to approximately study month 20. The ACM population was all randomized participants. For AEs the population was APaT, which consisted of participants who received at least 1 dose of study vaccination. The ACM and AEs for participants inadvertently vaccinated with both V114 and Prevenar 13™were reported separately from other participants.	42.5% 251/591 • Number of events 437 • Non-serious AEs reported from Day 1 through 14 days following each vaccination. Serious AEs reported from Day 1 up to approximately study month 20. All-cause mortality (ACM) reported from randomization up to approximately study month 20. The ACM population was all randomized participants. For AEs the population was APaT, which consisted of participants who received at least 1 dose of study vaccination. The ACM and AEs for participants inadvertently vaccinated with both V114 and Prevenar 13™were reported separately from other participants.	100.0% 1/1 • Number of events 1 • Non-serious AEs reported from Day 1 through 14 days following each vaccination. Serious AEs reported from Day 1 up to approximately study month 20. All-cause mortality (ACM) reported from randomization up to approximately study month 20. The ACM population was all randomized participants. For AEs the population was APaT, which consisted of participants who received at least 1 dose of study vaccination. The ACM and AEs for participants inadvertently vaccinated with both V114 and Prevenar 13™were reported separately from other participants.
Infections and infestations Rhinitis	4.9% 29/587 • Number of events 33 • Non-serious AEs reported from Day 1 through 14 days following each vaccination. Serious AEs reported from Day 1 up to approximately study month 20. All-cause mortality (ACM) reported from randomization up to approximately study month 20. The ACM population was all randomized participants. For AEs the population was APaT, which consisted of participants who received at least 1 dose of study vaccination. The ACM and AEs for participants inadvertently vaccinated with both V114 and Prevenar 13™were reported separately from other participants.	7.4% 44/591 • Number of events 51 • Non-serious AEs reported from Day 1 through 14 days following each vaccination. Serious AEs reported from Day 1 up to approximately study month 20. All-cause mortality (ACM) reported from randomization up to approximately study month 20. The ACM population was all randomized participants. For AEs the population was APaT, which consisted of participants who received at least 1 dose of study vaccination. The ACM and AEs for participants inadvertently vaccinated with both V114 and Prevenar 13™were reported separately from other participants.	0.00% 0/1 • Non-serious AEs reported from Day 1 through 14 days following each vaccination. Serious AEs reported from Day 1 up to approximately study month 20. All-cause mortality (ACM) reported from randomization up to approximately study month 20. The ACM population was all randomized participants. For AEs the population was APaT, which consisted of participants who received at least 1 dose of study vaccination. The ACM and AEs for participants inadvertently vaccinated with both V114 and Prevenar 13™were reported separately from other participants.
Infections and infestations Upper respiratory tract infection	1.5% 9/587 • Number of events 9 • Non-serious AEs reported from Day 1 through 14 days following each vaccination. Serious AEs reported from Day 1 up to approximately study month 20. All-cause mortality (ACM) reported from randomization up to approximately study month 20. The ACM population was all randomized participants. For AEs the population was APaT, which consisted of participants who received at least 1 dose of study vaccination. The ACM and AEs for participants inadvertently vaccinated with both V114 and Prevenar 13™were reported separately from other participants.	1.4% 8/591 • Number of events 8 • Non-serious AEs reported from Day 1 through 14 days following each vaccination. Serious AEs reported from Day 1 up to approximately study month 20. All-cause mortality (ACM) reported from randomization up to approximately study month 20. The ACM population was all randomized participants. For AEs the population was APaT, which consisted of participants who received at least 1 dose of study vaccination. The ACM and AEs for participants inadvertently vaccinated with both V114 and Prevenar 13™were reported separately from other participants.	100.0% 1/1 • Number of events 2 • Non-serious AEs reported from Day 1 through 14 days following each vaccination. Serious AEs reported from Day 1 up to approximately study month 20. All-cause mortality (ACM) reported from randomization up to approximately study month 20. The ACM population was all randomized participants. For AEs the population was APaT, which consisted of participants who received at least 1 dose of study vaccination. The ACM and AEs for participants inadvertently vaccinated with both V114 and Prevenar 13™were reported separately from other participants.
Metabolism and nutrition disorders Decreased appetite	33.9% 199/587 • Number of events 354 • Non-serious AEs reported from Day 1 through 14 days following each vaccination. Serious AEs reported from Day 1 up to approximately study month 20. All-cause mortality (ACM) reported from randomization up to approximately study month 20. The ACM population was all randomized participants. For AEs the population was APaT, which consisted of participants who received at least 1 dose of study vaccination. The ACM and AEs for participants inadvertently vaccinated with both V114 and Prevenar 13™were reported separately from other participants.	33.5% 198/591 • Number of events 334 • Non-serious AEs reported from Day 1 through 14 days following each vaccination. Serious AEs reported from Day 1 up to approximately study month 20. All-cause mortality (ACM) reported from randomization up to approximately study month 20. The ACM population was all randomized participants. For AEs the population was APaT, which consisted of participants who received at least 1 dose of study vaccination. The ACM and AEs for participants inadvertently vaccinated with both V114 and Prevenar 13™were reported separately from other participants.	0.00% 0/1 • Non-serious AEs reported from Day 1 through 14 days following each vaccination. Serious AEs reported from Day 1 up to approximately study month 20. All-cause mortality (ACM) reported from randomization up to approximately study month 20. The ACM population was all randomized participants. For AEs the population was APaT, which consisted of participants who received at least 1 dose of study vaccination. The ACM and AEs for participants inadvertently vaccinated with both V114 and Prevenar 13™were reported separately from other participants.
Nervous system disorders Somnolence	46.2% 271/587 • Number of events 507 • Non-serious AEs reported from Day 1 through 14 days following each vaccination. Serious AEs reported from Day 1 up to approximately study month 20. All-cause mortality (ACM) reported from randomization up to approximately study month 20. The ACM population was all randomized participants. For AEs the population was APaT, which consisted of participants who received at least 1 dose of study vaccination. The ACM and AEs for participants inadvertently vaccinated with both V114 and Prevenar 13™were reported separately from other participants.	41.8% 247/591 • Number of events 473 • Non-serious AEs reported from Day 1 through 14 days following each vaccination. Serious AEs reported from Day 1 up to approximately study month 20. All-cause mortality (ACM) reported from randomization up to approximately study month 20. The ACM population was all randomized participants. For AEs the population was APaT, which consisted of participants who received at least 1 dose of study vaccination. The ACM and AEs for participants inadvertently vaccinated with both V114 and Prevenar 13™were reported separately from other participants.	0.00% 0/1 • Non-serious AEs reported from Day 1 through 14 days following each vaccination. Serious AEs reported from Day 1 up to approximately study month 20. All-cause mortality (ACM) reported from randomization up to approximately study month 20. The ACM population was all randomized participants. For AEs the population was APaT, which consisted of participants who received at least 1 dose of study vaccination. The ACM and AEs for participants inadvertently vaccinated with both V114 and Prevenar 13™were reported separately from other participants.
Psychiatric disorders Irritability	71.7% 421/587 • Number of events 1094 • Non-serious AEs reported from Day 1 through 14 days following each vaccination. Serious AEs reported from Day 1 up to approximately study month 20. All-cause mortality (ACM) reported from randomization up to approximately study month 20. The ACM population was all randomized participants. For AEs the population was APaT, which consisted of participants who received at least 1 dose of study vaccination. The ACM and AEs for participants inadvertently vaccinated with both V114 and Prevenar 13™were reported separately from other participants.	66.3% 392/591 • Number of events 1038 • Non-serious AEs reported from Day 1 through 14 days following each vaccination. Serious AEs reported from Day 1 up to approximately study month 20. All-cause mortality (ACM) reported from randomization up to approximately study month 20. The ACM population was all randomized participants. For AEs the population was APaT, which consisted of participants who received at least 1 dose of study vaccination. The ACM and AEs for participants inadvertently vaccinated with both V114 and Prevenar 13™were reported separately from other participants.	100.0% 1/1 • Number of events 1 • Non-serious AEs reported from Day 1 through 14 days following each vaccination. Serious AEs reported from Day 1 up to approximately study month 20. All-cause mortality (ACM) reported from randomization up to approximately study month 20. The ACM population was all randomized participants. For AEs the population was APaT, which consisted of participants who received at least 1 dose of study vaccination. The ACM and AEs for participants inadvertently vaccinated with both V114 and Prevenar 13™were reported separately from other 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 If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
Publication restrictions are in place

Restriction type: OTHER

Measure	V114 n=588 Participants Full-term infants received a 0.5 mL intramuscular injection of V114 at approximately 2, 4, and 11-15 months of age (Study Day 1, Month 2, and Month 9-13). Preterm infants received a 0.5 mL intramuscular injection of V114 at approximately 2, 3, 4,and 11-15 months of age (Study Day 1, Month 1, Month 2, and Month 9-13). All infants also received licensed background intramuscular injections of 0.5 mL Infanrix™ hexa at approximately 2, 3, 4, and 11-15 months of age (Study Day 1, Months 1, 2, and Month 9-13); and also 1.5 mL oral dose of Rotarix™ at 2 and 4 months of age (Study Day 1 and Month 2).	Prevenar 13™ n=591 Participants Full-term infants received a 0.5 mL intramuscular injection of Prevenar 13™ at approximately 2, 4, and 11-15 months of age (Study Day 1, Month 2, and Month 9-13). Preterm infants received a 0.5 mL intramuscular injection of Prevenar 13™ at approximately 2, 3, 4, and 11-15 months of age (Study Day 1, Month 1, Month 2, and Month 9-13). All infants also received licensed background intramuscular injections of 0.5 mL Infanrix™ hexa at approximately 2, 3, 4, and 11-15 months of age (Study Day 1, Months 1, 2, and Month 9-13); and also 1.5 mL oral dose of Rotarix™ at 2 and 4 months of age (Study Day 1 and Month 2).
Anti-pneumococcal Polysaccharide (PnPs) Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMC) for Each Serotype at 30 Days Post Toddler Dose (PTD) Serotype 1	1.29 μg/mL NA means that per protocol, no within-group measures of dispersion (MOD) were planned or calculated.	2.08 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.
Anti-pneumococcal Polysaccharide (PnPs) Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMC) for Each Serotype at 30 Days Post Toddler Dose (PTD) Serotype 3	0.84 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	0.66 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.
Anti-pneumococcal Polysaccharide (PnPs) Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMC) for Each Serotype at 30 Days Post Toddler Dose (PTD) Serotype 4	1.29 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	1.73 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.
Anti-pneumococcal Polysaccharide (PnPs) Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMC) for Each Serotype at 30 Days Post Toddler Dose (PTD) Serotype 5	1.97 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	3.06 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.
Anti-pneumococcal Polysaccharide (PnPs) Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMC) for Each Serotype at 30 Days Post Toddler Dose (PTD) Serotype 6A	3.10 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	4.57 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.
Anti-pneumococcal Polysaccharide (PnPs) Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMC) for Each Serotype at 30 Days Post Toddler Dose (PTD) Serotype 6B	4.17 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	4.37 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.
Anti-pneumococcal Polysaccharide (PnPs) Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMC) for Each Serotype at 30 Days Post Toddler Dose (PTD) Serotype 7F	3.09 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	3.93 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.
Anti-pneumococcal Polysaccharide (PnPs) Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMC) for Each Serotype at 30 Days Post Toddler Dose (PTD) Serotype 9V	2.14 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	2.99 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.
Anti-pneumococcal Polysaccharide (PnPs) Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMC) for Each Serotype at 30 Days Post Toddler Dose (PTD) Serotype 14	5.26 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	7.04 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.
Anti-pneumococcal Polysaccharide (PnPs) Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMC) for Each Serotype at 30 Days Post Toddler Dose (PTD) Serotype 18C	1.94 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	2.22 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.
Anti-pneumococcal Polysaccharide (PnPs) Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMC) for Each Serotype at 30 Days Post Toddler Dose (PTD) Serotype 19A	4.68 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	5.65 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.
Anti-pneumococcal Polysaccharide (PnPs) Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMC) for Each Serotype at 30 Days Post Toddler Dose (PTD) Serotype 19F	4.09 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	4.63 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.
Anti-pneumococcal Polysaccharide (PnPs) Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMC) for Each Serotype at 30 Days Post Toddler Dose (PTD) Serotype 23F	1.52 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	1.75 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.
Anti-pneumococcal Polysaccharide (PnPs) Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMC) for Each Serotype at 30 Days Post Toddler Dose (PTD) Serotype 22F	5.98 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	0.08 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.
Anti-pneumococcal Polysaccharide (PnPs) Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMC) for Each Serotype at 30 Days Post Toddler Dose (PTD) Serotype 33F	3.41 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	0.07 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.

Measure	V114 n=588 Participants Full-term infants received a 0.5 mL intramuscular injection of V114 at approximately 2, 4, and 11-15 months of age (Study Day 1, Month 2, and Month 9-13). Preterm infants received a 0.5 mL intramuscular injection of V114 at approximately 2, 3, 4,and 11-15 months of age (Study Day 1, Month 1, Month 2, and Month 9-13). All infants also received licensed background intramuscular injections of 0.5 mL Infanrix™ hexa at approximately 2, 3, 4, and 11-15 months of age (Study Day 1, Months 1, 2, and Month 9-13); and also 1.5 mL oral dose of Rotarix™ at 2 and 4 months of age (Study Day 1 and Month 2).	Prevenar 13™ n=591 Participants Full-term infants received a 0.5 mL intramuscular injection of Prevenar 13™ at approximately 2, 4, and 11-15 months of age (Study Day 1, Month 2, and Month 9-13). Preterm infants received a 0.5 mL intramuscular injection of Prevenar 13™ at approximately 2, 3, 4, and 11-15 months of age (Study Day 1, Month 1, Month 2, and Month 9-13). All infants also received licensed background intramuscular injections of 0.5 mL Infanrix™ hexa at approximately 2, 3, 4, and 11-15 months of age (Study Day 1, Months 1, 2, and Month 9-13); and also 1.5 mL oral dose of Rotarix™ at 2 and 4 months of age (Study Day 1 and Month 2).
Anti-PnPs Serotype-specific IgG GMCs for Each Serotype at 30 Days PPS Serotype 1	1.30 μg/mL NA means that per protocol, no within-group measures of dispersion (MOD) were planned or calculated.	1.62 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.
Anti-PnPs Serotype-specific IgG GMCs for Each Serotype at 30 Days PPS Serotype 3	0.88 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	0.48 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.
Anti-PnPs Serotype-specific IgG GMCs for Each Serotype at 30 Days PPS Serotype 4	1.41 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	1.30 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.
Anti-PnPs Serotype-specific IgG GMCs for Each Serotype at 30 Days PPS Serotype 5	0.89 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	1.06 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.
Anti-PnPs Serotype-specific IgG GMCs for Each Serotype at 30 Days PPS Serotype 6A	0.64 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	1.42 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.
Anti-PnPs Serotype-specific IgG GMCs for Each Serotype at 30 Days PPS Serotype 6B	0.43 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	0.36 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.
Anti-PnPs Serotype-specific IgG GMCs for Each Serotype at 30 Days PPS Serotype 7F	2.04 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	2.46 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.
Anti-PnPs Serotype-specific IgG GMCs for Each Serotype at 30 Days PPS Serotype 9V	1.23 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	1.43 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.
Anti-PnPs Serotype-specific IgG GMCs for Each Serotype at 30 Days PPS Serotype 14	3.87 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	5.14 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.
Anti-PnPs Serotype-specific IgG GMCs for Each Serotype at 30 Days PPS Serotype 18C	1.17 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	1.37 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.
Anti-PnPs Serotype-specific IgG GMCs for Each Serotype at 30 Days PPS Serotype 19A	1.71 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	2.20 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.
Anti-PnPs Serotype-specific IgG GMCs for Each Serotype at 30 Days PPS Serotype 19F	2.63 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	3.40 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.
Anti-PnPs Serotype-specific IgG GMCs for Each Serotype at 30 Days PPS Serotype 23F	0.76 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	0.62 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.
Anti-PnPs Serotype-specific IgG GMCs for Each Serotype at 30 Days PPS Serotype 22F	2.76 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	0.05 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.
Anti-PnPs Serotype-specific IgG GMCs for Each Serotype at 30 Days PPS Serotype 33F	0.31 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.	0.05 μg/mL NA means that per protocol, no within-group MOD were planned or calculated.