Trial Outcomes & Findings for A Study of V419 Given Concomitantly With Prevnar 13™ and RotaTeq™ (V419-006) (NCT NCT01340937)

Last Updated: 2018-11-15

Results Overview

Participant serum samples were collected for testing with a radioimmunoassay for antibodies to Haemophilus influenza type b capsular polysaccharide polyribosylribitol phosphate.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

2808 participants

Primary outcome timeframe

Postdose 3 (Month 7)

Results posted on

2018-11-15

Participant Flow

The infant series of vaccinations were those administered at 2, 4, and 6 months of age; the toddler vaccinations were those administered at 15 months of age. The Interim Period is the time between the last vaccination of the infant series and the time of administration of the toddler vaccination.

Participant milestones

Participant milestones
Measure	V419 Lot A V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	V419 Lot B V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	V419 Lot C V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	Control Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
Period 1: Infant Series STARTED	800	797	809	402
Period 1: Infant Series COMPLETED	742	737	753	370
Period 1: Infant Series NOT COMPLETED	58	60	56	32
Period 2: Interim Period STARTED	742	737	753	370
Period 2: Interim Period COMPLETED	675	658	669	329
Period 2: Interim Period NOT COMPLETED	67	79	84	41
Period 3: Toddler Vaccinations STARTED	675	658	669	329
Period 3: Toddler Vaccinations COMPLETED	666	641	660	319
Period 3: Toddler Vaccinations NOT COMPLETED	9	17	9	10

Reasons for withdrawal

Reasons for withdrawal
Measure	V419 Lot A V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	V419 Lot B V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	V419 Lot C V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	Control Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
Period 1: Infant Series Other protocol criterion not met	0	1	1	0
Period 1: Infant Series Adverse Event	0	1	4	0
Period 1: Infant Series Death	2	0	2	0
Period 1: Infant Series Lost to Follow-up	20	14	12	13
Period 1: Infant Series Physician Decision	2	3	1	0
Period 1: Infant Series Protocol Violation	1	4	4	3
Period 1: Infant Series Withdrawal by Subject	33	32	30	15
Period 1: Infant Series Randomized but not vaccinated	0	5	2	1
Period 2: Interim Period Withdrawal by Subject	28	23	17	12
Period 2: Interim Period Adverse Event	1	0	1	0
Period 2: Interim Period Lost to Follow-up	29	48	53	23
Period 2: Interim Period Physician Decision	0	1	1	0
Period 2: Interim Period Protocol Violation	5	3	6	3
Period 2: Interim Period Technical problems	4	4	6	3
Period 3: Toddler Vaccinations Withdrawal by Subject	2	2	1	1
Period 3: Toddler Vaccinations Lost to Follow-up	6	14	7	8
Period 3: Toddler Vaccinations Protocol Violation	0	0	0	1
Period 3: Toddler Vaccinations Technical problem	1	1	1	0

Baseline Characteristics

A Study of V419 Given Concomitantly With Prevnar 13™ and RotaTeq™ (V419-006)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	V419 Lot A n=800 Participants V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	V419 Lot B n=797 Participants V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	V419 Lot C n=809 Participants V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	Control n=402 Participants Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.	Total n=2808 Participants Total of all reporting groups
Age, Continuous	64.6 Days STANDARD_DEVIATION 6.7 • n=5 Participants	64.4 Days STANDARD_DEVIATION 6.2 • n=7 Participants	64.7 Days STANDARD_DEVIATION 6.6 • n=5 Participants	64.3 Days STANDARD_DEVIATION 6.6 • n=4 Participants	64.5 Days STANDARD_DEVIATION 6.5 • n=21 Participants
Sex: Female, Male Female	377 Participants n=5 Participants	366 Participants n=7 Participants	380 Participants n=5 Participants	215 Participants n=4 Participants	1338 Participants n=21 Participants
Sex: Female, Male Male	423 Participants n=5 Participants	431 Participants n=7 Participants	429 Participants n=5 Participants	187 Participants n=4 Participants	1470 Participants n=21 Participants

PRIMARY outcome

Timeframe: Postdose 3 (Month 7)

Population: The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.

Participant serum samples were collected for testing with a radioimmunoassay for antibodies to Haemophilus influenza type b capsular polysaccharide polyribosylribitol phosphate.

Outcome measures

Outcome measures
Measure	V419 Lot A n=604 Participants V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	V419 Lot B n=596 Participants V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	V419 Lot C n=595 Participants V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	Control n=288 Participants Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.	V419 Lots A, B, and C Combined n=1795 Participants V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
Geometric Mean Concentration of Antibodies to Polyribosylribitol Phosphate Antigen	5.51 µg/mL Interval 4.88 to 6.21	6.10 µg/mL Interval 5.38 to 6.92	6.59 µg/mL Interval 5.8 to 7.47	3.76 µg/mL Interval 3.11 to 4.55	6.05 µg/mL Interval 5.63 to 6.5

PRIMARY outcome

Timeframe: Postdose 3 (Month 7)

Participant serum samples were collected for testing with an enhanced chemiluminescence assay for antibodies to Hepatitis B Surface Antigen. The unit of measure is milli International Units/mL (mIU/mL).

Outcome measures

Outcome measures
Measure	V419 Lot A n=588 Participants V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	V419 Lot B n=599 Participants V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	V419 Lot C n=580 Participants V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	Control n=286 Participants Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.	V419 Lots A, B, and C Combined V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
Geometric Mean Concentration of Antibodies to Hepatitis B Surface Antigen	1195.96 mIU/mL Interval 1081.62 to 1322.39	1376.86 mIU/mL Interval 1264.74 to 1498.92	1414.52 mIU/mL Interval 1297.52 to 1542.06	609.08 mIU/mL Interval 515.29 to 719.93	—

PRIMARY outcome

Timeframe: Postdose 3 (Month 7)

Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to diphtheria toxin. The unit of measure is International Units/mL (IU/mL).

Outcome measures

Outcome measures
Measure	V419 Lot A n=622 Participants V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	V419 Lot B n=625 Participants V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	V419 Lot C n=618 Participants V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	Control n=301 Participants Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.	V419 Lots A, B, and C Combined V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
Geometric Mean Concentration of Antibodies to Diphtheria Toxin	0.37 IU/mL Interval 0.34 to 0.4	0.36 IU/mL Interval 0.33 to 0.4	0.38 IU/mL Interval 0.34 to 0.41	0.40 IU/mL Interval 0.35 to 0.45	—

PRIMARY outcome

Timeframe: Postdose 3 (Month 7)

Participant serum samples were collected for testing with an Enzyme-linked Immunosorbent Assay (ELISA) for anti-tetanus antibodies.

Outcome measures

Outcome measures
Measure	V419 Lot A n=622 Participants V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	V419 Lot B n=609 Participants V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	V419 Lot C n=612 Participants V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	Control n=300 Participants Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.	V419 Lots A, B, and C Combined V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
Geometric Mean Concentration of Antibodies to Tetanus Toxin	1.59 IU/mL Interval 1.51 to 1.67	1.63 IU/mL Interval 1.55 to 1.71	1.55 IU/mL Interval 1.48 to 1.63	0.89 IU/mL Interval 0.81 to 0.97	—

PRIMARY outcome

Timeframe: Postdose 3 (Month 7)

Participant serum samples were collected for testing with an ELISA for antibodies to pertussis toxin. The unit of measure is ELISA units/mL (EU/mL).

Outcome measures

Outcome measures
Measure	V419 Lot A n=647 Participants V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	V419 Lot B n=634 Participants V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	V419 Lot C n=622 Participants V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	Control n=309 Participants Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.	V419 Lots A, B, and C Combined n=1903 Participants V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
Geometric Mean Concentration of Antibodies to Pertussis Toxin	100.83 EU/mL Interval 95.98 to 105.91	96.82 EU/mL Interval 92.1 to 101.79	98.52 EU/mL Interval 93.84 to 103.43	82.45 EU/mL Interval 77.26 to 87.98	98.72 EU/mL Interval 95.96 to 101.57

PRIMARY outcome

Timeframe: Postdose 3 (Month 7)

Participant serum samples were collected for testing with an ELISA for antibodies to pertussis filamentous hemagglutinin.

Outcome measures

Outcome measures
Measure	V419 Lot A n=644 Participants V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	V419 Lot B n=631 Participants V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	V419 Lot C n=628 Participants V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	Control n=312 Participants Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.	V419 Lots A, B, and C Combined n=1903 Participants V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
Geometric Mean Concentration of Antibodies to Pertussis Filamentous Hemagglutinin	43.98 EU/mL Interval 41.45 to 46.66	49.19 EU/mL Interval 46.52 to 52.02	56.93 EU/mL Interval 53.73 to 60.31	73.25 EU/mL Interval 67.94 to 78.97	49.70 EU/mL Interval 48.06 to 51.4

PRIMARY outcome

Timeframe: Postdose 3 (Month 7)

Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin.

Outcome measures

Outcome measures
Measure	V419 Lot A n=632 Participants V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	V419 Lot B n=616 Participants V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	V419 Lot C n=611 Participants V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	Control n=303 Participants Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.	V419 Lots A, B, and C Combined n=1859 Participants V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
Geometric Mean Concentration of Antibodies to Pertussis Pertactin	51.30 EU/mL Interval 47.46 to 55.44	52.32 EU/mL Interval 47.85 to 57.21	54.78 EU/mL Interval 50.33 to 59.61	50.96 EU/mL Interval 45.38 to 57.21	52.76 EU/mL Interval 50.27 to 55.37

PRIMARY outcome

Timeframe: Postdose 3 (Month 7)

Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae.

Outcome measures

Outcome measures
Measure	V419 Lot A n=641 Participants V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	V419 Lot B n=632 Participants V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	V419 Lot C n=623 Participants V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	Control n=309 Participants Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.	V419 Lots A, B, and C Combined n=1896 Participants V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
Geometric Mean Concentration of Antibodies to Pertussis Fimbriae	228.78 EU/mL Interval 213.87 to 244.73	286.74 EU/mL Interval 268.86 to 305.81	283.28 EU/mL Interval 264.52 to 303.36	175.65 EU/mL Interval 159.14 to 193.87	264.61 EU/mL Interval 254.54 to 275.07

PRIMARY outcome

Timeframe: Postdose 3 (Month 7)

Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to Poliovirus Type 1. The unit of measure is titer (reciprocal of highest dilution with neutralizing activity).

Outcome measures

Outcome measures
Measure	V419 Lot A n=630 Participants V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	V419 Lot B n=632 Participants V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	V419 Lot C n=628 Participants V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	Control n=307 Participants Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.	V419 Lots A, B, and C Combined V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
Geometric Mean Titer for Antibodies to Poliovirus Type 1	579.77 Titer Interval 533.82 to 629.68	684.68 Titer Interval 628.4 to 746.01	666.18 Titer Interval 612.3 to 724.79	269.95 Titer Interval 232.21 to 313.83	—

PRIMARY outcome

Timeframe: Postdose 3 (Month 7)

Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to Poliovirus Type 2.

Outcome measures

Outcome measures
Measure	V419 Lot A n=630 Participants V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	V419 Lot B n=632 Participants V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	V419 Lot C n=633 Participants V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	Control n=307 Participants Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.	V419 Lots A, B, and C Combined V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
Geometric Mean Titer for Antibodies to Poliovirus Type 2	1212.40 Titer Interval 1116.4 to 1316.65	1276.56 Titer Interval 1172.86 to 1389.43	1359.78 Titer Interval 1248.13 to 1481.42	846.14 Titer Interval 751.81 to 952.3	—

PRIMARY outcome

Timeframe: Postdose 3 (Month 7)

Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to Poliovirus Type 3.

Outcome measures

Outcome measures
Measure	V419 Lot A n=624 Participants V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	V419 Lot B n=625 Participants V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	V419 Lot C n=625 Participants V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	Control n=304 Participants Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.	V419 Lots A, B, and C Combined V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
Geometric Mean Titer for Antibodies to Poliovirus Type 3	901.70 Titer Interval 819.52 to 992.12	851.34 Titer Interval 772.96 to 937.66	825.31 Titer Interval 746.52 to 912.42	784.24 Titer Interval 682.28 to 901.44	—

SECONDARY outcome

Timeframe: Postdose 3 (Month 7)

Population: The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.

Participant serum samples were collected for testing with a radioimmunoassay for antibodies to Haemophilus influenza type b capsular polysaccharide polyribosylribitol phosphate. Response was evaluated for a titer \>=0.15 µg/mL and \>=1.0 µg/mL.

Outcome measures

Outcome measures
Measure	V419 Lot A n=604 Participants V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	V419 Lot B n=596 Participants V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	V419 Lot C n=595 Participants V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	Control n=288 Participants Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.	V419 Lots A, B, and C Combined n=1795 Participants V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
Percentage of Participants Responding to Polyribosylribitol Phosphate Antigen Titer >=1 µg/mL	86.75 Percentage of participants Interval 83.79 to 89.36	87.25 Percentage of participants Interval 84.3 to 89.82	88.40 Percentage of participants Interval 85.55 to 90.86	79.51 Percentage of participants Interval 74.39 to 84.02	87.47 Percentage of participants Interval 85.84 to 88.96
Percentage of Participants Responding to Polyribosylribitol Phosphate Antigen Titer >=0.15 µg/mL	99.01 Percentage of participants Interval 97.85 to 99.63	98.32 Percentage of participants Interval 96.94 to 99.19	97.82 Percentage of participants Interval 96.29 to 98.83	96.18 Percentage of participants Interval 93.27 to 98.08	98.38 Percentage of participants Interval 97.69 to 98.92

SECONDARY outcome

Timeframe: Postdose 3 (Month 7)

Participant serum samples were collected for testing with an enhanced chemiluminescence assay for antibodies to Hepatitis B Surface Antigen. Response was defined as a titer \>=10 mIU/mL.

Outcome measures

Outcome measures
Measure	V419 Lot A n=588 Participants V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	V419 Lot B n=599 Participants V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	V419 Lot C n=580 Participants V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	Control n=286 Participants Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.	V419 Lots A, B, and C Combined n=1767 Participants V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
Percentage of Participants Responding to Hepatitis B Surface Antigen	99.66 Percentage of participants Interval 98.78 to 99.96	100.00 Percentage of participants Interval 99.39 to 100.0	100.00 Percentage of participants Interval 99.37 to 100.0	98.95 Percentage of participants Interval 96.97 to 99.78	99.89 Percentage of participants Interval 99.59 to 99.99

SECONDARY outcome

Timeframe: Postdose 3 (Month 7)

Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to diphtheria toxin. Response was defined as a titer \>=0.1 IU/mL.

Outcome measures

Outcome measures
Measure	V419 Lot A n=622 Participants V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	V419 Lot B n=625 Participants V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	V419 Lot C n=618 Participants V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	Control n=301 Participants Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.	V419 Lots A, B, and C Combined n=1865 Participants V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
Percentage of Participants Responding to Diphtheria Toxin	85.05 Percentage of participants Interval 82.0 to 87.76	84.80 Percentage of participants Interval 81.74 to 87.52	86.41 Percentage of participants Interval 83.45 to 89.01	87.71 Percentage of participants Interval 83.46 to 91.2	85.42 Percentage of participants Interval 83.73 to 86.99

SECONDARY outcome

Timeframe: Postdose 3 (Month 7)

Participant serum samples were collected for testing with an ELISA for anti-tetanus antibodies. Response was defined as a titer \>=0.1 IU/mL.

Outcome measures

Outcome measures
Measure	V419 Lot A n=622 Participants V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	V419 Lot B n=609 Participants V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	V419 Lot C n=612 Participants V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	Control n=300 Participants Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.	V419 Lots A, B, and C Combined n=1843 Participants V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
Percentage of Participants Responding to Tetanus Toxin	99.84 Percentage of participants Interval 99.11 to 100.0	100.00 Percentage of participants Interval 99.4 to 100.0	100.00 Percentage of participants Interval 99.4 to 100.0	98.67 Percentage of participants Interval 96.62 to 99.64	99.95 Percentage of participants Interval 99.7 to 100.0

SECONDARY outcome

Timeframe: Postdose 3 (Month 7)

Participant serum samples were collected for testing with an ELISA for antibodies to pertussis toxin. Response was defined as follows: 1) if the predose titer was \<4 times the lower limit of quantitation (4X LLOQ) then the postdose titer was \>=4X LLOQ; 2) if the predose titer was \>=4X LLOQ then the postdose titer was \>= the predose titer.

Outcome measures

Outcome measures
Measure	V419 Lot A n=596 Participants V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	V419 Lot B n=585 Participants V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	V419 Lot C n=580 Participants V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	Control n=289 Participants Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.	V419 Lots A, B, and C Combined n=1761 Participants V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
Percentage of Participants Responding to Pertussis Toxin	99.33 Percentage of participants Interval 98.29 to 99.82	97.61 Percentage of participants Interval 96.02 to 98.69	98.97 Percentage of participants Interval 97.76 to 99.62	97.92 Percentage of participants Interval 95.54 to 99.23	98.64 Percentage of participants Interval 97.98 to 99.12

SECONDARY outcome

Timeframe: Postdose 3 (Month 7)

Participant serum samples were collected for testing with an ELISA for antibodies to pertussis filamentous hemagglutinin. Response was defined as follows: 1) if the predose titer was \<4X LLOQ then the postdose titer was \>=4X LLOQ; 2) if the predose titer was \>=4X LLOQ then the postdose titer was \>= the predose titer.

Outcome measures

Outcome measures
Measure	V419 Lot A n=620 Participants V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	V419 Lot B n=615 Participants V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	V419 Lot C n=601 Participants V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	Control n=304 Participants Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.	V419 Lots A, B, and C Combined n=1836 Participants V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
Percentage of Participants Responding to Pertussis Filamentous Hemagglutinin	85.97 Percentage of participants Interval 82.98 to 88.61	87.32 Percentage of participants Interval 84.43 to 89.84	89.02 Percentage of participants Interval 86.24 to 91.4	92.11 Percentage of participants Interval 88.48 to 94.88	87.42 Percentage of participants Interval 85.81 to 88.9

SECONDARY outcome

Timeframe: Postdose 3 (Month 7)

Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin. Response was defined as follows: 1) if the predose titer was \<4X LLOQ then the postdose titer was \>=4X LLOQ; 2) if the predose titer was \>=4X LLOQ then the postdose titer was \>= the predose titer.

Outcome measures

Outcome measures
Measure	V419 Lot A n=590 Participants V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	V419 Lot B n=574 Participants V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	V419 Lot C n=560 Participants V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	Control n=286 Participants Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.	V419 Lots A, B, and C Combined n=1724 Participants V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
Percentage of Participants Responding to Pertussis Pertactin	81.19 Percentage of participants Interval 77.79 to 84.26	78.40 Percentage of participants Interval 74.8 to 81.7	78.75 Percentage of participants Interval 75.13 to 82.07	76.22 Percentage of participants Interval 70.86 to 81.04	79.47 Percentage of participants Interval 77.48 to 81.35

SECONDARY outcome

Timeframe: Postdose 3 (Month 7)

Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae. Response was defined as follows: 1) if the predose titer was \<4X LLOQ then the postdose titer was \>=4X LLOQ; 2) if the predose titer was \>=4X LLOQ then the postdose titer was \>= the predose titer.

Outcome measures

Outcome measures
Measure	V419 Lot A n=613 Participants V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	V419 Lot B n=611 Participants V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	V419 Lot C n=594 Participants V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	Control n=298 Participants Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.	V419 Lots A, B, and C Combined n=1818 Participants V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
Percentage of Participants Responding to Pertussis Fimbriae	86.95 Percentage of participants Interval 84.02 to 89.51	91.00 Percentage of participants Interval 88.44 to 93.15	91.08 Percentage of participants Interval 88.49 to 93.25	86.91 Percentage of participants Interval 82.55 to 90.53	89.66 Percentage of participants Interval 88.17 to 91.02

SECONDARY outcome

Timeframe: Postdose 3 (Month 7)

Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to Poliovirus Type 1. Response is defined as a titer \>=8.

Outcome measures

Outcome measures
Measure	V419 Lot A n=630 Participants V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	V419 Lot B n=632 Participants V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	V419 Lot C n=628 Participants V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	Control n=307 Participants Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.	V419 Lots A, B, and C Combined n=1890 Participants V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
Percentage of Participants Responding to Poliovirus Type 1	100.00 Percentage of participants Interval 99.42 to 100.0	100.00 Percentage of participants Interval 99.42 to 100.0	100.00 Percentage of participants Interval 99.41 to 100.0	99.35 Percentage of participants Interval 97.67 to 99.92	100.00 Percentage of participants Interval 99.81 to 100.0

SECONDARY outcome

Timeframe: Postdose 3 (Month 7)

Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to Poliovirus Type 2. Response is defined as a titer \>=8.

Outcome measures

Outcome measures
Measure	V419 Lot A n=630 Participants V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	V419 Lot B n=632 Participants V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	V419 Lot C n=633 Participants V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	Control n=307 Participants Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.	V419 Lots A, B, and C Combined n=1895 Participants V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
Percentage of Participants Responding to Poliovirus Type 2	100.00 Percentage of participants Interval 99.42 to 100.0	100.00 Percentage of participants Interval 99.42 to 100.0	100.00 Percentage of participants Interval 99.42 to 100.0	100.00 Percentage of participants Interval 98.81 to 100.0	100.00 Percentage of participants Interval 99.81 to 100.0

SECONDARY outcome

Timeframe: Postdose 3 (Month 7)

Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to Poliovirus Type 3. Response is defined as a titer \>=8.

Outcome measures

Outcome measures
Measure	V419 Lot A n=624 Participants V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	V419 Lot B n=625 Participants V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	V419 Lot C n=625 Participants V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	Control n=304 Participants Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.	V419 Lots A, B, and C Combined n=1874 Participants V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
Percentage of Participants Responding to Poliovirus Type 3	100.00 Percentage of participants Interval 99.41 to 100.0	100.00 Percentage of participants Interval 99.41 to 100.0	100.00 Percentage of participants Interval 99.41 to 100.0	99.67 Percentage of participants Interval 98.18 to 99.99	100.00 Percentage of participants Interval 99.8 to 100.0

SECONDARY outcome

Timeframe: Postdose 4 (Month 16)

Participant serum samples were collected for testing with an ELISA for antibodies to pertussis toxin. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control.

Outcome measures

Outcome measures
Measure	V419 Lot A n=1744 Participants V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	V419 Lot B n=271 Participants V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	V419 Lot C n=584 Participants V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	Control n=572 Participants Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.	V419 Lots A, B, and C Combined n=588 Participants V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
Geometric Mean Concentration of Antibodies to Pertussis Toxin	110.61 EU/mL Interval 106.92 to 114.42	102.82 EU/mL Interval 93.7 to 112.82	110.41 EU/mL Interval 104.08 to 117.14	110.62 EU/mL Interval 104.14 to 117.51	110.79 EU/mL Interval 104.65 to 117.29

SECONDARY outcome

Timeframe: Postdose 4 (Month 16)

Participant serum samples were collected for testing with an ELISA for antibodies to pertussis filamentous hemagglutinin. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control.

Outcome measures

Outcome measures
Measure	V419 Lot A n=1742 Participants V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	V419 Lot B n=271 Participants V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	V419 Lot C n=583 Participants V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	Control n=572 Participants Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.	V419 Lots A, B, and C Combined n=587 Participants V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
Geometric Mean Concentration of Antibodies to Pertussis Filamentous Hemagglutinin	106.30 EU/mL Interval 102.73 to 110.0	121.00 EU/mL Interval 110.19 to 132.87	101.81 EU/mL Interval 95.85 to 108.14	104.70 EU/mL Interval 98.66 to 111.12	112.60 EU/mL Interval 106.27 to 119.31

SECONDARY outcome

Timeframe: Postdose 4 (Month 16)

Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control.

Outcome measures

Outcome measures
Measure	V419 Lot A n=1746 Participants V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	V419 Lot B n=271 Participants V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	V419 Lot C n=584 Participants V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	Control n=573 Participants Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.	V419 Lots A, B, and C Combined n=589 Participants V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
Geometric Mean Concentration of Antibodies to Pertussis Pertactin	104.51 EU/mL Interval 100.14 to 109.07	142.32 EU/mL Interval 126.68 to 159.89	94.26 EU/mL Interval 87.23 to 101.85	108.69 EU/mL Interval 101.41 to 116.51	111.42 EU/mL Interval 103.44 to 120.02

SECONDARY outcome

Timeframe: Postdose 4 (Month 16)

Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control.

Outcome measures

Outcome measures
Measure	V419 Lot A n=1746 Participants V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	V419 Lot B n=271 Participants V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	V419 Lot C n=584 Participants V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	Control n=573 Participants Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.	V419 Lots A, B, and C Combined n=589 Participants V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
Geometric Mean Concentration of Antibodies to Pertussis Fimbriae	451.04 EU/mL Interval 433.21 to 469.6	337.79 EU/mL Interval 299.43 to 381.05	409.37 EU/mL Interval 379.54 to 441.54	475.65 EU/mL Interval 444.85 to 508.59	471.52 EU/mL Interval 441.3 to 503.81

SECONDARY outcome

Timeframe: Postdose 4 (Month 16)

Participant serum samples were collected for testing with an ELISA for antibodies to pertussis toxin. Response was defined as follows: 1) if the predose titer was \<4X LLOQ then the postdose titer was \>=4X LLOQ; 2) if the predose titer was \>=4X LLOQ then the postdose titer was \>= the predose titer. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control.

Outcome measures

Outcome measures
Measure	V419 Lot A n=1616 Participants V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	V419 Lot B n=254 Participants V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	V419 Lot C n=535 Participants V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	Control n=531 Participants Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.	V419 Lots A, B, and C Combined n=550 Participants V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
Percentage of Participants Responding to Pertussis Toxin	98.51 Percentage of participants Interval 97.8 to 99.05	98.43 Percentage of participants Interval 96.02 to 99.57	99.25 Percentage of participants Interval 98.1 to 99.8	98.12 Percentage of participants Interval 96.56 to 99.09	98.18 Percentage of participants Interval 96.68 to 99.12

SECONDARY outcome

Timeframe: Postdose 4 (Month 16)

Outcome measures

Outcome measures
Measure	V419 Lot A n=1669 Participants V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	V419 Lot B n=261 Participants V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	V419 Lot C n=559 Participants V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	Control n=550 Participants Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.	V419 Lots A, B, and C Combined n=560 Participants V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
Percentage of Participants Responding to Pertussis Filamentous Hemagglutinin	95.33 Percentage of participants Interval 94.2 to 96.29	95.40 Percentage of participants Interval 92.11 to 97.6	96.06 Percentage of participants Interval 94.1 to 97.52	94.36 Percentage of participants Interval 92.09 to 96.14	95.54 Percentage of participants Interval 93.48 to 97.09

SECONDARY outcome

Timeframe: Postdose 4 (Month 16)

Outcome measures

Outcome measures
Measure	V419 Lot A n=1608 Participants V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	V419 Lot B n=258 Participants V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	V419 Lot C n=539 Participants V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	Control n=530 Participants Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.	V419 Lots A, B, and C Combined n=539 Participants V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
Percentage of Participants Responding to Pertussis Pertactin	92.16 Percentage of participants Interval 90.74 to 93.43	91.09 Percentage of participants Interval 86.92 to 94.26	91.28 Percentage of participants Interval 88.57 to 93.52	92.08 Percentage of participants Interval 89.44 to 94.23	93.14 Percentage of participants Interval 90.66 to 95.12

SECONDARY outcome

Timeframe: Postdose 4 (Month 16)

Outcome measures

Outcome measures
Measure	V419 Lot A n=1664 Participants V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	V419 Lot B n=264 Participants V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	V419 Lot C n=556 Participants V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	Control n=549 Participants Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.	V419 Lots A, B, and C Combined n=559 Participants V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
Percentage of Participants Responding to Pertussis Fimbriae	92.97 Percentage of participants Interval 91.63 to 94.15	90.15 Percentage of participants Interval 85.9 to 93.47	91.91 Percentage of participants Interval 89.32 to 94.04	94.17 Percentage of participants Interval 91.87 to 95.98	92.84 Percentage of participants Interval 90.38 to 94.84

SECONDARY outcome

Timeframe: Postdose 3 (Month 7)

Participant serum samples were collected for testing with a multiplex electrochemiluminescence-based detection assay for serotype-specific pneumococcal polysaccharide antibodies. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control.

Outcome measures

Outcome measures
Measure	V419 Lot A n=1256 Participants V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	V419 Lot B n=191 Participants V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	V419 Lot C n=414 Participants V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	Control n=419 Participants Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.	V419 Lots A, B, and C Combined n=423 Participants V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes Serotype 1 (n=1256, 191, 414, 419, 423)	1.44 µg/mL Interval 1.38 to 1.5	1.55 µg/mL Interval 1.39 to 1.73	1.47 µg/mL Interval 1.36 to 1.59	1.40 µg/mL Interval 1.3 to 1.51	1.44 µg/mL Interval 1.34 to 1.55
Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes Serotype 3 (n=1255, 191, 414, 418, 423)	0.48 µg/mL Interval 0.46 to 0.5	0.50 µg/mL Interval 0.45 to 0.56	0.48 µg/mL Interval 0.45 to 0.51	0.48 µg/mL Interval 0.44 to 0.51	0.47 µg/mL Interval 0.44 to 0.5
Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes Serotype 4 (n=1255, 189, 414, 418, 423)	1.22 µg/mL Interval 1.17 to 1.27	1.22 µg/mL Interval 1.1 to 1.35	1.27 µg/mL Interval 1.18 to 1.36	1.16 µg/mL Interval 1.08 to 1.25	1.24 µg/mL Interval 1.16 to 1.34
Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes Serotype 5 (n=1256, 191, 414, 419, 423)	1.49 µg/mL Interval 1.42 to 1.57	1.61 µg/mL Interval 1.41 to 1.82	1.49 µg/mL Interval 1.36 to 1.64	1.49 µg/mL Interval 1.36 to 1.63	1.49 µg/mL Interval 1.36 to 1.63
Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes Serotype 6A (n=1251, 191, 412, 417, 422)	2.57 µg/mL Interval 2.45 to 2.69	2.96 µg/mL Interval 2.64 to 3.32	2.49 µg/mL Interval 2.29 to 2.71	2.66 µg/mL Interval 2.45 to 2.9	2.55 µg/mL Interval 2.36 to 2.75
Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes Serotype 6B (n=1255, 190, 414, 419, 422)	1.01 µg/mL Interval 0.94 to 1.09	1.29 µg/mL Interval 1.07 to 1.54	1.01 µg/mL Interval 0.88 to 1.14	1.01 µg/mL Interval 0.89 to 1.15	1.01 µg/mL Interval 0.89 to 1.14
Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes Serotype 7F (n=1256, 191, 414, 419, 423)	2.74 µg/mL Interval 2.64 to 2.85	3.08 µg/mL Interval 2.77 to 3.41	2.78 µg/mL Interval 2.6 to 2.97	2.75 µg/mL Interval 2.58 to 2.94	2.70 µg/mL Interval 2.53 to 2.87
Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes Serotype 9V (n=1256, 189, 414, 419, 423)	1.35 µg/mL Interval 1.29 to 1.41	1.35 µg/mL Interval 1.19 to 1.52	1.40 µg/mL Interval 1.29 to 1.52	1.30 µg/mL Interval 1.21 to 1.41	1.35 µg/mL Interval 1.25 to 1.46
Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes Serotype 14 (n=1256, 191, 414, 419, 423)	4.74 µg/mL Interval 4.48 to 5.01	4.83 µg/mL Interval 4.26 to 5.48	4.91 µg/mL Interval 4.45 to 5.42	4.85 µg/mL Interval 4.42 to 5.32	4.47 µg/mL Interval 4.05 to 4.93
Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes Serotype 18C (n=1253, 191, 413, 418, 422)	1.62 µg/mL Interval 1.55 to 1.69	1.82 µg/mL Interval 1.62 to 2.03	1.69 µg/mL Interval 1.57 to 1.82	1.62 µg/mL Interval 1.51 to 1.75	1.55 µg/mL Interval 1.44 to 1.67
Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes Serotype 19A (n=1254, 191, 413, 418, 423)	1.60 µg/mL Interval 1.53 to 1.68	1.75 µg/mL Interval 1.55 to 1.99	1.67 µg/mL Interval 1.55 to 1.81	1.52 µg/mL Interval 1.41 to 1.65	1.61 µg/mL Interval 1.49 to 1.74
Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes Serotype 19F (n=1256, 191, 414, 419, 423)	2.18 µg/mL Interval 2.1 to 2.27	2.26 µg/mL Interval 2.03 to 2.5	2.24 µg/mL Interval 2.09 to 2.41	2.11 µg/mL Interval 1.97 to 2.26	2.19 µg/mL Interval 2.05 to 2.33
Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes Serotype 23F (n=1254, 190, 412, 419, 423)	1.10 µg/mL Interval 1.04 to 1.16	1.20 µg/mL Interval 1.04 to 1.38	1.16 µg/mL Interval 1.05 to 1.28	1.07 µg/mL Interval 0.97 to 1.18	1.07 µg/mL Interval 0.97 to 1.19

SECONDARY outcome

Timeframe: Up to 5 days after any infant vaccination (up to 6 months)

Population: Participants included in these analyses were All Subjects as Treated population and were defined as all vaccinated participants with safety follow up. This outcome applied only to V419 Lots A, B, and C Combined and Control; therefore, data for the individual V419 lots are not reported.

Solicited injection site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability. Grade 3 Solicited injection site reaction: Pain, Cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling, \>5 cm. Grade 3 Solicited systemic reactions: Fever (Pyrexia), \>=39.5°C rectal; Vomiting, \>=6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal, \>3 hours; Drowsiness (Somnolence), Sleeping most of the time or difficult to wake up; Appetite lost, Refuses \>=3 feeds or refuses most feeds; Irritability, Inconsolable.

Outcome measures

Outcome measures
Measure	V419 Lot A n=397 Participants V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	V419 Lot B n=2390 Participants V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	V419 Lot C V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	Control Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.	V419 Lots A, B, and C Combined V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Severe injection-site pain	5.5 Percentage of participants	6.0 Percentage of participants	—	—	—
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Severe injection-site swelling	0.5 Percentage of participants	0.5 Percentage of participants	—	—	—
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Any crying abnormal	72.5 Percentage of participants	74.8 Percentage of participants	—	—	—
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Severe somnolence	3.0 Percentage of participants	3.5 Percentage of participants	—	—	—
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Any vomiting	24.9 Percentage of participants	26.7 Percentage of participants	—	—	—
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Severe vomiting	1.5 Percentage of participants	0.8 Percentage of participants	—	—	—
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Any injection-site erythema	40.8 Percentage of participants	44.6 Percentage of participants	—	—	—
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Severe crying abnormal	12.6 Percentage of participants	9.5 Percentage of participants	—	—	—
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Severe injection-site erythema	0.8 Percentage of participants	0.3 Percentage of participants	—	—	—
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Any injection-site pain	72.0 Percentage of participants	70.0 Percentage of participants	—	—	—
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Any decreased appetite	47.4 Percentage of participants	48.5 Percentage of participants	—	—	—
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Severe decreased appetite	1.3 Percentage of participants	1.4 Percentage of participants	—	—	—
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Any irritability	79.8 Percentage of participants	80.7 Percentage of participants	—	—	—
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Any injection-site swelling	34.5 Percentage of participants	34.5 Percentage of participants	—	—	—
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Severe irritability	6.5 Percentage of participants	7.8 Percentage of participants	—	—	—
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Any pyrexia	33.2 Percentage of participants	47.1 Percentage of participants	—	—	—
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Severe pyrexia	1.3 Percentage of participants	1.4 Percentage of participants	—	—	—
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Any somnolence	73.3 Percentage of participants	73.2 Percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Up to 5 days after any infant vaccination (up to 6 months)

Population: Participants included in this analyses were All Subjects as Treated population defined as all vaccinated participants with safety follow up and temperature data. This outcome applied only to V419 Lots A, B, and C Combined and Control; therefore, data for the individual V419 lots are not reported.

Maximum temperature (all routes) was based on actual temperatures recorded with no adjustments to the measurement route. Maximum temperature (rectal) was required of all participants if the reading by another method was \>=38.0°C.

Outcome measures

Outcome measures
Measure	V419 Lot A n=2308 Participants V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	V419 Lot B n=378 Participants V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	V419 Lot C V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	Control Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.	V419 Lots A, B, and C Combined V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
Percentage of Participants With Elevated Temperature by Severity All routes <38.0°C	50.8 Percentage of participants Interval 1.38 to 1.5	64.6 Percentage of participants Interval 1.39 to 1.73	—	—	—
Percentage of Participants With Elevated Temperature by Severity All routes >=38.0°C and <38.5°C, mild	27.2 Percentage of participants Interval 0.46 to 0.5	23.3 Percentage of participants Interval 0.45 to 0.56	—	—	—
Percentage of Participants With Elevated Temperature by Severity All routes >=38.5°C and <39.5°C, moderate	19.5 Percentage of participants Interval 1.17 to 1.27	10.8 Percentage of participants Interval 1.1 to 1.35	—	—	—
Percentage of Participants With Elevated Temperature by Severity All routes >=39.5°C, severe	2.4 Percentage of participants Interval 1.42 to 1.57	1.3 Percentage of participants Interval 1.41 to 1.82	—	—	—
Percentage of Participants With Elevated Temperature by Severity Rectal <38.0°C	47.7 Percentage of participants Interval 2.45 to 2.69	59.0 Percentage of participants Interval 2.64 to 3.32	—	—	—
Percentage of Participants With Elevated Temperature by Severity Rectal >=38.0°C and <38.5°C, mild	26.5 Percentage of participants Interval 0.94 to 1.09	23.0 Percentage of participants Interval 1.07 to 1.54	—	—	—
Percentage of Participants With Elevated Temperature by Severity Rectal >=38.5°C and <39.5°C, moderate	19.0 Percentage of participants Interval 2.64 to 2.85	10.6 Percentage of participants Interval 2.77 to 3.41	—	—	—
Percentage of Participants With Elevated Temperature by Severity Rectal >=39.5°C, severe	2.4 Percentage of participants Interval 1.29 to 1.41	1.3 Percentage of participants Interval 1.19 to 1.52	—	—	—

Adverse Events

V419 Lots A, B, and C Combined

Serious events: 94 serious events

Other events: 2259 other events

Deaths: 0 deaths

Control

Serious events: 15 serious events

Other events: 371 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	V419 Lots A, B, and C Combined n=2390 participants at risk V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.	Control n=397 participants at risk Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
Gastrointestinal disorders Diarrhoea	8.0% 192/2390 • Number of events 215 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up. For safety analysis, participants who received the 3 V419 lots were combined.	5.8% 23/397 • Number of events 24 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up. For safety analysis, participants who received the 3 V419 lots were combined.
Gastrointestinal disorders Vomiting	30.3% 723/2390 • Number of events 1139 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up. For safety analysis, participants who received the 3 V419 lots were combined.	27.7% 110/397 • Number of events 171 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up. For safety analysis, participants who received the 3 V419 lots were combined.
General disorders Crying	78.1% 1867/2390 • Number of events 4597 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up. For safety analysis, participants who received the 3 V419 lots were combined.	75.6% 300/397 • Number of events 763 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up. For safety analysis, participants who received the 3 V419 lots were combined.
General disorders Irritability	83.4% 1993/2390 • Number of events 5595 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up. For safety analysis, participants who received the 3 V419 lots were combined.	81.6% 324/397 • Number of events 925 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up. For safety analysis, participants who received the 3 V419 lots were combined.
General disorders Pyrexia	53.8% 1285/2390 • Number of events 2302 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up. For safety analysis, participants who received the 3 V419 lots were combined.	43.8% 174/397 • Number of events 274 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up. For safety analysis, participants who received the 3 V419 lots were combined.
Infections and infestations Otitis media	6.2% 147/2390 • Number of events 162 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up. For safety analysis, participants who received the 3 V419 lots were combined.	9.8% 39/397 • Number of events 44 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up. For safety analysis, participants who received the 3 V419 lots were combined.
Infections and infestations Upper respiratory tract infection	11.5% 276/2390 • Number of events 306 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up. For safety analysis, participants who received the 3 V419 lots were combined.	12.1% 48/397 • Number of events 54 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up. For safety analysis, participants who received the 3 V419 lots were combined.
Metabolism and nutrition disorders Decreased appetite	56.7% 1355/2390 • Number of events 2586 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up. For safety analysis, participants who received the 3 V419 lots were combined.	54.7% 217/397 • Number of events 402 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up. For safety analysis, participants who received the 3 V419 lots were combined.
Nervous system disorders Somnolence	76.0% 1816/2390 • Number of events 4497 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up. For safety analysis, participants who received the 3 V419 lots were combined.	75.1% 298/397 • Number of events 717 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up. For safety analysis, participants who received the 3 V419 lots were combined.
General disorders Injection-site bruising	5.4% 128/2390 • Number of events 174 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up. For safety analysis, participants who received the 3 V419 lots were combined.	5.5% 22/397 • Number of events 31 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up. For safety analysis, participants who received the 3 V419 lots were combined.
General disorders Injection-site erythema	54.5% 1302/2390 • Number of events 5189 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up. For safety analysis, participants who received the 3 V419 lots were combined.	51.1% 203/397 • Number of events 911 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up. For safety analysis, participants who received the 3 V419 lots were combined.
General disorders Injection-site pain	78.8% 1883/2390 • Number of events 8854 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up. For safety analysis, participants who received the 3 V419 lots were combined.	79.1% 314/397 • Number of events 1815 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up. For safety analysis, participants who received the 3 V419 lots were combined.
General disorders Injection-site swelling	44.9% 1073/2390 • Number of events 3652 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up. For safety analysis, participants who received the 3 V419 lots were combined.	41.8% 166/397 • Number of events 687 • SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up. For safety analysis, participants who received the 3 V419 lots were combined.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

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

Restriction type: OTHER