Safety, Tolerability, and Immunogenicity of V419 Given Co... | NCT01337167

Name	Class
MCM Vaccines B.V.	INDUSTRY

Label	Type	Description	Intervention Names
V419	Experimental	V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 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.	Biological: V419 Biological: DAPTACEL™ Biological: PedvaxHIB™ Biological: Prevnar 13™ Biological: RotaTeq™
Control	Active Comparator	Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 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.	Biological: DAPTACEL™ Biological: Prevnar 13™ Biological: RotaTeq™ Biological: PENTACEL™ Biological: Recombivax HB vaccine Biological: ActHIB™

Name	Type	Description	Arm Group Labels	Other Names
V419	Biological	V419 (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate [Meningococcal Outer Membrane Protein Complex], and Hepatitis B [Recombinant] Vaccine) 0.5 mL intramuscular injection at 2, 4, and 6 months of age

Measure	Description	Time Frame
Percentage of Participants Responding to Polyribosylribitol Phosphate Antigen	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 titer >=0.15 μg/mL and >=1.0 μg/mL.	Postdose 3 (Month 7)
Percentage of Participants Responding to Hepatitis B Surface Antigen	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 milli International units (mIU)/mL.	Postdose 3 (Month 7)
Percentage of Participants Responding to Diphtheria Toxin	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 International unit (IU)/mL.	Postdose 3 (Month 7)
Percentage of Participants Responding to Tetanus Toxin	Participant serum samples were collected for testing with an ELISA for anti-tetanus antibodies. Response was defined as a titer >=0.1 IU/mL.	Postdose 3 (Month 7)
Percentage of Participants Responding to Pertussis Toxin	Participant serum samples were collected for testing with an Enzyme-linked Immunosorbent Assay (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.	Postdose 3 (Month 7)

Measure	Description	Time Frame
Geometric Mean Concentration of Antibodies to Polyribosylribitol Phosphate Antigen	Participant serum samples were collected for testing with a radioimmunoassay for antibodies to Haemophilus influenza type b capsular polysaccharide polyribosylribitol phosphate.	Postdose 3 (Month 7)
Geometric Mean Concentration of Immunoglobulin A (IgA) Antibodies to Rotavirus

Name	Affiliation	Role
Medical Director	Merck Sharp & Dohme LLC	Study Director

PubMed Identifier	Type	Citation	Retractions
26216331	Background	Marshall GS, Adams GL, Leonardi ML, Petrecz M, Flores SA, Ngai AL, Xu J, Liu G, Stek JE, Foglia G, Lee AW. Immunogenicity, Safety, and Tolerability of a Hexavalent Vaccine in Infants. Pediatrics. 2015 Aug;136(2):e323-32. doi: 10.1542/peds.2014-4102.

ID	Title	Description
FG000	V419	V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 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.
FG001	Control

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Participants Responding to Polyribosylribitol Phosphate Antigen

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 titer >=0.15 μg/mL and >=1.0 μg/mL.

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.

Posted

Number

95% Confidence Interval

Percentage of participants

Postdose 3 (Month 7)

ID	Title	Description
OG000	V419	V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 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.
OG001	Control	Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 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.

Units	Counts
Participants	OG000765 OG001382

Title

Denominators

Categories

Titer >=1.0 μg/mL

Title	Measurements
	OG00084.97(82.24 to 87.43) OG00175.39(70.76 to 79.63)

Titer >=0.15 μg/mL

Title	Measurements
	OG000

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Non-inferiority for titer >=1.0 μg/mL	Miettinen and Nurminen	Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine	<0.001		Response Rate Difference (V419 - Ctrl)	9.68			2-Sided	95	4.83	14.83					Non-Inferiority or Equivalence	Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is >= -10%

Primary

Percentage of Participants Responding to Hepatitis B Surface Antigen

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 milli International units (mIU)/mL.

Posted

Number

95% Confidence Interval

Percentage of participants

Postdose 3 (Month 7)

ID	Title	Description
OG000	V419	V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 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.
OG001	Control	Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 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.

Primary

Percentage of Participants Responding to Diphtheria Toxin

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 International unit (IU)/mL.

Posted

Number

95% Confidence Interval

Percentage of participants

Postdose 3 (Month 7)

ID	Title	Description
OG000	V419	V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 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.
OG001	Control	Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 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.

Primary

Percentage of Participants Responding to Tetanus Toxin

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

Posted

Number

95% Confidence Interval

Percentage of participants

Postdose 3 (Month 7)

ID	Title	Description
OG000	V419	V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 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.
OG001	Control	Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 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.

Units	Counts

Primary

Percentage of Participants Responding to Pertussis Toxin

Participant serum samples were collected for testing with an Enzyme-linked Immunosorbent Assay (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.

Posted

Number

95% Confidence Interval

Percentage of participants

Postdose 3 (Month 7)

ID	Title	Description
OG000	V419	V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 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.
OG001	Control	Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 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.

Primary

Percentage of Participants Responding to Pertussis Filamentous Hemagglutinin

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.

Posted

Number

95% Confidence Interval

Percentage of participants

Postdose 3 (Month 7)

ID	Title	Description
OG000	V419	V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 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.
OG001	Control	Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 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.

Primary

Percentage of Participants Responding to Pertussis Pertactin

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.

Posted

Number

95% Confidence Interval

Percentage of participants

Postdose 3 (Month 7)

ID	Title	Description
OG000	V419	V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 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.
OG001	Control	Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 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.

Primary

Percentage of Participants Responding to Pertussis Fimbriae

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.

Posted

Number

95% Confidence Interval

Percentage of participants

Postdose 3 (Month 7)

ID	Title	Description
OG000	V419	V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 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.
OG001	Control	Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 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.

Primary

Percentage of Participants Responding to Poliovirus Type 1

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.

Posted

Number

95% Confidence Interval

Percentage of participants

Postdose 3 (Month 7)

ID	Title	Description
OG000	V419	V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 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.
OG001	Control	Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 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.

Units

Primary

Percentage of Participants Responding to Poliovirus Type 2

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.

Posted

Number

95% Confidence Interval

Percentage of participants

Postdose 3 (Month 7)

ID	Title	Description
OG000	V419	V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 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.
OG001	Control	Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 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.

Units

Primary

Percentage of Participants Responding to Poliovirus Type 3

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.

Posted

Number

95% Confidence Interval

Percentage of participants

Postdose 3 (Month 7)

ID	Title	Description
OG000	V419	V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 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.
OG001	Control	Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 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.

Units

Primary

Geometric Mean Concentration of Antibodies to Pertussis Toxin

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).

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.

Posted

Geometric Mean

95% Confidence Interval

EU/mL

Postdose 3 (Month 7)

ID	Title	Description
OG000	V419	V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 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.
OG001	Control	Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 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.

Units	Counts

Primary

Geometric Mean Concentration of Antibodies to Pertussis Filamentous Hemagglutinin

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

Posted

Geometric Mean

95% Confidence Interval

EU/mL

Postdose 3 (Month 7)

ID	Title	Description
OG000	V419	V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 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.
OG001	Control	Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 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.

Units	Counts

Primary

Geometric Mean Concentration of Antibodies to Pertussis Pertactin

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

Posted

Geometric Mean

95% Confidence Interval

EU/mL

Postdose 3 (Month 7)

ID	Title	Description
OG000	V419	V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 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.
OG001	Control	Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 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.

Units	Counts

Primary

Geometric Mean Concentration of Antibodies to Pertussis Fimbriae

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

Posted

Geometric Mean

95% Confidence Interval

EU/mL

Postdose 3 (Month 7)

ID	Title	Description
OG000	V419	V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 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.
OG001	Control	Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 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.

Units	Counts

Primary

Percentage of Participants Responding to Pertussis Toxin

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.

Posted

Number

95% Confidence Interval

Percentage of participants

Postdose 4 (Month 16)

ID	Title	Description
OG000	V419	V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 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.
OG001	Control	Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 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.

Primary

Percentage of Participants Responding to Pertussis Filamentous Hemagglutinin

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 <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.

Posted

Number

95% Confidence Interval

Percentage of participants

Postdose 4 (Month 16)

ID	Title	Description
OG000	V419	V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 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.
OG001	Control	Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 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.

Primary

Percentage of Participants Responding to Pertussis Pertactin

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 <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.

Posted

Number

95% Confidence Interval

Percentage of participants

Postdose 4 (Month 16)

ID	Title	Description
OG000	V419	V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 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.
OG001	Control	Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 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.

Primary

Percentage of Participants Responding to Pertussis Fimbriae

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 <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.

Posted

Number

95% Confidence Interval

Percentage of participants

Postdose 4 (Month 16)

ID	Title	Description
OG000	V419	V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 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.
OG001	Control	Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 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.

Primary

Geometric Mean Concentration of Antibodies to Pertussis Toxin

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

Posted

Geometric Mean

95% Confidence Interval

EU/mL

Postdose 4 (Month 16)

ID	Title	Description
OG000	V419	V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 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.
OG001	Control	Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 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.

Units	Counts

Primary

Geometric Mean Concentration of Antibodies to Pertussis Filamentous Hemagglutinin

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

Posted

Geometric Mean

95% Confidence Interval

EU/mL

Postdose 4 (Month 16)

ID	Title	Description
OG000	V419	V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 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.
OG001	Control	Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 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.

Units	Counts

Primary

Geometric Mean Concentration of Antibodies to Pertussis Pertactin

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

Posted

Geometric Mean

95% Confidence Interval

EU/mL

Postdose 4 (Month 16)

ID	Title	Description
OG000	V419	V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 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.
OG001	Control	Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 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.

Units	Counts

Primary

Geometric Mean Concentration of Antibodies to Pertussis Fimbriae

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

Posted

Geometric Mean

95% Confidence Interval

EU/mL

Postdose 4 (Month 16)

ID	Title	Description
OG000	V419	V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 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.
OG001	Control	Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 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.

Units	Counts

Secondary

Geometric Mean Concentration of Antibodies to Polyribosylribitol Phosphate Antigen

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

Posted

Geometric Mean

95% Confidence Interval

μg/mL

Postdose 3 (Month 7)

ID	Title	Description
OG000	V419	V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 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.
OG001	Control	Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 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.

Secondary

Geometric Mean Concentration of Immunoglobulin A (IgA) Antibodies to Rotavirus

Participant serum samples were collected for testing with an Enzyme-linked Immunosorbent assay for IgA antibodies to rotavirus.

Posted

Geometric Mean

95% Confidence Interval

units/mL

Postdose 3 (Month 7)

ID	Title	Description
OG000	V419	V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 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.
OG001	Control	Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 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.

Units	Counts

Secondary

Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions

Solicited injection-site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Pyrexia, Vomiting, Crying abnormal, Somnolence, Decreased appetite, 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: Pyrexia, >=39.5°C (>=103.1°F) rectal; Vomiting, >=6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal, >3 hours; Somnolence, Sleeping most of the time or difficult to wake up; Decreased appetite, Refuses >=3 feeds or refuses most feeds; Irritability, Inconsolable.

Participants included in these analyses were All Subjects as Treated population and were defined as all vaccinated participants with safety follow up.

Posted

Number

Percentage of participants

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

ID	Title	Description
OG000	V419	V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 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.
OG001	Control	Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 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.

Secondary

Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug

Solicited systemic adverse events: pyrexia, vomiting, crying abnormal, somnolence, decreased appetite, and irritability. Adverse events deemed related to study drug were those judged to be definitely related, probably related, or possibly related by the investigator.

Participants included in this analyses were All Subjects as Treated population and were defined as all vaccinated participants with safety follow up.

Posted

Number

Percentage of participants

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

ID	Title	Description
OG000	V419	V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 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.
OG001	Control	Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 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.

Secondary

Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug

Participants included in this analyses were All Subjects as Treated population and were defined as all vaccinated participants with safety follow up.

Posted

Number

Percentage of participants

Up to 5 days after each infant vaccination (up to 6 months)

ID	Title	Description
OG000	V419	V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 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.
OG001	Control	Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 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.

Secondary

Percentage of Participants With Elevated Temperature by Severity

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.

Participants included in this analyses were All Subjects as Treated population and were defined as all vaccinated participants with safety follow up and temperature data.

Posted

Number

Percentage of participants

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

ID	Title	Description
OG000	V419	V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 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.
OG001	Control	Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 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.

Units

Secondary

Percentage of Participants With Pyrexia, Febrile Convulsion, or Convulsion

The percentage of participants with one or more adverse events (AE), serious adverse events (SAE), and vaccine-related SAE (pyrexia, febrile convulsion, and convulsion) is reported.

Participants included in this analyses were All Subjects as Treated population and were defined as all vaccinated participants with safety follow up.

Posted

Number

Percentage of participants

Up to 15 days after any infant vaccination (up to 6 months)

ID	Title	Description
OG000	V419	V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 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.
OG001	Control	Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 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.

Units	Counts

Secondary

Percentage of Participants With Pyrexia, Febrile Convulsion, or Convulsion

The percentage of participants with one or more adverse events (AE), serious adverse events (SAE), and vaccine-related SAE (pyrexia, febrile convulsion, and convulsion) is reported.

Participants included in this analyses were All Subjects as Treated population and were defined as all vaccinated participants with safety follow up.

Posted

Number

Percentage of participants

Up to 181 days after any infant vaccination (up to 12 months)

ID	Title	Description
OG000	V419	V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 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.
OG001	Control	Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 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.

Units	Counts

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Leukocytosis	Blood and lymphatic system disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected980 at risk EG0011 events1 affected483 at risk
Lymphadenitis	Blood and lymphatic system disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected980 at risk EG0012 events2 affected483 at risk
Cardiac arrest	Cardiac disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected980 at risk EG0011 events1 affected483 at risk
Pyloric stenosis	Congenital, familial and genetic disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected980 at risk EG0011 events1 affected483 at risk
Anal fistula	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected980 at risk EG0010 events0 affected483 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0004 events4 affected980 at risk EG0010 events0 affected483 at risk
Vomiting	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected980 at risk EG0010 events0 affected483 at risk
Device expulsion	General disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected980 at risk EG0010 events0 affected483 at risk
Pyrexia	General disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected980 at risk EG0011 events1 affected483 at risk
Abscess	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected980 at risk EG0010 events0 affected483 at risk
Bronchiolitis	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0006 events6 affected980 at risk EG0015 events5 affected483 at risk
Bronchopneumonia	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected980 at risk EG0011 events1 affected483 at risk
Croup infectious	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0005 events4 affected980 at risk EG0013 events3 affected483 at risk
Gastritis viral	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected980 at risk EG0010 events0 affected483 at risk
Gastroenteritis	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0005 events5 affected980 at risk EG0010 events0 affected483 at risk
Gastroenteritis salmonella	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected980 at risk EG0010 events0 affected483 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0002 events2 affected980 at risk EG0010 events0 affected483 at risk
Human herpesvirus 6 infection	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected980 at risk EG0010 events0 affected483 at risk
Influenza	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected980 at risk EG0011 events1 affected483 at risk
Meningitis enteroviral	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected980 at risk EG0010 events0 affected483 at risk
Meningitis viral	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected980 at risk EG0011 events1 affected483 at risk
Otitis media	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected980 at risk EG0011 events1 affected483 at risk
Pneumonia	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0005 events5 affected980 at risk EG0012 events2 affected483 at risk
Pyelonephritis	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected980 at risk EG0010 events0 affected483 at risk
Respiratory syncytial virus bronchiolitis	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0006 events6 affected980 at risk EG0014 events4 affected483 at risk
Respiratory syncytial virus infection	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected980 at risk EG0010 events0 affected483 at risk
Roseola	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected980 at risk EG0010 events0 affected483 at risk
Subcutaneous abscess	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0002 events2 affected980 at risk EG0010 events0 affected483 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected980 at risk EG0010 events0 affected483 at risk
Urinary tract infection	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0002 events2 affected980 at risk EG0011 events1 affected483 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected980 at risk EG0010 events0 affected483 at risk
Vulval abscess	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected980 at risk EG0011 events1 affected483 at risk
Wound infection staphylococcal	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected980 at risk EG0011 events1 affected483 at risk
Accidental overdose	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected980 at risk EG0011 events1 affected483 at risk
Foreign body	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected980 at risk EG0010 events0 affected483 at risk
Injury	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected980 at risk EG0011 events1 affected483 at risk
Post concussion syndrome	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected980 at risk EG0010 events0 affected483 at risk
Skull fracture	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected980 at risk EG0010 events0 affected483 at risk
Skull fracture base	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected980 at risk EG0010 events0 affected483 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected980 at risk EG0010 events0 affected483 at risk
Urine output decreased	Investigations	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected980 at risk EG0010 events0 affected483 at risk
Abnormal weight gain	Metabolism and nutrition disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected980 at risk EG0010 events0 affected483 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 16.0	Systematic Assessment	EG00012 events12 affected980 at risk EG0012 events2 affected483 at risk
Failure to thrive	Metabolism and nutrition disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected980 at risk EG0011 events1 affected483 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected980 at risk EG0010 events0 affected483 at risk
Convulsion	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected980 at risk EG0011 events1 affected483 at risk
Dyskinesia	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected980 at risk EG0010 events0 affected483 at risk
Dystonia	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected980 at risk EG0011 events1 affected483 at risk
Febrile convulsion	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0002 events2 affected980 at risk EG0010 events0 affected483 at risk
Movement disorder	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected980 at risk EG0011 events1 affected483 at risk
Tonic convulsion	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected980 at risk EG0011 events1 affected483 at risk
Renal failure acute	Renal and urinary disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected980 at risk EG0010 events0 affected483 at risk
Apparent life threatening event	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected980 at risk EG0010 events0 affected483 at risk
Asphyxia	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected980 at risk EG0010 events0 affected483 at risk
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected980 at risk EG0011 events1 affected483 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG0003 events2 affected980 at risk EG0011 events1 affected483 at risk
Bronchial hyperreactivity	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG0002 events1 affected980 at risk EG0010 events0 affected483 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected980 at risk EG0010 events0 affected483 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected980 at risk EG0011 events1 affected483 at risk
Infantile apnoeic attack	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected980 at risk EG0010 events0 affected483 at risk
Respiratory arrest	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected980 at risk EG0012 events2 affected483 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected980 at risk EG0011 events1 affected483 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected980 at risk EG0010 events0 affected483 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected980 at risk EG0010 events0 affected483 at risk
Kawasaki's disease	Vascular disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected980 at risk EG0011 events1 affected483 at risk

ID	Term
D001424	Bacterial Infections
D014777	Virus Diseases
D004165	Diphtheria
D013742	Tetanus
D014917	Whooping Cough
D011051	Poliomyelitis
D006509	Hepatitis B
D006192	Haemophilus Infections

ID	Term
D001423	Bacterial Infections and Mycoses
D007239	Infections
D003354	Corynebacterium Infections
D000193	Actinomycetales Infections
D016908	Gram-Positive Bacterial Infections
D003015	Clostridium Infections
D001885	Bordetella Infections
D016905	Gram-Negative Bacterial Infections
D012141	Respiratory Tract Infections
D012140	Respiratory Tract Diseases
D009187	Myelitis
D002494	Central Nervous System Infections
D004769	Enterovirus Infections
D010850	Picornaviridae Infections
D012327	RNA Virus Infections
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D013118	Spinal Cord Diseases
D000090862	Neuroinflammatory Diseases
D009468	Neuromuscular Diseases
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D018347	Hepadnaviridae Infections
D004266	DNA Virus Infections
D006525	Hepatitis, Viral, Human
D006505	Hepatitis
D008107	Liver Diseases
D004066	Digestive System Diseases
D016871	Pasteurellaceae Infections

ID	Term
D022681	Diphtheria-Tetanus-acellular Pertussis Vaccines
C061964	Haemophilus influenzae-type b polysaccharide-Neisseria meningitidis outer membrane protein conjugate vaccine
C538862	13-valent pneumococcal vaccine
C492535	RotaTeq
D022243	Rotavirus Vaccines
C512971	pentacel
C055753	Haemophilus influenza type b polysaccharide vaccine-tetanus toxin conjugate

ID	Term
D010567	Pertussis Vaccine
D001428	Bacterial Vaccines
D014612	Vaccines
D001688	Biological Products
D045424	Complex Mixtures
D004168	Diphtheria Toxoid
D014121	Toxoids
D013745	Tetanus Toxoid
D017778	Vaccines, Combined
D022282	Vaccines, Acellular
D022223	Vaccines, Subunit
D014765	Viral Vaccines

ID	Title	Description
BG000	V419	V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 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.
BG001	Control	Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 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.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	V419	V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 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.			58	980	939	980
EG001	Control	Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 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.			32	483	458	483

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG00068 events61 affected980 at risk EG00125 events22 affected483 at risk
Vomiting	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG000432 events282 affected980 at risk EG001186 events125 affected483 at risk
Crying	General disorders	MedDRA 16.0	Systematic Assessment	EG0001,933 events788 affected980 at risk EG001857 events370 affected483 at risk
Irritability	General disorders	MedDRA 16.0	Systematic Assessment	EG0002,389 events853 affected980 at risk EG0011,109 events415 affected483 at risk
Pyrexia	General disorders	MedDRA 16.0	Systematic Assessment	EG0001,014 events560 affected980 at risk EG001356 events216 affected483 at risk
Otitis media	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG00076 events69 affected980 at risk EG00128 events26 affected483 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG000108 events100 affected980 at risk EG00141 events40 affected483 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 16.0	Systematic Assessment	EG0001,087 events577 affected980 at risk EG001469 events271 affected483 at risk
Somnolence	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0001,863 events755 affected980 at risk EG001887 events369 affected483 at risk
Injection-site bruising	General disorders	MedDRA 16.0	Systematic Assessment	EG000103 events62 affected980 at risk EG00161 events36 affected483 at risk
Injection-site erythema	General disorders	MedDRA 16.0	Systematic Assessment	EG0002,665 events597 affected980 at risk EG0011,365 events277 affected483 at risk
Injection-site pain	General disorders	MedDRA 16.0	Systematic Assessment	EG0004,276 events826 affected980 at risk EG0012,234 events391 affected483 at risk
Injection-site swelling	General disorders	MedDRA 16.0	Systematic Assessment	EG0001,974 events513 affected980 at risk EG001989 events219 affected483 at risk