Concomitant Use of Hepatitis A Vaccine With Measles, Mumps, Rubella and Varicella Vaccine and Pneumococcal 7-Valent Conjugate Vaccine in Healthy 12-Month-Old Children (V251-067)

An Open, Randomized, Multicenter Study of the Safety, Tolerability, & Immunogenicity of VAQTA™ Given Concomitantly With PROQUAD™ and PREVNAR™ in Healthy Children 12 Months of Age

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00312858

Enrollment

653

Registered

2006-04-11

Start date

2006-04-30

Completion date

2008-03-31

Last updated

2017-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis A Virus

Keywords

Hepatitis A Virus

Brief summary

Hepatitis A vaccine will be given either alone or together with measles, mumps, rubella, and varicella vaccine and pneumococcal 7-valent conjugate vaccine at the first dose and together with measles, mumps, rubella, and varicella \[Oka/Merck\] virus vaccine at the second dose. Immunogenicity and safety data will be collected after each dose of vaccine.

Detailed description

Vaccines: V251, Hepatitis A Vaccine, Inactivated (VAQTA™) administered with Measles, Mumps, Rubella and Varicella Vaccine (ProQuad™) and Pneumococcal 7-Valent Conjugate Vaccine (Prevnar™) will have a Duration of Treatment: 2 Doses, 6 months apart. Vaccine: Hepatitis A Vaccine, Inactivated (VAQTA™), administered alone will have a Duration of Treatment: 2 Doses, 6 months apart.

Interventions

BIOLOGICALComparator: VAQTA™ (Hepatitis A vaccine)

VAQTA™ 0.5 mL injection

BIOLOGICALComparator: ProQuad™ (Measles, Mumps, Rubella and Varicella vaccine)

ProQuad™ 0.5 mL injection

BIOLOGICALComparator: Prevnar™ (Pneumococcal 7-Valent Conjugate vaccine)

Prevnar™ 0.5 mL injection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

12 Months to 15 Months

Healthy volunteers

Yes

Inclusion criteria

* 12- to 15-month-old males and females with no active liver disease * A negative history of hepatitis A, measles, mumps, rubella, chickenpox, and/or zoster

Exclusion criteria

* Males and females previously vaccinated with hepatitis A, measles, mumps, rubella, and/or chickenpox vaccine * Any immune deficiency * History of allergy to any of the vaccine components * History of any seizure disorder

Design outcomes

Primary

Measure	Time frame	Description
Antibody Response to Hepatitis A - Participants With a Serological Response	4 weeks Postdose 2 of hepatitis A vaccine (VAQTA™)	Number of participants with titer ≥10 mIU/mL, i.e., seropositive for hepatitis A antibody, regardless of initial serostatus
Antibody Response to Varicella - Participants With a Serological Response	6 weeks Postdose 1 of varicella-containing vaccine (ProQuad™)	Participants with varicella baseline antibody titer \<1.25 gpELISA units/mL and Postdose 1 titers ≥1.25 gpELISA units/mL (seroconversion) and ≥5 gpELISA units/mL (seroprotection)
Antibody Response to Streptococcus Pneumoniae - Geometric Mean Titers	6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)	Serum antibodies to serotype-specific pneumococcal polysaccharides were determined by enzyme-linked immunosorbent assay
Participants With 1 or More Systemic Adverse Experience	6 weeks post dose 1	Systemic adverse experiences are unfavorable or unintended changes in the body after getting study vaccine. They are collected the first 14 days after receipt of dose 1 of hepatitis A vaccine (VAQTA™) (Days 1 to 14) within the 6 week study period.
Participants With 1 or More Systemic Adverse Experience.	6 months	Systemic adverse experiences are unfavorable or unintended changes in the body after getting study vaccine. Collected the first 14 days after each of the 2 doses of hepatitis A vaccine (VAQTA™) (Days 1 to 14), given 6 months apart
Participants With 1 or More Injection-site Adverse Experience	6 weeks post dose 1	Injection-site adverse experiences collected the first 5 days after receipt of dose 1 of hepatitis A vaccine (VAQTA™) (Days 1 to 5) within the 6 week study period.
Participants With Elevated Temperature (≥102.2F/ ≥39.0C)	6 weeks post dose 1	Elevated temperatures measured the first 5 days after receipt of dose 1 of hepatitis A vaccine (VAQTA™) (Days 1 to 5) within the 6 week study period.
Participants With 1 or More Serious Vaccine-related Adverse Experience	6 weeks post dose 1	Serious vaccine-related adverse experience causes death, persistent or significant disability, causes or prolong a hospital stay, is a cancer, an overdose, or life-threatening. They were collected during the entire study and believed due to study vaccine

Other

Measure	Time frame	Description
Antibody Response to Hepatitis A - Geometric Mean Titer	4 weeks Postdose 2 of hepatitis A vaccine (VAQTA™)	Geometric Mean Titer of hepatitis A antibody, regardless of initial serostatus
Antibody Response to S. Pneumoniae Serotype 23F - Participants With a Serological Response	6 weeks postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)	Number of participants with a postvaccination titer \>=0.2 mcg/mL for S. pneumoniae serotype 23F
Antibody Response to Varicella - Geometric Mean Titer	6 weeks Postdose 1 of varicella-containing vaccine (ProQuad™)	Geometric Mean Titer of varicella antibody, baseline antibody titer was \<1.25 gpELISA units/mL
Antibody Response to S. Pneumoniae Serotype 4 - Participants With a Serological Response	6 weeks postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)	Number of participants with a postvaccination titer \>=0.2 mcg/mL for S. pneumoniae serotype 4
Antibody Response to S. Pneumoniae Serotype 6B - Participants With a Serological Response	6 weeks postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)	Number of participants with a postvaccination titer \>=0.2 mcg/mL for S. pneumoniae serotype 6B
Antibody Response to S. Pneumoniae Serotype 9V - Participants With a Serological Response	6 weeks postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)	Number of participants with a postvaccination titer \>=0.2 mcg/mL for S. pneumoniae serotype 9V
Antibody Response to S. Pneumoniae Serotype 14 - Participants With a Serological Response	6 weeks postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)	Number of participants with a postvaccination titer \>=0.2 mcg/mL for S. pneumoniae serotype 14
Antibody Response to S. Pneumoniae Serotype 18C - Participants With a Serological Response	6 weeks postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)	Number of participants with a postvaccination titer \>=0.2 mcg/mL for S. pneumoniae serotype 18C
Antibody Response to S. Pneumoniae Serotype 19F - Participants With a Serological Response	6 weeks postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)	Number of participants with a postvaccination titer \>=0.2 mcg/mL for S. pneumoniae serotype 19F

Participant flow

Recruitment details

39 clinical sites in the United States Date first participant visit: 14-Apr-2006 Date last participant visit: 25-Mar-2008

Participants by arm

Arm	Count
Arm 1: VAQTA™ + ProQuad™ + Prevnar™ VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.	330
Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™ VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.	323
Total	653

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Adverse Event	0	1
Overall Study	Lost to Follow-up	25	42
Overall Study	Other	9	12
Overall Study	Participant Moved	11	10
Overall Study	Protocol Violation	3	8
Overall Study	Withdraw by Participant	20	20

Baseline characteristics

Characteristic	Arm 1: VAQTA™ + ProQuad™ + Prevnar™	Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™	Total
Age, Continuous	12.4 months STANDARD_DEVIATION 0.8	12.5 months STANDARD_DEVIATION 0.89	12.4 months STANDARD_DEVIATION 0.85
Sex: Female, Male Female	156 Participants	166 Participants	322 Participants
Sex: Female, Male Male	174 Participants	157 Participants	331 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	231 / —	172 / —
serious Total, serious adverse events	2 / —	6 / —

Outcome results

Primary

Antibody Response to Hepatitis A - Participants With a Serological Response

Number of participants with titer ≥10 mIU/mL, i.e., seropositive for hepatitis A antibody, regardless of initial serostatus

Time frame: 4 weeks Postdose 2 of hepatitis A vaccine (VAQTA™)

Population: Per-protocol analysis set includes participants who received 2 doses of VAQTA™ (hepatitis A vaccine), had a Postdose 2 serology results, and followed the protocol procedures.

Arm	Measure	Value (NUMBER)
Arm 1: VAQTA™ + ProQuad™ + Prevnar™	Antibody Response to Hepatitis A - Participants With a Serological Response	182 Participants
Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™	Antibody Response to Hepatitis A - Participants With a Serological Response	158 Participants

Comparison: Comparison of the difference (percentage points) in estimated response rates of Arm 1 - Arm 2.p-value: <0.00195% CI: [-1.4, 3.8]Miettinen and Nurminen

Primary

Antibody Response to Streptococcus Pneumoniae - Geometric Mean Titers

Serum antibodies to serotype-specific pneumococcal polysaccharides were determined by enzyme-linked immunosorbent assay

Time frame: 6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)

Population: Per-protocol analysis set includes participants who received Prevnar™ (pneumococcal 7-valent conjugate vaccine), had a postvaccination serology result, and followed the protocol procedures

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Arm 1: VAQTA™ + ProQuad™ + Prevnar™	Antibody Response to Streptococcus Pneumoniae - Geometric Mean Titers	Serotype 9V (n=247, 247)	3.7 mcg/mL
Arm 1: VAQTA™ + ProQuad™ + Prevnar™	Antibody Response to Streptococcus Pneumoniae - Geometric Mean Titers	Serotype 18C (n=247, 247)	2.9 mcg/mL
Arm 1: VAQTA™ + ProQuad™ + Prevnar™	Antibody Response to Streptococcus Pneumoniae - Geometric Mean Titers	Serotype 6B (n=246, 246)	9.5 mcg/mL
Arm 1: VAQTA™ + ProQuad™ + Prevnar™	Antibody Response to Streptococcus Pneumoniae - Geometric Mean Titers	Serotype 19F (n=248, 248)	4.0 mcg/mL
Arm 1: VAQTA™ + ProQuad™ + Prevnar™	Antibody Response to Streptococcus Pneumoniae - Geometric Mean Titers	Serotype 14 (n=248, 247)	7.7 mcg/mL
Arm 1: VAQTA™ + ProQuad™ + Prevnar™	Antibody Response to Streptococcus Pneumoniae - Geometric Mean Titers	Serotype 23F (n=247, 247)	4.9 mcg/mL
Arm 1: VAQTA™ + ProQuad™ + Prevnar™	Antibody Response to Streptococcus Pneumoniae - Geometric Mean Titers	Serotype 4 (n=246, 247)	1.8 mcg/mL
Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™	Antibody Response to Streptococcus Pneumoniae - Geometric Mean Titers	Serotype 23F (n=247, 247)	4.5 mcg/mL
Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™	Antibody Response to Streptococcus Pneumoniae - Geometric Mean Titers	Serotype 4 (n=246, 247)	1.6 mcg/mL
Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™	Antibody Response to Streptococcus Pneumoniae - Geometric Mean Titers	Serotype 6B (n=246, 246)	9.6 mcg/mL
Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™	Antibody Response to Streptococcus Pneumoniae - Geometric Mean Titers	Serotype 9V (n=247, 247)	4.1 mcg/mL
Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™	Antibody Response to Streptococcus Pneumoniae - Geometric Mean Titers	Serotype 14 (n=248, 247)	7.4 mcg/mL
Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™	Antibody Response to Streptococcus Pneumoniae - Geometric Mean Titers	Serotype 18C (n=247, 247)	2.6 mcg/mL
Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™	Antibody Response to Streptococcus Pneumoniae - Geometric Mean Titers	Serotype 19F (n=248, 248)	3.8 mcg/mL

Comparison: Serotype 4p-value: <0.00195% CI: [0.9, 1.3]ANCOVA

Comparison: Serotype 6Bp-value: <0.00195% CI: [0.8, 1.2]ANCOVA

Comparison: Serotype 9Vp-value: <0.00195% CI: [0.8, 1]ANCOVA

Comparison: Serotype 14p-value: <0.00195% CI: [0.9, 1.2]ANCOVA

Comparison: Serotype 18Cp-value: <0.00195% CI: [0.9, 1.3]ANCOVA

Comparison: Serotype 19Fp-value: <0.00195% CI: [0.9, 1.2]ANCOVA

Comparison: Serotype 23Fp-value: <0.00195% CI: [1, 1.3]ANCOVA

Primary

Antibody Response to Varicella - Participants With a Serological Response

Participants with varicella baseline antibody titer \<1.25 gpELISA units/mL and Postdose 1 titers ≥1.25 gpELISA units/mL (seroconversion) and ≥5 gpELISA units/mL (seroprotection)

Time frame: 6 weeks Postdose 1 of varicella-containing vaccine (ProQuad™)

Population: Per-protocol analysis set includes participants who received the initial dose of ProQuad™ (varicella-containing vaccine), had a Postdose 1 serology result, and followed the protocol procedures.

Arm	Measure	Group	Value (NUMBER)
Arm 1: VAQTA™ + ProQuad™ + Prevnar™	Antibody Response to Varicella - Participants With a Serological Response	Number of participants ≥1.25 gpELISA units/mL	222 Participants
Arm 1: VAQTA™ + ProQuad™ + Prevnar™	Antibody Response to Varicella - Participants With a Serological Response	Number of participants ≥5 gpELISA units/mL	210 Participants
Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™	Antibody Response to Varicella - Participants With a Serological Response	Number of participants ≥1.25 gpELISA units/mL	231 Participants
Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™	Antibody Response to Varicella - Participants With a Serological Response	Number of participants ≥5 gpELISA units/mL	228 Participants

Comparison: Comparison of the difference (percentage points) in estimated response rates of Arm 1 - Arm 2 for participants with initial serostatus \<1.25 gpELISA units/mLp-value: 0.01395% CI: [-9.3, -1.4]Miettinen and Nurminen

Primary

Participants With 1 or More Injection-site Adverse Experience

Injection-site adverse experiences collected the first 5 days after receipt of dose 1 of hepatitis A vaccine (VAQTA™) (Days 1 to 5) within the 6 week study period.

Time frame: 6 weeks post dose 1

Population: Includes all participants who provided safety follow-up after receipt of Dose 1 of VAQTA™ (hepatitis A vaccine)

Arm	Measure	Value (NUMBER)
Arm 1: VAQTA™ + ProQuad™ + Prevnar™	Participants With 1 or More Injection-site Adverse Experience	83 Participants
Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™	Participants With 1 or More Injection-site Adverse Experience	61 Participants

Primary

Participants With 1 or More Injection-site Adverse Experience

Injection-site adverse experiences collected the first 5 days after receipt of each dose of hepatitis A vaccine (VAQTA™) (Days 1 to 5) over the 6 months in which the 2 doses of vaccine were administered.

Time frame: 6 months

Population: Includes all participants who provided safety follow-up after receipt of any dose of VAQTA™ (hepatitis A vaccine)

Arm	Measure	Value (NUMBER)
Arm 1: VAQTA™ + ProQuad™ + Prevnar™	Participants With 1 or More Injection-site Adverse Experience	105 Participants
Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™	Participants With 1 or More Injection-site Adverse Experience	95 Participants

Primary

Participants With 1 or More Injection-site Adverse Experience

Injection-site adverse experiences collected the first 5 days after receipt of dose 2 of hepatitis A vaccine (VAQTA™) (Days 1 to 5) within the 4 week study period.

Time frame: 4 weeks post dose 2

Population: Includes all participants who provided safety follow-up after receipt of Dose 2 of VAQTA™ (hepatitis A vaccine)

Arm	Measure	Value (NUMBER)
Arm 1: VAQTA™ + ProQuad™ + Prevnar™	Participants With 1 or More Injection-site Adverse Experience	54 Participants
Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™	Participants With 1 or More Injection-site Adverse Experience	66 Participants

Primary

Participants With 1 or More Serious Vaccine-related Adverse Experience

Serious vaccine-related adverse experience causes death, persistent or significant disability, causes or prolong a hospital stay, is a cancer, an overdose, or life-threatening. They were collected during the entire study and believed due to study vaccine

Time frame: 4 weeks post dose 2

Population: Includes all participants who provided safety follow-up after receipt of Dose 2 of VAQTA™ (hepatitis A vaccine)

Arm	Measure	Value (NUMBER)
Arm 1: VAQTA™ + ProQuad™ + Prevnar™	Participants With 1 or More Serious Vaccine-related Adverse Experience	0 Participants
Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™	Participants With 1 or More Serious Vaccine-related Adverse Experience	0 Participants

Primary

Participants With 1 or More Serious Vaccine-related Adverse Experience

Time frame: 6 weeks post dose 1

Population: Includes all participants who provided safety follow-up after receipt of Dose 1 of VAQTA™ (hepatitis A vaccine)

Arm	Measure	Value (NUMBER)
Arm 1: VAQTA™ + ProQuad™ + Prevnar™	Participants With 1 or More Serious Vaccine-related Adverse Experience	0 Participants
Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™	Participants With 1 or More Serious Vaccine-related Adverse Experience	1 Participants

Primary

Participants With 1 or More Serious Vaccine-related Adverse Experience

Time frame: 6 months

Population: Includes all participants who provided safety follow-up after receipt of any dose of VAQTA™ (hepatitis A vaccine)

Arm	Measure	Value (NUMBER)
Arm 1: VAQTA™ + ProQuad™ + Prevnar™	Participants With 1 or More Serious Vaccine-related Adverse Experience	0 Participants
Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™	Participants With 1 or More Serious Vaccine-related Adverse Experience	1 Participants

Primary

Participants With 1 or More Systemic Adverse Experience

Systemic adverse experiences are unfavorable or unintended changes in the body after getting study vaccine. They are collected the first 14 days after receipt of dose 1 of hepatitis A vaccine (VAQTA™) (Days 1 to 14) within the 6 week study period.

Time frame: 6 weeks post dose 1

Population: Includes all participants who provided safety follow-up after receipt of Dose 1 of VAQTA™ (hepatitis A vaccine)

Arm	Measure	Value (NUMBER)
Arm 1: VAQTA™ + ProQuad™ + Prevnar™	Participants With 1 or More Systemic Adverse Experience	178 Participants
Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™	Participants With 1 or More Systemic Adverse Experience	80 Participants

Primary

Participants With 1 or More Systemic Adverse Experience

Systemic adverse experiences are unfavorable or unintended changes in the body after getting study vaccine. They are collected the first 14 days after receipt of dose 2 of hepatitis A vaccine (VAQTA™) (Days 1 to 14) within the 4 week study period.

Time frame: 4 weeks post dose 2

Population: Includes all participants who provided safety follow-up after receipt of Dose 2 of VAQTA™ (hepatitis A vaccine)

Arm	Measure	Value (NUMBER)
Arm 1: VAQTA™ + ProQuad™ + Prevnar™	Participants With 1 or More Systemic Adverse Experience	88 Participants
Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™	Participants With 1 or More Systemic Adverse Experience	77 Participants

Primary

Participants With 1 or More Systemic Adverse Experience.

Systemic adverse experiences are unfavorable or unintended changes in the body after getting study vaccine. Collected the first 14 days after each of the 2 doses of hepatitis A vaccine (VAQTA™) (Days 1 to 14), given 6 months apart

Time frame: 6 months

Population: Includes all participants who provided safety follow-up after receipt of any dose of VAQTA™ (hepatitis A vaccine)

Arm	Measure	Value (NUMBER)
Arm 1: VAQTA™ + ProQuad™ + Prevnar™	Participants With 1 or More Systemic Adverse Experience.	204 Participants
Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™	Participants With 1 or More Systemic Adverse Experience.	133 Participants

Primary

Participants With Elevated Temperature (≥102.2F/ ≥39.0C)

Elevated temperatures measured the first 5 days after receipt of dose 2 of hepatitis A vaccine (VAQTA™) (Days 1 to 5) within the 4 week study period.

Time frame: 4 weeks post dose 2

Population: Includes all participants who provided safety follow-up after receipt of Dose 2 of VAQTA™ (hepatitis A vaccine)

Arm	Measure	Value (NUMBER)
Arm 1: VAQTA™ + ProQuad™ + Prevnar™	Participants With Elevated Temperature (≥102.2F/ ≥39.0C)	6 Participants
Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™	Participants With Elevated Temperature (≥102.2F/ ≥39.0C)	5 Participants

Primary

Participants With Elevated Temperature (≥102.2F/ ≥39.0C)

Elevated temperatures measured the first 5 days after receipt of each dose of hepatitis A vaccine (VAQTA™) (Days 1 to 5) over the 6 months in which the 2 doses of vaccine were administered.

Time frame: 6 months

Population: Includes all participants who provided safety follow-up after receipt of any dose of VAQTA™ (hepatitis A vaccine)

Arm	Measure	Value (NUMBER)
Arm 1: VAQTA™ + ProQuad™ + Prevnar™	Participants With Elevated Temperature (≥102.2F/ ≥39.0C)	16 Participants
Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™	Participants With Elevated Temperature (≥102.2F/ ≥39.0C)	10 Participants

Primary

Participants With Elevated Temperature (≥102.2F/ ≥39.0C)

Elevated temperatures measured the first 5 days after receipt of dose 1 of hepatitis A vaccine (VAQTA™) (Days 1 to 5) within the 6 week study period.

Time frame: 6 weeks post dose 1

Population: Includes all participants who provided safety follow-up after receipt of Dose 1 of VAQTA™ (hepatitis A vaccine)

Arm	Measure	Value (NUMBER)
Arm 1: VAQTA™ + ProQuad™ + Prevnar™	Participants With Elevated Temperature (≥102.2F/ ≥39.0C)	10 Participants
Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™	Participants With Elevated Temperature (≥102.2F/ ≥39.0C)	5 Participants

Other Pre-specified

Antibody Response to Hepatitis A - Geometric Mean Titer

Geometric Mean Titer of hepatitis A antibody, regardless of initial serostatus

Time frame: 4 weeks Postdose 2 of hepatitis A vaccine (VAQTA™)

Population: Per-protocol analysis set includes participants who received 2 doses of VAQTA™ (hepatitis A vaccine), had a Postdose 2 serology results, and followed the protocol procedures

Arm	Measure	Value (GEOMETRIC_MEAN)
Arm 1: VAQTA™ + ProQuad™ + Prevnar™	Antibody Response to Hepatitis A - Geometric Mean Titer	4976.6 mIU/mL
Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™	Antibody Response to Hepatitis A - Geometric Mean Titer	6123.2 mIU/mL

Other Pre-specified