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)

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

653 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2008-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hepatitis A Virus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

Arm 1: VAQTA™ 0.5 mL injection (2 doses 6 months apart), ProQuad™ 0.5 mL injection (2 doses 6 months apart), Prevnar™ 0.5 mL injection (one dose), all vaccines administered concomitantly. 28 weeks of study duration.

Group Type ACTIVE_COMPARATOR

Comparator: VAQTA™ (Hepatitis A vaccine)

Intervention Type BIOLOGICAL

VAQTA™ 0.5 mL injection

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

Intervention Type BIOLOGICAL

ProQuad™ 0.5 mL injection

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

Intervention Type BIOLOGICAL

Prevnar™ 0.5 mL injection

2

Arm 2: ProQuad™ 0.5 mL injection (2 doses \~8 months apart), Prevnar™ 0.5 mL injection (one dose), both administered concomitantly, VAQTA™ 0.5 mL injection (2 doses 6 months apart) administered alone. 34 weeks of study duration.

Group Type ACTIVE_COMPARATOR

Comparator: VAQTA™ (Hepatitis A vaccine)

Intervention Type BIOLOGICAL

VAQTA™ 0.5 mL injection

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

Intervention Type BIOLOGICAL

ProQuad™ 0.5 mL injection

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

Intervention Type BIOLOGICAL

Prevnar™ 0.5 mL injection

Interventions

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Comparator: VAQTA™ (Hepatitis A vaccine)

VAQTA™ 0.5 mL injection

Intervention Type BIOLOGICAL

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

ProQuad™ 0.5 mL injection

Intervention Type BIOLOGICAL

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

Prevnar™ 0.5 mL injection

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

12 Months

Maximum Eligible Age

15 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes