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)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 4

Conditions: Hepatitis A Virus

Treatments: Biological: Comparator: ProQuad™ (Measles, Mumps, Rubella and Varicella vaccine); Biological: Comparator: VAQTA™ (Hepatitis A vaccine); Biological: Comparator: Prevnar™ (Pneumococcal 7-Valent Conjugate vaccine)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00312858

2005_075

V251-067

Details and patient eligibility

About

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.

Full 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.

Enrollment: 653 patients

Sex: All

Ages: 12 to 15 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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653 participants in 2 patient groups

1

Active Comparator group

Description:

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.

Treatment:

Biological: Comparator: VAQTA™ (Hepatitis A vaccine)

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

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

2

Active Comparator group

Description:

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.

Treatment:

Biological: Comparator: VAQTA™ (Hepatitis A vaccine)

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

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