A Study of 2 Doses of VAQTA™ in Healthy Children 12 to 23 Months of Age (V251-069)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Hepatitis A Virus Infection

Treatments: Biological: Hepatitis A Vaccine, Purified Inactivated (VAQTA™)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00835380

V251-069

2009_531

Details and patient eligibility

About

This study will demonstrate the immunogenicity and evaluate the safety/tolerability of the vaccine in Chinese children between 12 and 23 months of age.

Enrollment: 80 patients

Sex: All

Ages: 12 to 23 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy Chinese children 12 to 17 months old at receipt of the first study vaccination

Exclusion criteria

• Subject is Hepatitis A virus antibody positive at screening or has a history of Hepatitis A infection
• Subject has a fever 72 hours prior to first injection
• Subject has already been vaccinated for Hepatitis A
• Subject is allergic to aluminum, formaldehyde, sodium borate, latex, or any component of the vaccine
• Subject has received inactivated vaccines within 14 days of screening or live vaccines within 30 days of screening

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 1 patient group

1

Experimental group

Description:

VAQTA™

Treatment:

Biological: Hepatitis A Vaccine, Purified Inactivated (VAQTA™)