Status:
COMPLETED
A Study of 2 Doses of VAQTA™ in Healthy Children 12 to 23 Months of Age (V251-069)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Hepatitis A Virus Infection
Eligibility:
All Genders
12-23 years
Phase:
PHASE3
Brief Summary
This study will demonstrate the immunogenicity and evaluate the safety/tolerability of the vaccine in Chinese children between 12 and 23 months of age.
Eligibility Criteria
Inclusion
- Healthy Chinese children 12 to 17 months old at receipt of the first study vaccination
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00835380
Start Date
March 1 2008
End Date
October 1 2008
Last Update
April 13 2017
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