Phase 3 N=80 Prevention

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

Hepatitis A Virus Infection

Bottom Line

View on ClinicalTrials.gov: NCT00835380 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2010

Primary outcome: Primary: Hepatitis A Virus (HAV) Seroconversion Rate, i.e. the Percentage of Subjects Who Were Seronegative at Baseline and Developed Seropositive at Month 7 After Administration of a 2-dose Regime of Vaccines. — 2; 68 Percentage of Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Hepatitis A Vaccine, Purified Inactivated (VAQTA™) (Biological)
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: Merck Sharp & Dohme LLC
Primary completion: Oct 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Hepatitis A Virus (HAV) Seroconversion Rate, i.e. the Percentage of Subjects Who Were Seronegative at Baseline and Developed Seropositive at Month 7 After Administration of a 2-dose Regime of Vaccines.	2; 68	—
SECONDARY Serious Adverse Experiences and Systemic Adverse Experiences Occurring Within 14 Days After Each Vaccination, and Injection-site Complaints Occurring Day 1 Through Day 5 After Each Vaccination	0; 10; 54	—

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 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00835380). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.