CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 80 enrolled
Drug / intervention
Hepatitis A Vaccine, Purified Inactivated (VAQTA™)biological
Likely dose
Hepatitis A Vaccine, Purified Inactivated (VAQTA™) 0.5 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00835380
NCT00835380Phase 3Completed
CompareCT.gov

A Phase III Open-Label Study of Immunogenicity, Safety, and Tolerability of 2 Doses of VAQTA™ (Formalin, Inactivated, Alum-Adjuvanted Hepatitis A Vaccine) in Healthy Children 12 to 23 Months of Age

Merck Sharp & Dohme LLC·interventional·Posted Feb 3, 2009·Updated Apr 13, 2017

In Brief

A Phase 3 clinical trial evaluating Hepatitis A Vaccine, Purified Inactivated (VAQTA™) for Hepatitis A Virus Infection. Completed, enrolled 80 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis A Virus Infection
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 3, 2009
Enrollment StartMar 1, 2008
Primary CompletionOct 1, 2008
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 17.4 years ago

Interventions

Hepatitis A Vaccine, Purified Inactivated (VAQTA™)biological

Subjects will be given a 25-U/0.5 mL intramuscular injections of VAQTA™ at Day 1 and Month 6.