CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 722 enrolled
Drug / intervention
2XP HEPTAVAX™-II SC +2 morebiological
Likely dose
Not stated in 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/NCT01463683
NCT01463683Phase 3Completed
CompareCT.gov

A Study in Healthy Japanese Young Adults to Assess the Safety, Tolerability, and Immunogenicity of HEPTAVAX-II Manufactured Using a Modified Process

Merck Sharp & Dohme LLC·interventional·Posted Nov 2, 2011·Updated Jul 18, 2018

In Brief

A Phase 3 clinical trial evaluating 2XP HEPTAVAX™-II SC, 1XP HEPTAVAX™-II SC, and 1 other intervention for Hepatitis B. Completed, enrolled 722 participants.

Detailed Summary

This is a study to evaluate immunogenicity, safety, and tolerability of 2XP HEPTAVAX™-II compared with the 1XP HEPTAVAX™-II in healthy Japanese young adults.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis B
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedNov 2, 2011
Enrollment StartNov 29, 2011
Primary CompletionNov 6, 2012
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 14.7 years ago

Interventions

2XP HEPTAVAX™-II SCbiological

1XP HEPTAVAX™-II SCbiological

2XP HEPTAVAX™-II IMbiological