CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 204 enrolled
Drug / intervention
Modified Process Hepatitis B Vaccinebiological
Likely dose
Modified Process Hepatitis B Vaccine 1.0 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/NCT01251276
NCT01251276Phase 3Completed
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A Study to Estimate the Immune Response Following a Challenge Dose in Adults (≥50 Years Old) Vaccinated With a Primary Series of an Hepatitis B Vaccine

Merck Sharp & Dohme LLC·interventional·Posted Dec 1, 2010·Updated Sep 13, 2022

In Brief

A Phase 3 clinical trial evaluating Modified Process Hepatitis B Vaccine for Hepatitis B. Completed, enrolled 204 participants.

Detailed Summary

The purpose of this trial is to describe the Seroprotection Rate (SPR) at least 2 years following completion of a primary series with a hepatitis B vaccine (Base Study V232-059, NCT00440531) and 1 month following a challenge dose with a Modified Process Hepatitis B vaccine.

Study Details

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

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedDec 1, 2010
Enrollment StartNov 30, 2010
Primary CompletionApr 12, 2011
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 15.6 years ago

Interventions

Modified Process Hepatitis B Vaccinebiological

Modified Process Hepatitis B Vaccine given IM (intramuscular) as a single 1.0 mL (10 mcg) challenge dose on Day 1 of the Challenge Dose Study