CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,478 enrolled
Drug / intervention
Comparator: Modified Process Hepatitis B Vaccine +1 morebiological
Likely dose
Comparator: Modified Process Hepatitis B Vaccine 5 µgfrom 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/NCT00393523
NCT00393523Phase 3Completed
CompareCT.gov

A Study to Assess the Anamnestic Immune Response 4 to 8 Years After a Primary Vaccination Series With HBVAXPRO

Merck Sharp & Dohme LLC·interventional·Posted Oct 27, 2006·Updated Apr 12, 2017

In Brief

A Phase 3 clinical trial evaluating Comparator: Modified Process Hepatitis B Vaccine and Comparator: Comparator: ENGERIX-B for Hepatitis B. Completed, enrolled 1,478 participants.

Detailed Summary

To assess the safety and immunogenicity of a booster dose of hepatitis B vaccine in children who have received a 3-dose primary series of either RECOMBIVAX HB or ENGERIX-B. The primary vaccination series (was given 4 to 8 years prior to study entry and consisted of a licensed hepatitis B vaccine product (either RECOMBIVAX HB or ENGERIX-B). The booster dose given in this study will be either an investigational Merck product (Modified Process Hepatitis B Vaccine) or licensed ENGERIX-B vaccine.

Study Details

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

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 27, 2006
Enrollment StartSep 1, 2006
Primary CompletionJun 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 19.7 years ago

Interventions

Comparator: Modified Process Hepatitis B Vaccinebiological

Single dose 5 µg/0.5ml modified process hepatitis B vaccine

Comparator: Comparator: ENGERIX-Bbiological

Single dose 10 µg/0.5ml ENGERIX-B