CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 540 enrolled
Drug / intervention
Comparator: RECOMBIVAX HB™ Hepatitis B Vaccine (Recombinant) +2 morebiological
Likely dose
Comparator: RECOMBIVAX HB™ Hepatitis B Vaccine (Recombinant) 10 mcgfrom 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/NCT00440531
NCT00440531Phase 3Completed
CompareCT.gov

A Study in Healthy Adults of the Safety, Tolerability, and Immunogenicity of Recombinant Hepatitis B Vaccine Manufactured With a Modified Process

Merck Sharp & Dohme LLC·interventional·Posted Feb 27, 2007·Updated Apr 13, 2017

In Brief

A Phase 3 clinical trial evaluating Comparator: RECOMBIVAX HB™ Hepatitis B Vaccine (Recombinant), Comparator: Modified Process Hepatitis B Vaccine (Experimental), and 1 other intervention for Hepatitis B. Completed, enrolled 540 participants.

Detailed Summary

The purpose of this trial is to determine if there is an improvement in the immune response of older adults over 50 years of age using a modified process hepatitis B vaccine and a currently licensed hepatitis B vaccine (RECOMBIVAX HB™).

Study Details

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

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 27, 2007
Enrollment StartNov 1, 2006
Primary CompletionNov 1, 2007
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 19.3 years ago

Interventions

Comparator: RECOMBIVAX HB™ Hepatitis B Vaccine (Recombinant)biological

RECOMBIVAX HB™ (currently licensed product) given IM (Intramuscular) in 3 doses of 10 mcg (micrograms)/1.0 mL each over 6 months.

Comparator: Modified Process Hepatitis B Vaccine (Experimental)biological

Modified Process Hepatitis B Vaccine (Experimental) given IM (Intramuscular) in 3 doses of 10 mcg (micrograms)/1.0 mL each over 6 months.

Comparator: ENGERIX-B™ (currently licensed product)biological

ENGERIX-B™ given IM (Intramuscular) in 3 doses of 20 mcg (micrograms)/1.0 mL each over 6 months.