CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,718 enrolled
Drug / intervention
Modified Process Hepatitis B Vaccine (Experimental) +2 morebiological
Likely dose
Modified Process Hepatitis B Vaccine (Experimental) 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/NCT00414050
NCT00414050Phase 3Completed
CompareCT.gov

A Study to Assess the Safety, Tolerability, and Immunogenicity of 2 Antigen Doses of Recombinant Hepatitis B Vaccine Manufactured With a Modified Process Administered to Healthy Infants at 2, 4, and 6 Months of Age

Merck Sharp & Dohme LLC·interventional·Posted Dec 21, 2006·Updated May 23, 2017

In Brief

A Phase 3 clinical trial evaluating Modified Process Hepatitis B Vaccine (Experimental) and Hepatitis B Vaccine (Recombinant) for Hepatitis B. Completed, enrolled 1,718 participants.

Detailed Summary

This study was conducted in healthy infants and will provide new immunogenicity and safety data for the modified process hepatitis B vaccine. This study was conducted to address the following: to evaluate the immunogenicity and safety data of the 5 microgram dose of the modified process hepatitis B vaccine compared with a 10 microgram dose of the modified process hepatitis B vaccine, to evaluate another dosing schedule of 2, 4, and 6 months, and to provide descriptive immunogenicity data of another marketed vaccine (ENGERIX-B®).

Study Details

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

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 21, 2006
Enrollment StartOct 6, 2006
Primary CompletionOct 22, 2007
Study CompletionOct 24, 2007
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 19.5 years ago

Interventions

Modified Process Hepatitis B Vaccine (Experimental)biological

Modified Process Hepatitis B Vaccine given intramuscularly (IM) in 3 injections of 5 ug (micrograms)/0.5 mL each over 4 months (Modified Process Hepatitis B vaccine 5 μg arm). Modified Process Hepatitis B Vaccine given IM in 3 Injections of 10 ug (micrograms)/0.5 mL each over 4 months (Modified Process Hepatitis B vaccine 10 μg arm).

Hepatitis B Vaccine (Recombinant)biological

RECOMBIVAX HB™ (currently licensed product) given IM in 3 Injections of 5 ug/0.5 mL each over 4 months.

Hepatitis B Vaccine (Recombinant)biological

ENGERIX-B® (currently licensed product) given IM in 3 Injections of 10 ug/0.5 mL each over 4 months