At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 546 enrolled

Drug / intervention

Comparator: Modified Process Vaccine +1 morebiological

Likely dose

Comparator: Modified Process Vaccine 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/NCT00441012

NCT00441012Phase 3Completed

Compare CT.gov

A Study in Healthy Infants of the Safety, Tolerability, and Immunogenicity of Haemophilus Influenzae, Type b/Hepatitis B Vaccine Manufactured With a Modified Process

Merck Sharp & Dohme LLC·interventional·Posted Feb 27, 2007·Updated Mar 19, 2015

In Brief

A Phase 3 clinical trial evaluating Comparator: Modified Process Vaccine and Comparator: COMVAX™ for Haemophilus Influenzae Type B and Hepatitis B. Completed, enrolled 546 participants.

Detailed Summary

To determine if there is an improvement in the immune response to HBsAg (hepatitis B virus) in healthy infants using a modified process in a combination Haemophilus Influenzae, type b/Hepatitis B vaccine and a currently licensed Haemophilus Influenzae, type b/Hepatitis B vaccine

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsHaemophilus Influenzae Type B, Hepatitis B

Countries--

Collaborators--

Timeline

Phase 3CompletedFinished

200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartDec 2006

First PostedFeb 2007

Primary CompletionJun 2008

TodayJul 2026

First PostedFeb 27, 2007

Enrollment StartDec 1, 2006

Primary CompletionJun 1, 2008

TodayJul 2, 2026

Enrollment to primary: 1.5 yearsPosted 19.3 years ago

Interventions

Comparator: Modified Process Vaccinebiological

Modified process vaccine HBsAg 5 ug/0.5 mL and PRP \[OMPC\] 7.5 ug/0.5 mL in a 3-dose regimen at 2, 4 \& 12 months of age. Duration of treatment is 11 months.

Comparator: COMVAX™biological

COMVAX™ HBsAg 5 ug/0.5 mL and PRP \[OMPC\] 7.5 ug/0.5 mL in a 3-dose regimen at 2, 4, and 12 months of age. Duration of treatment is 11 months.