CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 270 enrolled
Drug / intervention
MenHibrix (Hib-MenCY-TT) +1 morebiological
Likely dose
Not stated in 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/NCT00359983
NCT00359983Phase 3Completed
CompareCT.gov

A Study to Evaluate the Long-term Antibody Persistence at 1, 3 & 5 Years After the Administration of a Fourth Dose of Hib-MenCY-TT Vaccine Compared to ActHIB in Subjects Boosted in a Previous Study.

GlaxoSmithKline·interventional·Posted Aug 3, 2006·Updated Dec 16, 2016

In Brief

A Phase 3 clinical trial evaluating MenHibrix (Hib-MenCY-TT) and Hib conjugate vaccine (ActHIB) for Neisseria Meningitidis and Haemophilus Influenzae Type b. Completed, enrolled 270 participants across 21 sites.

Detailed Summary

This study is evaluating antibody persistence at 1, 3 \& 5 years post-fourth dose (i.e., at 2, 4 \& 6 years of age, respectively) in subjects vaccinated in a previous study. This protocol posting deals with objectives \& outcome measures of the extension phase at years 1, 3 and 5. The objectives \& outcome measures of the first four doses are presented in a separate protocol posting (NCT00129129). This protocol posting has been amended in order to comply with the FDA Amendment Act of September 26, 2007.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeisseria Meningitidis, Haemophilus Influenzae Type b
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 3, 2006
Enrollment StartSep 1, 2006
Primary CompletionNov 1, 2007
Study CompletionMay 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 19.9 years ago

Interventions

MenHibrix (Hib-MenCY-TT)biological

First three doses: 3 intramuscular doses Fourth dose: 1 intramuscular dose

Hib conjugate vaccine (ActHIB)biological

First three doses: 3 intramuscular doses Fourth dose: 1 intramuscular dose