CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 4,021 enrolled
Drug / intervention
GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine combined (792014) +4 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/NCT00345683
NCT00345683Phase 3Completed
CompareCT.gov

Single-blind, Randomized, Controlled, Multinational Study for the Evaluation of Safety of GSK Biologicals' Hib-MenCY-TT Vaccine Compared to Monovalent Hib Control Vaccine in Healthy Infants at 2, 4, 6, and 12 to 15 Months of Age.

GlaxoSmithKline·interventional·Posted Jun 28, 2006·Updated Nov 29, 2016

In Brief

A Phase 3 clinical trial evaluating GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine combined (792014), PedvaxHIB, and 3 other interventions for Haemophilus Influenzae Type b and Neisseria Meningitidis. Completed, enrolled 4,021 participants across 57 sites in 2 countries.

Detailed Summary

The booster phase of the study will evaluate the safety of Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine at 12 to 15 months of age. This protocol posting deals with objectives \& outcome measures of the booster phase. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00345579). No new recruitment will take place during this booster phase of the study. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHaemophilus Influenzae Type b, Neisseria Meningitidis
CountriesMexico, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 28, 2006
Enrollment StartJul 1, 2007
Primary CompletionSep 1, 2008
Study CompletionNov 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 20.0 years ago

Interventions

GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine combined (792014)biological

Booster dose by intramuscular injection

PedvaxHIBbiological

Booster dose by intramuscular injection

Prevnarbiological

Booster dose by intramuscular injection

M-M-R IIbiological

Single dose by subcutaneous injection

Varivaxbiological

Single dose by subcutaneous injection