CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 300 enrolled
Drug / intervention
Zilbrix-Hib +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/NCT00473668
NCT00473668Phase 3Completed
CompareCT.gov

Non-inferiority of One Formulation of GSK Biologicals' DTPw-HBV/Hib to 2 Formulations of GSK Biologicals' DTPw-HBV/Hib With Respect to the Immune Response to the PRP Antigen, When Administered to Healthy Infants at 6, 10, 14 Weeks of Age

GlaxoSmithKline·interventional·Posted May 15, 2007·Updated Aug 18, 2017

In Brief

A Phase 3 clinical trial evaluating Zilbrix-Hib and Tritanrix™-HepB/ Hiberix™ for Whole Cell Pertussis and 4 related conditions. Completed, enrolled 300 participants across 3 sites.

Detailed Summary

The purpose of this observer-blind study is to generate immunogenicity data with one formulation of GSK Biologicals' DTPw-HBV/Hib vaccine after the primary vaccination course and to demonstrate non-inferiority of this vaccine as compared to two formulations of GSK Biologicals' DTPw-HBV/Hib vaccine with respect to the anti-PRP antibody response. Additionally to assess the reactogenicity and safety of GSK Biologicals' DTPw-HBV/Hib vaccine. 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--
ConditionsWhole Cell Pertussis, Haemophilus Influenzae Type b, Tetanus, Diphtheria, Hepatitis B
CountriesIndia
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 15, 2007
Enrollment StartJun 1, 2007
Primary CompletionJan 30, 2008
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 19.1 years ago

Interventions

Zilbrix-Hibbiological

Intramuscular injection, 1 dose

Tritanrix™-HepB/ Hiberix™biological

Intramuscular injection, 1 dose