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Non-inferiority of GSK Biologicals' DTPw-HBV/Hib Compared to Two Formulations of GSK Biologicals' DTPw-HBV/Hib

NCT00473668 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2017-08-18

Study results available
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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.

Conditions

  • Whole Cell Pertussis
  • Haemophilus Influenzae Type b
  • Tetanus
  • Diphtheria
  • Hepatitis B

Interventions

BIOLOGICAL

Zilbrix-Hib

Intramuscular injection, 1 dose

BIOLOGICAL

Tritanrix™-HepB/ Hiberix™

Intramuscular injection, 1 dose

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
6 Weeks
Max Age
8 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-06-01
Primary Completion
2008-01-30
Completion
2008-01-30

Countries

  • India

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00473668 on ClinicalTrials.gov