Trials / Completed
CompletedNCT00473668
Non-inferiority of GSK Biologicals' DTPw-HBV/Hib Compared to Two Formulations of GSK Biologicals' DTPw-HBV/Hib
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 300 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 6 Weeks – 8 Weeks
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Zilbrix-Hib | Intramuscular injection, 1 dose |
| BIOLOGICAL | Tritanrix™-HepB/ Hiberix™ | Intramuscular injection, 1 dose |
Timeline
- Start date
- 2007-06-01
- Primary completion
- 2008-01-30
- Completion
- 2008-01-30
- First posted
- 2007-05-15
- Last updated
- 2017-08-18
- Results posted
- 2017-08-18
Locations
3 sites across 1 country: India
Source: ClinicalTrials.gov record NCT00473668. Inclusion in this directory is not an endorsement.