Trials / Completed
CompletedNCT00317161
Immunogenicity & Safety Study of a Vaccine Against Meningitis in Infants (2,4,6 Months) After a Hepatitis B Birth Dose.
Study to Show Lot-to-lot Consistency of Hib-MenAC Mixed With Tritanrix™-HBV, Its Non-inferiority to Tritanrix™-HBV/Hiberix™ With or Without Meningitec™, and MenA Response in 2, 4, 6 Month Infants With Hepatitis B Birth Dose
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,000 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 56 Days – 83 Days
- Healthy volunteers
- Accepted
Summary
The purpose of the study is to demonstrate consistent results in 3 production lots of Hib-MenAC vaccine when extemporaneously mixed with Tritanrix™-HepB and administered as a single injection, with respect to immunogenicity, safety and reactogenicity. Tritanrix™-HepB/Hiberix™ given alone and Wyeth Lederle's meningococcal C conjugate vaccine (Meningitec™), given concomitantly with Tritanrix™-HepB/Hiberix™ will be used as benchmark vaccines for all antigens except for MenA. The immunogenicity of MenA will also be evaluated.
Detailed description
Randomized study with five groups to receive one of the following vaccination regimens after a birth dose of hepatitis B vaccine: One of the 3 lots of GSK Biologicals' Hib-MenAC mixed with GSK Biologicals' Tritanrix™-HBV (3 different groups) GSK Biologicals' Tritanrix™-HBV/Hiberix™ GSK Biologicals' Tritanrix™-HBV/Hiberix™ +Meningitec™
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | DTPw-HBV/Hib-MenAC conjugate vaccine |
Timeline
- Start date
- 2004-08-01
- Primary completion
- 2005-04-01
- Completion
- 2005-04-01
- First posted
- 2006-04-24
- Last updated
- 2016-09-20
Locations
3 sites across 1 country: Thailand
Source: ClinicalTrials.gov record NCT00317161. Inclusion in this directory is not an endorsement.