Trials / Completed
CompletedNCT00291967
Assess Immune Response Following Primary Vaccination With Tritanrix™-HepB Vaccine Mixed With 3 Formulations of Hib-MenAC Vaccine to Infants
Evaluate the Feasibility of GSK Biologicals' Tritanrix™-HepB/Hib-MenAC Vaccine Administered as a 3 Dose Primary Vaccination Course at 6, 10 & 14 Weeks of Age
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 525 (planned)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 6 Weeks – 10 Weeks
- Healthy volunteers
- Accepted
Summary
To compare three formulations of Hib-MenAC vaccines mixed with Tritanrix™-HepB vaccine with that of Tritanrix™-HepB vaccine concomitantly administered with GSK Biologicals' Hiberix™ vaccine and Tritanrix™-HepB vaccine mixed with Hiberix™ vaccine and concomitantly administered with Wyeth Lederle's meningococcal C conjugate vaccine (Meningitec™), with respect to antibody response to vaccine antigens (meningococcal serogroups A and C and PRP) after a three-dose primary vaccination course.
Detailed description
Randomized study with five groups to receive one of the following vaccination regimens: One of the three formulations of GSK Biologicals' Hib-MenAC mixed with GSK Biologicals' Tritanrix™-HepB (3 different groups) GSK Biologicals' Tritanrix™-HepB + GSK Biologicals' Hiberix™ GSK Biologicals' Tritanrix™-HepB mixed with GSK Biologicals' Hiberix™ + Wyeth Lederle's Meningitec™
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | DTPw-HBV/Hib-MenAC conjugate vaccine |
Timeline
- Start date
- 2002-11-01
- First posted
- 2006-02-15
- Last updated
- 2006-12-08
Locations
1 site across 1 country: Philippines
Source: ClinicalTrials.gov record NCT00291967. Inclusion in this directory is not an endorsement.