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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
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.
Details
| Lead sponsor | GlaxoSmithKline |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 1000 |
| Start date | 2004-08 |
| Completion | 2005-04 |
Conditions
- Diphtheria
- Hepatitis B
- Haemophilus Influenzae Type b
- Whole Cell Pertussis
- Tetanus
Interventions
- DTPw-HBV/Hib-MenAC conjugate vaccine
Primary outcomes
- Post-dose 3, bactericidal titers & antibody levels to meningococcal serogroups A & C; & PRP; & antibody levels to HBs, diphtheria, tetanus & BPT (subset of subjects).
Countries
Thailand