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Study to Assess the Immunogenicity and Reactogenicity of DTPa-HBV-IPV Vaccine Mixed With Hib Vaccine to Healthy Infants at 3, 5 and 11 Months of Age, Compared to Each Vaccine Administered Separately
This study will assess the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals' (formerly SB Biologicals') DTPa-HBV-IPV/Hib (Infanrix hexa™) vaccine compared with separate administration of DTPa-HBV-IPV (Infanrix penta™) and Hib (Hiberix™) vaccine administered at 3, 5 and 11 (or 12) months of age.
Details
| Lead sponsor | GlaxoSmithKline |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 440 |
| Start date | 1999-01 |
| Completion | 2000-03 |
Conditions
- Hepatitis B
- Diphtheria
- Haemophilus Influenzae Type b (Hib)
- Poliomyelitis
- Pertussis
- Tetanus
Interventions
- DTPa-HBV-IPV/Hib (Infanrix hexa™)
- DTPa-HBV-IPV (Infanrix penta™)
- Hib (Hiberix™)
Primary outcomes
- Immunogenicity with respect to the components of the study vaccine in terms of number of subjects with antibody titres greater than or equal to cut off value — One month after the 2nd dose of the primary vaccination course ( Month 3)