drugset / Trial / NCT01457495
Immunogenicity and Safety of DTPa-HBV-IPV/Hib Compared to DTPa-IPV/Hib and HBV Administered Concomitantly
RandomizedParallel-groupOpen-labelPrevention
Summary
This study will assess the immunogenicity of GlaxoSmithKline (GSK) Biologicals' (formerly SmithKline Beecham Biologicals') DTPa-HBV-IPV/Hib (Infanrix hexa™) vaccine compared to the separate administration of DTPa-HBV-IPV (Infanrix™ penta) and Hib (Hiberix™) vaccines administered at 3 and 5 months of age.
Timeline
- Start
- 1998-09
- Primary completion
- 1999-09
- Completion
- 1999-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | DTPa-HBV-IPV/Hib | Vaccine | — | Intramuscular |
| Comparator | DTPa-IPV/Hib | Unknown | — | Intramuscular |
| Comparator | Engerix-B | Vaccine | — | Intramuscular |