drugset / Trial / NCT00315055
Immunogenicity of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® at 2-3-4 Months Schedule
RandomizedParallel-groupOpen-labelPrevention
Summary
To demonstrate that the immune response to hepatitis B antigen of the DTaP-IPV-Hep B-PRP\~T is non-inferior to that of the association of PENTAXIM™ and ENGERIX B® one month after a three dose (2-3-4 month) primary series. Immunogenicity * To assess pre- and post-primary series * To assess pre- and post-booster series.
Timeline
- Start
- 2006-07
- Primary completion
- 2007-07
- Completion
- 2008-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | DTaP-IPV-HB-PRP~T | Vaccine | 0.5 ml | Intramuscular |
| Comparator | DTaP-IPV//PRP~T | Vaccine | 0.5 ml | Intramuscular |
| Comparator | Hepatitis B vaccine | Vaccine | 0.5 ml | Intramuscular |