drugset / Trial / NCT00534833
Immunogenicity Study of Antibody Persistence and Booster Effect of DTaP-HB-PRP~T Combined Vaccine or Tritanrix-HepB/Hib™
Non-randomizedParallel-groupOpen-labelPrevention
Summary
The present trial is a follow-up of AL203 study (NCT00343889). Primary Objectives: To describe the antibody persistence at 15 to 18 months of age and the booster effect of a dose of DTaP-HB-PRP\~T or Tritanrix-HepB/Hib™ (given concomitantly with Oral Polio Vaccine \[OPV\]). Secondary Objective: To describe the safety profile of a booster dose of DTaP-HB-PRP\~T or Tritanrix-HepB/Hib™ when administered concomitantly with OPV in each vaccine group.
Timeline
- Start
- 2007-09
- Primary completion
- 2008-09
- Completion
- 2009-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | DTaP-HB-PRP~T vaccine | Vaccine | 0.5 ml | Intramuscular |
| Comparator | Tritanrix-HepB/Hib™ | Vaccine | 0.5 ml | Intramuscular |
| Background | Oral Polio Vaccine | Vaccine | 0.5 ml | Oral |