drugset / Trial / NCT01444781
Study of the Booster Effect of DTaP-IPV-Hep B-PRP~T Combined Vaccine or Infanrix Hexa™ and Prevenar™ in Healthy Infants
RandomizedParallel-groupSingle-blindPrevention
Summary
This is a follow-up of the primary series vaccination schedule in Study A3L24 (NCT01177722). The objectives are: * To describe the antibody persistence to any antigen contained in the investigational DTaP-IPV-Hep B-PRP-T vaccine and Infanrix hexa™ prior to the booster dose * To describe the safety and immunogenicity of the booster dose of either DTaP-IPV-Hep B-PRP-T or Infanrix hexa™ vaccine. * To describe the immunogenicity of a booster dose of Prevenar™ given at 12 to 24 months.
Timeline
- Start
- 2011-09
- Primary completion
- 2013-04
- Completion
- 2013-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Infanrix hexa | Vaccine | 0.5 ml | Intramuscular |
| Subject | Prevnar 13 | Vaccine | 0.5 ml | Intramuscular |