drugset / Trial / NCT01926015
Immunogenicity and Safety of Concomitant Administration of RotaTeq™ (V260) and the Diphtheria, Tetanus, Pertussis and Inactivated Poliovirus Vaccine (DTP-IPV) in Healthy Japanese Infants (V260-060)
RandomizedParallel-groupOpen-labelPrevention
Summary
The study will evaluate the immunogenicity of the Diphtheria, Tetanus, Pertussis and Inactivated Poliovirus Vaccine (DTP-IPV) with concomitant administration of RotaTeq™ (V260) in healthy Japanese infants. The hypothesis to be tested is that the antibody response rates to DTP-IPV with concomitant administration of RotaTeq™ are non-inferior to those with staggered administration of RotaTeq™.
Timeline
- Start
- 2013-09-19
- Primary completion
- 2014-06-06
- Completion
- 2014-06-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | DPT-IPV | Vaccine | 0.5 ml | Subcutaneous |
| Subject | Rotarix | Vaccine | 2 ml | Oral |