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)

NCT01926015

Phase 4 Completed 192 enrolled Merck Sharp & Dohme LLC
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

EvaluationDrugModalityDoseRoute
Subject DPT-IPV Vaccine 0.5 ml Subcutaneous
Subject Rotarix Vaccine 2 ml Oral

Indications