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)

Post-marketing, Randomized, Open-label Study to Assess the Immunogenicity and Safety of Concomitant Administration of V260 and Diphtheria, Tetanus, Pertussis and Inactivated Poliovirus Vaccine (DTP-IPV) in Japanese Healthy Infants

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 192 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 6 Weeks – 11 Weeks
• Healthy volunteers: Accepted

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™.

Conditions

• Rotavirus Disease

Interventions

Type	Name	Description
BIOLOGICAL	RotaTeq™ (V260)	Live, oral, pentavalent vaccine containing 5 human-bovine reassortant rotavirus strains
BIOLOGICAL	DTP-IPV	Diphtheria, tetanus, pertussis, inactivated polio vaccine used as part of the Japanese vaccination schedule

Timeline

• Start date: 2013-09-19
• Primary completion: 2014-06-06
• Completion: 2014-06-06
• First posted: 2013-08-20
• Last updated: 2018-11-14
• Results posted: 2015-04-09