NCT02062385

Efficacy, Safety, and Immunogenicity of V260 in Healthy Chinese Infants (V260-024)

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy, Safety, and Immunogenicity of V260 in Healthy Chinese Infants

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 4,040 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 6 Weeks – 12 Weeks
• Healthy volunteers: Accepted

Summary

This study will assess the efficacy, safety, and immunogenicity of a 3-dose regimen of RotaTeq™ (V260) in healthy Chinese infants. Approximately 4040 participants at least 6 weeks and up to 12 weeks of age at the time of the first vaccination with V260 or placebo will be enrolled and randomized (1:1) to receive either V260 or placebo. Participants will also receive the routine China Expanded Program on Immunization (EPI) vaccines (oral poliovirus vaccine \[OPV\] and diphtheria, tetanus, and acellular pertussis vaccine \[DTaP\]) either staggered or concomitantly with V260 or placebo. All participants will be followed for efficacy and safety. Immune responses to OPV and DTaP will be evaluated in a subset of participants. The primary hypothesis of the study states that V260 will be efficacious in preventing any severity of rotavirus gastroenteritis as compared with placebo.

Conditions

• Rotavirus Gastroenteritis

Interventions

Type	Name	Description
BIOLOGICAL	V260	V260 (RotaTeq™; live, oral, pentavalent rotavirus vaccine)
BIOLOGICAL	Placebo to V260	Placebo control
BIOLOGICAL	OPV	Oral poliovirus vaccine administered according to the standard of care
BIOLOGICAL	DTaP	Diphtheria, Tetanus, Acellular Pertussis vaccine administered according to the standard of care

Timeline

• Start date: 2014-05-30
• Primary completion: 2015-06-11
• Completion: 2015-06-11
• First posted: 2014-02-13
• Last updated: 2018-11-27
• Results posted: 2016-04-04