At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy, Safety, and Immunogenicity of V260 in Healthy Chinese Infants
In Brief
A Phase 3 clinical trial evaluating V260, Placebo to V260, and 2 other interventions for Rotavirus Gastroenteritis. Completed, enrolled 4,040 participants.
Detailed 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.
Study Details
Timeline
Interventions
V260 (RotaTeq™; live, oral, pentavalent rotavirus vaccine)
Placebo control
Oral poliovirus vaccine administered according to the standard of care
Diphtheria, Tetanus, Acellular Pertussis vaccine administered according to the standard of care