At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III, Observer-blind, Randomized, Multicenter Study to Evaluate Immunogenicity, Reactogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Rotarix Porcine Circovirus (PCV)-Free Liquid as Compared to GSK's Rotarix Liquid, Given in 2-doses in Healthy Chinese Infants Starting at Age 6-16 Weeks
In Brief
A Phase 3 clinical trial evaluating GSK's liquid oral live attenuated HRV and PCV-free liquid formulation of GSK's oral live attenuated HRV for Gastroenteritis. Completed, enrolled 2,000 participants across 12 sites.
Detailed Summary
The purpose of this study is to evaluate the immunogenicity, reactogenicity and safety of the Porcine circovirus (PCV)-free liquid formulation of GlaxoSmithKline Biologicals' SA (GSK) oral live attenuated human rotavirus (HRV) study intervention compared to GSK's liquid oral live attenuated HRV study intervention in healthy Chinese infants 6 to 16 weeks of age at the time of the first study intervention administration.
Study Details
Timeline
Interventions
2 doses of GSK's liquid oral live attenuated HRV study intervention administered orally at Day 1 and Month 1, according to the immunization schedule for HRV study intervention licensed outside of China.
2 doses of PCV-free liquid formulation of GSK's oral live attenuated HRV study intervention administered orally at Day 1 and Month 1, according to the immunization schedule for HRV study intervention licensed outside of China.