NCT06025695

Immunogenicity, Reactogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Rotarix Porcine Circovirus (PCV)-Free Liquid Compared to Rotarix Liquid Given in 2-doses in Healthy Chinese Infants Starting at Age 6-16 Weeks

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,000 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 6 Weeks – 16 Weeks
• Healthy volunteers: Accepted

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.

Conditions

• Gastroenteritis

Interventions

Type	Name	Description
COMBINATION_PRODUCT	GSK's liquid oral live attenuated HRV	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.
COMBINATION_PRODUCT	PCV-free liquid formulation of GSK's oral live attenuated HRV	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.

Timeline

• Start date: 2023-09-01
• Primary completion: 2024-05-28
• Completion: 2024-10-23
• First posted: 2023-09-06
• Last updated: 2025-05-09
• Results posted: 2025-05-09

Locations

12 sites across 1 country: China