drugset / Trial / 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

NCT06025695

Phase 3 Completed 2000 enrolled GlaxoSmithKline
RandomizedParallel-groupQuadruple-blindPrevention

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.

Timeline

Start
2023-09-01
Primary completion
2024-05-28
Completion
2024-10-23

Drugs

EvaluationDrugModalityDoseRoute
Subject Rotarix Vaccine Oral
Subject Rotarix Porcine Circovirus (PCV)-Free Liquid Unknown Oral

Indications