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

PHASE3CompletedINTERVENTIONAL
Enrollment

2,000

Participants

Timeline

Start Date

September 1, 2023

Primary Completion Date

May 28, 2024

Study Completion Date

October 23, 2024

Conditions
Gastroenteritis
Interventions
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.

Trial Locations (12)

610041

GSK Investigational Site, Mianyang

637300

GSK Investigational Site, Nanbu-Nanchong

641200

GSK Investigational Site, Neijiang

650034

GSK Investigational Site, Wenshan

652399

GSK Investigational Site, Honghe

663300

GSK Investigational Site, Wenshan

672499

GSK Investigational Site, Dali

678099

GSK Investigational Site, Baoshan

678199

GSK Investigational Site, Baoshan

678399

GSK Investigational Site, Baoshan

679100

GSK Investigational Site, Tengchong

Unknown

GSK Investigational Site, Mianyang

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

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 | Biotech Hunter | Biotech Hunter