A Study on the Immune Response and Safety of Inactivated Poliovirus Vaccine (IPV) When Co-administered With Human Rotavirus (HRV) Porcine Circovirus (PCV)-Free Vaccine in Healthy Chinese Infants

PHASE3CompletedINTERVENTIONAL
Enrollment

400

Participants

Timeline

Start Date

March 22, 2024

Primary Completion Date

October 22, 2024

Study Completion Date

October 22, 2024

Conditions
Gastroenteritis
Interventions
COMBINATION_PRODUCT

HRV PCV-free

2 doses of HRV PCV-free vaccine are administered orally at Month 0.5 and Month 1.5 (Co-administration Group) and at Day 1 and Month 1 (Staggered Group), according to the immunization schedule for HRV vaccine licensed outside of China. PCV-free implies no detection of PCV-1 and PCV-2 according to the limit of detection of the tests used.

COMBINATION_PRODUCT

IPV

3 doses of IPV vaccine are administered intramuscularly at Month 0.5, Month 1.5 and Month 2.5 (Co-administration Group and Staggered Group), according to the recommended schedule for vaccination against poliovirus in China.

Trial Locations (5)

610041

GSK Investigational Site, Mianyang

638300

GSK Investigational Site, Yuechi-Guang'an

641200

GSK Investigational Site, Neijiang

663100

GSK Investigational Site, Wenshan

663300

GSK Investigational Site, Wenshan

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT06331156 - A Study on the Immune Response and Safety of Inactivated Poliovirus Vaccine (IPV) When Co-administered With Human Rotavirus (HRV) Porcine Circovirus (PCV)-Free Vaccine in Healthy Chinese Infants | Biotech Hunter | Biotech Hunter