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COMPLETEDPHASE3

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

A Phase III, Open-label, Randomized, Controlled Study to Evaluate the Immunogenicity and Safety of Inactivated Poliovirus Vaccine (IPV) When Co-administered With Porcine Circovirus (PCV)-Free Liquid Formulation of an Oral Live Attenuated Human Rotavirus (HRV) Vaccine in Healthy Chinese Infants

NCT06331156•GlaxoSmithKline

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the immune response and safety of the inactivated poliovirus (IPV) vaccine when co-administered with the human rotavirus (HRV) porcine circovirus (PCV)-free vaccine in healthy Chinese infants 6-10 weeks of age at the time of study enrolment.

Eligibility

Age

0 - 0 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Participants' parent(s)/Legally Acceptable Representative(s) \[LAR(s)\], who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
•Written or witnessed/thumb printed informed consent obtained from the parent(s)/LAR(s) of the participant prior to performance of any study specific procedure.
•Healthy participants as established by medical history and clinical examination before entering into the study.
•A male or female of Chinese origin, between and including, 6 and 10 weeks (42-76 days) of age at the time of study enrolment.
•Born after a gestation period of 36 to 42 weeks inclusive.

Exclusion Criteria

•Medical conditions
•History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions.
•Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
•Hypersensitivity to latex.
•History of severe combined immunodeficiency.
•History of seizures or progressive neurological disease.
•Family history of congenital or hereditary immunodeficiency.
•Uncorrected congenital malformation of the gastrointestinal tract that would predispose for intussusception (IS).
•History of IS.
•Major congenital defects, or serious chronic illness as assessed by the investigator.
+17 more criteria

Locations (5)

GSK Investigational Site

Mianyang, China

GSK Investigational Site

Neijiang, China

GSK Investigational Site

Wenshan, China

GSK Investigational Site

Wenshan, China

GSK Investigational Site

Yuechi-Guang'an, China

Key Dates

Start Date

March 22, 2024

Primary Completion Date

October 22, 2024

Completion Date

October 22, 2024

Last Updated

October 22, 2025

Enrollment

400

ACTUAL participants

Conditions

Gastroenteritis

Interventions

HRV PCV-free

COMBINATION_PRODUCT

IPV

COMBINATION_PRODUCT

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 22, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

Eosinophilic Gastrointestinal Disorders Registry

Burden of Recreational Water Illness Due to Exposure to Cyanobacteria and Their Toxins in Freshwater Beaches in Canada

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