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

NCT ID: NCT06331156

Last Updated: 2025-10-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-22
• Study Completion Date: 2024-10-22

Brief 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.

Conditions

Gastroenteritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Co-administration Group

Participants received 2 doses of PCV-free liquid formulation of GSK's oral live attenuated HRV vaccine co-administered with the first 2 doses of IPV vaccine at Month 0.5 and Month 1.5, followed by the third dose of IPV vaccine administered at Month 2.5.

Group Type: EXPERIMENTAL

HRV PCV-free

Intervention Type: COMBINATION_PRODUCT

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.

IPV

Intervention Type: COMBINATION_PRODUCT

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.

Staggered Group

Participants received 2 doses of Porcine circovirus (PCV)-free liquid formulation of GSK's oral live attenuated human rotavirus (HRV) vaccine at Day 1 and Month 1, and 3 doses of Inactivated poliovirus vaccine (IPV) vaccine administered at Month 0.5, Month 1.5, and Month 2.5.

Group Type: ACTIVE_COMPARATOR

HRV PCV-free

Intervention Type: COMBINATION_PRODUCT

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.

IPV

Intervention Type: COMBINATION_PRODUCT

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: COMBINATION_PRODUCT

Other Intervention Names

Rotarix PCV-free; Beijing Biological Products Institute Co.,Ltd.'s Inactivated Poliomyelitis Vaccine Made From Sabin Strains (Vero Cells)

Eligibility Criteria

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.
• Any contraindications to IPV.
• Previous confirmed occurrence of rotavirus gastroenteritis (RVGE).
• History of poliomyelitis.
• Participants with confirmed or suspected Coronavirus Disease 2019 (COVID-19).

Prior/Concomitant therapy

• Use of any investigational or non-registered product other than the study interventions during the period beginning 30 days before the first dose of study interventions (Day -29 to Day 1), or planned use during the study period.
• Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the first dose and ending 30 days after the last dose of study interventions administration*, with the exception of the inactivated influenza vaccine, which is allowed at any time during the study and other licensed routine childhood vaccinations.

*In case emergency mass vaccination for an unforeseen public health threat (e.g., a pandemic) is recommended and/or organized by public health authorities outside the routine immunization program, the time period described above can be reduced if, necessary for that vaccine, provided it is used according to the local governmental recommendations and that the Sponsor is notified accordingly.

• Administration of long-acting immune-modifying drugs from birth or planned administration at any time during the study period.
• Administration of immunoglobulins and/or any blood products or plasma derivatives from birth or planned administration during the study period.
• Chronic administration of immunosuppressants or other immune-modifying drugs since birth. For corticosteroids, this will mean prednisone >=0.5 milligram/kilogram (kg)/day, or equivalent. Inhaled, intra-articular and topical steroids are allowed.
• Previous vaccination against RV.
• Previous vaccination against poliomyelitis.

Prior/Concurrent clinical study experience

• Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational intervention.

Other exclusions

• Child in care.

• Minimum Eligible Age: 6 Weeks
• Maximum Eligible Age: 10 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Countries

China

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2022-000708-36

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

218485

Identifier Type: -

Identifier Source: org_study_id