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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Gastroenteritis

Treatments: Combination Product: GSK's liquid oral live attenuated HRV; Combination Product: PCV-free liquid formulation of GSK's oral live attenuated HRV

Study type: Interventional

Funder types: Industry

Identifiers

NCT06025695

212692

2020-000972-38 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 2,000 patients

Sex: All

Ages: 6 to 16 weeks old

Volunteers: Accepts Healthy Volunteers

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.
• A male or female with Chinese origin, between, and including, 6 and 16 weeks (42-112 days) of age at the time of the first study intervention administration.
• Healthy participants as established by medical history and clinical examination before entering into the study.
• Born after a gestation period of 36 to 42 weeks inclusive.

Exclusion criteria

Medical conditions

• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
• History of severe combined immunodeficiency.
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention.
• 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.
• Previous confirmed occurrence of rotavirus gastroenteritis (RVGE).
• 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 second dose of study intervention 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 organized by public health authorities outside the routine immunization programme, the time period described above can be reduced if, necessary for that mass vaccination vaccine, provided it is licensed and used according to its Product Information.

• Administration of immunoglobulins and/or any blood products or plasma derivatives from birth or planned administration during the study period.

• Administration of long-acting immune-modifying drugs from birth or planned administration at any time 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 and topical steroids are allowed.

• Previous vaccination against RV.

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 vaccine/product.

Other exclusions

• Child in care.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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2,000 participants in 2 patient groups

Human Rotavirus (HRV) Group

Active Comparator group

Description:

Participants received 2 doses of GSK's liquid oral live attenuated HRV study intervention at Day 1 and Month 1.

Treatment:

Combination Product: GSK's liquid oral live attenuated HRV

HRV Porcine Circovirus (PCV)-free Group

Experimental group

Description:

Participants received 2 doses of the PCV-free liquid formulation of GSK's oral live attenuated HRV study intervention at Day 1 and Month 1.

Treatment:

Combination Product: PCV-free liquid formulation of GSK's oral live attenuated HRV