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

Study Overview
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Brief Summary
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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.

Official Title
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A Phase III, Observer-blind, Randomized, Multicenter Study to Evaluate Immunogenicity, Reactogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Rotarix Porcine Circovirus (PCV)-Free Liquid as Compared to GSK's Rotarix Liquid, Given in 2-doses in Healthy Chinese Infants Starting at Age 6-16 Weeks

Conditions
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Gastroenteritis

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


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Weeks
Maximum Age: 16 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: HRV Group<br>Participants receive 2 doses of GSK's liquid oral live attenuated HRV study intervention administered at Day 1 and Month 1, according to the immunization schedule for HRV study intervention licensed outside of China. | Combination Product: GSK's liquid oral live attenuated HRV<br>* 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.<br>* Other names: Rotarix;|
| Experimental: HRV PCV-free Group<br>Participants receive 2 doses of the PCV-free liquid formulation of GSK's oral live attenuated HRV study intervention administered 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<br>* 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. PCV-free implies no detection of PCV-1 and PCV-2 according to the limit of detection of the tests used.<br>* Other names: Rotarix PCV-free;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of seroconverted participants for anti-rotavirus (RV) immunoglobulin A (IgA) antibody (Ab) | A seroconverted participant is a participant who was initially seronegative (i.e., with anti-RV IgA Ab concentration below [<] 20 unit per milliliter [U/mL] prior to the first dose of study intervention) and developed anti-RV IgA Ab concentration greater than or equal to (>=) 20 U/mL at Month 2 (1 month post Dose 2). | At Month 2 (1 month post-Dose 2) | 
| Serum anti-RV IgA Ab concentrations expressed as geometric mean concentrations (GMCs) |  | At Month 2 (1 month post-Dose 2) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants with serum anti-RV IgA Ab concentrations >= 90 U/mL |  | At Month 2 (1 month post-Dose 2) | 
| Percentage of participants reporting solicited systemic events | Solicited systemic events include fever, diarrhea, vomiting, irritability/fussiness, loss of appetite, cough/runny nose. Fever is defined as body temperature >= 37.5 degrees Celsius (°C) and the preferred location for measuring temperature is the axilla. | Within 14 days after each study intervention administration occurring at Day 1 and Month 1 | 
| Percentage of participants reporting unsolicited adverse events (AEs) | Unsolicited AEs include any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited adverse event. | Within 31 days after each study intervention administration occurring at Day 1 and Month 1 | 
| Percentage of participants reporting serious adverse events (SAEs) | An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity or in other situations that are considered serious per medical or scientific judgment. | From Dose 1 (Day 1) of the study intervention up to study end (Month 7) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rotavirus (RV), Human rotavirus (HRV), Rotarix Porcine circovirus (PCV)-free liquid, Rotarix liquid, Healthy Chinese infants, Immunogenicity, Reactogenicity, Safety