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

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

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.

Study Overview

• Status: Completed
• Conditions: Gastroenteritis
• Intervention / Treatment: 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
• Enrollment (Actual): 2000
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Baoshan, China, 678099
    • GSK Investigational Site
  • Baoshan, China, 678199
    • GSK Investigational Site
  • Baoshan, China, 678399
    • GSK Investigational Site
  • Dali, China, 672499
    • GSK Investigational Site
  • Honghe, China, 652399
    • GSK Investigational Site
  • Mianyang, China
    • GSK Investigational Site
  • Mianyang, China, 610041
    • GSK Investigational Site
  • Nanbu-Nanchong, China, 637300
    • GSK Investigational Site
  • Neijiang, China, 641200
    • GSK Investigational Site
  • Tengchong, China, 679100
    • GSK Investigational Site
  • Wenshan, China, 663300
    • GSK Investigational Site
  • Wenshan, China, 650034
    • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Human Rotavirus (HRV) Group; Participants received 2 doses of GSK's liquid oral live attenuated HRV study intervention at Day 1 and Month 1.	Combination product: GSK's liquid oral live attenuated HRV; 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.; Other Names: Rotarix
Experimental: HRV Porcine Circovirus (PCV)-free Group; 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.	Combination product: PCV-free liquid formulation of GSK's oral live attenuated HRV; 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.; Other Names: Rotarix PCV-free

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Anti-rotavirus (RV) Immunoglobulin A (IgA) Antibody (Ab) Seroconversion Rate	Seroconversion rate is defined as the percentage of participants who were initially seronegative (i.e., with anti-RV IgA Ab concentration below [<] 20 unit per milliliter [U/mL] prior 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)
Number of Participants Reporting Solicited Systemic Events	Solicited systemic events include fever/pyrexia, diarrhoea, 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. Any = occurrence of the event regardless of intensity grade or relation to the study vaccination.	Within 14 days (the day of vaccination and 13 subsequent days) after each vaccination (occurring at Day 1 and Month 1)
Number 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. Any = occurrence the event regardless of intensity grade or relation to the study vaccination	Within 31 days (the day of vaccination and 30 subsequent days) after each vaccination (occurring at Day 1 and Month 1)
Number 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 as per medical or scientific judgment. Any = occurrence of the SAE regardless of intensity grade or relation to the study vaccination.	From Day 1 to Month 7

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Actual): May 28, 2024
• Study Completion (Actual): October 23, 2024

Study Registration Dates

• First Submitted: August 29, 2023
• First Submitted That Met QC Criteria: August 29, 2023
• First Posted (Actual): September 6, 2023

Study Record Updates

• Last Update Posted (Actual): May 9, 2025
• Last Update Submitted That Met QC Criteria: April 23, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Safety; Immunogenicity; Reactogenicity; Rotavirus (RV); Human rotavirus (HRV); Rotarix Porcine circovirus (PCV)-free liquid; Rotarix liquid; Healthy Chinese infants
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis
• Other Study ID Numbers: 212692; 2020-000972-38 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD for this study will be made available via the Clinical Study Data Request site.
• IPD Sharing Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, a key secondary endpoints and safety data of the study.
• IPD Sharing Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No