Clinical trial NCT06025695: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastroenteritis
Keywords: Rotavirus (RV)
Human rotavirus (HRV)
Rotarix Porcine circovirus (PCV)-free liquid
Rotarix liquid
Healthy Chinese infants
Immunogenicity
Reactogenicity
Safety
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2023-09-06
Enrollment: 2000
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


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.
* 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.

Primary outcomes:
measure: Percentage of Participants With Anti-rotavirus (RV) Immunoglobulin A (IgA) Antibody (Ab) Seroconversion Rate
timeFrame: At Month 2 (1-month post-Dose 2)
measure: Serum Anti-RV IgA Ab Concentrations Expressed as Geometric Mean Concentrations (GMCs)
timeFrame: At Month 2 (1-month post-Dose 2)
Secondary outcomes:
measure: Percentage of Participants With Serum Anti-RV IgA Ab Concentrations >= 90 U/mL
timeFrame: At Month 2 (1-month post-Dose 2)
measure: Number of Participants Reporting Solicited Systemic Events
timeFrame: Within 14 days (the day of vaccination and 13 subsequent days) after each vaccination (occurring at Day 1 and Month 1)
measure: Number of Participants Reporting Unsolicited Adverse Events (AEs)
timeFrame: Within 31 days (the day of vaccination and 30 subsequent days) after each vaccination (occurring at Day 1 and Month 1)
measure: Number of Participants Reporting Serious Adverse Events (SAEs)
timeFrame: From Day 1 to Month 7
Other outcomes:
Locations:
city: Baoshan
country: China
facility: GSK Investigational Site
city: Baoshan
country: China
facility: GSK Investigational Site
city: Baoshan
country: China
facility: GSK Investigational Site
city: Dali
country: China
facility: GSK Investigational Site
city: Honghe
country: China
facility: GSK Investigational Site
city: Mianyang
country: China
facility: GSK Investigational Site
city: Mianyang
country: China
facility: GSK Investigational Site
city: Nanbu-Nanchong
country: China
facility: GSK Investigational Site
city: Neijiang
country: China
facility: GSK Investigational Site
city: Tengchong
country: China
facility: GSK Investigational Site
city: Wenshan
country: China
facility: GSK Investigational Site
city: Wenshan
country: China
facility: GSK Investigational Site
Study officials:
References: