GastroenteritisPhase 3NCT06025695

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 3 study testing GSK's liquid oral live attenuated HRV and PCV-free liquid formulation of GSK's oral live attenuated HRV in people with Gastroenteritis, run by GlaxoSmithKline at 12 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 6 to 16 weeksHealthy volunteers can take part
Conditions the study is for: Gastroenteritis
What is being tested?: GSK's liquid oral live attenuated HRV and PCV-free liquid formulation of GSK's oral live attenuated HRV
Type of treatment: Vaccines, Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2,000 participants
Where: 12 sitesChina
Study dates: 1 Sep 2023to 23 Oct 2024
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 to 16 weeks
All sexes
Healthy volunteers accepted
Child

Who may be able to join

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.

Who cannot join

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.

Show all 23Show fewer

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 locations and contacts

12 sites in 1 country.

City, postcode or hospital

12 sites in 1 country

China12 sites

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

Other trials in China

About this study

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

Conditions: Gastroenteritis
Being tested: GSK's liquid oral live attenuated HRV, PCV-free liquid formulation of GSK's oral live attenuated HRV
Keywords: Rotavirus (RV), Human rotavirus (HRV), Rotarix Porcine circovirus (PCV)-free liquid, Rotarix liquid, Healthy Chinese infants, Immunogenicity, Reactogenicity, Safety
Medical subject headings: Gastroenteritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GSK's liquid oral live attenuated HRVCombination product
Also called Rotarix
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.
PCV-free liquid formulation of GSK's oral live attenuated HRVCombination product
Also called Rotarix PCV-free
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.

Study groups in NCT06025695
Study group	Role	What they receive
Human Rotavirus (HRV) Group	Active comparator	Participants received 2 doses of GSK's liquid oral live attenuated HRV study intervention at Day 1 and Month 1. Receives: Combination Product: GSK's liquid oral live attenuated HRV
HRV Porcine Circovirus (PCV)-free Group	Experimental	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. Receives: Combination Product: PCV-free liquid formulation of GSK's oral live attenuated HRV

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: At Month 2 (1-month post-Dose 2)
Serum Anti-RV IgA Ab Concentrations Expressed as Geometric Mean Concentrations (GMCs)
Measured: At Month 2 (1-month post-Dose 2)

Secondary outcomes (4)

Percentage of Participants With Serum Anti-RV IgA Ab Concentrations >= 90 U/mL
Measured: 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.
Measured: 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
Measured: 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.
Measured: From Day 1 to Month 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 202323 Oct 2024

First posted6 Sep 2023
Study start1 Sep 2023
Primary completion28 May 2024
Study completion23 Oct 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for GastroenteritisStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 2,000 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06025695
Sponsor's protocol ID: 212692
Other IDs: 2020-000972-38
Status last verified: Apr 2025
First submitted: 29 Aug 2023
Last updated: 9 May 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: IPD for this study will be made available via the Clinical Study Data Request site.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT06025695
Acronym / sponsor ID: 212692
Conditions: Gastroenteritis
Keywords: Rotavirus (RV), Human rotavirus (HRV), Rotarix Porcine circovirus (PCV)-free liquid, Rotarix liquid, Healthy Chinese infants, Immunogenicity, Reactogenicity, Safety
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 2,000 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 1 Sep 2023 (actual)
Primary completion: 28 May 2024 (actual)
Study completion: 23 Oct 2024 (actual)
First posted: 6 Sep 2023 (actual)
Results: Posted 9 May 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Human Rotavirus (HRV) Group	Active comparator	Combination Product: GSK's liquid oral live attenuated HRVParticipants received 2 doses of GSK's liquid oral live attenuated HRV study intervention at Day 1 and Month 1.
HRV Porcine Circovirus (PCV)-free Group	Experimental	Combination Product: PCV-free liquid formulation of GSK's oral live attenuated HRVParticipants received 2 doses of the PCV-free liquid formulation of GSK's oral live attenuated HRV study intervention at Day 1 and Month 1.

Who may qualify

Ages: 6 to 16 weeks
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (23 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
GSK's liquid oral live attenuated HRVAlso: Rotarix2 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.	Combination product	Human Rotavirus (HRV) Group
PCV-free liquid formulation of GSK's oral live attenuated HRVAlso: Rotarix PCV-free2 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.	Combination product	HRV Porcine Circovirus (PCV)-free Group

Primary outcome

Percentage of Participants With Anti-rotavirus (RV) Immunoglobulin A (IgA) Antibody (Ab) Seroconversion Rate
Time frame: At Month 2 (1-month post-Dose 2)
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).
Serum Anti-RV IgA Ab Concentrations Expressed as Geometric Mean Concentrations (GMCs)
Time frame: At Month 2 (1-month post-Dose 2)

4 secondary outcomes

Percentage of Participants With Serum Anti-RV IgA Ab Concentrations >= 90 U/mL
Time frame: At Month 2 (1-month post-Dose 2)
Number of Participants Reporting Solicited Systemic Events
Time frame: 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)
Time frame: 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)
Time frame: From Day 1 to Month 7

Results and safety

Results posted to the registry on 9 May 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Human Rotavirus (HRV) Group	998	956
HRV Porcine Circovirus (PCV)-Free Group	1,002	967

Primary outcome: Percentage of Participants With Anti-rotavirus (RV) Immunoglobulin A (IgA) Antibody (Ab) Seroconversion Rate

Time frame: At Month 2 (1-month post-Dose 2). Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Human Rotavirus (HRV) Group n = 865	HRV Porcine Circovirus (PCV)-Free Group n = 870
Value	88.7 (86.4 to 90.7)	84.9 (82.4 to 87.3)

Human Rotavirus (HRV) Group vs HRV Porcine Circovirus (PCV)-Free Group: Difference in seroconversion rate: -3.73 (95% CI -6.93 to -0.55)

Population analysed: Analysis was performed on Per Protocol Set (PPS), which includes all participants who adhered to the study protocol, ensuring they received no unapproved treatments, remained blinded, had anti-RV concentration \<20 U/mL before intervention, had available anti-RV results at Month 2, complied with blood sampling schedules, and had no concurrent infections. Only participants with data available at specified timepoints were included in the analysis.

Primary outcome: Serum Anti-RV IgA Ab Concentrations Expressed as Geometric Mean Concentrations (GMCs)

Time frame: At Month 2 (1-month post-Dose 2). Geometric mean (95% Confidence Interval). Unit: U/mL

Measure	Human Rotavirus (HRV) Group n = 865	HRV Porcine Circovirus (PCV)-Free Group n = 870
Value	222.82 (198.03 to 250.71)	157.31 (139.31 to 177.64)

Human Rotavirus (HRV) Group vs HRV Porcine Circovirus (PCV)-Free Group: GMC Ratio: 0.71 (95% CI 0.60 to 0.84)

Population analysed: Analysis was performed on PPS. Only participants with data available at the specified timepoints were included in this analysis.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs were collected from Day 1 to Month 7.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Human Rotavirus (HRV) Group	251 of 998 (25.2%)	596 of 998 (59.7%)	1 of 998
HRV Porcine Circovirus (PCV)-Free Group	262 of 1,002 (26.1%)	617 of 1,002 (61.6%)	0 of 1,002

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. IPD for this study will be made available via the Clinical Study Data Request site.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

12 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Anti-rotavirus (RV) Immunoglobulin A (IgA) Antibody (Ab) Seroconversion Rate (time frame: At Month 2 (1-month post-Dose 2)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06025695.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2025.