GastroenteritisPhase 3NCT06331156

A Study on the Immune Response and Safety of Inactivated Poliovirus Vaccine (IPV) When Co-administered With Human Rotavirus (HRV) Porcine Circovirus (PCV)-Free Vaccine in Healthy Chinese Infants

A Phase 3 study testing HRV PCV-free and IPV in people with Gastroenteritis, run by GlaxoSmithKline at 5 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 immune response and safety of the inactivated poliovirus (IPV) vaccine when co-administered with the human rotavirus (HRV) porcine circovirus (PCV)-free vaccine in healthy Chinese infants 6-10 weeks of age at the time of study enrolment. Read more about this study

Who is it for?: Ages 6 to 10 weeksHealthy volunteers can take part
Conditions the study is for: Gastroenteritis
What is being tested?: HRV PCV-free and IPV
Type of treatment: Vaccines, Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 400 participants
Where: 5 sitesChina
Study dates: 22 Mar 2024to 22 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 10 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.
Healthy participants as established by medical history and clinical examination before entering into the study.
A male or female of Chinese origin, between and including, 6 and 10 weeks (42-76 days) of age at the time of study enrolment.
Born after a gestation period of 36 to 42 weeks inclusive.

Who cannot join

Medical conditions
History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
Hypersensitivity to latex.
History of severe combined immunodeficiency.
History of seizures or progressive neurological disease.

Show all 27Show fewer

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.
Any contraindications to IPV.
Previous confirmed occurrence of rotavirus gastroenteritis (RVGE).
History of poliomyelitis.
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 last dose of study interventions 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 recommended and/or organized by public health authorities outside the routine immunization program, the time period described above can be reduced if, necessary for that vaccine, provided it is used according to the local governmental recommendations and that the Sponsor is notified accordingly.
Administration of long-acting immune-modifying drugs from birth or planned administration at any time during the study period.
Administration of immunoglobulins and/or any blood products or plasma derivatives from birth or planned administration 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, intra-articular and topical steroids are allowed.
Previous vaccination against RV.
Previous vaccination against poliomyelitis.
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 intervention.
Other exclusions
Child in care.

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

China5 sites

GSK Investigational Site
Mianyang, 610041
GSK Investigational Site
Neijiang, 641200
GSK Investigational Site
Wenshan, 663100
GSK Investigational Site
Wenshan, 663300
GSK Investigational Site
Yuechi-Guang'an, 638300

Other trials in China

About this study

Official title: A Phase III, Open-label, Randomized, Controlled Study to Evaluate the Immunogenicity and Safety of Inactivated Poliovirus Vaccine (IPV) When Co-administered With Porcine Circovirus (PCV)-Free Liquid Formulation of an Oral Live Attenuated Human Rotavirus (HRV) Vaccine in Healthy Chinese Infants

Conditions: Gastroenteritis
Being tested: HRV PCV-free, IPV
Keywords: Human rotavirus (HRV), Rotarix Porcine circovirus (PCV)-free liquid, Inactivated poliovirus vaccine (IPV), Healthy Chinese infants, Immunogenicity, Safety
Medical subject headings: Gastroenteritis

What participants receive

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

HRV PCV-freeCombination product
Also called Rotarix PCV-free
2 doses of HRV PCV-free vaccine are administered orally at Month 0.5 and Month 1.5 (Co-administration Group) and at Day 1 and Month 1 (Staggered Group), according to the immunization schedule for HRV vaccine 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.
IPVCombination product
Also called Beijing Biological Products Institute Co.,Ltd.'s Inactivated Poliomyelitis Vaccine Made From Sabin Strains (Vero Cells)
3 doses of IPV vaccine are administered intramuscularly at Month 0.5, Month 1.5 and Month 2.5 (Co-administration Group and Staggered Group), according to the recommended schedule for vaccination against poliovirus in China.

Study groups in NCT06331156
Study group	Role	What they receive
Co-administration Group	Experimental	Participants received 2 doses of PCV-free liquid formulation of GSK's oral live attenuated HRV vaccine co-administered with the first 2 doses of IPV vaccine at Month 0.5 and Month 1.5, followed by the third dose of IPV vaccine administered at Month 2.5. Receives: Combination Product: HRV PCV-free; Combination Product: IPV
Staggered Group	Active comparator	Participants received 2 doses of Porcine circovirus (PCV)-free liquid formulation of GSK's oral live attenuated human rotavirus (HRV) vaccine at Day 1 and Month 1, and 3 doses of Inactivated poliovirus vaccine (IPV) vaccine administered at Month 0.5, Month 1.5, and Month 2.5. Receives: Combination Product: HRV PCV-free; Combination Product: IPV

What is being measured

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

Percentage of Participants With Seroconversion for Anti-poliovirus Types 1, 2 and 3 Neutralizing Antibody (Ab)
Seroconversion for anti-poliovirus types 1, 2 and 3 neutralizing Ab is defined as: - Ab titer greater than or equal to (>=) 1:8 at 1 month after the 3 dose primary vaccination schedule of IPV in participants with Ab titer lower than (<) 1:8 at pre-vaccination, >= 4-fold increase in Ab titer at 1 month after the 3 dose primary vaccination schedule of IPV in participants with Ab titer >= 1:8 at pre-vaccination.
Measured: At Month 3.5 (1 month post-Dose 3 of IPV)

Secondary outcomes (8)

Geometric Mean Titers (GMTs) of Anti-poliovirus Types 1, 2 and 3 Neutralizing Ab
Measured: At Month 3.5 (1 month post-Dose 3 of IPV)
Percentage of Participants With Anti-poliovirus Types 1, 2 and 3 Neutralizing Ab Titers >=1:8 and >=1:64
Measured: At Month 3.5 (1 month post-Dose 3 of IPV)
Percentage of Participants With Seroconversion for Anti-rotavirus (RV) Immunoglobulin A (IgA) Ab
Seroconversion for anti-RV IgA Ab is defined as: anti-RV IgA Ab concentration >= 20 unit per milliliter (U/mL) at 1 month post-Dose 2 of HRV PCV-free vaccine, in participants who were initially seronegative (i.e., with anti-RV IgA Ab concentration < 20 U/mL prior to the first dose of HRV PCV-free vaccine).
Measured: At 1 month post-Dose 2 of HRV PCV-free vaccine (Month 2 for Staggered Group and Month 2.5 for Co-administration Group)
Geometric Mean Concentrations (GMCs) of Anti-RV IgA Ab
Measured: At 1 month post-Dose 2 of HRV PCV-free vaccine (Month 2 for Staggered Group and Month 2.5 for Co-administration Group)
Percentage of Participants With Anti-RV IgA Ab Concentrations >= 90 U/mL
Measured: At 1 month post-Dose 2 of HRV PCV-free vaccine (Month 2 for Staggered Group and Month 2.5 for Co-administration Group)
Number of Participants Reporting Any Solicited Systemic Events
Solicited systemic events include cough/runny nose, diarrhoea, fever (pyrexia), irritability/fussiness, loss of appetite and vomiting. 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 after Dose 1 & 2: HRV PCV-free vaccine administered at Day 1 & Month 1 (Staggered group) and at Month 0.5 & Month 1.5 (Co-administration group); IPV administered at Month 0.5 & Month 1.5 (Staggered and Co-administration group)
Number of Participants Reporting Any 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 after each dose of HRV PCV-free vaccine (administered at Day 1 and Month 1 for Staggered Group and at Month 0.5 and Month 1.5 for Co-administration group)
Number of Participants Reporting Any 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. Any = occurrence the event regardless of intensity grade or relation to the study vaccination.
Measured: From the first dose of the study intervention (Day 1 for Staggered group and Month 0.5 for Co-administration group) up to study end (Month 3.5)

Timeline

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

22 Mar 202422 Oct 2024

First posted26 Mar 2024
Study start22 Mar 2024
Primary completion22 Oct 2024
Study completion22 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: None (open label)
Enrolment: 400 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06331156
Sponsor's protocol ID: 218485
Other IDs: 2022-000708-36
Status last verified: Sep 2025
First submitted: 19 Mar 2024
Last updated: 22 Oct 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

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?

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Study at a glance

From the registry record, last updated by the sponsor on 22 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III, Open-label, Randomized, Controlled Study to Evaluate the Immunogenicity and Safety of Inactivated Poliovirus Vaccine (IPV) When Co-administered With Porcine Circovirus (PCV)-Free Liquid Formulation of an Oral Live Attenuated Human Rotavirus (HRV) Vaccine in Healthy Chinese Infants
ClinicalTrials.gov ID: NCT06331156
Acronym / sponsor ID: 218485
Conditions: Gastroenteritis
Keywords: Human rotavirus (HRV), Rotarix Porcine circovirus (PCV)-free liquid, Inactivated poliovirus vaccine (IPV), Healthy Chinese infants, Immunogenicity, Safety
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 400 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 22 Mar 2024 (actual)
Primary completion: 22 Oct 2024 (actual)
Study completion: 22 Oct 2024 (actual)
First posted: 26 Mar 2024 (actual)
Results: Posted 22 Oct 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: None (open label)
Number of arms: 2

Arm	Type	Receives
Co-administration Group	Experimental	Combination Product: HRV PCV-free, Combination Product: IPVParticipants received 2 doses of PCV-free liquid formulation of GSK's oral live attenuated HRV vaccine co-administered with the first 2 doses of IPV vaccine at Month 0.5 and Month 1.5, followed by the third dose of IPV vaccine administered at Month 2.5.
Staggered Group	Active comparator	Combination Product: HRV PCV-free, Combination Product: IPVParticipants received 2 doses of Porcine circovirus (PCV)-free liquid formulation of GSK's oral live attenuated human rotavirus (HRV) vaccine at Day 1 and Month 1, and 3 doses of Inactivated poliovirus vaccine (IPV) vaccine administered at Month 0.5, Month 1.5, and Month 2.5.

Who may qualify

Ages: 6 to 10 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.
Healthy participants as established by medical history and clinical examination before entering into the study.
A male or female of Chinese origin, between and including, 6 and 10 weeks (42-76 days) of age at the time of study enrolment.
Born after a gestation period of 36 to 42 weeks inclusive.

Key exclusion criteria (27 listed)

Medical conditions
History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
Hypersensitivity to latex.
History of severe combined immunodeficiency.

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
HRV PCV-freeAlso: Rotarix PCV-free2 doses of HRV PCV-free vaccine are administered orally at Month 0.5 and Month 1.5 (Co-administration Group) and at Day 1 and Month 1 (Staggered Group), according to the immunization schedule for HRV vaccine 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.	Combination product	Co-administration Group, Staggered Group
IPVAlso: Beijing Biological Products Institute Co.,Ltd.'s Inactivated Poliomyelitis Vaccine Made From Sabin Strains (Vero Cells)3 doses of IPV vaccine are administered intramuscularly at Month 0.5, Month 1.5 and Month 2.5 (Co-administration Group and Staggered Group), according to the recommended schedule for vaccination against poliovirus in China.	Combination product	Co-administration Group, Staggered Group

Primary outcome

Percentage of Participants With Seroconversion for Anti-poliovirus Types 1, 2 and 3 Neutralizing Antibody (Ab)
Time frame: At Month 3.5 (1 month post-Dose 3 of IPV)
Seroconversion for anti-poliovirus types 1, 2 and 3 neutralizing Ab is defined as: - Ab titer greater than or equal to (>=) 1:8 at 1 month after the 3 dose primary vaccination schedule of IPV in participants with Ab titer lower than (<) 1:8 at pre-vaccination, >= 4-fold increase in Ab titer at 1 month after the 3 dose primary vaccination schedule of IPV in participants with Ab titer >= 1:8 at pre-vaccination.

8 secondary outcomes

Geometric Mean Titers (GMTs) of Anti-poliovirus Types 1, 2 and 3 Neutralizing Ab
Time frame: At Month 3.5 (1 month post-Dose 3 of IPV)
Percentage of Participants With Anti-poliovirus Types 1, 2 and 3 Neutralizing Ab Titers >=1:8 and >=1:64
Time frame: At Month 3.5 (1 month post-Dose 3 of IPV)
Percentage of Participants With Seroconversion for Anti-rotavirus (RV) Immunoglobulin A (IgA) Ab
Time frame: At 1 month post-Dose 2 of HRV PCV-free vaccine (Month 2 for Staggered Group and Month 2.5 for Co-administration Group)
Geometric Mean Concentrations (GMCs) of Anti-RV IgA Ab
Time frame: At 1 month post-Dose 2 of HRV PCV-free vaccine (Month 2 for Staggered Group and Month 2.5 for Co-administration Group)
Percentage of Participants With Anti-RV IgA Ab Concentrations >= 90 U/mL
Time frame: At 1 month post-Dose 2 of HRV PCV-free vaccine (Month 2 for Staggered Group and Month 2.5 for Co-administration Group)
Number of Participants Reporting Any Solicited Systemic Events
Time frame: Within 14 days after Dose 1 & 2: HRV PCV-free vaccine administered at Day 1 & Month 1 (Staggered group) and at Month 0.5 & Month 1.5 (Co-administration group); IPV administered at Month 0.5 & Month 1.5 (Staggered and Co-administration group)
Number of Participants Reporting Any Unsolicited Adverse Events (AEs)
Time frame: Within 31 days after each dose of HRV PCV-free vaccine (administered at Day 1 and Month 1 for Staggered Group and at Month 0.5 and Month 1.5 for Co-administration group)
Number of Participants Reporting Any Serious Adverse Events (SAEs)
Time frame: From the first dose of the study intervention (Day 1 for Staggered group and Month 0.5 for Co-administration group) up to study end (Month 3.5)

Results and safety

Results posted to the registry on 22 Oct 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
Staggered Group	199	186
Co-administration Group	193	189

Primary outcome: Percentage of Participants With Seroconversion for Anti-poliovirus Types 1, 2 and 3 Neutralizing Antibody (Ab)

Time frame: At Month 3.5 (1 month post-Dose 3 of IPV). Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Staggered Group n = 125	Co-administration Group n = 143
anti-poliovirus serotype1	99.2 (95.6 to 100)	99.3 (96.2 to 100)
anti-poliovirus serotype2	100 (97.1 to 100)	99.3 (96.2 to 100)
anti-poliovirus serotype3	100 (97.1 to 100)	100 (97.5 to 100)

Staggered Group vs Co-administration Group: Difference in seroconversion rate: 0.10 (95% CI -3.14 to 3.76)
Staggered Group vs Co-administration Group: Difference in seroconversion rate: -0.70 (95% CI -3.86 to 2.30)
Staggered Group vs Co-administration Group: Difference in seroconversion rate: 0.00 (95% CI -2.63 to 2.99)

Population analysed: Analysis was performed on the per protocol set (PPS) for IPV, comprising participants who adhered to their assigned intervention schedule without conditions affecting immunogenicity or using prohibited treatments. For anti-poliovirus types 1, 2, and 3 at 1 month post-Dose 3, participants must have pre- and post-vaccination immunogenicity data for at least one antigen and adhered to the interval between Dose 3 and blood sample at the specified timepoint.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Solicited AEs: Within 14 days after Dose 1 & 2: HRV PCV-free vaccine administered at Day 1 & Month 1 (Staggered group) and at Month 0.5 & Month 1.5 (Co-administration group); IPV administered at Month 0.5 & Month 1.5 (Staggered and Co-administration group), Unsolicited AEs: Within 31 days after each dose of HRV PCV-free vaccine. All-cause mortality and SAEs were collected throughout the study period (From Day 1 to Month 3.5).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Staggered Group	30 of 199 (15.1%)	141 of 199 (70.9%)	0 of 199
Co-administration Group	30 of 193 (15.5%)	129 of 193 (66.8%)	0 of 193

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

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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.

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing HRV PCV-free and IPV in people with Gastroenteritis, run by GlaxoSmithKline at 5 sites in China.

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 27 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 22 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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 22 Oct 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 Seroconversion for Anti-poliovirus Types 1, 2 and 3 Neutralizing Antibody (Ab) (time frame: At Month 3.5 (1 month post-Dose 3 of IPV)). 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 NCT06331156.

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 22 Oct 2025.