A Phase 3 interventional study of HRV PCV-free and IPV in Gastroenteritis, sponsored by GlaxoSmithKline. Completed at 5 sites in China. Open to participants aged 6 Weeks to 10 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-10-22.
Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Prevention
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.
237 studies on the registry are indexed under Gastroenteritis; 16 are open to participants now.
This study's enrollment of 400 is above the median of 136 across 164 interventional studies indexed under Gastroenteritis.
Browse Gastroenteritis studies →GlaxoSmithKline is the lead sponsor of 3,650 studies on the registry; 118 are open to participants now.
Of its 264 completed or terminated interventional studies of FDA-regulated products, 241 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Medical conditions
Prior/Concomitant therapy
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.
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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Combination Product: HRV PCV-free · Combination Product: IPV
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.
Combination Product: HRV PCV-free · Combination Product: IPV
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.
Also known as: Rotarix PCV-free
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.
Also known as: Beijing Biological Products Institute Co.,Ltd.'s Inactivated Poliomyelitis Vaccine Made From Sabin Strains (Vero Cells)
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.
Time frame: At Month 3.5 (1 month post-Dose 3 of IPV)
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
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).
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
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.
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)
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.
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)
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.
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)
This study was conducted in China.
| Milestone | Staggered Group | Co-administration Group |
|---|---|---|
| Started | 199 | 193 |
| Completed | 186 | 189 |
| Not completed | 13 | 4 |
| Withdrew: Adverse event | 1 | 0 |
| Withdrew: Lost to follow-up | 1 | 0 |
| Withdrew: Migrated / moved from the study area | 4 | 3 |
| Withdrew: Other | 7 | 0 |
| Withdrew: Adverse event requiring expedited reporting | 0 | 1 |
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.
| Percentage of participants | Staggered Group | Co-administration Group |
|---|---|---|
| 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) |
| Titers | Staggered Group | Co-administration Group |
|---|---|---|
| anti-poliovirus serotype1 | 1369.71 (1140.65 to 1644.78) | 1374.44 (1148.21 to 1645.25) |
| anti-poliovirus serotype2 | 194.95 (168.13 to 226.06) | 190.44 (164.90 to 219.94) |
| anti-poliovirus serotype3 | 451.36 (389.37 to 523.23) | 450.15 (395.92 to 511.79) |
| Percentage of participants | Staggered Group | Co-administration Group |
|---|---|---|
| anti-poliovirus serotype1, >=1:8 | 100 (97.1 to 100) | 100 (97.5 to 100) |
| anti-poliovirus serotype1, >=1:64 | 100 (97.1 to 100) | 100 (97.5 to 100) |
| anti-poliovirus serotype2, >=1:8 | 100 (97.1 to 100) | 100 (97.5 to 100) |
| anti-poliovirus serotype2, >=1:64 | 91.2 (84.8 to 95.5) | 91.6 (85.8 to 95.6) |
| anti-poliovirus serotype3, >=1:8 | 100 (97.1 to 100) | 100 (97.5 to 100) |
| anti-poliovirus serotype3, >=1:64 | 98.4 (94.3 to 99.8) | 99.3 (96.2 to 100) |
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).
| Percentage of participants | Staggered Group | Co-administration Group |
|---|---|---|
| Percentage of Participants With Seroconversion for Anti-rotavirus (RV) Immunoglobulin A (IgA) Ab | 78.5 (70.4 to 85.2) | 90.4 (84.4 to 94.7) |
| U/mL | Staggered Group | Co-administration Group |
|---|---|---|
| Geometric Mean Concentrations (GMCs) of Anti-RV IgA Ab | 160.59 (114.49 to 225.25) | 222.15 (165.98 to 297.34) |
| Percentage of participants | Staggered Group | Co-administration Group |
|---|---|---|
| Percentage of Participants With Anti-RV IgA Ab Concentrations >= 90 U/mL | 63.8 (55.0 to 72.1) | 68.5 (60.3 to 75.9) |
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.
| Participants | Staggered Group | Co-administration Group |
|---|---|---|
| Cough/Runny Nose, post vaccination at Day 1 | 21 | — |
| Cough/Runny Nose, post vaccination at Month 0.5 | 28 | 27 |
| Cough/Runny Nose, post vaccination at Month 1 | 27 | — |
| Cough/Runny Nose, post vaccination at Month 1.5 | 23 | 22 |
| Diarrhoea, post vaccination at Day 1 | 8 | — |
| Diarrhoea, post vaccination at Month 0.5 | 10 | 9 |
| Diarrhoea, post vaccination at Month 1 | 11 | — |
| Diarrhoea, post vaccination at Month 1.5 | 7 | 12 |
| Fever, post vaccination at Day 1 | 15 | — |
| Fever, post vaccination at Month 0.5 | 46 | 23 |
| Fever, post vaccination at Month 1 | 33 | — |
| Fever, post vaccination at Month 1.5 | 25 | 21 |
| Irritability/Fussiness, post vaccination at Day 1 | 15 | — |
| Irritability/Fussiness, post vaccination at Month 0.5 | 11 | 19 |
| Irritability/Fussiness, post vaccination at Month 1 | 6 | — |
| Irritability/Fussiness, post vaccination at Month 1.5 | 6 | 7 |
| Loss of appetite, post vaccination at Day 1 | 14 | — |
| Loss of appetite, post vaccination at Month 0.5 | 10 | 20 |
| Loss of appetite, post vaccination at Month 1 | 5 | — |
| Loss of appetite, post vaccination at Month 1.5 | 5 | 4 |
| Vomiting, post vaccination at Day 1 | 12 | — |
| Vomiting, post vaccination at Month 0.5 | 6 | 18 |
| Vomiting, post vaccination at Month 1 | 6 | — |
| Vomiting, post vaccination at Month 1.5 | 1 | 7 |
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.
| Participants | Staggered Group | Co-administration Group |
|---|---|---|
| HRV PCV-free: post-Dose 1 | 38 | 45 |
| HRV PCV-free: post-Dose 2 | 39 | 34 |
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.
| Participants | Staggered Group | Co-administration Group |
|---|---|---|
| Number of Participants Reporting Any Serious Adverse Events (SAEs) | 30 | 30 |
Collected over 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).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Staggered Group | 0/199 (0%) | 30/199 (15.1%) | 141/199 (70.9%) |
| Co-administration Group | 0/193 (0%) | 30/193 (15.5%) | 129/193 (66.8%) |
| Event | Staggered Group | Co-administration Group |
|---|---|---|
| PneumoniaInfections and infestations | 17/199 | 16/193 |
| Febrile infectionInfections and infestations | 4/199 | 5/193 |
| Upper respiratory tract infectionInfections and infestations | 3/199 | 2/193 |
| LaryngitisInfections and infestations | 3/199 | 0/193 |
| PertussisInfections and infestations | 0/199 | 2/193 |
| BronchitisInfections and infestations | 2/199 | 1/193 |
| Pneumonia mycoplasmalInfections and infestations | 2/199 | 0/193 |
| COVID-19Infections and infestations | 1/199 | 1/193 |
| Exanthema subitumInfections and infestations | 0/199 | 1/193 |
| PharyngitisInfections and infestations | 0/199 | 1/193 |
| Event | Staggered Group | Co-administration Group |
|---|---|---|
| PyrexiaGeneral disorders | 70/199 | 50/193 |
| Respiratory tract infectionInfections and infestations | 66/199 | 40/193 |
| DiarrhoeaGastrointestinal disorders | 32/199 | 25/193 |
| IrritabilityPsychiatric disorders | 30/199 | 24/193 |
| Decreased appetiteMetabolism and nutrition disorders | 28/199 | 22/193 |
| VomitingGastrointestinal disorders | 18/199 | 22/193 |
| CoughRespiratory, thoracic and mediastinal disorders | 4/199 | 11/193 |
| Upper respiratory tract infectionInfections and infestations | 7/199 | 9/193 |
| ConstipationGastrointestinal disorders | 6/199 | 7/193 |
| RhinorrhoeaRespiratory, thoracic and mediastinal disorders | 3/199 | 7/193 |
| Age, Continuous(Weeks) | Staggered Group | Co-administration Group | Total |
|---|---|---|---|
| Mean | 8.1 ± 1.2 | 8.2 ± 1.3 | 8.1 ± 1.3 |
| Sex: Female, Male(Participants) | Staggered Group | Co-administration Group | Total |
|---|---|---|---|
| Female | 96 | 92 | 188 |
| Male | 103 | 101 | 204 |
| Race/Ethnicity, Customized(Participants) | Staggered Group | Co-administration Group | Total |
|---|---|---|---|
| ASIAN | 199 | 193 | 392 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: 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/
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
Access criteria: Anonymized IPD is shared with researchers whose proposals are approved by an 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 may be granted, when justified, for up to 6 months.
Data sharing details ↗ · www.gsk.com
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Poliovirus Vaccine, Inactivated