A Phase 3 interventional study of GSK's liquid oral live attenuated HRV and PCV-free liquid formulation of GSK's oral live attenuated HRV in Gastroenteritis, sponsored by GlaxoSmithKline. Completed at 12 sites in China. Open to participants aged 6 Weeks to 16 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-09.
Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Prevention
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.
237 studies on the registry are indexed under Gastroenteritis; 16 are open to participants now.
This study's enrollment of 2,000 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.
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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 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.
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.
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.
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.
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 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.
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.
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.
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 GSK's liquid oral live attenuated HRV study intervention at Day 1 and Month 1.
Combination Product: GSK's liquid oral live attenuated HRV
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 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.
Also known as: Rotarix
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.
Also known as: Rotarix PCV-free
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).
Time frame: 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)
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
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.
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)
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 (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.
Time frame: From Day 1 to Month 7
This study was conducted in China.
| Milestone | Human Rotavirus (HRV) Group | HRV Porcine Circovirus (PCV)-Free Group |
|---|---|---|
| Started | 998 | 1002 |
| Completed | 956 | 967 |
| Not completed | 42 | 35 |
| Withdrew: Adverse event | 5 | 6 |
| Withdrew: Migrated / moved from the study area | 13 | 10 |
| Withdrew: Other | 23 | 19 |
| Withdrew: Adverse event requiring expedited report | 1 | 0 |
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).
| Percentage of participants | Human Rotavirus (HRV) Group | HRV Porcine Circovirus (PCV)-Free Group |
|---|---|---|
| Percentage of Participants With Anti-rotavirus (RV) Immunoglobulin A (IgA) Antibody (Ab) Seroconversion Rate | 88.7 (86.4 to 90.7) | 84.9 (82.4 to 87.3) |
| U/mL | Human Rotavirus (HRV) Group | HRV Porcine Circovirus (PCV)-Free Group |
|---|---|---|
| Serum Anti-RV IgA Ab Concentrations Expressed as Geometric Mean Concentrations (GMCs) | 222.82 (198.03 to 250.71) | 157.31 (139.31 to 177.64) |
| Percentage of participants | Human Rotavirus (HRV) Group | HRV Porcine Circovirus (PCV)-Free Group |
|---|---|---|
| Percentage of Participants With Serum Anti-RV IgA Ab Concentrations >= 90 U/mL | 69.2 (66.1 to 72.3) | 62.9 (59.6 to 66.1) |
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.
| Participants | Human Rotavirus (HRV) Group | HRV Porcine Circovirus (PCV)-Free Group |
|---|---|---|
| Cough/Runny Nose, post vaccination at Day 1 | 158 | 200 |
| Cough/Runny Nose, post vaccination at Month 1 | 131 | 157 |
| Diarrhoea, post vaccination at Day 1 | 66 | 66 |
| Diarrhoea, post vaccination at Month 1 | 38 | 40 |
| Fever/Pyrexia, post vaccination at Day 1 | 122 | 100 |
| Fever/Pyrexia, post vaccination at Month 1 | 104 | 91 |
| Irritability/Fussiness, post vaccination at Day 1 | 126 | 150 |
| Irritability/Fussiness, post vaccination at Month 1 | 61 | 59 |
| Loss of appetite, post vaccination at Day 1 | 73 | 92 |
| Loss of appetite, post vaccination at Month 1 | 32 | 34 |
| Vomiting, post vaccination at Day 1 | 71 | 69 |
| Vomiting, post vaccination at Month 1 | 30 | 36 |
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 | Human Rotavirus (HRV) Group | HRV Porcine Circovirus (PCV)-Free Group |
|---|---|---|
| Post-vaccination at Day 1 | 236 | 234 |
| Post-vaccination at Month 1 | 223 | 229 |
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.
| Participants | Human Rotavirus (HRV) Group | HRV Porcine Circovirus (PCV)-Free Group |
|---|---|---|
| Number of Participants Reporting Serious Adverse Events (SAEs) | 251 | 262 |
Collected over 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.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Human Rotavirus (HRV) Group | 1/998 (0.1%) | 251/998 (25.2%) | 596/998 (59.7%) |
| HRV Porcine Circovirus (PCV)-Free Group | 0/1,002 (0%) | 262/1,002 (26.1%) | 617/1,002 (61.6%) |
| Event | Human Rotavirus (HRV) Group | HRV Porcine Circovirus (PCV)-Free Group |
|---|---|---|
| PneumoniaInfections and infestations | 140/998 | 138/1002 |
| BronchitisInfections and infestations | 39/998 | 36/1002 |
| Febrile infectionInfections and infestations | 21/998 | 20/1002 |
| PharyngitisInfections and infestations | 5/998 | 13/1002 |
| Upper respiratory tract infectionInfections and infestations | 11/998 | 11/1002 |
| Gastrointestinal infectionInfections and infestations | 3/998 | 8/1002 |
| LaryngitisInfections and infestations | 7/998 | 3/1002 |
| GastroenteritisInfections and infestations | 6/998 | 6/1002 |
| Pneumonia bacterialInfections and infestations | 6/998 | 6/1002 |
| LaryngopharyngitisInfections and infestations | 6/998 | 1/1002 |
| Event | Human Rotavirus (HRV) Group | HRV Porcine Circovirus (PCV)-Free Group |
|---|---|---|
| Respiratory tract infectionInfections and infestations | 181/998 | 219/1002 |
| PyrexiaGeneral disorders | 178/998 | 178/1002 |
| IrritabilityPsychiatric disorders | 149/998 | 155/1002 |
| DiarrhoeaGastrointestinal disorders | 123/998 | 118/1002 |
| Decreased appetiteMetabolism and nutrition disorders | 91/998 | 102/1002 |
| VomitingGastrointestinal disorders | 85/998 | 95/1002 |
| CoughRespiratory, thoracic and mediastinal disorders | 91/998 | 87/1002 |
| RhinorrhoeaRespiratory, thoracic and mediastinal disorders | 61/998 | 81/1002 |
| Upper respiratory tract infectionInfections and infestations | 46/998 | 45/1002 |
| Nasal obstructionRespiratory, thoracic and mediastinal disorders | 35/998 | 25/1002 |
| Age, Continuous(WEEKS) | Human Rotavirus (HRV) Group | HRV Porcine Circovirus (PCV)-Free Group | Total |
|---|---|---|---|
| Mean | 10.1 ± 2.9 | 10.2 ± 2.9 | 10.1 ± 2.9 |
| Sex: Female, Male(Participants) | Human Rotavirus (HRV) Group | HRV Porcine Circovirus (PCV)-Free Group | Total |
|---|---|---|---|
| Female | 455 | 512 | 967 |
| Male | 543 | 490 | 1033 |
| Race/Ethnicity, Customized(Participants) | Human Rotavirus (HRV) Group | HRV Porcine Circovirus (PCV)-Free Group | Total |
|---|---|---|---|
| ASIAN - EAST ASIAN HERITAGE | 998 | 1002 | 2000 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — IPD for this study will be made available via the Clinical Study Data Request site.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
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.
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.
This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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