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
NCT06025695, Phase 3, Completed, GlaxoSmithKline; results first posted 2025-05-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 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. Trials, record NCT06025695. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06025695
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
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
- NCT number
- NCT06025695
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,000 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Gastroenteritis
- Interventions
- GSK's liquid oral live attenuated HRV, PCV-free liquid formulation of GSK's oral live attenuated HRV
- First posted
- 2023-09-06
- Last updated
- 2025-05-09
- Other registries' IDs
- eudract:2020-000972-38
- Results first posted
- 2025-05-09
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Anti-rotavirus (RV) Immunoglobulin A (IgA) Antibody (Ab) Seroconversion Rate | 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). |
| Primary | Serum Anti-RV IgA Ab Concentrations Expressed as Geometric Mean Concentrations (GMCs) | At Month 2 (1-month post-Dose 2) | |
| Secondary | Percentage of Participants With Serum Anti-RV IgA Ab Concentrations >= 90 U/mL | At Month 2 (1-month post-Dose 2) | |
| Secondary | Number of Participants Reporting Solicited Systemic Events | Within 14 days (the day of vaccination and 13 subsequent days) after each vaccination (occurring at Day 1 and Month 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. |
| Secondary | Number of Participants Reporting Unsolicited Adverse Events (AEs) | Within 31 days (the day of vaccination and 30 subsequent days) after each vaccination (occurring at Day 1 and Month 1) | 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 |
| Secondary | Number of Participants Reporting Serious Adverse Events (SAEs) | From Day 1 to Month 7 | 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. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Anti-rotavirus (RV) Immunoglobulin A (IgA) Antibody (Ab) Seroconversion Rate | At Month 2 (1-month post-Dose 2) | 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. | Percentage of participants | NUMBER |
| PRIMARY | Serum Anti-RV IgA Ab Concentrations Expressed as Geometric Mean Concentrations (GMCs) | At Month 2 (1-month post-Dose 2) | Analysis was performed on PPS. Only participants with data available at the specified timepoints were included in this analysis. | U/mL | GEOMETRIC_MEAN |
| SECONDARY | Percentage of Participants With Serum Anti-RV IgA Ab Concentrations >= 90 U/mL | At Month 2 (1-month post-Dose 2) | Analysis was performed on PPS. Only participants with data available at the specified timepoints were included in this analysis. | Percentage of participants | NUMBER |
| SECONDARY | Number of Participants Reporting Solicited Systemic Events | Within 14 days (the day of vaccination and 13 subsequent days) after each vaccination (occurring at Day 1 and Month 1) | Analysis was performed on the Exposed Set which includes all participants with at least 1 dose of the study intervention administered and with the solicited systemic events diary card data available after the corresponding vaccination for the specified timepoint. Only participants with data available at the specified timepoints were included in this analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Reporting Unsolicited Adverse Events (AEs) | Within 31 days (the day of vaccination and 30 subsequent days) after each vaccination (occurring at Day 1 and Month 1) | Analysis was performed on the Exposed Set which includes all participants with at least 1 dose of the study intervention administered and for whom unsolicited AEs data were available after the corresponding vaccination for the specified timepoint. Only participants with data available at the specified timepoints were included in this analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Reporting Serious Adverse Events (SAEs) | From Day 1 to Month 7 | Analysis was performed on the Exposed Set which includes all participants with at least 1 dose of the study intervention administered and for whom SAE data were available after the corresponding vaccination for the specified timepoint. Only participants with data available at the specified timepoints were included in this analysis. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Anti-rotavirus (RV) Immunoglobulin A (IgA) Antibody (Ab) Seroconversion Rate | Human Rotavirus (HRV) Group | 88.7 | 95% Confidence Interval 86.4 to 90.7 | Percentage of participants | |
| Percentage of Participants With Anti-rotavirus (RV) Immunoglobulin A (IgA) Antibody (Ab) Seroconversion Rate | HRV Porcine Circovirus (PCV)-Free Group | 84.9 | 95% Confidence Interval 82.4 to 87.3 | Percentage of participants | |
| Serum Anti-RV IgA Ab Concentrations Expressed as Geometric Mean Concentrations (GMCs) | Human Rotavirus (HRV) Group | 222.82 | 95% Confidence Interval 198.03 to 250.71 | U/mL | |
| Serum Anti-RV IgA Ab Concentrations Expressed as Geometric Mean Concentrations (GMCs) | HRV Porcine Circovirus (PCV)-Free Group | 157.31 | 95% Confidence Interval 139.31 to 177.64 | U/mL | |
| Percentage of Participants With Serum Anti-RV IgA Ab Concentrations >= 90 U/mL | Human Rotavirus (HRV) Group | 69.2 | 95% Confidence Interval 66.1 to 72.3 | Percentage of participants | |
| Percentage of Participants With Serum Anti-RV IgA Ab Concentrations >= 90 U/mL | HRV Porcine Circovirus (PCV)-Free Group | 62.9 | 95% Confidence Interval 59.6 to 66.1 | Percentage of participants | |
| Number of Participants Reporting Solicited Systemic Events | Human Rotavirus (HRV) Group | Cough/Runny Nose, post vaccination at Day 1 | 158 | Participants | |
| Number of Participants Reporting Solicited Systemic Events | HRV Porcine Circovirus (PCV)-Free Group | Cough/Runny Nose, post vaccination at Day 1 | 200 | Participants | |
| Number of Participants Reporting Solicited Systemic Events | Human Rotavirus (HRV) Group | Cough/Runny Nose, post vaccination at Month 1 | 131 | Participants | |
| Number of Participants Reporting Solicited Systemic Events | HRV Porcine Circovirus (PCV)-Free Group | Cough/Runny Nose, post vaccination at Month 1 | 157 | Participants |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Human Rotavirus (HRV) Group | 998 | |
| Overall Study | STARTED | HRV Porcine Circovirus (PCV)-Free Group | 1,002 | |
| Overall Study | COMPLETED | Human Rotavirus (HRV) Group | 956 | |
| Overall Study | COMPLETED | HRV Porcine Circovirus (PCV)-Free Group | 967 | |
| Overall Study | NOT COMPLETED | Human Rotavirus (HRV) Group | 42 | |
| Overall Study | NOT COMPLETED | HRV Porcine Circovirus (PCV)-Free Group | 35 |
Source ClinicalTrials.gov
Adverse events458
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Respiratory tract infection | Infections and infestations | Human Rotavirus (HRV) Group | 181 | 998 | 203 |
| other | Respiratory tract infection | Infections and infestations | HRV Porcine Circovirus (PCV)-Free Group | 219 | 1,002 | 255 |
| other | Upper respiratory tract infection | Infections and infestations | Human Rotavirus (HRV) Group | 46 | 998 | 48 |
| other | Upper respiratory tract infection | Infections and infestations | HRV Porcine Circovirus (PCV)-Free Group | 45 | 1,002 | 55 |
| other | Bronchitis | Infections and infestations | Human Rotavirus (HRV) Group | 13 | 998 | 13 |
| other | Bronchitis | Infections and infestations | HRV Porcine Circovirus (PCV)-Free Group | 14 | 1,002 | 14 |
| other | Pharyngitis | Infections and infestations | Human Rotavirus (HRV) Group | 14 | 998 | 15 |
| other | Pharyngitis | Infections and infestations | HRV Porcine Circovirus (PCV)-Free Group | 9 | 1,002 | 9 |
| other | Nasopharyngitis | Infections and infestations | Human Rotavirus (HRV) Group | 8 | 998 | 8 |
| other | Nasopharyngitis | Infections and infestations | HRV Porcine Circovirus (PCV)-Free Group | 9 | 1,002 | 9 |
1 to 10 of 458Source ClinicalTrials.gov
See all 458 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Human Rotavirus (HRV) Group | 1 | 998 |
| Total, all-cause mortality | HRV Porcine Circovirus (PCV)-Free Group | 0 | 1,002 |
| Total, other adverse events | Human Rotavirus (HRV) Group | 596 | 998 |
| Total, other adverse events | HRV Porcine Circovirus (PCV)-Free Group | 617 | 1,002 |
| Total, serious adverse events | Human Rotavirus (HRV) Group | 251 | 998 |
| Total, serious adverse events | HRV Porcine Circovirus (PCV)-Free Group | 262 | 1,002 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Human Rotavirus (HRV) Group vs HRV Porcine Circovirus (PCV)-Free Group: Number of Participants Reporting Serious Adverse Events (SAEs) | Trial comparisons |
| Human Rotavirus (HRV) Group vs HRV Porcine Circovirus (PCV)-Free Group: deaths from any cause | Trial comparisons |
| Human Rotavirus (HRV) Group vs HRV Porcine Circovirus (PCV)-Free Group: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06025695
GET https://conductscience.org/api/trials/v1/NCT06025695/results?page=2