Comparison · NCT06025695-1cf74973
Human Rotavirus (HRV) Group vs HRV Porcine Circovirus (PCV)-Free Group: Number of Participants Reporting Serious Adverse Events (SAEs)
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Human Rotavirus (HRV) Group vs HRV Porcine Circovirus (PCV)-Free Group: Number of Participants Reporting Serious Adverse Events (SAEs). Trial comparisons, record NCT06025695-1cf74973. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT06025695-1cf74973
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.252 | 0.226 | 0.279 | wilson | |
| Risk in group 2 | 0.261 | 0.235 | 0.29 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00997 | -0.0482 | 0.0283 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.962 | 0.828 | 1.12 | log | |
| Odds ratio, group 1 over group 2 | 0.949 | 0.776 | 1.16 | log | |
| Number needed to treat, for one fewer participant with the outcome on Human Rotavirus (HRV) Group than on HRV Porcine Circovirus (PCV)-Free Group | 100 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Human Rotavirus (HRV) Group | Participants received 2 doses of GSK's liquid oral live attenuated HRV study intervention at Day 1 and Month 1. | 251 | 998 | OG000 |
| Group 2 | HRV Porcine Circovirus (PCV)-Free Group | 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. | 262 | 1,002 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants Reporting Serious Adverse Events (SAEs)
- Description
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
- Population
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.
Source ClinicalTrials.gov
Trial
- 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
- Phases
- PHASE3
- Conditions
- Gastroenteritis
- Interventions
- GSK's liquid oral live attenuated HRV, PCV-free liquid formulation of GSK's oral live attenuated HRV
- Lead sponsor
- GlaxoSmithKline
- Results first posted
- 2025-05-09
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT06025695?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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