Comparison · NCT00420316-sae
Rotarix Group vs Placebo Group: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Rotarix Group vs Placebo Group: serious adverse events. Trial comparisons, record NCT00420316-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00420316-sae
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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 | 0.0037 | 0.00144 | 0.00947 | wilson | |
| Risk in group 2 | 0.0132 | 0.0064 | 0.027 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00949 | -0.0234 | -0.000581 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.28 | 0.0825 | 0.954 | log | |
| Odds ratio, group 1 over group 2 | 0.278 | 0.081 | 0.953 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Rotarix Group than on Placebo Group | 105 | 42.7 | 1,720 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Rotarix Group | Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two powdered oral doses of Rotarix™ vaccine in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study. | 4 | 1,082 | EG000 |
| Group 2 | Placebo Group | Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two liquid oral doses of placebo in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study. | 7 | 531 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Serious adverse events (SAEs): during the study period for the long-term follow-up (i.e. 6 months)
Source ClinicalTrials.gov
Trial
- Title
- Long-term Efficacy and Safety of Subjects Approximately 3 Years After Priming With 2 Doses of GSK Bio's HRV Vaccine.
- NCT number
- NCT00420316
- Phases
- PHASE3
- Conditions
- Infections, Rotavirus
- Interventions
- Rotarix (primary vaccination study), Placebo (primary vaccination study)
- Lead sponsor
- GlaxoSmithKline
- Results first posted
- 2017-02-23
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00420316?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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