Comparison · NCT00363545-sae
Liquid Rotarix Group vs Lyophilized Rotarix 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
Cite this record
ConductScience Library. Liquid Rotarix Group vs Lyophilized Rotarix Group: serious adverse events. Trial comparisons, record NCT00363545-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00363545-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 | 0.0582 | 0.0425 | 0.0792 | wilson | |
| Risk in group 2 | 0.0596 | 0.0437 | 0.0807 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00139 | -0.0277 | 0.0249 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.977 | 0.63 | 1.52 | log | |
| Odds ratio, group 1 over group 2 | 0.975 | 0.612 | 1.56 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Liquid Rotarix Group than on Lyophilized Rotarix Group | 722 | 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 | Liquid Rotarix Group | Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the liquid formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule. | 37 | 636 | EG000 |
| Group 2 | Lyophilized Rotarix Group | Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the lyophilized formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule. | 38 | 638 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Solicited general symptoms: within the 15-day (Day 0-14) follow-up period after each vaccine dose; Unsolicited AEs: within 31 days (Day 0-30) after any vaccine dose; SAEs: throughout the entire study period (from Day 0 to Month 4).
Source ClinicalTrials.gov
Trial
- Title
- To Assess Immunogenicity, Reactogenicity & Safety of 2 Formulations of GSK's HRV Vaccine as 2-dose Vaccination (Infants)
- NCT number
- NCT00363545
- Phases
- PHASE3
- Conditions
- Infections, Rotavirus
- Interventions
- Lyophilized formulation of HRV vaccine, Liquid formulation of HRV vaccine
- Lead sponsor
- GlaxoSmithKline
- Results first posted
- 2017-02-23
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00363545?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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