Comparison · NCT01171963-71192ab3
Rotarix Group vs Placebo Group: Number of Subjects With Any Unsolicited Adverse Events (AEs)
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: Number of Subjects With Any Unsolicited Adverse Events (AEs). Trial comparisons, record NCT01171963-71192ab3. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01171963-71192ab3
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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 | 0.186 | 0.168 | 0.205 | wilson | |
| Risk in group 2 | 0.221 | 0.202 | 0.241 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0347 | -0.062 | -0.00735 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.843 | 0.736 | 0.965 | log | |
| Odds ratio, group 1 over group 2 | 0.807 | 0.681 | 0.956 | log | |
| Number needed to treat, for one fewer participant with the outcome on Rotarix Group than on Placebo Group | 28.8 | 16.1 | 136 | 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 | Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix and OPV vaccines were administered orally; the Infanrix vaccine was administered intramuscularly in the left anterolateral thigh. | 310 | 1,666 | OG000 |
| Group 2 | Placebo Group | Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix vaccine was administered intramuscularly in the left anterolateral thigh. | 368 | 1,667 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Subjects With Any Unsolicited Adverse Events (AEs)
- Description
An unsolicited AE is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of an unsolicited AE regardless of the intensity grade or relationship to vaccination.
- Time frame
- Within the 31-day (Days 0-30) follow-up periods following any dose of the Rotarix vaccine or placebo
- Population
- The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the Rotarix™ vaccine or placebo administration documented.
Source ClinicalTrials.gov
Trial
- Title
- Study to Assess the Efficacy, Immunogenicity and Safety of Liquid Human Rotavirus Vaccine, in Healthy Chinese Infants
- NCT number
- NCT01171963
- Phases
- PHASE3
- Conditions
- Infections, Rotavirus
- Interventions
- GSK Biologicals' liquid human rotavirus vaccine 444563, Placebo, Infanrix™, Institute of Medical Biology Chinese Academy of Medical Sciences' Oral poliovirus vaccine (OPV)
- Lead sponsor
- GlaxoSmithKline
- Results first posted
- 2013-06-24
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01171963?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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