Comparison · NCT02669121-sae
NoV GI.1/GII.4 Bivalent VLP Vaccine vs Placebo: 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. NoV GI.1/GII.4 Bivalent VLP Vaccine vs Placebo: serious adverse events. Trial comparisons, record NCT02669121-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02669121-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 | 0.0123 | 0.00859 | 0.0176 | wilson | |
| Risk in group 2 | 0.0148 | 0.0107 | 0.0206 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00254 | -0.00937 | 0.00421 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.829 | 0.509 | 1.35 | log | |
| Odds ratio, group 1 over group 2 | 0.827 | 0.504 | 1.36 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on NoV GI.1/GII.4 Bivalent VLP Vaccine than on Placebo | 394 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | NoV GI.1/GII.4 Bivalent VLP Vaccine | NoV GI.1/GII.4 bivalent VLP vaccine, 0.5 mL injection, IM, once, on Day 1. | 29 | 2,355 | EG001 |
| Group 2 | Placebo | NoV placebo-matching 0.5 mL solution for injection, IM, once, on Day 1. | 35 | 2,357 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From Day 1 up to the end of the study (Up to 47 days)
Source ClinicalTrials.gov
Trial
- Title
- Efficacy and Immunogenicity of Norovirus GI.1/GII.4 Bivalent Virus-like Particle Vaccine in Adults
- NCT number
- NCT02669121
- Phases
- PHASE2
- Conditions
- Healthy Volunteers
- Interventions
- NoV Placebo-matching Saline, NoV GI.1/GII.4 Bivalent VLP Vaccine
- Lead sponsor
- Takeda
- Results first posted
- 2021-06-10
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02669121?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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