Comparison · NCT02669121-01471d1d
NoV GI.1/GII.4 Bivalent VLP Vaccine vs Placebo: Number of Participants With Moderate or Severe Acute Gastroenteritis (AGE) Occurring for >7 Days After Dosing Due to GI.1 or GII.4 Norovirus Strains (Excluding Co-infection)
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: Number of Participants With Moderate or Severe Acute Gastroenteritis (AGE) Occurring for >7 Days After Dosing Due to GI.1 or GII.4 Norovirus Strains (Excluding Co-infection). Trial comparisons, record NCT02669121-01471d1d. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02669121-01471d1d
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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 | 0.000425 | 0.000075 | 0.0024 | wilson | |
| Risk in group 2 | 0.00212 | 0.000906 | 0.00496 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0017 | -0.00455 | 0.000624 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.2 | 0.0234 | 1.71 | log | |
| Odds ratio, group 1 over group 2 | 0.2 | 0.0233 | 1.71 | log | |
| Number needed to treat, for one fewer participant with the outcome on NoV GI.1/GII.4 Bivalent VLP Vaccine than on Placebo | 589 | 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. | 1 | 2,355 | OG001 |
| Group 2 | Placebo | NoV placebo-matching 0.5 mL solution for injection, IM, once, on Day 1. | 5 | 2,357 | OG000 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants With Moderate or Severe Acute Gastroenteritis (AGE) Occurring for >7 Days After Dosing Due to GI.1 or GII.4 Norovirus Strains (Excluding Co-infection)
- Description
Acute gastroenteritis (AGE) is a sudden inflammation or swelling in the lining of the stomach causing diarrhea and vomiting. A norovirus AGE case was defined as meeting the work-up definition plus a norovirus positive stool sample or vomitus sample confirmed by reverse transcriptase polymerase chain reaction (RT-PCR). The severity of AGE was graded by the investigator as per CTCAE criteria. AGE occurring due to NoV strains excluding co-infection with Salmonella, Shigella or Campylobacter is reported. The Norovirus strains included: GI.1, GI.7a, GII.2 and GII.4.
- Time frame
- Up to Day 47
- Population
- Full Analysis Set included all participants who were randomized and received the trial dose.
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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