Comparison · NCT00287469-sae
20mcg Recombinant HEV 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. 20mcg Recombinant HEV vs Placebo: serious adverse events. Trial comparisons, record NCT00287469-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00287469-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 | 0.143 | 0.123 | 0.166 | wilson | |
| Risk in group 2 | 0.2 | 0.176 | 0.226 | wilson | |
| Risk difference, group 1 minus group 2 | -0.057 | -0.0899 | -0.024 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.715 | 0.588 | 0.87 | log | |
| Odds ratio, group 1 over group 2 | 0.667 | 0.528 | 0.844 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on 20mcg Recombinant HEV than on Placebo | 17.5 | 11.1 | 41.7 | 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 | 20mcg Recombinant HEV | 20mcg of recombinant HEV antigen administered intramuscularly in the deltoid according to a 0, 1 and 6 month schedule~Hepatitis E vaccine, recombinant (Sar 56 kDa): 20mcg or rhE Sar 56 kDa/dose of 0.5 mL, aluminium hydroxide (0.5 mg/dose) and phenoxyethanol (2.5 mg/dose) | 143 | 1,000 | EG001 |
| Group 2 | Placebo | PBS buffer placebo containing alum was administered intramuscularly in the deltoid according to a 0, 1 and 6 month schedule.~Placebo: PBS buffer placebo containing alum | 200 | 1,000 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Within 31 days (days 0-30) post-vaccination
Source ClinicalTrials.gov
Trial
- Title
- A Safety and Efficacy Study of the Hepatitis E Vaccine in Nepal.
- NCT number
- NCT00287469
- Phases
- PHASE2
- Conditions
- Hepatitis
- Interventions
- Hepatitis E vaccine, recombinant (Sar 56 kDa), Placebo
- Lead sponsor
- U.S. Army Medical Research and Development Command
- Results first posted
- 2019-05-29
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00287469?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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