Comparison · NCT03393754-sae
Engerix-B® Hepatitis B Vaccination vs Sci-B-Vac® Hepatitis B Vaccination: 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. Engerix-B® Hepatitis B Vaccination vs Sci-B-Vac® Hepatitis B Vaccination: serious adverse events. Trial comparisons, record NCT03393754-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03393754-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 | 0.0259 | 0.017 | 0.0393 | wilson | |
| Risk in group 2 | 0.0402 | 0.0286 | 0.0562 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0143 | -0.0326 | 0.00338 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.644 | 0.375 | 1.11 | log | |
| Odds ratio, group 1 over group 2 | 0.635 | 0.363 | 1.11 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Engerix-B® Hepatitis B Vaccination than on Sci-B-Vac® Hepatitis B Vaccination | 69.9 | 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 | Engerix-B® Hepatitis B Vaccination | Engerix-B® (hepatitis B vaccine) Hepatitis B Vaccination, Solution, 20ug, IM injection at Days 0, 28, and 168.~Hepatitis B Vaccination: Prophylactic Hepatitis B Vaccination | 21 | 811 | EG000 |
| Group 2 | Sci-B-Vac® Hepatitis B Vaccination | Sci-B-Vac® (hepatitis B vaccine) Hepatitis B Vaccination, Solution, 10ug, IM injection at Days 0, 28, and 168.~Hepatitis B Vaccination: Prophylactic Hepatitis B Vaccination | 32 | 796 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 1 year
Source ClinicalTrials.gov
Trial
- Title
- Immunogenicity and Safety of Sci-B-Vac® to Engerix-B® in Adults
- NCT number
- NCT03393754
- Phases
- PHASE3
- Conditions
- Hepatitis B Vaccines
- Interventions
- Hepatitis B Vaccination
- Lead sponsor
- VBI Vaccines Inc.
- Results first posted
- 2020-07-07
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03393754?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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