Comparison · NCT03408730-b98e245e
Comparator: ENGERIX-B Hep B Vaccination vs Pooled Sci-B-Vac®: Seroprotection Rate (SPR) of Anti-HBs at Day 196 for Sci-B-Vac® Compared to Day 196 for Engerix-B® (Per Protocol Set 2)
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. Comparator: ENGERIX-B Hep B Vaccination vs Pooled Sci-B-Vac®: Seroprotection Rate (SPR) of Anti-HBs at Day 196 for Sci-B-Vac® Compared to Day 196 for Engerix-B® (Per Protocol Set 2). Trial comparisons, record NCT03408730-b98e245e. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03408730-b98e245e
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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 | 0.948 | 0.927 | 0.963 | wilson | |
| Risk in group 2 | 0.993 | 0.987 | 0.996 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0449 | -0.0662 | -0.0288 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.955 | 0.936 | 0.973 | log | |
| Odds ratio, group 1 over group 2 | 0.135 | 0.0703 | 0.26 | log | |
| Number needed to treat, for one fewer participant with the outcome on Comparator: ENGERIX-B Hep B Vaccination than on Pooled Sci-B-Vac® | 22.2 | 15.1 | 34.7 | from the risk difference interval |
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 | Comparator: ENGERIX-B Hep B Vaccination | Active Comparator: ENGERIX-B Hepatitis B Vaccination~Engerix-B® Hepatitis B Vaccination, 20ug, intramuscular (IM) injection at Days 0, 28, and 168. | 561 | 592 | OG000 |
| Group 2 | Pooled Sci-B-Vac® | Pooled Sci-B-Vac Lot A, B and C Hepatitis B Vaccination~Sci-B-Vac® Hepatitis B Vaccination, 10ug, intramuscular (IM) injection at Days 0, 28, and 168. | 1,740 | 1,753 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Seroprotection Rate (SPR) of Anti-HBs at Day 196 for Sci-B-Vac® Compared to Day 196 for Engerix-B® (Per Protocol Set 2)
- Description
The difference in proportions \[SPR(Sci-B-Vac®)-SPR(Engerix-B®)\] and two-sided 95% CIs were summarized. If the lower bound of the 95% CI was \> 5%, Sci-B-Vac® was to be declared non-inferior to Engerix-B®
- Time frame
- 4 weeks after third vaccination (Study Day 196)
- Population
- Per Protocol Set 2 included all subjects in Per Protocol Set 1 excluding subjects who attended visits outside of windows including Visit 3/Day 168 (±28 days) and Visit 44/Day 196 (-7/+14 days)
Source ClinicalTrials.gov
Trial
- Title
- Lot-to-lot Consistency of Sci-B-Vac™ in Adults
- NCT number
- NCT03408730
- Phases
- PHASE3
- Conditions
- Hepatitis B Vaccines
- Interventions
- Hepatitis B Vaccination
- Lead sponsor
- VBI Vaccines Inc.
- Results first posted
- 2020-10-14
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03408730?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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