Comparison · NCT01005407-sae
HEPLISAV and/or Placebo vs Engerix-B(1): 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. HEPLISAV and/or Placebo vs Engerix-B(1): serious adverse events. Trial comparisons, record NCT01005407-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01005407-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 | 0.0396 | 0.0319 | 0.0492 | wilson | |
| Risk in group 2 | 0.0478 | 0.0321 | 0.0707 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00818 | -0.0324 | 0.0102 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.829 | 0.526 | 1.31 | log | |
| Odds ratio, group 1 over group 2 | 0.822 | 0.51 | 1.32 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on HEPLISAV and/or Placebo than on Engerix-B(1) | 122 | 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 | HEPLISAV and/or Placebo | 0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018)~HEPLISAV and/or Placebo: Intramuscular (IM) injections at Week 0, Week 4, plus a placebo (saline) injection at Week 24 | 78 | 1,968 | EG000 |
| Group 2 | Engerix-B(1) | 1.0 mL Engerix-B~Engerix-B: Intramuscular (IM) injections on Week 0, Week 4 and Week 24 | 23 | 481 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- Safety and Immunogenicity Study of the Hepatitis B Virus (HBV) Vaccine, HEPLISAV Compared to Engerix-B Vaccine
- NCT number
- NCT01005407
- Phases
- PHASE3
- Conditions
- Healthy
- Interventions
- HEPLISAV and/or Placebo, Engerix-B
- Lead sponsor
- Dynavax Technologies Corporation
- Results first posted
- 2018-01-11
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01005407?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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