Comparison · NCT00457249-sae
ADACEL® Vaccine Group vs DECAVAC® Vaccine Group: 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. ADACEL® Vaccine Group vs DECAVAC® Vaccine Group: serious adverse events. Trial comparisons, record NCT00457249-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00457249-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 | 0.0419 | 0.0318 | 0.0549 | wilson | |
| Risk in group 2 | 0.0512 | 0.0334 | 0.0777 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00927 | -0.0376 | 0.0128 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.819 | 0.493 | 1.36 | log | |
| Odds ratio, group 1 over group 2 | 0.811 | 0.476 | 1.38 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on ADACEL® Vaccine Group than on DECAVAC® Vaccine Group | 108 | 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 | ADACEL® Vaccine Group | Participants received a single dose of ADACEL® vaccine. | 49 | 1,170 | EG000 |
| Group 2 | DECAVAC® Vaccine Group | Participants received a single dose of ADACEL® vaccine. | 20 | 391 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse events data were collected from the day of vaccination (Day 0) for up to 6 months post-vaccination.
Source ClinicalTrials.gov
Trial
- Title
- A Trial to Evaluate the Safety and Immunogenicity of ADACEL® Vaccine in Persons 65 Years of Age and Older
- NCT number
- NCT00457249
- Phases
- PHASE4
- Conditions
- Pertussis, Tetanus, Diphtheria
- Interventions
- ADACEL®: Tetanus, Reduced Diphtheria and Acellular Pertussis Adsorbed, DECAVAC®: Tetanus and Diphtheria Toxoids Adsorbed
- Lead sponsor
- Sanofi
- Results first posted
- 2012-10-19
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00457249?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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