Comparison · NCT01439165-sae
Adacel Vaccine vs Td Adsorbed Vaccine: 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 vs Td Adsorbed Vaccine: serious adverse events. Trial comparisons, record NCT01439165-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01439165-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 | 0.00801 | 0.00406 | 0.0157 | wilson | |
| Risk in group 2 | 0.00305 | 0.000538 | 0.0171 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00496 | -0.0096 | 0.0131 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.63 | 0.33 | 20.9 | log | |
| Odds ratio, group 1 over group 2 | 2.64 | 0.329 | 21.2 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Adacel Vaccine than on Td Adsorbed Vaccine | 202 | 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 | Healthy adults \<65 years of age who received Adacel 10 years ago received a repeat dose of Adacel vaccine. | 8 | 999 | EG000 |
| Group 2 | Td Adsorbed Vaccine | Healthy adults \<65 years of age who received Adacel 10 years ago received TENIVAC® (Td Adsorbed vaccine). | 1 | 328 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse event data were collected from Day 0 up to 1 month post-booster vaccination.
Source ClinicalTrials.gov
Trial
- Title
- Safety and Immunogenicity in Adults of Revaccination With Adacel® Vaccine 10 Years After a Previous Dose
- NCT number
- NCT01439165
- Phases
- PHASE4
- Conditions
- Tetanus, Diphtheria, Pertussis, Whooping Cough
- Interventions
- Tetanus Toxoid, Diphtheria Toxoid and Pertussis Vaccine, Tetanus and Diphtheria Toxoids Adsorbed For Adult Use
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Results first posted
- 2017-10-09
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01439165?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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