Comparison · NCT00601835-sae
Canadian Td Vaccine Group vs United States Td 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. Canadian Td Vaccine Group vs United States Td Vaccine Group: serious adverse events. Trial comparisons, record NCT00601835-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00601835-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 | 0.0197 | 0.0152 | 0.0253 | wilson | |
| Risk in group 2 | 0.0629 | 0.0472 | 0.0833 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0432 | -0.0641 | -0.0265 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.313 | 0.213 | 0.459 | log | |
| Odds ratio, group 1 over group 2 | 0.299 | 0.2 | 0.446 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Canadian Td Vaccine Group than on United States Td Vaccine Group | 23.2 | 15.6 | 37.7 | 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 | Canadian Td Vaccine Group | Participants received the Canadian manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine for Adult Use (TENIVAC™) | 58 | 2,950 | EG000 |
| Group 2 | United States Td Vaccine Group | Participants received the US manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine for Adult Use (DECAVAC®) | 44 | 700 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse event data were collected for 6 months post-vaccination in all participants enrolled in the study.
Source ClinicalTrials.gov
Trial
- Title
- Canadian Manufactured Tetanus and Diphtheria Toxoids Adsorbed (Td) Vaccine Compared With U.S. Manufactured Td
- NCT number
- NCT00601835
- Phases
- PHASE4
- Conditions
- Diphtheria, Tetanus
- Interventions
- Tetanus and Diphtheria Toxoids Adsorbed (Td) Vaccine, Tetanus and Diphtheria Toxoids Adsorbed (Td) Vaccine
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Results first posted
- 2011-02-18
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00601835?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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