Comparison · NCT00346073-sae
Boostrix Group vs Adacel 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
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ConductScience Library. Boostrix Group vs Adacel Group: serious adverse events. Trial comparisons, record NCT00346073-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00346073-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 | 0.0138 | 0.00904 | 0.021 | wilson | |
| Risk in group 2 | 0.0171 | 0.01 | 0.029 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00326 | -0.0161 | 0.00683 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.809 | 0.407 | 1.61 | log | |
| Odds ratio, group 1 over group 2 | 0.806 | 0.401 | 1.62 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Boostrix Group than on Adacel Group | 306 | 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 | Boostrix Group | Subjects, male or female, between, and including, 19 and 64 years of age received a single dose of Boostrix® vaccine administered intramuscularly in the deltoid region of the non-dominant upper arm at Day 0. | 21 | 1,522 | EG000 |
| Group 2 | Adacel Group | Subjects, male or female, between, and including, 19 and 64 years of age received a single dose of Adacel™ vaccine administered intramuscularly in the deltoid region of the non-dominant upper arm at Day 0. | 13 | 762 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Solicited local and general symptoms: during the 15-day (Day 0-14) follow-up period after vaccination; Unsolicited AEs: during the 31-day (Day 0-30) follow-up period after vaccination; SAEs: during the entire study period, including the ESFU phase (Month 0 - Month 6).
Source ClinicalTrials.gov
Trial
- Title
- Safety and Immunogenicity of GSK's Tdap Vaccine (Boostrix) in Adults Aged 19 to 64 Years
- NCT number
- NCT00346073
- Phases
- PHASE3
- Conditions
- Acellular Pertussis, Diphtheria, Tetanus
- Interventions
- Boostrix™, ADACEL®
- Lead sponsor
- GlaxoSmithKline
- Results first posted
- 2018-08-07
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00346073?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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