Comparison · NCT00346073-a4bc4a0d
Boostrix Group vs Adacel Group: Number of Subjects With Serious Adverse Events (SAEs)
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: Number of Subjects With Serious Adverse Events (SAEs). Trial comparisons, record NCT00346073-a4bc4a0d. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00346073-a4bc4a0d
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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 | 0.0083 | 0.00476 | 0.0145 | wilson | |
| Risk in group 2 | 0.0153 | 0.00856 | 0.0272 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00699 | -0.0194 | 0.00213 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.543 | 0.241 | 1.22 | log | |
| Odds ratio, group 1 over group 2 | 0.539 | 0.237 | 1.23 | log | |
| Number needed to treat, for one fewer participant with the outcome on Boostrix Group than on Adacel Group | 143 | 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. | 12 | 1,445 | OG000 |
| 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. | 11 | 719 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Subjects With Serious Adverse Events (SAEs)
- Description
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
- Time frame
- During the extended safety follow-up (ESFU) phase (Day 31 - Month 6)
- Population
The analysis was performed on the Extended Safety Follow Up (ESFU) cohort, which included all the subjects for whom the ESFU contact was completed. Two subjects were not contacted after the active phase of study, but had SAEs reported in the ESFU period.
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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