Comparison · NCT00346073-02f59107
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
Cite this record
ConductScience Library. Boostrix Group vs Adacel Group: Number of Subjects With Serious Adverse Events (SAEs). Trial comparisons, record NCT00346073-02f59107. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00346073-02f59107
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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 | 0.00591 | 0.00311 | 0.0112 | wilson | |
| Risk in group 2 | 0.00262 | 0.00072 | 0.00952 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00329 | -0.00415 | 0.00891 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.25 | 0.488 | 10.4 | log | |
| Odds ratio, group 1 over group 2 | 2.26 | 0.487 | 10.5 | log | |
| Number needed to treat, for one more participant with the outcome on Boostrix Group than on Adacel Group | 304 | 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. | 9 | 1,522 | 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. | 2 | 762 | 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 active phase of the study (Day 0 - Day 30)
- Population
- The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.
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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