Comparison · NCT00346073-39928482
Boostrix Group vs Adacel Group: Number of Subjects With Any Unsolicited Adverse Events (AEs)
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 Any Unsolicited Adverse Events (AEs). Trial comparisons, record NCT00346073-39928482. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00346073-39928482
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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 | 0.178 | 0.16 | 0.198 | wilson | |
| Risk in group 2 | 0.222 | 0.194 | 0.253 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0437 | -0.0797 | -0.00926 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.803 | 0.676 | 0.953 | log | |
| Odds ratio, group 1 over group 2 | 0.76 | 0.613 | 0.943 | log | |
| Number needed to treat, for one fewer participant with the outcome on Boostrix Group than on Adacel Group | 22.9 | 12.6 | 108 | 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 | 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. | 271 | 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. | 169 | 762 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Subjects With Any Unsolicited Adverse Events (AEs)
- Description
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
- Time frame
- During the 31-day period (Days 0-30) following vaccination
- 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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