Comparison · NCT00385255-sae
Boostrix+Fluarix Group vs Fluarix Boostrix 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. Boostrix+Fluarix Group vs Fluarix Boostrix Group: serious adverse events. Trial comparisons, record NCT00385255-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00385255-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 | 0.00349 | 0.00119 | 0.0102 | wilson | |
| Risk in group 2 | 0.00816 | 0.00396 | 0.0167 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00467 | -0.0136 | 0.00325 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.428 | 0.111 | 1.65 | log | |
| Odds ratio, group 1 over group 2 | 0.426 | 0.11 | 1.65 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Boostrix+Fluarix Group than on Fluarix Boostrix Group | 214 | 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+Fluarix Group | Healthy male or female adults, aged between 19 to 64 years inclusive and 65 years or older, who received Boostrix® vaccine co-administered with Fluarix® vaccine at Day 0, injected intramuscularly in the left and right upper deltoid regions, respectively. | 3 | 860 | EG000 |
| Group 2 | Fluarix Boostrix Group | Healthy male or female adults, aged between 19 to 64 years inclusive and 65 years or older, who received Fluarix® vaccine at Day 0 and Boostrix® vaccine at Month 1, both injected intramuscularly in the upper left deltoid region. | 7 | 858 | 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) period following each vaccination; Unsolicited AEs: during the 31-day period (Day 0-30) following each vaccination; SAEs: throughout the whole study period (from Day 0 to Month 2).
Source ClinicalTrials.gov
Trial
- Title
- Immunogenicity, Safety of GSKs Tdap Vaccine Boostrix When Coadministered With GSKs Influenza Vaccine Fluarix in Adults
- NCT number
- NCT00385255
- Phases
- PHASE3
- Conditions
- Acellular Pertussis, Diphtheria, Tetanus
- Interventions
- Fluarix®, Boostrix®
- Lead sponsor
- GlaxoSmithKline
- Results first posted
- 2018-09-17
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00385255?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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