Comparison · NCT00377611-sae
Fluarix 50-64 Years Group vs Fluarix 65+ Years 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. Fluarix 50-64 Years Group vs Fluarix 65+ Years Group: serious adverse events. Trial comparisons, record NCT00377611-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00377611-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 | 0.022 | 0.0147 | 0.0327 | wilson | |
| Risk in group 2 | 0.0523 | 0.0434 | 0.0629 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0303 | -0.0432 | -0.0164 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.42 | 0.269 | 0.655 | log | |
| Odds ratio, group 1 over group 2 | 0.407 | 0.257 | 0.643 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Fluarix 50-64 Years Group than on Fluarix 65+ Years Group | 32.9 | 23.1 | 61.1 | 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 | Fluarix 50-64 Years Group | Adult subjects aged between and including 50-64 years who received a single dose of Fluarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm, were enrolled for investigation of influenza and influenza-related complications. | 23 | 1,047 | EG000 |
| Group 2 | Fluarix 65+ Years Group | Elderly subjects aged 65 and over who received a single dose of Fluarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm, were enrolled for investigation of influenza and influenza-related complications. | 105 | 2,007 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- SAEs during the entire study period [from pre-season and up to the influenza surveillance period (from Month 0 up to Month 6)]
Source ClinicalTrials.gov
Trial
- Title
- Study on the Incidence of Influenza and Its Complications, in Subjects Aged 50 Years and Over Vaccinated With Fluarix™
- NCT number
- NCT00377611
- Phases
- PHASE4
- Conditions
- Influenza
- Interventions
- Fluarix™
- Lead sponsor
- GlaxoSmithKline
- Results first posted
- 2018-10-09
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00377611?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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