Comparison · NCT00383123-ad0882b5
Fluarix Group vs Fluzone Group: Number of Subjects Reporting Rare Serious 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 Group vs Fluzone Group: Number of Subjects Reporting Rare Serious Events. Trial comparisons, record NCT00383123-ad0882b5. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00383123-ad0882b5
On this page
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 | 0.0052 | 0.00291 | 0.00929 | wilson | |
| Risk in group 2 | 0.00909 | 0.00508 | 0.0162 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00389 | -0.0114 | 0.00183 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.572 | 0.249 | 1.32 | log | |
| Odds ratio, group 1 over group 2 | 0.57 | 0.246 | 1.32 | log | |
| Number needed to treat, for one fewer participant with the outcome on Fluarix Group than on Fluzone Group | 257 | 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 | Fluarix Group | Subjects in this group received Fluarix and will be further stratified by 3 age groups~* 1:1 in 6 months to \< 36 months~* 1:1 in 3 to \< 5 years~* 3:1 in 5 to \< 18 years | 11 | 2,115 | OG000 |
| Group 2 | Fluzone Group | Subjects in this group received Fluzone and will be further stratified by 3 age groups~* 1:1 in 6 months to \< 36 months~* 1:1 in 3 to \< 5 years~* 3:1 in 5 to \< 18 years | 11 | 1,210 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Subjects Reporting Rare Serious Events
- Description
Rare serious event is defined as any untoward medical event with an occurrence rate of ≥1/300 that:~* resulted in death,~* was life-threatening,~* required hospitalization or prolongation of existing hospitalization,~* resulted in disability/incapacity, or~* was a congenital anomaly/birth defect in the offspring of a study subject.
- Time frame
- Up to 6 months after vaccination
- Population
Source ClinicalTrials.gov
Trial
- Title
- Study Comparing the Immune Response and Safety of Fluarix and Fluzone Influenza Vaccines in Children
- NCT number
- NCT00383123
- Phases
- PHASE3
- Conditions
- Influenza
- Interventions
- Fluarix™, Fluzone
- Lead sponsor
- GlaxoSmithKline
- Results first posted
- 2008-12-04
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00383123?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.
For software
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT00383123-ad0882b5