Comparison · NCT00735475-sae
Afluria® Group vs Fluzone® 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. Afluria® Group vs Fluzone® Group: serious adverse events. Trial comparisons, record NCT00735475-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00735475-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 | 0.0349 | 0.0232 | 0.0523 | wilson | |
| Risk in group 2 | 0.0409 | 0.028 | 0.0592 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00596 | -0.0277 | 0.0156 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.854 | 0.489 | 1.49 | log | |
| Odds ratio, group 1 over group 2 | 0.849 | 0.476 | 1.51 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Afluria® Group than on Fluzone® Group | 168 | 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 | Afluria® Group | Participants received one dose of the 2008/2009 formulation of Afluria® by intramuscular injection. | 22 | 630 | EG000 |
| Group 2 | Fluzone® Group | Participants received one dose of the 2008/2009 formulation of Fluzone® by intramuscular injection. | 26 | 636 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- SAEs were collected up to 180 days after the study vaccination. Other adverse events were unsolicited adverse events that were collected up to 21 days after the study vaccination.
Source ClinicalTrials.gov
Trial
- Title
- A Study to Determine the Immunogenicity and Safety Profile of CSL Limited's Influenza Virus Vaccine Compared to a US Licensed Comparator Influenza Virus Vaccine
- NCT number
- NCT00735475
- Phases
- PHASE4
- Conditions
- Influenza
- Interventions
- CSL Limited Influenza Virus Vaccine (Afluria®), US Licensed Influenza Virus Vaccine (Fluzone®)
- Lead sponsor
- Seqirus
- Results first posted
- 2011-09-01
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00735475?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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