Comparison · NCT00980005-sae
Flulaval 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. Flulaval Group vs Fluzone Group: serious adverse events. Trial comparisons, record NCT00980005-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00980005-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 | 0.00948 | 0.00516 | 0.0174 | wilson | |
| Risk in group 2 | 0.00566 | 0.00259 | 0.0123 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00382 | -0.00409 | 0.0123 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.68 | 0.611 | 4.6 | log | |
| Odds ratio, group 1 over group 2 | 1.68 | 0.609 | 4.65 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Flulaval Group than on Fluzone Group | 262 | 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 | Flulaval Group | subjects received Flulaval™ vaccine according to their priming status and age:~* 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~* 9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid. | 10 | 1,055 | EG000 |
| Group 2 | Fluzone Group | subjects received Fluzone® Sanofi Pasteur's vaccine according to their priming status and age:~* 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~* 9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid. | 6 | 1,061 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Solicited AEs: During a 4-day follow-up period (Days 0-3) after vaccination; Unsolicited AEs:During a 28 day follow-up period (Days 0-27) after vaccination.; SAEs: During the entire study period (From Day 0 up to Day 180).
Source ClinicalTrials.gov
Trial
- Title
- Study to Assess the Immunogenicity and Safety of an Investigational Influenza Vaccine in Children
- NCT number
- NCT00980005
- Phases
- PHASE3
- Conditions
- Influenza
- Interventions
- GSK investigational vaccine GSK1557482A, Fluzone®
- Lead sponsor
- GlaxoSmithKline
- Results first posted
- 2012-02-15
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00980005?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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