Comparison · NCT00539981-sae
FluBlok (Lots A, B, C) vs Placebo: 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. FluBlok (Lots A, B, C) vs Placebo: serious adverse events. Trial comparisons, record NCT00539981-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00539981-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 | 0.0128 | 0.00898 | 0.0182 | wilson | |
| Risk in group 2 | 0.0148 | 0.0106 | 0.0205 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00196 | -0.0089 | 0.00488 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.867 | 0.533 | 1.41 | log | |
| Odds ratio, group 1 over group 2 | 0.866 | 0.528 | 1.42 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on FluBlok (Lots A, B, C) than on Placebo | 511 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | FluBlok (Lots A, B, C) | Participants received a single 0.5 mL dose of FluBlok vaccine from any of the Lots A, B, or C, intramuscularly on Day 0 (Visit 1). Participants were followed up to 6 months after vaccination. | 30 | 2,344 | EG000 |
| Group 2 | Placebo | Participants received a single dose of placebo matched to FluBlok, intramuscularly on Day 0 (Visit 1). Participants were followed up to 6 months after vaccination. | 34 | 2,304 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Unsolicited non-serious AEs: Day 0 to Day 28 post vaccination, Solicited reactions: within 7 days post vaccination, SAE: through the end of influenza season (up to 6 months)
Source ClinicalTrials.gov
Trial
- Title
- Immunogenicity, Safety, Reactogenicity, Efficacy, Effectiveness and Lot Consistency of FluBlok
- NCT number
- NCT00539981
- Phases
- PHASE3
- Conditions
- Influenza
- Interventions
- FluBlok®, Placebo
- Lead sponsor
- Sanofi
- Results first posted
- 2021-02-15
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00539981?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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