Comparison · NCT00539981-848b40f0
FluBlok (Lots A, B, C) vs Placebo: Number of Participants Reporting Unsolicited Adverse Events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. FluBlok (Lots A, B, C) vs Placebo: Number of Participants Reporting Unsolicited Adverse Events. Trial comparisons, record NCT00539981-848b40f0. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00539981-848b40f0
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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 | 0.026 | 0.0203 | 0.0333 | wilson | |
| Risk in group 2 | 0.0291 | 0.023 | 0.0368 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00306 | -0.0126 | 0.00644 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.895 | 0.636 | 1.26 | log | |
| Odds ratio, group 1 over group 2 | 0.892 | 0.628 | 1.27 | log | |
| Number needed to treat, for one fewer participant with the outcome on FluBlok (Lots A, B, C) than on Placebo | 327 | 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. | 61 | 2,344 | OG000 |
| 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. | 67 | 2,304 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants Reporting Unsolicited Adverse Events
- Description
An AE was defined as any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a study vaccine, whether or not considered to be related to the study vaccine. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination, ascertained during follow-up visit or telephone contact up to (and including) the Day 28 contact, whether reported spontaneously by the participant or in response to general questions about current or interim health status.
- Time frame
- From Day 0 (post-vaccination) through Day 28 post vaccination
- Population
- Analysis was performed on safety population.
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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