Comparison · NCT01825200-sae
Flublok vs Afluria: serious 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 vs Afluria: serious adverse events. Trial comparisons, record NCT01825200-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01825200-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 | 0.00381 | 0.00163 | 0.00888 | wilson | |
| Risk in group 2 | 0.00762 | 0.00414 | 0.014 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00381 | -0.0105 | 0.00234 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.5 | 0.171 | 1.46 | log | |
| Odds ratio, group 1 over group 2 | 0.498 | 0.17 | 1.46 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Flublok than on Afluria | 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 | Flublok | Flublok containing 3x45µg (135µg total) of rHA0 derived from influenza A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL~Flublok: A Biologics Licensing Application (BLA) for Flublok was approved by the FDA for influenza immunization of adults 18-49 years of age. Flublok is produced using recombinant technology under serum-free conditions. | 5 | 1,314 | EG000 |
| Group 2 | Afluria | Afluria, containing 3x15µg (45µg total), of trivalent, inactivated influenza vaccine (licensed IIV) containing influenza antigen derived from A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL~Afluria: Afluria is approved for use in persons 5 years of age and older and is produced by inactivation and disruption of live influenza virus grown in embryonated chicken eggs. | 10 | 1,313 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 30 days following vaccine administration
Source ClinicalTrials.gov
Trial
- Title
- Comparison of the Safety of Flublok® Versus Licensed IIV in Healthy, Medically Stable Adults ≥ 50 Years of Age
- NCT number
- NCT01825200
- Phases
- PHASE3
- Conditions
- Influenza
- Interventions
- Flublok, Afluria
- Lead sponsor
- Protein Sciences Corporation
- Results first posted
- 2015-02-18
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01825200?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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