Comparison · NCT01825200-431233b2
Flublok vs Afluria: Number of Participants With Common Hypersensitivity Reactions as Measure of Safety
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: Number of Participants With Common Hypersensitivity Reactions as Measure of Safety. Trial comparisons, record NCT01825200-431233b2. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01825200-431233b2
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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 | 0.0236 | 0.0167 | 0.0333 | wilson | |
| Risk in group 2 | 0.016 | 0.0105 | 0.0243 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0076 | -0.00324 | 0.0188 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.48 | 0.852 | 2.55 | log | |
| Odds ratio, group 1 over group 2 | 1.49 | 0.85 | 2.6 | log | |
| Number needed to treat, for one more participant with the outcome on Flublok than on Afluria | 132 | 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. | 31 | 1,314 | OG000 |
| 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. | 21 | 1,313 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants With Common Hypersensitivity Reactions as Measure of Safety
- Description
- Number of participants who experience a pre-defined common systemic hypersensitivity adverse event, including rash, urticaria, swelling or edema through Day 30 post-vaccine administration.
- Time frame
- 30 Days
- Population
The primary analysis population, includes all randomized subjects who received a dose of study vaccine and for whom some safety data were available after administration of vaccine. Subjects were analyzed according to the vaccine received, regardless of whether this was the treatment group to which they were randomized.
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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