Comparison · NCT02290509-sae
Flublok Quadrivalent Influenza Vaccine vs Inactivated Influenza Vaccine (IIV4): 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 Quadrivalent Influenza Vaccine vs Inactivated Influenza Vaccine (IIV4): serious adverse events. Trial comparisons, record NCT02290509-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02290509-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 | 0.01 | 0.00545 | 0.0183 | wilson | |
| Risk in group 2 | 0.00602 | 0.00165 | 0.0217 | wilson | |
| Risk difference, group 1 minus group 2 | 0.004 | -0.0123 | 0.0134 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.66 | 0.366 | 7.55 | log | |
| Odds ratio, group 1 over group 2 | 1.67 | 0.364 | 7.66 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Flublok Quadrivalent Influenza Vaccine than on Inactivated Influenza Vaccine (IIV4) | 250 | 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 Quadrivalent Influenza Vaccine | Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL~Flublok Quadrivalent: Intramuscular injection of study vaccine | 10 | 998 | EG000 |
| Group 2 | Inactivated Influenza Vaccine (IIV4) | Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.~Inactivated Influenza Vaccine (IIV4): Intramuscular injection of study vaccine | 2 | 332 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- All AEs collected 28 days after study immunization and all Serious Adverse Events (SAEs) collected through six (6) months after study immunization.
Source ClinicalTrials.gov
Trial
- Title
- Safety and Immunogenicity of Flublok Quadrivalent vs IIV4 in Adults 18-49 Years of Age
- NCT number
- NCT02290509
- Phases
- PHASE3
- Conditions
- Influenza
- Interventions
- Flublok Quadrivalent, Inactivated Influenza Vaccine (IIV4)
- Lead sponsor
- Protein Sciences Corporation
- Results first posted
- 2016-09-22
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02290509?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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