Flublok Quadrivalent Influenza Vaccine vs Inactivated Influenza Vaccine: Number of Participants With Unsolicited Adverse Events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
Measures 6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note | Source |
|---|---|---|---|---|---|---|
| Risk in group 1 | 0.311 | 0.297 | 0.325 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.312 | 0.298 | 0.326 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | -0.00116 | -0.0206 | 0.0183 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 0.996 | 0.936 | 1.06 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 0.995 | 0.908 | 1.09 | log | ClinicalTrials.gov | |
| Number needed to treat, for one fewer participant with the outcome on Flublok Quadrivalent Influenza Vaccine than on Inactivated Influenza Vaccine | 864 | from the risk difference interval | the interval includes no difference | ClinicalTrials.gov |
Groups 2
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 | Source |
|---|---|---|---|---|---|---|
| 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 Influenza Vaccine: Intramuscular injection of vaccine | 1,345 | 4,328 | OG000 | ClinicalTrials.gov |
| Group 2 | Inactivated Influenza Vaccine | 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: Intramuscular injection of vaccine | 1,355 | 4,344 | OG001 | ClinicalTrials.gov |
Outcome 5
| Field | Value | Source |
|---|---|---|
| Type | SECONDARY | ClinicalTrials.gov |
| Title | Number of Participants With Unsolicited Adverse Events | ClinicalTrials.gov |
| Description | Unsolicited adverse events reported in the 28 days following vaccine administration. | ClinicalTrials.gov |
| Time frame | Days 0 through 28 | ClinicalTrials.gov |
| Population | The safety population includes all randomized and vaccinated subjects who provided any safety data (solicited or unsolicited) following administration of study vaccine. | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| Title | Protective Efficacy of Flublok® Quadrivalent Versus Licensed Inactivated Influenza Vaccine in Adults ≥50 Years of Age | ClinicalTrials.gov |
| NCT number | NCT02285998 | ClinicalTrials.gov |
| Phases | PHASE3 | ClinicalTrials.gov |
| Conditions | Influenza | ClinicalTrials.gov |
| Interventions | Flublok Quadrivalent Influenza Vaccine, Inactivated Influenza Vaccine | ClinicalTrials.gov |
| Lead sponsor | Protein Sciences Corporation | ClinicalTrials.gov |
| Results first posted | 2016-10-04 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT02285998?tab=results | ClinicalTrials.gov |
Source 4
| Field | Value | Source |
|---|---|---|
| Release | trial-comparisons-2026-03-23-0.1.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57 | ClinicalTrials.gov |
| AACT copy | 2026-03-23 | ClinicalTrials.gov |
| 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 | ClinicalTrials.gov |
Release trial-comparisons-2026-03-23-0.1.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.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.
ClinicalTrials.gov: none 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.