aQIV vs Non-influenza Comparator Vaccine: serious 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 | 0.0704 | 0.0623 | 0.0795 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.0693 | 0.0612 | 0.0784 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | 0.00112 | -0.0111 | 0.0133 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 1.02 | 0.854 | 1.21 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 1.02 | 0.844 | 1.23 | log | ClinicalTrials.gov | |
| Number needed to harm, for one more participant with a serious adverse event on aQIV than on Non-influenza Comparator Vaccine | 891 | 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 | aQIV | A single dose of approximately 0.5 mL of aQIV was administered on Day 1 (NH 2016/17, SH 2017). | 238 | 3,380 | EG000 | ClinicalTrials.gov |
| Group 2 | Non-influenza Comparator Vaccine | Non-influenza Comparator Vaccine / A single dose of approximately 0.5 mL dose of Boostrix was administered on Day 1 (NH 2016/17, SH 2017). (Boostrix = Non-influenza comparator vaccine) | 234 | 3,377 | EG001 | ClinicalTrials.gov |
Harm 2
| Field | Value | Source |
|---|---|---|
| What it counts | Total, serious adverse events | ClinicalTrials.gov |
| Time frame | Solicited AEs: Day 1 to Day 7; SAEs: Day 1 to Day 366; and Unsolicited AEs: Day 1 to Day 22. | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| Title | Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of an MF59-Adjuvanted Quadrivalent Influenza Vaccine Compared to Non-influenza Vaccine Comparator in Adults ≥ 65 Years of Age | ClinicalTrials.gov |
| NCT number | NCT02587221 | ClinicalTrials.gov |
| Phases | PHASE3 | ClinicalTrials.gov |
| Conditions | Influenza | ClinicalTrials.gov |
| Interventions | MF59-adjuvanted Quadrivalent Subunit Inactivated Egg-derived Influenza Vaccine (aQIV), Non-Influenza Comparator (Boostrix) | ClinicalTrials.gov |
| Lead sponsor | Seqirus | ClinicalTrials.gov |
| Results first posted | 2020-06-09 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT02587221?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.