Fluzone® High Dose vs Fluzone®: 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 | 0.0807 | 0.0741 | 0.0878 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.0774 | 0.0684 | 0.0874 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | 0.00334 | -0.00865 | 0.0148 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 1.04 | 0.899 | 1.21 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 1.05 | 0.891 | 1.23 | log | ClinicalTrials.gov | |
| Number needed to harm, for one more participant with a serious adverse event on Fluzone® High Dose than on Fluzone® | 300 | 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 | Fluzone® High Dose | All participants received a single dose of Fluzone High Dose vaccine on Day 0. | 493 | 6,108 | EG000 | ClinicalTrials.gov |
| Group 2 | Fluzone® | All subjects received a single dose of Fluzone vaccine on Day 0. | 236 | 3,050 | EG001 | ClinicalTrials.gov |
Harm 2
| Field | Value | Source |
|---|---|---|
| What it counts | Total, serious adverse events | ClinicalTrials.gov |
| Time frame | Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination. | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| Title | Multi-Year Study of Fluzone High-Dose Influenza Vaccine Compared With Fluzone® Vaccine in Adults Aged 65 Years and Older | ClinicalTrials.gov |
| NCT number | NCT00976027 | ClinicalTrials.gov |
| Phases | PHASE3 | ClinicalTrials.gov |
| Conditions | Influenza | ClinicalTrials.gov |
| Interventions | Trivalent inactivated influenza vaccine High Dose, Trivalent inactivated influenza vaccine | ClinicalTrials.gov |
| Lead sponsor | Sanofi | ClinicalTrials.gov |
| Results first posted | 2012-07-25 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT00976027?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.