Group 1: QIV-HD vs Group 2: QIV-SD: Number of Participants With Non-fatal SAEs
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 | 0.000121 | 0.0000331 | 0.000441 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0 | 0.0000000000000000000136 | 0.000232 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | 0.000121 | -0.000127 | 0.000441 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | ClinicalTrials.gov | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | ClinicalTrials.gov | |||
| Number needed to treat, for one more participant with the outcome on Group 1: QIV-HD than on Group 2: QIV-SD | 8,270 | 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 | Group 1: QIV-HD | Participants received a single injection of 0.7 mL QIV-HD, IM at Day 0. | 2 | 16,549 | OG000 | ClinicalTrials.gov |
| Group 2 | Group 2: QIV-SD | Participants received a single injection of 0.5 mL QIV-SD, IM at Day 0. | 0 | 16,544 | OG001 | ClinicalTrials.gov |
Outcome 5
| Field | Value | Source |
|---|---|---|
| Type | SECONDARY | ClinicalTrials.gov |
| Title | Number of Participants With Non-fatal SAEs | ClinicalTrials.gov |
| Description | SAEs were defined as any untoward medical occurrence that at any dose was life-threatening, required inpatient hospitalization/ prolongation of existing hospitalization, resulted in persistent/ significant disability/ incapacity, was congenital anomaly/ birth defect or was an important medical event. Information on non-fatal SAEs was collected from the health registers. | ClinicalTrials.gov |
| Time frame | From 14 days post-vaccination up to 31 May 2020 post-vaccination (i.e., up to a duration of 6 months post-vaccination) | ClinicalTrials.gov |
| Population | Analysis was performed on all vaccinated participants. | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| Title | Study to Evaluate the Effectiveness of a High-Dose Quadrivalent Influenza Vaccine (QIV-HD) Compared to a Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) in Adults 65 Years of Age and Older | ClinicalTrials.gov |
| NCT number | NCT04137887 | ClinicalTrials.gov |
| Phases | PHASE3 | ClinicalTrials.gov |
| Conditions | Influenza (Healthy Volunteers) | ClinicalTrials.gov |
| Interventions | Quadrivalent Influenza Vaccine (split virion, inactivated) High-Dose (QIV-HD), Standard-Dose Inactivated Influenza Vaccine Quadrivalent, Northern Hemisphere strains (QIV-SD) | ClinicalTrials.gov |
| Lead sponsor | Sanofi Pasteur, a Sanofi Company | ClinicalTrials.gov |
| Results first posted | 2023-06-08 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT04137887?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.