Comparison · NCT04024228-33e22390
Group 1: QIV-HD vs Group 2: QIV-SD: Number of Participants Reporting Immediate Unsolicited Adverse Events (AEs)
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. Group 1: QIV-HD vs Group 2: QIV-SD: Number of Participants Reporting Immediate Unsolicited Adverse Events (AEs). Trial comparisons, record NCT04024228-33e22390. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04024228-33e22390
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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 | 0.00259 | 0.000711 | 0.0094 | wilson | |
| Risk in group 2 | 0.00131 | 0.000232 | 0.00741 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00128 | -0.0051 | 0.00817 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.97 | 0.179 | 21.7 | log | |
| Odds ratio, group 1 over group 2 | 1.97 | 0.179 | 21.8 | log | |
| Number needed to treat, for one more participant with the outcome on Group 1: QIV-HD than on Group 2: QIV-SD | 783 | 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 | Group 1: QIV-HD | Participants received a single injection of 0.7 mL QIV-HD; IM at Day 0. | 2 | 772 | OG000 |
| Group 2 | Group 2: QIV-SD | Participants received a single injection of 0.5 mL QIV-SD; IM at Day 0. | 1 | 761 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants Reporting Immediate Unsolicited Adverse Events (AEs)
- Description
An AE was any untoward medical occurrence in a patient or in a clinical investigation participant administered a medicinal product and which did not had any casual relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination. All participants were observed for 30 minutes after vaccination, and any unsolicited AEs occurred during that time were recorded as immediate unsolicited AEs in the CRB.
- Time frame
- Within 30 minutes post-vaccination
- Population
- Analysis was performed on safety analysis set (SafAS) which included participants who had received the study vaccine and had any safety data available.
Source ClinicalTrials.gov
Trial
- Title
Study to Assess the Immune Response and the Safety Profile of a High-Dose Quadrivalent Influenza Vaccine (QIV-HD) Compared to a Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) in Europeans Adults 60 Years of Age and Older
- NCT number
- NCT04024228
- Phases
- PHASE3
- Conditions
- Influenza Immunization, Healthy Volunteers
- Interventions
Standard-Dose influenza virus surface antigens (haemagglutinin and neuraminidase), Inactivated, Influenza Vaccine Quadrivalent, 2019-2020 Northern Hemisphere Strains (QIV-SD), High-Dose Influenza Vaccine (split virion, inactivated), Quadrivalent (QIV-HD) 2019-2020 Northern Hemisphere formulation
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Results first posted
- 2021-01-19
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04024228?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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