Comparison · NCT05513053-8d124c6a
Cohort 1: Participants Aged 9 to 17 Years vs Cohort 2: Participants Aged 18 to 49 Years: Number of Participants With Medically Attended Adverse Events (MAAEs)
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. Cohort 1: Participants Aged 9 to 17 Years vs Cohort 2: Participants Aged 18 to 49 Years: Number of Participants With Medically Attended Adverse Events (MAAEs). Trial comparisons, record NCT05513053-8d124c6a. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT05513053-8d124c6a
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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 | 0.0421 | 0.0291 | 0.0606 | wilson | |
| Risk in group 2 | 0.0532 | 0.0385 | 0.0731 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0111 | -0.0348 | 0.0125 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.792 | 0.485 | 1.29 | log | |
| Odds ratio, group 1 over group 2 | 0.783 | 0.468 | 1.31 | log | |
| Number needed to treat, for one fewer participant with the outcome on Cohort 1: Participants Aged 9 to 17 Years than on Cohort 2: Participants Aged 18 to 49 Years | 90.3 | 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 | Cohort 1: Participants Aged 9 to 17 Years | Participants received a single IM injection of RIV4 0.5 mL on Day 1. | 27 | 641 | OG000 |
| Group 2 | Cohort 2: Participants Aged 18 to 49 Years | Participants received a single IM injection of RIV4 0.5 mL on Day 1. | 35 | 658 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Medically Attended Adverse Events (MAAEs)
- Description
- An MAAE was a new onset or a worsening of a condition that prompted the participant or participant's parent/guardian to seek unplanned medical advice at a physician's office or emergency department.
- Time frame
- From Day 1 up to 28 days post-vaccination (up to Day 29)
- Population
- Analysis was performed on the Safety analysis set which included participants who received 1 dose of the study vaccine.
Source ClinicalTrials.gov
Trial
- Title
- Study With Quadrivalent Recombinant Influenza Vaccine (RIV4) in Participants 9 Through 49 Years of Age.
- NCT number
- NCT05513053
- Phases
- PHASE3
- Conditions
- Influenza Immunization
- Interventions
- Quadrivalent Recombinant influenza vaccine (RIV4) season/2022-2023/NH
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Results first posted
- 2024-05-30
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT05513053?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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