Comparison · NCT05513053-81808cd6
Cohort 1: Participants Aged 9 to 17 Years vs Cohort 2: Participants Aged 18 to 49 Years: Number of Participants With 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
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ConductScience Library. Cohort 1: Participants Aged 9 to 17 Years vs Cohort 2: Participants Aged 18 to 49 Years: Number of Participants With Immediate Unsolicited Adverse Events (AEs). Trial comparisons, record NCT05513053-81808cd6. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT05513053-81808cd6
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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 | 0.00156 | 0.000275 | 0.00878 | wilson | |
| Risk in group 2 | 0 | 0 | 0.0058 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00156 | -0.00438 | 0.00878 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat, for one more participant with the outcome on Cohort 1: Participants Aged 9 to 17 Years than on Cohort 2: Participants Aged 18 to 49 Years | 641 | 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. | 1 | 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. | 0 | 658 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Immediate Unsolicited Adverse Events (AEs)
- Description
An AE was any untoward medical occurrence in a clinical investigation participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions, that is, prelisted in the CRF 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.
- Time frame
- Within 30 minutes post-vaccination on Day 1
- 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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