Comparison · NCT05437510-7da5ef8e
Nirsevimab vs No Intervention: Number of Participants With Recurrent Wheeze (for United Kingdom Reconsented Participants)
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. Nirsevimab vs No Intervention: Number of Participants With Recurrent Wheeze (for United Kingdom Reconsented Participants). Trial comparisons, record NCT05437510-7da5ef8e. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT05437510-7da5ef8e
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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 | 0.109 | 0.0904 | 0.131 | wilson | |
| Risk in group 2 | 0.108 | 0.0893 | 0.13 | wilson | |
| Risk difference, group 1 minus group 2 | 0.000728 | -0.0281 | 0.0294 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.01 | 0.773 | 1.31 | log | |
| Odds ratio, group 1 over group 2 | 1.01 | 0.749 | 1.35 | log | |
| Number needed to treat, for one more participant with the outcome on Nirsevimab than on No Intervention | 1,370 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: no intervention.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Nirsevimab | Participants received nirsevimab 50 mg (if weight \<5 kg) or 100 mg (if weight ≥5 kg) as a single IM injection on Day 1. | 101 | 928 | OG000 |
| Group 2 | No Intervention | Participants received no RSV preventive intervention on Day 1. | 96 | 888 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Recurrent Wheeze (for United Kingdom Reconsented Participants)
- Description
Wheeze was defined as a physician-diagnosed wheeze or asthma or related ear, nose and throat (ENT)/respiratory symptoms at an office visit or an illness for which the child was prescribed medication to treat an ENT/respiratory condition. Recurrent wheeze event was defined as 2 or more protocol-defined wheeze episodes throughout follow-up period.
- Time frame
- From dosing/randomization (Day 1) to Day 731
- Population
- The All Randomized Set consisted of all participants randomly assigned to either the nirsevimab group or the no intervention group. Only participants with data collected are reported.
Source ClinicalTrials.gov
Trial
- Title
Study of a Single Intramuscular Dose of Nirsevimab in the Prevention of Hospitalizations Due to Respiratory Syncytial Virus (RSV) Infection in Healthy Term and Preterm Infants During the First Year of Life
- NCT number
- NCT05437510
- Phases
- PHASE3
- Conditions
- RSV Immunization, Healthy Volunteer
- Interventions
- Nirsevimab
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Results first posted
- 2025-04-11
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT05437510?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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