Comparison · NCT05437510-6d6a678f
Nirsevimab vs No Intervention: Number of Participants With Hospitalization for All-Cause Lower Respiratory Tract Infection From Days 366 to 731 Post-dosing/Randomization (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 Hospitalization for All-Cause Lower Respiratory Tract Infection From Days 366 to 731 Post-dosing/Randomization (for United Kingdom Reconsented Participants). Trial comparisons, record NCT05437510-6d6a678f. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT05437510-6d6a678f
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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 | 0.0164 | 0.0104 | 0.0258 | wilson | |
| Risk in group 2 | 0.00976 | 0.00531 | 0.0179 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00667 | -0.00343 | 0.0171 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.68 | 0.781 | 3.63 | log | |
| Odds ratio, group 1 over group 2 | 1.69 | 0.779 | 3.69 | log | |
| Number needed to treat, for one more participant with the outcome on Nirsevimab than on No Intervention | 150 | 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. | 18 | 1,096 | OG000 |
| Group 2 | No Intervention | Participants received no RSV preventive intervention on Day 1. | 10 | 1,025 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Hospitalization for All-Cause Lower Respiratory Tract Infection From Days 366 to 731 Post-dosing/Randomization (for United Kingdom Reconsented Participants)
- Description
LRTI included the following common symptoms: clinical finding of rhonchi, rales, crackles, or wheeze; increased respiratory rate at rest (age: \<2 months, ≥60 breaths/min; 2 to 6 months, ≥50 breaths/min; \>6 months, ≥40 breaths/min), and hypoxemia (in room air: oxygen saturation \<95%). Hospitalization was defined as the decision to admit to in-patient care by the treating physician. Number of participants with hospitalization for all-cause LRTI from Days 366 to 731 post-dosing/randomization (with no hospitalizations for all-cause LRTI before Day 366) in UK reconsented participants is presented.
- Time frame
- From Day 366 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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