Nirsevimab vs No Intervention: Number of Participants With Very Severe Respiratory Syncytial Virus Lower Respiratory Tract Infection Through the Respiratory Syncytial Virus Season
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
Measures 6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note | Source |
|---|---|---|---|---|---|---|
| Risk in group 1 | 0.00124 | 0.000529 | 0.0029 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.00523 | 0.00342 | 0.00798 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | -0.00399 | -0.00683 | -0.00154 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 0.237 | 0.0894 | 0.628 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 0.236 | 0.0889 | 0.627 | log | ClinicalTrials.gov | |
| Number needed to treat, for one fewer participant with the outcome on Nirsevimab than on No Intervention | 251 | 146 | 651 | from the risk difference interval | ClinicalTrials.gov |
Groups 2
Group 2 names the comparator: no intervention.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code | Source |
|---|---|---|---|---|---|---|
| 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. | 5 | 4,038 | OG000 | ClinicalTrials.gov |
| Group 2 | No Intervention | Participants received no RSV preventive intervention on Day 1. | 21 | 4,019 | OG001 | ClinicalTrials.gov |
Outcome 5
| Field | Value | Source |
|---|---|---|
| Type | SECONDARY | ClinicalTrials.gov |
| Title | Number of Participants With Very Severe Respiratory Syncytial Virus Lower Respiratory Tract Infection Through the Respiratory Syncytial Virus Season | ClinicalTrials.gov |
| 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%). Very severe RSV LRTI was defined as RSV LRTI hospitalization with oxygen saturation \<90% (at any time during hospitalization) and oxygen supplementation. Hospitalization was defined as the decision to admit to in-patient care by the treating physician. RSV season was the period of increased RSV infection. | ClinicalTrials.gov |
| Time frame | From dosing/randomization (Day 1) up to approximately 7 months | ClinicalTrials.gov |
| Population | The All Randomized Set consisted of all participants randomly assigned to either the nirsevimab group or the no intervention group. | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| 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 | ClinicalTrials.gov |
| NCT number | NCT05437510 | ClinicalTrials.gov |
| Phases | PHASE3 | ClinicalTrials.gov |
| Conditions | RSV Immunization, Healthy Volunteer | ClinicalTrials.gov |
| Interventions | Nirsevimab | ClinicalTrials.gov |
| Lead sponsor | Sanofi Pasteur, a Sanofi Company | ClinicalTrials.gov |
| Results first posted | 2025-04-11 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT05437510?tab=results | ClinicalTrials.gov |
Source 4
| Field | Value | Source |
|---|---|---|
| Release | trial-comparisons-2026-03-23-0.1.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57 | ClinicalTrials.gov |
| AACT copy | 2026-03-23 | ClinicalTrials.gov |
| 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 | ClinicalTrials.gov |
Release trial-comparisons-2026-03-23-0.1.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.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.
ClinicalTrials.gov: none 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.