Nirsevimab vs No Intervention: serious adverse events
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 | 0.0652 | 0.058 | 0.0733 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.0553 | 0.0486 | 0.0627 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | 0.00999 | -0.000429 | 0.0204 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 1.18 | 0.993 | 1.4 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 1.19 | 0.992 | 1.44 | log | ClinicalTrials.gov | |
| Number needed to harm, for one more participant with a serious adverse event on Nirsevimab than on No Intervention | 100 | from the risk difference interval | the interval includes no difference | 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. | 262 | 4,016 | EG000 | ClinicalTrials.gov |
| Group 2 | No Intervention | Participants received no RSV preventive intervention on Day 1. | 222 | 4,018 | EG001 | ClinicalTrials.gov |
Harm 2
| Field | Value | Source |
|---|---|---|
| What it counts | Total, serious adverse events | ClinicalTrials.gov |
| Time frame | SAEs and all-cause mortality were collected from dosing/randomization (Day 1) up to end of follow-up (Day 366 for France, Germany, UK non-reconsented participants and Day 731 for UK reconsented participants). Non-serious AEs were collected from dosing/randomization (Day 1) up to Day 31 as pre-specified in protocol. | 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.