Nirsevimab vs No Intervention: Number of Participants With Immediate Treatment-Emergent Adverse Events (TEAEs)
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 | 0.00672 | 0.00462 | 0.00976 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0 | 0.0000000000000000000542 | 0.000955 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | 0.00672 | 0.00442 | 0.00976 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | ClinicalTrials.gov | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | ClinicalTrials.gov | |||
| Number needed to treat, for one more participant with the outcome on Nirsevimab than on No Intervention | 149 | 102 | 226 | 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. | 27 | 4,016 | OG000 | ClinicalTrials.gov |
| Group 2 | No Intervention | Participants received no RSV preventive intervention on Day 1. | 0 | 4,018 | OG001 | ClinicalTrials.gov |
Outcome 5
| Field | Value | Source |
|---|---|---|
| Type | SECONDARY | ClinicalTrials.gov |
| Title | Number of Participants With Immediate Treatment-Emergent Adverse Events (TEAEs) | ClinicalTrials.gov |
| Description | An adverse event (AE) was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were either events with the start date and time posterior to the start of the treatment period and up to the end of the treatment period or events with the start date and time prior to the start of the treatment period, whose severity was greater than 1 or missing and stop date is missing or not before the treatment period. Immediate events were recorded to capture medically relevant AEs which occurred within the first 30 minutes after immunization. | ClinicalTrials.gov |
| Time frame | Up to 30 minutes post-dosing/randomization on Day 1 | ClinicalTrials.gov |
| Population | The Safety Analysis Set (SafAS) consisted of all participants who received nirsevimab in the study and all randomized participants who were randomized to the no intervention group and did not receive nirsevimab inadvertently. As pre-specified in the protocol and SAP, results are presented by treatment 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.