Comparison · NCT05437510-df7663da
Nirsevimab vs No Intervention: Number of Participants With Treatment-Related Serious Adverse Event (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 Treatment-Related Serious Adverse Event (for United Kingdom Reconsented Participants). Trial comparisons, record NCT05437510-df7663da. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT05437510-df7663da
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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 | 0 | 0.00336 | wilson | |
| Risk in group 2 | 0 | 0 | 0.00353 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.00353 | 0.00336 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat | from the risk difference interval | the two groups' risks are equal |
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. | 0 | 1,140 | OG000 |
| Group 2 | No Intervention | Participants received no RSV preventive intervention on Day 1. | 0 | 1,084 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Treatment-Related Serious Adverse Event (for United Kingdom Reconsented Participants)
- Description
An 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. SAE: AE at any dose resulting in death, persistent or significant disability/incapacity, required inpatient hospitalization/prolongation of existing hospitalization, was life-threatening or congenital anomaly/birth defect or medically important event. A treatment-related TEAE was a TEAE considered by the investigator as related or with unknown/missing relationship to treatment for participants who received nirsevimab on Day 1.
- Time frame
- From Day 366 to Day 731
- Population
The 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.
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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