# 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

> **NCT05437510** · PHASE3 · COMPLETED · sponsor: **Sanofi Pasteur, a Sanofi Company** · enrollment: 8057 (actual)

## Conditions studied

- RSV Immunization
- Healthy Volunteer

## Interventions

- **BIOLOGICAL:** Nirsevimab

## Key facts

- **NCT ID:** NCT05437510
- **Lead sponsor:** Sanofi Pasteur, a Sanofi Company
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2022-08-08
- **Primary completion:** 2024-03-27
- **Final completion:** 2025-04-09
- **Target enrollment:** 8057 (ACTUAL)
- **Last updated:** 2025-10-09

## Collaborators

- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT05437510

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT05437510, "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". Retrieved via AI Analytics 2026-06-02 from https://api.ai-analytics.org/clinical/NCT05437510. Licensed CC0.

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