drugset / Trial / NCT07109297

Study of Monoclonal Antibody Nirsevimab Against Respiratory Syncytial Virus (RSV) in Participants up to 24 Months of Age in India

NCT07109297

Phase 4 Active not recruiting 110 enrolled Sanofi
NaSingle-groupOpen-labelPrevention

Summary

The purpose of this study is to describe the safety and efficacy outcomes associated with the use of nirsevimab, administered as per routine clinical practice, in neonates and infants aged 0 to 12 months born during or entering their first RSV season and in children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.

Timeline

Start
2025-07-31
Primary completion
2026-06-30
Completion
2026-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Nirsevimab Monoclonal antibody Intramuscular