NCT07109297

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

A Phase 4, Open-label, Single-arm Clinical Study to Describe Safety and Efficacy Outcomes Associated With the Use of Nirsevimab in Neonates and Infants Born During or Entering Their First Respiratory Syncytial Virus (RSV) Season and in Children up to 24 Months of Age Who Remain Vulnerable to Severe RSV Disease Through Their Second RSV Season

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 0 Months – 24 Months
• Healthy volunteers: Accepted

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.

Detailed description

Study duration: up to 16 months, including 10 months of enrollment and 6 months of follow-up * Treatment duration: 1 day; 1 intramuscular (IM) injection * Visit frequency: * 1 in-person visit for immunization (Visit \[V\] 01) at Day (D) 1. * 3 phone call visits (V2, V3 and V4) at D31 (+ 14 days), D91 (+ 14 days) and D181 (+14 days) respectively.

Conditions

• RSV Immunization

Interventions

Type	Name	Description
BIOLOGICAL	Nirsevimab	Pharmaceutical form:Sterile solution for injection-Route of administration:Intramuscular

Timeline

• Start date: 2025-07-31
• Primary completion: 2026-06-30
• Completion: 2026-06-30
• First posted: 2025-08-07
• Last updated: 2026-03-23

Locations

7 sites across 1 country: India

Regulatory

• FDA-regulated drug study