NCT07200206

A Post-marketing Surveillance Study of Beyfortus (Nirsevimab) in Republic of Korea

A Prospective, Single-arm, Non-interventional, Multi-center, Post-marketing Surveillance Study of Beyfortus (Nirsevimab) in Republic of Korea

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 3,000 (estimated)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 0 Days – 24 Months
• Healthy volunteers: Accepted

Summary

This study is conducted as part of the local risk management plan to collect and understand the following information about the surveillance drug under the real-world clinical practice settings. To evaluate the safety of Beyfortus in Korean children who received Beyfortus under the real-world clinical practice settings per the approved indication. The investigator will decide whether to enroll participants if they determine that administering Beyfortus according to current practice can provide clinical benefits in terms of safety and efficacy Participants will be followed-up for 180 days after Beyfortus administration.

Conditions

• Respiratory Syncytial Virus

Interventions

Type	Name	Description
BIOLOGICAL	Nirsevimab	Route of Administration: Intramuscular Pharmaceutical Form: Solution for injection

Timeline

• Start date: 2025-10-02
• Primary completion: 2029-09-26
• Completion: 2029-09-26
• First posted: 2025-10-01
• Last updated: 2025-12-03

Locations

1 site across 1 country: South Korea

Regulatory

• FDA-regulated drug study