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A Post-marketing Surveillance Study of Beyfortus (Nirsevimab) in Republic of Korea
Sponsor: Sanofi
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.
Official title: A Prospective, Single-arm, Non-interventional, Multi-center, Post-marketing Surveillance Study of Beyfortus (Nirsevimab) in Republic of Korea
Key Details
Gender
All
Age Range
0 Days - 24 Months
Study Type
OBSERVATIONAL
Enrollment
3000
Start Date
2025-10-02
Completion Date
2029-09-26
Last Updated
2025-12-03
Healthy Volunteers
Yes
Conditions
Interventions
Nirsevimab
Route of Administration: Intramuscular Pharmaceutical Form: Solution for injection
Locations (1)
Nam Seung Woo Pediatric: 4100007
Hwaseong-si, Gyeonggi-do, South Korea