Clinical Trial

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

Recruiting
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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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-09-29.
Status change: Not Yet Recruiting → Recruiting 2025-11-25
Trial Details
NCT Number NCT07200206
Lead Sponsor Sanofi
Conditions Respiratory Syncytial Virus
Enrollment 3,000 participants
Start Date 2025-10-02
Primary Completion 2029-09-26 (estimated)
Study Completion 2029-09-26 (estimated)
Updated on ClinicalTrials.gov 2025-12-03