Status:
RECRUITING
A Post-marketing Surveillance Study of Beyfortus (Nirsevimab) in Republic of Korea
Lead Sponsor:
Sanofi
Conditions:
Respiratory Syncytial Virus
Eligibility:
All Genders
Up to 24 years
Brief 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 e...
Eligibility Criteria
Inclusion
- Children up to 24 months of age who received Beyfortus according to the approved indications.
- Informed consent signed by the parents / legally accepted representatives (LARs) of the participant.
Exclusion
- Participation at the time of study enrollment (or in the 4 weeks preceding the enrollment) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device or a medical procedure.
- Any contraindications according to the approved local product label of Beyfortus.
Key Trial Info
Start Date :
October 2 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 26 2029
Estimated Enrollment :
3000 Patients enrolled
Trial Details
Trial ID
NCT07200206
Start Date
October 2 2025
End Date
September 26 2029
Last Update
December 3 2025
Active Locations (1)
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1
Nam Seung Woo Pediatric: 4100007
Hwaseong-si, Gyeonggi-do, South Korea, 18478