Actively Recruiting
A Post-marketing Surveillance Study of Beyfortus (Nirsevimab) in Republic of Korea
Led by Sanofi · Updated on 2025-12-03
3000
Participants Needed
1
Research Sites
207 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Post-marketing Surveillance Study of Beyfortus (Nirsevimab) in Republic of Korea
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children up to 24 months of age who received Beyfortus according to the approved indications.
- Informed consent signed by the parents or legally accepted representatives of the participant.
You will not qualify if you...
- Participation in another clinical study involving vaccines, drugs, medical devices, or procedures within 4 weeks before enrollment or planned participation during this study.
- Any contraindications according to the approved local product label of Beyfortus.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Nam Seung Woo Pediatric: 4100007
Hwaseong-si, Gyeonggi-do, South Korea, 18478
Actively Recruiting
Research Team
T
Trial Transparency email recommended (Toll free for US & Canada)
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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