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

Recruiting now

Conditions studied: Respiratory Syncytial Virus

In brief

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.

Key facts

Study ID

NCT07200206

Run by

Sanofi

People needed

3000

Starts

2025-10-02

Expected to finish

2029-09-26

Last updated by the study team

2025-12-03

Who can join

Age: any, up to 2. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Nam Seung Woo Pediatric: 4100007 — Hwaseong-si, Gyeonggi-do, South Korea (enrolling)

Full record on ClinicalTrials.gov

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