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RECRUITING
NCT07200206

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

Sponsor: Sanofi

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

Nirsevimab

Route of Administration: Intramuscular Pharmaceutical Form: Solution for injection

Locations (1)

Nam Seung Woo Pediatric: 4100007

Hwaseong-si, Gyeonggi-do, South Korea