Post-Marketing Safety Study of Beyfortus Nirsevimab Injection in Korean Children Up to 24 Months Old

What this Trial Is About

This research aims to evaluate the safety of Beyfortus Nirsevimab in children up to 24 months old in South Korea. It is conducted as part of a local risk management plan to collect real-world safety information on Beyfortus when used according to approved indications. The study focuses on children who have received Beyfortus in regular clinical practice and is sponsored by Sanofi. Participants in this single-arm, non-interventional study will be children up to 24 months of age who are scheduled to receive Beyfortus via intramuscular injection as per approved guidelines. The study does not assign treatments but observes children receiving Beyfortus naturally during clinical care. Follow-up will continue for 180 days after the administration of Beyfortus to monitor safety. During the study, participants will be monitored for adverse events, serious adverse events, adverse events of special interest, adverse drug reactions as noted in the product label, and occurrences of respiratory syncytial virus lower respiratory tract infection. Data will be collected through clinical practice visits over the 180-day follow-up period. The study aims to gather comprehensive safety information under real-world conditions for up to nearly four years.

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