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

Not yet recruiting

• Conditions: Respiratory Syncytial Virus
• Interventions: Biological: Nirsevimab

• Registration Number: NCT07200206
• Lead Sponsor: Sanofi

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 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-29
• Study First Submitted QC: 2025-09-29
• Last Update Submitted: 2025-09-29
• Study Start: 2025-10-01
• Study First Posted: 2025-10-01
• Last Update Posted: 2025-10-01
• Primary Completion: 2030-04-29
• Study Completion: 2030-04-29

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

• 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 Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort 1	Nirsevimab	Children up to 24 months of age who are scheduled to receive Beyfortus according to the approved indications will be selected as participants under the real-world clinical practice settings during the surveillance period.

Primary Outcome Measures

Name	Time	Method
Occurence of Adverse Events (AEs)	Up to 180 days post dose	Number of participants (and occurrences) experiencing AEs will be assessed.
Occurence of Serious Adverse Events (SAEs)	Up to 180 days post dose	Number of participants (and occurrences) experiencing SAEs will be assessed.
Occurrence of AE of special interest (AESI)	Up to 180 days post dose	Number of participants (and occurrences) experiencing AESI will be assessed. The definition of AESI is as follow: 1. Hypersensitivity, including anaphylaxis; 2. Immune complex disease; 3. Thrombocytopenia
Occurence of Adverse Drug Reaction (ADRs) as Specified in Approved Local Label	Up to 180 days post dose	Number of participants (and occurrences) experiencing ADRs will be assessed.
Occurrence of Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Infection (LRTI)	Up to 180 days post dose	Number of participants (and occurrences) experiencing RSV LRTI will be assessed.