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

Sanofi

Status: Enrolling

Conditions: Respiratory Syncytial Virus

Treatments: Biological: Nirsevimab

Study type: Observational

Funder types: Industry

Identifiers

NCT07200206

VAS00011 (Other Identifier)

U1111-1316-0081 (Registry Identifier)

Details and patient eligibility

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.

Enrollment: 3,000 estimated patients

Sex: All

Ages: Under 24 months old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

3,000 participants in 1 patient group

Cohort 1

Description:

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.

Treatment:

Biological: Nirsevimab