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

NCT07200206 | Recruiting FDA Drug

• 2 other identifiers: VAS00011U1111-1316-0081
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Syncytial Virus

Outcome Measures

Primary Outcomes (5)

• Occurence of Adverse Events (AEs)

  Number of participants (and occurrences) experiencing AEs will be assessed.

  Up to 180 days post dose

• Occurence of Serious Adverse Events (SAEs)

  Number of participants (and occurrences) experiencing SAEs will be assessed.

  Up to 180 days post dose

• Occurrence of AE of special interest (AESI)

  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

  Up to 180 days post dose

• Occurence of Adverse Drug Reaction (ADRs) as Specified in Approved Local Label

  Number of participants (and occurrences) experiencing ADRs will be assessed.

  Up to 180 days post dose

• Occurrence of Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Infection (LRTI)

  Number of participants (and occurrences) experiencing RSV LRTI will be assessed.

  Up to 180 days post dose

Study Arms (1)

Cohort 1

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.

Biological: Nirsevimab

Interventions

Nirsevimab BIOLOGICAL

Route of Administration: Intramuscular Pharmaceutical Form: Solution for injection

Also known as: Beyfortus™

Cohort 1

Eligibility Criteria

• Age: 0 Days - 24 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

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 after the contract date at the institution. The participants must meet all study inclusion criteria and must not meet any of the study exclusion criteria.

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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Nam Seung Woo Pediatric: 4100007

Hwaseong-si, Gyeonggi-do, 18478, South Korea

RECRUITING

MeSH Terms

Interventions

nirsevimab

Central Study Contacts

Trial Transparency email recommended (Toll free for US & Canada)

CONTACT

800-633-1610; Contact-US@sanofi.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2025
• First Posted: October 1, 2025
• Study Start: October 2, 2025
• Primary Completion (Estimated): September 26, 2029
• Study Completion (Estimated): September 26, 2029
• Last Updated: December 3, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share

Locations

KR (1)