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

NCT07200206 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 3000

Last updated 2025-12-03

No results posted yet for this study

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

Interventions

BIOLOGICAL

Nirsevimab

Route of Administration: Intramuscular Pharmaceutical Form: Solution for injection

Sponsors & Collaborators

Eligibility

Min Age
0 Days
Max Age
24 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-10-02
Primary Completion
2029-09-26
Completion
2029-09-26
FDA Drug
Yes

Countries

  • South Korea

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07200206 on ClinicalTrials.gov