Real-world safety monitoring of Beyfortus (nirsevimab) in Korean infants and toddlers
A Prospective, Single-arm, Non-interventional, Multi-center, Post-marketing Surveillance Study of Beyfortus (Nirsevimab) in Republic of Korea
This program follows children up to 24 months in Korea who receive Beyfortus to see if the medicine is safe when used in routine care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 3000 (estimated) |
| Ages | 0 Days to 24 Months |
| Sex | All |
| Sponsor | Sanofi Industry-sponsored |
| Locations | 1 site (Hwaseong-si, Gyeonggi-do) |
| Trial ID | NCT07200206 on ClinicalTrials.gov |
What this trial studies
This post-marketing surveillance follows children up to 24 months who receive Beyfortus in routine clinical practice in the Republic of Korea. Investigators enroll infants given the approved dose per the local product label and obtain parental informed consent, then monitor participants for 180 days after administration for adverse events and other safety outcomes. Participants with contraindications per the product label or those enrolled in another clinical investigation within four weeks are excluded. Data are collected from clinical visits and routine care records to characterize safety in a real-world setting.
Who should consider this trial
Good fit: Ideal candidates are children in Korea up to 24 months of age who receive Beyfortus according to the approved indication and whose parent or legal representative provides informed consent.
Not a fit: Children with label contraindications, those enrolled in another interventional study within four weeks, or those older than 24 months are unlikely to receive benefit from participation.
Why it matters
Potential benefit: If successful, the surveillance could confirm Beyfortus's real-world safety in Korean children and increase clinician and parent confidence in its use.
How similar studies have performed: Randomized trials of nirsevimab have demonstrated reduced RSV lower respiratory tract infection in infants, and post-marketing safety monitoring is commonly performed to confirm findings in routine care.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Hwaseong-si, Gyeonggi-do
- Nam Seung Woo Pediatric: 4100007 — Hwaseong-si, Gyeonggi-do, South Korea (Recruiting)
Study contacts
- Study coordinator: Trial Transparency email recommended (Toll free for US & Canada)
- Email: Contact-US@sanofi.com
- Phone: 800-633-1610
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.