NCT07200206 A Post-marketing Surveillance Study of Beyfortus (Nirsevimab) in Republic of Korea
| NCT ID | NCT07200206 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sanofi |
| Condition | Respiratory Syncytial Virus |
| Study Type | OBSERVATIONAL |
| Enrollment | 3,000 participants |
| Start Date | 2025-10-02 |
| Primary Completion | 2029-09-26 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 3,000 participants in total. It began in 2025-10-02 with a primary completion date of 2029-09-26.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Trial Transparency email recommended (Toll free for US & Canada)
✉ Contact-US@sanofi.com📞 800-633-1610
Frequently Asked Questions
Who can join the NCT07200206 clinical trial?
This trial is open to participants of all sexes, aged 0 Days or older, up to 24 Months, studying Respiratory Syncytial Virus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07200206 currently recruiting?
Yes, NCT07200206 is actively recruiting participants. Contact the research team at Contact-US@sanofi.com for enrollment information.
Where is the NCT07200206 trial being conducted?
This trial is being conducted at Hwaseong-si, Gyeonggi-do, South Korea.
Who is sponsoring the NCT07200206 clinical trial?
NCT07200206 is sponsored by Sanofi. The trial plans to enroll 3,000 participants.