A Post-marketing Surveillance Study of Beyfortus (Nirsevimab) in Republic of Korea
Recruiting
Observational Study
Respiratory Syncytial Virus
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 0 Days – 24 Months
- Sex
- Any
- Study type
- Observational
- Participants needed
- 3,000 (estimated)
- Sponsor
- Sanofi · Industry
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About This Trial
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 pa…
Trial Locations
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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…
Contacts
Trial Transparency email recommended (Toll free for US & Canada)
800-633-1610
CONTACT