A Post-marketing Surveillance Study of Beyfortus (Nirsevimab) in Republic of Korea
ConditionRespiratory Syncytial Virus
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-24
SponsorSanofi
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 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
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Nirsevimab
Treatment groups
3,000 Participants
are divided into 1 treatment groupLocations
1Map coordinates are unavailable for these locations. Locations are shown below instead.
Nam Seung Woo Pediatric: 4100007Recruiting18478, Hwaseong-si, Gyeonggi-doSouth Korea
Sponsors and collaborators
Source ClinicalTrials.gov