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
This trial accepts healthy volunteersQualifiers
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 population
Children up to 24 months of age who are scheduled to receive Beyfortus according to the approved indications will be selected as participants under the real-world clinical practice settings during the surveillance period after the contract date at the institution. The participants must meet all study inclusion criteria and must not meet any of the study exclusion criteria.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Nirsevimab
Biological/VaccineRoute of Administration: Intramuscular Pharmaceutical Form: Solution for injection
Treatment groups
3,000 Participants
are divided into 1 treatment groupGroup A: Cohort 11 intervention
Trial outcomes
Primary outcomes
1
Occurence of Adverse Events (AEs)
Number of participants (and occurrences) experiencing AEs will be assessed.
Time frame
Up to 180 days post dose2
Occurence of Serious Adverse Events (SAEs)
Number of participants (and occurrences) experiencing SAEs will be assessed.
Time frame
Up to 180 days post dose3
Occurrence of AE of special interest (AESI)
Number of participants (and occurrences) experiencing AESI will be assessed. The definition of AESI is as follow: 1. Hypersensitivity, including anaphylaxis 2. Immune complex disease 3. Thrombocytopenia
Time frame
Up to 180 days post dose4
Occurence of Adverse Drug Reaction (ADRs) as Specified in Approved Local Label
Number of participants (and occurrences) experiencing ADRs will be assessed.
Time frame
Up to 180 days post doseLocations
1Map coordinates are unavailable for these locations. Locations are shown below instead.
Nam Seung Woo Pediatric: 4100007Recruiting18478, Hwaseong-si, Gyeonggi-doSouth Korea
Source ClinicalTrials.gov