Respiratory Syncytial Virus
Conditions
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.
Interventions
BIOLOGICALNirsevimab
Route of Administration: Intramuscular Pharmaceutical Form: Solution for injection
Sponsors
Sanofi
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
0 Days to 24 Months
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurence of Adverse Events (AEs) | Up to 180 days post dose | Number of participants (and occurrences) experiencing AEs will be assessed. |
| Occurence of Serious Adverse Events (SAEs) | Up to 180 days post dose | Number of participants (and occurrences) experiencing SAEs will be assessed. |
| Occurrence of AE of special interest (AESI) | Up to 180 days post dose | 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 |
| Occurence of Adverse Drug Reaction (ADRs) as Specified in Approved Local Label | Up to 180 days post dose | Number of participants (and occurrences) experiencing ADRs will be assessed. |
| Occurrence of Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Infection (LRTI) | Up to 180 days post dose | Number of participants (and occurrences) experiencing RSV LRTI will be assessed. |
Countries
South Korea
Contacts
Primary ContactTrial Transparency email recommended (Toll free for US & Canada)
Outcome results
None listed