A Post-marketing Surveillance Study of Beyfortus (Nirsevimab) in Republic of Korea
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Nirsevimab.
- Who it may be relevant to
- Registry conditions: Respiratory Syncytial Virus. Basic parameters: 0 Days — 24 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Prospective, Single-arm, Non-interventional, Multi-center, Post-marketing Surveillance Study of Beyfortus (Nirsevimab) in Republic of Korea
Overview
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
- Biological Nirsevimab
Route of Administration: Intramuscular Pharmaceutical Form: Solution for injection
Primary outcome measures
- Occurence of Adverse Events (AEs) [Time frame: Up to 180 days post dose]
- Occurence of Serious Adverse Events (SAEs) [Time frame: Up to 180 days post dose]
- Occurrence of AE of special interest (AESI) [Time frame: Up to 180 days post dose]
- Occurence of Adverse Drug Reaction (ADRs) as Specified in Approved Local Label [Time frame: Up to 180 days post dose]
- Occurrence of Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Infection (LRTI) [Time frame: Up to 180 days post dose]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Other
Study locations
South Korea · 1 center
- Nam Seung Woo Pediatric: 4100007 — Hwaseong-si, Gyeonggi-do
Identifiers
NCT: NCT07200206 · VAS00011 · U1111-1316-0081