A Prospective, Single-arm, Non-interventional, Multi-center, Post-marketing Surveillance Study of Beyfortus (Nirsevimab) in Republic of Korea
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Sanofi
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- Occurence of Adverse Events (AEs)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 0 Days 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Cohort 1
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.
干预措施: Nirsevimab (Biological)
结局指标
主要结局
Occurence of Adverse Events (AEs)
时间窗: Up to 180 days post dose
Number of participants (and occurrences) experiencing AEs will be assessed.
Occurence of Serious Adverse Events (SAEs)
时间窗: Up to 180 days post dose
Number of participants (and occurrences) experiencing SAEs will be assessed.
Occurrence of AE of special interest (AESI)
时间窗: 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
时间窗: 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)
时间窗: Up to 180 days post dose
Number of participants (and occurrences) experiencing RSV LRTI will be assessed.
次要结局
未报告次要终点