Korean Post Marketing Surveillance for Comirnaty Injection
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Pfizer
- 入组人数
- 660
- 试验地点
- 1
- 主要终点
- Number of subjects with Solicited adverse events
研究概览
简要总结
This study is to identify any problems and questions with respect to the safety of Comirnaty Injection (Bretovameran) during the post-marketing period.
详细描述
All assessments are performed as part of normal clinical practice or standard practice guidelines for the subject population and healthcare provider specialty in the countries where this non-interventional study is being conducted.
This study is conducted under normal clinical practice in accordance with regulatory requirements. Therefore, the inclusion and exclusion criteria for study subjects are related to indications and contraindications outlined in the local product document. This study will not provide or make recommendations on any vaccine use. The vaccines are all given as part of the standard of care. All enrolled subjects have to meet the general prescription criteria for Comirnaty Injection (Bretovameran) according to the local product document and have to be enrolled at the doctor's discretion.
This is an open-label, non-comparative, non-interventional, prospective, and multi-center study conducted in Korean health care centers by accredited physicians (investigator). The study population is Korean subjects who are scheduled for COVID-19 vaccination. Comirnaty Injection (Bretovameran) will be administered according to the "Dosage and Administration" of the authorized label. There is no visit or activity mandated by this study. The investigator will collect data from the subject's medical records and diary and record data on each subject's case report form (CRF).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Korean subjects who are eligible for administration of Comirnaty Injection according to the locally authorized label
- •Subjects with evidence of a personally signed and dated informed consent/assent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study
排除标准
- •Subjects who involved in the contraindications of use indicated in the locally authorized label
- •Subjects with a history of hypersensitivity to any ingredients of this product or this product
- •Any subjects (or a legally acceptable representative) who does not agree that Pfizer and companies working with Pfizer use his/her information
研究组 & 干预措施
Bretovameran
Korean subjects who are eligible for administration of Comirnaty Injection (Bretovameran) according to the locally authorized label
干预措施: Bretovameran (Biological)
结局指标
主要结局
Number of subjects with Solicited adverse events
时间窗: 1 week after administration of Comirnaty Injection (Bretovameran)
Solicited adverse events within 1 week after each dose of Comirnaty Injection (Bretovameran) and the number of subjects with such events will be collected.
Number of subjects with Unsolicited adverse events
时间窗: 28 days after administration of Comirnaty Injection (Bretovameran)
Unsolicited adverse events within 28 days after each dose of Comirnaty Injection (Bretovameran) and the number of subjects with such events will be collected.
次要结局
- Number of subjects with Adverse events (AEs)(28 days after administration of Comirnaty Injection (Bretovameran))
- Number of subjects with Serious Adverse Events (SAEs)(28 days after administration of Comirnaty Injection (Bretovameran))
- Number of subjects with Expected Adverse Events(28 days after administration of Comirnaty Injection (Bretovameran))
- Number of subjects with Unexpected Adverse Events(28 days after administration of Comirnaty Injection (Bretovameran))
- Number of subjects with Adverse Drug Reactions(28 days after administration of Comirnaty Injection (Bretovameran))
- Number of subjects with Serious Adverse Drug Reactions(28 days after administration of Comirnaty Injection (Bretovameran))
- Number of subjects with Expected Adverse Drug Reactions(28 days after administration of Comirnaty Injection (Bretovameran))
- Number of subjects with Unexpected Adverse Drug Reactions(28 days after administration of Comirnaty Injection (Bretovameran))