Regulatory Post-Marketing Surveillance (PMS) Study for AVAXIM 160U (Hepatitis A Vaccine)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 614
- 主要终点
- Safety profile in terms of solicited and unsolicited adverse events following the administration of AVAXIM 160U vaccine
研究概览
简要总结
This safety surveillance study is being conducted in accordance with Korea Food and Drug Administration (KFDA) "Basic standard for reexamination of new drug".
Primary objective:
- To assess the safety of AVAXIM 160U (Hepatitis A vaccine) administered under the routine practice, according to Korea Food and Drug Administration "Basic standard for reexamination of new drug" based on the pharmaceutical law in Korea.
详细描述
The study will be conducted under the real clinical practices in accordance with Korea Food and Drug Administration "Basic standard for reexamination of new drug".
No vaccine will be provided and/or administered as part of this protocol, however only participants that has received AVAXIM 160U vaccine administered under the routine practice according to Summary of Product Characteristics will be part of the surveillance.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects aged 16 years and older
- •Informed consent signed by the subject and by parent or legal representative for subject aged 16 to 19 years
- •Informed consent sign by subject for subject aged of 20 year of age and older
- •Receipt of AVAXIM 160U according to Summary of Product Characteristics (SmPC).
排除标准
- •Contraindications to vaccination according to AVAXIM 160U Summary of Product Characteristics (SmPC)
- •Subject is known to be pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be pre-menarche or post-menopausal for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence for at least 4 weeks prior to the vaccination until at least 4 weeks after)
结局指标
主要结局
Safety profile in terms of solicited and unsolicited adverse events following the administration of AVAXIM 160U vaccine
时间窗: Day 0 up to 30 Days post-vaccination
Solicited injection site: Pain, Erythema, and Swelling: Solicited Systemic Reactions: Fever (temperature), headache, and myalgia. Unsolicited averse events including non serious and serious adverse events.
次要结局
未报告次要终点