NCT01137435已完成4 期
Regulatory Post-Marketing Surveillance (PMS) Study for ADACEL™ (Adsorbed Diphtheria, Tetanus Toxoids and Component Pertussis Combined Vaccine for Adult)
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 659
- 试验地点
- 2
- 主要终点
- Summary of Adverse Events Reported in Participants That Received a Single Intramuscular Dose of Adacel™
研究概览
简要总结
This safety surveillance study is being conducted in accordance with Korea Food and Drug Administration (KFDA) Notification No. 2009-46 "Basic standard for reexamination of new drug".
The study objective is to assess within 30 days post-administration, the safety of ADACEL™ administered under the real clinical practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 11 Years 至 64 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who are 11 through 64 years of age (as indicated in the currently approved local product labeling) , who are given a single dose of the study vaccine, during a routine health-care visit, as active booster immunization for the prevention of tetanus, diphtheria and pertussis.
- •Written informed consent obtained from the subject. For subjects below the legal age of consent, written informed consent must be obtained from the parent or legal guardian (legally acceptable representative -LAR) of the subject.
排除标准
- 未提供
研究组 & 干预措施
Study Group
Experimental
干预措施: ADACEL™:Adsorbed Diphtheria, Tetanus Toxoids and Component Pertussis Combined (Biological)
结局指标
主要结局
Summary of Adverse Events Reported in Participants That Received a Single Intramuscular Dose of Adacel™
时间窗: 30 days post-vaccination
All adverse event reported by vaccinated subjects within 30 days post-vaccination during the 6 year post marketing surveillance period.
次要结局
未报告次要终点
研究者
研究点 (2)
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