NCT00189943已完成1 期
Phase I Study on Safety, Tolerability and Immunogenicity of the MVA-BN Vaccine Administered to Healthy Subjects
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
研究概览
简要总结
The purpose of this study is to collect information on the safety, tolerability and immunogenicity of an investigational smallpox vaccine at different doses and using different routes of administration in vaccinia-naive and vaccinated healthy volunteers
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male subjects, aged 20 - 55 years
- •Signed informed consent
排除标准
- •Prior vaccination against smallpox (study part I only)
- •Abnormalities suspicious of any underlying disease, detected at routine tests prior to study inclusion.
- •Any immune modifying therapy within 4 weeks prior to entry
- •Participation in any other investigating drug trial
- •Known allergy to a component which may be part of the vaccine
- •Allergic reaction or any other severe adverse effects experienced after previous smallpox vaccination (study Part II only)
研究者
研究点 (2)
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