EUCTR2015-003714-24-AT进行中（未招募）1 期
Phase 2 Clinical Trial of the BioMed rTSST-1 Variant Vaccine in Healthy Adults
Biomedizinische Forschung und Bio-Produkte AG0 个研究点目标入组 140 人开始时间: 2015年10月22日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 140
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •males or females aged 18-64 years
- •signed informed consent
- •physical exam: no abnormal findings unless considered irrelevant by the investigator
- •uneventful medical history
- •females with childbearing potential: adequate contraception
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 140
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •females with childbearing potential: pregnancy, lactation or unreliable contraception
- •positive HIV Ab and/or positive HCV Ab and/or positive HBsAG
- •signs and symptoms of autoimmunity
- •TSST-1 Ab titer > or = 1:1000
- •current or recent (< 1 month) immunosuppressive therapy with corticosteroids or immunomodulators
研究者
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