NCT00812071已完成1 期
Phase 1 Study of the Safety and Immunogenicity of RiVax With Alum in Healthy Adults
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- assess the safety of 3 dose levels
研究概览
简要总结
Dose escalation study: 3 dose groups. 5 patients in each dose group, then 15 more patients in "best" group. 3 vaccinations in volunteers, at 0 6 and 16 weeks.
详细描述
Final report was submitted to Dr. Karen Russell at FDA, Rockville on September 26, 2012.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 31 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy volunteers aged 18-31, m or f
排除标准
- •immunodeficiency
- •chronic disease
- •parental IgG
- •abnormal labs
结局指标
主要结局
assess the safety of 3 dose levels
时间窗: one year
次要结局
- determine the immunogenicity of the 3 dose levels(one year)
研究者
Ellen Vitetta
Director
University of Texas Southwestern Medical Center
研究点 (2)
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