NCT00365443撤回2 期
Proprietary Information - Exploratory (Non-Confirmatory) Trial
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Proprietary Information - Exploratory (Non-Confirmatory) Trial
研究概览
简要总结
This study is to evaluate an investigational vaccine with the following objectives: (1) To demonstrate prevention of cervical, vulvar, and vaginal cancers and related precancers, external genital lesions, and persistent infection caused by the HPV types in the study vaccine, (2) To demonstrate that the vaccine is well-tolerated in women, (3) To evaluate vaccine immune responses in women.
This is an early phase trial and some specific protocol information is proprietary and not publicly available at this time. (Full information is available to trial participants).
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
- 16 Years 至 26 Years(Child, Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female, between the ages of 16 and 26
排除标准
- •History of an abnormal PAP test or abnormal cervical biopsy result
- •History of external genital/vaginal warts
- •History of positive HPV test
- •Currently a user of any illegal drugs or an alcohol abuser
- •Are pregnant
- •Currently enrolled in another clinical trial
- •Currently has or has a history of certain medical conditions or is currently taking or has taken certain medications (details will be discussed at the time of consent).
结局指标
主要结局
Proprietary Information - Exploratory (Non-Confirmatory) Trial
次要结局
- Proprietary Information - Exploratory (Non-Confirmatory) Trial
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