NCT00520598已完成2 期
A Phase IIa Randomized, Double-Blind Controlled With Gardasil, Clinical Trial to Study theTolerability and Immunogenicity of V505 (a Multivalent Human Papilloma Virus [HPV] L1 Virus Like Particle [VLP] Vaccine) in Healthy 16 to 26 Year Old Women
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 511
- 主要终点
- Geometric mean titers (GMTs) to HPV types contained in the vaccines administered in a 3-dose regimen
研究概览
简要总结
The purpose of this study is to evaluate the safety and immunogenicity of V505 in comparison to GARDASIL (TM)
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 (Participant, Investigator)
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 16 to 26 years old
- •Has never had Pap testing or have only had normal Pap test results
- •Lifetime history of 0 to 4 sexual partners
排除标准
- •History of an abnormal cervical biopsy result; History of a positive test for HPV; History of external genital/vaginal warts; Currently a user of any illegal drugs or an alcohol abuser
- •History of severe allergic reaction that required medical attention
- •Are pregnant
- •Received a marketed HPV vaccine
- •Currently enrolled in a 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 time of consent)
结局指标
主要结局
Geometric mean titers (GMTs) to HPV types contained in the vaccines administered in a 3-dose regimen
时间窗: 4 weeks post dose 3
次要结局
- Geometric mean titers (GMTs) to HPV types contained in the vaccines administered in a 2-dose regimen(4 weeks post dose 2)
研究者
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