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
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)
研究组 & 干预措施
1
Arm 1: 0.5 ml injection of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine as 3 dose regimen.
干预措施: Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (Biological)
2
Arm 2: 0.5 ml injection of V505 formulation 1 as 3 dose regimen.
干预措施: Comparator: V505 formulation 1 (Biological)
3
Arm 3: 0.5 ml injection of V505 formulation 2 as 3 dose regimen
干预措施: Comparator: V505 formulation 2 (Drug)
4
Arm 4: 0.5 ml injection of V505 formulation 2 as 2 dose regimen and 1 Pbo injection
干预措施: Comparator: V505 formulation 2 (Drug)
4
Arm 4: 0.5 ml injection of V505 formulation 2 as 2 dose regimen and 1 Pbo injection
干预措施: Comparator: Placebo (unspecified) (Biological)
5
Arm 5: 0.5 ml injection of V505 formulation 3 as 2 dose regimen and 1 Pbo injection
干预措施: Comparator: V505 formulation 3 (Biological)
5
Arm 5: 0.5 ml injection of V505 formulation 3 as 2 dose regimen and 1 Pbo injection
干预措施: Comparator: Placebo (unspecified) (Biological)
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)