A Study to Evaluate the Efficacy of Quadrivalent HPV Vaccine in Reducing the Incidence of HPV 6-, 11-, 16-, and 18-Related CIN, AIS, and Cervical Cancer, and HPV 6-, 11-, 16-, and 18-Related External Genital Warts, Vulvar Intraepithelial Neoplasia Vaginal Intraepithelial Neoplasia, Vulvar Cancer, and Vaginal Cancer in 16- to 23-Year-Old Women
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 5,759
- 主要终点
- Incidence of HPV 6/11/16/18-related Cervical Intraepithelial Neoplasia (CIN)(Any Grade), Adenocarcinoma In Situ (AIS) or Cervical Cancer
研究概览
简要总结
The primary purpose of the study is to determine if GARDASIL (V501) with four components is able to prevent cervical cancer, cervical dysplasia, including Cervical Intraepithelial Neoplasia (CIN)(Any Grade) and Adenocarcinoma In Situ (AIS), and genital warts.
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 23 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female with an intact uterus with lifetime history of 0-4 sexual partners
排除标准
- •Prior Human Papillomavirus (HPV) vaccination
- •Prior abnormal paps
- •History of genital warts
研究组 & 干预措施
1
V501
干预措施: V501 (Biological)
2
Placebo
干预措施: Comparator: Placebo (Biological)
3
HPV 16 Monovalent Vaccine
干预措施: Human Papillomavirus (HPV) 16 Monovalent (Biological)
结局指标
主要结局
Incidence of HPV 6/11/16/18-related Cervical Intraepithelial Neoplasia (CIN)(Any Grade), Adenocarcinoma In Situ (AIS) or Cervical Cancer
时间窗: Follow-up through end of study (4 years)
Incidence of HPV 6/11/16/18-related External Genital Lesions (EGL) [Genital Warts, Vulvar/Vaginal Intraepithelial Neoplasia (Any Grade), Vulvar/Vaginal Cancer]
时间窗: Follow-up through end of study (4 years)
次要结局
未报告次要终点