临床试验/NCT00092521

NCT00092521已完成3 期

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

Merck Sharp & Dohme LLC0 个研究点目标入组 5,759 人开始时间: 2001年12月最近更新: 2015年9月25日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: Merck Sharp & Dohme LLC
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

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

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

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

研究者

发起方

Merck Sharp & Dohme LLC

申办方类型

Industry

责任方

Sponsor

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