NCT00365716已完成2 期
A Placebo-Controlled, Dose-Ranging Study of Quadrivalent HPV Virus-Like Particle (VLP) Vaccine in 16- to 23-Year-Old Women
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 1,158
- 主要终点
- Number of Subjects With Injection Site Adverse Experiences
研究概览
简要总结
This study was conducted in 2 parts. Part A was a randomized, double-blind, placebo-controlled, multicenter, sequential dose-escalating evaluation. Part B was a randomized, double-blind (operating under in-house blinding procedures), placebo-controlled, multicenter, dose-ranging study.
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
- •Healthy females 16 to 23 years of age
- •Not pregnant at enrollment and must have agreed to use effective contraception through Month 7 of the study
- •Lifetime history of 0 to 4 male sexual partners (individuals with whom penetrative sexual intercourse occurred)
排除标准
- •No prior receipt of an Human Papillomavirus (HPV) vaccine
- •No receipt of inactivated or recombinant vaccines within 14 days prior to enrollment or receipt of live vaccines within 21 days prior to enrollment
- •No prior abnormal Pap test showing squamous intraepithelial lesion (SIL) or biopsy showing cervical intraepithelial neoplasia (CIN)
- •No prior history of genital warts or treatment for genital warts
结局指标
主要结局
Number of Subjects With Injection Site Adverse Experiences
时间窗: Days 1-5 following any vaccination visit
次要结局
- Incidence of HPV 6-, 11-, 16- or 18-related Persistent Infection or Disease (Cervical Intraepithelial Neoplasia, Vulvar Intraepithelial Neoplasia, Vaginal Intraepithelial Neoplasia, Adenocarcinoma in Situ, Cervical Cancer, and Genital Warts)(Through 36 Months)
研究者
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