NCT00092482已完成3 期
Immunogenicity and Safety of Gardasil (V501) Quadrivalent HPV (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) Vaccine in Consistency Lots for 16- to 23-Year-Old Women With and Additional Immunogenicity Bridge to the Monovalent HPV 16 Vaccine Pilot Manufacturing Lot Study-The F.U.T.U.R.E. Study (Females United to Unilaterally Reduce Endo/Ectocervical Disease)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 3,882
- 主要终点
- Tolerability and immune responses at week 4 post dose 3.
研究概览
简要总结
The purpose of the study is to determine if an investigational vaccine with a single component develops an immune response that is similar to the equivalent investigational vaccine with four components to reduce cervical disease.
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 Vaccine (HPV) vaccination;
- •Prior abnormal paps;
- •Prior history of genital warts
结局指标
主要结局
Tolerability and immune responses at week 4 post dose 3.
次要结局
未报告次要终点
研究者
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