NCT00517309已完成3 期
Immunogenicity and Safety of Quadrivalent HPV L1 Virus-Like Particle (VLP) Vaccine in 16- to 23-Year-Old Women When Administered Alone or Concomitantly With Hepatitis B Vaccine (Recombinant)--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
- 1,877
- 主要终点
- Quadrivalent HPV vaccine is generally well tolerated when administered alone or concomitantly with hepatitis B vaccine.
研究概览
简要总结
The primary purpose of the study is to test the safety of HPV Vaccine in Women
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
- •Females age 16 to 23 years old
- •Must agree to refrain from sexual activity (vaginal or anal) for 48 hours prior to any scheduled visit
排除标准
- •History of vaccination with an HPV vaccine
- •History of hepatitis B infection
- •History of vaccination with hepatitis B vaccine
- •History of genital warts or treatment for genital warts
结局指标
主要结局
Quadrivalent HPV vaccine is generally well tolerated when administered alone or concomitantly with hepatitis B vaccine.
次要结局
- HPV vaccine is well tolerated in 16-23 year old females.
研究者
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