Study of the Efficacy of Candidate HPV 16/18 VLP Vaccine in the Prevention of HPV-16 and/or HPV-18 Cervical Infection in Adolescent & Young Adult Women in North America and Brazil Vaccinated in Primary Study 580299/001
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 776
- 试验地点
- 28
- 主要终点
- Incident cervical infection with HPV-16 and/or HPV-18
研究概览
简要总结
Human Papilloma virus (HPV) are viruses that cause a common infection of the skin and genitals in men and women. Several types of HPV infection are transmitted by sexual activity and, in women, can infect the cervix (part of the uterus or womb). This infection often goes away by itself, but if it does not go away (this is called persistent infection), it can lead in women over a long period of time to cancer of the cervix. If a woman is not infected by HPV, it is very unlikely that she will get cervical cancer. This is an observer blind follow up study of the study HPV-001, which evaluated the ability of the HPV vaccine to prevent HPV infection. The current study invites all of the 1113 subjects in the HPV-001 study that received all three doses of vaccine/placebo to be enrolled and followed-up for several additional years to see if the HPV vaccine prevents HPV-16 and HPV-18 infections and to evaluate the safety of the vaccine. Subjects will remain in the same study group as in the primary study. No vaccine or placebo will be administered in this study.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 30 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Participated in study 580299/001 and received all three doses of vaccine/placebo.
- •Written informed consent obtained from the subject prior to enrollment
排除标准
- •Decoding of the subject's treatment allocation to either the subject or the investigator in study 580299/001.
结局指标
主要结局
Incident cervical infection with HPV-16 and/or HPV-18
次要结局
- Persistent cervical infection (6-month definition) with HPV 16 and/or HPV 18.
- Persistent cervical infection (6-month definition) with oncogenic HPV types.
- Incident cervical infection with oncogenic HPV types.
- Histopathologically-confirmed CIN 1+ or CIN 2+ associated with HPV 16 and/or HPV 18 detected within the lesional component of the cervical tissue specimen.
- Histopathologically-confirmed CIN 1+ or CIN 2+ associated with oncogenic HPV types detected within the lesional component of the cervical tissue specimen.
- Abnormal cytology associated with an HPV-16 and/or HPV-18 cervical infection.
- Abnormal cytology associated with oncogenic HPV type cervical infection.