NCT02009800已完成3 期
ICI-VPH: Impact Des Calendriers d'Immunisation Contre Les HPV
CHU de Quebec-Universite Laval4 个研究点 分布在 1 个国家目标入组 3,364 人开始时间: 2013年11月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 3,364
- 试验地点
- 4
- 主要终点
- Incidence of persistent HPV-16/18 infections
研究概览
简要总结
This randomised clinical trial aims to determine whether an immunization schedule comprising two doses of Gardasil administered six months apart is non-inferior to a schedule comprising three doses administered at 0, 6 and 60 months for the prevention of HPV-16 and HPV-18 infections that persist for at least six months, up to ten years after the initial vaccination.
The study hypothesis is that the two-dose schedule would offer similar protection as that of a three-dose schedule against persistent HPV-16/18 infections.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 14 Years 至 16 Years（Child）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Having received two doses of Gardasil in 2008-2009, 2009-2010,2010-2011 or 2011-2012 according to 0, 6 months Schedule (between 4 and 12 months)
- •Resident of the regions chosen for the study
排除标准
- •Being considered immunosuppressed at time of vaccination (9-10 years-old) or at recruitment visit
- •Being pregnant at recruitment visit
结局指标
主要结局
Incidence of persistent HPV-16/18 infections
时间窗: 5 years after recruitment visite
次要结局
- Geometric mean titres of antibodies and seropositivity for HPV types 6, 11, 16 and 18(5 years after recruitment visit)
研究者
Chantal Sauvageau
Co-principal investigator
CHU de Quebec-Universite Laval
研究点 (4)
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