NCT03431246已完成3 期
Persistance of Anti-HPV After a Single Dose of Gardasil and the Effect of a Dose of Gardasil-9 When Administered 3-8 Years Later
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Anti-HPV seropositivity
研究概览
简要总结
This study will assess the immunogenicity of one dose of Gardasil and one dose of Gardasil-9
详细描述
This is a one group exploratory study.
The main objective of this study is to assess the persistance of anti-HPV after a single dose Gardasil and the effect of one dose of Gardasil-9 when administered 3-8 years later.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Have received a single dose of Gardasil 3-8 years before recruitement.
排除标准
- •Immunossupressed or blood coagulation problems
研究组 & 干预措施
Gardasil and Gardasil-9
Experimental
干预措施: Gardasil and Gardasil-9 (Biological)
结局指标
主要结局
Anti-HPV seropositivity
时间窗: One month post vaccine administration.
Seropositivity to 9 HPV types included in Gardasil-9 vaccine will be assessed.
次要结局
- HPV antibody titers(One month post vaccine administration)
研究者
Vladimir Gilca
Medical Epidemiologist
Laval University
研究点 (2)
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