NCT01621945已完成3 期
Phase 3, Vaccinal Activity Assessment of MenBVac Against Neisseria Meningitidis B:14,P1.7,16 Strain in Child
University Hospital, Rouen2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2012年4月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Vaccine Immunity
研究概览
简要总结
The main objective of the study is to estimate the proportion of children, born between the 06/04/2004 and the 17/004/2008, living around Neufchatel en Bray, vaccinated by MenBVac, with a serum bactericidal activity against B:14,P1-7,16 clone related to a protection (>= 4), before the fourth dose of MenBvac and after: 6 weeks and one year after the fourth dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •children born between 06/04/2004 and 17/04/2008, living in Neufchatel en Bray,and Having participated to the first study,
- •children who Have to be Vaccinated MenBVac® for the four times,
- •parental authority(ies)assent.
排除标准
- •no parental authority(ies)assent,
- •no blood sample,
- •impossibility of fourth vaccination,
- •children yet vaccinated or non eligible for vaccination.
研究组 & 干预措施
Bras A
Experimental
children, born between the 06/04/2004 and the 17/04/2008, living around Neufchatel en Bray, before the fourth dose of MenBVac
干预措施: MenBvac (Biological)
结局指标
主要结局
Vaccine Immunity
时间窗: after the fourth dose of MenbVac
Assessment of vaccine Immunity with measure of percentage of children who have hSBA title \>= 4 six weeks after the fourth dose of vaccine
次要结局
未报告次要终点
研究者
研究点 (2)
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