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临床试验/NCT01565577
NCT01565577已完成3 期

Phase 3, Vaccinal Activity Assessment of MenBVac Against Nesseiria Menigitidis B:14,P1.7,16 Strain in Child Vaccinated With MenBVac®

University Hospital, Rouen2 个研究点 分布在 1 个国家目标入组 117 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
117
试验地点
2
主要终点
vaccine Immunity

研究概览

简要总结

This study aims to estimate the vaccinal immunity four years after four doses of MenbVac in children aged 4-8 years.

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
7 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • children born between 01/01/2000 and 06/23/2005, living in Dieppe-Est, Dieppe-Ouest and Offranville, vaccinated with four doses of MenBVac in the first MenbVac clinical trial study,
  • parental authority(ies)assent.

排除标准

  • no parental authority(ies)assent,
  • no parental authority(ies)assent,
  • no blood sample during the third vaccination,
  • impossibility of third vaccination.

研究组 & 干预措施

Bras A

Experimental

干预措施: MenbVac (Biological)

结局指标

主要结局

vaccine Immunity

时间窗: two and a half years after the fouth vaccination

assessment of vaccine Immunity with measure of percentage of children with an hSBA title \>= 4 four years after four doses of MenbVac

次要结局

未报告次要终点

研究者

发起方
University Hospital, Rouen
申办方类型
Other
责任方
Sponsor

研究点 (2)

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