EUCTR2016-002894-36-AT进行中（未招募）1 期
An open, monocentric, uncontrolled phase 4 trial to characterise cellular and humoral immune responses following the first booster immunisation with the inactivated, purified Japanese Encephalitis vaccine IXIARO® in elderly compared to young individuals. - Immune responses after a booster immunisation with IXIARO® in elderly compared to young individuals.
Medical University of Vienna (MUW)0 个研究点目标入组 64 人开始时间: 2017年11月20日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 64
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- participation in the preceeding study IXIARO®-senescence (EudraCTno: 2010-018630-52) without protocoll violation OR 2 documented IXIARO® vaccinations 28 days (-8/+ 30 days) apart between January 2010 and April 2014 at the age of 18 to 40 years or above the age of 60.
- •-good state of health including individuals with medically controlled minor underlying disease (such as hypertension, hypercholesterinemia, NIDDM)
- •-willingness to sign written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 32
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 32
排除标准
- •- Already received an booster (3rd dose) of IXIARO ®
- •- past infection with the JEV
- •- yellow fever vaccination within the last 6 months
- •- TBE vaccination within the last 30 days
- •- current acute infection
研究者
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