NCT01398540已完成4 期
Characterisation of Cellular and Humoral Immunity in Elderly People After Immunization With a Purified, Inactivated Japanese Encephalitis Vaccine.
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 主要终点
- cellular immunity (cytokine production upon stimulation with Japanese Encephalitis (JE) Virus Antigen) 7 days after the 2. JE-vaccination
研究概览
简要总结
The aim of this project is to investigate humoral and cellular immune responses before and after immunisation with the Japanese encephalitis vaccine IXIARO in subjects above 60 years of age and 18-40 years old subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •adults (18-40 years old)
- •adults (≥60 years),
- •both sexes
- •willingness to sign written informed consent form
排除标准
- •age below 18 years or between 41-59 years old
- •status post japanese encephalitis, tick born encephalitis (TBE), dengue, yellow fever or West Nile virus infection
- •previous immunization against yellow fever, japanese encephalitis (dengue or WNV)
- •current acute infection (body temperature above 37,9°C)
研究组 & 干预措施
young
Experimental
subjects 18 to 40 years old, receiving 2 immunisations with IXIARO
干预措施: IXIARO (Biological)
elderly
Experimental
subjects are at least 60 years old (with no upper age limit), receiving 2 immunisations with IXIARO
干预措施: IXIARO (Biological)
结局指标
主要结局
cellular immunity (cytokine production upon stimulation with Japanese Encephalitis (JE) Virus Antigen) 7 days after the 2. JE-vaccination
时间窗: 7 days after the 2 JE vaccinations
次要结局
未报告次要终点
研究者
Univ. Prof. Dr. Ursula Wiedermann
Univ.Prof. MD, PhD
Medical University of Vienna
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