EUCTR2016-003124-23-AT进行中（未招募）1 期
Induction of Cross-neutralizing Antibodies After Primary Vaccination With Two Different Tick- borne Encephalitis Virus Vaccines - Induction of Cross-neutralizing Antibodies After Primary Vaccination With Two Different Tick- borne
Medical University of Vienna, ISPTM0 个研究点目标入组 60 人开始时间: 2016年8月10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
- 60
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
- •Male and female subjects will be eligible for participation in this study if they:
- •Are healthy adults, aged >18 – <50 years of age, who are naïve towards west-nile virus (WNV), yellow fever virus (YFV), Japanese encephalitis virus (JEV), Dengue viruses and TBE virus, i.e. who have never been either vaccinated against the above mentioned viral infections nor have had any of the mentioned diseases in their medical history.
- •Confirm willingness to comply with the study protocol by signing the 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 60
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects will not be eligible to participate in this study if any of the following apply:
- •Age < 18 or > 50 years
- •History of vaccination against WNV, YFV, JE, Dengue or TBE
- •History of a WNV, YFV, JE, Dengue or TBE infection
- •Contraindication against vaccination with a tick-borne encephalitis vaccine, according to the respective SmPC
- •Pregnancy or breast feeding
- •Medication treatment influencing the immune system: e.g. systemic corticoids (> 20mg/d), immunotherapy (e.g. allergy), chemotherapy, immunosuppressive drugs within 4 weeks of study start or during the study
- •Other vaccinations within 4 weeks of study start till 4 weeks after the second vaccination and 4 weeks before till 4 weeks after the third vaccination
- •Any surgery, requiring hospitalization, within 4 weeks of study start and/or planned surgery during the study
- •Severe medical condition requiring hospitalization within 3 months of study start
- •Any current malignancy within 5 years of study start
- •Autoimmune disease²
- •Progressive, unstable or uncontrolled clinical conditions
- •Abuse disorder (abuse of drug, alcohol, chemical or psychoactive substance) or mental disability
- •Receipt of plasma, blood or blood products, as well as immunoglobulins within 3 months of study start and during the study
- •Plasma, blood and blood product donation within 3 months of study start and during the study
- •Concomitant participation in another clinical trial
- •Employee of the study center with direct study involvement or family member of the Investigator or employee with direct study involvement
研究者
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