EUCTR2014-000570-19-AT进行中（未招募）1 期
Applikation of FSME-IMMUN® in obese persons
Institute of Specific Prophylaxis and Tropical Medicine0 个研究点目标入组 148 人开始时间: 2014年6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
- 148
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
- •willingness to sign written informed consent form
- •completed primary TBE immunization and at least 1 booster vaccination
- •participants of both sexes between 18 and 60 years of age
- •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 74
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •age < 18 and > 60 years
- •BMI 25-30
- •previous TBE infection
- •pregnancy or breast feeding
- •acute infection on day of inclusion (day 0) or at visit 5 (36 months), body temperature > 37,9°C
- •concomitant medications: systemic cortison therapy, chemotherapy, immunotherapy (allergy) immunsuppressive therapy 4 weeks prior or during the study
- •administration of other vaccines 4 weeks before/after day 0
- •planned surgery within 2 weeks before/after TBE booster
- •any contraindication to administration of FSME-Immun® vaccine according to manufacturer's instructions
- •malignant diseases within 5 years prior to the study
- •autoimmune diseases
- •kidney insufficiency, dialysis
- •drug addiction
- •plasma donor
- •receipt of blood transfusions or immunoglobulins within 3 months prior to study entry / within 3 months prior to visit 5
- •Severe disease with hospitalization or surgery 3 months before or during the study
研究者
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Unknown
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