EUCTR2012-001453-74-AT进行中(未招募)1 期
Comparison of vaccination routes:subcutaneus versus intramuscular application of FSME-Immun® - FSME_RV_im/sc
Institute of Specific Prophylaxis and Tropical Medicine0 个研究点开始时间: 2012年4月11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
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
- •completed primary TBE immunization + at least one booster immunization
- •adults of both sexes between 18 and 60 years of age
- •willingness to sign written informed consent form
- •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 116
- •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
- •proir TBE infection
- •pregnancy and breast feeding
- •acute infection on day of inclusion (day 0), (body temperature > 37,9°C)
- •concomitant medications: systemic cortison therapy, chemotherapy, immunesuppressive therapy 4 weeks prior to or during study
- •administration of other vaccines 4 weeks before/after day 0
- •planned surgery within 2 weeks before/after TBE booster vacciantion
- •spezific immunotherapy (Hypo-/Desensibilisierung) 14 days before/after vaccination
- •any contraindication to adminstration of FSME-Immun® vaccine according to manufacturer's instructions
- •history of malignant disease within the last 5 years
- •autoimmune diseases
- •drug addictions
- •plasma donors
- •receipt of blood transfusions or immuno globulins within 3 month before study entry
研究者
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