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临床试验/EUCTR2012-001453-74-AT
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

发起方
Institute of Specific Prophylaxis and Tropical Medicine

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