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临床试验/EUCTR2010-018377-38-NL
EUCTR2010-018377-38-NL进行中(未招募)不适用

Immune respons after inactivated oral cholera vaccin (Dukoral) in renal transplant recipientsMucosal response in ImmunoCompromised Host (MICH) - MICH

eiden University Medical Centre0 个研究点开始时间: 2010年1月20日最近更新:
适应症
相关药物

试验速览

阶段
不适用
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

  • - Age = 18 years
  • - Creatinin clearance = 40 ml/min
  • - Stable renal function for 1 year prior to inclusion
  • - Stabe immunosuppressive medication for 3 months prior to inclusion, consisting of prednisone in combination with either a calcineurine inhibitor, mycophenolate mofetil or an mTOR inhibitor
  • 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
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range

排除标准

  • - A chronic disease which may influence the immune system, other than the renal transplant and accompanying immunosupressive medication
  • - Chronic infection
  • - Treatment for graft rejection in the year prior to inclusion
  • - Prior vaccination with Dukoral or another oral cholera or ETEC vaccine.
  • - Prior Vibrio cholerae infection
  • - Travellers' diarrhea 6 months prior to inclusion
  • - Known allergy to the vaccine or to one of the vaccine components
  • - History of an anaphylactic reaction following vaccination
  • - Treatment with plasma or blood products in the 3 months prior to inclusion
  • - Pregnancy or breast feeding
  • - Immunosuppressive medication other than prednisone, a calcineurine inhibitor, mycophenolate mofetil or an mTOR inhibitor

研究者

发起方
eiden University Medical Centre

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