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临床试验/EUCTR2017-003523-30-FR
EUCTR2017-003523-30-FR进行中(未招募)1 期

Vaccination after hematopoietic stem cell transplantation : a randomized study estimating the interest of an additional injection for patients not reponding at M3. - EVaxAll

niversity Hospital Grenoble0 个研究点目标入组 200 人开始时间: 2018年3月15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
200

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 greater than or equal to 18 years
  • - Realization of an allograft of haematopoietic stem cells at least 6 months, and at the most 24 months before inclusion
  • - Discontinuation of immunosuppressive therapy for at least 3 months
  • - Absence of GVH superior to grade I at the initiation of vaccination
  • - 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 200
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • - Pregnant, parturient or nursing women
  • - Person deprived of liberty by judicial or administrative decision, person subject to a legal protection measure, subject to administrative or judicial supervision
  • - Patients who received supplementation in the last 3 months with multivalent immunoglobulins, or for whom this treatment is planned
  • - Contra-indication to Infanrix hexa® (hypersensitivity during an earlier injection)
  • - Fever (=38 ° C) during consultation (delays inclusion at 1 week)

研究者

发起方
niversity Hospital Grenoble

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