EUCTR2013-003403-19-SE进行中（未招募）1 期
Study of T- and B-cell immunity after vaccination with a virosomebased influenza vaccine (Inflexal V) in patients who have undergone hematopoietic allogeneic stem cell transplantation.
Karolinska University Hospital0 个研究点目标入组 30 人开始时间: 2013年8月2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
- 30
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
- •Adult allogeneic stem cell transplant patients who has undergone transplant 3-24 months before transplantation and who shall get influenza vaccine according to national and international guidelines.
- •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 25
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •1. Patients < 3 months and > 24 months after HSCT
- •2. Patients who has been influenzavaccinated during the actual season.
- •3. Patients who has been diagnosed with influenza during the actual season.
- •4. Patients with severe acute GVHD (grade III-IV)
- •5. Patienter with extensive or severe chronic GVHD treated with photopheresis or mesenchymal stem cells
- •6. Patients treated with drugs produced by gene- or celltherapeutical techniques
- •7. Patients with relapse of the original disease undergoing or planned to undergo chemotherapy
- •8. Patients treated with iv or sc immune globulins
- •9. Patients requiring platelet transfusions
- •10. Patienter allergic to any of the in the vaccine included substances.
- •11. Patients who are pregnant or nursing
- •12. Patients not giving informed consent
研究者
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