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临床试验/EUCTR2012-004486-41-SE
EUCTR2012-004486-41-SE进行中(未招募)1 期

Vaccination of antibody deficient patients with Prevenar13 - a comparative study between antibody response and cellular immunity. - PNEUMOCE

Karolinska University Hospital, Huddinge, Sweden0 个研究点目标入组 20 人开始时间: 2012年12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
入组人数
20

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

  • 1. The patients should have been diagnosed with IgG-deficiency; IgG1<2.8 g/l and/or IgG2<1.15 g/L.
  • 2. The patient should be between 18-65 years of age
  • 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 20
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range 20

排除标准

  • 1. The patient should not have been given Prevenar 7 or 13 prior to the study inclusion.
  • 2. The patient should not have been given PPV23 2 years prior to the study inclusion.
  • 3. The patient should not be pregnant.
  • 4. The patient should not take part in any other clinical study involving drugs or vaccines.
  • The healthy controls should be healthy and not be on any drugs that could interfere with an immune response (systemic steroids, NSAIDs, immunosuppressive drugs).

研究者

发起方
Karolinska University Hospital, Huddinge, Sweden

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