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临床试验/EUCTR2019-002781-12-DK
EUCTR2019-002781-12-DK进行中(未招募)1 期

sing BCG vaccine to strengthen the immune system in the elderly and improve the response to influenza vaccine. A randomized clinical trial. - BCG-DENMARK-INFLUENZA

niversity of Southern Denmark, Bandim Health Project0 个研究点目标入组 300 人开始时间: 2021年6月25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
300

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

  • Elderly people > 65 years and eligible for seasonal influenza vaccination. Participants must have access to ‘e-Boks’.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) no
  • 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 300

排除标准

  • Known allergy to (components of) the BCG vaccine or serious adverse events in relation to prior BCG administration
  • Previous Mycobacterium tuberculosis (M. tuberculosis) infection or known active or latent infection with M. tuberculosis or other mycobacterial species
  • Fever (>38 C) within the past 24 hours or suspicion of active viral or bacterial infection
  • Vaccination with other live attenuated vaccine within the last 4 weeks
  • Severely immunocompromised subjects. This exclusion category comprises:
  • Subjects with known infection with the human immunodeficiency virus (HIV)
  • Subjects with solid organ transplantation or bone marrow transplantation
  • Subjects under chemotherapy
  • Subjects with primary immunodeficiency
  • Treatment with any anti-cytokine therapy within the last year
  • Treatment with oral or intravenous steroids defined as daily doses of 10 mg prednisone or equivalent for longer than 3 months
  • Active solid or non-solid malignancy or lymphoma within the prior two years
  • Subjects who do not have access to e-Boks.
  • Participant in BCG-DENMARK-SENIOR study

研究者

发起方
niversity of Southern Denmark, Bandim Health Project

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