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临床试验/EUCTR2021-003188-90-DK
EUCTR2021-003188-90-DK进行中(未招募)1 期

A Phase IV Vaccine Study under the National Cohort Study of Effectiveness and Safety of SARS-CoV-2/Covid-19 vaccines (ENFORCE PLUS) - ENFORCE

CHIP - Rigshospitalet - University of Copenhagen0 个研究点目标入组 1,000 人开始时间: 2021年6月11日最近更新:
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试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
1,000

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.Written informed consent obtained before any trial related procedures are performed
  • 2.Male or female eligible for SARS-CoV-2 immunization (as defined by SST in the national vaccination plan/Tilvalgsordningen)
  • 3.The subject must be willing and able to comply with trial protocol (re-visits and biological samples)
  • 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 1000
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • 1.Male and female under the age of 18
  • 2.Any subgroup of individuals for which the vaccines are contra-indicated
  • 3.Previous SARS-CoV-2 vaccination
  • Specific for the Johnson & Johnson vaccine:
  • 4.Experience of a serious allergic reaction after injection of any other vaccine
  • 5.Serious infection with high fever (> 38 0C)
  • A temporary postponement of the vaccination is allowed, when participant has been well for at least 48 hours. Mild fever or upper airway infection like a cold is not a problem
  • 6.Problems with bleeding or bruising, or use of anticoagulant medicine (to prevent blood clots)
  • 7.Immunodeficiency or use of medicines that weaken the immune system (such as high-dose corticosteroids, immunosuppressants or cancer medicines)

研究者

发起方
CHIP - Rigshospitalet - University of Copenhagen

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