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:
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
- 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
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