EUCTR2020-004066-19-DE进行中（未招募）1 期
COVID-19: A Phase 3, Randomized, Observer-Blinded, Placebo-Controlled Clinical Study Evaluating the Safety and Immunogenicity of Investigational SARS-CoV-2 mRNA Vaccine CVnCoV in Adult Health Care Workers in Mainz (Germany) - Immunogenicity and Safety of CVnCoV in Adults
CureVac AG0 个研究点目标入组 2,520 人开始时间: 2020年11月20日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2,520
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. Male or female subjects 18 years of age or older.
- •2. HCWs, employees or students in clinical training.
- •3. Provide written informed consent prior to initiation of any trial procedures.
- •4. Expected compliance with protocol procedures and availability for clinical follow-up through the last planned visit.
- •The full list of inclusion criteria is provided in the protocol.
- •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 2500
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •1. History of virologically-confirmed SARS-CoV-2 infection or SARS-CoV-2 positive serology.
- •2. For females: pregnancy or lactation.
- •3. Use of any investigational or non-registered product (vaccine or drug) within 28 days preceding the administration of the first trial vaccine or planned use during the trial.
- •4. Receipt of licensed vaccines within 28 days (for live vaccines) or 14 days (for inactivated vaccines) prior to the administration of the first trial vaccine.
- •5. Prior administration of any investigational SARS-CoV-2 vaccine or another coronavirus (SARS-CoV, MERS-CoV) vaccine or planned use during the trial.
- •The full list of exclusion criteria is provided in the protocol.
研究者
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