EUCTR2021-001978-37-ES进行中（未招募）1 期
A Phase 2, Comparative, Randomised, Adaptive Trial to Evaluate the safety and immunogenicity of one dose of COMIRNATY in subjects that had received one dose of VAXZEVRIA. - CombiVacS
Instituto de Salud Carlos III. ISCIII0 个研究点目标入组 600 人开始时间: 2021年5月6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
- 600
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. Adult subjects (18 years old) having received a previous single dose of VAXZEVRIA vaccination between 8 and 12 weeks before the screening visit.
- •2. Subjects in good health or stable clinical situation.
- •3. Subject providing informed consent to participate in the trial.
- •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 300
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 300
排除标准
- •1. Participant has a clinically significant acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection) or temperature =38.0oC within 24 hours prior to the planned dose of study vaccine.
- •2. Participant has a known or suspected allergy or history of anaphylaxis or other serious adverse reactions to COMINARTY excipients.
- •3. Subjects have symptoms or signs compatible with COVID19
研究者
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