EUCTR2021-002030-16-AT进行中(未招募)1 期
Immune response and breakthrough infections following an in-label vaccination with Comirnaty against SARS-CoV-2 in the district of Schwaz - Shieldvacc-2
Medizinische Universität Innsbruck, Institut für Virologie0 个研究点目标入组 3,340 人开始时间: 2021年4月29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
- 3,340
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.Participant is = 18 years of age on the day of signing the ICF and provides written informed consent
- •participant is between 16 and 18 years of age and provides informed consent as well as his/her legal representative/custodial
- •2.Subject has been already vaccinated with Comirnaty (two doses), with the second dose having been administered within up to 6 weeks (35 days ± 7 days) before study inclusion
- •3.Subject understands and agrees to comply with study procedures
- •4.Subject must be willing to be contacted by telephone or willing to complete an eDiary during study participation
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 340
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 2600
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 400
排除标准
- •1.Prior administration of an investigational coronavirus (SARS-CoV, MERS-CoV) vaccine or current/planned simultaneous participation in another interventional study to either prevent or treat COVID-19
- •2.Participant has a contraindication to blood draws (eg, bleeding disorders)
- •3.Has participated in an interventional clinical study within 30 days prior to study inclusion
研究者
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