EUCTR2021-001512-28-DE进行中（未招募）1 期
Immunogenicity of COVID-19 vaccines in medical staff and special risk populations
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 3,050
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
- •- Subject is willing, understanding and able to provide written informed consent (exception: for cohort 8 (Elderly) subjects unable to give informed consent may be included, provided that legal representative gives written informed consent)
- •- Written informed consent prior to initiation of any study procedures
- •- Subject understands and agrees to comply with planned study procedures.
- •- Male or female adult =18 years of age at time of enrolment.
- •- Participant belongs to only one of the following categories:
- •- Healthy health care worker at one of the participating trial centers (HCW)
- •- Participant with history of kidney transplantation (NTx)
- •- haemato-oncological participant and participant with B-cell neoplasia (B-NPL)
- •- Participant with neuroimmunological diseases such as multiple sclerosis (MS) and neuromyelitis optica spectrum disorders (NMOSD)
- •- Participant with rheumatic and autoimmune diseases under immunosuppression (RAID)
- •- Participant with primary immunodeficiency (PID)
- •- Participant with chronic kidney failure undergoing a chemo dialysis (HD)
- •- Participant = 70 years-of age, with none of the medical conditions specified above (elderly)
- •- One of the following vaccination scenarios apply:
- •- Subject will be vaccinated with a COVID-19 vaccine for the first time
- •- Subject already received the first COVID-19 vaccination no longer than 6 month prior to enrolment
- •- Absence of any conditions that prohibit or impede supplemental blood-sampling or throat swab.
- •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 1375
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1675
排除标准
- •An individual who meets any of the following criteria will be excluded from participation in this study:
- •- Any contraindications for SARS-CoV-2 vaccination (according to SmPCs)
- •- Refusal to participate.
- •- Participants unwilling or unable to consent to saving and propagation of pseudonymized medical data for study reasons.
- •- Persons who are legally detained in an official institution
- •- Persons who might be dependent on the sponsor, the investigator or the trial site. This exclusion criterion does not apply for cohort 1 (HCWs), as it is necessary for this population to participate. In order to assure that no pressure to participate is put on them, the recruitment procedure of HCWs must follow the respective SOP of the sponsor.
研究者
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