NL-OMON54387招募中4 期
Prospective monitoring of antibody response following COVID-19 vaccination in patients with Down syndrome - PRIDE
niversitair Medisch Centrum Utrecht0 个研究点目标入组 640 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 640
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 0 至 99（—）
入选标准
- •1. All patients have opted to receive routine COVID-19 vaccination.
- •2. Age: >=16 years or <16 years if vaccine is recommended for routine use for
- •that age group
- •3. Either Down syndrome or healthy household contact
- •- All participants who participated in part 1 of the study and who have opted
- •to receive a third SARS-CoV-2 vaccination by the studyteam or the Dutch
- •government.
- •Additional Durability time point: All individuals already participating in the
- •PRIDE study are eligble to participate in this additional time point
排除标准
- •Down syndrome cohort: History of severe adverse reaction associated with a
- •vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of
- •the study intervention(s), organ transplant recipients, active malignancy or
- •completion of treatment for malignancy in previous 3 months, infection with
- •Human Immunodeficiency Virus (HIV), bleeding diathesis or condition associated
- •with prolonged bleeding that would, in the opinion of the investigator,
- •contraindicate intramuscular injection.
- •Healthy control cohort: as in Down Syndrome cohort plus active care for
- •inherited or acquired immune deficiency, any moderate to severe comorbidity for
- •which regular medical care is needed (pe heart failure, COPD, diabetes).
- •Anaphylactic reaction to previous COVID-19 vaccination
研究者
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暂停
不适用
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