A Phase 2, Comparative Randomised Trial to Evaluate the impact of reduced COVID-19 mRNA vaccination regimen on immunological responses and reactogenicity in paediatric subjects with prior SARS-CoV-2 immunity - CoVacc

niversitair Medisch Centrum Utrecht0 个研究点目标入组 50 人开始时间: 待定最近更新: 2024年4月15日

试验速览

阶段: 2 期
状态: 招募中
发起方
入组人数: 50

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

年龄范围: 2 至 11（—）

入选标准

•1.Aged >=5 years to <=11 years of age on day of signing the informed consent form.
•2.In good health or stable clinical condition.
•3.Legally Acceptable Representative (LAR) has reviewed the subject information
•and signed the informed consent form on behalf of the subject and the subject
•has expressed willingness to participate.

排除标准

•1.Has previously received any investigational or licensed COVID-19 vaccine.
•2. Has known congenital or acquired immune disorder or immunodeficiency that
•may interfere with vaccine response e.g. known infection with human
•immunodeficiency virus (HIV) with low CD4 count or other immunosuppression at
•time of signing informed consent form.
•3. Has a history of autoimmune disease or an active autoimmune disease
•requiring therapeutic intervention (including systemic glucocorticoids), or
•findings that may have a significant effect on the target endpoints and which
•may therefore mask or inhibit the therapeutic effect under investigation as
•judged by the investigator.
•4. Bleeding diathesis or condition associated with prolonged bleeding that
•would, in the opinion of the investigator, contraindicate intramuscular
•injection or venepuncture.
•5. History of severe adverse reaction associated with a vaccine and/or severe
•allergic reaction (eg, anaphylaxis) to any component of the study
•intervention(s).
•6. Receipt of medications intended to prevent COVID-19.
•7. Uses drugs with significant interaction with the investigational product or
•has any contraindications as per the Summary of Product Characteristics.
•8. Other medical or psychiatric condition or laboratory abnormality that may
•increase the risk of study participation or, in the investigator*s judgment,
•make the subject inappropriate for the study.
•9. Has any kind of dependency on the principal investigator or member of the
•study team or LAR is employed by the principal investigator or within the same
•department as the PI or study team at the institution where the study is
•10. Is unable to report solicited adverse events.

研究者

发起方

niversitair Medisch Centrum Utrecht

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