EUCTR2021-005043-71-NO进行中（未招募）1 期
A Phase 2, Comparative Randomised Trial to Evaluate the impact ofreduced COVID-19 mRNA vaccination regimen on immunologicalresponses and reactogenicity in paediatric subjects withprior SARS-CoV-2 immunity - Immunogenicity and reactogenicity of reduced COVID-19 mRNA vaccination regimen in children (CoVacc)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 200
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. 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
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 200
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
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, in case of such medications receiving
- •approval in this age group during the trial.
- •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
- •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 executed.
- •10. Is unable to report solicited adverse events.
研究者
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