EUCTR2021-005043-71-GR进行中（未招募）1 期
A Phase 2, Comparative Randomised Trial to Evaluate the impact of reduced COVID-19 mRNA vaccination regimens on immunological responses and reactogenicity in paediatric subjects with and without prior SARS-CoV-2 infection. - CoVacc
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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
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 Accepted 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
- •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 sponsor or 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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