EUCTR2021-000281-15-Outside-EU/EEA进行中（未招募）1 期
A Phase 2/3, Three-Part, Open-Label, Dose-Escalation, Age De-escalation and Randomized, Observer-Blind, Placebo-Controlled Expansion Study to Evaluate the Safety, Tolerability, Reactogenicity, and Effectiveness of mRNA-1273 SARS-CoV-2 Vaccine in Healthy Children 6 Months to Less Than 12 Years of Age
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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
- •Healthy children and those with stable chronic disease.
- •For children 2 years of age or older has a body mass index at or above the third percentile according to World Health Organization Child Growth Standards at the Screening Visit.
- •For children 6 months to <12 months of age: born at full-term with a minimum birth weight of 2.5 kilograms.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 11950
- •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
- •Known history of SARS-CoV-2 infection within 2 weeks prior to administration of vaccine or known close contact.
- •Prior administration of an investigational or approved CoV (such as, SARS-CoV-2, SARS CoV, Middle East Respiratory Syndrome CoV) vaccine.
- •Treatment with investigational or approved agents for prophylaxis against COVID 19 (such as, receipt of SARS-CoV-2 monoclonal antibodies) within 6 months prior to enrollment.
- •Known hypersensitivity to a component of the vaccine or its excipients.
- •Received intravenous or subcutaneous blood products (red blood cells, platelets, immunoglobulins) within 3 months prior to Day 1.
- •Participated in an interventional clinical study within 28 days prior to Day 0.
研究者
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