EUCTR2021-005197-25-DE进行中（未招募）1 期
A PHASE 3 MASTER PROTOCOL TO EVALUATE ADDITIONAL DOSE(S) OF BNT162b2 IN HEALTHY INDIVIDUALS PREVIOUSLY VACCINATED WITH BNT162b2
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- BioNTech SE
- 入组人数
- 13,900
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
- •Participants are eligible to be included in the study only if all of the substudy-specific
- •inclusion criteria are met.
- •For Substudy A, see Section 10.7.5.1. of the Study Protocol;
- •For Substudy B, see Section 10.8.5.1. of the Study Protocol;
- •For Substudy C, see Section 10.9.5.1. of the Study Protocol.
- •Some inclusion criteria are common to all substudies: participants (and their parent(s)/legal guardian(s) willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, and other study procedures; participants should be healthy; and participants (or their parent[s]/legal guardian[s]) must be capable of giving personal signed informed consent.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 1188
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 10172
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2676
排除标准
- •Participants are excluded from the study if any of the substudy-specific exclusion criteria apply.
- •Some exclusion criteria are common to all substudies: participants with medical or psychiatric conditions that may increase the risk of study participation; history of severe adverse reactions associated with a vaccine and/or severe allergic reaction to any component of the study vaccination; previous clinical or microbiological diagnosis of COVID-19; immunocompromised individuals; or participants with bleeding diathesis.
- •For Substudy A, see Section 10.7.5.2. of the Study Protocol;
- •For Substudy B, see Section 10.8.5.2. of the Study Protocol;
- •For Substudy C, see Section 10.9.5.2. of the Study Protocol.
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