Effectiveness of Chinese COVID-19 Vaccines in Latin America and the Caribbean
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- P95
- 入组人数
- 59
- 试验地点
- 5
- 主要终点
- SARS-CoV-2 detection
研究概览
简要总结
This multi-country study seeks to collect real-world evidence (RWE), from Latin American and Caribbean countries, on the effectiveness of China-made COVID-19 vaccines in different populations, against different clinical outcomes, and when administered in different schedules.
详细描述
This multi-country study seeks to collect RWE, from Latin American and Caribbean countries, on the effectiveness of China-made COVID-19 vaccines in different populations, against different clinical outcomes and when administered in different schedules.
The vaccines of interest are the following:
- 'Sinovac-CoronaVac' (Sinovac Biotech Ltd., Beijing, China),
- 'BIBP COVID-19 Vaccine' ('Covilo'; 'BIBP-CorV') (Sinopharm, Beijing Institute of Biological Products, China),
- 'Convidecia' ('AD5-nCOV') (CanSino Biologics, Tianjin, China).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
SARS-CoV-2 detection
时间窗: Specimen collected between d-14 and d0, where d0 is the day at ER visit or hospital admission (or specimen collected within 24 hours upon arrival at the hospital)
The outcome of interest for the primary analysis will be the SARS-CoV-2 detection from study participants who present to the ER ("ER visit") or are hospitalized with SARI, as determined through the standard of care diagnostic testing (i.e., antigen test or PCR).
次要结局
- Level of disease severity(- The Time Frame will be defined as the time from ER/Hospital admission to the date of hospital discharge or date of death at hospital)