Effectiveness of COVID-19 Vaccine (Vero Cell), Inactivated (CoronaVac) for Preventing Symptomatic SARS-CoV-2 Infections and Hospitalizations in the Dominican Republic - Test-Negative Case-Control Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,400
- 试验地点
- 10
- 主要终点
- Protective effectiveness of complete vaccination of CoronaVac against symptomatic SARS-COV-2 infections
研究概览
简要总结
This study is a multisite ,grouped test-negative case-control , phase Ⅳ clinical trial of an inactivated SARS-CoV-2 vaccine (CoronaVac) manufactured by Sinovac Research and Development Co., Ltd.The purpose of this study is to estimate the protective effectiveness of complete vaccination (measured ≥14 days after the second dose) of CoronaVac against symptomatic SARS-COV-2 infections ,COVID-19 hospitalizations and severe cases.
详细描述
This study is a multisite,grouped test-negative case-control , phase Ⅳ clinical trial in population aged 18 years and older. The experimental vaccine will be manufactured by Sinovac Research and Development Co.,Ltd.The study is planned to be carried out in ten (10) selected hospitals and their catchment communities in five provinces of the Dominican Republic (DR): National District, La Altagracia, Puerto Plata, Santiago, and Santo Domingo from July 1, 2021 to April 30, 2022 . A total of 1400 subjects will be enrolled with 700 estimated clinic cases who are diagnosed as SARS-CoV-2 infection by real-time polymerase chain reaction (RT-PCR); and 700 estimated clinic controls who have a negative RT-PCR test.And subjects will receive two doses of vaccine for primary immunization .
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
- 是
入选标准
- •Aged ≥18 years;
- •Permanent residents of study provinces;
- •Able and willing to provide informed consent to participate in the study;
- •Able and willing to provide nasopharyngeal swab and venous blood sample;
- •Able and willing to complete a questionnaire survey for collecting information on histories of COVID-19 vaccination and disease;
- •Considered as suspected cases of SARS-CoV-2 infections by the physicians in the study clinics according to DR national protocol.
排除标准
- 未提供
结局指标
主要结局
Protective effectiveness of complete vaccination of CoronaVac against symptomatic SARS-COV-2 infections
时间窗: Day 14 after the second dose
SARS-COV-2 infections confirmed by real-time polymerase chain reaction (RT-PCR) in newly collected nasopharyngeal swab sample among patients visiting the ER in the study hospitals during the study period without a positive RT-PCR test in the preceding 90 days period
Protective effectiveness of complete vaccination of CoronaVac against COVID-19 hospitalizations and severe cases.
时间窗: Day 14 after the second dose
Severe disease (including death), defined as a score \>5 in terms of WHO clinical progression scale due to SARS-CoV-2 infection
次要结局
- To profile the circulating strains of SARS-CoV-2 in DR(Day 14 after the second dose)