Effectiveness of CoronaVac® First Booster Dose for Preventing Symptomatic Acute Respiratory Infection Caused by SARS-CoV-2 Virus in Adults in São Paulo City, Brazil: a Retrospective Test-negative Case-control Study
试验速览
- 阶段
- 不适用
- 入组人数
- 14,000
- 试验地点
- 1
- 主要终点
- Effectiveness of homologous booster-dose vaccination with CoronaVac®
研究概览
简要总结
This is a retrospective test-negative case-control study of COVID-19 Vaccine (CoronaVac®) manufactured by Sinovac Research and Development Co., Ltd.The main purpose of this study is to measure vaccine effectiveness of homologous booster-dose vaccination with CoronaVac® against laboratory-confirmed symptomatic disease.
详细描述
This is a retrospective test-negative case-control study in São Paulo city, Brazil . The COVID-19 Vaccine (CoronaVac® )produced by Sinovac Research and Development Co., Ltd.The main purpose of this study is to measure vaccine effectiveness of homologous booster-dose vaccination with CoronaVac® against laboratory-confirmed symptomatic disease.A total of 14000 subjects will be enrolled,including 7,000 positive cases and 7,000 test negative COVID-19 cases The Statistical Analysis Plan (SAP) will include univariate (and, when required, multivariable) models of logistic regression.Data will be recovered from three health surveillance information electronic health records (EHRs):
- VACIVIDA, comprising individual data for people vaccinated against SARS-Cov-2.
- E-SUS, mandatory report database for mild to moderate COVID-19.
- SIVEP-GRIPE, mandatory report database for severe cases of COVID-19. All those RWD sources are available at the São Paulo Municipality Centers for Health Surveillance.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
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
- •Exposure group 1: Adults (≥ 18 years of age) registered in the E-SUS or SIVEP-gripe RWD source data from August 16th, 2021 through April 21st, 2022 and received a three-dose homologous vaccination with CoronaVac. Specifically, ≥14 days after receipt of the third vaccine dose using a homologous regimen with CoronaVac.
- •Exposure group 2: Adults (≥ 18 years of age) registered in the E-SUS or SIVEP-gripe RWD source data from August 16th, 2021 through April 21st, 2022, who received a two-dose vaccination with CoronaVac and did not receive any booster vaccine. Specifically, ≥14 days after receipt of the second vaccine dose and before the third dose of CoronaVac.
- •Exposure group 3: Adults (≥ 18 years of age) registered in the E-SUS or SIVEP-gripe RWD source data from August 16th, 2021 through April 21st, 2022, who received only one dose vaccination with CoronaVac and did not receive any other vaccine dose. Specifically, ≥14 days after receipt of the first vaccine dose and before the second dose of CoronaVac.
- •Non-Exposure group: Adults (≥ 18 years of age) registered in the E-SUS or SIVEP-gripe RWD source data from August 16th, 2021 through April 21st, 2022, who were not vaccinated. No history of vaccination for any type of COVID-19 vaccine, or <14 days after receipt of the first vaccine of CoronaVac.
排除标准
- •Anyone who received other vaccines for the first doses.
- •Anyone who received CoronaVac for the two initial doses but other vaccines for the booster (heterologous immunization).
- •Subjects with incomplete vaccination history.
结局指标
主要结局
Effectiveness of homologous booster-dose vaccination with CoronaVac®
时间窗: 6 months after the third dose of COVID-19 vaccine
To measure vaccine effectiveness of homologous booster-dose vaccination with CoronaVac® against laboratory-confirmed symptomatic disease
次要结局
- effectiveness of homologous booster-dose vaccination with CoronaVac®(6 months after the third dose of COVID-19 vaccine)
- vaccine effectiveness of homologous booster-dose vaccination with CoronaVac®(6 months after the third dose of COVID-19 vaccine)
- Vaccine effectiveness of homologous booster-dose vaccination with CoronaVac®(6 months after the third dose of COVID-19 vaccine)