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Effectiveness of Inactivated COVID-19 Vaccine of the First Booster Dose

COVID-19 Clinical Trial

Official title:
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

Clinical Trial Summary

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.

Clinical Trial Description

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): 1. VACIVIDA, comprising individual data for people vaccinated against SARS-Cov-2. 2. E-SUS, mandatory report database for mild to moderate COVID-19. 3. 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05367895
Study type Observational
Source Sinovac Biotech Co., Ltd
Contact
Status Active, not recruiting
Phase
Start date July 30, 2022
Completion date February 15, 2023
View Details
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