NCT05367895

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 14,000 (estimated)
• Sponsor: Sinovac Research and Development Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	COVID-19 Vaccine (Vero Cell), Inactivated	Form: CoronaVac® is a milky-white suspension. Stratified precipitate may form that can be dispersed by shaking. Presentation: Each vial contains 0.5 mL (a single dose) and contains 600SU of inactivated SARS-CoV-2 virus antigen. Administration and schedule: Two doses with an interval of 21 days should be administered for primary immunization. 0.5 mL per dose. Route: IM in the deltoid region of the upper arm after shaking the vial well before use.

Timeline

• Start date: 2022-07-30
• Primary completion: 2022-08-15
• Completion: 2023-02-15
• First posted: 2022-05-10
• Last updated: 2023-01-12

Locations

1 site across 1 country: Brazil