Status:
UNKNOWN
Effectiveness of Inactivated COVID-19 Vaccine of the First Booster Dose
Lead Sponsor:
Sinovac Research and Development Co., Ltd.
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Brief 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...
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 st...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
July 30 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 15 2023
Estimated Enrollment :
14000 Patients enrolled
Trial Details
Trial ID
NCT05367895
Start Date
July 30 2022
End Date
February 15 2023
Last Update
January 12 2023
Active Locations (1)
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1
Instituto Nacional de Infectologia Evandro Chagas (INI-FIOCRUZ)
Manguinhos, Brazil