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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.
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):
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COVID-19 Vaccine (Vero Cell), Inactivated | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness of homologous booster-dose vaccination with CoronaVac® | To measure vaccine effectiveness of homologous booster-dose vaccination with CoronaVac® against laboratory-confirmed symptomatic disease | 6 months after the third dose of COVID-19 vaccine |
| Measure | Description | Time Frame |
|---|---|---|
| effectiveness of homologous booster-dose vaccination with CoronaVac® | To measure vaccine effectiveness of homologous booster-dose vaccination with CoronaVac® against laboratory-confirmed COVID-19 hospital admissions | 6 months after the third dose of COVID-19 vaccine |
| vaccine effectiveness of homologous booster-dose vaccination with CoronaVac® |
| Measure | Description | Time Frame |
|---|---|---|
| vaccine effectiveness of homologous booster-dose vaccination | To compare vaccine effectiveness of homologous booster-dose vaccination with CoronaVac® in periods with predominance of Delta and Omicron SARS-CoV-2 variants | 6 months after the third dose of COVID-19 vaccine |
| help support the approval of new indication (i.e. boosters) of the CoronaVac®. |
Inclusion Criteria:
Exclusion Criteria:
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The study population is community-dwelling individuals aged 18 years and above with no contra-indication for COVID-19 vaccination who consult a participating general practitioner or a hospital in São Paulo city, Brazil if they develop illness of interests (i.e., WHO definition of suspected COVID-19 cases) and had RT-PCR for SARS-Cov-2 colleceted.
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| Name | Affiliation | Role |
|---|---|---|
| André Machado amsiqueira@gmail.com, Doctor | amsiqueira@gmail.com | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Nacional de Infectologia Evandro Chagas (INI-FIOCRUZ) | Manguinhos | Brazil |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000086663 | COVID-19 Vaccines |
| C000722216 | sinovac COVID-19 vaccine |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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The samples without DNA. Only data will be recovered from three health surveillance information electronic health records:
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To measure vaccine effectiveness of homologous booster-dose vaccination with CoronaVac® against laboratory-confirmed COVID-19 intensive care unit admissions. |
| 6 months after the third dose of COVID-19 vaccine |
| Vaccine effectiveness of homologous booster-dose vaccination with CoronaVac® | To measure vaccine effectiveness of homologous booster-dose vaccination with CoronaVac® against laboratory-confirmed COVID-19 intensive care unit deaths. | 6 months after the third dose of COVID-19 vaccine |
To generate data to help support the approval of new indication (i.e. boosters) of the CoronaVac®. |
| 6 months after the third dose of COVID-19 vaccine |
| support post-approval study requirements of CoronaVac®. | To support post-approval study requirements of CoronaVac®. | 6 months after the third dose of COVID-19 vaccine |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |