Effectiveness of Inactivated COVID-19 Vaccine of the First Booster Dose
NCT ID: NCT05367895
Last Updated: 2023-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
14000 participants
OBSERVATIONAL
2022-07-30
2023-02-15
Brief Summary
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Detailed Description
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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
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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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.
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.
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.
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.
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.
No interventions assigned to this group
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.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* Anyone who received CoronaVac for the two initial doses but other vaccines for the booster (heterologous immunization).
* Subjects with incomplete vaccination history.
18 Years
ALL
Yes
Sponsors
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Sinovac Research and Development Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Locations
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Instituto Nacional de Infectologia Evandro Chagas (INI-FIOCRUZ)
Manguinhos, , Brazil
Countries
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Other Identifiers
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EFFERVESCENCE/ BRAZIL
Identifier Type: -
Identifier Source: org_study_id
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