Ignite Creation Date:
2025-12-24 @ 1:41 PM
Ignite Modification Date:
2025-12-30 @ 8:13 AM
Study NCT ID:
NCT05367895
Status:
UNKNOWN
Last Update Posted:
2023-01-12
First Post:
2022-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Inactivated COVID-19 Vaccine of the First Booster Dose
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000086663', 'term': 'COVID-19 Vaccines'}, {'id': 'C000722216', 'term': 'sinovac COVID-19 vaccine'}], 'ancestors': [{'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'The samples without DNA. Only data will be recovered from three health surveillance information electronic health records:\n\n1. VACIVIDA, comprising individual data for people vaccinated against SARS-Cov-2.\n2. E-SUS, mandatory report database for mild to moderate COVID-19.\n3. 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.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 14000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-07-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2023-02-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-11', 'studyFirstSubmitDate': '2022-04-28', 'studyFirstSubmitQcDate': '2022-05-07', 'lastUpdatePostDateStruct': {'date': '2023-01-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'vaccine effectiveness of homologous booster-dose vaccination', 'timeFrame': '6 months after the third dose of COVID-19 vaccine', 'description': 'To compare vaccine effectiveness of homologous booster-dose vaccination with CoronaVac® in periods with predominance of Delta and Omicron SARS-CoV-2 variants'}, {'measure': 'help support the approval of new indication (i.e. boosters) of the CoronaVac®.', 'timeFrame': '6 months after the third dose of COVID-19 vaccine', 'description': 'To generate data to help support the approval of new indication (i.e. boosters) of the CoronaVac®.'}, {'measure': 'support post-approval study requirements of CoronaVac®.', 'timeFrame': '6 months after the third dose of COVID-19 vaccine', 'description': 'To support post-approval study requirements of CoronaVac®.'}], 'primaryOutcomes': [{'measure': 'Effectiveness of homologous booster-dose vaccination with CoronaVac®', 'timeFrame': '6 months after the third dose of COVID-19 vaccine', 'description': 'To measure vaccine effectiveness of homologous booster-dose vaccination with CoronaVac® against laboratory-confirmed symptomatic disease'}], 'secondaryOutcomes': [{'measure': 'effectiveness of homologous booster-dose vaccination with CoronaVac®', 'timeFrame': '6 months after the third dose of COVID-19 vaccine', 'description': 'To measure vaccine effectiveness of homologous booster-dose vaccination with CoronaVac® against laboratory-confirmed COVID-19 hospital admissions'}, {'measure': 'vaccine effectiveness of homologous booster-dose vaccination with CoronaVac®', 'timeFrame': '6 months after the third dose of COVID-19 vaccine', 'description': 'To measure vaccine effectiveness of homologous booster-dose vaccination with CoronaVac® against laboratory-confirmed COVID-19 intensive care unit admissions.'}, {'measure': 'Vaccine effectiveness of homologous booster-dose vaccination with CoronaVac®', 'timeFrame': '6 months after the third dose of COVID-19 vaccine', 'description': 'To measure vaccine effectiveness of homologous booster-dose vaccination with CoronaVac® against laboratory-confirmed COVID-19 intensive care unit deaths.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID-19']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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):\n\n1. VACIVIDA, comprising individual data for people vaccinated against SARS-Cov-2.\n2. E-SUS, mandatory report database for mild to moderate COVID-19.\n3. 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n* 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.\n* 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.\n* 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.\n\nExclusion Criteria:\n\n* Anyone who received other vaccines for the first doses.\n* Anyone who received CoronaVac for the two initial doses but other vaccines for the booster (heterologous immunization).\n* Subjects with incomplete vaccination history.'}, 'identificationModule': {'nctId': 'NCT05367895', 'briefTitle': 'Effectiveness of Inactivated COVID-19 Vaccine of the First Booster Dose', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sinovac Biotech Co., Ltd'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'EFFERVESCENCE/ BRAZIL'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Exposure group 1', 'description': '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.', 'interventionNames': ['Biological: COVID-19 Vaccine (Vero Cell), Inactivated']}, {'label': 'Exposure group 2', 'description': '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.', 'interventionNames': ['Biological: COVID-19 Vaccine (Vero Cell), Inactivated']}, {'label': 'Exposure group 3', 'description': '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.'}, {'label': 'Non-Exposure group', 'description': '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.', 'interventionNames': ['Biological: COVID-19 Vaccine (Vero Cell), Inactivated']}], 'interventions': [{'name': 'COVID-19 Vaccine (Vero Cell), Inactivated', 'type': 'BIOLOGICAL', 'otherNames': ['CoronaVac®'], 'description': 'Form: CoronaVac® is a milky-white suspension. Stratified precipitate may form that can be dispersed by shaking.\n\nPresentation: Each vial contains 0.5 mL (a single dose) and contains 600SU of inactivated SARS-CoV-2 virus antigen.\n\nAdministration and schedule: Two doses with an interval of 21 days should be administered for primary immunization. 0.5 mL per dose.\n\nRoute: IM in the deltoid region of the upper arm after shaking the vial well before use.', 'armGroupLabels': ['Exposure group 1', 'Exposure group 2', 'Non-Exposure group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Manguinhos', 'country': 'Brazil', 'facility': 'Instituto Nacional de Infectologia Evandro Chagas (INI-FIOCRUZ)', 'geoPoint': {'lat': -22.78333, 'lon': -41.93333}}], 'overallOfficials': [{'name': 'André Machado amsiqueira@gmail.com, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'amsiqueira@gmail.com'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sinovac Research and Development Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}