Ignite Creation Date:
2025-12-24 @ 5:18 PM
Ignite Modification Date:
2025-12-29 @ 3:24 AM
Study NCT ID:
NCT05126550
Status:
UNKNOWN
Last Update Posted:
2022-09-08
First Post:
2021-11-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Immunogenicity, Safety, and Effectiveness of the COVID-19 Inactivated Vaccine
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'}], 'ancestors': [{'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 435}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-11-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-04', 'studyFirstSubmitDate': '2021-11-12', 'studyFirstSubmitQcDate': '2021-11-17', 'lastUpdatePostDateStruct': {'date': '2022-09-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-13', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The percent inhibition of SARS-CoV-2 surrogate Virus Neutralization Test neutralizing antibody (sVNT NAb)', 'timeFrame': 'At 14 days, 3 months, and 6 months after 2 doses of vaccination', 'description': 'To evaluate the percent inhibition of SARS-CoV-2 sVNT NAb following the SARS-CoV-2 vaccine (Vero cell) inactivated administration at 14 days, 3 months, and 6 months after 2 doses of vaccination'}], 'secondaryOutcomes': [{'measure': 'The geometric mean titer (GMT) of anti-spike protein receptor binding domain (sRBD) immunoglobulin G (IgG) antibody and the proportion of seropositivity of anti-nucleocapsid antibody', 'timeFrame': 'At 14 days, 3 months, and 6 months after 2 doses of vaccination', 'description': 'To evaluate the GMT of anti-sRBD IgG antibody and the proportion of seropositivity of anti-nucleocapsid antibody following the SARS-CoV-2 vaccine (Vero cell) inactivated administration at 14 days, 3 months, and 6 months after 2 doses of vaccination'}, {'measure': 'The proportion of adverse event following immunization', 'timeFrame': 'Within 28 days after 2 doses of vaccination', 'description': 'To evaluate the proportion of adverse event following immunization (AEFI) following the SARS-CoV-2 vaccine (Vero cell) inactivated administration after the first dose until 28 days after the second dose of vaccination'}, {'measure': 'The proportion of serious adverse event', 'timeFrame': 'Within 6 months after 2 doses of vaccination', 'description': 'To evaluate the proportion of serious adverse event following the SARS-CoV-2 vaccine (Vero cell) inactivated administration after the first dose until 6 months after the second dose of vaccination'}, {'measure': 'The proportion of symptomatic and PCR-confirmed SARS-CoV-2 infection', 'timeFrame': 'Within 6 months after 2 doses of vaccination', 'description': 'To evaluate the proportion of symptomatic and PCR-confirmed SARS-CoV-2 infection following the SARS-CoV-2 vaccine (Vero cell) inactivated administration within 6 months after second dose of vaccination'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID-19']}, 'descriptionModule': {'briefSummary': 'To fast respond the coronavirus disease of 2019 (COVID-19) pandemic, the Indonesian government has launched "Vaksinasi Gotong Royong" (a mutual cooperation vaccination program) in which any company/legal entity/business entity may purchase vaccines to be given free of charge to their employees and families of employees (The Indonesian Ministry of Health, 2021). Vaccines provided for this program include the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) inactivated vaccines produced by Sinopharm.\n\nThe Indonesian National Agency of Drug and Food Control (NADFC) has issued an Emergency Use Authorization (EUA) for several COVID-19 vaccines, including the SARS-CoV-2 vaccine (Vero cell) inactivated produced by Sinopharm (NADFC, 2021). Following EUA, Kimia Farma Indonesia as the holder of EUA has the obligation to monitor the safety and effectiveness in Indonesian population.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The recruitment will target potential participants via local company/legal entity/business entity registering for "Vaksinasi Gotong Royong"', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nMale or female subjects aged 18 years old and above; Will receive the SARS-CoV-2 vaccine (Vero cell) inactivated produced by Sinopharm; Obtain informed consent to participate this study\n\nExclusion Criteria:\n\nPrevious SARS-CoV-2 vaccination, except for drop out after the first vaccine dose of more than 6 months ago; History of SARS-CoV-2 infection within the last 3 months'}, 'identificationModule': {'nctId': 'NCT05126550', 'briefTitle': 'The Immunogenicity, Safety, and Effectiveness of the COVID-19 Inactivated Vaccine', 'organization': {'class': 'INDUSTRY', 'fullName': 'PT. Kimia Farma (Persero) Tbk'}, 'officialTitle': 'The Immunogenicity, Safety, and Effectiveness of the SARS-CoV-2 Vaccine (Vero Cell) Inactivated in Adult Population Aged 18 Years Old and Above in Indonesia', 'orgStudyIdInfo': {'id': 'Sinopharm21'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Immunogenicity', 'description': 'Group 1 constitutes the immunogenicity group which will be evaluated regarding immunogenicity, safety, and effectiveness of the SARS-CoV-2 vaccine (Vero cell) inactivated produced by Sinopharm', 'interventionNames': ['Biological: SARS-CoV-2 vaccine (Vero cell) inactivated']}, {'label': 'Non-Immunogenicity', 'description': 'Group 2 that constitutes the non-immunogenicity group which will be evaluated regarding only safety and effectiveness of the aforementioned vaccine', 'interventionNames': ['Biological: SARS-CoV-2 vaccine (Vero cell) inactivated']}], 'interventions': [{'name': 'SARS-CoV-2 vaccine (Vero cell) inactivated', 'type': 'BIOLOGICAL', 'description': 'Two doses of 0.5 mL intramuscular injection containing 4 mcg (6.5 Unit) antigens with an interval of 21-28 days in accordance with "Vaksinasi Gotong Royong" (mutual cooperation vaccination program)', 'armGroupLabels': ['Immunogenicity', 'Non-Immunogenicity']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bandung', 'country': 'Indonesia', 'facility': 'Laboratorium Klinik Kimia Farma Diponegoro Bandung', 'geoPoint': {'lat': -6.92222, 'lon': 107.60694}}, {'city': 'Jakarta', 'country': 'Indonesia', 'facility': 'Laboratorium Klinik Kimia Farma Cikini', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}, {'city': 'Medan', 'country': 'Indonesia', 'facility': 'Laboratorium Klinik Kimia Farma Medan', 'geoPoint': {'lat': 3.58333, 'lon': 98.66667}}, {'city': 'Semarang', 'country': 'Indonesia', 'facility': 'Laboratorium Klinik Kimia Farma Sutomo Semarang', 'geoPoint': {'lat': -6.99306, 'lon': 110.42083}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PT. Kimia Farma (Persero) Tbk', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, Internist', 'investigatorFullName': 'Prenali Dwisthi Sattwika', 'investigatorAffiliation': 'Gadjah Mada University'}}}}