Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-26 @ 2:34 AM
Study NCT ID:
NCT06690502
Status:
COMPLETED
Last Update Posted:
2024-11-15
First Post:
2024-11-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Post Authorization Safety Profile of Booster IndoVac COVID-19 Vaccination
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1208}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-12-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-06-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-13', 'studyFirstSubmitDate': '2024-11-13', 'studyFirstSubmitQcDate': '2024-11-13', 'lastUpdatePostDateStruct': {'date': '2024-11-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serious adverse event following IndoVac booster vaccination', 'timeFrame': 'until 30 minutes after each dose', 'description': 'Any serious adverse event occurring from inclusion until 30 minutes after IndoVac booster vaccination'}], 'secondaryOutcomes': [{'measure': '0-7 Days Reactions', 'timeFrame': 'Within 0-7 Days after each dose', 'description': 'Number and percentage of any solicited and unsolicited local reaction and systemic events within 0-7 days after IndoVac booster vaccination.'}, {'measure': '8-28 Days Reactions', 'timeFrame': 'Within 8-28 Days after each dose', 'description': 'Number and percentage of any solicited and unsolicited local reaction and systemic events within 8-28 days after IndoVac booster vaccination.'}, {'measure': '28 Days Reactions', 'timeFrame': '28 Days after each dose', 'description': 'Number and percentage of any serious adverse event after IndoVac booster vaccination'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19', 'IndoVac', 'Safety Vaccine'], 'conditions': ['COVID-19']}, 'descriptionModule': {'briefSummary': 'This study is Post Authorization Safety Study (PASS) Phase IV of Booster IndoVac COVID-19 Vaccination', 'detailedDescription': 'This study is Post Authorization Safety Study (PASS) Phase IV, to assess any local and systemic reaction after immunization with IndoVac using retrospective cohort study trial design to assess safety profile following IndoVac booster vaccine in healthy populations aged 18 years and above.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy adults aged 18 years and above', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Clinically healthy subjects aged 18 years and above\n2. Subjects have been injected with IndoVac booster.\n3. Minimum 6-month interval from primary or booster COVID-19 vaccination.\n4. Subjects have been informed properly regarding the study and signed the informed consent form.\n\nExclusion Criteria:\n\n1. Subjects concomitantly enrolled or scheduled to be enrolled in another study when the subjects got IndoVac booster vaccination.\n2. Subject's telephone number is invalid or cannot be contacted."}, 'identificationModule': {'nctId': 'NCT06690502', 'briefTitle': 'Post Authorization Safety Profile of Booster IndoVac COVID-19 Vaccination', 'organization': {'class': 'INDUSTRY', 'fullName': 'PT Bio Farma'}, 'officialTitle': 'Safety Profile of Booster IndoVac COVID-19 Vaccination in Healthy Populations Aged 18 Years and Above', 'orgStudyIdInfo': {'id': 'COV19REC-0423'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'IndoVac COVID-19 Vaccine', 'description': 'Clinically healthy adults aged 18 years and above who received Booster IndoVac COVID-19 Vaccination'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jakarta', 'state': 'Center Jakarta', 'country': 'Indonesia', 'facility': 'Gambir Public Health Center', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}, {'city': 'Jakarta', 'state': 'Center Jakarta', 'country': 'Indonesia', 'facility': 'Kemayoran Public Health Center', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}, {'city': 'Jakarta', 'state': 'Center Jakarta', 'country': 'Indonesia', 'facility': 'Menteng Public Health Center', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}, {'city': 'Jakarta', 'state': 'Center Jakarta', 'country': 'Indonesia', 'facility': 'Sawah Besar Public Health Center', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}, {'city': 'Jakarta', 'state': 'Center Jakarta', 'country': 'Indonesia', 'facility': 'Tanah Abang Public Health Center', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}, {'city': 'Jakarta', 'state': 'East Jakarta', 'country': 'Indonesia', 'facility': 'Cakung Public Health Center', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}, {'city': 'Jakarta', 'state': 'East Jakarta', 'country': 'Indonesia', 'facility': 'Cipayung Public Health Center', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}, {'city': 'Jakarta', 'state': 'East Jakarta', 'country': 'Indonesia', 'facility': 'Ciracas Public Health Center', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}, {'city': 'Jakarta', 'state': 'East Jakarta', 'country': 'Indonesia', 'facility': 'Makasar Public Health Center', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}, {'city': 'Jakarta', 'state': 'East Jakarta', 'country': 'Indonesia', 'facility': 'Matraman Public Health Center', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}, {'city': 'Jakarta', 'state': 'East Jakarta', 'country': 'Indonesia', 'facility': 'Pulogadung Public Health Center', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}, {'city': 'Jakarta', 'state': 'North Jakarta', 'country': 'Indonesia', 'facility': 'Cilincing Public Health Center', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}, {'city': 'Jakarta', 'state': 'North Jakarta', 'country': 'Indonesia', 'facility': 'Kelapa Gading Public Health Center', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}, {'city': 'Jakarta', 'state': 'North Jakarta', 'country': 'Indonesia', 'facility': 'Koja Public Health Center', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}, {'city': 'Jakarta', 'state': 'North Jakarta', 'country': 'Indonesia', 'facility': 'Pademangan Public Health Center', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}, {'city': 'Jakarta', 'state': 'South Jakarta', 'country': 'Indonesia', 'facility': 'Cilandak Public Health Center', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}, {'city': 'Jakarta', 'state': 'South Jakarta', 'country': 'Indonesia', 'facility': 'Jagakarsa Public Health Center', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}, {'city': 'Jakarta', 'state': 'South Jakarta', 'country': 'Indonesia', 'facility': 'Kebayoran Baru Public Health Center', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}, {'city': 'Jakarta', 'state': 'South Jakarta', 'country': 'Indonesia', 'facility': 'Mampang Public Health Center', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}, {'city': 'Jakarta', 'state': 'South Jakarta', 'country': 'Indonesia', 'facility': 'Pancoran Public Health Center', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}, {'city': 'Jakarta', 'state': 'South Jakarta', 'country': 'Indonesia', 'facility': 'Pesanggrahan Public Health Center', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}, {'city': 'Jakarta', 'state': 'West Jakarta', 'country': 'Indonesia', 'facility': 'Cengkareng Public Health Center', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}, {'city': 'Jakarta', 'state': 'West Jakarta', 'country': 'Indonesia', 'facility': 'Grogol Petamburan Public Health Center', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}, {'city': 'Jakarta', 'state': 'West Jakarta', 'country': 'Indonesia', 'facility': 'Kalideres Public Health Center', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}, {'city': 'Jakarta', 'state': 'West Jakarta', 'country': 'Indonesia', 'facility': 'Kebon Jeruk Public Health Center', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}, {'city': 'Jakarta', 'state': 'West Jakarta', 'country': 'Indonesia', 'facility': 'Kembangan Public Health Center', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}, {'city': 'Jakarta', 'state': 'West Jakarta', 'country': 'Indonesia', 'facility': 'Palmerah Public Health Center', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}, {'city': 'Bandung', 'state': 'West Java', 'country': 'Indonesia', 'facility': 'Imunicare Bio Farma', 'geoPoint': {'lat': -6.92222, 'lon': 107.60694}}], 'overallOfficials': [{'name': 'Hindra Irawan Satari, Prof., Dr., dr., SpA(K), M. Trop. Paed', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Committee of Adverse Events Following Immunization / NC Indonesia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PT Bio Farma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}