Ignite Creation Date:
2025-12-25 @ 12:18 AM
Ignite Modification Date:
2025-12-25 @ 10:21 PM
Study NCT ID:
NCT06006858
Status:
COMPLETED
Last Update Posted:
2023-11-18
First Post:
2023-08-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Post Authorization Safety Study Moderna COVID-19 Primary 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': 'D000090983', 'term': '2019-nCoV Vaccine mRNA-1273'}], 'ancestors': [{'id': 'D000087503', 'term': 'mRNA Vaccines'}, {'id': 'D000087504', 'term': 'Nucleic Acid-Based Vaccines'}, {'id': 'D014614', 'term': 'Vaccines, Synthetic'}, {'id': 'D011994', 'term': 'Recombinant Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D000086663', 'term': 'COVID-19 Vaccines'}, {'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D000941', 'term': 'Antigens'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1284}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-16', 'studyFirstSubmitDate': '2023-08-22', 'studyFirstSubmitQcDate': '2023-08-22', 'lastUpdatePostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Local Reactions Following Moderna COVID-19 Vaccine', 'timeFrame': '28 Days after each dose', 'description': 'Percentage of subject with local reactions following immunization with Moderna COVID-19 vaccine.'}, {'measure': 'Systemic Reactions Following Moderna COVID-19 Vaccine', 'timeFrame': '28 Days after each dose', 'description': 'Percentage of subject with systemic reactions following immunization with Moderna COVID-19'}], 'secondaryOutcomes': [{'measure': 'Immediate Reactions', 'timeFrame': '30 minutes after each dose', 'description': 'percentage of subject with adverse event following immunization with Moderna COVID-19 vaccine.'}, {'measure': '1-3 Days Reactions', 'timeFrame': '1-3 minutes after each dose', 'description': 'percentage of subject with adverse event following immunization with Moderna COVID-19 vaccine.'}, {'measure': '4-7 Days Reactions', 'timeFrame': '4-7 Days after each dose', 'description': 'percentage of subject with adverse event following immunization with Moderna COVID-19 vaccine.'}, {'measure': '8-28 Days Reactions', 'timeFrame': '8-28 Days after each dose', 'description': 'percentage of subject with adverse event following immunization with Moderna COVID-19 vaccine.'}, {'measure': 'Serious Reactions', 'timeFrame': '28 Days after each dose', 'description': 'Any serious adverse events following immunization with Moderna COVID-19 vaccine'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19', 'Moderna Vaccine', 'Safety Vaccine'], 'conditions': ['COVID-19']}, 'descriptionModule': {'briefSummary': 'This study is Post Authorization Safety Study (PASS) Phase IV of Moderna COVID-19 Primary Vaccine', 'detailedDescription': 'This study is Post Authorization Safety Study (PASS) Phase IV, to assess any local and systemic reaction after immunization with Moderna COVID-19 vaccine using retrospective cohort study trial design to assess safety profile following Moderna COVID-19 primary vaccine in healthy adults aged ≥ 18 years in Indonesia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy adults aged ≥ 18 years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinically healthy adults aged ≥ 18 years.\n* Subjects have been informed properly regarding the study and accepted to be enrolled in this study.\n\nExclusion Criteria:\n\n\\- Subjects concomitantly enrolled or scheduled to be enrolled in another trial at the time of receiving the Moderna COVID-19 vaccine.'}, 'identificationModule': {'nctId': 'NCT06006858', 'briefTitle': 'Post Authorization Safety Study Moderna COVID-19 Primary Vaccine', 'organization': {'class': 'INDUSTRY', 'fullName': 'PT Bio Farma'}, 'officialTitle': 'Safety Profile Following Moderna COVID-19 Primary Vaccine in Healthy Adults Aged ≥ 18 Years in Indonesia', 'orgStudyIdInfo': {'id': 'COV19M-0422'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Moderna COVID-19 Vaccine', 'description': 'Clinically healthy adults aged ≥ 18 years who received Primary Moderna COVID-19 Vaccine', 'interventionNames': ['Biological: Moderna COVID-19 Vaccine']}], 'interventions': [{'name': 'Moderna COVID-19 Vaccine', 'type': 'BIOLOGICAL', 'description': 'Moderna COVID-19 Vaccine is provided as a white to off-white suspension for intramuscular injection. Each 0.5 mL dose of Moderna COVID-19 Vaccine contains 100 mcg of nucleoside-modified messenger RNA (mRNA) encoding the pre-fusion stabilized Spike glycoprotein (S) of SARS-CoV-2 virus.', 'armGroupLabels': ['Moderna COVID-19 Vaccine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10130', 'city': 'Jakarta Pusat', 'state': 'Jakarta Special Capital Region', 'country': 'Indonesia', 'facility': 'Gambir Public Health Center', 'geoPoint': {'lat': -6.1818, 'lon': 106.8223}}, {'zip': '10560', 'city': 'Jakarta Pusat', 'state': 'Jakarta Special Capital Region', 'country': 'Indonesia', 'facility': 'Johar Baru Public Health Center', 'geoPoint': {'lat': -6.1818, 'lon': 106.8223}}, {'zip': '10570', 'city': 'Jakarta Pusat', 'state': 'Jakarta Special Capital Region', 'country': 'Indonesia', 'facility': 'Cempaka Putih Public Health Center', 'geoPoint': {'lat': -6.1818, 'lon': 106.8223}}, {'zip': '10640', 'city': 'Jakarta Pusat', 'state': 'Jakarta Special Capital Region', 'country': 'Indonesia', 'facility': 'Kemayoran Public Health Center', 'geoPoint': {'lat': -6.1818, 'lon': 106.8223}}, {'zip': '11480', 'city': 'Jakarta', 'country': 'Indonesia', 'facility': 'Palmerah Public Health Center', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}, {'zip': '11530', 'city': 'Jakarta', 'country': 'Indonesia', 'facility': 'Kebon Jeruk Public Health Center', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}, {'zip': '11730', 'city': 'Jakarta', 'country': 'Indonesia', 'facility': 'Cengkareng Public Health Center', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}, {'zip': '12240', 'city': 'Jakarta', 'country': 'Indonesia', 'facility': 'Kebayoran Lama Public Health Center', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}, {'zip': '12820', 'city': 'Jakarta', 'country': 'Indonesia', 'facility': 'Tebet Public Health Center', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}, {'zip': '12980', 'city': 'Jakarta', 'country': 'Indonesia', 'facility': 'Setiabudi Public Health Center', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}, {'zip': '13260', 'city': 'Jakarta', 'country': 'Indonesia', 'facility': 'Pulo Gadung Public Health Center', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}, {'zip': '13420', 'city': 'Jakarta', 'country': 'Indonesia', 'facility': 'Duren Sawit Public Health Center', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}, {'zip': '13440', 'city': 'Jakarta', 'country': 'Indonesia', 'facility': 'Regional Hospital Duren Sawit', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}, {'zip': '13510', 'city': 'Jakarta', 'country': 'Indonesia', 'facility': 'Kramat Jati Public Health Center', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}, {'zip': '14120', 'city': 'Jakarta', 'country': 'Indonesia', 'facility': 'Cilincing Public Health Center', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}, {'zip': '14260', 'city': 'Jakarta', 'country': 'Indonesia', 'facility': 'Koja Public Health Center', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}, {'zip': '14310', 'city': 'Jakarta', 'country': 'Indonesia', 'facility': 'Tanjung Priok Public Health Center', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}, {'zip': '14410', 'city': 'Jakarta', 'country': 'Indonesia', 'facility': 'Pademangan Public Health Center', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}], 'overallOfficials': [{'name': 'Julitasari Sundoro, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Advisory Immunization Committee'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PT Bio Farma', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'National Advisory Immunization Committee Indonesia', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}