Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2025-12-29 @ 7:55 PM
Study NCT ID:
NCT06333704
Status:
RECRUITING
Last Update Posted:
2025-03-19
First Post:
2024-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post-marketing Surveillance (PMS) Use-Result Surveillance With SPIKEVAX BIVALENT and SPIKEVAX X Injection.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000722934', 'term': 'CVnCoV COVID-19 vaccine'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 4206}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2028-12-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-17', 'studyFirstSubmitDate': '2024-03-20', 'studyFirstSubmitQcDate': '2024-03-20', 'lastUpdatePostDateStruct': {'date': '2025-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With AEs', 'timeFrame': 'Up to 28 days post vaccination'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['mRNA-1273', 'mRNA-1273 vaccine', 'SARS-CoV-2', 'SARS-CoV-2 Vaccine', 'Coronavirus', 'Virus Diseases', 'Messenger RNA', 'COVID-19', 'COVID-19 Vaccine', 'Moderna'], 'conditions': ['SARS-CoV-2']}, 'descriptionModule': {'briefSummary': 'The main objective of the surveillance is to evaluate the incidence of the adverse events (AEs), and other safety related information in South-Korean population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The population of this survey is Korean participants vaccinated with SPIKEVAX BIVALENT or SPIKEVAX X injection who meet the inclusion/exclusion criteria.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participants should be 18 years or older for Spikevax bivalent BA.1, SPIKEVAX BIVALENT BA.4/5 vaccine, and 12 years or older for Spikevax XBB.1.5 injection.\n* Participants of any age which is approved for the use of SPIKEVAX BIVALENT BA.1, SPIKEVAX BIVALENT BA.4/5 or SPIKEVAX XBB.1.5 for active immunization to prevent COVID-19 caused by SARS-CoV-2.\n* Participant who will be vaccinated with SPIKEVAX BIVALENT BA.1, SPIKEVAX BIVALENT BA.4/5 or SPIKEVAX XBB.1.5 following local label approved by Ministry of Food and Drug Safety (MFDS).\n* Participant who will be vaccinated with at least one dose of SPIKEVAX BIVALENT BA.1, SPIKEVAX BIVALENT BA.4/5 or SPIKEVAX XBB.1.5.\n\nExclusion Criteria:\n\n* Participant whose participation is deemed inappropriate at the investigator's discretion.\n\nNote: Other protocol-defined inclusion/exclusion criteria may apply."}, 'identificationModule': {'nctId': 'NCT06333704', 'briefTitle': 'Post-marketing Surveillance (PMS) Use-Result Surveillance With SPIKEVAX BIVALENT and SPIKEVAX X Injection.', 'organization': {'class': 'INDUSTRY', 'fullName': 'ModernaTX, Inc.'}, 'officialTitle': 'A Multi-Centre, Prospective, Observational Post-Marketing Surveillance to Investigate the Long-Term Safety of SPIKEVAX BIVALENT and SPIKEVAX X Injection Under Routine Clinical Care in Korea', 'orgStudyIdInfo': {'id': 'mRNA-1273-P924'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'SPIKEVAX BIVALENT or SPIKEVAX X', 'description': 'Participants receiving at least 1 dose of SPIKEVAX BIVALENT vaccine or SPIKEVAX X Injection are monitored for safety parameters up to 28 days post vaccination.', 'interventionNames': ['Biological: SPIKEVAX Bivalent', 'Biological: SPIKEVAX X']}], 'interventions': [{'name': 'SPIKEVAX Bivalent', 'type': 'BIOLOGICAL', 'otherNames': ['SPIKEVAX Bivalent BA.1', 'SPIKEVAX BIVALENT BA.4/5', 'SARS-CoV-2-mRNA vaccine'], 'description': 'No study drug will be administered during this study as this is an observational study.', 'armGroupLabels': ['SPIKEVAX BIVALENT or SPIKEVAX X']}, {'name': 'SPIKEVAX X', 'type': 'BIOLOGICAL', 'otherNames': ['SPIKEVAX XBB.1.5', 'SARS-CoV-2-mRNA vaccine'], 'description': 'No study drug will be administered during this study as this is an observational study.', 'armGroupLabels': ['SPIKEVAX BIVALENT or SPIKEVAX X']}]}, 'contactsLocationsModule': {'locations': [{'zip': '26428', 'city': 'Wŏnju', 'state': 'Gangwon-do', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Yonseimin Clinic', 'geoPoint': {'lat': 37.35139, 'lon': 127.94528}}, {'zip': '14483', 'city': 'Bucheon-si', 'state': 'Gyeonggi-do', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Hyundai Clinic', 'geoPoint': {'lat': 37.49889, 'lon': 126.78306}}, {'zip': '14614', 'city': 'Bucheon-si', 'state': 'Gyeonggi-do', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Ma Hak ki Family Medicine Clinic', 'geoPoint': {'lat': 37.49889, 'lon': 126.78306}}, {'zip': '10108', 'city': 'Gimpo-si', 'state': 'Gyeonggi-do', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Nalee Hospital', 'geoPoint': {'lat': 37.62361, 'lon': 126.71417}}, {'zip': '10234', 'city': 'Goyang-si', 'state': 'Gyeonggi-do', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'COA ENT Clinic', 'geoPoint': {'lat': 37.65639, 'lon': 126.835}}, {'zip': '14250', 'city': 'Gwangmyeong', 'state': 'Gyeonggi-do', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Joon Pediatric Clinic', 'geoPoint': {'lat': 37.47722, 'lon': 126.86639}}, {'zip': '14998', 'city': 'Siheung', 'state': 'Gyeonggi-do', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Janghyeon Medicine Clinic'}, {'zip': '11404', 'city': 'Yangju', 'state': 'Gyeonggi-do', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Hanyang Union Rehabilitation Medicine Clinic', 'geoPoint': {'lat': 37.83311, 'lon': 127.06169}}, {'zip': '11456', 'city': 'Yangju', 'state': 'Gyeonggi-do', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'KimHyungjoo Clinic', 'geoPoint': {'lat': 37.83311, 'lon': 127.06169}}, {'zip': '54072', 'city': 'Gunsan', 'state': 'Jeollabuk-do', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Kium Children Hospital', 'geoPoint': {'lat': 35.97861, 'lon': 126.71139}}, {'zip': '48111', 'city': 'Busan', 'status': 'TERMINATED', 'country': 'South Korea', 'facility': 'Sinsegie ENT Clinic', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '61108', 'city': 'Gwangju', 'status': 'WITHDRAWN', 'country': 'South Korea', 'facility': 'Jeil Family Medicine Clinic', 'geoPoint': {'lat': 35.15472, 'lon': 126.91556}}, {'zip': '21405', 'city': 'Incheon', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Bupyeong Yonsei Medical Clinic', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'zip': '22332', 'city': 'Incheon', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Inha University Hospital', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'zip': '01684', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Woori Medical Clinic', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '01851', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Yonsei Kids Pediatrics Clinic', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '03912', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Star Pediatrics Clinic', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '04032', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Seoul Bon Clinic', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '05351', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': "Dr Cho's Family Medical Clinic", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '05769', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Songpa Korea Neurosurgical Clinic', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '06568', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'GF Pediatrics Clinic', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '06727', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Kim Il Joong Internal Medicine Clinic', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '07327', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'New Yonsei ENT Clinic', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '08701', 'city': 'Seoul', 'status': 'TERMINATED', 'country': 'South Korea', 'facility': 'Soo Orthopedics Clinic', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Moderna WeCare Team', 'role': 'CONTACT', 'email': 'WeCareClinicalTrials@modernatx.com', 'phone': '1-866-663-3762'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ModernaTX, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}