Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 11:55 PM
Study NCT ID:
NCT03541694
Status:
COMPLETED
Last Update Posted:
2019-03-26
First Post:
2018-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Passive Enhanced Safety Surveillance of Stamaril® Vaccine in Korea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015004', 'term': 'Yellow Fever'}], 'ancestors': [{'id': 'D000096724', 'term': 'Mosquito-Borne Diseases'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D001102', 'term': 'Arbovirus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018177', 'term': 'Flavivirus Infections'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006482', 'term': 'Hemorrhagic Fevers, Viral'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 622}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2018-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-25', 'studyFirstSubmitDate': '2018-04-23', 'studyFirstSubmitQcDate': '2018-05-17', 'lastUpdatePostDateStruct': {'date': '2019-03-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants reporting suspected related adverse events', 'timeFrame': 'Within 30 days after vaccination', 'description': 'Spontaneous reporting of suspected related adverse events'}], 'secondaryOutcomes': [{'measure': 'Number of participants reporting suspected serious related adverse events', 'timeFrame': 'Within 30 days after vaccination', 'description': 'Spontaneous reporting of serious suspected related adverse events'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Yellow fever', 'Stamaril®'], 'conditions': ['Yellow Fever']}, 'descriptionModule': {'briefSummary': 'This is a passive enhance safety surveillance (ESS) of Stamaril® vaccine in Korea. The objective is to collect suspected related adverse events following vaccination with Stamaril® in routine practice.', 'detailedDescription': 'This ESS replaces the routing post-marketing surveillance required after product approval in Korea.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants who have been vaccinated against yellow fever with Stamaril® vaccine in Korean yellow fever vaccination centers during the enhanced surveillance period.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Vaccination with Stamaril® vaccine in routine practice in Korea'}, 'identificationModule': {'nctId': 'NCT03541694', 'briefTitle': 'Passive Enhanced Safety Surveillance of Stamaril® Vaccine in Korea', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Passive Enhanced Safety Surveillance of the Live Attenuated Yellow Fever Virus Vaccine Stamaril® in Korea', 'orgStudyIdInfo': {'id': 'STA10'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Stamaril®', 'type': 'BIOLOGICAL', 'description': 'Routine vaccination with Stamaril yellow fever vaccine'}]}, 'contactsLocationsModule': {'locations': [{'zip': '04564', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Sanofi Pasteur Investigational Site 001', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi Pasteur, a Sanofi Company'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi Pasteur, a Sanofi Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}