Ignite Creation Date:
2025-12-24 @ 9:06 PM
Ignite Modification Date:
2026-01-22 @ 1:08 PM
Study NCT ID:
NCT02917304
Status:
COMPLETED
Last Update Posted:
2017-05-30
First Post:
2016-09-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Efficacy and Safety of GC3110A in Healthy Subjects Aged 65 Years and Older
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007251', 'term': 'Influenza, Human'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009976', 'term': 'Orthomyxoviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 274}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2017-05-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-24', 'studyFirstSubmitDate': '2016-09-26', 'studyFirstSubmitQcDate': '2016-09-26', 'lastUpdatePostDateStruct': {'date': '2017-05-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Achieving Pre-defined Seroconversion Before and following vaccination', 'timeFrame': 'Day 0 (Pre-Vaccination) and Day 21 (Post-Vaccination)', 'description': 'Percentage of Participants Achieving Pre-defined Seroconversion Before and following vaccination'}, {'measure': 'Percentage of Participants Achieving Pre-defined Seroprotection Before and following vaccination', 'timeFrame': 'Day 0 (Pre-Vaccination) and Day 21 (Post-Vaccination)', 'description': 'Percentage of Participants Achieving Pre-defined Seroprotection Before and following vaccination'}], 'secondaryOutcomes': [{'measure': 'Geometric Mean Titer and Geometric Mean Titer Ratios of Antibodies to the GC3110A Before and Following Vaccination', 'timeFrame': 'Day 0 (Pre-Vaccination) and Day 21 (Post-Vaccination)', 'description': 'Geometric Mean Titer and Geometric Mean Titer Ratios of Antibodies to the GC3110A Before and Following Vaccination'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Quadrivalent Influenza Vaccines'], 'conditions': ['Influenza, Human']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate immunological efficacy and safety of GC3110A among healthy adults over 65 years of age.', 'detailedDescription': 'Adults over 65 years of age will be once administered GC3110A(Quadrivalent influenza vaccine).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adults aged 65 years and older\n* Informed consent form has been signed and dated\n* Able to comply with the requirements of the study\n\nExclusion Criteria:\n\n* Known systemic hypersensitivity to eggs, chicken proteins, or any of the vaccine components\n* Personal history of Guillain-Barre syndrome(GBS)\n* Subjects with severe chronic disease who are considered by investigator to be ineligible for the study\n* Subjects who received a vaccination within 28 days before enrollment or who are scheduled for another vaccination during the study\n* Immunocompromised subjects with immunodeficiency disease or subjects receiving immunosuppressive or immunomodulating therapy'}, 'identificationModule': {'nctId': 'NCT02917304', 'briefTitle': 'A Study to Evaluate the Efficacy and Safety of GC3110A in Healthy Subjects Aged 65 Years and Older', 'organization': {'class': 'INDUSTRY', 'fullName': 'GC Biopharma Corp'}, 'officialTitle': 'A Multicenter, Open-label, Single Arm Study to Evaluate the Immunological Efficacy and Safety of GC3110A. Administered Intramuscularly in Healthy Subjects Aged 65 Years and Older', 'orgStudyIdInfo': {'id': 'GC3110A_ED_P3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GC3110A vaccine group', 'description': 'Participants administered a single dose of GC3110A(Quadrivalent Influenza Vaccine).', 'interventionNames': ['Biological: GC3110A vaccine']}], 'interventions': [{'name': 'GC3110A vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['GC3110A'], 'description': '0.5mL, Intramuscular', 'armGroupLabels': ['GC3110A vaccine group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Daejeon', 'country': 'South Korea', 'facility': "The Catholic Univ. of Korea Daejeon St.Mary's Hospital", 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}, {'city': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Soon Chun Hyang University Bucheon Hospital', 'geoPoint': {'lat': 37.58944, 'lon': 126.76917}}, {'city': 'Gyeonggi-do', 'country': 'South Korea', 'facility': "The Catholic Univ.of Korea Bucheon St.Mary's Hospital", 'geoPoint': {'lat': 37.58944, 'lon': 126.76917}}, {'city': 'Gyeonggi-do', 'country': 'South Korea', 'facility': "The Catholic Univ.of Korea Uijeongbu St.Mary's Hospital", 'geoPoint': {'lat': 37.58944, 'lon': 126.76917}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': "EWHA woman's university mokdong hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'KyungHee University Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Soon Chun Hyang University Seoul Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': "The Catholic Univ. of Korea Incheon St.Mary's Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': "The Catholic Univ.of Korea Seoul St.Mary's Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': "The Catholic Univ.of Korea Yeouido St.Mary's Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Green Cross Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}