Ignite Creation Date:
2025-12-24 @ 4:43 PM
Ignite Modification Date:
2026-01-05 @ 7:13 PM
Study NCT ID:
NCT02361866
Status:
COMPLETED
Last Update Posted:
2015-02-12
First Post:
2014-04-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Evaluate the Effectiveness(Immunogeneicity) and Safety of 'GC1107' Administered Intramuscularly in Healthy Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001424', 'term': 'Bacterial Infections'}], 'ancestors': [{'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013745', 'term': 'Tetanus Toxoid'}], 'ancestors': [{'id': 'D014121', 'term': 'Toxoids'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 376}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-11', 'studyFirstSubmitDate': '2014-04-22', 'studyFirstSubmitQcDate': '2015-02-11', 'lastUpdatePostDateStruct': {'date': '2015-02-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-02-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'seroprotection rate of diphtheria and tetanus', 'timeFrame': '28days'}], 'secondaryOutcomes': [{'measure': 'GMT (Geometric Mean Titer)', 'timeFrame': '28days'}, {'measure': 'Boosting response of diphtheria and tetanus compared participants with before and after the injection', 'timeFrame': '28days', 'description': 'Boosting response is defined as more 4 times increase of the antibody titer after the injection'}, {'measure': 'solicited adverse events', 'timeFrame': '7days'}, {'measure': 'unsolicited adverse events', 'timeFrame': '28 days'}, {'measure': 'Seroprotection rate according to the respective age group', 'timeFrame': '28days'}, {'measure': 'GMT according to the respective age group', 'timeFrame': '28days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Bacterial Infections']}, 'referencesModule': {'references': [{'pmid': '30686952', 'type': 'DERIVED', 'citation': 'Lee J, Choi JH, Wie SH, Park SH, Choi SM, Lee MS, Kim TH, Lee HJ, Kang JH. A Phase III Study to Evaluate the Immunogenicity and Safety of GC1107 (Adult Tetanus Diphtheria Vaccine) in Healthy Adults. J Korean Med Sci. 2019 Jan 16;34(4):e31. doi: 10.3346/jkms.2019.34.e31. eCollection 2019 Jan 28.'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to evaluate the effectiveness(immunogeneicity) and safety of 'GC1107' administered intramuscularly in healthy Adults.", 'detailedDescription': 'Randomized, double blind, multicenter, phaseⅢ study'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy Korean adults (age: over 18 years)\n* who got the basic vaccination of DTP(Diphtheria, tetanus, pertussis) in the past\n* Subjects willing to provide written informed consent and able to comply with the requirements for the study\n\nExclusion Criteria:\n\n* subjects who have already got the additional vaccination of Td within 5 years\n* subjects with antitoxin of diphtheria and tetanus ≥1.0 IU/mL (ELISA)\n\n * only applicable in step I\n* subjects who have not recovered from the acute disease within 2 weeks\n* subjects who have the medical history of allergic disease related to the components of investigational drug\n* who got the treatment of blood product and immunoglobulin product within 3 months\n* females who are pregnant\n* females who are breastfeeding\n* subjects who are infected from the diphtheria and tetanus\n* subjects who have experienced the severe adverse events for the diphtheria and tetanus vaccination\n* Subjects who are scheduled to participate in other clinical trial studies during the study\n* Subjects who have participated in any other clinical trials within 4 weeks of the administration of the study\n* Those who take the other medicine that affects this study or are vaccinated other vaccines\n* Subject who have received adrenocortical hormones or immunosuppressive drug within 4weeks of enrollment\n* Subjects with a history of chronic disease obstacles to the study.\n* Subjects who have episode of acute febrile (at least 37.4) after injection of vaccine during the study\n* Subject who have plan of operation during the study.\n* Individuals with other clinically significant medical or psychological condition who are considered by the investigator to be ineligible for the study.'}, 'identificationModule': {'nctId': 'NCT02361866', 'briefTitle': "To Evaluate the Effectiveness(Immunogeneicity) and Safety of 'GC1107' Administered Intramuscularly in Healthy Adults", 'organization': {'class': 'INDUSTRY', 'fullName': 'GC Biopharma Corp'}, 'officialTitle': "Randomized, Double Blind, Multicenter, Phase III Study to Evaluate the Effectiveness(Immunogeneicity) and Safety of 'GC1107' Administered Intramuscularly in Healthy Adults", 'orgStudyIdInfo': {'id': 'GC1107_AD_P3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GC1107', 'description': '0.5ml, intramuscular, a single dosing', 'interventionNames': ['Biological: GC1107']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Tetanus and Diphtheria(Td vaccine)', 'description': '0.5ml, intramuscular, a single dosing', 'interventionNames': ['Biological: Tetanus and Diphtheria(Td vaccine)']}], 'interventions': [{'name': 'GC1107', 'type': 'BIOLOGICAL', 'description': '0.5 ml, Intramuscular, single dose(day0)', 'armGroupLabels': ['GC1107']}, {'name': 'Tetanus and Diphtheria(Td vaccine)', 'type': 'BIOLOGICAL', 'description': '0.5ml, Intramuscular, single dose(day0) only applicable step1', 'armGroupLabels': ['Tetanus and Diphtheria(Td vaccine)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1544-9004', 'city': 'Incheon', 'state': 'Bupyeong 6-dong, Bupyeong-gu,', 'country': 'South Korea', 'facility': "Incheon St. Mary's Hospital Catholic Univ.", 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}], 'overallOfficials': [{'name': 'JungHyeon Choi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Incheon St. Mary's Hospital Catholic University"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Green Cross Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}