Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2025-12-27 @ 6:42 PM
Study NCT ID:
NCT01389466
Status:
COMPLETED
Last Update Posted:
2014-11-21
First Post:
2011-06-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate the Safety and Immunogenicity of MG1109 in Healthy Adult Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007251', 'term': 'Influenza, Human'}, {'id': 'D005585', 'term': 'Influenza in Birds'}], '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'}, {'id': 'D001715', 'term': 'Bird Diseases'}, {'id': 'D000820', 'term': 'Animal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000601529', 'term': 'SE 1-step Futurabond M'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 346}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-20', 'studyFirstSubmitDate': '2011-06-19', 'studyFirstSubmitQcDate': '2011-07-07', 'lastUpdatePostDateStruct': {'date': '2014-11-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of subjects achieving post-vaccination Hemagglutination Inhibition(HI) antibody titer ≥ 1:40 in each dose group', 'timeFrame': '42 days after vaccination'}, {'measure': 'Number of subjects with Solicited / Unsolicited adverse events', 'timeFrame': 'With in 24 weeks after vaccination'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Avian influenza'], 'conditions': ['Influenza']}, 'descriptionModule': {'briefSummary': 'This study was designed in two steps with Step 1, a single-center, double-blind, randomized clinical Pilot study and Step 2, a multi-center, single-blind, randomized clinical Pivotal study. The investigator evaluate the immunogenicity and safety of the investigational vaccine in the subjects during their participation in the study.', 'detailedDescription': 'MG1109 is purified, inactivated influenza viral antigen.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '58 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adults who are available for follow-up during the study\n\nExclusion Criteria:\n\n* Subjects with history of exposure to the H5N1 subtype or H5N1 subtype vaccine\n* Subjects with immune system disorder including immune deficiency disease'}, 'identificationModule': {'nctId': 'NCT01389466', 'briefTitle': 'Study to Evaluate the Safety and Immunogenicity of MG1109 in Healthy Adult Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'GC Biopharma Corp'}, 'officialTitle': "Randomized Phase I/II Study to Evaluate the Safety and Immunogenicity of 'MG1109(Egg-based, Pre-pandemic Influenza(H5N1) Vaccine)' Administered Intramuscularly in Healthy Adult Volunteers", 'orgStudyIdInfo': {'id': 'MG1109_P1/2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MG1109 - Step 1', 'interventionNames': ['Biological: Step 1']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Normal Saline - Step 1', 'interventionNames': ['Biological: Step 1']}, {'type': 'EXPERIMENTAL', 'label': 'MG1109 - Step 2', 'interventionNames': ['Biological: Step 2']}], 'interventions': [{'name': 'Step 1', 'type': 'BIOLOGICAL', 'description': 'Investigational Product : MG1109 Dose : Cohort 1 : 0.125 mL Cohort 2 :0.25 mL Cohort 3 :0.5 mL Cohort 4 :1.0 mL intramuscularly injection, twice at an interval of 21 days', 'armGroupLabels': ['MG1109 - Step 1', 'Normal Saline - Step 1']}, {'name': 'Step 2', 'type': 'BIOLOGICAL', 'description': 'Investigational Product : MG1109 Dose : Cohort 1 :0.5 mL Cohort 2 :1.0 mL intramuscularly injection, twice at an interval of 21 days', 'armGroupLabels': ['MG1109 - Step 2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ansan', 'country': 'South Korea', 'facility': 'Korea University Ansan Hospital', 'geoPoint': {'lat': 36.8741, 'lon': 126.2116}}, {'city': 'Inchon', 'country': 'South Korea', 'facility': 'Inha University Hospital', 'geoPoint': {'lat': 35.55479, 'lon': 126.6251}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Korea University Guro Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Suwon', 'country': 'South Korea', 'facility': "Catholic University Of Korea ST. Vincent's Hospital", 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}], 'overallOfficials': [{'name': 'Woo Joo Kim, MD, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Korea University Guro Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Green Cross Corporation', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Korean Center for Disease Control and Prevention', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}