Ignite Creation Date:
2025-12-24 @ 3:44 PM
Ignite Modification Date:
2026-01-04 @ 5:32 PM
Study NCT ID:
NCT05739292
Status:
COMPLETED
Last Update Posted:
2023-12-20
First Post:
2023-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Immunogenicity of Pentavalent Meningococcal Conjugate Vaccine (EuNmCV-5) in Healthy Adults Aged 19 to 55 Years Old
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008589', 'term': 'Meningococcal Infections'}], 'ancestors': [{'id': 'D016870', 'term': 'Neisseriaceae Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018074', 'term': 'Vaccines, Conjugate'}, {'id': 'D022401', 'term': 'Meningococcal Vaccines'}], 'ancestors': [{'id': 'D014614', 'term': 'Vaccines, Synthetic'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D000941', 'term': 'Antigens'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D001428', 'term': 'Bacterial Vaccines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-10-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-19', 'studyFirstSubmitDate': '2023-02-12', 'studyFirstSubmitQcDate': '2023-02-12', 'lastUpdatePostDateStruct': {'date': '2023-12-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of solicited adverse events', 'timeFrame': 'within 7 days post vaccination', 'description': 'local and systemic AEs'}, {'measure': 'Occurrence of unsolicited adverse events', 'timeFrame': 'within 28 days post vaccination'}, {'measure': 'Occurrence of serious adverse events', 'timeFrame': 'within 180 days post vaccination'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Infection, Meningococcal']}, 'referencesModule': {'references': [{'pmid': '39112515', 'type': 'DERIVED', 'citation': 'Kim Y, Bae S, Yu KS, Lee S, Lee C, Kim J, Her H, Oh J. A randomized study to evaluate the safety and immunogenicity of a pentavalent meningococcal vaccine. NPJ Vaccines. 2024 Aug 7;9(1):140. doi: 10.1038/s41541-024-00935-8.'}]}, 'descriptionModule': {'briefSummary': 'Phase I study to evaluate safety and immunogenicity in healthy adult subjects following a single dose administration of Meningococcal (Group A, C, W-135, X, and Y)-CRM197 Conjugate vaccine'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects 19 to 55 years of age\n* Written informed consent\n* Available for all visits and telephone calls scheduled for the study\n\nExclusion Criteria:\n\n* Previous or suspected disease caused by N. meningitides\n* Household and/or intimate exposure to an individual with culture-proven N. meningitides infection within 60 days prior to screening\n* Serious acute, chronic or progressive disease as determined by investigator\n* History of alcohol or substance abuse'}, 'identificationModule': {'nctId': 'NCT05739292', 'briefTitle': 'Safety and Immunogenicity of Pentavalent Meningococcal Conjugate Vaccine (EuNmCV-5) in Healthy Adults Aged 19 to 55 Years Old', 'organization': {'class': 'INDUSTRY', 'fullName': 'EuBiologics Co.,Ltd'}, 'officialTitle': 'A Single Center, Randomized, Observer-blinded, Active Comparator Phase I Study to Assess the Safety and Immunogenicity of Meningococcal (Groups A, C, W-135, X and Y) Conjugate Vaccine in Healthy Adults Aged 19 to 55 Years Old', 'orgStudyIdInfo': {'id': 'EuVCT_MCV102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'EuNmCV-5', 'description': 'Healthy adults received 0.5mL single intramuscular dose on Day 0.', 'interventionNames': ['Biological: EuNmCV-5']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Menveo', 'description': 'Healthy adults received 0.5mL single intramuscular dose on Day 0.', 'interventionNames': ['Biological: Menveo']}], 'interventions': [{'name': 'EuNmCV-5', 'type': 'BIOLOGICAL', 'otherNames': ['Meningococcal(Groups A, C, W-135, X, and Y) Conjugate Vaccine'], 'description': '0.5mL single intramuscular dose on Day 0', 'armGroupLabels': ['EuNmCV-5']}, {'name': 'Menveo', 'type': 'BIOLOGICAL', 'otherNames': ['Meningococcal(Groups A, C, Y, and W-135) Conjugate Vaccine'], 'description': '0.5mL single intramuscular dose on Day 0', 'armGroupLabels': ['Menveo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'YJ Choi', 'role': 'STUDY_DIRECTOR', 'affiliation': 'EuBiologics Co.,Ltd'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'EuBiologics Co.,Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}