Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2026-01-02 @ 11:17 AM
Study NCT ID:
NCT04830358
Status:
COMPLETED
Last Update Posted:
2021-10-07
First Post:
2021-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Immunogenicity of the 'EuPCV15' in Healthy Korean Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011008', 'term': 'Pneumococcal Infections'}], 'ancestors': [{'id': 'D013290', 'term': 'Streptococcal Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C538862', 'term': '13-valent pneumococcal vaccine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-06', 'studyFirstSubmitDate': '2021-03-31', 'studyFirstSubmitQcDate': '2021-04-01', 'lastUpdatePostDateStruct': {'date': '2021-10-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Solicited AEs (Local and Systemic)', 'timeFrame': 'within 14 days after vaccination'}, {'measure': 'Incidence of Unsolicited AEs', 'timeFrame': 'within 28 days after vaccination'}, {'measure': 'Incidence of SAEs', 'timeFrame': 'within 180 days after vaccination'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pneumococcal Disease']}, 'descriptionModule': {'briefSummary': 'The safety and immunogenicity of EuPCV15 compared to Prevenar13 are assessed in healthy adults.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Healthy adults aged 19 to 50 years old\n2. Participants willing to give written informed consent to participate in the trial\n\nExclusion Criteria:\n\n1. History of invasive pneumococcal infection within 5 years at screening\n2. Known hypersensitivity to any component of the study vaccine\n3. Immune deficiency or immunosuppressive disorder\n4. Immunized with any licensed vaccine within 4 weeks prior to screening\n5. Pregnant, lactating women or women of childbearing age not using a reliable method of contraception\n6. Participants who in the opinion of the investigator will not be able to comply with any of the protocol required procedure'}, 'identificationModule': {'nctId': 'NCT04830358', 'briefTitle': "Safety and Immunogenicity of the 'EuPCV15' in Healthy Korean Adults", 'organization': {'class': 'INDUSTRY', 'fullName': 'EuBiologics Co.,Ltd'}, 'officialTitle': "A Single Center, Randomized, Single-blind, Active Comparator Phase 1 Clinical Trial to Assess the Safety and Immunogenicity of the 'EuPCV15' in Healthy Korean Adults", 'orgStudyIdInfo': {'id': 'EuVCT_PCV101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'EuPCV15', 'description': 'Single dose of Pneumococcal Conjugate Vaccine will be administered intramuscularly at Day 0.', 'interventionNames': ['Biological: EuPCV15']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Prevenar13', 'description': 'Single dose of Pneumococcal Conjugate Vaccine will be administered intramuscularly at Day 0.', 'interventionNames': ['Biological: Prevenar13']}], 'interventions': [{'name': 'EuPCV15', 'type': 'BIOLOGICAL', 'description': '15-valent Pneumococcal conjugate vaccine', 'armGroupLabels': ['EuPCV15']}, {'name': 'Prevenar13', 'type': 'BIOLOGICAL', 'description': '13-valent Pneumococcal conjugate vaccine', 'armGroupLabels': ['Prevenar13']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': "The Catholic University of Seoul St.Mary's Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'EuBiologics Co.,Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}