Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2026-02-22 @ 6:44 PM
Study NCT ID:
NCT02532569
Status:
COMPLETED
Last Update Posted:
2017-02-06
First Post:
2015-08-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-term Immunogenicity and Safety of Fourth Administration of Boryung Cell-Culture Japanese Encephalitis Vaccineinj
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004672', 'term': 'Encephalitis, Japanese'}], 'ancestors': [{'id': 'D004671', 'term': 'Encephalitis, Arbovirus'}, {'id': 'D018792', 'term': 'Encephalitis, Viral'}, {'id': 'D020805', 'term': 'Central Nervous System Viral Diseases'}, {'id': 'D002494', 'term': 'Central Nervous System Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000069544', 'term': 'Infectious Encephalitis'}, {'id': 'D001102', 'term': 'Arbovirus Infections'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}, {'id': 'D000096724', 'term': 'Mosquito-Borne Diseases'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D018177', 'term': 'Flavivirus Infections'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D004660', 'term': 'Encephalitis'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D022321', 'term': 'Japanese Encephalitis Vaccines'}], 'ancestors': [{'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Open Label'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 94}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-03', 'studyFirstSubmitDate': '2015-08-21', 'studyFirstSubmitQcDate': '2015-08-25', 'lastUpdatePostDateStruct': {'date': '2017-02-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-08-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess the seroconversion rates before and after the fourth dose of JEV', 'timeFrame': 'Day 28 (28 days after booster dose)]'}], 'secondaryOutcomes': [{'measure': 'To assess the seropositive rates before and after the fourth dose of JEV', 'timeFrame': 'Day 28 (28 days after booster dose)]'}, {'measure': 'To assess the geometric mean titer (GMT) before and after the fourth dose of JEV', 'timeFrame': 'Day 28 (28 days after booster dose)]'}, {'measure': 'To assess the percentage of subjects who develop neutralizing antibody titers', 'timeFrame': 'Day 28 (28 days after booster dose)'}, {'measure': 'To assess the percentage of subjects in their neutralizing anti-body titers', 'timeFrame': 'Day 28 (28 days after booster dose)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Japanese Encephalitis']}, 'referencesModule': {'references': [{'pmid': '29429815', 'type': 'DERIVED', 'citation': 'Yun KW, Lee HJ, Park JY, Cho HK, Kim YJ, Kim KH, Kim NH, Hong YJ, Kim DH, Kim HM, Cha SH. Long-term immunogenicity of an initial booster dose of an inactivated, Vero cell culture-derived Japanese encephalitis vaccine (JE-VC) and the safety and immunogenicity of a second JE-VC booster dose in children previously vaccinated with an inactivated, mouse brain-derived Japanese encephalitis vaccine. Vaccine. 2018 Mar 7;36(11):1398-1404. doi: 10.1016/j.vaccine.2018.01.075.'}]}, 'descriptionModule': {'briefSummary': 'A multi-center, open, phase 4 clinical trial to assess the long-term immunogenicity and safety of fourth administration of Boryung Cell-Culture Japanese Encephalitis Vaccine inj. and to conduct an exploratory investigation on vaccine interchangeability in Korean children aged 6 years who received primary 3 doses with ENCEVAC® or Japanese Encephalitis Vaccine-GCC® inj.', 'detailedDescription': 'This is a follow-up study of KD287-BR-CT-301 (ClinicalTrials.gov identifier: NCT01150942), a phase 3 study to investigate the efficacy and safety of a cell-culture Japanese encephalitis vaccine (ENCEVAC®) compared with that of a mouse brain-derived Japanese encephalitis vaccine (Japanese Encephalitis vaccine-GCC® inj). Subjects participated in KD287-BR-CT-301 study were to receive 3 doses of Japanese encephalitis vaccine (JEV) assigned by randomization from the age of 12 months and those subjects who completed the 3 doses of JEV are the target population in this study. The purpose of this study is to investigate the long-term immunogenicity and safety of the booster (fourth) dose of JEV, which will be given as Boryung Cell-Culture Japanese Encephalitis Vaccine inj, proven to be same with ENCEVAC® but manufactured by a different manufacturer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Years', 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Parent/guardian (legally authorized representative) has given voluntary written consent to the subject's participation after being fully informed of the purpose, methods, risks, and benefits of the study.\n* Male and female children who have completed the primary 3 doses of JEV in the KD287-BR-CT-301study.\n* Male and female children reaching at least 6 years of age on the day of booster dosing of JEV.\n* Male and female children who are identified to be healthy based on physical examination and medical history.\n\nExclusion Criteria:\n\n* Children who have acute febrile illness with tympanic temperature of ≥38.0 ℃ on the day of booster dosing of JEV.\n* Children who have moderate or severe acute disease (regardless of fever).\n* Children who have history of encephalitis, encephalopathy, cerebromeningitis, or convulsion.\n* Children who have received JEV (including live JEV) other than the investigational products administered in the KD287-BR-CT-301study.\n* Children who have had fever (≥ 40 °C) or systemic allergy within 48 hours after vaccination.\n* Children who have shown anaphylactic reaction to the investigational products administered in the KD287-BR-CT-301study or who are likely to be allergic to the ingredients of the investigational product.\n* Children who have been diagnosed with immunodeficiency such as acquired immune deficiency or who have family history of immunodeficiency.\n* Children who have received other vaccines within 28 days before booster dosing of JEV (vaccines to be administered according to the national vaccination program.\n* Children who have received immunosuppressive thera-py within 28 days before booster dosing of JEV.\n* There is a possibility that immune globulin preparations has not been excreted enough on the day of booster dosing of JEV if children have received such a product.\n* Children who are currently participating or planning to participate in other clinical stud-ies during the study period.\n* Other ineligible conditions judged at the discretion of principal investigators or subinvestigators."}, 'identificationModule': {'nctId': 'NCT02532569', 'acronym': 'BR-JELITE', 'briefTitle': 'Long-term Immunogenicity and Safety of Fourth Administration of Boryung Cell-Culture Japanese Encephalitis Vaccineinj', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boryung Pharmaceutical Co., Ltd'}, 'officialTitle': 'A Multi-center, Open, phase4 Study to Assess the Long-term Immunogenicity and Safety of Fourth Administration of BR JEV and to Investigate on Vaccine Interchangeability in Children Aged 6 Years Who Received 3 Doses With ENCEVAC or JEV-GCC', 'orgStudyIdInfo': {'id': 'BR-KD-287-CT-401'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Japanese encephalitis vaccine', 'description': 'After reconstitution with 0.7 mL of the provided diluent, 0.5-mL dose,SC', 'interventionNames': ['Biological: Japanese encephalitis vaccine']}], 'interventions': [{'name': 'Japanese encephalitis vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['Boryung Cell-Culture Japanese Encephalitis Vaccine'], 'description': 'Dosage and administration: After reconstitution with 0.7 mL of the provided diluent, 0.5-mL dose is administered subcutaneously in the lateral aspect of the upper arm.', 'armGroupLabels': ['Japanese encephalitis vaccine']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Wŏnju', 'state': 'Gangwon-do', 'country': 'South Korea', 'facility': 'Wonju Sevrance Christian Hospital', 'geoPoint': {'lat': 37.35139, 'lon': 127.94528}}, {'city': 'Goyang-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Inje University Ilsan Paik Hospital', 'geoPoint': {'lat': 37.65639, 'lon': 126.835}}, {'city': 'Incheon', 'country': 'South Korea', 'facility': 'Gachon University Gil Medical Center', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'city': 'Incheon', 'country': 'South Korea', 'facility': 'Inha University Hospital', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Ewha Womans University Mokdong Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Korea Cancer Center Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'KyungHee University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'HJ Jung, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Boryung Pharmaceutical Company'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boryung Pharmaceutical Co., Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}