Ignite Creation Date:
2025-12-24 @ 3:16 PM
Ignite Modification Date:
2026-03-02 @ 4:01 PM
Study NCT ID:
NCT03188692
Status:
COMPLETED
Last Update Posted:
2025-01-03
First Post:
2017-06-13
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of BK1310 Intramuscular Injection in Healthy Infants
Sponsor:
Organization:
Raw JSON
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Foundation for Microbial Diseases of Osaka University'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Through study completion, an average of 1 year', 'eventGroups': [{'id': 'EG000', 'title': 'BK1310', 'description': 'DPT-IPV-Hib (Combined Vaccine): 0.5mL, intramuscular injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.', 'otherNumAtRisk': 33, 'deathsNumAtRisk': 33, 'otherNumAffected': 33, 'seriousNumAtRisk': 33, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J Version 20.'}, {'term': 'Crying', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J Version 20.'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 16}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J Version 20.'}, {'term': 'Injection site induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J Version 20.'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J Version 20.'}, {'term': 'Irritability postvaccinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J Version 20.'}, {'term': 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'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J Version 20.'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J Version 20.'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J Version 20.'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J Version 20.'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J Version 20.'}, {'term': 'Arthropod sting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J Version 20.'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J Version 20.'}, {'term': 'Hypersomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 10}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J Version 20.'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 7}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J Version 20.'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J Version 20.'}, {'term': 'Upper respiratory tract inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 11}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J Version 20.'}, {'term': 'Asteatosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J Version 20.'}, {'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 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'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'BK1310', 'description': 'DPT-IPV-Hib (Combined Vaccine): 0.5mL, intramuscular injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '>=2 and <3 months', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}]}]}, {'title': '>=3 months', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian (Japanese)', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-05-24', 'size': 2445337, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-03-22T05:57', 'hasProtocol': True}, {'date': '2018-11-09', 'size': 595379, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-03-22T05:58', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2018-08-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-18', 'studyFirstSubmitDate': '2017-06-13', 'resultsFirstSubmitDate': '2024-03-26', 'studyFirstSubmitQcDate': '2017-06-13', 'lastUpdatePostDateStruct': {'date': '2025-01-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-11-18', 'studyFirstPostDateStruct': {'date': '2017-06-15', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-01-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-11-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Antibody Prevalence Rate Against Anti-PRP With 1 μg/mL or Higher, Diphtheria Toxin, 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With 1 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody', 'timeFrame': '4 weeks after the booster dose (Visit 6)'}, {'measure': 'Anti-PRP Antibody Prevalence Rate With 0.15 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody', 'timeFrame': '4 weeks after the booster dose (Visit 6)'}, {'measure': 'Geometric Mean Antibody Titer of Anti-PRP Antibody', 'timeFrame': '4 weeks after the booster dose (Visit 6)'}, {'measure': 'Geometric Mean Antibody Titer Against Diphtheria Toxin', 'timeFrame': '4 weeks after the primary immunization (Visit 4)'}, {'measure': 'Geometric Mean Antibody Titer Against Pertussis （PT）', 'timeFrame': '4 weeks after the primary immunization (Visit 4)'}, {'measure': 'Geometric Mean Antibody Titer Against Pertussis （FHA）', 'timeFrame': '4 weeks after the primary immunization (Visit 4)'}, {'measure': 'Geometric Mean Antibody Titer Against Tetanus Toxin', 'timeFrame': '4 weeks after the primary immunization (Visit 4)'}, {'measure': 'Fold Change in Geometric Mean Antibody Titer Against Polio Virus', 'timeFrame': 'Baseline and 4 weeks after the primary immunization (Visit 4)'}, {'measure': 'Antibody Prevalence Rate Against Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus', 'timeFrame': '4 weeks after the booster dose (Visit 6)', 'description': 'Antibody prevalence rate is defined as the percentage of participants whose criteria of each antibody titer: Anti-diphtheria antibody concentrations: \\>=0.1 IU/mL, Anti-PT antibody concentrations: \\>=10.0 EU/mL, Anti-FHA antibody concentrations: \\>=10.0 EU/mL, Anti-tetanus antibody concentrations: \\>=0.01 IU/mL, Anti-poliovirus serotype 1,2 and 3 antibody titers (fold) \\>=8'}, {'measure': 'Geometric Mean Antibody Titer Against Diphtheria Toxin', 'timeFrame': '4 weeks after the booster dose (Visit 6)'}, {'measure': 'Geometric Mean Antibody Titer Against Pertussis （PT）', 'timeFrame': '4 weeks after the booster dose (Visit 6)'}, {'measure': 'Geometric Mean Antibody Titer Against Pertussis （FHA）', 'timeFrame': '4 weeks after the booster dose (Visit 6)'}, {'measure': 'Geometric Mean Antibody Titer Against Tetanus Toxin', 'timeFrame': '4 weeks after the booster dose (Visit 6)'}, {'measure': 'Fold Change in Geometric Mean Antibody Titer Against Polio Virus', 'timeFrame': 'Baseline and 4 weeks after the primary immunization (Visit 6)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Haemophilus influenza type b', 'Adsorbed Diphtheria-Purified Pertussis-Tetanus-Inactivate', 'poliovirus combined vaccine', 'Hib', 'DPT-IPV', 'Intramuscular'], 'conditions': ['Immunization']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and efficacy of an 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