Ignite Creation Date:
2025-12-24 @ 1:07 PM
Ignite Modification Date:
2026-01-20 @ 8:43 AM
Study NCT ID:
NCT02118961
Status:
COMPLETED
Last Update Posted:
2017-01-13
First Post:
2014-04-13
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of BK1301 (DTaP Vaccine) as a Booster in Adolescents
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004165', 'term': 'Diphtheria'}, {'id': 'D013742', 'term': 'Tetanus'}, {'id': 'D014917', 'term': 'Whooping Cough'}], 'ancestors': [{'id': 'D003354', 'term': 'Corynebacterium Infections'}, {'id': 'D000193', 'term': 'Actinomycetales Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D003015', 'term': 'Clostridium Infections'}, {'id': 'D001885', 'term': 'Bordetella Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013745', 'term': 'Tetanus Toxoid'}, {'id': 'D022681', 'term': 'Diphtheria-Tetanus-acellular Pertussis Vaccines'}], 'ancestors': [{'id': 'D014121', 'term': 'Toxoids'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D010567', 'term': 'Pertussis Vaccine'}, {'id': 'D001428', 'term': 'Bacterial Vaccines'}, {'id': 'D004168', 'term': 'Diphtheria Toxoid'}, {'id': 'D017778', 'term': 'Vaccines, Combined'}, {'id': 'D022282', 'term': 'Vaccines, Acellular'}, {'id': 'D022223', 'term': 'Vaccines, Subunit'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'cti-inq-ml@ml.mt-pharma.co.jp/clinicaldevelopment@mail.biken.or.jp', 'title': 'Clinical Trials, Information Desk / Clinical Development counter', 'organization': 'Mitsubishi Tanabe Pharma Corporation / The Research Foundation for Microbial Diseases of Osaka University'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'BK1301', 'description': 'Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301): 0.5 mL, subcutaneous injection', 'otherNumAtRisk': 223, 'otherNumAffected': 200, 'seriousNumAtRisk': 223, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'DT Toxoid', 'description': 'Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid): 0.1 mL, subcutaneous injection', 'otherNumAtRisk': 222, 'otherNumAffected': 194, 'seriousNumAtRisk': 222, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 167}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 160}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 17'}, {'term': 'Injection site induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 95}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 84}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 17'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 125}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 85}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 17'}, {'term': 'Injection site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 132}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 113}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 17'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 162}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 148}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 17'}, {'term': 'Injection site warmth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 115}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 87}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 17'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 3}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 17'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 15}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 17'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 222, 'numAffected': 13}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 17'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Booster Responses for Anti-diphtheria Toxoid (Anti-D) and Anti-tetanus Toxoid (Anti-T) Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}, {'value': '222', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BK1301', 'description': 'Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301): 0.5 mL, subcutaneous injection'}, {'id': 'OG001', 'title': 'DT Toxoid', 'description': 'Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid): 0.1 mL, subcutaneous injection'}], 'classes': [{'title': 'anti-D', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '98.4', 'upperLimit': '100.0'}, {'value': '99.5', 'groupId': 'OG001', 'lowerLimit': '97.5', 'upperLimit': '100.0'}]}]}, {'title': 'anti-T', 'categories': [{'measurements': [{'value': '98.7', 'groupId': 'OG000', 'lowerLimit': '96.1', 'upperLimit': '99.7'}, {'value': '97.3', 'groupId': 'OG001', 'lowerLimit': '94.2', 'upperLimit': '99.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'pre-vaccination and 28-42 days after vaccination', 'description': 'Booster response was defined as post titer ≥ 0.4 IU/mL and post/pre titer ≥ 4 increase.', 'unitOfMeasure': 'percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Booster Responses for Anti-pertussis Toxoid (Anti-PT) and Anti-Filamentous Hemagglutinin (Anti-FHA) Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BK1301', 'description': 'Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301): 0.5 mL, subcutaneous injection'}], 'classes': [{'title': 'anti-PT', 'categories': [{'measurements': [{'value': '91.0', 'groupId': 'OG000', 'lowerLimit': '86.5', 'upperLimit': '94.4'}]}]}, {'title': 'anti-FHA', 'categories': [{'measurements': [{'value': '91.5', 'groupId': 'OG000', 'lowerLimit': '87.0', 'upperLimit': '94.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'pre-vaccination and 28-42 days after vaccination', 'description': 'Booster response was defined as post titer ≥ 20 EU/mL and post/pre titer ≥ 4 increase in a subject with pre titer \\< 20 EU/mL, or post/pre titer ≥ 2 increase in a subject with pre titer ≥ 20 EU/mL.', 'unitOfMeasure': 'percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Outcome Measure was only pre-specified for the BK1301 Arm/Group.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Anti-D and Anti-T Antibody Titers Above Protocol Defined Cut-off Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}, {'value': '222', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BK1301', 'description': 'Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301): 0.5 mL, subcutaneous injection'}, {'id': 'OG001', 'title': 'DT Toxoid', 'description': 'Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid): 0.1 mL, subcutaneous injection'}], 'classes': [{'title': 'anti-D', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '98.4', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '98.4', 'upperLimit': '100.0'}]}]}, {'title': 'anti-T', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '98.4', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '98.4', 'upperLimit': '100.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '28-42 days after vaccination', 'description': 'Protocol defined cut-off values were 0.1 IU/mL for anti-D and 0.01 IU/mL for anti-T.', 'unitOfMeasure': 'percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Anti-PT and Anti-FHA Antibody Titers Above Protocol Defined Cut-off Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BK1301', 'description': 'Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301): 0.5 mL, subcutaneous injection'}], 'classes': [{'title': 'anti-PT', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '98.4', 'upperLimit': '100.0'}]}]}, {'title': 'anti-FHA', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '98.4', 'upperLimit': '100.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '28-42 days after vaccination', 'description': 'Protocol defined cut-off values were 10 EU/mL.', 'unitOfMeasure': 'percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Outcome Measure was only pre-specified for the BK1301 Arm/Group.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Titers (GMTs) of Anti-D and Anti-T Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}, {'value': '222', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BK1301', 'description': 'Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301): 0.5 mL, subcutaneous injection'}, {'id': 'OG001', 'title': 'DT Toxoid', 'description': 'Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid): 0.1 mL, subcutaneous injection'}], 'classes': [{'title': 'anti-D', 'categories': [{'measurements': [{'value': '20.856', 'groupId': 'OG000', 'lowerLimit': '18.221', 'upperLimit': '23.872'}, {'value': '15.581', 'groupId': 'OG001', 'lowerLimit': '13.748', 'upperLimit': '17.658'}]}]}, {'title': 'anti-T', 'categories': [{'measurements': [{'value': '13.378', 'groupId': 'OG000', 'lowerLimit': '11.838', 'upperLimit': '15.118'}, {'value': '11.638', 'groupId': 'OG001', 'lowerLimit': '10.348', 'upperLimit': '13.090'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '28-42 days after vaccination', 'unitOfMeasure': 'IU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Titers (GMTs) of Anti-PT and Anti-FHA Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BK1301', 'description': 'Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301): 0.5 mL, subcutaneous injection'}], 'classes': [{'title': 'anti-PT', 'categories': [{'measurements': [{'value': '241.15', 'groupId': 'OG000', 'lowerLimit': '210.65', 'upperLimit': '276.07'}]}]}, {'title': 'anti-FHA', 'categories': [{'measurements': [{'value': '344.46', 'groupId': 'OG000', 'lowerLimit': '309.72', 'upperLimit': '383.10'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '28-42 days after vaccination', 'unitOfMeasure': 'EU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Outcome Measure was only pre-specified for the BK1301 Arm/Group.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Titer Ratios of Anti-D and Anti-T Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}, {'value': '222', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BK1301', 'description': 'Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301): 0.5 mL, subcutaneous injection'}, {'id': 'OG001', 'title': 'DT Toxoid', 'description': 'Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid): 0.1 mL, subcutaneous injection'}], 'classes': [{'title': 'anti-D', 'categories': [{'measurements': [{'value': '137.5', 'groupId': 'OG000', 'lowerLimit': '107.8', 'upperLimit': '175.5'}, {'value': '106.3', 'groupId': 'OG001', 'lowerLimit': '83.9', 'upperLimit': '134.7'}]}]}, {'title': 'anti-T', 'categories': [{'measurements': [{'value': '47.9', 'groupId': 'OG000', 'lowerLimit': '38.9', 'upperLimit': '59.0'}, {'value': '44.3', 'groupId': 'OG001', 'lowerLimit': '36.4', 'upperLimit': '53.9'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'pre vaccination and 28-42 days after vaccination', 'description': 'Ratios were calculated as 28-42 days after vaccination titers over pre vaccination titers', 'unitOfMeasure': 'titer ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Titer Ratios of Anti-PT and Anti-FHA Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BK1301', 'description': 'Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301): 0.5 mL, subcutaneous injection'}], 'classes': [{'title': 'anti-PT', 'categories': [{'measurements': [{'value': '12.6', 'groupId': 'OG000', 'lowerLimit': '10.5', 'upperLimit': '15.2'}]}]}, {'title': 'anti-FHA', 'categories': [{'measurements': [{'value': '8.5', 'groupId': 'OG000', 'lowerLimit': '7.2', 'upperLimit': '10.0'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'pre vaccination and 28-42 days after vaccination', 'description': 'Ratios were calculated as 28-42 days after vaccination titers over pre vaccination titers', 'unitOfMeasure': 'titer ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Outcome Measure was only pre-specified for the BK1301 Arm/Group.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}, {'value': '222', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BK1301', 'description': 'Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301): 0.5 mL, subcutaneous injection'}, {'id': 'OG001', 'title': 'DT Toxoid', 'description': 'Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid): 0.1 mL, subcutaneous injection'}], 'classes': [{'categories': [{'measurements': [{'value': '90.1', 'groupId': 'OG000'}, {'value': '89.6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '28-42 days following vaccination', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'BK1301', 'description': 'Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301): 0.5 mL, subcutaneous injection'}, {'id': 'FG001', 'title': 'DT Toxoid', 'description': 'Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid): 0.1 mL, subcutaneous injection'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '224'}, {'groupId': 'FG001', 'numSubjects': '222'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '223'}, {'groupId': 'FG001', 'numSubjects': '222'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '224', 'groupId': 'BG000'}, {'value': '222', 'groupId': 'BG001'}, {'value': '446', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'BK1301', 'description': 'Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301): 0.5 mL, subcutaneous injection'}, {'id': 'BG001', 'title': 'DT Toxoid', 'description': 'Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid): 0.1 mL, subcutaneous injection'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '224', 'groupId': 'BG000'}, {'value': '222', 'groupId': 'BG001'}, {'value': '446', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '113', 'groupId': 'BG000'}, {'value': '104', 'groupId': 'BG001'}, {'value': '217', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '111', 'groupId': 'BG000'}, {'value': '118', 'groupId': 'BG001'}, {'value': '229', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 446}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-24', 'studyFirstSubmitDate': '2014-04-13', 'resultsFirstSubmitDate': '2016-05-16', 'studyFirstSubmitQcDate': '2014-04-18', 'lastUpdatePostDateStruct': {'date': '2017-01-13', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-09-30', 'studyFirstPostDateStruct': {'date': '2014-04-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-11-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Booster Responses for Anti-diphtheria Toxoid (Anti-D) and Anti-tetanus Toxoid (Anti-T) Antibodies', 'timeFrame': 'pre-vaccination and 28-42 days after vaccination', 'description': 'Booster response was defined as post titer ≥ 0.4 IU/mL and post/pre titer ≥ 4 increase.'}, {'measure': 'Percentage of Participants With Booster Responses for Anti-pertussis Toxoid (Anti-PT) and Anti-Filamentous Hemagglutinin (Anti-FHA) Antibodies', 'timeFrame': 'pre-vaccination and 28-42 days after vaccination', 'description': 'Booster response was defined as post titer ≥ 20 EU/mL and post/pre titer ≥ 4 increase in a subject with pre titer \\< 20 EU/mL, or post/pre titer ≥ 2 increase in a subject with pre titer ≥ 20 EU/mL.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Anti-D and Anti-T Antibody Titers Above Protocol Defined Cut-off Values', 'timeFrame': '28-42 days after vaccination', 'description': 'Protocol defined cut-off values were 0.1 IU/mL for anti-D and 0.01 IU/mL for anti-T.'}, {'measure': 'Percentage of Participants With Anti-PT and Anti-FHA Antibody Titers Above Protocol Defined Cut-off Values', 'timeFrame': '28-42 days after vaccination', 'description': 'Protocol defined cut-off values were 10 EU/mL.'}, {'measure': 'Geometric Mean Titers (GMTs) of Anti-D and Anti-T Antibodies', 'timeFrame': '28-42 days after vaccination'}, {'measure': 'Geometric Mean Titers (GMTs) of Anti-PT and Anti-FHA Antibodies', 'timeFrame': '28-42 days after vaccination'}, {'measure': 'Geometric Mean Titer Ratios of Anti-D and Anti-T Antibodies', 'timeFrame': 'pre vaccination and 28-42 days after vaccination', 'description': 'Ratios were calculated as 28-42 days after vaccination titers over pre vaccination titers'}, {'measure': 'Geometric Mean Titer Ratios of Anti-PT and Anti-FHA Antibodies', 'timeFrame': 'pre vaccination and 28-42 days after vaccination', 'description': 'Ratios were calculated as 28-42 days after vaccination titers over pre vaccination titers'}, {'measure': 'Percentage of Participants With Adverse Events', 'timeFrame': '28-42 days following vaccination'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Diphtheria', 'Tetanus', 'Pertussis', 'DTaP vaccine', 'Adolescents'], 'conditions': ['Diphtheria', 'Tetanus', 'Pertussis']}, 'descriptionModule': {'briefSummary': 'This study is designed to assess the immunogenicity and safety of DTaP vaccine (BK1301) as a booster dose in adolescents.\n\nThe purposes of this study are as follows:\n\n* To confirm the non-inferiority of BK1301 to Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid) with respect to booster responses for anti-diphtheria toxoid (anti-D) and anti-tetanus toxoid (anti-T) antibodies\n* To confirm that booster responses for anti-pertussis toxoid (anti-PT) and anti-Filamentous Hemagglutinin (anti-FHA) antibodies are more than 80% of participants received BK1301'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '11 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 11 or 12 years on the day of injection\n* Received 3 or 4 doses of DTaP vaccine\n\nExclusion Criteria:\n\n* History of pertussis, diphtheria, tetanus\n* History of anaphylaxis to vaccine components\n* Serious conditions or diseases of the heart, vein, blood, respiratory, hepar, kidney, digestive system, psychiatric or nervous system\n* Transfused or received gamma globulin within 3 months, or received high-dose gamma globulin within 6 months before the day of injection'}, 'identificationModule': {'nctId': 'NCT02118961', 'briefTitle': 'Study of BK1301 (DTaP Vaccine) as a Booster in Adolescents', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tanabe Pharma Corporation'}, 'officialTitle': 'Confirmatory Study to Evaluate the Immunogenicity of Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP Vaccine, BK1301) as a Booster in Adolescents', 'orgStudyIdInfo': {'id': 'BKD1A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BK1301', 'interventionNames': ['Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'DT toxoid', 'interventionNames': ['Biological: Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid)']}], 'interventions': [{'name': 'Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301)', 'type': 'BIOLOGICAL', 'otherNames': ['TRIBIK®'], 'description': '0.5 mL, subcutaneous injection', 'armGroupLabels': ['BK1301']}, {'name': 'Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid)', 'type': 'BIOLOGICAL', 'otherNames': ['DTBIK®'], 'description': '0.1 mL, subcutaneous injection', 'armGroupLabels': ['DT toxoid']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Fukuoka', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'Investigational site', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'city': 'Itoshima-shi', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'Investigational site'}, {'city': 'Kasuga-shi', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'Investigational site'}, {'city': 'Hiroshima', 'state': 'Hiroshima', 'country': 'Japan', 'facility': 'Investigational site', 'geoPoint': {'lat': 34.4, 'lon': 132.45}}, {'city': 'Kumagaya-shi', 'state': 'Saitama', 'country': 'Japan', 'facility': 'Inverstigational site'}, {'city': 'Shizuoka', 'state': 'Shizuoka', 'country': 'Japan', 'facility': 'Investigational site', 'geoPoint': {'lat': 34.98333, 'lon': 138.38333}}, {'city': 'Shinjuku-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Inverstigational site'}], 'overallOfficials': [{'name': 'Shintaro Okada, M.D., Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Osaka University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanabe Pharma Corporation', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'The Research Foundation for Microbial Diseases of Osaka University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}