Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 10:15 PM
Study NCT ID:
NCT03891758
Status:
COMPLETED
Last Update Posted:
2025-01-06
First Post:
2019-03-24
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Confirmatory Study of BK1310 in Healthy Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013742', 'term': 'Tetanus'}, {'id': 'D004165', 'term': 'Diphtheria'}, {'id': 'D014917', 'term': 'Whooping Cough'}, {'id': 'D011051', 'term': 'Poliomyelitis'}, {'id': 'D016920', 'term': 'Meningitis, Bacterial'}, {'id': 'D006192', 'term': 'Haemophilus Infections'}], 'ancestors': [{'id': 'D003015', 'term': 'Clostridium 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': 'D003354', 'term': 'Corynebacterium Infections'}, {'id': 'D000193', 'term': 'Actinomycetales 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'}, {'id': 'D009187', 'term': 'Myelitis'}, {'id': 'D002494', 'term': 'Central Nervous System Infections'}, {'id': 'D004769', 'term': 'Enterovirus Infections'}, {'id': 'D010850', 'term': 'Picornaviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D020806', 'term': 'Central Nervous System Bacterial Infections'}, {'id': 'D008581', 'term': 'Meningitis'}, {'id': 'D016871', 'term': 'Pasteurellaceae Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C061963', 'term': 'HibTITER protein, Haemophilus influenzae'}, {'id': 'C055753', 'term': 'Haemophilus influenza type b polysaccharide vaccine-tetanus toxin conjugate'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'cti-inq-ml@ml.mt-pharma.co.jp, clinicaldevelopment@mail.biken.or.jp', 'phone': 'Please email', 'title': 'Clinical Trials, Information Desk', 'organization': 'Mitsubishi Tanabe Pharma Corporation / The Research 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, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.', 'otherNumAtRisk': 133, 'deathsNumAtRisk': 133, 'otherNumAffected': 131, 'seriousNumAtRisk': 133, 'deathsNumAffected': 0, 'seriousNumAffected': 9}, {'id': 'EG001', 'title': 'ActHIB® and Tetrabik (Control)', 'description': 'Hib vaccine and DPT-IPV 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.', 'otherNumAtRisk': 134, 'deathsNumAtRisk': 134, 'otherNumAffected': 132, 'seriousNumAtRisk': 134, 'deathsNumAffected': 0, 'seriousNumAffected': 11}], 'otherEvents': [{'term': 'Crying', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 38}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 105}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 107}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Injection site induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 63}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 72}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 26}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 47}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Irritability postvaccinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 46}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 91}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 88}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 18}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 38}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 21}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 23}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Hypersomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 31}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 28}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Upper respiratory tract inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 17}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Dermatitis diaper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 11}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 17}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Eczema infantile', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 7}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}], 'seriousEvents': [{'term': 'Cholangiectasis congenital', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Adenovirus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Enterocolitis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Gastroenteritis norovirus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Hand-foot-and-mouth disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Pyelonephritis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Respiratory syncytial virus bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Respiratory syncytial virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Fractured skull depressed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Febrile convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}, {'term': "Kawasaki's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Antibody Prevalence Rate Against Anti-PRP With 1 μg/mL or Higher, Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Anti-PRP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BK1310', 'description': 'DPT-IPV-Hib (Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.'}, {'id': 'OG001', 'title': 'ActHIB® and Tetrabik (Control)', 'description': 'Hib vaccine and DPT-IPV 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.'}], 'classes': [{'title': 'Antibody prevalence rate against anti-PRP with 1 μg/mL or higher', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '97.3', 'upperLimit': '100.0'}, {'value': '88.7', 'groupId': 'OG001', 'lowerLimit': '82.1', 'upperLimit': '93.5'}]}]}, {'title': 'Antibody prevalence rate against diphtheria toxin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '99.2', 'groupId': 'OG000', 'lowerLimit': '95.9', 'upperLimit': '100.0'}, {'value': '98.5', 'groupId': 'OG001', 'lowerLimit': '94.7', 'upperLimit': '99.8'}]}]}, {'title': 'Antibody prevalence rate against pertussis （PT）', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '97.3', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '97.3', 'upperLimit': '100.0'}]}]}, {'title': 'Antibody prevalence rate against pertussis (FHA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '97.3', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '97.3', 'upperLimit': '100.0'}]}]}, {'title': 'Antibody prevalence rate against tetanus toxin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '97.3', 'upperLimit': '100.0'}, {'value': '99.2', 'groupId': 'OG001', 'lowerLimit': '95.9', 'upperLimit': '100.0'}]}]}, {'title': 'Antibody prevalence rate against polio virus serotype 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '97.2', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '97.2', 'upperLimit': '100.0'}]}]}, {'title': 'Antibody prevalence rate against polio virus serotype 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '97.2', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '97.2', 'upperLimit': '100.0'}]}]}, {'title': 'Antibody prevalence rate against polio virus serotype 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '97.2', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '97.2', 'upperLimit': '100.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 weeks after the primary immunization (Visit 4)', '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', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'For antibody analysis at Visit 4, number of subjects decreased from 267 to 266. Control group: due to withdrawal by parent/guardian (n=1) . In BK1310 group number of subjects further decreased due to insufficient sample volume (polio serotype1,2 and 3: n=2 each). In control group number of subjects further decreased due to insufficient sample volume (polio serotype1,2 and 3: n=1 each).'}, {'type': 'SECONDARY', 'title': 'Anti-PRP Antibody Prevalence Rate With 0.15 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BK1310', 'description': 'DPT-IPV-Hib (Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.'}, {'id': 'OG001', 'title': 'ActHIB® and Tetrabik (Control)', 'description': 'Hib vaccine and DPT-IPV 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '97.3', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '97.3', 'upperLimit': '100.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4weeks after the primary immunization (Visit 4)', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'For antibody analysis at Visit 4, number of subjects decreased from 267 to 266. Control group: due to withdrawal by parent/guardian (n=1) .'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Antibody Titer of Anti-PRP Antibody', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BK1310', 'description': 'DPT-IPV-Hib (Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.'}, {'id': 'OG001', 'title': 'ActHIB® and Tetrabik (Control)', 'description': 'Hib vaccine and DPT-IPV 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '23.688', 'groupId': 'OG000', 'lowerLimit': '20.208', 'upperLimit': '27.768'}, {'value': '6.698', 'groupId': 'OG001', 'lowerLimit': '5.357', 'upperLimit': '8.374'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '4weeks after the primary immunization (Visit 4)', 'unitOfMeasure': 'µg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'For antibody analysis at Visit 4, number of subjects decreased from 267 to 266. Control group: due to withdrawal by parent/guardian (n=1) .'}, {'type': 'SECONDARY', 'title': 'Anti-PRP Antibody Prevalence Rate With 1 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BK1310', 'description': 'DPT-IPV-Hib (Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.'}, {'id': 'OG001', 'title': 'ActHIB® and Tetrabik (Control)', 'description': 'Hib vaccine and DPT-IPV 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '97.2', 'upperLimit': '100.0'}, {'value': '98.5', 'groupId': 'OG001', 'lowerLimit': '94.6', 'upperLimit': '99.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 weeks after the booster dose (Visit 6)', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'For antibody analysis at Visit 4, number of subjects decreased from 267 to 266. Control group: due to withdrawal by parent/guardian (n=1) .\n\nFor antibody analysis at Visit 6, number of subjects decreased from 266 to 264. BK1310 group: due to Adverse event (n=2, onty 1 patient was able to collect a sample at discontinuation. The data at this time point was included in Visit 6). Control group: due to withdrawal by parent/guardian (n=1) .'}, {'type': 'SECONDARY', 'title': 'Anti-PRP Antibody Prevalence Rate With 0.15 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BK1310', 'description': 'DPT-IPV-Hib (Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.'}, {'id': 'OG001', 'title': 'ActHIB® and Tetrabik (Control)', 'description': 'Hib vaccine and DPT-IPV 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '97.2', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '97.2', 'upperLimit': '100.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 weeks after the booster dose (Visit 6)', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'For antibody analysis at Visit 4, number of subjects decreased from 267 to 266. Control group: due to withdrawal by parent/guardian (n=1) .\n\nFor antibody analysis at Visit 6, number of subjects decreased from 266 to 264. BK1310 group: due to Adverse event (n=2, onty 1 patient was able to collect a sample at discontinuation. The data at this time point was included in Visit 6). Control group: due to withdrawal by parent/guardian (n=1) .'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Antibody Titer of Anti-PRP Antibody', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BK1310', 'description': 'DPT-IPV-Hib (Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.'}, {'id': 'OG001', 'title': 'ActHIB® and Tetrabik (Control)', 'description': 'Hib vaccine and DPT-IPV 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '56.545', 'groupId': 'OG000', 'lowerLimit': '47.963', 'upperLimit': '66.661'}, {'value': '34.246', 'groupId': 'OG001', 'lowerLimit': '28.835', 'upperLimit': '40.672'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '4 weeks after the booster dose (Visit 6)', 'unitOfMeasure': 'µg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'For antibody analysis at Visit 4, number of subjects decreased from 267 to 266. Control group: due to withdrawal by parent/guardian (n=1) .\n\nFor antibody analysis at Visit 6, number of subjects decreased from 266 to 264. BK1310 group: due to Adverse event (n=2, onty 1 patient was able to collect a sample at discontinuation. The data at this time point was included in Visit 6). Control group: due to withdrawal by parent/guardian (n=1) .'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Antibody Titer Against Diphtheria Toxin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BK1310', 'description': 'DPT-IPV-Hib (Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.'}, {'id': 'OG001', 'title': 'ActHIB® and Tetrabik (Control)', 'description': 'Hib vaccine and DPT-IPV 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.841', 'groupId': 'OG000', 'lowerLimit': '1.533', 'upperLimit': '2.211'}, {'value': '1.283', 'groupId': 'OG001', 'lowerLimit': '1.050', 'upperLimit': '1.567'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '4 weeks after the primary immunization (Visit 4)', 'unitOfMeasure': 'IU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'For antibody analysis at Visit 4, number of subjects decreased from 267 to 266. Control group: due to withdrawal by parent/guardian (n=1) .'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Antibody Titer Against Pertussis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BK1310', 'description': 'DPT-IPV-Hib (Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.'}, {'id': 'OG001', 'title': 'ActHIB® and Tetrabik (Control)', 'description': 'Hib vaccine and DPT-IPV 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.'}], 'classes': [{'title': 'pertussis （PT）', 'categories': [{'measurements': [{'value': '155.30', 'groupId': 'OG000', 'lowerLimit': '141.53', 'upperLimit': '170.41'}, {'value': '200.24', 'groupId': 'OG001', 'lowerLimit': '183.42', 'upperLimit': '218.61'}]}]}, {'title': 'pertussis （FHA）', 'categories': [{'measurements': [{'value': '56.48', 'groupId': 'OG000', 'lowerLimit': '51.07', 'upperLimit': '62.46'}, {'value': '85.24', 'groupId': 'OG001', 'lowerLimit': '76.96', 'upperLimit': '94.40'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '4 weeks after the primary immunization (Visit 4)', 'unitOfMeasure': 'EU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'For antibody analysis at Visit 4, number of subjects decreased from 267 to 266. Control group: due to withdrawal by parent/guardian (n=1) .'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Antibody Titer Against Tetanus Toxin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BK1310', 'description': 'DPT-IPV-Hib (Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.'}, {'id': 'OG001', 'title': 'ActHIB® and Tetrabik (Control)', 'description': 'Hib vaccine and DPT-IPV 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.473', 'groupId': 'OG000', 'lowerLimit': '0.408', 'upperLimit': '0.548'}, {'value': '0.158', 'groupId': 'OG001', 'lowerLimit': '0.124', 'upperLimit': '0.203'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '4 weeks after the primary immunization (Visit 4)', 'unitOfMeasure': 'IU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'For antibody analysis at Visit 4, number of subjects decreased from 267 to 266. Control group: due to withdrawal by parent/guardian (n=1) .'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Antibody Titer Against Polio Virus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BK1310', 'description': 'DPT-IPV-Hib (Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.'}, {'id': 'OG001', 'title': 'ActHIB® and Tetrabik (Control)', 'description': 'Hib vaccine and DPT-IPV 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.'}], 'classes': [{'title': 'polio virus serotype 1', 'categories': [{'measurements': [{'value': '684.95', 'groupId': 'OG000', 'lowerLimit': '539.57', 'upperLimit': '869.49'}, {'value': '663.98', 'groupId': 'OG001', 'lowerLimit': '512.66', 'upperLimit': '859.96'}]}]}, {'title': 'polio virus serotype 2', 'categories': [{'measurements': [{'value': '2026.44', 'groupId': 'OG000', 'lowerLimit': '1733.39', 'upperLimit': '2369.04'}, {'value': '1767.97', 'groupId': 'OG001', 'lowerLimit': '1498.47', 'upperLimit': '2085.94'}]}]}, {'title': 'polio virus serotype 3', 'categories': [{'measurements': [{'value': '1729.00', 'groupId': 'OG000', 'lowerLimit': '1487.12', 'upperLimit': '2010.23'}, {'value': '2075.06', 'groupId': 'OG001', 'lowerLimit': '1777.90', 'upperLimit': '2421.90'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '4 weeks after the primary immunization (Visit 4)', 'unitOfMeasure': 'IU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'For antibody analysis at Visit 4, number of subjects decreased from 267 to 266. Control group: due to withdrawal by parent/guardian (n=1) . In BK1310 group number of subjects further decreased due to insufficient sample volume (polio serotype1,2 and 3: n=2 each). In control group number of subjects further decreased due to insufficient sample volume (polio serotype1,2 and 3: n=1 each).'}, {'type': 'SECONDARY', 'title': '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', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BK1310', 'description': 'DPT-IPV-Hib (Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.'}, {'id': 'OG001', 'title': 'ActHIB® and Tetrabik (Control)', 'description': 'Hib vaccine and DPT-IPV 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.'}], 'classes': [{'title': 'Antibody prevalence rate against diphtheria toxin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '97.2', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '97.2', 'upperLimit': '100.0'}]}]}, {'title': 'Antibody prevalence rate against pertussis （PT）', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '97.2', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '97.2', 'upperLimit': '100.0'}]}]}, {'title': 'Antibody prevalence rate against pertussis （FHA）', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '97.2', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '97.2', 'upperLimit': '100.0'}]}]}, {'title': 'Antibody prevalence rate against tetanus toxin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '97.2', 'upperLimit': '100.0'}, {'value': '99.2', 'groupId': 'OG001', 'lowerLimit': '95.9', 'upperLimit': '100.0'}]}]}, {'title': 'Antibody prevalence rate against polio virus serotype 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '97.2', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '97.2', 'upperLimit': '100.0'}]}]}, {'title': 'Antibody prevalence rate against polio virus serotype 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '97.2', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '97.2', 'upperLimit': '100.0'}]}]}, {'title': 'Antibody prevalence rate against polio virus serotype 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '97.2', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '97.2', 'upperLimit': '100.0'}]}]}], 'paramType': 'NUMBER', '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', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'For antibody analysis at Visit 4, number of subjects decreased from 267 to 266. Control group: due to withdrawal by parent/guardian (n=1). For antibody analysis at Visit 6, number of subjects decreased from 266 to 264. BK1310 group: due to Adverse event (n=2). Control group: due to withdrawal by parent/guardian (n=1) .In BK1310 group number of subjects further decreased due to insufficient sample volume (tetanus: n=1, polio serotype1,2 and 3: n=1 each).'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Antibody Titer Against Diphtheria Toxin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BK1310', 'description': 'DPT-IPV-Hib (Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.'}, {'id': 'OG001', 'title': 'ActHIB® and Tetrabik (Control)', 'description': 'Hib vaccine and DPT-IPV 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.766', 'groupId': 'OG000', 'lowerLimit': '8.758', 'upperLimit': '10.890'}, {'value': '8.961', 'groupId': 'OG001', 'lowerLimit': '8.035', 'upperLimit': '9.994'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '4 weeks after the booster dose (Visit 6)', 'unitOfMeasure': 'IU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'For antibody analysis at Visit 4, number of subjects decreased from 267 to 266. Control group: due to withdrawal by parent/guardian (n=1) .\n\nFor antibody analysis at Visit 6, number of subjects decreased from 266 to 264. BK1310 group: due to Adverse event (n=2, onty 1 patient was able to collect a sample at discontinuation. The data at this time point was included in Visit 6). Control group: due to withdrawal by parent/guardian (n=1) .'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Antibody Titer Against Pertussis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BK1310', 'description': 'DPT-IPV-Hib (Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.'}, {'id': 'OG001', 'title': 'ActHIB® and Tetrabik (Control)', 'description': 'Hib vaccine and DPT-IPV 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.'}], 'classes': [{'title': 'Geometric mean antibody titer against pertussis （PT）', 'categories': [{'measurements': [{'value': '209.05', 'groupId': 'OG000', 'lowerLimit': '189.40', 'upperLimit': '230.74'}, {'value': '279.62', 'groupId': 'OG001', 'lowerLimit': '254.28', 'upperLimit': '307.49'}]}]}, {'title': 'Geometric mean antibody titer against pertussis （FHA）', 'categories': [{'measurements': [{'value': '144.73', 'groupId': 'OG000', 'lowerLimit': '128.04', 'upperLimit': '163.59'}, {'value': '221.34', 'groupId': 'OG001', 'lowerLimit': '194.79', 'upperLimit': '251.51'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '4 weeks after the booster dose (Visit 6)', 'unitOfMeasure': 'EU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'For antibody analysis at Visit 4, number of subjects decreased from 267 to 266. Control group: due to withdrawal by parent/guardian (n=1) .\n\nFor antibody analysis at Visit 6, number of subjects decreased from 266 to 264. BK1310 group: due to Adverse event (n=2, onty 1 patient was able to collect a sample at discontinuation. The data at this time point was included in Visit 6). Control group: due to withdrawal by parent/guardian (n=1) .'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Antibody Titer Against Tetanus Toxin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BK1310', 'description': 'DPT-IPV-Hib (Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.'}, {'id': 'OG001', 'title': 'ActHIB® and Tetrabik (Control)', 'description': 'Hib vaccine and DPT-IPV 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.904', 'groupId': 'OG000', 'lowerLimit': '1.595', 'upperLimit': '2.272'}, {'value': '0.598', 'groupId': 'OG001', 'lowerLimit': '0.457', 'upperLimit': '0.783'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '4 weeks after the booster dose (Visit 6)', 'unitOfMeasure': 'IU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'For antibody analysis at Visit 4, number of subjects decreased from 267 to 266. Control group: due to withdrawal by parent/guardian (n=1) . For antibody analysis at Visit 6, number of subjects decreased from 266 to 264. BK1310 group: due to Adverse event (n=2). Control group: due to withdrawal by parent/guardian (n=1) .In BK1310 group number of subjects further decreased due to insufficient sample volume (n=1).'}, {'type': 'SECONDARY', 'title': 'Fold Change in Geometric Mean Antibody Titer Against Polio Virus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BK1310', 'description': 'DPT-IPV-Hib (Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.'}, {'id': 'OG001', 'title': 'ActHIB® and Tetrabik (Control)', 'description': 'Hib vaccine and DPT-IPV 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.'}], 'classes': [{'title': 'Geometric mean antibody titer against polio virus serotype 1', 'categories': [{'measurements': [{'value': '2524.05', 'groupId': 'OG000', 'lowerLimit': '2110.26', 'upperLimit': '3018.98'}, {'value': '2662.91', 'groupId': 'OG001', 'lowerLimit': '2254.04', 'upperLimit': '3145.95'}]}]}, {'title': 'Geometric mean antibody titer against polio virus serotype 2', 'categories': [{'measurements': [{'value': '8821.88', 'groupId': 'OG000', 'lowerLimit': '7678.48', 'upperLimit': '10135.54'}, {'value': '7512.10', 'groupId': 'OG001', 'lowerLimit': '6425.09', 'upperLimit': '8783.01'}]}]}, {'title': 'Geometric mean antibody titer against polio virus serotype 3', 'categories': [{'measurements': [{'value': '6439.23', 'groupId': 'OG000', 'lowerLimit': '5472.88', 'upperLimit': '7576.21'}, {'value': '7355.96', 'groupId': 'OG001', 'lowerLimit': '6324.16', 'upperLimit': '8556.09'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline and 4 weeks after the primary immunization (Visit 6)', 'unitOfMeasure': 'fold change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'For antibody analysis at Visit 4, number of subjects decreased from 267 to 266. Control group: due to withdrawal by parent/guardian (n=1) . For antibody analysis at Visit 6, number of subjects decreased from 266 to 264. BK1310 group: due to Adverse event (n=2). Control group: due to withdrawal by parent/guardian (n=1) .In BK1310 group number of subjects further decreased due to insufficient sample volume (polio serotype1,2 and 3: n=1 each).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'BK1310', 'description': 'DPT-IPV-Hib (Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.'}, {'id': 'FG001', 'title': 'ActHIB® and Tetrabik (Control)', 'description': 'Hib vaccine and DPT-IPV 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '133'}, {'groupId': 'FG001', 'numSubjects': '134'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '131'}, {'groupId': 'FG001', 'numSubjects': '132'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by parent/guardian', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'BG000'}, {'value': '133', 'groupId': 'BG001'}, {'value': '266', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'BK1310', 'description': 'DPT-IPV-Hib (Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.'}, {'id': 'BG001', 'title': 'ActHIB® and Tetrabik (Control)', 'description': 'Hib vaccine and DPT-IPV 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '>=2 and <3 months', 'categories': [{'measurements': [{'value': '124', 'groupId': 'BG000'}, {'value': '125', 'groupId': 'BG001'}, {'value': '249', 'groupId': 'BG002'}]}]}, {'title': '>=3 months', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '73', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '135', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '131', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian (Japanese)', 'categories': [{'measurements': [{'value': '133', 'groupId': 'BG000'}, {'value': '133', 'groupId': 'BG001'}, {'value': '266', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Excluding 1 subject(control: 1 subject) whose all antibody titers could not be measured at Visit 4'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-12-19', 'size': 2669198, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-03-22T06:01', 'hasProtocol': True}, {'date': '2020-09-10', 'size': 823519, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-03-22T06:03', 'hasProtocol': False}]}}, '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': 267}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2020-08-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-18', 'studyFirstSubmitDate': '2019-03-24', 'resultsFirstSubmitDate': '2024-03-26', 'studyFirstSubmitQcDate': '2019-03-26', 'lastUpdatePostDateStruct': {'date': '2025-01-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-11-18', 'studyFirstPostDateStruct': {'date': '2019-03-27', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-01-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Antibody Prevalence Rate Against Anti-PRP With 1 μg/mL or Higher, Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Anti-PRP', 'timeFrame': '4 weeks after the primary immunization (Visit 4)', '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'}], 'secondaryOutcomes': [{'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': '4weeks after the primary immunization (Visit 4)'}, {'measure': 'Geometric Mean Antibody Titer of Anti-PRP Antibody', 'timeFrame': '4weeks after the primary immunization (Visit 4)'}, {'measure': 'Anti-PRP Antibody Prevalence Rate 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', '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': 'Geometric Mean Antibody Titer Against Polio Virus', 'timeFrame': '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', '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'], 'conditions': ['Tetanus', 'Diphtheria', 'Pertussis', 'Poliomyelitis', 'Bacterial Meningitis']}, 'referencesModule': {'references': [{'pmid': '38582691', 'type': 'RESULT', 'citation': 'Nakano T, Hasegawa M, Endo M, Matsuda K, Tamai H. Immunogenicity and safety of adsorbed diphtheria-purified pertussis-tetanus-inactivated polio (Sabin strain)-Haemophilus type b conjugate combined vaccine (DPT-IPV-Hib) in healthy Japanese Infants >/= 2 and < 43 months of Age: A phase III, multicenter, active controlled, assessor-blinded, randomized, parallel-group study. Vaccine. 2024 Apr 30;42(12):3134-3143. doi: 10.1016/j.vaccine.2023.03.077. Epub 2024 Apr 6.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate immunogenicity of BK1310 for all antigens (anti-PRP, diphtheria toxin, pertussis, tetanus toxin, and polio virus), after 3 times of injection, when compared noninferiority with co-administration of ActHIB® and Tetrabik, as well as efficacy and safety, in healthy infants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '42 Months', 'minimumAge': '2 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy infants aged ≥2 and \\<43 months at the first vaccination of the study drug (recommended: ≥2 and \\<7 months)\n* Written informed consent is obtained from a legal guardian (parent)\n\nExclusion Criteria:\n\n* Possibility of anaphylaxis due to food or pharmaceuticals\n* With experience of Hib infection, diphtheria, pertussis, tetanus or acute poliomyelitis\n* With experience of Hib, diphteria, pertussis, tetanus or polio vaccination.\n* Participated in other studies within 12 weeks before obtaining consent\n* Considered to be not eligible by the principal investigators (sub-investigators) of the enrollment\n\nAdditional screening criteria check may apply for qualification.'}, 'identificationModule': {'nctId': 'NCT03891758', 'briefTitle': 'Confirmatory Study of BK1310 in Healthy Infants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tanabe Pharma Corporation'}, 'officialTitle': 'Phase 3 Study of BK1310 Compared With ActHIB® and Tetrabik in Healthy Infants: A Randomized, Assessor-blind, Active-controlled', 'orgStudyIdInfo': {'id': 'BK1310-J03'}, 'secondaryIdInfos': [{'id': 'jRCT2080224611', 'type': 'REGISTRY', 'domain': 'Japan Registry of Clinical Trials (jRCT)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BK1310', 'interventionNames': ['Biological: DPT-IPV-Hib']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ActHIB® and Tetrabik', 'interventionNames': ['Biological: Hib vaccine', 'Biological: DPT-IPV']}], 'interventions': [{'name': 'DPT-IPV-Hib', 'type': 'BIOLOGICAL', 'otherNames': ['BK1310'], 'description': '0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.', 'armGroupLabels': ['BK1310']}, {'name': 'Hib vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['ActHIB®'], 'description': '0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.', 'armGroupLabels': ['ActHIB® and Tetrabik']}, {'name': 'DPT-IPV', 'type': 'BIOLOGICAL', 'otherNames': ['Tetrabik'], 'description': '0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.', 'armGroupLabels': ['ActHIB® and Tetrabik']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Fukuoka', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'Investigational Site', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}], 'overallOfficials': [{'name': 'General Manager', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Tanabe Pharma Corporation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanabe Pharma Corporation', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'The Research Foundation for Microbial Diseases of Osaka University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}