Ignite Creation Date:
2025-12-25 @ 4:42 AM
Ignite Modification Date:
2026-02-03 @ 5:55 PM
Study NCT ID:
NCT02555618
Status:
COMPLETED
Last Update Posted:
2016-12-29
First Post:
2015-09-17
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Phase 2 Study of TAK-850 in Comparison With Influenza Hemagglutinin (HA) Vaccine in Healthy Adult Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'trialdisclosures@takeda.com', 'phone': '+1-877-825-3327', 'title': 'Medical Director, Clinical Science', 'organization': 'Takeda'}, 'certainAgreement': {'otherDetails': 'The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '22 Days', 'description': 'At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'TAK-850', 'description': 'A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin \\[HA\\] antigen per strain) is injected subcutaneously into the upper arm.', 'otherNumAtRisk': 200, 'otherNumAffected': 117, 'seriousNumAtRisk': 200, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Influenza HA Vaccine', 'description': 'A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.', 'otherNumAtRisk': 200, 'otherNumAffected': 122, 'seriousNumAtRisk': 200, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 68}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 79}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 56}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 40}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Injection site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 31}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Injection site warmth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 29}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 22}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Injection site induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 20}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 18}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 11}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Seroconversion Rate of Hemagglutination Inhibition (HI) Antibody Titer (Egg-Derived Antigen)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '200', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TAK-850', 'description': 'A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin \\[HA\\] antigen per strain) is injected subcutaneously into the upper arm.'}, {'id': 'OG001', 'title': 'Influenza HA Vaccine', 'description': 'A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.'}], 'classes': [{'title': 'A/H1N1 Strain', 'categories': [{'measurements': [{'value': '47.7', 'groupId': 'OG000', 'lowerLimit': '40.627', 'upperLimit': '54.918'}, {'value': '46.0', 'groupId': 'OG001', 'lowerLimit': '38.948', 'upperLimit': '53.172'}]}]}, {'title': 'A/H3N2 Strain', 'categories': [{'measurements': [{'value': '31.2', 'groupId': 'OG000', 'lowerLimit': '24.795', 'upperLimit': '38.088'}, {'value': '36.0', 'groupId': 'OG001', 'lowerLimit': '29.350', 'upperLimit': '43.071'}]}]}, {'title': 'B Strain', 'categories': [{'measurements': [{'value': '28.6', 'groupId': 'OG000', 'lowerLimit': '22.472', 'upperLimit': '35.463'}, {'value': '26.0', 'groupId': 'OG001', 'lowerLimit': '20.068', 'upperLimit': '32.658'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.7', 'ciLowerLimit': '-7.983', 'ciUpperLimit': '11.415', 'estimateComment': 'TAK-850 - Influenza HA Vaccine', 'groupDescription': 'The analysis is difference of seroconversion rate between treatment groups for A/H1N1 Strain-Day 22.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non inferiority margin is set to -20%.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.8', 'ciLowerLimit': '-13.974', 'ciUpperLimit': '4.403', 'estimateComment': 'TAK-850 - Influenza HA Vaccine', 'groupDescription': 'The analysis is difference of seroconversion rate between treatment groups for A/H3N2 Strain-Day 22.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non inferiority margin is set to -20%.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.6', 'ciLowerLimit': '-6.082', 'ciUpperLimit': '11.320', 'estimateComment': 'TAK-850 - Influenza HA Vaccine', 'groupDescription': 'The analysis is difference of seroconversion rate between treatment groups for B Strain-Day 22.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non inferiority margin is set to -20%.'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Day 22', 'description': 'Seroconversion rate was measured by hemagglutination inhibition (HI) antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination.\n\nSeroconversion rate was defined as the percentage of participants achieving a minimal 4-fold increase from the Baseline HI antibody titer in participants with a Baseline titer ≥10, or achieving an HI antibody titer of ≥40 in participants with a Baseline titer \\<10.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) included all randomized participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Titer (GMT) of HI Antibody Titer (Egg-Derived Antigen)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '200', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TAK-850', 'description': 'A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin \\[HA\\] antigen per strain) is injected subcutaneously into the upper arm.'}, {'id': 'OG001', 'title': 'Influenza HA Vaccine', 'description': 'A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.'}], 'classes': [{'title': 'A/H1N1 Strain-Day 1', 'categories': [{'measurements': [{'value': '39.04', 'spread': '5.256', 'groupId': 'OG000', 'lowerLimit': '30.955', 'upperLimit': '49.228'}, {'value': '43.77', 'spread': '4.794', 'groupId': 'OG001', 'lowerLimit': '35.178', 'upperLimit': '54.463'}]}]}, {'title': 'A/H1N1 Strain-Day 22', 'categories': [{'measurements': [{'value': '239.24', 'spread': '3.098', 'groupId': 'OG000', 'lowerLimit': '204.264', 'upperLimit': '280.206'}, {'value': '241.88', 'spread': '2.839', 'groupId': 'OG001', 'lowerLimit': '209.128', 'upperLimit': '279.763'}]}]}, {'title': 'A/H3N2 Strain-Day 1', 'categories': [{'measurements': [{'value': '21.39', 'spread': '4.558', 'groupId': 'OG000', 'lowerLimit': '17.300', 'upperLimit': '26.439'}, {'value': '22.62', 'spread': '4.823', 'groupId': 'OG001', 'lowerLimit': '18.163', 'upperLimit': '28.168'}]}]}, {'title': 'A/H3N2 Strain-Day 22', 'categories': [{'measurements': [{'value': '64.80', 'spread': '4.643', 'groupId': 'OG000', 'lowerLimit': '52.282', 'upperLimit': '80.314'}, {'value': '84.93', 'spread': '5.496', 'groupId': 'OG001', 'lowerLimit': '66.967', 'upperLimit': '107.707'}]}]}, {'title': 'B Strain-Day 1', 'categories': [{'measurements': [{'value': '24.65', 'spread': '3.898', 'groupId': 'OG000', 'lowerLimit': '20.380', 'upperLimit': '29.812'}, {'value': '25.34', 'spread': '4.211', 'groupId': 'OG001', 'lowerLimit': '20.734', 'upperLimit': '30.960'}]}]}, {'title': 'B Strain-Day 22', 'categories': [{'measurements': [{'value': '70.14', 'spread': '3.652', 'groupId': 'OG000', 'lowerLimit': '58.523', 'upperLimit': '84.063'}, {'value': '65.89', 'spread': '4.197', 'groupId': 'OG001', 'lowerLimit': '53.945', 'upperLimit': '80.475'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of GMTs', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.99', 'ciLowerLimit': '0.7984', 'ciUpperLimit': '1.2253', 'estimateComment': 'TAK-850/Influenza HA Vaccine', 'groupDescription': 'The analysis is Geometric Mean Ratio between treatment groups for A/H1N1 Strain-Day 22.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non inferiority margin is set to 0.5.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of GMTs', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.76', 'ciLowerLimit': '0.5544', 'ciUpperLimit': '1.0500', 'estimateComment': 'TAK-850/Influenza HA Vaccine', 'groupDescription': 'The analysis is Geometric Mean Ratio between treatment groups for A/H3N2 Strain-Day 22.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non inferiority margin is set to 0.5.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of GMTs', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.06', 'ciLowerLimit': '0.8134', 'ciUpperLimit': '1.3931', 'estimateComment': 'TAK-850/Influenza HA Vaccine', 'groupDescription': 'The analysis is Geometric Mean Ratio between treatment groups for B Strain-Day 22.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non inferiority margin is set to 0.5.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Days 1 and 22', 'description': 'Geometric mean titer (GMT) of HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination. Day 1 data is reported for reference.', 'unitOfMeasure': 'titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.'}, {'type': 'SECONDARY', 'title': 'Seroprotection Rate of HI Antibody Titer (Egg-Derived Antigen)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '200', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TAK-850', 'description': 'A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin \\[HA\\] antigen per strain) is injected subcutaneously into the upper arm.'}, {'id': 'OG001', 'title': 'Influenza HA Vaccine', 'description': 'A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.'}], 'classes': [{'title': 'A/H1N1 Strain-Day 1', 'categories': [{'measurements': [{'value': '62.8', 'groupId': 'OG000', 'lowerLimit': '55.697', 'upperLimit': '69.543'}, {'value': '67.5', 'groupId': 'OG001', 'lowerLimit': '60.535', 'upperLimit': '73.937'}]}]}, {'title': 'A/H1N1 Strain-Day 22', 'categories': [{'measurements': [{'value': '95.5', 'groupId': 'OG000', 'lowerLimit': '91.589', 'upperLimit': '97.911'}, {'value': '97.0', 'groupId': 'OG001', 'lowerLimit': '93.585', 'upperLimit': '98.891'}]}]}, {'title': 'A/H3N2 Strain-Day 1', 'categories': [{'measurements': [{'value': '46.7', 'groupId': 'OG000', 'lowerLimit': '39.645', 'upperLimit': '53.921'}, {'value': '47.5', 'groupId': 'OG001', 'lowerLimit': '40.412', 'upperLimit': '54.663'}]}]}, {'title': 'A/H3N2 Strain-Day 22', 'categories': [{'measurements': [{'value': '77.9', 'groupId': 'OG000', 'lowerLimit': '71.477', 'upperLimit': '83.451'}, {'value': '78.0', 'groupId': 'OG001', 'lowerLimit': '71.614', 'upperLimit': '83.536'}]}]}, {'title': 'B Strain-Day 1', 'categories': [{'measurements': [{'value': '53.3', 'groupId': 'OG000', 'lowerLimit': '46.079', 'upperLimit': '60.355'}, {'value': '51.0', 'groupId': 'OG001', 'lowerLimit': '43.852', 'upperLimit': '58.118'}]}]}, {'title': 'B Strain-Day 22', 'categories': [{'measurements': [{'value': '81.4', 'groupId': 'OG000', 'lowerLimit': '75.295', 'upperLimit': '86.558'}, {'value': '76.0', 'groupId': 'OG001', 'lowerLimit': '69.469', 'upperLimit': '81.743'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 1 and 22', 'description': 'Seroprotection rate, defined as the percentage of participants with HI antibody titer of ≥40, was measured by HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination. Day 1 data is reported for reference.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Fold Increase in HI Antibody Titer (Egg-Derived Antigen)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '200', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TAK-850', 'description': 'A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin \\[HA\\] antigen per strain) is injected subcutaneously into the upper arm.'}, {'id': 'OG001', 'title': 'Influenza HA Vaccine', 'description': 'A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.'}], 'classes': [{'title': 'A/H1N1 Strain', 'categories': [{'measurements': [{'value': '6.13', 'spread': '5.496', 'groupId': 'OG000', 'lowerLimit': '4.830', 'upperLimit': '7.777'}, {'value': '5.53', 'spread': '5.353', 'groupId': 'OG001', 'lowerLimit': '4.373', 'upperLimit': '6.982'}]}]}, {'title': 'A/H3N2 Strain', 'categories': [{'measurements': [{'value': '3.03', 'spread': '4.268', 'groupId': 'OG000', 'lowerLimit': '2.474', 'upperLimit': '3.711'}, {'value': '3.75', 'spread': '4.861', 'groupId': 'OG001', 'lowerLimit': '3.012', 'upperLimit': '4.681'}]}]}, {'title': 'B Strain', 'categories': [{'measurements': [{'value': '2.85', 'spread': '3.399', 'groupId': 'OG000', 'lowerLimit': '2.398', 'upperLimit': '3.376'}, {'value': '2.60', 'spread': '3.356', 'groupId': 'OG001', 'lowerLimit': '2.196', 'upperLimit': '3.079'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline and Day 22', 'description': 'Geometric mean fold increase in HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination, as compared with Baseline.', 'unitOfMeasure': 'fold increase', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.'}, {'type': 'SECONDARY', 'title': 'Seroconversion Rate of Single Radial Hemolysis (SRH) Antibody Titer (Egg-Derived Antigen)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '200', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TAK-850', 'description': 'A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin \\[HA\\] antigen per strain) is injected subcutaneously into the upper arm.'}, {'id': 'OG001', 'title': 'Influenza HA Vaccine', 'description': 'A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.'}], 'classes': [{'title': 'A/H1N1 Strain', 'categories': [{'measurements': [{'value': '50.8', 'groupId': 'OG000', 'lowerLimit': '43.591', 'upperLimit': '57.894'}, {'value': '44.0', 'groupId': 'OG001', 'lowerLimit': '37.006', 'upperLimit': '51.175'}]}]}, {'title': 'A/H3N2 Strain', 'categories': [{'measurements': [{'value': '38.7', 'groupId': 'OG000', 'lowerLimit': '31.890', 'upperLimit': '45.839'}, {'value': '47.5', 'groupId': 'OG001', 'lowerLimit': '40.412', 'upperLimit': '54.663'}]}]}, {'title': 'B Strain', 'categories': [{'measurements': [{'value': '31.7', 'groupId': 'OG000', 'lowerLimit': '25.262', 'upperLimit': '38.611'}, {'value': '34.0', 'groupId': 'OG001', 'lowerLimit': '27.467', 'upperLimit': '41.016'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.8', 'ciLowerLimit': '-3.020', 'ciUpperLimit': '16.348', 'groupDescription': 'The analysis is difference of seroconversion rate between treatment groups for A/H1N1 Strain-Day 22.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non inferiority margin is set to -20%.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.8', 'ciLowerLimit': '-18.282', 'ciUpperLimit': '0.901', 'groupDescription': 'The analysis is difference of seroconversion rate between treatment groups for A/H3N2 Strain-Day 22.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non inferiority margin is set to -20%.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.3', 'ciLowerLimit': '-11.461', 'ciUpperLimit': '6.835', 'groupDescription': 'The analysis is difference of seroconversion rate between treatment groups for B Strain-Day 22.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non inferiority margin is set to -20%.'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Day 22', 'description': 'Seroconversion rate, defined as the percentage of participants with a Baseline SRH antibody titer of \\>4 mm\\^2 achieving a minimal 50% increase, or a Baseline SRH antibody titer of ≤4 mm\\^2 achieving a SRH antibody titer of ≥25 mm\\^2, as measured by single radial hemolysis (SRH) antibody titer (egg-derived antigen) for each of the three strains, 21 days after vaccination.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.'}, {'type': 'SECONDARY', 'title': 'GMT of SRH Antibody Titer (Egg-Derived Antigen)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '200', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TAK-850', 'description': 'A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin \\[HA\\] antigen per strain) is injected subcutaneously into the upper arm.'}, {'id': 'OG001', 'title': 'Influenza HA Vaccine', 'description': 'A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.'}], 'classes': [{'title': 'A/H1N1 Strain-Day 1', 'categories': [{'measurements': [{'value': '32.4939', 'spread': '2.98861', 'groupId': 'OG000', 'lowerLimit': '27.88271', 'upperLimit': '37.86773'}, {'value': '33.7752', 'spread': '2.85080', 'groupId': 'OG001', 'lowerLimit': '29.18491', 'upperLimit': '39.08753'}]}]}, {'title': 'A/H1N1 Strain-Day 22', 'categories': [{'measurements': [{'value': '83.6792', 'spread': '1.70398', 'groupId': 'OG000', 'lowerLimit': '77.67132', 'upperLimit': '90.15189'}, {'value': '79.9046', 'spread': '1.46596', 'groupId': 'OG001', 'lowerLimit': '75.75435', 'upperLimit': '84.28212'}]}]}, {'title': 'A/H3N2 Strain-Day 1', 'categories': [{'measurements': [{'value': '23.6364', 'spread': '2.99866', 'groupId': 'OG000', 'lowerLimit': '20.27267', 'upperLimit': '27.55832'}, {'value': '24.8424', 'spread': '2.79368', 'groupId': 'OG001', 'lowerLimit': '21.52683', 'upperLimit': '28.66874'}]}]}, {'title': 'A/H3N2 Strain-Day 22', 'categories': [{'measurements': [{'value': '48.0742', 'spread': '2.03848', 'groupId': 'OG000', 'lowerLimit': '43.51841', 'upperLimit': '53.10687'}, {'value': '53.5757', 'spread': '1.87521', 'groupId': 'OG001', 'lowerLimit': '49.07889', 'upperLimit': '58.48463'}]}]}, {'title': 'B Strain-Day 1', 'categories': [{'measurements': [{'value': '45.6214', 'spread': '2.00064', 'groupId': 'OG000', 'lowerLimit': '41.40641', 'upperLimit': '50.26551'}, {'value': '46.3984', 'spread': '1.89520', 'groupId': 'OG001', 'lowerLimit': '42.44118', 'upperLimit': '50.72466'}]}]}, {'title': 'B Strain-Day 22', 'categories': [{'measurements': [{'value': '74.3848', 'spread': '1.32537', 'groupId': 'OG000', 'lowerLimit': '71.51260', 'upperLimit': '77.37238'}, {'value': '75.8772', 'spread': '1.32751', 'groupId': 'OG001', 'lowerLimit': '72.93820', 'upperLimit': '78.93464'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of GMTs', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.05', 'ciLowerLimit': '0.9559', 'ciUpperLimit': '1.1473', 'estimateComment': 'TAK-850/Influenza HA Vaccine', 'groupDescription': 'The analysis is Geometric Mean Ratio between treatment groups for A/H1N1 Strain-Day 22.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non inferiority 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strain) is injected subcutaneously into the upper arm.'}], 'classes': [{'title': 'A/H1N1 Strain', 'categories': [{'measurements': [{'value': '24.1', 'groupId': 'OG000', 'lowerLimit': '18.352', 'upperLimit': '30.677'}, {'value': '23.0', 'groupId': 'OG001', 'lowerLimit': '17.358', 'upperLimit': '29.461'}]}]}, {'title': 'A/H3N2 Strain', 'categories': [{'measurements': [{'value': '41.2', 'groupId': 'OG000', 'lowerLimit': '34.294', 'upperLimit': '48.385'}, {'value': '42.0', 'groupId': 'OG001', 'lowerLimit': '35.074', 'upperLimit': '49.166'}]}]}, {'title': 'B Strain', 'categories': [{'measurements': [{'value': '43.2', 'groupId': 'OG000', 'lowerLimit': '36.230', 'upperLimit': '50.408'}, {'value': '40.0', 'groupId': 'OG001', 'lowerLimit': '33.155', 'upperLimit': '47.146'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.1', 'ciLowerLimit': '-7.195', 'ciUpperLimit': '9.423', 'estimateComment': 'TAK-850 - Influenza HA Vaccine', 'groupDescription': 'The analysis is difference of seroconversion rate between treatment groups for A/H1N1 Strain-Day 22.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non inferiority margin is set to -20%.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.8', 'ciLowerLimit': '-10.369', 'ciUpperLimit': '8.803', 'estimateComment': 'TAK-850 - Influenza HA Vaccine', 'groupDescription': 'The analysis is difference of seroconversion rate between treatment groups for A/H3N2 Strain-Day 22.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non inferiority margin is set to -20%.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.2', 'ciLowerLimit': '-6.406', 'ciUpperLimit': '12.757', 'estimateComment': 'TAK-850 - Influenza HA Vaccine', 'groupDescription': 'The analysis is difference of seroconversion rate between treatment groups for B Strain-Day 22.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non inferiority margin is set to -20%.'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Day 22', 'description': 'Seroconversion rate, defined as the percentage of participants with a Baseline SRH antibody titer of \\>4 mm\\^2 achieving a minimal 50% increase, or a Baseline SRH antibody titer of ≤4 mm\\^2 achieving a SRH antibody titer of ≥25 mm\\^2, was measured by SRH antibody titer (Vero-derived antigen) for each of the three strains, 21 days after vaccination.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.'}, {'type': 'SECONDARY', 'title': 'GMT of SRH Antibody Titer (Vero-Derived Antigen)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '200', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TAK-850', 'description': 'A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin \\[HA\\] antigen per strain) is injected subcutaneously into the upper arm.'}, {'id': 'OG001', 'title': 'Influenza HA Vaccine', 'description': 'A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.'}], 'classes': [{'title': 'A/H1N1 Strain-Day 1', 'categories': [{'measurements': [{'value': '7.4041', 'spread': '2.32428', 'groupId': 'OG000', 'lowerLimit': '6.58060', 'upperLimit': '8.33056'}, {'value': '7.7958', 'spread': '2.26942', 'groupId': 'OG001', 'lowerLimit': '6.95397', 'upperLimit': '8.73955'}]}]}, {'title': 'A/H1N1 Strain-Day 22', 'categories': [{'measurements': [{'value': '16.2670', 'spread': '2.13276', 'groupId': 'OG000', 'lowerLimit': '14.63265', 'upperLimit': '18.08382'}, {'value': '15.2566', 'spread': '2.32297', 'groupId': 'OG001', 'lowerLimit': '13.56496', 'upperLimit': '17.15930'}]}]}, {'title': 'A/H3N2 Strain-Day 1', 'categories': [{'measurements': [{'value': '19.7055', 'spread': '2.07033', 'groupId': 'OG000', 'lowerLimit': '17.79947', 'upperLimit': '21.81561'}, {'value': '19.1990', 'spread': '2.14468', 'groupId': 'OG001', 'lowerLimit': '17.26128', 'upperLimit': '21.35415'}]}]}, {'title': 'A/H3N2 Strain-Day 22', 'categories': [{'measurements': [{'value': '32.4796', 'spread': '1.76234', 'groupId': 'OG000', 'lowerLimit': '30.00608', 'upperLimit': '35.15703'}, {'value': '33.2751', 'spread': '1.85480', 'groupId': 'OG001', 'lowerLimit': '30.52867', 'upperLimit': '36.26852'}]}]}, {'title': 'B Strain-Day 1', 'categories': [{'measurements': [{'value': '28.2050', 'spread': '2.17963', 'groupId': 'OG000', 'lowerLimit': '25.29425', 'upperLimit': '31.45059'}, {'value': '28.2142', 'spread': '2.23368', 'groupId': 'OG001', 'lowerLimit': '25.22323', 'upperLimit': '31.55982'}]}]}, {'title': 'B Strain-Day 22', 'categories': [{'measurements': [{'value': '52.1647', 'spread': '1.53822', 'groupId': 'OG000', 'lowerLimit': '49.11712', 'upperLimit': '55.40139'}, {'value': '49.7468', 'spread': '1.55670', 'groupId': 'OG001', 'lowerLimit': '46.76970', 'upperLimit': '52.91348'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of GMTs', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.07', 'ciLowerLimit': '0.9106', 'ciUpperLimit': '1.2484', 'estimateComment': 'TAK-850/Influenza HA Vaccine', 'groupDescription': 'The analysis is Geometric Mean Ratio between treatment groups for A/H1N1 Strain-Day 22.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non inferiority margin is set to 0.5.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of GMTs', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.98', 'ciLowerLimit': '0.8686', 'ciUpperLimit': '1.0969', 'estimateComment': 'TAK-850/Influenza HA Vaccine', 'groupDescription': 'The analysis is Geometric Mean Ratio between treatment groups for A/H3N2-Day 22.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non inferiority margin is set to 0.5.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of GMTs', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.05', 'ciLowerLimit': '0.9622', 'ciUpperLimit': '1.1427', 'estimateComment': 'TAK-850/Influenza HA Vaccine', 'groupDescription': 'The analysis is Geometric Mean Ratio between treatment groups for B Strain-Day 22.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non inferiority margin is set to 0.5.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Days 1 and 22', 'description': 'GMT of SRH antibody titer (Vero-derived antigen) for each of the three strains, 21 days after vaccination. Day 1 data is reported for reference.', 'unitOfMeasure': 'titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.'}, {'type': 'SECONDARY', 'title': 'Seroprotection Rate of SRH Antibody Titer (Vero-Derived Antigen)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '200', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TAK-850', 'description': 'A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin \\[HA\\] antigen per strain) is injected subcutaneously into the upper arm.'}, {'id': 'OG001', 'title': 'Influenza HA Vaccine', 'description': 'A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.'}], 'classes': [{'title': 'A/H1N1 Strain-Day 1', 'categories': [{'measurements': [{'value': '17.1', 'groupId': 'OG000', 'lowerLimit': '12.132', 'upperLimit': '23.048'}, {'value': '13.0', 'groupId': 'OG001', 'lowerLimit': '8.671', 'upperLimit': '18.465'}]}]}, {'title': 'A/H1N1 Strain-Day 22', 'categories': [{'measurements': [{'value': '33.7', 'groupId': 'OG000', 'lowerLimit': '27.140', 'upperLimit': '40.692'}, {'value': '33.0', 'groupId': 'OG001', 'lowerLimit': '26.530', 'upperLimit': '39.983'}]}]}, {'title': 'A/H3N2 Strain-Day 1', 'categories': [{'measurements': [{'value': '38.2', 'groupId': 'OG000', 'lowerLimit': '31.411', 'upperLimit': '45.328'}, {'value': '42.5', 'groupId': 'OG001', 'lowerLimit': '35.556', 'upperLimit': '49.670'}]}]}, {'title': 'A/H3N2 Strain-Day 22', 'categories': [{'measurements': [{'value': '71.9', 'groupId': 'OG000', 'lowerLimit': '65.065', 'upperLimit': '77.990'}, {'value': '74.0', 'groupId': 'OG001', 'lowerLimit': '67.342', 'upperLimit': '79.932'}]}]}, {'title': 'B Strain-Day 1', 'categories': [{'measurements': [{'value': '65.3', 'groupId': 'OG000', 'lowerLimit': '58.272', 'upperLimit': '71.917'}, {'value': '65.5', 'groupId': 'OG001', 'lowerLimit': '58.469', 'upperLimit': '72.063'}]}]}, {'title': 'B Strain-Day 22', 'categories': [{'measurements': [{'value': '92.5', 'groupId': 'OG000', 'lowerLimit': '87.872', 'upperLimit': '95.720'}, {'value': '93.5', 'groupId': 'OG001', 'lowerLimit': '89.141', 'upperLimit': '96.494'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 1 and 22', 'description': 'Seroprotection rate, defined as the percentage of participants with SRH antibody titer ≥25 mm\\^2, was measured by SRH antibody titer (Vero-derived antigen) for each of the three strains, 21 days after vaccination. Day 1 data is reported for reference.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Fold Increase in SRH Antibody Titer (Vero-Derived Antigen)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '200', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TAK-850', 'description': 'A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin \\[HA\\] antigen per strain) is injected subcutaneously into the upper arm.'}, {'id': 'OG001', 'title': 'Influenza HA Vaccine', 'description': 'A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.'}], 'classes': [{'title': 'A/H1N1 Strain', 'categories': [{'measurements': [{'value': '2.1970', 'spread': '2.03685', 'groupId': 'OG000', 'lowerLimit': '1.98906', 'upperLimit': '2.42676'}, {'value': '1.9570', 'spread': '2.16354', 'groupId': 'OG001', 'lowerLimit': '1.75737', 'upperLimit': '2.17938'}]}]}, {'title': 'A/H3N2 Strain', 'categories': [{'measurements': [{'value': '1.6483', 'spread': '1.71298', 'groupId': 'OG000', 'lowerLimit': '1.52879', 'upperLimit': '1.77705'}, {'value': '1.7332', 'spread': '1.71960', 'groupId': 'OG001', 'lowerLimit': '1.60699', 'upperLimit': '1.86926'}]}]}, {'title': 'B Strain', 'categories': [{'measurements': [{'value': '1.8495', 'spread': '1.91583', 'groupId': 'OG000', 'lowerLimit': '1.6881', 'upperLimit': '2.02546'}, {'value': '1.7632', 'spread': '2.03032', 'groupId': 'OG001', 'lowerLimit': '1.59739', 'upperLimit': '1.94618'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline and Day 22', 'description': 'Geometric mean fold increase in SRH antibody titer (Vero-derived antigen) for each of the three strains, 21 days after vaccination, as compared with Baseline.', 'unitOfMeasure': 'fold increase', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Solicited Local and Systemic Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}, {'value': '200', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TAK-850', 'description': 'A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin \\[HA\\] antigen per strain) is injected subcutaneously into the upper arm.'}, {'id': 'OG001', 'title': 'Influenza HA Vaccine', 'description': 'A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.'}], 'classes': [{'title': 'Injection site pain', 'categories': [{'measurements': [{'value': '34.0', 'groupId': 'OG000'}, {'value': '39.5', 'groupId': 'OG001'}]}]}, {'title': 'Injection site redness', 'categories': [{'measurements': [{'value': '23.5', 'groupId': 'OG000'}, {'value': '28.0', 'groupId': 'OG001'}]}]}, {'title': 'Injection site swelling', 'categories': [{'measurements': [{'value': '15.5', 'groupId': 'OG000'}, {'value': '20.0', 'groupId': 'OG001'}]}]}, {'title': 'Injection site induration', 'categories': [{'measurements': [{'value': '7.0', 'groupId': 'OG000'}, {'value': '10.0', 'groupId': 'OG001'}]}]}, {'title': 'Injection site ecchymosis', 'categories': [{'measurements': [{'value': '3.5', 'groupId': 'OG000'}, {'value': '4.5', 'groupId': 'OG001'}]}]}, {'title': 'Pyrexia', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'Malaise', 'categories': [{'measurements': [{'value': '10.5', 'groupId': 'OG000'}, {'value': '11.0', 'groupId': 'OG001'}]}]}, {'title': 'Chills', 'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000'}, {'value': '4.5', 'groupId': 'OG001'}]}]}, {'title': 'Fatigue', 'categories': [{'measurements': [{'value': '10.5', 'groupId': 'OG000'}, {'value': '6.5', 'groupId': 'OG001'}]}]}, {'title': 'Headache', 'categories': [{'measurements': [{'value': '7.0', 'groupId': 'OG000'}, {'value': '9.0', 'groupId': 'OG001'}]}]}, {'title': 'Sweaty', 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000'}, {'value': '1.5', 'groupId': 'OG001'}]}]}, {'title': 'Myalgia', 'categories': [{'measurements': [{'value': '3.5', 'groupId': 'OG000'}, {'value': '5.5', 'groupId': 'OG001'}]}]}, {'title': 'Arthralgia', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.5', 'groupId': 'OG001'}]}]}, {'title': 'Nausea', 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000'}, {'value': '2.0', 'groupId': 'OG001'}]}]}, {'title': 'Vomiting', 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000'}, {'value': '1.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '22 Days', 'description': 'Participants recorded solicited injection site and systemic adverse events in a Subject Diary. Solicited Locals AEs were: Injection Site Pain, Injection Site Redness, Injection Site Swelling, Injection Site Induration and Injection Site Ecchymosis. Solicited Systemic AEs were: Pyrexia, Malaise, Chills, Fatigue, Headache, Sweaty, Myalgia, Arthralgia, Nausea and Vomiting.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set included all participants who received vaccination with study vaccine.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}, {'value': '200', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TAK-850', 'description': 'A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin \\[HA\\] antigen per strain) is injected subcutaneously into the upper arm.'}, {'id': 'OG001', 'title': 'Influenza HA Vaccine', 'description': 'A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '62.0', 'groupId': 'OG000'}, {'value': '64.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '22 days', 'description': 'Adverse events are defined as unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product, regardless of relationship to the medicinal product. TEAE is defined as an adverse event with an onset that occurs after receiving study drug.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set included all participants who received vaccination with study vaccine.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Abnormal Safety Laboratory Tests at Least Once Post Dose Reported as AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}, {'value': '200', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TAK-850', 'description': 'A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin \\[HA\\] antigen per strain) is injected subcutaneously into the upper arm.'}, {'id': 'OG001', 'title': 'Influenza HA Vaccine', 'description': 'A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.'}], 'classes': [{'title': 'Blood creatine phosphokinase increased', 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000'}, {'value': '1.0', 'groupId': 'OG001'}]}]}, {'title': 'Protein urine present', 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000'}, {'value': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'Blood bilirubin increased', 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Liver function test abnormal', 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'White blood cell count increased', 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Alanine aminotransferase increased', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'Blood glucose increased', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '22 Days', 'description': 'The percentage of participants with any abnormal standard safety laboratory values (Chemistry, Hematology and Urinalysis) collected throughout the study reported as AEs.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set included all participants who received vaccination with study vaccine.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'TAK-850', 'description': 'A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin \\[HA\\] antigen per strain) is injected subcutaneously into the upper arm.'}, {'id': 'FG001', 'title': 'Influenza HA Vaccine', 'description': 'A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '200'}, {'groupId': 'FG001', 'numSubjects': '200'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '199'}, {'groupId': 'FG001', 'numSubjects': '200'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': "Sponsor's Circumstances", 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants took part in the study at 1 investigative site in Japan from 24 September 2015 to 18 November 2015.', 'preAssignmentDetails': 'Healthy Volunteers were enrolled equally in 1 of 2 groups, TAK-850 subcutaneous (SC) or Influenza hemagglutinin (HA) vaccine SC.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'BG000'}, {'value': '200', 'groupId': 'BG001'}, {'value': '400', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'TAK-850', 'description': 'A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin \\[HA\\] antigen per strain) is injected subcutaneously into the upper arm.'}, {'id': 'BG001', 'title': 'Influenza HA Vaccine', 'description': 'A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '31.2', 'spread': '9.61', 'groupId': 'BG000'}, {'value': '31.5', 'spread': '9.46', 'groupId': 'BG001'}, {'value': '31.4', 'spread': '9.52', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '20 to 29 years', 'categories': [{'measurements': [{'value': '102', 'groupId': 'BG000'}, {'value': '98', 'groupId': 'BG001'}, {'value': '200', 'groupId': 'BG002'}]}]}, {'title': '30 to 39 years', 'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}]}]}, {'title': '40 to 49 years', 'categories': [{'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '107', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '94', 'groupId': 'BG000'}, {'value': '95', 'groupId': 'BG001'}, {'value': '189', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '106', 'groupId': 'BG000'}, {'value': '105', 'groupId': 'BG001'}, {'value': '211', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Japan', 'categories': [{'measurements': [{'value': '200', 'groupId': 'BG000'}, {'value': '200', 'groupId': 'BG001'}, {'value': '400', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '166.3', 'spread': '8.41', 'groupId': 'BG000'}, {'value': '166.0', 'spread': '8.32', 'groupId': 'BG001'}, {'value': '166.2', 'spread': '8.35', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '58.67', 'spread': '8.918', 'groupId': 'BG000'}, {'value': '57.69', 'spread': '7.937', 'groupId': 'BG001'}, {'value': '58.18', 'spread': '8.445', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '21.10', 'spread': '1.912', 'groupId': 'BG000'}, {'value': '20.86', 'spread': '1.752', 'groupId': 'BG001'}, {'value': '20.98', 'spread': '1.835', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Influenza Infection within 1 Year', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '186', 'groupId': 'BG000'}, {'value': '189', 'groupId': 'BG001'}, {'value': '375', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Hemagglutination Inhibition (HI) Antibody Titer (Egg-derived)-A/H1N1 Strain', 'classes': [{'title': 'Titer <40', 'categories': [{'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}]}]}, {'title': 'Titer ≥40', 'categories': [{'measurements': [{'value': '125', 'groupId': 'BG000'}, {'value': '135', 'groupId': 'BG001'}, {'value': '260', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'HI Antibody Titer data is only available for N=199, 200 respectively.', 'unitOfMeasure': 'participants'}, {'title': 'HI Antibody Titer (Egg-derived)-A/H3N2 Strain', 'classes': [{'title': 'Titer <40', 'categories': [{'measurements': [{'value': '106', 'groupId': 'BG000'}, {'value': '105', 'groupId': 'BG001'}, {'value': '211', 'groupId': 'BG002'}]}]}, {'title': 'Titer ≥40', 'categories': [{'measurements': [{'value': '93', 'groupId': 'BG000'}, {'value': '95', 'groupId': 'BG001'}, {'value': '188', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'HI Antibody Titer data is only available for N=199, 200 respectively.', 'unitOfMeasure': 'participants'}, {'title': 'HI Antibody Titer (Egg-derived)-B Strain', 'classes': [{'title': 'Titer <40', 'categories': [{'measurements': [{'value': '93', 'groupId': 'BG000'}, {'value': '98', 'groupId': 'BG001'}, {'value': '191', 'groupId': 'BG002'}]}]}, {'title': 'Titer ≥40', 'categories': [{'measurements': [{'value': '106', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '208', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'HI Antibody Titer data is only available for N=199, 200 respectively.', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Randomized Set included all randomized participants.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 400}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-02', 'studyFirstSubmitDate': '2015-09-17', 'resultsFirstSubmitDate': '2016-11-02', 'studyFirstSubmitQcDate': '2015-09-17', 'lastUpdatePostDateStruct': {'date': '2016-12-29', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-11-02', 'studyFirstPostDateStruct': {'date': '2015-09-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-12-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Seroconversion Rate of Hemagglutination Inhibition (HI) Antibody Titer (Egg-Derived Antigen)', 'timeFrame': 'Baseline and Day 22', 'description': 'Seroconversion rate was measured by hemagglutination inhibition (HI) antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination.\n\nSeroconversion rate was defined as the percentage of participants achieving a minimal 4-fold increase from the Baseline HI antibody titer in participants with a Baseline titer ≥10, or achieving an HI antibody titer of ≥40 in participants with a Baseline titer \\<10.'}, {'measure': 'Geometric Mean Titer (GMT) of HI Antibody Titer (Egg-Derived Antigen)', 'timeFrame': 'Days 1 and 22', 'description': 'Geometric mean titer (GMT) of HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination. Day 1 data is reported for reference.'}], 'secondaryOutcomes': [{'measure': 'Seroprotection Rate of HI Antibody Titer (Egg-Derived Antigen)', 'timeFrame': 'Days 1 and 22', 'description': 'Seroprotection rate, defined as the percentage of participants with HI antibody titer of ≥40, was measured by HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination. Day 1 data is reported for reference.'}, {'measure': 'Geometric Mean Fold Increase in HI Antibody Titer (Egg-Derived Antigen)', 'timeFrame': 'Baseline and Day 22', 'description': 'Geometric mean fold increase in HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination, as compared with Baseline.'}, {'measure': 'Seroconversion Rate of Single Radial Hemolysis (SRH) Antibody Titer (Egg-Derived Antigen)', 'timeFrame': 'Baseline and Day 22', 'description': 'Seroconversion rate, defined as the percentage of participants with a Baseline SRH antibody titer of \\>4 mm\\^2 achieving a minimal 50% increase, or a Baseline SRH antibody titer of ≤4 mm\\^2 achieving a SRH antibody titer of ≥25 mm\\^2, as measured by single radial hemolysis (SRH) antibody titer (egg-derived antigen) for each of the three strains, 21 days after vaccination.'}, {'measure': 'GMT of SRH Antibody Titer (Egg-Derived Antigen)', 'timeFrame': 'Days 1 and 22', 'description': 'GMT of SRH antibody titer (egg-derived antigen) for each of the three strains, 21 days after vaccination. Day 1 data is reported for reference.'}, {'measure': 'Seroprotection Rate of SRH Antibody Titer (Egg-Derived Antigen)', 'timeFrame': 'Days 1 and 22', 'description': 'Seroprotection rate, defined as the percentage of participants with SRH antibody titer ≥25 mm\\^2, was measured by SRH antibody titer (egg-derived antigen) for each of the three strains, 21 days after vaccination. Day 1 data is reported for reference.'}, {'measure': 'Geometric Mean Fold Increase in SRH Antibody Titer (Egg-Derived Antigen)', 'timeFrame': 'Baseline and Day 22', 'description': 'Geometric mean fold increase in SRH antibody titer (egg-derived antigen) for each of the three strains, 21 days after vaccination, as compared with Baseline.'}, {'measure': 'Seroconversion Rate of HI Antibody Titer (Vero-Derived Antigen)', 'timeFrame': 'Baseline and Day 22', 'description': 'Seroconversion rate, defined as the percentage of participants with a Baseline HI antibody titer of ≥10 achieving a minimal 4-fold increase, or a Baseline HI antibody titer of \\<10 achieving a HI antibody titer of ≥40, was measured by HI antibody titer (Vero-derived antigen) for each of the three strains, 21 days after vaccination.'}, {'measure': 'GMT of HI Antibody Titer (Vero-Derived Antigen)', 'timeFrame': 'Days 1 and 22', 'description': 'GMT of HI antibody titer (Vero-derived antigen) for each of the three strains, 21 days after vaccination. Day 1 data is reported for reference.'}, {'measure': 'Seroprotection Rate of HI Antibody Titer (Vero-Derived Antigen)', 'timeFrame': 'Days 1 and 22', 'description': 'Seroprotection rate, defined as the percentage of participants with HI antibody titer ≥40, was measured by HI antibody titer (Vero-derived antigen) for each of the three strains, 21 days after vaccination. Day 1 data is reported for reference.'}, {'measure': 'Geometric Mean Fold Increase in HI Antibody Titer (Vero-Derived Antigen)', 'timeFrame': 'Baseline and Day 22', 'description': 'Geometric mean fold increase in HI antibody titer (Vero-derived antigen) for each of the three strains, 21 days after vaccination, as compared with Baseline.'}, {'measure': 'Seroconversion Rate of SRH Antibody Titer (Vero-Derived Antigen)', 'timeFrame': 'Baseline and Day 22', 'description': 'Seroconversion rate, defined as the percentage of participants with a Baseline SRH antibody titer of \\>4 mm\\^2 achieving a minimal 50% increase, or a Baseline SRH antibody titer of ≤4 mm\\^2 achieving a SRH antibody titer of ≥25 mm\\^2, was measured by SRH antibody titer (Vero-derived antigen) for each of the three strains, 21 days after vaccination.'}, {'measure': 'GMT of SRH Antibody Titer (Vero-Derived Antigen)', 'timeFrame': 'Days 1 and 22', 'description': 'GMT of SRH antibody titer (Vero-derived antigen) for each of the three strains, 21 days after vaccination. Day 1 data is reported for reference.'}, {'measure': 'Seroprotection Rate of SRH Antibody Titer (Vero-Derived Antigen)', 'timeFrame': 'Days 1 and 22', 'description': 'Seroprotection rate, defined as the percentage of participants with SRH antibody titer ≥25 mm\\^2, was measured by SRH antibody titer (Vero-derived antigen) for each of the three strains, 21 days after vaccination. Day 1 data is reported for reference.'}, {'measure': 'Geometric Mean Fold Increase in SRH Antibody Titer (Vero-Derived Antigen)', 'timeFrame': 'Baseline and Day 22', 'description': 'Geometric mean fold increase in SRH antibody titer (Vero-derived antigen) for each of the three strains, 21 days after vaccination, as compared with Baseline.'}, {'measure': 'Percentage of Participants With Solicited Local and Systemic Adverse Events (AEs)', 'timeFrame': '22 Days', 'description': 'Participants recorded solicited injection site and systemic adverse events in a Subject Diary. Solicited Locals AEs were: Injection Site Pain, Injection Site Redness, Injection Site Swelling, Injection Site Induration and Injection Site Ecchymosis. Solicited Systemic AEs were: Pyrexia, Malaise, Chills, Fatigue, Headache, Sweaty, Myalgia, Arthralgia, Nausea and Vomiting.'}, {'measure': 'Percentage of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE)', 'timeFrame': '22 days', 'description': 'Adverse events are defined as unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product, regardless of relationship to the medicinal product. TEAE is defined as an adverse event with an onset that occurs after receiving study drug.'}, {'measure': 'Percentage of Participants With Abnormal Safety Laboratory Tests at Least Once Post Dose Reported as AEs', 'timeFrame': '22 Days', 'description': 'The percentage of participants with any abnormal standard safety laboratory values (Chemistry, Hematology and Urinalysis) collected throughout the study reported as AEs.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Vaccine'], 'conditions': ['Influenza Infection']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the immunogenicity and safety of TAK-850 administered subcutaneously as a single dose versus influenza HA vaccination in an exploratory manner.', 'detailedDescription': 'This study is a phase 2, single dose study of TAK-850 (cell-culture derived TIV) administered subcutaneously in healthy Japanese adults, designed as a randomized, double-blind, parallel-group, comparative study to evaluate the immunogenicity and safety compared to an egg-derived TIV.\n\nThe drug being tested in this study is called TAK-850. TAK-850 was tested in healthy volunteers. This study looked at immunogenicity and safety of TAK-850 (cell-derived) compared to an egg-derived influenza vaccine.\n\nThe study enrolled 400 patients. Participants were randomly assigned (by chance, like flipping a coin) to one of the two groups-which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):\n\n* TAK-850\n* Influenza HA vaccine All participants received one injection. This single center trial was conducted in Japan. The overall time to participate in this study was 22 days. Participants made multiple visits to the clinic, including a final visit 21 days after the vaccination for a follow-up assessment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. In the opinion of the investigator or subinvestigator, the participant is capable of understanding and complying with protocol requirements.\n2. The participant signs and dates a written, informed consent form prior to the initiation of any study procedures.\n3. The participant is a healthy Japanese adult male or female.\n4. The participant is aged 20 to 49 years, inclusive, at the time of informed consent.\n5. The participant has a body mass index (BMI) between 18.5 and 25.0 kg/m\\^2, inclusive, at the time of the eligibility evaluation.\n6. A female participant of childbearing potential who is sexually active with a nonsterilized male partner agreed to routinely use adequate contraception from signing of the informed consent throughout the duration of the study.\n\nExclusion Criteria:\n\n1. The participant has received any investigational compound within 4 months prior to injection of study vaccine.\n2. The participant has been vaccinated with seasonal influenza vaccine within 6 months prior to injection of study vaccine.\n3. The participant has a history of influenza infection within 6 months prior to injection of study vaccine.\n4. The participant has been vaccinated with TAK-850 before.\n5. The participant is a study site employee, an immediate family member of such an employee, or in a dependent relationship with a study site employee who is involved in the conduct of this study (e.g., spouse, parent, child, sibling), or may consent under duress.\n6. The participant has uncontrolled, clinically significant manifestations of neurological, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, endocrine, or other disorders, which may impact the ability of the participant to participate or potentially confound the study results.\n7. The participant has an oral temperature \\>= 37.5 °C prior to injection of study vaccine on Day 1.\n8. The participant has any medically diagnosed or suspected immune deficient condition.\n9. The participant has an immune compromising condition or disease, or is currently undergoing a form of treatment or was undergoing a form of treatment that can be expected to influence immune response within 30 days prior to injection of study vaccine. Such treatments include systemic or high dose inhaled corticosteroids (\\> 800 µg/day of beclomethasone dipropionate or equivalent; the use of inhaled and nasal steroids that do not exceed this level will be permitted), radiation therapy, and other immunosuppressive and cytotoxic drugs.\n10. The participant has received antipyretics within 4 hours prior to the injection of study vaccine.\n11. The participant has a history of Guillain-Barré Syndrome, demyelinating disorders (including acute disseminated encephalomyelitis \\[ADEM\\] and multiple sclerosis), or convulsions.\n12. The participant has a functional or surgical asplenia.\n13. The participant has a rash, other dermatologic conditions, or tattoos which may interfere with the evaluation of injection site reaction.\n14. The participant has a history of, or is infected with the Hepatitis B Virus (HBsAgs), Hepatitis C Virus (HCV), or Human Immunodeficiency Virus (HIV).\n15. The participant has known hypersensitivity to any component of TAK-850 or Influenza HA Vaccine.\n16. The participant has a history of severe allergic reactions or anaphylaxis.\n17. The participant has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 1 year prior to injection of study vaccine or is unwilling to agree to abstain from excessive alcohol and drugs throughout the study.\n18. The participant has received any blood products (blood transfusion or immunoglobulin) within 90 days prior to injection of study vaccine.\n19. The participant has received a live vaccine within 4 weeks (28 days) or an inactivated vaccine within 2 weeks (14 days) prior to injection of study vaccine.\n20. If female, the participant is pregnant or lactating or intending to become pregnant before signing of informed consent, during treatment, or within 12 weeks after injection of study vaccine; or intending to donate ova during this time period.\n21. The participant has donated whole blood \\>= 200 mL within 4 weeks (28 days), \\>= 400 mL within 12 weeks (84 days), \\>= 800 mL within 52 weeks (364 days) or blood components within 2 weeks (14 days) prior to injection of study vaccine.\n22. The participant has abnormal laboratory values that suggest a clinically significant underlying disease at the assessment prior to the injection of study vaccine, or the participant has the following laboratory abnormalities: alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) more than 3 times the respective upper limits of normal.\n23. In the opinion of the investigator or subinvestigator, the participant is unlikely to comply with protocol requirements or is considered ineligible for any other reasons.'}, 'identificationModule': {'nctId': 'NCT02555618', 'briefTitle': 'Phase 2 Study of TAK-850 in Comparison With Influenza Hemagglutinin (HA) Vaccine in Healthy Adult Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'A Randomized Double-Blind Parallel-Group Comparative Phase 2 Study to Evaluate the Immunogenicity and Safety of a Single Subcutaneous Injection of TAK-850 in Comparison With Influenza HA Vaccine in Healthy Adult Subjects', 'orgStudyIdInfo': {'id': 'TAK-850/CPH-003'}, 'secondaryIdInfos': [{'id': 'U1111-1174-1290', 'type': 'REGISTRY', 'domain': 'WHO'}, {'id': 'JapicCTI-153019', 'type': 'REGISTRY', 'domain': 'JapicCTI'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TAK-850', 'description': 'A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin \\[HA\\] antigen per strain) is injected subcutaneously into the upper arm.', 'interventionNames': ['Biological: TAK-850']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Influenza HA Vaccine', 'description': 'A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.', 'interventionNames': ['Biological: Influenza HA vaccine']}], 'interventions': [{'name': 'TAK-850', 'type': 'BIOLOGICAL', 'description': 'TAK-850 subcutaneous injection', 'armGroupLabels': ['TAK-850']}, {'name': 'Influenza HA vaccine', 'type': 'BIOLOGICAL', 'description': 'Influenza HA vaccine subcutaneous injection', 'armGroupLabels': ['Influenza HA Vaccine']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Takeda'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Takeda', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}