Ignite Creation Date:
2025-12-24 @ 10:54 PM
Ignite Modification Date:
2025-12-25 @ 8:22 PM
Study NCT ID:
NCT06054269
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-05-29
First Post:
2023-09-19
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Clinical Trial to Evaluate the Immunogenicity of an Adjuvanted Influenza Vaccine Among HCP
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D007251', 'term': 'Influenza, Human'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009976', 'term': 'Orthomyxoviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'pmarcenac@cdc.gov', 'phone': '6782830242', 'title': 'Perrine Marcenac', 'organization': 'CDC'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data were collected from the moment of vaccination to the 7 days following vaccination. In the study, this corresponded to monitoring study participants from first enrollments in November 2022 to final enrollments in January 2023.', 'eventGroups': [{'id': 'EG000', 'title': 'FLUAD Quadrivalent', 'description': 'Participants administered a single dose of adjuvanted egg-based quadrivalent influenza vaccine (FLUAD Quadrivalent by Seqirus, 15 µg of HA from each strain).\n\nFLUAD Quadrivalent: 0.5 mL intramuscular dose of FLUAD Quadrivalent', 'otherNumAtRisk': 95, 'deathsNumAtRisk': 95, 'otherNumAffected': 70, 'seriousNumAtRisk': 95, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'FluQuadri', 'description': 'Participants administered a single dose of standard dose egg-based quadrivalent influenza vaccine (FluQuadri by Sanofi-Pasteur, 15 µg of HA from each strain).\n\nFluQuadri: 0.5 mL intramuscular dose of FluQuadri', 'otherNumAtRisk': 97, 'deathsNumAtRisk': 97, 'otherNumAffected': 61, 'seriousNumAtRisk': 97, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Local pain at the vaccine injection site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 32}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 16}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Muscle/articular pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Local swelling at the vaccine injection site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Local induration at the vaccine injection site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Local redness at the vaccine injection site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Local itchiness at the vaccine injection site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sore throat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Measured or subjective fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lack of appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rhinorrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Loose stool', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hematoma at the vaccine injection site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Itchiness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Increase of systolic blood pressure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain in left eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sneezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Shortness of breath', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Right malar hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyposmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest tightness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Itchiness and rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Itchiness and rash at vaccine injection site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Hemagglutination Inhibition (HI) Geometric Mean Titers (GMT) Post-vaccination (Day 28) of Each Vaccine Reference Virus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FLUAD Quadrivalent', 'description': 'Participants administered a single dose of adjuvanted egg-based quadrivalent influenza vaccine (FLUAD Quadrivalent by Seqirus, 15 µg of HA from each strain).\n\nFLUAD Quadrivalent: 0.5 mL intramuscular dose of FLUAD Quadrivalent'}, {'id': 'OG001', 'title': 'FluQuadri', 'description': 'Participants administered a single dose of standard dose egg-based quadrivalent influenza vaccine (FluQuadri by Sanofi-Pasteur, 15 µg of HA from each strain).\n\nFluQuadri: 0.5 mL intramuscular dose of FluQuadri'}], 'classes': [{'title': 'Influenza A(H1N1)pdm09', 'categories': [{'measurements': [{'value': '584.2', 'groupId': 'OG000', 'lowerLimit': '453.1', 'upperLimit': '753.3'}, {'value': '342.8', 'groupId': 'OG001', 'lowerLimit': '265.9', 'upperLimit': '442.0'}]}]}, {'title': 'Influenza A(H3N2)', 'categories': [{'measurements': [{'value': '217.4', 'groupId': 'OG000', 'lowerLimit': '173.0', 'upperLimit': '273.1'}, {'value': '169.0', 'groupId': 'OG001', 'lowerLimit': '134.5', 'upperLimit': '212.3'}]}]}, {'title': 'Influenza B/Victoria', 'categories': [{'measurements': [{'value': '102.1', 'groupId': 'OG000', 'lowerLimit': '76.5', 'upperLimit': '136.2'}, {'value': '107.8', 'groupId': 'OG001', 'lowerLimit': '80.8', 'upperLimit': '143.9'}]}]}, {'title': 'Influenza B/Yamagata', 'categories': [{'measurements': [{'value': '211.1', 'groupId': 'OG000', 'lowerLimit': '170.5', 'upperLimit': '261.4'}, {'value': '184.4', 'groupId': 'OG001', 'lowerLimit': '148.9', 'upperLimit': '228.4'}]}]}], 'analyses': [{'pValue': '0.004', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'For comparison of post-vaccination geometric mean antibody titers to the influenza A(H1N1)pdm09 vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.066', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'For comparison of post-vaccination geometric mean antibody titers to the influenza A(H3N2) vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.694', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'For comparison of post-vaccination geometric mean antibody titers to the influenza B/Victoria vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.408', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'For comparison of post-vaccination geometric mean antibody titers to the influenza B/Yamagata vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'GEOMETRIC_LEAST_SQUARES_MEAN', 'timeFrame': '28 days post-vaccination', 'description': 'The geometric mean of antibody titers after a single dose of FLUAD Quadrivalent (adjuvanted dose, AD) vs. FluQuadri (standard dose, SD) as measured by HI assay for egg-grown influenza A(H1N1)pdm09, A(H3N2), B/Yamagata, and B/Victoria vaccine reference viruses at approximately 28 days post-vaccination', 'unitOfMeasure': 'antibody titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'HI GMT Post-vaccination (6 Months) of Each Vaccine Reference Virus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FLUAD Quadrivalent', 'description': 'Participants administered a single dose of adjuvanted egg-based quadrivalent influenza vaccine (FLUAD Quadrivalent by Seqirus, 15 µg of HA from each strain).\n\nFLUAD Quadrivalent: 0.5 mL intramuscular dose of FLUAD Quadrivalent'}, {'id': 'OG001', 'title': 'FluQuadri', 'description': 'Participants administered a single dose of standard dose egg-based quadrivalent influenza vaccine (FluQuadri by Sanofi-Pasteur, 15 µg of HA from each strain).\n\nFluQuadri: 0.5 mL intramuscular dose of FluQuadri'}], 'classes': [{'title': 'Influenza A(H1N1)pdm09', 'categories': [{'measurements': [{'value': '177.4', 'groupId': 'OG000', 'lowerLimit': '137.2', 'upperLimit': '229.3'}, {'value': '128.4', 'groupId': 'OG001', 'lowerLimit': '99.6', 'upperLimit': '165.5'}]}]}, {'title': 'Influenza A(H3N2)', 'categories': [{'measurements': [{'value': '94.1', 'groupId': 'OG000', 'lowerLimit': '75.0', 'upperLimit': '118.0'}, {'value': '67.2', 'groupId': 'OG001', 'lowerLimit': '53.7', 'upperLimit': '84.1'}]}]}, {'title': 'Influenza B/Victoria', 'categories': [{'measurements': [{'value': '34.5', 'groupId': 'OG000', 'lowerLimit': '25.8', 'upperLimit': '46.1'}, {'value': '41.2', 'groupId': 'OG001', 'lowerLimit': '30.9', 'upperLimit': '54.9'}]}]}, {'title': 'Influenza B/Yamagata', 'categories': [{'measurements': [{'value': '55.5', 'groupId': 'OG000', 'lowerLimit': '43.2', 'upperLimit': '71.4'}, {'value': '57.0', 'groupId': 'OG001', 'lowerLimit': '44.4', 'upperLimit': '73.0'}]}]}], 'analyses': [{'pValue': '0.164', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'For comparison of post-vaccination geometric mean antibody titers to the influenza A(H1N1)pdm09 vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.113', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'For comparison of post-vaccination geometric mean antibody titers to the influenza A(H3N2) vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.404', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'For comparison of post-vaccination geometric mean antibody titers to the influenza B/Victoria vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.879', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'For comparison of post-vaccination geometric mean antibody titers to the influenza B/Yamagata vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'GEOMETRIC_LEAST_SQUARES_MEAN', 'timeFrame': '6 months post-vaccination', 'description': 'The geometric mean of antibody titers after a single dose of AD vs SD vaccine as measured by HI assay for egg-grown influenza A(H1N1)pdm09, A(H3N2), B/Yamagata, and B/Victoria vaccine reference viruses at approximately 6 months post-vaccination', 'unitOfMeasure': 'antibody titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Seroconversion Rate (SCR) to Each Vaccine Reference Virus Post-vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FLUAD Quadrivalent', 'description': 'Participants administered a single dose of adjuvanted egg-based quadrivalent influenza vaccine (FLUAD Quadrivalent by Seqirus, 15 µg of HA from each strain).\n\nFLUAD Quadrivalent: 0.5 mL intramuscular dose of FLUAD Quadrivalent'}, {'id': 'OG001', 'title': 'FluQuadri', 'description': 'Participants administered a single dose of standard dose egg-based quadrivalent influenza vaccine (FluQuadri by Sanofi-Pasteur, 15 µg of HA from each strain).\n\nFluQuadri: 0.5 mL intramuscular dose of FluQuadri'}], 'classes': [{'title': 'Influenza A(H1N1)pdm09', 'categories': [{'measurements': [{'value': '88.4', 'groupId': 'OG000', 'lowerLimit': '80.4', 'upperLimit': '93.4'}, {'value': '62.1', 'groupId': 'OG001', 'lowerLimit': '52.1', 'upperLimit': '71.2'}]}]}, {'title': 'Influenza A(H3N2)', 'categories': [{'measurements': [{'value': '82.1', 'groupId': 'OG000', 'lowerLimit': '73.2', 'upperLimit': '88.5'}, {'value': '62.1', 'groupId': 'OG001', 'lowerLimit': '52.1', 'upperLimit': '71.2'}]}]}, {'title': 'Influenza B/Victoria', 'categories': [{'measurements': [{'value': '47.4', 'groupId': 'OG000', 'lowerLimit': '37.6', 'upperLimit': '57.3'}, {'value': '52.6', 'groupId': 'OG001', 'lowerLimit': '42.7', 'upperLimit': '62.4'}]}]}, {'title': 'Influenza B/Yamagata', 'categories': [{'measurements': [{'value': '63.2', 'groupId': 'OG000', 'lowerLimit': '53.1', 'upperLimit': '72.2'}, {'value': '49.5', 'groupId': 'OG001', 'lowerLimit': '39.6', 'upperLimit': '59.4'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'For comparison of post-vaccination seroconversion rate to the influenza A(H1N1)pdm09 vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'For comparison of post-vaccination seroconversion rate to the influenza A(H3N2) vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.468', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'For comparison of post-vaccination seroconversion rate to the influenza B/Victoria vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.057', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'For comparison of post-vaccination seroconversion rate to the influenza B/Yamagata vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '28 days post-vaccination', 'description': 'The percent of participants with paired samples that achieved ≥4-fold rises comparing post- (approximately 28 days) versus pre-vaccination titers, and post-vaccination titers ≥40 for each vaccine reference virus (egg-grown influenza A(H1N1)pdm09, A(H3N2), B/Yamagata, and B/Victoria vaccine reference viruses) following a single dose of AD vs. SD vaccine.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'SCR to Each Vaccine Reference Virus Post-vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FLUAD Quadrivalent', 'description': 'Participants administered a single dose of adjuvanted egg-based quadrivalent influenza vaccine (FLUAD Quadrivalent by Seqirus, 15 µg of HA from each strain).\n\nFLUAD Quadrivalent: 0.5 mL intramuscular dose of FLUAD Quadrivalent'}, {'id': 'OG001', 'title': 'FluQuadri', 'description': 'Participants administered a single dose of standard dose egg-based quadrivalent influenza vaccine (FluQuadri by Sanofi-Pasteur, 15 µg of HA from each strain).\n\nFluQuadri: 0.5 mL intramuscular dose of FluQuadri'}], 'classes': [{'title': 'Influenza A(H1N1)pdm09', 'categories': [{'measurements': [{'value': '53.2', 'groupId': 'OG000', 'lowerLimit': '43.2', 'upperLimit': '63.0'}, {'value': '41.7', 'groupId': 'OG001', 'lowerLimit': '32.3', 'upperLimit': '51.7'}]}]}, {'title': 'Influenza A(H3N2)', 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000', 'lowerLimit': '40.1', 'upperLimit': '59.9'}, {'value': '39.6', 'groupId': 'OG001', 'lowerLimit': '30.4', 'upperLimit': '49.6'}]}]}, {'title': 'Influenza B/Victoria', 'categories': [{'measurements': [{'value': '18.1', 'groupId': 'OG000', 'lowerLimit': '11.6', 'upperLimit': '27.1'}, {'value': '28.1', 'groupId': 'OG001', 'lowerLimit': '20.1', 'upperLimit': '37.8'}]}]}, {'title': 'Influenza B/Yamagata', 'categories': [{'measurements': [{'value': '16.0', 'groupId': 'OG000', 'lowerLimit': '9.9', 'upperLimit': '24.7'}, {'value': '10.4', 'groupId': 'OG001', 'lowerLimit': '5.8', 'upperLimit': '18.1'}]}]}], 'analyses': [{'pValue': '0.112', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'For comparison of post-vaccination seroconversion rate to the influenza A(H1N1)pdm09 vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.149', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'For comparison of post-vaccination seroconversion rate to the influenza A(H3N2) vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.101', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'For comparison of post-vaccination seroconversion rate to the influenza B/Victoria vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.259', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'For comparison of post-vaccination seroconversion rate to the influenza B/Yamagata vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '6 months post-vaccination', 'description': 'The percent of participants with paired samples that achieved ≥4-fold rises comparing post- (approximately 6 months) versus pre-vaccination titers, and post-vaccination titers ≥40 for each vaccine reference virus (egg-grown influenza A(H1N1)pdm09, A(H3N2), B/Yamagata, and B/Victoria vaccine reference viruses) following a single dose of AD vs. SD vaccine.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Seroprotection Rate (SPR) to Each Vaccine Reference Virus Post-vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FLUAD Quadrivalent', 'description': 'Participants administered a single dose of adjuvanted egg-based quadrivalent influenza vaccine (FLUAD Quadrivalent by Seqirus, 15 µg of HA from each strain).\n\nFLUAD Quadrivalent: 0.5 mL intramuscular dose of FLUAD Quadrivalent'}, {'id': 'OG001', 'title': 'FluQuadri', 'description': 'Participants administered a single dose of standard dose egg-based quadrivalent influenza vaccine (FluQuadri by Sanofi-Pasteur, 15 µg of HA from each strain).\n\nFluQuadri: 0.5 mL intramuscular dose of FluQuadri'}], 'classes': [{'title': 'Influenza A(H1N1)pdm09', 'categories': [{'measurements': [{'value': '98.9', 'groupId': 'OG000', 'lowerLimit': '94.3', 'upperLimit': '99.9'}, {'value': '94.7', 'groupId': 'OG001', 'lowerLimit': '88.3', 'upperLimit': '97.7'}]}]}, {'title': 'Influenza A(H3N2)', 'categories': [{'measurements': [{'value': '95.8', 'groupId': 'OG000', 'lowerLimit': '89.7', 'upperLimit': '98.4'}, {'value': '94.7', 'groupId': 'OG001', 'lowerLimit': '88.3', 'upperLimit': '97.7'}]}]}, {'title': 'Influenza B/Victoria', 'categories': [{'measurements': [{'value': '81.1', 'groupId': 'OG000', 'lowerLimit': '72.0', 'upperLimit': '87.7'}, {'value': '76.8', 'groupId': 'OG001', 'lowerLimit': '67.4', 'upperLimit': '84.2'}]}]}, {'title': 'Influenza B/Yamagata', 'categories': [{'measurements': [{'value': '98.9', 'groupId': 'OG000', 'lowerLimit': '94.3', 'upperLimit': '99.9'}, {'value': '96.8', 'groupId': 'OG001', 'lowerLimit': '91.1', 'upperLimit': '98.9'}]}]}], 'analyses': [{'pValue': '0.097', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'For comparison of post-vaccination seroprotection rate to the influenza A(H1N1)pdm09 vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.733', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'For comparison of post-vaccination seroprotection rate to the influenza A(H3N2) vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.477', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'For comparison of post-vaccination seroprotection rate to the influenza B/Victoria vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.312', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'For comparison of post-vaccination seroprotection rate to the influenza B/Yamagata vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '28 days post-vaccination', 'description': 'The percent of participants with post-vaccination titers ≥40 for each vaccine reference virus (egg-grown influenza A(H1N1)pdm09, A(H3N2), B/Yamagata, and B/Victoria vaccine reference viruses) following a single dose of AD vs. SD vaccine.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'SPR to Each Vaccine Reference Virus Post-vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FLUAD Quadrivalent', 'description': 'Participants administered a single dose of adjuvanted egg-based quadrivalent influenza vaccine (FLUAD Quadrivalent by Seqirus, 15 µg of HA from each strain).\n\nFLUAD Quadrivalent: 0.5 mL intramuscular dose of FLUAD Quadrivalent'}, {'id': 'OG001', 'title': 'FluQuadri', 'description': 'Participants administered a single dose of standard dose egg-based quadrivalent influenza vaccine (FluQuadri by Sanofi-Pasteur, 15 µg of HA from each strain).\n\nFluQuadri: 0.5 mL intramuscular dose of FluQuadri'}], 'classes': [{'title': 'Influenza A(H1N1)pdm09', 'categories': [{'measurements': [{'value': '93.6', 'groupId': 'OG000', 'lowerLimit': '86.8', 'upperLimit': '97.0'}, {'value': '88.5', 'groupId': 'OG001', 'lowerLimit': '80.6', 'upperLimit': '93.5'}]}]}, {'title': 'Influenza A(H3N2)', 'categories': [{'measurements': [{'value': '90.4', 'groupId': 'OG000', 'lowerLimit': '82.8', 'upperLimit': '94.9'}, {'value': '74.0', 'groupId': 'OG001', 'lowerLimit': '64.4', 'upperLimit': '81.7'}]}]}, {'title': 'Influenza B/Victoria', 'categories': [{'measurements': [{'value': '55.3', 'groupId': 'OG000', 'lowerLimit': '45.3', 'upperLimit': '65.0'}, {'value': '56.2', 'groupId': 'OG001', 'lowerLimit': '46.3', 'upperLimit': '65.7'}]}]}, {'title': 'Influenza B/Yamagata', 'categories': [{'measurements': [{'value': '73.4', 'groupId': 'OG000', 'lowerLimit': '63.7', 'upperLimit': '81.3'}, {'value': '74.0', 'groupId': 'OG001', 'lowerLimit': '64.4', 'upperLimit': '81.7'}]}]}], 'analyses': [{'pValue': '0.220', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'For comparison of post-vaccination seroprotection rate to the influenza A(H1N1)pdm09 vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.003', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'For comparison of post-vaccination seroprotection rate to the influenza A(H3N2) vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.897', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'For comparison of post-vaccination seroprotection rate to the influenza B/Victoria vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.931', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'For comparison of post-vaccination seroprotection rate to the influenza B/Yamagata vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '6 months post-vaccination', 'description': 'The percent of participants with post-vaccination titers ≥40 for each vaccine reference virus (egg-grown influenza A(H1N1)pdm09, A(H3N2), B/Yamagata, and B/Victoria vaccine reference viruses) following a single dose of AD vs. SD vaccine.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'FLUAD Quadrivalent', 'description': 'Participants administered a single dose of adjuvanted egg-based quadrivalent influenza vaccine (FLUAD Quadrivalent by Seqirus, 15 µg of HA from each strain).\n\nFLUAD Quadrivalent: 0.5 mL intramuscular dose of FLUAD Quadrivalent'}, {'id': 'FG001', 'title': 'FluQuadri', 'description': 'Participants administered a single dose of standard dose egg-based quadrivalent influenza vaccine (FluQuadri by Sanofi-Pasteur, 15 µg of HA from each strain).\n\nFluQuadri: 0.5 mL intramuscular dose of FluQuadri'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '95'}, {'groupId': 'FG001', 'numSubjects': '97'}]}, {'type': 'Provided 28 Days Post-vaccination Blood Specimen', 'achievements': [{'groupId': 'FG000', 'numSubjects': '95'}, {'groupId': 'FG001', 'numSubjects': '95'}]}, {'type': 'Provided 6 Months Post-vaccination Blood Specimen', 'achievements': [{'groupId': 'FG000', 'numSubjects': '94'}, {'groupId': 'FG001', 'numSubjects': '96'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '95'}, {'groupId': 'FG001', 'numSubjects': '97'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'BG000'}, {'value': '97', 'groupId': 'BG001'}, {'value': '192', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'FLUAD Quadrivalent', 'description': 'Participants administered a single dose of adjuvanted egg-based quadrivalent influenza vaccine (FLUAD Quadrivalent by Seqirus, 15 µg of HA from each strain).\n\nFLUAD Quadrivalent: 0.5 mL intramuscular dose of FLUAD Quadrivalent'}, {'id': 'BG001', 'title': 'FluQuadri', 'description': 'Participants administered a single dose of standard dose egg-based quadrivalent influenza vaccine (FluQuadri by Sanofi-Pasteur, 15 µg of HA from each strain).\n\nFluQuadri: 0.5 mL intramuscular dose of FluQuadri'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Age group', 'categories': [{'title': '18-50 years old', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}]}, {'title': '50-65 years old', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}, {'title': '>65 years old', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '112', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race/ethnicity', 'categories': [{'title': 'Mixed', 'measurements': [{'value': '77', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '166', 'groupId': 'BG002'}]}, {'title': 'Quechua', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'African Peruvian', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Caucasian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Aymara', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body mass index', 'classes': [{'categories': [{'title': 'Healthy (18.5-24.9)', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': 'Overweight (25.0-29.9)', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}]}, {'title': 'Obese (>=30.0)', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Current smoking habit', 'classes': [{'categories': [{'title': 'Non-smoker', 'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '91', 'groupId': 'BG001'}, {'value': '176', 'groupId': 'BG002'}]}, {'title': 'Smoke periodically-daily', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'History of chronic conditions', 'classes': [{'categories': [{'title': 'No', 'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '162', 'groupId': 'BG002'}]}, {'title': 'Yes', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-04-14', 'size': 890999, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-04-08T11:24', 'hasProtocol': True}]}}, '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': 192}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-11-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-12', 'studyFirstSubmitDate': '2023-09-19', 'resultsFirstSubmitDate': '2025-04-11', 'studyFirstSubmitQcDate': '2023-09-19', 'lastUpdatePostDateStruct': {'date': '2025-05-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-05-12', 'studyFirstPostDateStruct': {'date': '2023-09-26', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-05-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hemagglutination Inhibition (HI) Geometric Mean Titers (GMT) Post-vaccination (Day 28) of Each Vaccine Reference Virus', 'timeFrame': '28 days post-vaccination', 'description': 'The geometric mean of antibody titers after a single dose of FLUAD Quadrivalent (adjuvanted dose, AD) vs. FluQuadri (standard dose, SD) as measured by HI assay for egg-grown influenza A(H1N1)pdm09, A(H3N2), B/Yamagata, and B/Victoria vaccine reference viruses at approximately 28 days post-vaccination'}, {'measure': 'HI GMT Post-vaccination (6 Months) of Each Vaccine Reference Virus', 'timeFrame': '6 months post-vaccination', 'description': 'The geometric mean of antibody titers after a single dose of AD vs SD vaccine as measured by HI assay for egg-grown influenza A(H1N1)pdm09, A(H3N2), B/Yamagata, and B/Victoria vaccine reference viruses at approximately 6 months post-vaccination'}, {'measure': 'Seroconversion Rate (SCR) to Each Vaccine Reference Virus Post-vaccination', 'timeFrame': '28 days post-vaccination', 'description': 'The percent of participants with paired samples that achieved ≥4-fold rises comparing post- (approximately 28 days) versus pre-vaccination titers, and post-vaccination titers ≥40 for each vaccine reference virus (egg-grown influenza A(H1N1)pdm09, A(H3N2), B/Yamagata, and B/Victoria vaccine reference viruses) following a single dose of AD vs. SD vaccine.'}, {'measure': 'SCR to Each Vaccine Reference Virus Post-vaccination', 'timeFrame': '6 months post-vaccination', 'description': 'The percent of participants with paired samples that achieved ≥4-fold rises comparing post- (approximately 6 months) versus pre-vaccination titers, and post-vaccination titers ≥40 for each vaccine reference virus (egg-grown influenza A(H1N1)pdm09, A(H3N2), B/Yamagata, and B/Victoria vaccine reference viruses) following a single dose of AD vs. SD vaccine.'}, {'measure': 'Seroprotection Rate (SPR) to Each Vaccine Reference Virus Post-vaccination', 'timeFrame': '28 days post-vaccination', 'description': 'The percent of participants with post-vaccination titers ≥40 for each vaccine reference virus (egg-grown influenza A(H1N1)pdm09, A(H3N2), B/Yamagata, and B/Victoria vaccine reference viruses) following a single dose of AD vs. SD vaccine.'}, {'measure': 'SPR to Each Vaccine Reference Virus Post-vaccination', 'timeFrame': '6 months post-vaccination', 'description': 'The percent of participants with post-vaccination titers ≥40 for each vaccine reference virus (egg-grown influenza A(H1N1)pdm09, A(H3N2), B/Yamagata, and B/Victoria vaccine reference viruses) following a single dose of AD vs. SD vaccine.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Influenza']}, 'referencesModule': {'references': [{'pmid': '41232749', 'type': 'DERIVED', 'citation': 'Marcenac P, Soto G, Yau T, Carreon JD, Romero C, Gonzales M, La Rosa S, Arriola CS, Prouty M, Diaz RAH, Romero FA, Llanos-Cuentas A, Prado EDM, Silva M, Fowlkes A, Levine MZ, Azziz-Baumgartner E, Duca LM, Neyra J. Comparison of the immunogenicity of adjuvanted and conventional egg-based quadrivalent influenza vaccines among healthcare personnel in Lima, Peru: A randomized controlled trial. Int J Infect Dis. 2025 Nov 11;162:108205. doi: 10.1016/j.ijid.2025.108205. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': 'This randomized, double-blinded trial will assess humoral immune responses to adjuvanted, egg-based quadrivalent influenza vaccines compared to standard dose, egg-based quadrivalent influenza vaccines among healthcare personnel (HCP). The trial will be conducted at two sites in Lima, Peru during 2022 and 2023.', 'detailedDescription': 'The trial will be conducted at two hospital sites in Lima, Peru during 2022-2023 among HCP who were previously enrolled in the Cohort study of Influenza and other Respiratory Viruses among HCP in Peru (cohort size: approximately 1500 participants). The minimum number of participants to be enrolled is 248 in total (142 subjects per vaccine group), and the aim is to enroll approximately 800 participants (400 subjects per vaccine group). The study design is a randomized, double-blind vaccine trial. Eligible HCP at each site who consent to participate will be randomized 1:1 to receive either a single dose of adjuvanted egg-based quadrivalent influenza vaccine (AD, FLUAD Quadrivalent by Seqirus, 15 µg of hemagglutinin \\[HA\\] from each strain) or standard dose, egg-based quadrivalent influenza vaccine (SD, FluQuadri by Sanofi-Pasteur, 15 µg of HA from each strain).\n\nParticipants will be invited to come to the study site to be screened for eligibility to participate in the clinical trial. After they consent to participate and sign informed consent form, participants will visit the site for medical assessment and vaccination. Additional brief medical adverse event assessments will be performed on days 3 and 7. Participants will be followed up to twice per week via SMS or phone calls to assess if they become sick with a respiratory event. In the event they become sick, they will be asked questions about their illness through an acute illness survey and a mid-turbinate nasal swab specimen will be collected and tested for influenza virus. Additional surveys will be administered on day 28 post-vaccination as well as at the end of the influenza season.\n\nParticipants will have blood collected just prior to vaccination (Day 0) and at approximately 28 days and 6 months post-vaccination (or at the end of influenza virus circulation as determined by active surveillance data) to evaluate humoral immune responses to vaccination. After these specimens are tested, differences in seroconversion and seroprotection between AD and SD vaccination groups will be assessed. In addition, we multivariable modelling will be used to assess risk factors for poor immunogenicity and to assess possible effects of repeated vaccination.\n\nAs an optional sub-study, indicators of cell-mediated immune (CMI) responses to influenza vaccination will be examined. This part of the study, which is optional to participants, will require collection of additional blood samples at prior to vaccination (Day 0) and at 7 and 28 days post-vaccination.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥18 years old;\n* Have participated in the healthcare personnel cohort study at Hospital Nacional Cayetano Heredia or Hospital Nacional Arzobispo Loayza during 2016-2021;\n* Work at the facility full-time (≥30 hours per week);\n* Have routine, direct, hands-on or face-to-face contact with patients (≤1 meter) as part of a typical work shift, including, but not limited to, physicians, nurses, respiratory therapists, physical therapists, unit clerks, radiograph technicians, medical assistants, and transporters;\n* Work at the facility for ≥1 year prior to enrollment and planning to continue working at the facility for one year after enrollment;\n* Willing to receive influenza vaccination (adjuvanted or standard dose);\n* Women of childbearing age must complete the following criteria to be eligible:\n\n 1. Have a negative urine pregnancy test performed by the study staff ≤24 hours preceding receipt of the vaccine;\n 2. Be willing to use a reliable form of contraception approved by the Investigator for ≤2 months after receiving the vaccine. If they are not currently using an approved contraceptive, study staff will provide access to contraceptives;\n 3. Must not be breastfeeding.\n\nExclusion Criteria:\n\n* Have received a vaccine against influenza during the 2022 influenza season (season of clinical trial);\n* Have a severe, life-threatening allergy to influenza vaccines, eggs, or influenza vaccine components;\n* Have a history of Guillain-Barre Syndrome or other autoimmune diseases;\n* Received blood or blood products within 3 months of enrollment;\n* Be pregnant, confirmed by rapid pregnancy test.'}, 'identificationModule': {'nctId': 'NCT06054269', 'acronym': 'EDUCATE', 'briefTitle': 'Clinical Trial to Evaluate the Immunogenicity of an Adjuvanted Influenza Vaccine Among HCP', 'organization': {'class': 'FED', 'fullName': 'Centers for Disease Control and Prevention'}, 'officialTitle': 'Randomized Controlled Trial, Double Blind, Phase III, to Evaluate the Immunogenicity of an Adjuvanted Influenza Vaccine Among Health Care Personnel (EDUCATE)', 'orgStudyIdInfo': {'id': 'NAMRU6.2019.0011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FLUAD Quadrivalent', 'description': 'Participants administered a single dose of adjuvanted egg-based quadrivalent influenza vaccine (FLUAD Quadrivalent by Seqirus, 15 µg of HA from each strain).', 'interventionNames': ['Biological: FLUAD Quadrivalent']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'FluQuadri', 'description': 'Participants administered a single dose of standard dose egg-based quadrivalent influenza vaccine (FluQuadri by Sanofi-Pasteur, 15 µg of HA from each strain).', 'interventionNames': ['Biological: FluQuadri']}], 'interventions': [{'name': 'FLUAD Quadrivalent', 'type': 'BIOLOGICAL', 'description': '0.5 mL intramuscular dose of FLUAD Quadrivalent', 'armGroupLabels': ['FLUAD Quadrivalent']}, {'name': 'FluQuadri', 'type': 'BIOLOGICAL', 'description': '0.5 mL intramuscular dose of FluQuadri', 'armGroupLabels': ['FluQuadri']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15082', 'city': 'Lima', 'country': 'Peru', 'facility': 'Hospital Nacional Arzobispo Loayza', 'geoPoint': {'lat': -12.04318, 'lon': -77.02824}}, {'zip': '15102', 'city': 'Lima', 'country': 'Peru', 'facility': 'Hospital Nacional Cayetano Heredia', 'geoPoint': {'lat': -12.04318, 'lon': -77.02824}}], 'overallOfficials': [{'name': 'Giselle Soto, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Naval Medical Research Unit- 6'}, {'name': 'Roger Antonio Hernandez Diaz, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Nacional Cayetano Heredia'}, {'name': 'Eduardo Demetrio Matos Prado, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Nacional Arzobispo Loayza'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No current plans to share IPD'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centers for Disease Control and Prevention', 'class': 'FED'}, 'collaborators': [{'name': 'Peruvian Clinical Research', 'class': 'OTHER'}, {'name': 'Hospital Nacional Cayetano Heredia', 'class': 'UNKNOWN'}, {'name': 'Hospital Nacional Arzobispo Loayza', 'class': 'OTHER'}, {'name': 'U.S. Naval Medical Research Unit No.6 (NAMRU-6)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}