Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2025-12-26 @ 2:44 AM
Study NCT ID:
NCT04576702
Status:
COMPLETED
Last Update Posted:
2024-04-17
First Post:
2020-09-17
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Safety and Immunogenicity of an MF59-Adjuvanted Influenza Vaccine in Older Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-04-04', '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': 'seqirus.clinicaltrials@Seqirus.com', 'phone': '1-855-358-8966', 'title': 'Seqirus Clinical Trial Manager', 'organization': 'Seqirus'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181; Nonserious unsolicited AEs: Day 1 to Day 29; Solicited AEs: Day 1 to Day 7 after vaccination', 'description': 'SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.', 'eventGroups': [{'id': 'EG000', 'title': 'Investigational aIIV4c Group', 'description': 'aIIV4c will be administered as a single dose intramuscularly on Day 1\n\nInvestigational aIIV4c: Investigational MF59 Adjuvanted Cell-derived Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.', 'otherNumAtRisk': 116, 'deathsNumAtRisk': 116, 'otherNumAffected': 86, 'seriousNumAtRisk': 116, 'deathsNumAffected': 1, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Licensed IIV4c Group', 'description': 'IIV4c will be administered as a single dose intramuscularly on Day 1\n\nIIV4c: Licensed, Non-adjuvanted, Cell-derived Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.', 'otherNumAtRisk': 119, 'deathsNumAtRisk': 119, 'otherNumAffected': 77, 'seriousNumAtRisk': 119, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Licensed aIIV4 Group', 'description': 'aIIV4 will be administered as a single dose intramuscularly on Day 1\n\naIIV4: Licensed, MF59-Adjuvanted, egg-derived Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.', 'otherNumAtRisk': 116, 'deathsNumAtRisk': 116, 'otherNumAffected': 84, 'seriousNumAtRisk': 116, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG003', 'title': 'Licensed RIV4 Group', 'description': 'RIV4 will be administered as a single dose intramuscularly on Day 1\n\nRIV4: Licensed, Recombinant Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.', 'otherNumAtRisk': 120, 'deathsNumAtRisk': 120, 'otherNumAffected': 83, 'seriousNumAtRisk': 120, 'deathsNumAffected': 0, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 116, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 120, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 116, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 120, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numEvents': 50, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 29, 'numAffected': 29}, {'groupId': 'EG002', 'numAtRisk': 116, 'numEvents': 30, 'numAffected': 30}, {'groupId': 'EG003', 'numAtRisk': 120, 'numEvents': 40, 'numAffected': 40}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'Induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 116, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 120, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numEvents': 70, 'numAffected': 70}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 51, 'numAffected': 51}, {'groupId': 'EG002', 'numAtRisk': 116, 'numEvents': 66, 'numAffected': 66}, {'groupId': 'EG003', 'numAtRisk': 120, 'numEvents': 51, 'numAffected': 51}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'loss of appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 116, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 120, 'numEvents': 20, 'numAffected': 20}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numEvents': 35, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 19, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 116, 'numEvents': 23, 'numAffected': 23}, {'groupId': 'EG003', 'numAtRisk': 120, 'numEvents': 28, 'numAffected': 28}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numEvents': 40, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 23, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 116, 'numEvents': 26, 'numAffected': 26}, {'groupId': 'EG003', 'numAtRisk': 120, 'numEvents': 27, 'numAffected': 27}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numEvents': 37, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 28, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 116, 'numEvents': 29, 'numAffected': 29}, {'groupId': 'EG003', 'numAtRisk': 120, 'numEvents': 36, 'numAffected': 36}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}, {'term': 'erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 119, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 116, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 120, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.1'}], 'seriousEvents': [{'term': 'Atrioventricular block second degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 120, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.0'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 120, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.0'}, {'term': 'Coronary artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 120, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.0'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 120, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.0'}, {'term': 'Enterocutaneous fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 120, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.0'}, {'term': 'Contrast media allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 120, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 120, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.0'}, {'term': 'Scrotal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 120, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 120, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.0'}, {'term': 'Anaemia postoperative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 120, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.0'}, {'term': 'Clear cell renal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 120, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 120, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.0'}, {'term': 'Guillain-Barre syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 120, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 120, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.0'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 120, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 120, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 120, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 24.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and Against A/H3N2 Strain Using Microneutralization Assay Using Cell-derived Target Viruses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}, {'value': '109', 'groupId': 'OG002'}, {'value': '116', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Investigational aIIV4c Group', 'description': 'aIIV4c will be administered as a single dose intramuscularly on Day 1\n\nInvestigational aIIV4c: Investigational MF59 Adjuvanted Cell-derived Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.'}, {'id': 'OG001', 'title': 'Licensed IIV4c Group', 'description': 'IIV4c will be administered as a single dose intramuscularly on Day 1\n\nIIV4c: Licensed, Non-adjuvanted, Cell-derived Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.'}, {'id': 'OG002', 'title': 'Licensed aIIV4 Group', 'description': 'aIIV4 will be administered as a single dose intramuscularly on Day 1\n\naIIV4: Licensed, MF59-Adjuvanted, egg-derived Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.'}, {'id': 'OG003', 'title': 'Licensed RIV4 Group', 'description': 'RIV4 will be administered as a single dose intramuscularly on Day 1\n\nRIV4: Licensed, Recombinant Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.'}], 'classes': [{'title': 'A/H1N1 Day 1 HI GMT', 'categories': [{'measurements': [{'value': '19.5', 'groupId': 'OG000', 'lowerLimit': '15.5', 'upperLimit': '24.5'}, {'value': '17.04', 'groupId': 'OG001', 'lowerLimit': '13.6', 'upperLimit': '21.3'}, {'value': '21.85', 'groupId': 'OG002', 'lowerLimit': '17.4', 'upperLimit': '27.5'}, {'value': '18.05', 'groupId': 'OG003', 'lowerLimit': '14.5', 'upperLimit': '22.5'}]}]}, {'title': 'A/H1N1 Day 29 HI GMT', 'categories': [{'measurements': [{'value': '146.05', 'groupId': 'OG000', 'lowerLimit': '116.1', 'upperLimit': '183.7'}, {'value': '111.38', 'groupId': 'OG001', 'lowerLimit': '88.8', 'upperLimit': '139.7'}, {'value': '119.54', 'groupId': 'OG002', 'lowerLimit': '95.0', 'upperLimit': '150.5'}, {'value': '173.08', 'groupId': 'OG003', 'lowerLimit': '138.5', 'upperLimit': '216.4'}]}]}, {'title': 'B/Yamagata Day 1 HI GMT', 'categories': [{'measurements': [{'value': '16.95', 'groupId': 'OG000', 'lowerLimit': '14.3', 'upperLimit': '20.1'}, {'value': '16.02', 'groupId': 'OG001', 'lowerLimit': '13.5', 'upperLimit': '19.0'}, {'value': '14.59', 'groupId': 'OG002', 'lowerLimit': '12.3', 'upperLimit': '17.3'}, {'value': '15.99', 'groupId': 'OG003', 'lowerLimit': '13.5', 'upperLimit': '18.9'}]}]}, {'title': 'B/Yamagata Day 29 HI GMT', 'categories': [{'measurements': [{'value': '69.35', 'groupId': 'OG000', 'lowerLimit': '58.7', 'upperLimit': '81.9'}, {'value': '50.99', 'groupId': 'OG001', 'lowerLimit': '43.3', 'upperLimit': '60.1'}, {'value': '37.51', 'groupId': 'OG002', 'lowerLimit': '31.7', 'upperLimit': '44.4'}, {'value': '60.25', 'groupId': 'OG003', 'lowerLimit': '51.2', 'upperLimit': '70.8'}]}]}, {'title': 'B/Victoria Day 1 HI GMT', 'categories': [{'measurements': [{'value': '21.86', 'groupId': 'OG000', 'lowerLimit': '18.5', 'upperLimit': '25.8'}, {'value': '22.02', 'groupId': 'OG001', 'lowerLimit': '18.7', 'upperLimit': '25.9'}, {'value': '20.42', 'groupId': 'OG002', 'lowerLimit': '17.3', 'upperLimit': '24.2'}, {'value': '24.82', 'groupId': 'OG003', 'lowerLimit': '21.1', 'upperLimit': '29.2'}]}]}, {'title': 'B/Victoria Day 29 HI GMT', 'categories': [{'measurements': [{'value': '94.82', 'groupId': 'OG000', 'lowerLimit': '80.4', 'upperLimit': '111.8'}, {'value': '69.49', 'groupId': 'OG001', 'lowerLimit': '59.1', 'upperLimit': '81.7'}, {'value': '52.35', 'groupId': 'OG002', 'lowerLimit': '44.3', 'upperLimit': '61.8'}, {'value': '75.50', 'groupId': 'OG003', 'lowerLimit': '64.3', 'upperLimit': '88.6'}]}]}, {'title': 'A/H3N2 Day 1 MN GMT', 'categories': [{'measurements': [{'value': '71.44', 'groupId': 'OG000', 'lowerLimit': '61.7', 'upperLimit': '82.7'}, {'value': '59.37', 'groupId': 'OG001', 'lowerLimit': '51.4', 'upperLimit': '68.6'}, {'value': '60.20', 'groupId': 'OG002', 'lowerLimit': '52.0', 'upperLimit': '69.7'}, {'value': '64.93', 'groupId': 'OG003', 'lowerLimit': '56.3', 'upperLimit': '74.9'}]}]}, {'title': 'A/H3N2 Day 29 MN GMT', 'categories': [{'measurements': [{'value': '138.88', 'groupId': 'OG000', 'lowerLimit': '120.7', 'upperLimit': '159.8'}, {'value': '117.28', 'groupId': 'OG001', 'lowerLimit': '102.2', 'upperLimit': '134.6'}, {'value': '106.22', 'groupId': 'OG002', 'lowerLimit': '92.3', 'upperLimit': '122.3'}, {'value': '174.78', 'groupId': 'OG003', 'lowerLimit': '152.6', 'upperLimit': '200.2'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '28 days post-vaccination', 'unitOfMeasure': 'titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Set (PPS): All subjects in the Full Analysis Set (FAS) Immunogenicity who:\n\n* Correctly received the vaccine (ie, received the vaccine to which the subject was randomized).\n* Had no clinical study report (CSR)-reportable protocol deviation (PD) leading to exclusion (ie, impacting the results) as defined prior to unblinding.\n* Had immunogenicity assessments within the window of +/- 7 days around the Day 29 visit, and Day 1 sample taken within 3 days before vaccination.'}, {'type': 'PRIMARY', 'title': 'Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aIIV4c/Comparator) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by HI Assay and Against A/H3N2 Strain Using MN Assay Using Cell-derived Target Viruses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Licensed IIV4c Group', 'description': 'IIV4c will be administered as a single dose intramuscularly on Day 1\n\nIIV4c: Licensed, Non-adjuvanted, Cell-derived Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.'}, {'id': 'OG001', 'title': 'Licensed aIIV4 Group', 'description': 'aIIV4 will be administered as a single dose intramuscularly on Day 1\n\naIIV4: Licensed, MF59-Adjuvanted, egg-derived Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.'}, {'id': 'OG002', 'title': 'Licensed RIV4 Group', 'description': 'RIV4 will be administered as a single dose intramuscularly on Day 1\n\nRIV4: Licensed, Recombinant Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.'}], 'classes': [{'title': 'A/H1N1 HI GMR (aIIV4c/comparator group)', 'categories': [{'measurements': [{'value': '1.31', 'groupId': 'OG000', 'lowerLimit': '0.96', 'upperLimit': '1.79'}, {'value': '1.22', 'groupId': 'OG001', 'lowerLimit': '0.89', 'upperLimit': '1.68'}, {'value': '0.84', 'groupId': 'OG002', 'lowerLimit': '0.62', 'upperLimit': '1.15'}]}]}, {'title': 'B/Yamagata HI GMR (aIIV4c/comparator group)', 'categories': [{'measurements': [{'value': '1.36', 'groupId': 'OG000', 'lowerLimit': '1.08', 'upperLimit': '1.71'}, {'value': '1.85', 'groupId': 'OG001', 'lowerLimit': '1.47', 'upperLimit': '2.33'}, {'value': '1.15', 'groupId': 'OG002', 'lowerLimit': '0.92', 'upperLimit': '1.44'}]}]}, {'title': 'B/Victoria HI GMR (aIIV4c/comparator group)', 'categories': [{'measurements': [{'value': '1.36', 'groupId': 'OG000', 'lowerLimit': '1.09', 'upperLimit': '1.71'}, {'value': '1.81', 'groupId': 'OG001', 'lowerLimit': '1.44', 'upperLimit': '2.27'}, {'value': '1.26', 'groupId': 'OG002', 'lowerLimit': '1.00', 'upperLimit': '1.57'}]}]}, {'title': 'A/H3N2 MN GMR (aIIV4c/comparator group)', 'categories': [{'measurements': [{'value': '1.18', 'groupId': 'OG000', 'lowerLimit': '0.98', 'upperLimit': '1.43'}, {'value': '1.31', 'groupId': 'OG001', 'lowerLimit': '1.08', 'upperLimit': '1.59'}, {'value': '0.79', 'groupId': 'OG002', 'lowerLimit': '0.66', 'upperLimit': '0.96'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '28 days post-vaccination', 'unitOfMeasure': 'Ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by HI Assay and Against A/H3N2 Strain Using MN Assay Using Cell-derived Target Viruses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}, {'value': '109', 'groupId': 'OG002'}, {'value': '116', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Investigational aIIV4c Group', 'description': 'aIIV4c will be administered as a single dose intramuscularly on Day 1\n\nInvestigational aIIV4c: Investigational MF59 Adjuvanted Cell-derived Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.'}, {'id': 'OG001', 'title': 'Licensed IIV4c Group', 'description': 'IIV4c will be administered as a single dose intramuscularly on Day 1\n\nIIV4c: Licensed, Non-adjuvanted, Cell-derived Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.'}, {'id': 'OG002', 'title': 'Licensed aIIV4 Group', 'description': 'aIIV4 will be administered as a single dose intramuscularly on Day 1\n\naIIV4: Licensed, MF59-Adjuvanted, egg-derived Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.'}, {'id': 'OG003', 'title': 'Licensed RIV4 Group', 'description': 'RIV4 will be administered as a single dose intramuscularly on Day 1\n\nRIV4: Licensed, Recombinant Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.'}], 'classes': [{'title': 'A/H1N1 HI seroconversion Day 29', 'categories': [{'measurements': [{'value': '61.8', 'groupId': 'OG000', 'lowerLimit': '52.1', 'upperLimit': '70.9'}, {'value': '54.4', 'groupId': 'OG001', 'lowerLimit': '44.8', 'upperLimit': '63.7'}, {'value': '50.5', 'groupId': 'OG002', 'lowerLimit': '40.7', 'upperLimit': '60.2'}, {'value': '61.2', 'groupId': 'OG003', 'lowerLimit': '51.7', 'upperLimit': '70.1'}]}]}, {'title': 'B/Yamagata HI seroconversion Day 29', 'categories': [{'measurements': [{'value': '42.7', 'groupId': 'OG000', 'lowerLimit': '33.3', 'upperLimit': '52.5'}, {'value': '31.6', 'groupId': 'OG001', 'lowerLimit': '23.2', 'upperLimit': '40.9'}, {'value': '19.3', 'groupId': 'OG002', 'lowerLimit': '12.3', 'upperLimit': '27.9'}, {'value': '37.9', 'groupId': 'OG003', 'lowerLimit': '29.1', 'upperLimit': '47.4'}]}]}, {'title': 'B/Victoria HI seroconversion Day 29', 'categories': [{'measurements': [{'value': '46.4', 'groupId': 'OG000', 'lowerLimit': '36.8', 'upperLimit': '56.1'}, {'value': '33.3', 'groupId': 'OG001', 'lowerLimit': '24.8', 'upperLimit': '42.8'}, {'value': '26.6', 'groupId': 'OG002', 'lowerLimit': '18.6', 'upperLimit': '35.9'}, {'value': '40.5', 'groupId': 'OG003', 'lowerLimit': '31.5', 'upperLimit': '50.0'}]}]}, {'title': 'A/H3N2 MN seroconversion Day 29', 'categories': [{'measurements': [{'value': '21.8', 'groupId': 'OG000', 'lowerLimit': '14.5', 'upperLimit': '30.7'}, {'value': '20.2', 'groupId': 'OG001', 'lowerLimit': '13.2', 'upperLimit': '28.7'}, {'value': '9.2', 'groupId': 'OG002', 'lowerLimit': '4.5', 'upperLimit': '16.2'}, {'value': '32.8', 'groupId': 'OG003', 'lowerLimit': '24.3', 'upperLimit': '42.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '28 days post-vaccination', 'description': 'Seroconversion is defined as ≥4-fold increase in titer postvaccination in those with pre-vaccination titer above or equal to the Lower Limit of Quantitation (LLOQ) (≥1:10), or a post-vaccination titer ≥1:40 for subjects with baseline titer below the LLOQ (1:10) for HI titers', 'unitOfMeasure': 'percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) Using Cell-derived Target Viruses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}, {'value': '109', 'groupId': 'OG002'}, {'value': '116', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Investigational aIIV4c Group', 'description': 'aIIV4c will be administered as a single dose intramuscularly on Day 1\n\nInvestigational aIIV4c: Investigational MF59 Adjuvanted Cell-derived Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.'}, {'id': 'OG001', 'title': 'Licensed IIV4c Group', 'description': 'IIV4c will be administered as a single dose intramuscularly on Day 1\n\nIIV4c: Licensed, Non-adjuvanted, Cell-derived Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.'}, {'id': 'OG002', 'title': 'Licensed aIIV4 Group', 'description': 'aIIV4 will be administered as a single dose intramuscularly on Day 1\n\naIIV4: Licensed, MF59-Adjuvanted, egg-derived Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.'}, {'id': 'OG003', 'title': 'Licensed RIV4 Group', 'description': 'RIV4 will be administered as a single dose intramuscularly on Day 1\n\nRIV4: Licensed, Recombinant Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.'}], 'classes': [{'title': 'A/H1N1 Day 1', 'categories': [{'measurements': [{'value': '44.5', 'groupId': 'OG000', 'lowerLimit': '35.1', 'upperLimit': '54.3'}, {'value': '36.8', 'groupId': 'OG001', 'lowerLimit': '28.0', 'upperLimit': '46.4'}, {'value': '41.3', 'groupId': 'OG002', 'lowerLimit': '31.9', 'upperLimit': '51.1'}, {'value': '38.8', 'groupId': 'OG003', 'lowerLimit': '29.9', 'upperLimit': '48.3'}]}]}, {'title': 'A/H1N1 Day 29', 'categories': [{'measurements': [{'value': '85.5', 'groupId': 'OG000', 'lowerLimit': '77.5', 'upperLimit': '91.5'}, {'value': '81.6', 'groupId': 'OG001', 'lowerLimit': '73.2', 'upperLimit': '88.2'}, {'value': '82.6', 'groupId': 'OG002', 'lowerLimit': '74.1', 'upperLimit': '89.2'}, {'value': '84.5', 'groupId': 'OG003', 'lowerLimit': '76.6', 'upperLimit': '90.5'}]}]}, {'title': 'B/Yamagata day 1', 'categories': [{'measurements': [{'value': '27.3', 'groupId': 'OG000', 'lowerLimit': '19.2', 'upperLimit': '36.6'}, {'value': '23.7', 'groupId': 'OG001', 'lowerLimit': '16.2', 'upperLimit': '32.6'}, {'value': '20.2', 'groupId': 'OG002', 'lowerLimit': '13.1', 'upperLimit': '28.9'}, {'value': '28.4', 'groupId': 'OG003', 'lowerLimit': '20.5', 'upperLimit': '37.6'}]}]}, {'title': 'B/Yamagata Day 29', 'categories': [{'measurements': [{'value': '81.8', 'groupId': 'OG000', 'lowerLimit': '73.3', 'upperLimit': '88.5'}, {'value': '64.0', 'groupId': 'OG001', 'lowerLimit': '54.5', 'upperLimit': '72.8'}, {'value': '52.3', 'groupId': 'OG002', 'lowerLimit': '42.5', 'upperLimit': '61.9'}, {'value': '65.5', 'groupId': 'OG003', 'lowerLimit': '56.1', 'upperLimit': '74.1'}]}]}, {'title': 'B/Victoria Day 1', 'categories': [{'measurements': [{'value': '32.7', 'groupId': 'OG000', 'lowerLimit': '24.1', 'upperLimit': '42.3'}, {'value': '32.5', 'groupId': 'OG001', 'lowerLimit': '24.0', 'upperLimit': '41.9'}, {'value': '30.3', 'groupId': 'OG002', 'lowerLimit': '21.8', 'upperLimit': '39.8'}, {'value': '38.8', 'groupId': 'OG003', 'lowerLimit': '29.9', 'upperLimit': '48.3'}]}]}, {'title': 'B/Victoria Day 29', 'categories': [{'measurements': [{'value': '90.0', 'groupId': 'OG000', 'lowerLimit': '82.8', 'upperLimit': '94.9'}, {'value': '72.8', 'groupId': 'OG001', 'lowerLimit': '63.7', 'upperLimit': '80.7'}, {'value': '69.7', 'groupId': 'OG002', 'lowerLimit': '60.9', 'upperLimit': '78.2'}, {'value': '79.3', 'groupId': 'OG003', 'lowerLimit': '70.8', 'upperLimit': '86.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '28 days post-vaccination', 'unitOfMeasure': 'percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Safety Endpoint: The Percentage of Subjects With Solicited Local and Systemic Reactions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '114', 'groupId': 'OG002'}, {'value': '119', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Investigational aIIV4c Group', 'description': 'aIIV4c will be administered as a single dose intramuscularly on Day 1\n\nInvestigational aIIV4c: Investigational MF59 Adjuvanted Cell-derived Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.'}, {'id': 'OG001', 'title': 'Licensed IIV4c Group', 'description': 'IIV4c will be administered as a single dose intramuscularly on Day 1\n\nIIV4c: Licensed, Non-adjuvanted, Cell-derived Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.'}, {'id': 'OG002', 'title': 'Licensed aIIV4 Group', 'description': 'aIIV4 will be administered as a single dose intramuscularly on Day 1\n\naIIV4: Licensed, MF59-Adjuvanted, egg-derived Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.'}, {'id': 'OG003', 'title': 'Licensed RIV4 Group', 'description': 'RIV4 will be administered as a single dose intramuscularly on Day 1\n\nRIV4: Licensed, Recombinant Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.'}], 'classes': [{'title': 'solicited AEs', 'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '83', 'groupId': 'OG002'}, {'value': '80', 'groupId': 'OG003'}]}]}, {'title': 'Solicited local AEs', 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}]}]}, {'title': 'Solicited systemic AEs', 'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '64', 'groupId': 'OG003'}]}]}, {'title': 'analgesic/antipyretic use', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '7 days post-vaccination', 'description': 'The percentage of subjects with at least one solicited AE Day 1 through Day 7 after study vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Solicited Safety Set, defined as all subjects in the FAS with any solicited AE data.'}, {'type': 'SECONDARY', 'title': 'Safety Endpoint: The Percentage of Subjects With Any Unsolicited Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}, {'value': '120', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Investigational aIIV4c Group', 'description': 'aIIV4c will be administered as a single dose intramuscularly on Day 1\n\nInvestigational aIIV4c: Investigational MF59 Adjuvanted Cell-derived Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.'}, {'id': 'OG001', 'title': 'Licensed IIV4c Group', 'description': 'IIV4c will be administered as a single dose intramuscularly on Day 1\n\nIIV4c: Licensed, Non-adjuvanted, Cell-derived Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.'}, {'id': 'OG002', 'title': 'Licensed aIIV4 Group', 'description': 'aIIV4 will be administered as a single dose intramuscularly on Day 1\n\naIIV4: Licensed, MF59-Adjuvanted, egg-derived Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.'}, {'id': 'OG003', 'title': 'Licensed RIV4 Group', 'description': 'RIV4 will be administered as a single dose intramuscularly on Day 1\n\nRIV4: Licensed, Recombinant Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.'}], 'classes': [{'title': 'Any Unsolicited AE', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}]}, {'title': 'Any Related Unsolicited AE', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '28 days post-vaccination', 'description': 'The percentage of subjects with at least one unsolicited AE from Day 1 to Day 29.\n\nRelated AEs = considered at least possibly related to study vaccination by the investigator.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Unsolicited Safety Set, defined as all subjects in the FAS with any unsolicited AE data'}, {'type': 'SECONDARY', 'title': 'Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) During the Entire Study Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}, {'value': '120', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Investigational aIIV4c Group', 'description': 'aIIV4c will be administered as a single dose intramuscularly on Day 1\n\nInvestigational aIIV4c: Investigational MF59 Adjuvanted Cell-derived Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.'}, {'id': 'OG001', 'title': 'Licensed IIV4c Group', 'description': 'IIV4c will be administered as a single dose intramuscularly on Day 1\n\nIIV4c: Licensed, Non-adjuvanted, Cell-derived Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.'}, {'id': 'OG002', 'title': 'Licensed aIIV4 Group', 'description': 'aIIV4 will be administered as a single dose intramuscularly on Day 1\n\naIIV4: Licensed, MF59-Adjuvanted, egg-derived Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.'}, {'id': 'OG003', 'title': 'Licensed RIV4 Group', 'description': 'RIV4 will be administered as a single dose intramuscularly on Day 1\n\nRIV4: Licensed, Recombinant Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.'}], 'classes': [{'title': 'Any Serious Unsolicited AE', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}, {'title': 'Any Related Serious Unsolicited AE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Any Unsolicited AE of Special Interest', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Any Medically Attended AE', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}]}]}, {'title': 'Any Unsolicited AE Leading to Withdrawal from the Study', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Any Death', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '180 days post-vaccination', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization (MN) Assay Using Cell-derived Target Viruses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}, {'value': '109', 'groupId': 'OG002'}, {'value': '116', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Investigational aIIV4c Group', 'description': 'aIIV4c will be administered as a single dose intramuscularly on Day 1\n\nInvestigational aIIV4c: Investigational MF59 Adjuvanted Cell-derived Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.'}, {'id': 'OG001', 'title': 'Licensed IIV4c Group', 'description': 'IIV4c will be administered as a single dose intramuscularly on Day 1\n\nIIV4c: Licensed, Non-adjuvanted, Cell-derived Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.'}, {'id': 'OG002', 'title': 'Licensed aIIV4 Group', 'description': 'aIIV4 will be administered as a single dose intramuscularly on Day 1\n\naIIV4: Licensed, MF59-Adjuvanted, egg-derived Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.'}, {'id': 'OG003', 'title': 'Licensed RIV4 Group', 'description': 'RIV4 will be administered as a single dose intramuscularly on Day 1\n\nRIV4: Licensed, Recombinant Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.'}], 'classes': [{'title': 'A/H1N1 Day 1', 'categories': [{'measurements': [{'value': '158.64', 'groupId': 'OG000', 'lowerLimit': '122.0', 'upperLimit': '206.3'}, {'value': '102.88', 'groupId': 'OG001', 'lowerLimit': '79.5', 'upperLimit': '133.1'}, {'value': '162.19', 'groupId': 'OG002', 'lowerLimit': '124.6', 'upperLimit': '211.1'}, {'value': '138.73', 'groupId': 'OG003', 'lowerLimit': '107.5', 'upperLimit': '179.0'}]}]}, {'title': 'A/H1N1 Day 29', 'categories': [{'measurements': [{'value': '1261.77', 'groupId': 'OG000', 'lowerLimit': '997.2', 'upperLimit': '1596.5'}, {'value': '1036.72', 'groupId': 'OG001', 'lowerLimit': '820.3', 'upperLimit': '1310.3'}, {'value': '1050.54', 'groupId': 'OG002', 'lowerLimit': '829.5', 'upperLimit': '1330.4'}, {'value': '1719.68', 'groupId': 'OG003', 'lowerLimit': '1368.0', 'upperLimit': '2161.7'}]}]}, {'title': 'B/Yamagata Day 1', 'categories': [{'measurements': [{'value': '19.48', 'groupId': 'OG000', 'lowerLimit': '17.0', 'upperLimit': '22.3'}, {'value': '15.55', 'groupId': 'OG001', 'lowerLimit': '13.6', 'upperLimit': '17.8'}, {'value': '17.50', 'groupId': 'OG002', 'lowerLimit': '15.2', 'upperLimit': '20.1'}, {'value': '17.62', 'groupId': 'OG003', 'lowerLimit': '15.4', 'upperLimit': '20.1'}]}]}, {'title': 'B/Yamagata Day 29', 'categories': [{'measurements': [{'value': '48.08', 'groupId': 'OG000', 'lowerLimit': '41.9', 'upperLimit': 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{'value': '14', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '67', 'groupId': 'BG004'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}]}, {'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '116', 'groupId': 'BG000'}, {'value': '119', 'groupId': 'BG001'}, {'value': '116', 'groupId': 'BG002'}, {'value': '120', 'groupId': 'BG003'}, {'value': '471', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'vaccinated within 3 previous influenza seasons', 'classes': [{'title': 'yes', 'categories': [{'measurements': [{'value': '84', 'groupId': 'BG000'}, {'value': '85', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}, {'value': '85', 'groupId': 'BG003'}, {'value': '338', 'groupId': 'BG004'}]}]}, {'title': 'no', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}, {'value': '133', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-03-30', 'size': 1349073, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-02-15T10:34', 'hasProtocol': True}, {'date': '2021-03-16', 'size': 384975, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-02-15T10:35', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 471}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'dispFirstSubmitDate': '2022-03-11', 'completionDateStruct': {'date': '2021-05-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-08', 'studyFirstSubmitDate': '2020-09-17', 'resultsFirstSubmitDate': '2024-03-05', 'studyFirstSubmitQcDate': '2020-10-02', 'dispFirstPostDateStruct': {'date': '2024-04-17', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2024-04-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-04-08', 'studyFirstPostDateStruct': {'date': '2020-10-06', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-04-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and Against A/H3N2 Strain Using Microneutralization Assay Using Cell-derived Target Viruses', 'timeFrame': '28 days post-vaccination'}, {'measure': 'Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aIIV4c/Comparator) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by HI Assay and Against A/H3N2 Strain Using MN Assay Using Cell-derived Target Viruses', 'timeFrame': '28 days post-vaccination'}, {'measure': 'Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by HI Assay and Against A/H3N2 Strain Using MN Assay Using Cell-derived Target Viruses', 'timeFrame': '28 days post-vaccination', 'description': 'Seroconversion is defined as ≥4-fold increase in titer postvaccination in those with pre-vaccination titer above or equal to the Lower Limit of Quantitation (LLOQ) (≥1:10), or a post-vaccination titer ≥1:40 for subjects with baseline titer below the LLOQ (1:10) for HI titers'}, {'measure': 'Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) Using Cell-derived Target Viruses', 'timeFrame': '28 days post-vaccination'}], 'secondaryOutcomes': [{'measure': 'Safety Endpoint: The Percentage of Subjects With Solicited Local and Systemic Reactions', 'timeFrame': '7 days post-vaccination', 'description': 'The percentage of subjects with at least one solicited AE Day 1 through Day 7 after study vaccination.'}, {'measure': 'Safety Endpoint: The Percentage of Subjects With Any Unsolicited Adverse Events', 'timeFrame': '28 days post-vaccination', 'description': 'The percentage of subjects with at least one unsolicited AE from Day 1 to Day 29.\n\nRelated AEs = considered at least possibly related to study vaccination by the investigator.'}, {'measure': 'Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) During the Entire Study Period', 'timeFrame': '180 days post-vaccination'}, {'measure': 'Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization (MN) Assay Using Cell-derived Target Viruses', 'timeFrame': '28 days post-vaccination'}, {'measure': 'Immunogenicity Endpoint: GMR (GMR is GMT Ratio of aIIV4c/Comparator) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization Assay Using Cell-derived Target Viruses', 'timeFrame': '28 days post-vaccination'}, {'measure': 'Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by MN Assay Using Cell-derived Target Viruses', 'timeFrame': '28 days post-vaccination', 'description': 'Seroconversion is defined as ≥4-fold increase in titer postvaccination in those with pre-vaccination titer above or equal to the Lower Limit of Quantitation (LLOQ) (≥1:10), or a post-vaccination titer ≥1:40 for subjects with baseline titer below the LLOQ (1:10) for HI titers'}, {'measure': 'Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay Using Cell-derived Target Viruses', 'timeFrame': '180 days post-vaccination'}, {'measure': 'Immunogenicity Endpoint: GMR (GMR is GMT Ratio of aIIV4c/Comparator) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay Using Cell-derived Target Viruses', 'timeFrame': '180 days post-vaccination'}, {'measure': 'Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay) Using Cell-derived Target Viruses', 'timeFrame': '180 days post-vaccination'}, {'measure': 'Immunogenicity Endpoint: Geometric Mean Titer (GMT) Against the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay Using Cell-derived Target Viruses', 'timeFrame': '180 days post-vaccination'}, {'measure': 'Immunogenicity Endpoint: GMR (GMR is GMT Ratio of aIIV4c/Comparator) Against the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay Using Cell-derived Target Viruses', 'timeFrame': '180 days post-vaccination'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Influenza', 'Vaccine', 'MF59', 'Adjuvant'], 'conditions': ['Influenza', 'Human']}, 'referencesModule': {'references': [{'pmid': '39946829', 'type': 'DERIVED', 'citation': 'Essink BJ, Vermeulen W, Andrade C, de Rooij R, Isakov L, Casula D, Albano FR. A randomised phase 2 immunogenicity and safety study of a MF59-adjuvanted quadrivalent subunit inactivated cell-derived influenza vaccine (aQIVc) in adults aged 50 years and older. Vaccine. 2025 Apr 2;51:126791. doi: 10.1016/j.vaccine.2025.126791. Epub 2025 Feb 12.'}]}, 'descriptionModule': {'briefSummary': 'This Phase 2, randomized, observer-blind, active controlled clinical study is evaluating the safety and immunogenicity of the investigational MF59-Adjuvanted Quadrivalent Subunit Inactivated Influenza Vaccine. Approximately 480 subjects are to be randomized into 1 of 4 possible treatment groups (investigational Influenza Vaccine or licensed Quadrivalent Influenza Vaccine comparators) at 120 participants per group. Every participant will receive an influenza vaccine injection on Day 1 and will be followed up for approximately 6 months following injection. The primary immunogenicity analysis is based on Day 29 serum.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Individuals 50 years of age and older on the day of informed consent.\n2. Individuals who have voluntarily given written consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry.\n3. Individuals who can comply with study procedures including follow-up.\n4. Males, females of non-childbearing potential or females of childbearing potential who are using an effective birth control method, at least 30 days prior to informed consent, which they intend to use for at least 2 months after the study vaccination.\n\nExclusion Criteria:\n\n1. Females of childbearing potential who are pregnant, lactating, or who have not adhered to a specified set of contraceptive methods from at least 30 days prior to informed consent and who do not plan to do so until 2 months after the study vaccination.\n2. Progressive, unstable or uncontrolled clinical conditions.\n3. Hypersensitivity, including allergy, to any component of vaccines, medicinal products or medical equipment whose use is foreseen in this study.\n4. History of any medical condition considered an adverse event of special interest.\n5. Known history of Guillain Barré syndrome or another demyelinating disease such as encephalomyelitis and transverse myelitis.\n6. Clinical conditions representing a contraindication to intramuscular administration of vaccines or blood draw.\n7. Abnormal function of the immune system resulting from:\n\n 1. Clinical conditions\n 2. Systemic administration of corticosteroids (PO/IV/IM) at a dose of ≥ 20 mg/day of prednisone or equivalent for more than 14 consecutive days within 90 days prior to informed consent5.\n 3. Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to informed consent.\n8. Received immunoglobulins or any blood products within 180 days prior to informed consent.\n9. Received an investigational or non-registered medicinal product within 30 days prior to vaccination.\n10. Individuals who received any other vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrolment in this study or who are planning to receive any vaccine within 28 days from the study vaccines.\n11. Study personnel or immediate family or household member of study personnel.\n12. Receipt of any influenza vaccine within 6 months prior to vaccination in this study, or plan to receive an influenza vaccine during the study period.\n13. Acute (severe) febrile illness\n14. Any other clinical condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study.'}, 'identificationModule': {'nctId': 'NCT04576702', 'briefTitle': 'Safety and Immunogenicity of an MF59-Adjuvanted Influenza Vaccine in Older Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'Seqirus'}, 'officialTitle': 'A Phase 2, Randomized, Stratified, Observer-Blind Clinical Study to Evaluate Safety and Immunogenicity of an MF59-Adjuvanted Quadrivalent Subunit Inactivated Influenza Vaccine in Older Adults', 'orgStudyIdInfo': {'id': 'V200_10'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Investigational aIIV4c group', 'description': 'aIIV4c will be administered as a single dose intramuscularly on Day 1', 'interventionNames': ['Biological: Investigational aIIV4c']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'licensed IIV4c group', 'description': 'IIV4c will be administered as a single dose intramuscularly on Day 1', 'interventionNames': ['Biological: IIV4c']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'licensed aIIV4 group', 'description': 'aIIV4 will be administered as a single dose intramuscularly on Day 1', 'interventionNames': ['Biological: aIIV4']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'licensed RIV4 group', 'description': 'RIV4 will be administered as a single dose intramuscularly on Day 1', 'interventionNames': ['Biological: RIV4']}], 'interventions': [{'name': 'Investigational aIIV4c', 'type': 'BIOLOGICAL', 'description': 'Investigational MF59 Adjuvanted Cell-derived Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.', 'armGroupLabels': ['Investigational aIIV4c group']}, {'name': 'IIV4c', 'type': 'BIOLOGICAL', 'description': 'Licensed, Non-adjuvanted, Cell-derived Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.', 'armGroupLabels': ['licensed IIV4c group']}, {'name': 'aIIV4', 'type': 'BIOLOGICAL', 'description': 'Licensed, MF59-Adjuvanted, egg-derived Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.', 'armGroupLabels': ['licensed aIIV4 group']}, {'name': 'RIV4', 'type': 'BIOLOGICAL', 'description': 'Licensed, Recombinant Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.', 'armGroupLabels': ['licensed RIV4 group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36608', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': '4022 - Coastal Clinical Research, an AMR company', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '85283', 'city': 'Tempe', 'state': 'Arizona', 'country': 'United States', 'facility': '4002 - Clinical Research Consortium, an AMR company', 'geoPoint': {'lat': 33.41477, 'lon': -111.90931}}, {'zip': '32205', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': '4006 - Westside Center for Clinical Research', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '32216', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': '4013 - Jacksonville Center for Clinical Research', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33334', 'city': 'Oakland', 'state': 'Florida', 'country': 'United States', 'facility': '4021 - Research Centers of America, LLC', 'geoPoint': {'lat': 28.555, 'lon': -81.63313}}, {'zip': '83642', 'city': 'Boise', 'state': 'Idaho', 'country': 'United States', 'facility': '4023 - Advanced Clinical Research', 'geoPoint': {'lat': 43.6135, 'lon': -116.20345}}, {'zip': '67114', 'city': 'Newton', 'state': 'Kansas', 'country': 'United States', 'facility': '4010 - Heartland Research Associates, LLC', 'geoPoint': {'lat': 38.04668, 'lon': -97.34504}}, {'zip': '67207', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': '4016 - Heartland Research Associates, LLC - An AMR Company', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '40509', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': '4001 - Central Kentucky Research Associates, an AMR company', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '70065', 'city': 'Kenner', 'state': 'Louisiana', 'country': 'United States', 'facility': '4014 - Medpharmi', 'geoPoint': {'lat': 29.99409, 'lon': -90.24174}}, {'zip': '64114', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': '4008 - The Center for Pharmaceutical Research, an AMR company', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '63141', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': '4024 - Sundance Clinical Research, LLC', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '68134', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': '4009 - Meridian Clinical Research, LLC', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '13901', 'city': 'Binghamton', 'state': 'New York', 'country': 'United States', 'facility': '4007 - Regional Clinical Research / United Medical Associates', 'geoPoint': {'lat': 42.09869, 'lon': -75.91797}}, {'zip': '27612', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': '4012 - M3 Wake Research, Inc.', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': '4004 - Sterling research', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44122', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': '4017 - Rapid Medical Research, Inc.', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '73112', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': '4011 - Lynn Health Science Institute', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': '4005 - Clinical Trials of Texas, Inc.', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '77375', 'city': 'Tomball', 'state': 'Texas', 'country': 'United States', 'facility': '4018 - Martin Diagnostic Clinic', 'geoPoint': {'lat': 30.09716, 'lon': -95.61605}}, {'zip': '84088', 'city': 'West Jordan', 'state': 'Utah', 'country': 'United States', 'facility': '4020 - Advanced Clinical Research', 'geoPoint': {'lat': 40.60967, 'lon': -111.9391}}], 'overallOfficials': [{'name': 'Clinical Program Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Seqirus'}]}, 'ipdSharingStatementModule': {'url': 'http://ClinicalTrials.gov', 'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'SEQIRUS discloses results from clinical studies within 12 months of last patient last visit (LPLV) unless otherwise mandated by local laws or regulations.', 'ipdSharing': 'YES', 'description': 'SEQIRUS supports the release of anonymized subject-level and study-level data in compliance with regulatory requirements, including Clinical Documents which are part of the Common Technical Documents (CTD) modules submitted to regulatory agencies for public release.\n\nSummary results disclosure is either in document form (e.g., International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E3 Clinical Study Report synopsis) or structured data form (such as summary results in ClinicalTrials.gov (United States) or eudract.ema.europa.eu (EU Clinical Trial Registry \\[EU CTR\\])', 'accessCriteria': 'SEQIRUS will consider requests from qualified scientific and medical researchers to disclose protocols, anonymized subject-level data and study-level data when there is medical, scientific and/or public health interest to ensure the safe use of a Seqirus product licensed on or after 1 January 2014 in the United States (US) and/or the European Union (EU). This applies to Seqirus-sponsored interventional studies initiated after 27 September 2007 and ongoing as of 26 December 2007, that have been included as part of a US or EU submission package which received approval in US and EU on or after 1 January 2014 and have been accepted for publication'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seqirus', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}