Ignite Creation Date:
2025-12-24 @ 2:09 PM
Ignite Modification Date:
2025-12-30 @ 5:20 AM
Study NCT ID:
NCT05044195
Status:
COMPLETED
Last Update Posted:
2023-09-28
First Post:
2021-09-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Clinical Study to Evaluate the Immunogenicity and Safety of an Adjuvanted Quadrivalent Influenza Vaccine Compared With a Licensed Quadrivalent Vaccine in Adults 50 to 64 Years of Age
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-09-05', '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': {'otherDetails': 'Seqirus will generally support publication of multicenter studies only in their entirety and not as individual center data.\n\nSeqirus must be notified of any intent to publish data collected from the study and prior approval from Seqirus must be obtained prior to submission for publication.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'SAEs: Day 1 through Day 271; nonserious unsolicited AEs: Day 1 through Day 22; solicited AEs: Day 1 through Day 7', 'description': 'Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs)\n\nAll-cause mortality and SAEs are reported for the Unsolicited Safety Set. In the category of "Other Adverse Events", no nonserious unsolicited AEs were reported at a frequency \\>5%; therefore, only solicited AEs occurring at a frequency \\>5% in the Solicited Safety Set are reported in this section.', 'eventGroups': [{'id': 'EG000', 'title': 'aQIV', 'description': 'Adjuvanted QIV containing 2 influenza type A strains and 2 influenza type B strains\n\naQIV: Participants receive a 0.5-mL intramuscular dose of aQIV on Day 1', 'otherNumAtRisk': 1020, 'deathsNumAtRisk': 1027, 'otherNumAffected': 660, 'seriousNumAtRisk': 1027, 'deathsNumAffected': 1, 'seriousNumAffected': 31}, {'id': 'EG001', 'title': 'Comparator QIV', 'description': 'Non-adjuvanted comparator QIV containing 2 influenza type A strains and 2 influenza type B strains\n\nComparator QIV: Participants receive a 0.5-mL intramuscular dose of Comparator QIV on Day 1', 'otherNumAtRisk': 1008, 'deathsNumAtRisk': 1016, 'otherNumAffected': 519, 'seriousNumAtRisk': 1016, 'deathsNumAffected': 0, 'seriousNumAffected': 31}], 'otherEvents': [{'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1020, 'numAffected': 81}, {'groupId': 'EG001', 'numAtRisk': 1008, 'numAffected': 71}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Solicited AE'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1020, 'numAffected': 74}, {'groupId': 'EG001', 'numAtRisk': 1008, 'numAffected': 44}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Solicited AE'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1020, 'numAffected': 67}, {'groupId': 'EG001', 'numAtRisk': 1008, 'numAffected': 55}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Solicited AE'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1020, 'numAffected': 301}, {'groupId': 'EG001', 'numAtRisk': 1008, 'numAffected': 245}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Solicited AE'}, {'term': 'Induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1020, 'numAffected': 81}, {'groupId': 'EG001', 'numAtRisk': 1008, 'numAffected': 35}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Solicited AE'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1020, 'numAffected': 480}, {'groupId': 'EG001', 'numAtRisk': 1008, 'numAffected': 283}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Solicited AE'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1020, 'numAffected': 62}, {'groupId': 'EG001', 'numAtRisk': 1008, 'numAffected': 48}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Solicited AE'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1020, 'numAffected': 140}, {'groupId': 'EG001', 'numAtRisk': 1008, 'numAffected': 95}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Solicited AE'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1020, 'numAffected': 133}, {'groupId': 'EG001', 'numAtRisk': 1008, 'numAffected': 73}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Solicited AE'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1020, 'numAffected': 226}, {'groupId': 'EG001', 'numAtRisk': 1008, 'numAffected': 206}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Solicited AE'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1020, 'numAffected': 80}, {'groupId': 'EG001', 'numAtRisk': 1008, 'numAffected': 31}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Solicited AE'}], 'seriousEvents': [{'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1027, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1016, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.0'}, {'term': 'Abscess limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1027, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1016, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.0'}, {'term': 'Streptococcal sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1027, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1016, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.0'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1027, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1016, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1027, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1016, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.0'}, {'term': 'Device related infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1027, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1016, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1027, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1016, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.0'}, {'term': 'Rectal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1027, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1016, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.0'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1027, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1016, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.0'}, {'term': 'Staphylococcal sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1027, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1016, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.0'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1027, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1016, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1027, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1016, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1027, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1016, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.0'}, {'term': 'Aortic valve stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1027, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1016, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.0'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1027, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1016, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.0'}, {'term': 'Cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1027, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1016, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1027, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1016, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.0'}, {'term': 'B-cell lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1027, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1016, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.0'}, {'term': 'Endometrial adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1027, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1016, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.0'}, {'term': 'Follicular lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1027, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1016, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.0'}, {'term': 'Huerthle cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1027, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1016, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.0'}, {'term': 'Lung adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1027, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1016, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.0'}, {'term': 'Bladder cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1027, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1016, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.0'}, {'term': 'Hepatic neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1027, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1016, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.0'}, {'term': 'Lip and/or oral cavity cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1027, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1016, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.0'}, {'term': 'Pancreatic carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1027, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1016, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.0'}, {'term': 'Plasmacytoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1027, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1016, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.0'}, {'term': 'Diverticulum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1027, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1016, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1027, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1016, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.0'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1027, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1016, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.0'}, {'term': 'Gastritis erosive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1027, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1016, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.0'}, {'term': 'Large intestine polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1027, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1016, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.0'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1027, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1016, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.0'}, {'term': 'Clavicle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1027, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1016, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.0'}, {'term': 'Femoral neck fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1027, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1016, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.0'}, {'term': 'Limb crushing injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1027, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1016, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.0'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1027, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1016, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.0'}, {'term': 'Scapula fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1027, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1016, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.0'}, {'term': 'Alcohol poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1027, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1016, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.0'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1027, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1016, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.0'}, {'term': 'Bladder injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1027, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1016, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.0'}, {'term': 'Radius fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1027, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1016, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.0'}, {'term': 'Adverse drug reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1027, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1016, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1027, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1016, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.0'}, {'term': 'Hernia pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1027, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1016, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1027, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1016, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.0'}, {'term': 'Spondylolisthesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1027, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1016, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.0'}, {'term': 'Ovarian cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1027, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1016, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.0'}, {'term': 'Vaginal prolapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1027, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1016, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1027, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1016, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.0'}, {'term': 'Pulmonary thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1027, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1016, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.0'}, {'term': 'Haemothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1027, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1016, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.0'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1027, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1016, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.0'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1027, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1016, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.0'}, {'term': 'Bile duct stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1027, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1016, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.0'}, {'term': 'Ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1027, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1016, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.0'}, {'term': 'Conversion disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1027, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1016, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.0'}, {'term': 'Psychiatric decompensation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1027, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1016, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.0'}, {'term': 'Alcohol abuse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1027, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1016, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 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'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.0'}, {'term': 'Cerebellar stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1027, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1016, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.0'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1027, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1016, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.0'}, {'term': 'Status epilepticus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1027, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1016, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.0'}, {'term': 'Subarachnoid haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1027, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1016, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 25.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Immunogenicity Endpoint: Geometric Mean Titer (GMT) and GMT Ratio of Hemagglutination Inhibition (HI) Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains', 'denoms': [{'units': 'Participants', 'counts': [{'value': '983', 'groupId': 'OG000'}, {'value': '985', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'aQIV', 'description': 'Adjuvanted QIV containing 2 influenza type A strains and 2 influenza type B strains\n\naQIV: Participants receive a 0.5-mL intramuscular dose of aQIV on Day 1'}, {'id': 'OG001', 'title': 'Comparator QIV', 'description': 'Non-adjuvanted comparator QIV containing 2 influenza type A strains and 2 influenza type B strains\n\nComparator QIV: Participants receive a 0.5-mL intramuscular dose of Comparator QIV on Day 1'}], 'classes': [{'title': 'A/H1N1', 'categories': [{'measurements': [{'value': '731.90', 'groupId': 'OG000', 'lowerLimit': '689.39', 'upperLimit': '777.04'}, {'value': '586.85', 'groupId': 'OG001', 'lowerLimit': '552.83', 'upperLimit': '622.96'}]}]}, {'title': 'A/H3N2', 'categories': [{'measurements': [{'value': '347.89', 'groupId': 'OG000', 'lowerLimit': '324.78', 'upperLimit': '372.64'}, {'value': '313.16', 'groupId': 'OG001', 'lowerLimit': '292.42', 'upperLimit': '335.36'}]}]}, {'title': 'B/Yamagata', 'categories': [{'measurements': [{'value': '154.40', 'groupId': 'OG000', 'lowerLimit': '146.80', 'upperLimit': '162.40'}, {'value': '145.74', 'groupId': 'OG001', 'lowerLimit': '138.57', 'upperLimit': '153.27'}]}]}, {'title': 'B/Victoria', 'categories': [{'measurements': [{'value': '144.41', 'groupId': 'OG000', 'lowerLimit': '136.97', 'upperLimit': '152.26'}, {'value': '143.32', 'groupId': 'OG001', 'lowerLimit': '135.97', 'upperLimit': '151.07'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.802', 'ciLowerLimit': '0.738', 'ciUpperLimit': '0.871', 'groupDescription': 'A/H1N1', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority criteria for the GMT ratio: upper limit (UL) of the 95% confidence interval (CI) for the inter-group GMT ratio is ≤1.5 for each vaccine strain'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.900', 'ciLowerLimit': '0.819', 'ciUpperLimit': '0.989', 'groupDescription': 'A/H3N2', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority criteria for the GMT ratio: UL of the 95% CI for the inter-group GMT ratio is ≤1.5 for each vaccine strain'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.944', 'ciLowerLimit': '0.880', 'ciUpperLimit': '1.012', 'groupDescription': 'B/Yamagata', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority criteria for the GMT ratio: UL of the 95% CI for the inter-group GMT ratio is ≤1.5 for each vaccine strain'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.992', 'ciLowerLimit': '0.923', 'ciUpperLimit': '1.067', 'groupDescription': 'B/Victoria', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority criteria for the GMT ratio: UL of the 95% CI for the inter-group GMT ratio is ≤1.5 for each vaccine strain'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 22', 'description': 'The GMT ratio is defined as the geometric mean of the postvaccination HI titer for Comparator QIV over the geometric mean of the postvaccination HI titer for aQIV.', 'unitOfMeasure': 'Titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Set (PPS) Immunogenicity, defined as all subjects in the Full Analysis Set (FAS) Immunogenicity who: had both Day 1 and Day 22 immunogenicity assessment; correctly received the vaccine (ie, received the vaccine to which the subjects were randomized and at the scheduled time points); had no protocol deviations leading to exclusion as defined prior to unblinding/analysis; were not excluded due to other reasons defined prior to unblinding or analysis. Note: Adjusted GMTs are presented.'}, {'type': 'PRIMARY', 'title': 'Immunogenicity Endpoint: Seroconversion Rate (SCR) and SCR Difference for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains', 'denoms': [{'units': 'Participants', 'counts': [{'value': '983', 'groupId': 'OG000'}, {'value': '985', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'aQIV', 'description': 'Adjuvanted QIV containing 2 influenza type A strains and 2 influenza type B strains\n\naQIV: Participants receive a 0.5-mL intramuscular dose of aQIV on Day 1'}, {'id': 'OG001', 'title': 'Comparator QIV', 'description': 'Non-adjuvanted comparator QIV containing 2 influenza type A strains and 2 influenza type B strains\n\nComparator QIV: Participants receive a 0.5-mL intramuscular dose of Comparator QIV on Day 1'}], 'classes': [{'title': 'A/H1N1', 'categories': [{'measurements': [{'value': '81.2', 'groupId': 'OG000', 'lowerLimit': '78.57', 'upperLimit': '83.58'}, {'value': '76.8', 'groupId': 'OG001', 'lowerLimit': '74.04', 'upperLimit': '79.42'}]}]}, {'title': 'A/H3N2', 'categories': [{'measurements': [{'value': '63.6', 'groupId': 'OG000', 'lowerLimit': '60.46', 'upperLimit': '66.63'}, {'value': '61.8', 'groupId': 'OG001', 'lowerLimit': '58.61', 'upperLimit': '64.82'}]}]}, {'title': 'B/Yamagata', 'categories': [{'measurements': [{'value': '43.4', 'groupId': 'OG000', 'lowerLimit': '40.27', 'upperLimit': '46.60'}, {'value': '41.0', 'groupId': 'OG001', 'lowerLimit': '37.92', 'upperLimit': '44.19'}]}]}, {'title': 'B/Victoria', 'categories': [{'measurements': [{'value': '44.5', 'groupId': 'OG000', 'lowerLimit': '41.39', 'upperLimit': '47.74'}, {'value': '40.6', 'groupId': 'OG001', 'lowerLimit': '37.52', 'upperLimit': '43.76'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'SCR difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.4', 'ciLowerLimit': '-7.97', 'ciUpperLimit': '-0.74', 'groupDescription': 'A/H1N1', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority criteria for the SCR difference: UL of the 95% CI for the difference in SCR is ≤10% for each vaccine strain'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'SCR difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.8', 'ciLowerLimit': '-6.14', 'ciUpperLimit': '2.48', 'groupDescription': 'A/H3N2', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority criteria for the SCR difference: UL of the 95% CI for the difference in SCR is ≤10% for each vaccine strain'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'SCR difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.4', 'ciLowerLimit': '-6.77', 'ciUpperLimit': '2.00', 'groupDescription': 'B/Yamagata', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority criteria for the SCR difference: UL of the 95% CI for the difference in SCR is ≤10% for each vaccine strain'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'SCR difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.9', 'ciLowerLimit': '-8.31', 'ciUpperLimit': '0.45', 'groupDescription': 'B/Victoria', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority criteria for the SCR difference: UL of the 95% CI for the difference in SCR is ≤10% for each vaccine strain'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 to Day 22', 'description': 'The SCR defined as the percentage of subjects with either a prevaccination HI titer \\<1:10 and a postvaccination (Day 22) HI titer ≥1:40, or with either a prevaccination HI titer ≥1:10 and a ≥4-fold increase in postvaccination HI titer.\n\nThe SCR difference is defined as the Comparator QIV SCR minus the aQIV SCR.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'PPS Immunogenicity'}, {'type': 'PRIMARY', 'title': 'Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1027', 'groupId': 'OG000'}, {'value': '1016', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'aQIV', 'description': 'Adjuvanted QIV containing 2 influenza type A strains and 2 influenza type B strains\n\naQIV: Participants receive a 0.5-mL intramuscular dose of aQIV on Day 1'}, {'id': 'OG001', 'title': 'Comparator QIV', 'description': 'Non-adjuvanted comparator QIV containing 2 influenza type A strains and 2 influenza type B strains\n\nComparator QIV: Participants receive a 0.5-mL intramuscular dose of Comparator QIV on Day 1'}], 'classes': [{'title': 'A/H1N1', 'categories': [{'measurements': [{'value': '729.17', 'groupId': 'OG000', 'lowerLimit': '687.51', 'upperLimit': '773.36'}, {'value': '589.07', 'groupId': 'OG001', 'lowerLimit': '555.25', 'upperLimit': '624.94'}]}]}, {'title': 'A/H3N2', 'categories': [{'measurements': [{'value': '347.09', 'groupId': 'OG000', 'lowerLimit': '324.44', 'upperLimit': '371.33'}, {'value': '315.69', 'groupId': 'OG001', 'lowerLimit': '295.04', 'upperLimit': '337.79'}]}]}, {'title': 'B/Yamagata', 'categories': [{'measurements': [{'value': '155.19', 'groupId': 'OG000', 'lowerLimit': '147.67', 'upperLimit': '163.09'}, {'value': '146.89', 'groupId': 'OG001', 'lowerLimit': '139.74', 'upperLimit': '154.40'}]}]}, {'title': 'B/Victoria', 'categories': [{'measurements': [{'value': '143.73', 'groupId': 'OG000', 'lowerLimit': '136.44', 'upperLimit': '151.42'}, {'value': '143.74', 'groupId': 'OG001', 'lowerLimit': '136.42', 'upperLimit': '151.45'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.808', 'ciLowerLimit': '0.745', 'ciUpperLimit': '0.876', 'groupDescription': 'A/H1N1', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.910', 'ciLowerLimit': '0.829', 'ciUpperLimit': '0.998', 'groupDescription': 'A/H3N2', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.947', 'ciLowerLimit': '0.884', 'ciUpperLimit': '1.014', 'groupDescription': 'B/Yamagata', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.000', 'ciLowerLimit': '0.931', 'ciUpperLimit': '1.075', 'groupDescription': 'B/Victoria', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 22', 'description': 'The GMT ratio is defined as the geometric mean of the postvaccination HI titer for Comparator QIV over the geometric mean of the postvaccination HI titer for aQIV.', 'unitOfMeasure': 'Titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Immunogenicity, defined as all subjects in the All Enrolled Set who were randomized, received study vaccination and provided immunogenicity data at any time point. Note: Adjusted GMTs are presented.'}, {'type': 'SECONDARY', 'title': 'Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1027', 'groupId': 'OG000'}, {'value': '1016', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'aQIV', 'description': 'Adjuvanted QIV containing 2 influenza type A strains and 2 influenza type B strains\n\naQIV: Participants receive a 0.5-mL intramuscular dose of aQIV on Day 1'}, {'id': 'OG001', 'title': 'Comparator QIV', 'description': 'Non-adjuvanted comparator QIV containing 2 influenza type A strains and 2 influenza type B strains\n\nComparator QIV: Participants receive a 0.5-mL intramuscular dose of Comparator QIV on Day 1'}], 'classes': [{'title': 'A/H1N1', 'categories': [{'measurements': [{'value': '351.73', 'groupId': 'OG000', 'lowerLimit': '331.61', 'upperLimit': '373.06'}, {'value': '306.11', 'groupId': 'OG001', 'lowerLimit': '288.62', 'upperLimit': '324.66'}]}]}, {'title': 'A/H3N2', 'categories': [{'measurements': [{'value': '165.17', 'groupId': 'OG000', 'lowerLimit': '155.85', 'upperLimit': '175.05'}, {'value': '157.34', 'groupId': 'OG001', 'lowerLimit': '148.48', 'upperLimit': '166.73'}]}]}, {'title': 'B/Yamagata', 'categories': [{'measurements': [{'value': '83.42', 'groupId': 'OG000', 'lowerLimit': '79.81', 'upperLimit': '87.20'}, {'value': '84.53', 'groupId': 'OG001', 'lowerLimit': '80.87', 'upperLimit': '88.36'}]}]}, {'title': 'B/Victoria', 'categories': [{'measurements': [{'value': '79.51', 'groupId': 'OG000', 'lowerLimit': '75.81', 'upperLimit': '83.40'}, {'value': '81.73', 'groupId': 'OG001', 'lowerLimit': '77.92', 'upperLimit': '85.72'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.870', 'ciLowerLimit': '0.803', 'ciUpperLimit': '0.944', 'groupDescription': 'A/H1N1', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.953', 'ciLowerLimit': '0.880', 'ciUpperLimit': '1.032', 'groupDescription': 'A/H3N2', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.013', 'ciLowerLimit': '0.953', 'ciUpperLimit': '1.077', 'groupDescription': 'B/Yamagata', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.028', 'ciLowerLimit': '0.963', 'ciUpperLimit': '1.098', 'groupDescription': 'B/Victoria', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 181', 'description': 'The GMT ratio is defined as the geometric mean of the postvaccination HI titer for Comparator QIV over the geometric mean of the postvaccination HI titer for aQIV.', 'unitOfMeasure': 'Titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Immunogenicity. Note: Adjusted GMTs are presented.'}, {'type': 'SECONDARY', 'title': 'Immunogenicity Endpoint: GMT of HI Antibodies on Day 1, Day 22, and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1027', 'groupId': 'OG000'}, {'value': '1016', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'aQIV', 'description': 'Adjuvanted QIV containing 2 influenza type A strains and 2 influenza type B strains\n\naQIV: Participants receive a 0.5-mL intramuscular dose of aQIV on Day 1'}, {'id': 'OG001', 'title': 'Comparator QIV', 'description': 'Non-adjuvanted comparator QIV containing 2 influenza type A strains and 2 influenza type B strains\n\nComparator QIV: Participants receive a 0.5-mL intramuscular dose of Comparator QIV on Day 1'}], 'classes': [{'title': 'A/H1N1 Day 1 GMT', 'categories': [{'measurements': [{'value': '54.37', 'groupId': 'OG000', 'lowerLimit': '49.71', 'upperLimit': '59.47'}, {'value': '50.41', 'groupId': 'OG001', 'lowerLimit': '46.13', 'upperLimit': '55.09'}]}]}, {'title': 'A/H1N1 Day 22 GMT', 'categories': [{'measurements': [{'value': '708.36', 'groupId': 'OG000', 'lowerLimit': '666.39', 'upperLimit': '752.98'}, {'value': '553.70', 'groupId': 'OG001', 'lowerLimit': '519.14', 'upperLimit': '590.56'}]}]}, {'title': 'A/H1N1 Day 181 GMT', 'categories': [{'measurements': [{'value': '330.76', 'groupId': 'OG000', 'lowerLimit': '308.44', 'upperLimit': '354.70'}, {'value': '276.24', 'groupId': 'OG001', 'lowerLimit': '257.32', 'upperLimit': '296.56'}]}]}, {'title': 'A/H3N2 Day 1 GMT', 'categories': [{'measurements': [{'value': '45.97', 'groupId': 'OG000', 'lowerLimit': '42.06', 'upperLimit': '50.25'}, {'value': '46.54', 'groupId': 'OG001', 'lowerLimit': '42.63', 'upperLimit': '50.81'}]}]}, {'title': 'A/H3N2 Day 22 GMT', 'categories': [{'measurements': [{'value': '323.40', 'groupId': 'OG000', 'lowerLimit': '300.77', 'upperLimit': '347.73'}, {'value': '292.50', 'groupId': 'OG001', 'lowerLimit': '271.72', 'upperLimit': '314.88'}]}]}, {'title': 'A/H3N2 Day 181 GMT', 'categories': [{'measurements': [{'value': '151.92', 'groupId': 'OG000', 'lowerLimit': '141.27', 'upperLimit': '163.37'}, {'value': '143.80', 'groupId': 'OG001', 'lowerLimit': '133.33', 'upperLimit': '155.09'}]}]}, {'title': 'B/Yamagata Day 1 GMT', 'categories': [{'measurements': [{'value': '38.50', 'groupId': 'OG000', 'lowerLimit': '35.83', 'upperLimit': '41.38'}, {'value': '38.33', 'groupId': 'OG001', 'lowerLimit': '35.68', 'upperLimit': '41.18'}]}]}, {'title': 'B/Yamagata Day 22 GMT', 'categories': [{'measurements': [{'value': '144.30', 'groupId': 'OG000', 'lowerLimit': '136.02', 'upperLimit': '153.08'}, {'value': '134.15', 'groupId': 'OG001', 'lowerLimit': '126.31', 'upperLimit': '142.48'}]}]}, {'title': 'B/Yamagata Day 181 GMT', 'categories': [{'measurements': [{'value': '76.87', 'groupId': 'OG000', 'lowerLimit': '72.33', 'upperLimit': '81.70'}, {'value': '77.34', 'groupId': 'OG001', 'lowerLimit': '72.72', 'upperLimit': '82.25'}]}]}, {'title': 'B/Victoria Day 1 GMT', 'categories': [{'measurements': [{'value': '36.24', 'groupId': 'OG000', 'lowerLimit': '33.78', 'upperLimit': '38.87'}, {'value': '37.06', 'groupId': 'OG001', 'lowerLimit': '34.56', 'upperLimit': '39.73'}]}]}, {'title': 'B/Victoria Day 22 GMT', 'categories': [{'measurements': [{'value': '134.45', 'groupId': 'OG000', 'lowerLimit': '126.24', 'upperLimit': '143.21'}, {'value': '132.45', 'groupId': 'OG001', 'lowerLimit': '124.32', 'upperLimit': '141.10'}]}]}, {'title': 'B/Victoria Day 181 GMT', 'categories': [{'measurements': [{'value': '74.17', 'groupId': 'OG000', 'lowerLimit': '69.66', 'upperLimit': '78.97'}, {'value': '75.99', 'groupId': 'OG001', 'lowerLimit': '71.42', 'upperLimit': '80.85'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 to Day 181', 'description': 'GMTs on Day 1 (prior to vaccination), Day 22 (3 weeks after vaccination), and Day 181 (6 months after vaccination) as determined by HI assay against each of the four vaccine strains', 'unitOfMeasure': 'Titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Immunogenicity. Note: Unadjusted GMTs are presented.'}, {'type': 'SECONDARY', 'title': 'Immunogenicity Endpoint: Geometric Mean Fold Increase (GMFI) for Day 22/Day 1 and Day 181/Day 1 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1027', 'groupId': 'OG000'}, {'value': '1016', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'aQIV', 'description': 'Adjuvanted QIV containing 2 influenza type A strains and 2 influenza type B strains\n\naQIV: Participants receive a 0.5-mL intramuscular dose of aQIV on Day 1'}, {'id': 'OG001', 'title': 'Comparator QIV', 'description': 'Non-adjuvanted comparator QIV containing 2 influenza type A strains and 2 influenza type B strains\n\nComparator QIV: Participants receive a 0.5-mL intramuscular dose of Comparator QIV on Day 1'}], 'classes': [{'title': 'A/H1N1 Fold increase Day 22 HI Titer', 'categories': [{'measurements': [{'value': '13.07', 'groupId': 'OG000', 'lowerLimit': '11.92', 'upperLimit': '14.34'}, {'value': '11.00', 'groupId': 'OG001', 'lowerLimit': '10.07', 'upperLimit': '12.02'}]}]}, {'title': 'A/H1N1 Fold increase Day 181 HI Titer', 'categories': [{'measurements': [{'value': '6.22', 'groupId': 'OG000', 'lowerLimit': '5.71', 'upperLimit': '6.76'}, {'value': '5.47', 'groupId': 'OG001', 'lowerLimit': '5.03', 'upperLimit': '5.95'}]}]}, {'title': 'A/H3N2 Fold increase Day 22 HI Titer', 'categories': [{'measurements': [{'value': '7.09', 'groupId': 'OG000', 'lowerLimit': '6.43', 'upperLimit': '7.83'}, {'value': '6.31', 'groupId': 'OG001', 'lowerLimit': '5.78', 'upperLimit': '6.89'}]}]}, {'title': 'A/H3N2 Fold increase Day 181 HI Titer', 'categories': [{'measurements': [{'value': '3.29', 'groupId': 'OG000', 'lowerLimit': '3.04', 'upperLimit': '3.56'}, {'value': '3.08', 'groupId': 'OG001', 'lowerLimit': '2.86', 'upperLimit': '3.31'}]}]}, {'title': 'B/Yamagata Fold increase Day 22 HI Titer', 'categories': [{'measurements': [{'value': '3.77', 'groupId': 'OG000', 'lowerLimit': '3.50', 'upperLimit': '4.07'}, {'value': '3.50', 'groupId': 'OG001', 'lowerLimit': '3.25', 'upperLimit': '3.77'}]}]}, {'title': 'B/Yamagata Fold increase Day 181 HI Titer', 'categories': [{'measurements': [{'value': '2.03', 'groupId': 'OG000', 'lowerLimit': '1.91', 'upperLimit': '2.16'}, {'value': '2.01', 'groupId': 'OG001', 'lowerLimit': '1.89', 'upperLimit': '2.14'}]}]}, {'title': 'B/Victoria Fold increase Day 22 HI Titer', 'categories': [{'measurements': [{'value': '3.73', 'groupId': 'OG000', 'lowerLimit': '3.45', 'upperLimit': '4.02'}, {'value': '3.60', 'groupId': 'OG001', 'lowerLimit': '3.33', 'upperLimit': '3.88'}]}]}, {'title': 'B/Victoria Fold increase Day 181 HI Titer', 'categories': [{'measurements': [{'value': '2.06', 'groupId': 'OG000', 'lowerLimit': '1.93', 'upperLimit': '2.19'}, {'value': '2.05', 'groupId': 'OG001', 'lowerLimit': '1.92', 'upperLimit': '2.20'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 to Day 181', 'description': 'The GMFI is defined as the geometric mean of the fold increase of postvaccination HI titer over the prevaccination HI titer.', 'unitOfMeasure': 'Fold Increase', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Immunogenicity'}, {'type': 'SECONDARY', 'title': 'Immunogenicity Endpoint: The Percentage of Subjects With a Titer ≥1:40 at Day 1, Day 22, and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1027', 'groupId': 'OG000'}, {'value': '1016', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'aQIV', 'description': 'Adjuvanted QIV containing 2 influenza type A strains and 2 influenza type B strains\n\naQIV: Participants receive a 0.5-mL intramuscular dose of aQIV on Day 1'}, {'id': 'OG001', 'title': 'Comparator QIV', 'description': 'Non-adjuvanted comparator QIV containing 2 influenza type A strains and 2 influenza type B strains\n\nComparator QIV: Participants receive a 0.5-mL intramuscular dose of Comparator QIV on Day 1'}], 'classes': [{'title': 'A/H1N1 HI Titer ≥1:40 at Day 1', 'categories': [{'measurements': [{'value': '65.2', 'groupId': 'OG000', 'lowerLimit': '62.20', 'upperLimit': '68.15'}, {'value': '64.2', 'groupId': 'OG001', 'lowerLimit': '61.14', 'upperLimit': '67.15'}]}]}, {'title': 'A/H1N1 HI Titer ≥1:40 at Day 22', 'categories': [{'measurements': [{'value': '99.7', 'groupId': 'OG000', 'lowerLimit': '99.14', 'upperLimit': '99.94'}, {'value': '99.2', 'groupId': 'OG001', 'lowerLimit': '98.44', 'upperLimit': '99.66'}]}]}, {'title': 'A/H1N1 HI Titer ≥1:40 at Day 181', 'categories': [{'measurements': [{'value': '98.2', 'groupId': 'OG000', 'lowerLimit': '97.13', 'upperLimit': '98.92'}, {'value': '96.3', 'groupId': 'OG001', 'lowerLimit': '94.89', 'upperLimit': '97.36'}]}]}, {'title': 'A/H3N2 HI Titer ≥1:40 at Day 1', 'categories': [{'measurements': [{'value': '60.3', 'groupId': 'OG000', 'lowerLimit': '57.16', 'upperLimit': '63.30'}, {'value': '61.7', 'groupId': 'OG001', 'lowerLimit': '58.61', 'upperLimit': '64.72'}]}]}, {'title': 'A/H3N2 HI Titer ≥1:40 at Day 22', 'categories': [{'measurements': [{'value': '97.5', 'groupId': 'OG000', 'lowerLimit': '96.39', 'upperLimit': '98.40'}, {'value': '97.3', 'groupId': 'OG001', 'lowerLimit': '96.12', 'upperLimit': '98.23'}]}]}, {'title': 'A/H3N2 HI Titer ≥1:40 at Day 181', 'categories': [{'measurements': [{'value': '92.0', 'groupId': 'OG000', 'lowerLimit': '90.08', 'upperLimit': '93.59'}, {'value': '89.9', 'groupId': 'OG001', 'lowerLimit': '87.81', 'upperLimit': '91.68'}]}]}, {'title': 'B/Yamagata HI Titer ≥1:40 at Day 1', 'categories': [{'measurements': [{'value': '60.8', 'groupId': 'OG000', 'lowerLimit': '57.77', 'upperLimit': '63.87'}, {'value': '61.9', 'groupId': 'OG001', 'lowerLimit': '58.81', 'upperLimit': '64.90'}]}]}, {'title': 'B/Yamagata HI Titer ≥1:40 at Day 22', 'categories': [{'measurements': [{'value': '95.9', 'groupId': 'OG000', 'lowerLimit': '94.47', 'upperLimit': '97.01'}, {'value': '94.6', 'groupId': 'OG001', 'lowerLimit': '93.05', 'upperLimit': '95.94'}]}]}, {'title': 'B/Yamagata HI Titer ≥1:40 at Day 181', 'categories': [{'measurements': [{'value': '83.9', 'groupId': 'OG000', 'lowerLimit': '81.48', 'upperLimit': '86.17'}, {'value': '84.0', 'groupId': 'OG001', 'lowerLimit': '81.60', 'upperLimit': '86.28'}]}]}, {'title': 'B/Victoria HI Titer ≥1:40 at Day 1', 'categories': [{'measurements': [{'value': '58.5', 'groupId': 'OG000', 'lowerLimit': '55.42', 'upperLimit': '61.57'}, {'value': '60.4', 'groupId': 'OG001', 'lowerLimit': '57.30', 'upperLimit': '63.43'}]}]}, {'title': 'B/Victoria HI Titer ≥1:40 at Day 22', 'categories': [{'measurements': [{'value': '94.4', 'groupId': 'OG000', 'lowerLimit': '92.79', 'upperLimit': '95.72'}, {'value': '93.3', 'groupId': 'OG001', 'lowerLimit': '91.63', 'upperLimit': '94.81'}]}]}, {'title': 'B/Victoria HI Titer ≥1:40 at Day 181', 'categories': [{'measurements': [{'value': '83.4', 'groupId': 'OG000', 'lowerLimit': '80.90', 'upperLimit': '85.66'}, {'value': '84.3', 'groupId': 'OG001', 'lowerLimit': '81.84', 'upperLimit': '86.48'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 to Day 181', 'description': 'Percentage of subjects with a titer ≥1:40 on Day 1, Day 22, and Day 181 as determined by HI assay against each of the four vaccine strains', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Immunogenicity'}, {'type': 'SECONDARY', 'title': 'Immunogenicity Endpoint: SCR at Day 22 and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1027', 'groupId': 'OG000'}, {'value': '1016', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'aQIV', 'description': 'Adjuvanted QIV containing 2 influenza type A strains and 2 influenza type B strains\n\naQIV: Participants receive a 0.5-mL intramuscular dose of aQIV on Day 1'}, {'id': 'OG001', 'title': 'Comparator QIV', 'description': 'Non-adjuvanted comparator QIV containing 2 influenza type A strains and 2 influenza type B strains\n\nComparator QIV: Participants receive a 0.5-mL intramuscular dose of Comparator QIV on Day 1'}], 'classes': [{'title': 'A/H1N1 Day 22 SCR', 'categories': [{'measurements': [{'value': '80.8', 'groupId': 'OG000', 'lowerLimit': '78.24', 'upperLimit': '83.20'}, {'value': '77.1', 'groupId': 'OG001', 'lowerLimit': '74.34', 'upperLimit': '79.65'}]}]}, {'title': 'A/H1N1 Day 181 SCR', 'categories': [{'measurements': [{'value': '64.5', 'groupId': 'OG000', 'lowerLimit': '61.46', 'upperLimit': '67.55'}, {'value': '56.1', 'groupId': 'OG001', 'lowerLimit': '52.94', 'upperLimit': '59.24'}]}]}, {'title': 'A/H3N2 Day 22 SCR', 'categories': [{'measurements': [{'value': '63.4', 'groupId': 'OG000', 'lowerLimit': '60.35', 'upperLimit': '66.42'}, {'value': '61.8', 'groupId': 'OG001', 'lowerLimit': '58.65', 'upperLimit': '64.79'}]}]}, {'title': 'A/H3N2 Day 181 SCR', 'categories': [{'measurements': [{'value': '39.4', 'groupId': 'OG000', 'lowerLimit': '36.28', 'upperLimit': '42.54'}, {'value': '38.6', 'groupId': 'OG001', 'lowerLimit': '35.51', 'upperLimit': '41.72'}]}]}, {'title': 'B/Yamagata Day 22 SCR', 'categories': [{'measurements': [{'value': '42.9', 'groupId': 'OG000', 'lowerLimit': '39.82', 'upperLimit': '46.02'}, {'value': '41.1', 'groupId': 'OG001', 'lowerLimit': '37.99', 'upperLimit': '44.19'}]}]}, {'title': 'B/Yamagata Day 181 SCR', 'categories': [{'measurements': [{'value': '22.4', 'groupId': 'OG000', 'lowerLimit': '19.82', 'upperLimit': '25.16'}, {'value': '22.4', 'groupId': 'OG001', 'lowerLimit': '19.86', 'upperLimit': '25.19'}]}]}, {'title': 'B/Victoria Day 22 SCR', 'categories': [{'measurements': [{'value': '43.9', 'groupId': 'OG000', 'lowerLimit': '40.86', 'upperLimit': '47.08'}, {'value': '40.6', 'groupId': 'OG001', 'lowerLimit': '37.50', 'upperLimit': '43.68'}]}]}, {'title': 'B/Victoria Day 181 SCR', 'categories': [{'measurements': [{'value': '24.3', 'groupId': 'OG000', 'lowerLimit': '21.64', 'upperLimit': '27.13'}, {'value': '23.6', 'groupId': 'OG001', 'lowerLimit': '20.97', 'upperLimit': '26.38'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 to Day 181', 'description': 'The SCR defined as the percentage of subjects with either a prevaccination HI titer \\<1:10 and a postvaccination (Day 22 or Day 181) HI titer ≥1:40, or with either a prevaccination HI titer ≥1:10 and a ≥4-fold increase in postvaccination HI titer.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Immunogenicity'}, {'type': 'SECONDARY', 'title': 'Safety Endpoint: Solicited Local and Systemic AEs for 7 Days Following Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1020', 'groupId': 'OG000'}, {'value': '1008', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'aQIV', 'description': 'Adjuvanted QIV containing 2 influenza type A strains and 2 influenza type B strains\n\naQIV: Participants receive a 0.5-mL intramuscular dose of aQIV on Day 1'}, {'id': 'OG001', 'title': 'Comparator QIV', 'description': 'Non-adjuvanted comparator QIV containing 2 influenza type A strains and 2 influenza type B strains\n\nComparator QIV: Participants receive a 0.5-mL intramuscular dose of Comparator QIV on Day 1'}], 'classes': [{'title': 'Any Solicited AEs', 'categories': [{'measurements': [{'value': '672', 'groupId': 'OG000'}, {'value': '541', 'groupId': 'OG001'}]}]}, {'title': 'Any Solicited Local AEs', 'categories': [{'measurements': [{'value': '508', 'groupId': 'OG000'}, {'value': '306', 'groupId': 'OG001'}]}]}, {'title': 'Any Solicited Systemic AEs', 'categories': [{'measurements': [{'value': '462', 'groupId': 'OG000'}, {'value': '403', 'groupId': 'OG001'}]}]}, {'title': 'Analgesic/Antipyretic Use', 'categories': [{'measurements': [{'value': '132', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 through Day 7', 'description': 'Number and percentage of subjects with solicited local and systemic AEs occurring for 7 days following vaccination', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Solicited Safety Set, defined as all subjects in the All Exposed Set with any solicited AE data including temperature measurements or use of analgesics/antipyretics'}, {'type': 'SECONDARY', 'title': 'Safety Endpoint: All Unsolicited AEs for 21 Days Following Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1027', 'groupId': 'OG000'}, {'value': '1016', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'aQIV', 'description': 'Adjuvanted QIV containing 2 influenza type A strains and 2 influenza type B strains\n\naQIV: Participants receive a 0.5-mL intramuscular dose of aQIV on Day 1'}, {'id': 'OG001', 'title': 'Comparator QIV', 'description': 'Non-adjuvanted comparator QIV containing 2 influenza type A strains and 2 influenza type B strains\n\nComparator QIV: Participants receive a 0.5-mL intramuscular dose of Comparator QIV on Day 1'}], 'classes': [{'title': 'Any AE', 'categories': [{'measurements': [{'value': '169', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}]}]}, {'title': 'Any AE (Mild)', 'categories': [{'measurements': [{'value': '116', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}]}, {'title': 'Any AE (Moderate)', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}]}, {'title': 'Any AE (Severe)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Related AE', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 through Day 22', 'description': 'The percentage of subjects with at least one unsolicited AE occurring 21 days following vaccination The severity of AEs is based on the maximum severity associated with a Preferred Term for a reported AE. Related AEs include possibly related AEs, probably related AEs and AEs with missing relatedness assessment. The severity and relatedness of AEs were determined by the investigator. For the any AE summary by severity, a subject with multiple AEs is counted according to the highest severity of their reported AEs.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Unsolicited Safety Set, defined as all subjects in the All Exposed Set with any unsolicited AE data. Note: Subjects are categorized according to the maximum symptom severity.'}, {'type': 'SECONDARY', 'title': 'Safety Endpoint: Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Withdrawal From the Study, and Adverse Events of Special Interest (AESIs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1027', 'groupId': 'OG000'}, {'value': '1016', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'aQIV', 'description': 'Adjuvanted QIV containing 2 influenza type A strains and 2 influenza type B strains\n\naQIV: Participants receive a 0.5-mL intramuscular dose of aQIV on Day 1'}, {'id': 'OG001', 'title': 'Comparator QIV', 'description': 'Non-adjuvanted comparator QIV containing 2 influenza type A strains and 2 influenza type B strains\n\nComparator QIV: Participants receive a 0.5-mL intramuscular dose of Comparator QIV on Day 1'}], 'classes': [{'title': 'SAE', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 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'groupId': 'OG001', 'lowerLimit': '521.77', 'upperLimit': '612.53'}]}]}, {'title': 'A/H3N2 (50 to 59 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '609', 'groupId': 'OG000'}, {'value': '595', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '345.83', 'groupId': 'OG000', 'lowerLimit': '317.55', 'upperLimit': '376.63'}, {'value': '319.55', 'groupId': 'OG001', 'lowerLimit': '293.19', 'upperLimit': '348.27'}]}]}, {'title': 'B/Yamagata (50 to 59 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '609', 'groupId': 'OG000'}, {'value': '595', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '161.27', 'groupId': 'OG000', 'lowerLimit': '150.98', 'upperLimit': '172.25'}, {'value': '149.36', 'groupId': 'OG001', 'lowerLimit': '139.72', 'upperLimit': '159.67'}]}]}, {'title': 'B/Victoria (50 to 59 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '609', 'groupId': 'OG000'}, {'value': '595', 'groupId': 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'groupDescription': 'A/H1N1 (60 to 64 years)', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.890', 'ciLowerLimit': '0.766', 'ciUpperLimit': '1.033', 'groupDescription': 'A/H3N2 (60 to 64 years)', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.974', 'ciLowerLimit': '0.879', 'ciUpperLimit': '1.079', 'groupDescription': 'B/Yamagata (60 to 64 years)', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.013', 'ciLowerLimit': '0.905', 'ciUpperLimit': '1.133', 'groupDescription': 'B/Victoria (60 to 64 years)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 22', 'description': 'The GMT ratio is defined as the geometric mean of the 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Subgroup analysis by age (50 to 59 years; 60 to 64 years). Note: Adjusted GMTs are presented.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains by Influenza Vaccination History (Subgroup Analysis)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1027', 'groupId': 'OG000'}, {'value': '1016', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'aQIV', 'description': 'Adjuvanted QIV containing 2 influenza type A strains and 2 influenza type B strains\n\naQIV: Participants receive a 0.5-mL intramuscular dose of aQIV on Day 1'}, {'id': 'OG001', 'title': 'Comparator QIV', 'description': 'Non-adjuvanted comparator QIV containing 2 influenza type A strains and 2 influenza type B strains\n\nComparator QIV: Participants receive a 0.5-mL intramuscular dose of Comparator QIV on Day 1'}], 'classes': [{'title': 'A/H1N1 (yes)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '586', 'groupId': 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Subgroup analysis by influenza vaccination history (Received at least one influenza vaccination within the previous 3 influenza seasons: yes; no). Note: Adjusted GMTs are presented.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains by Comorbidity Risk Score (Subgroup Analysis)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1027', 'groupId': 'OG000'}, {'value': '1016', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'aQIV', 'description': 'Adjuvanted QIV containing 2 influenza type A strains and 2 influenza type B strains\n\naQIV: Participants receive a 0.5-mL intramuscular dose of aQIV on Day 1'}, {'id': 'OG001', 'title': 'Comparator QIV', 'description': 'Non-adjuvanted comparator QIV containing 2 influenza type A strains and 2 influenza type B strains\n\nComparator QIV: Participants receive a 0.5-mL intramuscular dose of Comparator QIV on Day 1'}], 'classes': [{'title': 'A/H1N1 (Comorbidity Risk Score <50)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '912', 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Subgroup analysis by comorbidity risk score (\\<50; ≥50). Note: Adjusted GMTs are presented.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'aQIV', 'description': 'Adjuvanted QIV containing 2 influenza type A strains and 2 influenza type B strains\n\naQIV: Participants receive a 0.5-mL intramuscular dose of aQIV on Day 1'}, {'id': 'FG001', 'title': 'Comparator QIV', 'description': 'Non-adjuvanted comparator QIV containing 2 influenza type A strains and 2 influenza type B strains\n\nComparator QIV: Participants receive a 0.5-mL intramuscular dose of Comparator QIV on Day 1'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1027'}, {'groupId': 'FG001', 'numSubjects': '1017'}]}, {'type': 'Received Study Vaccine', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1027'}, {'groupId': 'FG001', 'numSubjects': '1016'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '982'}, {'groupId': 'FG001', 'numSubjects': '989'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}, {'groupId': 'FG001', 'numSubjects': '28'}]}]}], 'recruitmentDetails': 'Subjects were enrolled in the 2021/2022 Northern Hemisphere influenza season from 29 centers in Estonia (6 centers), Germany (11 centers), and the United States (12 centers).', 'preAssignmentDetails': 'In total, 2044 subjects were enrolled in the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1027', 'groupId': 'BG000'}, {'value': '1017', 'groupId': 'BG001'}, {'value': '2044', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'aQIV', 'description': 'Adjuvanted QIV containing 2 influenza type A strains and 2 influenza type B strains\n\naQIV: Participants receive a 0.5-mL intramuscular dose of aQIV on Day 1'}, {'id': 'BG001', 'title': 'Comparator QIV', 'description': 'Non-adjuvanted comparator QIV containing 2 influenza type A strains and 2 influenza type B strains\n\nComparator QIV: Participants receive a 0.5-mL intramuscular dose of Comparator QIV on Day 1'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '1027', 'groupId': 'BG000'}, {'value': '1017', 'groupId': 'BG001'}, {'value': '2044', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.8', 'spread': '4.17', 'groupId': 'BG000'}, {'value': '57.8', 'spread': '4.21', 'groupId': 'BG001'}, {'value': '57.8', 'spread': '4.19', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '50 to 59 years', 'categories': [{'measurements': [{'value': '609', 'groupId': 'BG000'}, {'value': '596', 'groupId': 'BG001'}, {'value': '1205', 'groupId': 'BG002'}]}]}, {'title': '60 to 64 years', 'categories': [{'measurements': [{'value': '418', 'groupId': 'BG000'}, {'value': '421', 'groupId': 'BG001'}, {'value': '839', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '635', 'groupId': 'BG000'}, {'value': '615', 'groupId': 'BG001'}, {'value': '1250', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '392', 'groupId': 'BG000'}, {'value': '402', 'groupId': 'BG001'}, {'value': '794', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '1013', 'groupId': 'BG000'}, {'value': '1001', 'groupId': 'BG001'}, {'value': '2014', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '982', 'groupId': 'BG000'}, {'value': '972', 'groupId': 'BG001'}, {'value': '1954', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '377', 'groupId': 'BG000'}, {'value': '367', 'groupId': 'BG001'}, {'value': '744', 'groupId': 'BG002'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '259', 'groupId': 'BG000'}, {'value': '254', 'groupId': 'BG001'}, {'value': '513', 'groupId': 'BG002'}]}]}, {'title': 'Estonia', 'categories': [{'measurements': [{'value': '391', 'groupId': 'BG000'}, {'value': '396', 'groupId': 'BG001'}, {'value': '787', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Received an influenza vaccination in the previous 3 influenza seasons', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '586', 'groupId': 'BG000'}, {'value': '598', 'groupId': 'BG001'}, {'value': '1184', 'groupId': 'BG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '441', 'groupId': 'BG000'}, {'value': '419', 'groupId': 'BG001'}, {'value': '860', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Comorbidity Risk Score', 'classes': [{'title': '<50', 'categories': [{'measurements': [{'value': '912', 'groupId': 'BG000'}, {'value': '919', 'groupId': 'BG001'}, {'value': '1831', 'groupId': 'BG002'}]}]}, {'title': '≥50', 'categories': [{'measurements': [{'value': '115', 'groupId': 'BG000'}, {'value': '98', 'groupId': 'BG001'}, {'value': '213', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "A subject's comorbidity risk score was obtained by adding scores for each applicable characteristic: age (\\<70; 70-74; 75-79; 80-89; ≥90 years); sex (female; male); number of outpatient visits during the previous year (0; 1-6; 7-12; ≥13); previous hospitalization due to pneumonia or influenza (no; yes); pre-existing comorbidity (pulmonary disease; heart disease; renal disease or renal transplant; dementia or stroke; nonhematological and hematological cancer). A cut-off score ≥50 defines higher probability of hospitalization due to pneumonia/influenza or death (Hak et al, J Infect Dis 2004).", 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-07-11', 'size': 1561682, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-05-31T21:03', 'hasProtocol': True}, {'date': '2022-10-20', 'size': 626370, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-05-31T01:05', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2044}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'dispFirstSubmitDate': '2022-07-26', 'completionDateStruct': {'date': '2022-09-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-25', 'studyFirstSubmitDate': '2021-09-06', 'resultsFirstSubmitDate': '2023-08-08', 'studyFirstSubmitQcDate': '2021-09-06', 'dispFirstPostDateStruct': {'date': '2023-09-28', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2023-09-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-09-25', 'studyFirstPostDateStruct': {'date': '2021-09-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-09-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains by Age (Subgroup Analysis)', 'timeFrame': 'Day 22', 'description': 'The GMT ratio is defined as the geometric mean of the postvaccination HI titer for Comparator QIV over the geometric mean of the postvaccination HI titer for aQIV.'}, {'measure': 'Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains by Influenza Vaccination History (Subgroup Analysis)', 'timeFrame': 'Day 22', 'description': 'The GMT ratio is defined as the geometric mean of the postvaccination HI titer for Comparator QIV over the geometric mean of the postvaccination HI titer for aQIV.'}, {'measure': 'Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains by Comorbidity Risk Score (Subgroup Analysis)', 'timeFrame': 'Day 22', 'description': 'The GMT ratio is defined as the geometric mean of the postvaccination HI titer for Comparator QIV over the geometric mean of the postvaccination HI titer for aQIV.'}], 'primaryOutcomes': [{'measure': 'Immunogenicity Endpoint: Geometric Mean Titer (GMT) and GMT Ratio of Hemagglutination Inhibition (HI) Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains', 'timeFrame': 'Day 22', 'description': 'The GMT ratio is defined as the geometric mean of the postvaccination HI titer for Comparator QIV over the geometric mean of the postvaccination HI titer for aQIV.'}, {'measure': 'Immunogenicity Endpoint: Seroconversion Rate (SCR) and SCR Difference for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains', 'timeFrame': 'Day 1 to Day 22', 'description': 'The SCR defined as the percentage of subjects with either a prevaccination HI titer \\<1:10 and a postvaccination (Day 22) HI titer ≥1:40, or with either a prevaccination HI titer ≥1:10 and a ≥4-fold increase in postvaccination HI titer.\n\nThe SCR difference is defined as the Comparator QIV SCR minus the aQIV SCR.'}, {'measure': 'Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains', 'timeFrame': 'Day 22', 'description': 'The GMT ratio is defined as the geometric mean of the postvaccination HI titer for Comparator QIV over the geometric mean of the postvaccination HI titer for aQIV.'}], 'secondaryOutcomes': [{'measure': 'Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains', 'timeFrame': 'Day 181', 'description': 'The GMT ratio is defined as the geometric mean of the postvaccination HI titer for Comparator QIV over the geometric mean of the postvaccination HI titer for aQIV.'}, {'measure': 'Immunogenicity Endpoint: GMT of HI Antibodies on Day 1, Day 22, and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains', 'timeFrame': 'Day 1 to Day 181', 'description': 'GMTs on Day 1 (prior to vaccination), Day 22 (3 weeks after vaccination), and Day 181 (6 months after vaccination) as determined by HI assay against each of the four vaccine strains'}, {'measure': 'Immunogenicity Endpoint: Geometric Mean Fold Increase (GMFI) for Day 22/Day 1 and Day 181/Day 1 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains', 'timeFrame': 'Day 1 to Day 181', 'description': 'The GMFI is defined as the geometric mean of the fold increase of postvaccination HI titer over the prevaccination HI titer.'}, {'measure': 'Immunogenicity Endpoint: The Percentage of Subjects With a Titer ≥1:40 at Day 1, Day 22, and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains', 'timeFrame': 'Day 1 to Day 181', 'description': 'Percentage of subjects with a titer ≥1:40 on Day 1, Day 22, and Day 181 as determined by HI assay against each of the four vaccine strains'}, {'measure': 'Immunogenicity Endpoint: SCR at Day 22 and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains', 'timeFrame': 'Day 1 to Day 181', 'description': 'The SCR defined as the percentage of subjects with either a prevaccination HI titer \\<1:10 and a postvaccination (Day 22 or Day 181) HI titer ≥1:40, or with either a prevaccination HI titer ≥1:10 and a ≥4-fold increase in postvaccination HI titer.'}, {'measure': 'Safety Endpoint: Solicited Local and Systemic AEs for 7 Days Following Vaccination', 'timeFrame': 'Day 1 through Day 7', 'description': 'Number and percentage of subjects with solicited local and systemic AEs occurring for 7 days following vaccination'}, {'measure': 'Safety Endpoint: All Unsolicited AEs for 21 Days Following Vaccination', 'timeFrame': 'Day 1 through Day 22', 'description': 'The percentage of subjects with at least one unsolicited AE occurring 21 days following vaccination The severity of AEs is based on the maximum severity associated with a Preferred Term for a reported AE. Related AEs include possibly related AEs, probably related AEs and AEs with missing relatedness assessment. The severity and relatedness of AEs were determined by the investigator. For the any AE summary by severity, a subject with multiple AEs is counted according to the highest severity of their reported AEs.'}, {'measure': 'Safety Endpoint: Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Withdrawal From the Study, and Adverse Events of Special Interest (AESIs)', 'timeFrame': 'Day 1 through Day 271', 'description': 'The percentage of subjects with any SAE, AE leading to withdrawal, or AESI during the study period'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Influenza, Vaccine, MF59 adjuvant'], 'conditions': ['Influenza, Human']}, 'descriptionModule': {'briefSummary': 'This Phase 3 study is a randomized, observer-blind immunogenicity and safety study of aQIV (an MF59-adjuvanted quadrivalent influenza vaccine) compared with a licensed quadrivalent influenza vaccine in adults 50 to 64 years of age.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nIn order to participate in this study, all subjects must meet ALL of the following inclusion criteria:\n\n* Individuals 50 to 64 years of age (i.e. 50 to ≤64 years) on the day of informed consent\n* 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\n* Individuals who can comply with study procedures including follow-up\n* 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\nIn order to participate in this study, all subjects must not meet ANY of the exclusion criteria described below:\n\n* 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 study entry and who do not plan to do so until 2 months after the study vaccination\n* Progressive, unstable or uncontrolled clinical conditions\n* Hypersensitivity, including allergy, to any component of vaccines, medicinal products or medical equipment whose use is foreseen in this study\n* History of any medical condition considered an AESI\n* Known history of Guillain Barré syndrome or another demyelinating disease such as encephalomyelitis and transverse myelitis\n* Clinical conditions representing a contraindication to intramuscular vaccination and blood draws\n* 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 equivalent to ≥20 mg/day of prednisone for more than 14 consecutive days within 90 days prior to informed consent. Topical, inhaled and intranasal corticosteroids are permitted. Intermittent use (one dose in 30 days) of intra-articular corticosteroids is also permitted\n 3. Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to informed consent\n* Received immunoglobulins or any blood products within 180 days prior to informed consent\n* Received an investigational or non-registered medicinal product within 30 days prior to informed consent, or who are unwilling to refuse participation in another clinical study at any time during the conduct of this study (notes: i. concomitant participation in a study not involving or no longer involving administration of drugs, vaccines, or medical devices, is acceptable (e.g. studies in safety follow-up phase, observational studies); ii. concomitant participation in a COVID-19 vaccine study is acceptable provided that the vaccine dosing interval mentioned in Exclusion Criterion #11 is adhered to)\n* Receipt of any influenza vaccine within 6 months prior to enrollment in this study, or plan to receive influenza vaccine during the study period\n* Receipt of any (investigational or licensed) COVID-19 vaccine within 14 days (non-replicating vaccines) or 28 days (replicating vaccines) prior to enrollment or plan to receive any COVID-19 vaccine within 7 days from study vaccination\n* Receipt of any inactivated non-influenza vaccine within 14 days or live-attenuated vaccine within 28 days prior to enrollment in this study or plan to receive any other non-influenza vaccine within 28 days from study vaccination\n* Acute (severe) febrile illness\n* 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\n* Study personnel or immediate family members or household member of study personnel'}, 'identificationModule': {'nctId': 'NCT05044195', 'briefTitle': 'A Clinical Study to Evaluate the Immunogenicity and Safety of an Adjuvanted Quadrivalent Influenza Vaccine Compared With a Licensed Quadrivalent Vaccine in Adults 50 to 64 Years of Age', 'organization': {'class': 'INDUSTRY', 'fullName': 'Seqirus'}, 'officialTitle': 'A Phase 3, Randomized, Observer-blind, Controlled, Multicenter, Clinical Study to Evaluate Immunogenicity and Safety of an MF59-adjuvanted Quadrivalent Subunit Inactivated Influenza Vaccine in Comparison With a Licensed Quadrivalent Influenza Vaccine, in Adults 50 to 64 Years of Age', 'orgStudyIdInfo': {'id': 'V118_23'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'aQIV', 'description': 'Adjuvanted QIV containing 2 influenza type A strains and 2 influenza type B strains', 'interventionNames': ['Biological: aQIV']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Comparator QIV', 'description': 'Non-adjuvanted comparator QIV containing 2 influenza type A strains and 2 influenza type B strains', 'interventionNames': ['Biological: Comparator QIV']}], 'interventions': [{'name': 'aQIV', 'type': 'BIOLOGICAL', 'description': 'Participants receive a 0.5-mL intramuscular dose of aQIV on Day 1', 'armGroupLabels': ['aQIV']}, {'name': 'Comparator QIV', 'type': 'BIOLOGICAL', 'description': 'Participants receive a 0.5-mL intramuscular dose of Comparator QIV on Day 1', 'armGroupLabels': ['Comparator QIV']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36608', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': '84013 Coastal Clinical Research, Inc.', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '85281', 'city': 'Tempe', 'state': 'Arizona', 'country': 'United States', 'facility': '84007 Alliance for Multispecialty Research', 'geoPoint': {'lat': 33.41477, 'lon': -111.90931}}, {'zip': '33462', 'city': 'Atlantis', 'state': 'Florida', 'country': 'United States', 'facility': '84005 JEM Research Institute', 'geoPoint': {'lat': 26.5909, 'lon': -80.10088}}, {'zip': '32819', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': '84010 Headlands Research Orlando', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '31406', 'city': 'Savannah', 'state': 'Georgia', 'country': 'United States', 'facility': '84001 Meridian Clinical Research', 'geoPoint': {'lat': 32.08354, 'lon': -81.09983}}, {'zip': '51106', 'city': 'Sioux City', 'state': 'Iowa', 'country': 'United States', 'facility': '84003 Meridian Clinical Research', 'geoPoint': {'lat': 42.49999, 'lon': -96.40031}}, {'zip': '64114', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': '84006 Alliance for Multispecialty Research', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '68510', 'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'facility': '84009 Meridian Clinical Research', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}, {'zip': '68701', 'city': 'Norfolk', 'state': 'Nebraska', 'country': 'United States', 'facility': '84002 Meridian Clinical Research', 'geoPoint': {'lat': 42.02834, 'lon': -97.417}}, {'zip': '68134', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': '84004 Meridian Clinical Research', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '13901', 'city': 'Binghamton', 'state': 'New York', 'country': 'United States', 'facility': '84008 United Medical Associates', 'geoPoint': {'lat': 42.09869, 'lon': -75.91797}}, {'zip': '13760', 'city': 'Endwell', 'state': 'New York', 'country': 'United States', 'facility': '84011 Meridian Clinical Research', 'geoPoint': {'lat': 42.11285, 'lon': -76.02103}}, {'city': 'Paide', 'country': 'Estonia', 'facility': '23302 Vee Family Doctors Centre', 'geoPoint': {'lat': 58.88768, 'lon': 25.54042}}, {'city': 'Tallinn', 'country': 'Estonia', 'facility': '23301 Innomedica OÜ - Outpatient', 'geoPoint': {'lat': 59.43696, 'lon': 24.75353}}, {'city': 'Tallinn', 'country': 'Estonia', 'facility': '23303 Al Mare Perearstikeskus OÜ', 'geoPoint': {'lat': 59.43696, 'lon': 24.75353}}, {'city': 'Tallinn', 'country': 'Estonia', 'facility': '23304 Merelahe Family Doctors Centre', 'geoPoint': {'lat': 59.43696, 'lon': 24.75353}}, {'city': 'Tallinn', 'country': 'Estonia', 'facility': '23306 Center for Clinical and Basic Research', 'geoPoint': {'lat': 59.43696, 'lon': 24.75353}}, {'city': 'Tartu', 'country': 'Estonia', 'facility': '23305 Clinical Research Center - Vaccine Trials', 'geoPoint': {'lat': 58.38062, 'lon': 26.72509}}, {'city': 'Berlin', 'country': 'Germany', 'facility': '27602 Klinische Forschung Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Berlin', 'country': 'Germany', 'facility': '27603 Emovis GmbH', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Dresden', 'country': 'Germany', 'facility': '27608 Klinische Forschung Dresden GmbH', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'city': 'Frankfurt', 'country': 'Germany', 'facility': '27609 IKF Pneumologie GmbH & Co. KG', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'city': 'Fulda', 'country': 'Germany', 'facility': '27611 Siteworks GmbH', 'geoPoint': {'lat': 50.55162, 'lon': 9.67518}}, {'city': 'Hamburg', 'country': 'Germany', 'facility': '27601 Klinische Forschung Hamburg GmbH', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'city': 'Hamburg', 'country': 'Germany', 'facility': '27605 Clinical Research Hamburg GmbH', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'city': 'Hanover', 'country': 'Germany', 'facility': '27604 Klinische Forschung Hannover-Mitte GmbH', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'city': 'Hanover', 'country': 'Germany', 'facility': '27607 Siteworks GmbH', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'city': 'Leipzig', 'country': 'Germany', 'facility': '27606 SIBAmed GmbH & Co KG', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'city': 'Stuttgart', 'country': 'Germany', 'facility': '27610 Studienzentrum Leitz Triderm', 'geoPoint': {'lat': 48.78232, 'lon': 9.17702}}], 'overallOfficials': [{'name': 'Clinical Program Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Seqirus'}]}, 'ipdSharingStatementModule': {'url': 'https://www.seqirus.us/partnering', '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 CTD modules submitted to regulatory agencies for public release.\n\nSummary results disclosure is either in document form (e.g., 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'}}}}