Viewing Study NCT01992094

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Ignite Creation Date: 2025-12-25 @ 1:46 AM
Ignite Modification Date: 2026-03-08 @ 4:47 AM
Study NCT ID: NCT01992094
Status: COMPLETED
Last Update Posted: 2015-12-10
First Post: 2013-11-07
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Safety and Immunogenicity of Three Influenza Vaccines Adults Ages 18 and Older
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'RegistryContactVaccinesUS@novartis.com', 'title': 'Posting Director', 'organization': 'Novartis Vaccines and Diagnostics'}, 'certainAgreement': {'otherDetails': "The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181', 'description': 'All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment.\n\nFor SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.', 'eventGroups': [{'id': 'EG000', 'title': 'QIVc (≥18 Years)', 'description': 'Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)', 'otherNumAtRisk': 1324, 'otherNumAffected': 681, 'seriousNumAtRisk': 1324, 'seriousNumAffected': 52}, {'id': 'EG001', 'title': 'TIV1c (≥ 18 Years)', 'description': 'Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season', 'otherNumAtRisk': 673, 'otherNumAffected': 332, 'seriousNumAtRisk': 673, 'seriousNumAffected': 22}, {'id': 'EG002', 'title': 'TIV2c (≥18 Years)', 'description': 'Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014', 'otherNumAtRisk': 665, 'otherNumAffected': 335, 'seriousNumAtRisk': 665, 'seriousNumAffected': 21}, {'id': 'EG003', 'title': 'Total', 'description': 'Total Number of Subjects', 'otherNumAtRisk': 2662, 'otherNumAffected': 1348, 'seriousNumAtRisk': 2662, 'seriousNumAffected': 95}], 'otherEvents': [{'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1324, 'numAffected': 91}, {'groupId': 'EG001', 'numAtRisk': 673, 'numAffected': 49}, {'groupId': 'EG002', 'numAtRisk': 665, 'numAffected': 48}, {'groupId': 'EG003', 'numAtRisk': 2662, 'numAffected': 188}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1324, 'numAffected': 96}, {'groupId': 'EG001', 'numAtRisk': 673, 'numAffected': 39}, {'groupId': 'EG002', 'numAtRisk': 665, 'numAffected': 46}, {'groupId': 'EG003', 'numAtRisk': 2662, 'numAffected': 181}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'CHILLS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1324, 'numAffected': 72}, {'groupId': 'EG001', 'numAtRisk': 673, 'numAffected': 35}, {'groupId': 'EG002', 'numAtRisk': 665, 'numAffected': 37}, {'groupId': 'EG003', 'numAtRisk': 2662, 'numAffected': 144}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'FATIGUE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1324, 'numAffected': 183}, {'groupId': 'EG001', 'numAtRisk': 673, 'numAffected': 113}, {'groupId': 'EG002', 'numAtRisk': 665, 'numAffected': 81}, {'groupId': 'EG003', 'numAtRisk': 2662, 'numAffected': 377}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'INJECTION SITE ERYTHEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1324, 'numAffected': 167}, {'groupId': 'EG001', 'numAtRisk': 673, 'numAffected': 80}, {'groupId': 'EG002', 'numAtRisk': 665, 'numAffected': 68}, {'groupId': 'EG003', 'numAtRisk': 2662, 'numAffected': 315}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'INJECTION SITE HAEMORRHAGE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1324, 'numAffected': 56}, {'groupId': 'EG001', 'numAtRisk': 673, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 665, 'numAffected': 35}, {'groupId': 'EG003', 'numAtRisk': 2662, 'numAffected': 117}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'INJECTION SITE INDURATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1324, 'numAffected': 134}, {'groupId': 'EG001', 'numAtRisk': 673, 'numAffected': 55}, {'groupId': 'EG002', 'numAtRisk': 665, 'numAffected': 60}, {'groupId': 'EG003', 'numAtRisk': 2662, 'numAffected': 249}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'INJECTION SITE PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1324, 'numAffected': 444}, {'groupId': 'EG001', 'numAtRisk': 673, 'numAffected': 187}, {'groupId': 'EG002', 'numAtRisk': 665, 'numAffected': 195}, {'groupId': 'EG003', 'numAtRisk': 2662, 'numAffected': 826}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'DECREASED APPETITE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1324, 'numAffected': 82}, {'groupId': 'EG001', 'numAtRisk': 673, 'numAffected': 45}, {'groupId': 'EG002', 'numAtRisk': 665, 'numAffected': 40}, {'groupId': 'EG003', 'numAtRisk': 2662, 'numAffected': 167}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'ARTHRALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1324, 'numAffected': 98}, {'groupId': 'EG001', 'numAtRisk': 673, 'numAffected': 56}, {'groupId': 'EG002', 'numAtRisk': 665, 'numAffected': 58}, {'groupId': 'EG003', 'numAtRisk': 2662, 'numAffected': 212}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'MYALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1324, 'numAffected': 160}, {'groupId': 'EG001', 'numAtRisk': 673, 'numAffected': 83}, {'groupId': 'EG002', 'numAtRisk': 665, 'numAffected': 79}, {'groupId': 'EG003', 'numAtRisk': 2662, 'numAffected': 322}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1324, 'numAffected': 191}, {'groupId': 'EG001', 'numAtRisk': 673, 'numAffected': 93}, {'groupId': 'EG002', 'numAtRisk': 665, 'numAffected': 93}, {'groupId': 'EG003', 'numAtRisk': 2662, 'numAffected': 377}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}], 'seriousEvents': [{'term': 'HISTIOCYTOSIS HAEMATOPHAGIC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1324, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 673, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 665, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2662, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'IRON DEFICIENCY ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1324, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 673, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 665, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2662, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'ANGINA PECTORIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1324, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 673, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 665, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2662, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'ARTERIOSCLEROSIS CORONARY ARTERY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1324, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 673, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 665, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2662, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'ATRIAL FIBRILLATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1324, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 673, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 665, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2662, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'CARDIAC ARREST', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1324, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 673, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 665, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2662, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'CARDIAC FAILURE ACUTE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1324, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 673, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 665, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2662, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'CARDIAC FAILURE CONGESTIVE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1324, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 673, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 665, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 2662, 'numAffected': 7}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'CORONARY ARTERY DISEASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1324, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 673, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 665, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2662, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'MITRAL VALVE INCOMPETENCE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1324, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 673, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 665, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2662, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'MYOCARDIAL INFARCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1324, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 673, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 665, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2662, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'MYOCARDIAL ISCHAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1324, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 673, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 665, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2662, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'VENTRICULAR FIBRILLATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1324, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 673, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 665, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2662, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'ABDOMINAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1324, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 673, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 665, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2662, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'GASTROINTESTINAL HAEMORRHAGE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1324, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 673, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 665, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2662, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'LOWER GASTROINTESTINAL HAEMORRHAGE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1324, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 673, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 665, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2662, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'SMALL INTESTINAL OBSTRUCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1324, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 673, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 665, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 2662, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'CHEST DISCOMFORT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1324, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 673, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 665, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2662, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'CHEST PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1324, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 673, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 665, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2662, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'CORONARY ARTERY RESTENOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1324, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 673, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 665, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2662, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'DEATH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1324, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 673, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 665, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2662, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'NON-CARDIAC CHEST PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1324, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 673, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 665, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2662, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'STRANGULATED HERNIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1324, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 673, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 665, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2662, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'ANAPHYLACTIC REACTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1324, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 673, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 665, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2662, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'APPENDICITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1324, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 673, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 665, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2662, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'BRONCHITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1324, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 673, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 665, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2662, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'CELLULITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1324, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 673, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 665, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2662, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'DIVERTICULITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1324, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 673, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 665, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2662, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'ESCHERICHIA SEPSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1324, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 673, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 665, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2662, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'GASTROENTERITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1324, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 673, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 665, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2662, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'GASTROENTERITIS VIRAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1324, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 673, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 665, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2662, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'MENINGITIS VIRAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1324, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 673, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 665, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2662, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'PNEUMONIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1324, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 673, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 665, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 2662, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'PNEUMONIA LEGIONELLA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1324, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 673, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 665, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2662, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'PYELONEPHRITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1324, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 673, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 665, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2662, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'SEPSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1324, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 673, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 665, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2662, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'URINARY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1324, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 673, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 665, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2662, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'HEAD INJURY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 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'302.8', 'groupId': 'OG000', 'lowerLimit': '281.8', 'upperLimit': '325.5'}, {'value': '298.9', 'groupId': 'OG001', 'lowerLimit': '270.3', 'upperLimit': '330.5'}, {'value': 'NA', 'comment': 'antigen not immunized', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'H3N2: Day 1(N=1250,635,NA)', 'categories': [{'measurements': [{'value': '122.5', 'groupId': 'OG000', 'lowerLimit': '112.7', 'upperLimit': '133.1'}, {'value': '128.1', 'groupId': 'OG001', 'lowerLimit': '113.6', 'upperLimit': '144.6'}, {'value': 'NA', 'comment': 'antigen not immunized', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'H3N2: Day 22(N=1250,635,NA)', 'categories': [{'measurements': [{'value': '372.3', 'groupId': 'OG000', 'lowerLimit': '349.2', 'upperLimit': '396.9'}, {'value': '378.4', 'groupId': 'OG001', 'lowerLimit': '345.1', 'upperLimit': '414.8'}, {'value': 'NA', 'comment': 'antigen not immunized', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'B1:Day 1(N=1250,635,NA)', 'categories': [{'measurements': [{'value': '45.3', 'groupId': 'OG000', 'lowerLimit': '42.6', 'upperLimit': '48.1'}, {'value': '43.8', 'groupId': 'OG001', 'lowerLimit': '40.2', 'upperLimit': '47.7'}, {'value': 'NA', 'comment': 'antigen not immunized', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'B1:Day 22(N=1250,635,NA)', 'categories': [{'measurements': [{'value': '133.2', 'groupId': 'OG000', 'lowerLimit': '125.3', 'upperLimit': '141.7'}, {'value': '115.6', 'groupId': 'OG001', 'lowerLimit': '106.4', 'upperLimit': '125.6'}, {'value': 'NA', 'comment': 'antigen not immunized', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'B2:Day 1(N=1250,NA,639)', 'categories': [{'measurements': [{'value': '59.2', 'groupId': 'OG000', 'lowerLimit': '56.0', 'upperLimit': '62.7'}, {'value': 'NA', 'comment': 'antigen not immunized', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '58.0', 'groupId': 'OG002', 'lowerLimit': '53.4', 'upperLimit': '63.0'}]}]}, {'title': 'B2:Day 22(N=1250,NA,639)', 'categories': [{'measurements': [{'value': '177.2', 'groupId': 'OG000', 'lowerLimit': '167.6', 'upperLimit': '187.5'}, {'value': 'NA', 'comment': 'antigen not immunized', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '164.0', 'groupId': 'OG002', 'lowerLimit': '151.4', 'upperLimit': '177.7'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratios of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.0', 'ciLowerLimit': '0.9', 'ciUpperLimit': '1.1', 'groupDescription': 'Non-inferiority of immune responses of QIVc to TIV1c, assessed in terms of ratios of GMT against influenza strain H1N1', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was established if the upper bound of the two-sided 95% confidence interval (CI) for the ratio of GMTs (GMT TIV1c/GMT QIVc) for HI antibody does not exceed the non-inferiority margin of 1.5'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratios of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.0', 'ciLowerLimit': '0.9', 'ciUpperLimit': '1.1', 'groupDescription': 'Non-inferiority of immune responses of QIVc to TIV1c, assessed in terms of ratios of GMT against influenza strain H3N2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was established if the upper bound of the two-sided 95% confidence interval (CI) for the ratio of GMTs (GMT TIV1c/GMT QIVc) for HI antibody does not exceed the non-inferiority margin of 1.5'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratios of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.9', 'ciLowerLimit': '0.8', 'ciUpperLimit': '1.0', 'groupDescription': 'Non-inferiority of immune responses of QIVc to TIV1c, assessed in terms of ratios of GMT against influenza strain B1', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was established if the upper bound of the two-sided 95% confidence interval (CI) for the ratio of GMTs (GMT TIV1c/GMT QIVc) for HI antibody does not exceed the non-inferiority margin of 1.5'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Ratios of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.9', 'ciLowerLimit': '0.9', 'ciUpperLimit': '1.0', 'groupDescription': 'Non-inferiority of immune responses of QIVc to TIV2c, assessed in terms of ratios of GMT against influenza strain B2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was established if the upper bound of the two-sided 95% confidence interval (CI) for the ratio of GMTs (GMT TIV2c/GMT QIVc) for HI antibody does not exceed the non-inferiority margin of 1.5'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Three weeks post vaccination (Day 22)', 'description': 'Immunogenicity of QIVc to comparator TIVc (For H1N1, H3N2 and B1 strain, the comparison is between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison is between QIVc and TIV2c) was assessed in terms of GMT in subjects measured by hemagglutination inhibition (HI) assay, three weeks after vaccination with one dose of either QIVc or TIV1c and TIV2c.\n\nNon-inferiority was established if the upper bound of the two-sided 95% confidence interval (CI) for the ratio of GMTs (GMT TIV1c or TIV2c /GMT QIVc) for HI antibody does not exceed the non-inferiority margin of 1.5.', 'unitOfMeasure': 'Titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on Per Protocol (PP) Population i.e. all subjects in the Full Analysis Set (FAS) efficacy/immunogenicity population correctly receive the vaccine, have no major protocol deviations leading to exclusion as defined prior to unblinding/analysis and are not excluded due to other reasons defined prior to unblinding or analysis'}, {'type': 'PRIMARY', 'title': '2. Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV1c or TIV2c', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1335', 'groupId': 'OG000'}, {'value': '676', 'groupId': 'OG001'}, {'value': '669', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'QIVc (≥18 Years)', 'description': 'Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)'}, {'id': 'OG001', 'title': 'TIV1c (≥18 Years)', 'description': 'Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season'}, {'id': 'OG002', 'title': 'TIV2c (≥18 Years)', 'description': 'Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014'}], 'classes': [{'title': 'H1N1: Day 22(N=1250, 635,NA)', 'categories': [{'measurements': [{'value': '49.2', 'groupId': 'OG000', 'lowerLimit': '46.4', 'upperLimit': '52.0'}, {'value': '48.7', 'groupId': 'OG001', 'lowerLimit': '44.7', 'upperLimit': '52.6'}, {'value': 'NA', 'comment': 'antigen not immunized', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'H3N2: Day 22(N=1250, 635,NA)', 'categories': [{'measurements': [{'value': '38.3', 'groupId': 'OG000', 'lowerLimit': '35.6', 'upperLimit': '41.1'}, {'value': '35.6', 'groupId': 'OG001', 'lowerLimit': '31.9', 'upperLimit': '39.5'}, {'value': 'NA', 'comment': 'antigen not immunized', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'B1: Day 22(N=1250, 635,NA)', 'categories': [{'measurements': [{'value': '36.6', 'groupId': 'OG000', 'lowerLimit': '33.9', 'upperLimit': '39.3'}, {'value': '34.8', 'groupId': 'OG001', 'lowerLimit': '31.1', 'upperLimit': '38.7'}, {'value': 'NA', 'comment': 'antigen not immunized', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'B2: Day 22(N=1250,NA, 639)', 'categories': [{'measurements': [{'value': '39.8', 'groupId': 'OG000', 'lowerLimit': '37.0', 'upperLimit': '42.5'}, {'value': 'NA', 'comment': 'antigen not immunized', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '35.4', 'groupId': 'OG002', 'lowerLimit': '31.7', 'upperLimit': '39.2'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference between seroconversion rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.5', 'ciLowerLimit': '-5.3', 'ciUpperLimit': '4.2', 'groupDescription': 'Non-inferiority of immune responses of QIVc to TIV1c in terms of differences in seroconversion rates against influenza strain H1N1', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was established if the upper bound of the two-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV1c - % seroconversion QIVc) for HI antibody does not exceed the margin of 10%'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference between seroconversion rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.7', 'ciLowerLimit': '-7.2', 'ciUpperLimit': '1.9', 'groupDescription': 'Non-inferiority of immune responses of QIVc to TIV1c in terms of differences in seroconversion rates against influenza strainH3N2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was established if the upper bound of the two-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV1c - % seroconversion QIVc) for HI antibody does not exceed the margin of 10%'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference between seroconversion rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.8', 'ciLowerLimit': '-6.2', 'ciUpperLimit': '2.8', 'groupDescription': 'Non-inferiority of immune responses of QIVc to TIV1c in terms of differences in seroconversion rates against influenza strain B1', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was established if the upper bound of the two-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV1c - % seroconversion QIVc) for HI antibody does not exceed the margin of 10%'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference between seroconversion rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.4', 'ciLowerLimit': '-8.9', 'ciUpperLimit': '0.2', 'groupDescription': 'Non-inferiority of immune responses of QIVc to TIV2c in terms of differences in seroconversion rates against influenza strain B2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was established if the upper bound of the two-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV2c - % seroconversion QIVc) for HI antibody does not exceed the margin of 10%'}], 'paramType': 'NUMBER', 'timeFrame': 'Three weeks post vaccination (Day 22)', 'description': 'Immunogenicity of QIVc to comparator TIVc (For H1N1, H3N2 and B1 strain, the comparison is between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison is between QIVc and TIV2c) was assessed in terms of percentages of subjects showing seroconversion or significant increase in HI antibody titers, three weeks (day 22) after vaccination with one dose of either QIVc,TIV1c or TIV2c Seroconversion is defined in subjects seronegative at baseline (i.e., HI titer \\<1:10 at Day 1) as post-vaccination HI titer ≥1:40, and defined in subjects sero-positive at baseline (i.e., HI titer ≥1:10 at Day 1) as a minimum of a 4-fold increase in post-vaccination HI titer', 'unitOfMeasure': 'percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on PP population'}, {'type': 'SECONDARY', 'title': '3. Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV1c or TIV2c in 18 to <65 and ≥ 65 Years Age Cohorts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '661', 'groupId': 'OG000'}, {'value': '650', 'groupId': 'OG001'}, {'value': '328', 'groupId': 'OG002'}, {'value': '336', 'groupId': 'OG003'}, {'value': '326', 'groupId': 'OG004'}, {'value': '332', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'QIVc (18 to <65 Years)', 'description': 'Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)'}, {'id': 'OG001', 'title': 'QIVc (≥ 65 Years)', 'description': 'Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)'}, {'id': 'OG002', 'title': 'TIV1c (18 to <65 Years)', 'description': 'Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013- 2014 season'}, {'id': 'OG003', 'title': 'TIV1c (≥ 65 Years)', 'description': 'Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1,H3N2, B1)recommended for 2013-2014 season'}, {'id': 'OG004', 'title': 'TIV2c (18 to <65 Years)', 'description': 'Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014'}, {'id': 'OG005', 'title': 'TIV2c (≥ 65 Years)', 'description': 'Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014'}], 'classes': [{'title': 'H1N1: Day 22(N=661, 650, 328, 336,NA,NA)', 'categories': [{'measurements': [{'value': '63.1', 'groupId': 'OG000', 'lowerLimit': '59.3', 'upperLimit': '66.8'}, {'value': '34.5', 'groupId': 'OG001', 'lowerLimit': '30.8', 'upperLimit': '38.3'}, {'value': '60.4', 'groupId': 'OG002', 'lowerLimit': '54.8', 'upperLimit': '65.7'}, {'value': '36.9', 'groupId': 'OG003', 'lowerLimit': '31.7', 'upperLimit': '42.3'}, {'value': 'NA', 'comment': 'antigen not immunized', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'antigen not immunized', 'groupId': 'OG005', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'H3N2: Day 22(N=661, 650, 328, 336,NA,NA)', 'categories': [{'measurements': [{'value': '49.2', 'groupId': 'OG000', 'lowerLimit': '45.3', 'upperLimit': '53.1'}, {'value': '27.2', 'groupId': 'OG001', 'lowerLimit': '23.8', 'upperLimit': '30.8'}, {'value': '47.3', 'groupId': 'OG002', 'lowerLimit': '41.7', 'upperLimit': '52.8'}, {'value': '24.7', 'groupId': 'OG003', 'lowerLimit': '20.2', 'upperLimit': '29.7'}, {'value': 'NA', 'comment': 'antigen not immunized', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'antigen not immunized', 'groupId': 'OG005', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'B1: Day 22(N=661, 650, 328, 336,NA,NA)', 'categories': [{'measurements': [{'value': '52.0', 'groupId': 'OG000', 'lowerLimit': '48.2', 'upperLimit': '55.9'}, {'value': '20.9', 'groupId': 'OG001', 'lowerLimit': '17.9', 'upperLimit': '24.3'}, {'value': '50.3', 'groupId': 'OG002', 'lowerLimit': '44.8', 'upperLimit': '55.8'}, {'value': '19.3', 'groupId': 'OG003', 'lowerLimit': '15.3', 'upperLimit': '24.0'}, {'value': 'NA', 'comment': 'antigen not immunized', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'antigen not immunized', 'groupId': 'OG005', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'B2: Day 22(N=661, 650,NA,NA, 326, 332)', 'categories': [{'measurements': [{'value': '52.8', 'groupId': 'OG000', 'lowerLimit': '48.9', 'upperLimit': '56.7'}, {'value': '26.3', 'groupId': 'OG001', 'lowerLimit': '23.0', 'upperLimit': '29.9'}, {'value': 'NA', 'comment': 'antigen not immunized', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'antigen not immunized', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '50.3', 'groupId': 'OG004', 'lowerLimit': '44.7', 'upperLimit': '55.9'}, {'value': '20.8', 'groupId': 'OG005', 'lowerLimit': '16.5', 'upperLimit': '25.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Three weeks post vaccination (Day 22)', 'description': 'Immunogenicity was assessed in terms of percentages of subjects showing seroconversion or significant increase in HI antibody titers, against each vaccine strains, three weeks (day 22) after vaccination with ether QIVc, TIV1c or TIV2c Seroconversion is defined in subjects seronegative at baseline (i.e., HI titer \\<1:10 at Day 1) as post-vaccination HI titer ≥1:40, and defined in subjects sero-positive at baseline (i.e., HI titer ≥1:10 at Day 1) as a minimum of a 4-fold increase in post-vaccination HI titer.The CBER criterion for 18 to \\<65 years age group is that the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroconversion for HI antibody should meet or exceed 40% and that for the ≥ 65 years age group should meet or exceed 30%', 'unitOfMeasure': 'percentages of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on FAS immunogenicity set i.e. all subjects in the enrolled set who receive the study vaccination and provide immunogenicity data at visit 1 and visit 2'}, {'type': 'SECONDARY', 'title': '4. Percentages of Subjects Achieving HI Titer ≥1:40 After One Dose of Either QIVc, TIV1c or TIV2c in 18 to <65 and ≥ 65 Years Age-cohorts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '661', 'groupId': 'OG000'}, {'value': '650', 'groupId': 'OG001'}, {'value': '328', 'groupId': 'OG002'}, {'value': '336', 'groupId': 'OG003'}, {'value': '326', 'groupId': 'OG004'}, {'value': '332', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'QIVc (18 to <65 Years)', 'description': 'Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)'}, {'id': 'OG001', 'title': 'QIVc (≥ 65 Years)', 'description': 'Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)'}, {'id': 'OG002', 'title': 'TIV1c (18 to <65 Years)', 'description': 'Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1,H3N2, B1) recommended for 2013-2014 season'}, {'id': 'OG003', 'title': 'TIV1c (≥ 65 Years)', 'description': 'Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1,H3N2, B1) recommended for 2013-2014 season'}, {'id': 'OG004', 'title': 'TIV2c (18 to <65 Years)', 'description': 'Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014'}, {'id': 'OG005', 'title': 'TIV2c (≥ 65 Years)', 'description': 'Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014'}], 'classes': [{'title': 'H1N1: Day 1(N=661, 650, 328, 336,NA,NA)', 'categories': [{'measurements': [{'value': '63.8', 'groupId': 'OG000', 'lowerLimit': '60.0', 'upperLimit': '67.5'}, {'value': '79.2', 'groupId': 'OG001', 'lowerLimit': '75.9', 'upperLimit': '82.3'}, {'value': '64.6', 'groupId': 'OG002', 'lowerLimit': '59.2', 'upperLimit': '69.8'}, {'value': '76.5', 'groupId': 'OG003', 'lowerLimit': '71.6', 'upperLimit': '80.9'}, {'value': 'NA', 'comment': 'antigen not immunized', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'antigen not immunized', 'groupId': 'OG005', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'H1N1: Day 22(N=661, 650, 328, 336,NA,NA)', 'categories': [{'measurements': [{'value': '98.5', 'groupId': 'OG000', 'lowerLimit': '97.2', 'upperLimit': '99.3'}, {'value': '94.3', 'groupId': 'OG001', 'lowerLimit': '92.2', 'upperLimit': '96.0'}, {'value': '97.0', 'groupId': 'OG002', 'lowerLimit': '94.5', 'upperLimit': '98.5'}, {'value': '96.1', 'groupId': 'OG003', 'lowerLimit': '93.5', 'upperLimit': '97.9'}, {'value': 'NA', 'comment': 'antigen not immunized', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'antigen not immunized', 'groupId': 'OG005', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'H3N2: Day 1(N=661, 650, 328, 336,NA,NA)', 'categories': [{'measurements': [{'value': '78.2', 'groupId': 'OG000', 'lowerLimit': '74.9', 'upperLimit': '81.3'}, {'value': '89.5', 'groupId': 'OG001', 'lowerLimit': '86.9', 'upperLimit': '91.8'}, {'value': '80.5', 'groupId': 'OG002', 'lowerLimit': '75.8', 'upperLimit': '84.6'}, {'value': '88.4', 'groupId': 'OG003', 'lowerLimit': '84.5', 'upperLimit': '91.6'}, {'value': 'NA', 'comment': 'antigen not immunized', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'antigen not immunized', 'groupId': 'OG005', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'H3N2: Day 22(N=661, 650, 328, 336,NA,NA)', 'categories': [{'measurements': [{'value': '98.6', 'groupId': 'OG000', 'lowerLimit': '97.4', 'upperLimit': '99.4'}, {'value': '98.3', 'groupId': 'OG001', 'lowerLimit': '97.0', 'upperLimit': '99.2'}, {'value': '99.1', 'groupId': 'OG002', 'lowerLimit': '97.4', 'upperLimit': '99.8'}, {'value': '98.2', 'groupId': 'OG003', 'lowerLimit': '96.2', 'upperLimit': '99.3'}, {'value': 'NA', 'comment': 'antigen not immunized', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'antigen not immunized', 'groupId': 'OG005', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'B1: Day 1(N=661, 650, 328, 336,NA,NA)', 'categories': [{'measurements': [{'value': '64.6', 'groupId': 'OG000', 'lowerLimit': '60.8', 'upperLimit': '68.2'}, {'value': '72.3', 'groupId': 'OG001', 'lowerLimit': '68.7', 'upperLimit': '75.7'}, {'value': '62.8', 'groupId': 'OG002', 'lowerLimit': '57.3', 'upperLimit': '68.1'}, {'value': '67.9', 'groupId': 'OG003', 'lowerLimit': '62.6', 'upperLimit': '72.8'}, {'value': 'NA', 'comment': 'antigen not immunized', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'antigen not immunized', 'groupId': 'OG005', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'B1: Day 22(N=661, 650, 328, 336,NA,NA)', 'categories': [{'measurements': [{'value': '95.6', 'groupId': 'OG000', 'lowerLimit': '93.8', 'upperLimit': '97.0'}, {'value': '92.2', 'groupId': 'OG001', 'lowerLimit': '89.8', 'upperLimit': '94.1'}, {'value': '95.7', 'groupId': 'OG002', 'lowerLimit': '92.9', 'upperLimit': '97.6'}, {'value': '87.8', 'groupId': 'OG003', 'lowerLimit': '83.8', 'upperLimit': '91.1'}, {'value': 'NA', 'comment': 'antigen not immunized', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'antigen not immunized', 'groupId': 'OG005', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'B2: Day 1(N=661, 650,NA,NA, 326, 332)', 'categories': [{'measurements': [{'value': '74.9', 'groupId': 'OG000', 'lowerLimit': '71.4', 'upperLimit': '78.2'}, {'value': '81.2', 'groupId': 'OG001', 'lowerLimit': '78.0', 'upperLimit': '84.2'}, {'value': 'NA', 'comment': 'antigen not immunized', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'antigen not immunized', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '73.3', 'groupId': 'OG004', 'lowerLimit': '68.2', 'upperLimit': '78.0'}, {'value': '81.0', 'groupId': 'OG005', 'lowerLimit': '76.4', 'upperLimit': '85.1'}]}]}, {'title': 'B2: Day 22(N=661, 650,NA,NA, 326, 332)', 'categories': [{'measurements': [{'value': '99.1', 'groupId': 'OG000', 'lowerLimit': '98.0', 'upperLimit': '99.7'}, {'value': '96.2', 'groupId': 'OG001', 'lowerLimit': '94.4', 'upperLimit': '97.5'}, {'value': 'NA', 'comment': 'antigen not immunized', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'antigen not immunized', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '98.8', 'groupId': 'OG004', 'lowerLimit': '96.9', 'upperLimit': '99.7'}, {'value': '95.2', 'groupId': 'OG005', 'lowerLimit': '92.3', 'upperLimit': '97.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Three weeks post vaccination (Day 22)', 'description': 'Immunogenicity was assessed in terms of percentages of subjects showing HI titer ≥1:40, three weeks (day 22) after vaccination with either QIVc, TIV1c or TIV2c The CBER criterion for 18 to \\<65 years age group is that the lower bound of the two-sided 95% CI for the percentage of subjects achieving an HI antibody titer ≥ 1:40 should meet or exceed 70% and that for the ≥ 65 years age group should meet or exceed 60%', 'unitOfMeasure': 'percentages of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on FAS immunogenicity set.'}, {'type': 'SECONDARY', 'title': '5.Geometric Mean Ratios (GMR) in Subjects After One Dose of Either QIVc, TIV1c or TIV2c in 18 to ≤60 Years and ≥ 61 Years Age Cohorts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '606', 'groupId': 'OG000'}, {'value': '705', 'groupId': 'OG001'}, {'value': '306', 'groupId': 'OG002'}, {'value': '358', 'groupId': 'OG003'}, {'value': '297', 'groupId': 'OG004'}, {'value': '361', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'QIVc (18 to ≤60 Years)', 'description': 'Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)'}, {'id': 'OG001', 'title': 'QIVc (≥ 61 Years)', 'description': 'Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)'}, {'id': 'OG002', 'title': 'TIV1c (18 to ≤60 Years)', 'description': 'Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1,H3N2, B1) recommended for 2013- 2014 season'}, {'id': 'OG003', 'title': 'TIV1c (≥ 61 Years)', 'description': 'Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1,H3N2, B1) recommended for 2013- 2014 season'}, {'id': 'OG004', 'title': 'TIV2c (18 to ≤60 Years)', 'description': 'Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014'}, {'id': 'OG005', 'title': 'TIV2c (≥ 61 Years)', 'description': 'Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014'}], 'classes': [{'title': 'A/H1N1(Day 22/Day1)(N=606,705,306,358,NA,NA)', 'categories': [{'measurements': [{'value': '9.2', 'groupId': 'OG000', 'lowerLimit': '8.0', 'upperLimit': '10.6'}, {'value': '3.0', 'groupId': 'OG001', 'lowerLimit': '2.7', 'upperLimit': '3.2'}, {'value': '9.1', 'groupId': 'OG002', 'lowerLimit': '7.5', 'upperLimit': '11.1'}, {'value': '3.0', 'groupId': 'OG003', 'lowerLimit': '2.7', 'upperLimit': '3.4'}, {'value': 'NA', 'comment': 'antigen not immunized', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'antigen not immunized', 'groupId': 'OG005', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'A/H3N2 (Day 22/Day1)(N=606,705,306,358,NA,NA)', 'categories': [{'measurements': [{'value': '4.2', 'groupId': 'OG000', 'lowerLimit': '3.8', 'upperLimit': '4.7'}, {'value': '2.3', 'groupId': 'OG001', 'lowerLimit': '2.1', 'upperLimit': '2.5'}, {'value': '4.2', 'groupId': 'OG002', 'lowerLimit': '3.6', 'upperLimit': '4.9'}, {'value': '2.2', 'groupId': 'OG003', 'lowerLimit': '2.0', 'upperLimit': '2.5'}, {'value': 'NA', 'comment': 'antigen not immunized', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'antigen not immunized', 'groupId': 'OG005', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'B1 (Day 22/Day1)(N=606,705,306,358,NA,NA)', 'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000', 'lowerLimit': '4.0', 'upperLimit': '5.0'}, {'value': '2.1', 'groupId': 'OG001', 'lowerLimit': '1.9', 'upperLimit': '2.2'}, {'value': '4.1', 'groupId': 'OG002', 'lowerLimit': '3.5', 'upperLimit': '4.8'}, {'value': '1.8', 'groupId': 'OG003', 'lowerLimit': '1.7', 'upperLimit': '2.0'}, {'value': 'NA', 'comment': 'antigen not immunized', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'antigen not immunized', 'groupId': 'OG005', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'B2 (Day 22/Day1)(N=606,705,NA,NA,297,361)', 'categories': [{'measurements': [{'value': '4.3', 'groupId': 'OG000', 'lowerLimit': '3.9', 'upperLimit': '4.8'}, {'value': '2.2', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': '2.3'}, {'value': 'NA', 'comment': 'antigen not immunized', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'antigen not immunized', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '4.1', 'groupId': 'OG004', 'lowerLimit': '3.5', 'upperLimit': '4.7'}, {'value': '2.1', 'groupId': 'OG005', 'lowerLimit': '1.9', 'upperLimit': '2.3'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Three weeks post vaccination (Day 22)', 'description': 'Immunogenicity was measured as the geometric mean ratio (GMR). The ratio of post-vaccination to pre-vaccination HI GMTs, three weeks (day 22) after vaccination with either QIVc, TIV1c or TIV2c Committee for Medicinal Products for Human Use (CHMP) criterion for 18 to ≤60 years age group is \\>2.5 and that for ≥ 61 years age group is \\>2.0', 'unitOfMeasure': 'Ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on FAS immunogenicity set.'}, {'type': 'SECONDARY', 'title': '6. Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV1c or TIV2c in 18 to ≤60 Years and ≥ 61 Years Age Cohorts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '606', 'groupId': 'OG000'}, {'value': '705', 'groupId': 'OG001'}, {'value': '306', 'groupId': 'OG002'}, {'value': '358', 'groupId': 'OG003'}, {'value': '297', 'groupId': 'OG004'}, {'value': '361', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'QIVc (18 to ≤60 Years)', 'description': 'Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)'}, {'id': 'OG001', 'title': 'QIVc (≥ 61 Years)', 'description': 'Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)'}, {'id': 'OG002', 'title': 'TIV1c (18 to ≤60 Years)', 'description': 'Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1,H3N2, B1) recommended for 2013- 2014 season'}, {'id': 'OG003', 'title': 'TIV1c (≥ 61 Years)', 'description': 'Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1,H3N2, B1) recommended for 2013- 2014 season'}, {'id': 'OG004', 'title': 'TIV2c (18 to ≤60 Years)', 'description': 'Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014'}, {'id': 'OG005', 'title': 'TIV2c (≥ 61 Years)', 'description': 'Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014'}], 'classes': [{'title': 'H1N1: Day 22(N=606,705,306,358,NA,NA)', 'categories': [{'measurements': [{'value': '63.5', 'groupId': 'OG000', 'lowerLimit': '59.6', 'upperLimit': '67.4'}, {'value': '36.3', 'groupId': 'OG001', 'lowerLimit': '32.8', 'upperLimit': '40.4'}, {'value': '62.1', 'groupId': 'OG002', 'lowerLimit': '56.4', 'upperLimit': '67.6'}, {'value': '36.9', 'groupId': 'OG003', 'lowerLimit': '31.9', 'upperLimit': '42.1'}, {'value': 'NA', 'comment': 'antigen not immunized', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'antigen not immunized', 'groupId': 'OG005', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'H3N2: Day 22(N=606,705,306,358,NA,NA)', 'categories': [{'measurements': [{'value': '49.8', 'groupId': 'OG000', 'lowerLimit': '45.8', 'upperLimit': '53.9'}, {'value': '28.4', 'groupId': 'OG001', 'lowerLimit': '25.1', 'upperLimit': '31.9'}, {'value': '48.7', 'groupId': 'OG002', 'lowerLimit': '43.0', 'upperLimit': '54.4'}, {'value': '24.9', 'groupId': 'OG003', 'lowerLimit': '20.5', 'upperLimit': '29.7'}, {'value': 'NA', 'comment': 'antigen not immunized', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'antigen not immunized', 'groupId': 'OG005', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'B1: Day 22(N=606,705,306,358,NA,NA)', 'categories': [{'measurements': [{'value': '53.3', 'groupId': 'OG000', 'lowerLimit': '49.2', 'upperLimit': '57.3'}, {'value': '22.3', 'groupId': 'OG001', 'lowerLimit': '19.2', 'upperLimit': '25.5'}, {'value': '52.3', 'groupId': 'OG002', 'lowerLimit': '46.5', 'upperLimit': '58.0'}, {'value': '19.6', 'groupId': 'OG003', 'lowerLimit': '15.6', 'upperLimit': '24.0'}, {'value': 'NA', 'comment': 'antigen not immunized', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'antigen not immunized', 'groupId': 'OG005', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'B2: Day 22(N=606,705,NA,NA,297,361)', 'categories': [{'measurements': [{'value': '53.8', 'groupId': 'OG000', 'lowerLimit': '49.7', 'upperLimit': '57.8'}, {'value': '27.5', 'groupId': 'OG001', 'lowerLimit': '24.3', 'upperLimit': '31.0'}, {'value': 'NA', 'comment': 'antigen not immunized', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'antigen not immunized', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '51.2', 'groupId': 'OG004', 'lowerLimit': '45.3', 'upperLimit': '57.0'}, {'value': '22.4', 'groupId': 'OG005', 'lowerLimit': '18.2', 'upperLimit': '27.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Three weeks post vaccination (Day 22)', 'description': 'Immunogenicity was assessed in terms of percentages of subjects showing seroconversion or significant increase in HI antibody titers, three weeks (day 22) after vaccination with either QIVc, TIV1c or TIV2c Seroconversion is defined in subjects seronegative at baseline (i.e., HI titer \\<1:10 at Day 1) as post-vaccination HI titer ≥1:40, and defined in subjects sero-positive at baseline (i.e., HI titer ≥1:10 at Day 1) as a minimum of a 4-fold increase in post-vaccination HI titer The CHMP criterion for 18 to ≤60 years age group is that the percentage of subjects achieving seroconversion or significant increase in HI titer is \\>40% and that for ≥ 61 years age group is \\>30%', 'unitOfMeasure': 'percentages of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on FAS immunogenicity set.'}, {'type': 'SECONDARY', 'title': '7. Percentages of Subjects Achieving HI Titer ≥1:40 After One Dose of Either QIVc, TIV1c or TIV2c in 18 to ≤60 Years and ≥ 61 Years Age Cohorts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '606', 'groupId': 'OG000'}, {'value': '705', 'groupId': 'OG001'}, {'value': '306', 'groupId': 'OG002'}, {'value': '358', 'groupId': 'OG003'}, {'value': '297', 'groupId': 'OG004'}, {'value': '361', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'QIVc (18 to ≤60 Years)', 'description': 'Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)'}, {'id': 'OG001', 'title': 'QIVc (≥ 61 Years)', 'description': 'Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)'}, {'id': 'OG002', 'title': 'TIV1c (18 to ≤60 Years)', 'description': 'Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1,H3N2, B1) recommended for 2013- 2014 season'}, {'id': 'OG003', 'title': 'TIV1c (≥ 61 Years)', 'description': 'Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1,H3N2, B1) recommended for 2013- 2014 season'}, {'id': 'OG004', 'title': 'TIV2c (18 to ≤60 Years)', 'description': 'Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014'}, {'id': 'OG005', 'title': 'TIV2c (≥ 61 Years)', 'description': 'Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014'}], 'classes': [{'title': 'H1N1: Day 1(N=606,705,306,358,NA,NA)', 'categories': [{'measurements': [{'value': '64.4', 'groupId': 'OG000', 'lowerLimit': '60.4', 'upperLimit': '68.2'}, {'value': '77.6', 'groupId': 'OG001', 'lowerLimit': '74.3', 'upperLimit': '80.6'}, {'value': '65.0', 'groupId': 'OG002', 'lowerLimit': '59.4', 'upperLimit': '70.4'}, {'value': '75.4', 'groupId': 'OG003', 'lowerLimit': '70.6', 'upperLimit': '79.8'}, {'value': 'NA', 'comment': 'antigen not immunized', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'antigen not immunized', 'groupId': 'OG005', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'H1N1: Day 22(N=606,705,306,358,NA,NA)', 'categories': [{'measurements': [{'value': '98.3', 'groupId': 'OG000', 'lowerLimit': '97.0', 'upperLimit': '99.2'}, {'value': '94.8', 'groupId': 'OG001', 'lowerLimit': '92.8', 'upperLimit': '96.3'}, {'value': '97.4', 'groupId': 'OG002', 'lowerLimit': '94.9', 'upperLimit': '98.9'}, {'value': '95.8', 'groupId': 'OG003', 'lowerLimit': '93.2', 'upperLimit': '97.6'}, {'value': 'NA', 'comment': 'antigen not immunized', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'antigen not immunized', 'groupId': 'OG005', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'H3N2: Day 1(N=606,705,306,358,NA,NA)', 'categories': [{'measurements': [{'value': '77.6', 'groupId': 'OG000', 'lowerLimit': '74.0', 'upperLimit': '80.8'}, {'value': '89.2', 'groupId': 'OG001', 'lowerLimit': '86.7', 'upperLimit': '91.4'}, {'value': '80.4', 'groupId': 'OG002', 'lowerLimit': '75.5', 'upperLimit': '84.7'}, {'value': '88.0', 'groupId': 'OG003', 'lowerLimit': '84.2', 'upperLimit': '91.2'}, {'value': 'NA', 'comment': 'antigen not immunized', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'antigen not immunized', 'groupId': 'OG005', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'H3N2: Day 22(N=606,705,306,358,NA,NA)', 'categories': [{'measurements': [{'value': '98.7', 'groupId': 'OG000', 'lowerLimit': '97.4', 'upperLimit': '99.4'}, {'value': '98.3', 'groupId': 'OG001', 'lowerLimit': '97.0', 'upperLimit': '99.1'}, {'value': '99.0', 'groupId': 'OG002', 'lowerLimit': '97.2', 'upperLimit': '99.8'}, {'value': '98.3', 'groupId': 'OG003', 'lowerLimit': '96.4', 'upperLimit': '99.4'}, {'value': 'NA', 'comment': 'antigen not immunized', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'antigen not immunized', 'groupId': 'OG005', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'B1: Day 1(N=606,705,306,358,NA,NA)', 'categories': [{'measurements': [{'value': '65.5', 'groupId': 'OG000', 'lowerLimit': '61.6', 'upperLimit': '69.3'}, {'value': '70.9', 'groupId': 'OG001', 'lowerLimit': '67.4', 'upperLimit': '74.3'}, {'value': '62.4', 'groupId': 'OG002', 'lowerLimit': '56.7', 'upperLimit': '67.9'}, {'value': '67.9', 'groupId': 'OG003', 'lowerLimit': '62.8', 'upperLimit': '72.7'}, {'value': 'NA', 'comment': 'antigen not immunized', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'antigen not immunized', 'groupId': 'OG005', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'B1: Day 22(N=606,705,306,358,NA,NA)', 'categories': [{'measurements': [{'value': '96.4', 'groupId': 'OG000', 'lowerLimit': '94.6', 'upperLimit': '97.7'}, {'value': '91.8', 'groupId': 'OG001', 'lowerLimit': '89.5', 'upperLimit': '93.7'}, {'value': '96.4', 'groupId': 'OG002', 'lowerLimit': '93.7', 'upperLimit': '98.2'}, {'value': '87.7', 'groupId': 'OG003', 'lowerLimit': '83.9', 'upperLimit': '90.9'}, {'value': 'NA', 'comment': 'antigen not immunized', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'antigen not immunized', 'groupId': 'OG005', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'B2: Day 1(N=606,705,NA,NA,297,361)', 'categories': [{'measurements': [{'value': '73.8', 'groupId': 'OG000', 'lowerLimit': '70.1', 'upperLimit': '77.2'}, {'value': '81.7', 'groupId': 'OG001', 'lowerLimit': '78.6', 'upperLimit': '84.5'}, {'value': 'NA', 'comment': 'antigen not immunized', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'antigen not immunized', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '72.7', 'groupId': 'OG004', 'lowerLimit': '67.3', 'upperLimit': '77.7'}, {'value': '80.9', 'groupId': 'OG005', 'lowerLimit': '76.4', 'upperLimit': '84.8'}]}]}, {'title': 'B2: Day 22(N=606,705,NA,NA,297,361)', 'categories': [{'measurements': [{'value': '99.3', 'groupId': 'OG000', 'lowerLimit': '98.3', 'upperLimit': '99.8'}, {'value': '96.2', 'groupId': 'OG001', 'lowerLimit': '94.5', 'upperLimit': '97.5'}, {'value': 'NA', 'comment': 'antigen not immunized', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'antigen not immunized', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '99.0', 'groupId': 'OG004', 'lowerLimit': '97.1', 'upperLimit': '99.8'}, {'value': '95.3', 'groupId': 'OG005', 'lowerLimit': '92.6', 'upperLimit': '97.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Three weeks post vaccination (Day 22)', 'description': 'Immunogenicity was assessed in terms of percentages of subjects showing HI titer ≥1:40, three weeks (day 22) after vaccination with either QIVc, TIV1c and TIV2c The CHMP criterion for 18 to ≤60 years age group is that the percentage of subjects achieving an HI titer ≥1:40 is \\>70% and that for ≥ 61 years age group is \\>60%', 'unitOfMeasure': 'percentages of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on FAS immunogenicity set.'}, {'type': 'SECONDARY', 'title': '8.Geometric Mean Titres (GMT) in Subjects After Receiving One Dose of Either QIVc, TIV1c Against B2 Strain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1311', 'groupId': 'OG000'}, {'value': '664', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QIVc (≥18 Years)', 'description': 'Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)'}, {'id': 'OG001', 'title': 'TIV1c (≥18 Years)', 'description': 'Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season'}], 'classes': [{'title': 'Day 1(N=1311,664)', 'categories': [{'measurements': [{'value': '45.9', 'groupId': 'OG000', 'lowerLimit': '43.3', 'upperLimit': '48.8'}, {'value': '55.7', 'groupId': 'OG001', 'lowerLimit': '51.6', 'upperLimit': '60.2'}]}]}, {'title': 'Day 22(N=1311,664)', 'categories': [{'measurements': [{'value': '135.4', 'groupId': 'OG000', 'lowerLimit': '127.6', 'upperLimit': '143.7'}, {'value': '91.7', 'groupId': 'OG001', 'lowerLimit': '85.7', 'upperLimit': '98.2'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratios of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.6', 'ciLowerLimit': '0.6', 'ciUpperLimit': '0.7', 'groupDescription': 'Superiority of immune responses of QIVc to TIV1c in terms of ratios of GMT against influenza strain B2', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The upper bound of the 2-sided 95% CI for the ratio of GMTs (GMT TIV1c or TIV2c /GMT QIVc) for HI antibody should not exceed the superiority margin of 1.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Three weeks post vaccination (Day 22)', 'description': 'Immunogenicity of QIVc to TIV1c was assessed by GMT in subjects measured by HI assay, three weeks after vaccination with one dose of either QIVc or TIV1c.\n\nSuperiority was established if the upper bound of the two-sided 95% CI for the ratio of GMTs (GMT TIV1c /GMT QIVc) for HI antibody does not exceed the superiority margin of 1.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on FAS population'}, {'type': 'SECONDARY', 'title': '9.Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV1c Against B2 Strain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1311', 'groupId': 'OG000'}, {'value': '664', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QIVc (≥18 Years)', 'description': 'Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)'}, {'id': 'OG001', 'title': 'TIV1c (≥18 Years)', 'description': 'Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season'}], 'classes': [{'categories': [{'measurements': [{'value': '36.6', 'groupId': 'OG000', 'lowerLimit': '34.0', 'upperLimit': '39.3'}, {'value': '17.2', 'groupId': 'OG001', 'lowerLimit': '14.4', 'upperLimit': '20.3'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference between seroconversion rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-19.4', 'ciLowerLimit': '-23.2', 'ciUpperLimit': '-15.5', 'groupDescription': 'Superiority of immune responses of QIVc to TIV1c in terms of seroconversion rates against influenza strain B2', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The upper bound of the 2-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV1c or TIV2c - % seroconversion QIVc) for HI antibody should not exceed the margin of 0 points.'}], 'paramType': 'NUMBER', 'timeFrame': 'Three weeks post vaccination (Day 22)', 'description': 'Immunogenicity of QIVc to TIV1c was assessed in terms of percentages of subjects showing seroconversion or significant increase in HI antibody titers, against influenza strain B2, three weeks (day 22) after vaccination with QIVc or TIV1c Superiority was established if the upper bound of the two-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV1c - % seroconversion QIVc) for HI antibody in ≥ 18 years age group does not exceed the margin of 0 points', 'unitOfMeasure': 'percentages of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on FAS population'}, {'type': 'SECONDARY', 'title': '10.GMT in Subjects After Receiving One Dose of Either QIVc, TIV2c Against B1 Strain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1311', 'groupId': 'OG000'}, {'value': '658', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QIVc (≥18 Years)', 'description': 'Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)'}, {'id': 'OG001', 'title': 'TIV2c (≥18 Years)', 'description': 'Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014'}], 'classes': [{'title': 'Day 1(N=1311,658)', 'categories': [{'measurements': [{'value': '59.7', 'groupId': 'OG000', 'lowerLimit': '56.4', 'upperLimit': '63.0'}, {'value': '43.8', 'groupId': 'OG001', 'lowerLimit': '40.3', 'upperLimit': '47.6'}]}]}, {'title': 'Day 22(N=1311,657)', 'categories': [{'measurements': [{'value': '177.1', 'groupId': 'OG000', 'lowerLimit': '167.8', 'upperLimit': '187.1'}, {'value': '76.3', 'groupId': 'OG001', 'lowerLimit': '70.4', 'upperLimit': '82.7'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratios of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.5', 'ciLowerLimit': '0.5', 'ciUpperLimit': '0.5', 'groupDescription': 'Superiority of immune responses of QIVc to TIV2c in terms of ratios of GMT against influenza strain B1', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The upper bound of the 2-sided 95% CI for the ratio of GMTs (GMT TIV1c or TIV2c /GMT QIVc) for HI antibody should not exceed the superiority margin of 1.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Three weeks post vaccination (Day 22)', 'description': 'Immunogenicity of QIVc to TIV2c was assessed by GMT in subjects measured by HI assay, three weeks after vaccination with one dose of either QIVc or TIV2c.\n\nSuperiority was established if the upper bound of the two-sided 95% CI for the ratio of GMTs (GMT TIV2c /GMT QIVc) for HI antibody does not exceed the superiority margin of 1', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on FAS population'}, {'type': 'SECONDARY', 'title': '11.Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV2c Against B1 Strain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1311', 'groupId': 'OG000'}, {'value': '657', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QIVc (≥18 Years)', 'description': 'Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)'}, {'id': 'OG001', 'title': 'TIV2c (≥18 Years)', 'description': 'Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014'}], 'classes': [{'categories': [{'measurements': [{'value': '39.7', 'groupId': 'OG000', 'lowerLimit': '37.0', 'upperLimit': '42.4'}, {'value': '18.0', 'groupId': 'OG001', 'lowerLimit': '15.1', 'upperLimit': '21.1'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference between seroconversion rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-21.7', 'ciLowerLimit': '-25.5', 'ciUpperLimit': '-17.7', 'groupDescription': 'Superiority of immune responses of QIVc to TIV2c in terms of seroconversion rates against influenza strain B1', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The upper bound of the 2-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV1c or TIV2c - %seroconversion QIVc) for HI antibody should not exceed the margin of 0 points.'}], 'paramType': 'NUMBER', 'timeFrame': 'Three weeks post vaccination (Day 22)', 'description': 'Immunogenicity of QIVc to TIV2c in terms of percentages of subjects showing seroconversion or significant increase in HI antibody titers, against influenza strain B1, three weeks (day 22) after vaccination with QIVc or TIV2c Superiority was established if the upper bound of the two-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV2c - % seroconversion QIVc) for HI antibody in ≥ 18 years age group does not exceed the margin of 0 points', 'unitOfMeasure': 'percentages of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on FAS population'}, {'type': 'SECONDARY', 'title': '12.Number of Subjects Reporting Solicited Adverse Events (AEs) After One Dose of Either QIVc, TIV1c or TIV2c by Overall Age Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1319', 'groupId': 'OG000'}, {'value': '670', 'groupId': 'OG001'}, {'value': '663', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'QIVc (≥18 Years)', 'description': 'Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)'}, {'id': 'OG001', 'title': 'TIV1c (≥18 Years)', 'description': 'Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season'}, {'id': 'OG002', 'title': 'TIV2c (≥18 Years)', 'description': 'Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014'}], 'classes': [{'title': 'Any local', 'categories': [{'measurements': [{'value': '551', 'groupId': 'OG000'}, {'value': '240', 'groupId': 'OG001'}, {'value': '242', 'groupId': 'OG002'}]}]}, {'title': 'Injection site induration(hardness)', 'categories': [{'measurements': [{'value': '134', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}]}, {'title': 'Injection site erythema (redness)', 'categories': [{'measurements': [{'value': '167', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}]}]}, {'title': 'Injection site ecchymosis(bruising)', 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}]}, {'title': 'Injection site pain', 'categories': [{'measurements': [{'value': '443', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}, {'value': '195', 'groupId': 'OG002'}]}]}, {'title': 'Any systemic', 'categories': [{'measurements': [{'value': '376', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}, {'value': '194', 'groupId': 'OG002'}]}]}, {'title': 'Chills', 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}]}, {'title': 'Nausea', 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}]}]}, {'title': 'Myalgia', 'categories': [{'measurements': [{'value': '156', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}]}]}, {'title': 'Arthralgia', 'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}]}]}, {'title': 'Headache', 'categories': [{'measurements': [{'value': '185', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '89', 'groupId': 'OG002'}]}]}, {'title': 'Fatigue', 'categories': [{'measurements': [{'value': '178', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}, {'value': '81', 'groupId': 'OG002'}]}]}, {'title': 'Vomiting', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Diarrhea', 'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}]}]}, {'title': 'Loss of appetite', 'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}]}]}, {'title': 'Any other', 'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}]}, {'title': 'Use of analgesics / antipyretics for prophylasis', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Use of analgesics / antipyretics for treatment', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Body temperature', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 to 7 post vaccination', 'description': 'Safety was assessed in terms of number (%) of subjects reporting solicited local and systemic reactions, day 1 to 7 after vaccination with one dose of either four (4) strain inactivated quadrivalent cell based influenza vaccine (QIVc) or trivalent inactivated influenza vaccine (TIV1c or TIV2c)', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on solicited safety data set i.e. all subjects in the exposed set with solicited adverse event data'}, {'type': 'SECONDARY', 'title': '13.Number of Subjects Reporting Unsolicited Adverse Events (AEs) After One Dose of Either QIVc, TIV1c or TIV2c by Overall Age Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1324', 'groupId': 'OG000'}, {'value': '673', 'groupId': 'OG001'}, {'value': '665', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'QIVc (≥18 Years)', 'description': 'Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)'}, {'id': 'OG001', 'title': 'TIV1c (≥18 Years)', 'description': 'Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season'}, {'id': 'OG002', 'title': 'TIV2c (≥18 Years)', 'description': 'Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014'}], 'classes': [{'title': 'Any AE', 'categories': [{'measurements': [{'value': '213', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}]}]}, {'title': 'Any possibly related AE', 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}]}, {'title': 'SAE', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}]}, {'title': 'Possibly/probably related SAE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'AE leading to study withdrawal', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Medically attended AE', 'categories': [{'measurements': [{'value': '344', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}, {'value': '166', 'groupId': 'OG002'}]}]}, {'title': 'NOCD', 'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}]}, {'title': 'Death(N=1355,676,669)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 to 181 post vaccination', 'description': 'Safety was assessed in terms of number (%) of subjects reporting unsolicited AEs (day 1 to 22 after vaccination), serious adverse events (SAEs), medically attended AEs, AEs leading to withdrawal from the study, new onset of chronic diseases (NOCDs), and concomitant medications (day 1 to day 181 post vaccination) after receiving one dose of either four (4) strain inactivated quadrivalent cell based influenza vaccine (QIVc) or trivalent inactivated influenza vaccine (TIV1c or TIV2c)', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on unsolicited safety data set i.e. all subjects in the exposed set with unsolicited adverse event data'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'QIVc (≥18 Years)', 'description': 'Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)'}, {'id': 'FG001', 'title': 'TIV1c (≥18 Years)', 'description': 'Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1,H3N2, B1) recommended for 2013-2014 season'}, {'id': 'FG002', 'title': 'TIV2c (≥18 Years)', 'description': 'Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1335'}, {'groupId': 'FG001', 'numSubjects': '676'}, {'groupId': 'FG002', 'numSubjects': '669'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1285'}, {'groupId': 'FG001', 'numSubjects': '652'}, {'groupId': 'FG002', 'numSubjects': '648'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '24'}, {'groupId': 'FG002', 'numSubjects': '21'}]}], 'dropWithdraws': [{'type': 'ADMINISTRATIVE REASON', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '13'}]}, {'type': 'OTHER', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '4'}]}]}], 'recruitmentDetails': 'Subjects were enrolled from 40 centers in US', 'preAssignmentDetails': 'All enrolled subjects were included in the trial'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1335', 'groupId': 'BG000'}, {'value': '676', 'groupId': 'BG001'}, {'value': '669', 'groupId': 'BG002'}, {'value': '2680', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'QIVc (≥18 Years)', 'description': 'Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)'}, {'id': 'BG001', 'title': 'TIV1c (≥18 Years)', 'description': 'Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1,H3N2, B1) recommended for 2013-2014 season'}, {'id': 'BG002', 'title': 'TIV2c (≥18 Years)', 'description': 'Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.4', 'spread': '17.8', 'groupId': 'BG000'}, {'value': '57.2', 'spread': '18.0', 'groupId': 'BG001'}, {'value': '57.1', 'spread': '18.1', 'groupId': 'BG002'}, {'value': '57.3', 'spread': '17.9', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'year', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '732', 'groupId': 'BG000'}, {'value': '392', 'groupId': 'BG001'}, {'value': '392', 'groupId': 'BG002'}, {'value': '1516', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '603', 'groupId': 'BG000'}, {'value': '284', 'groupId': 'BG001'}, {'value': '277', 'groupId': 'BG002'}, {'value': '1164', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, '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': 2680}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-02', 'studyFirstSubmitDate': '2013-11-07', 'resultsFirstSubmitDate': '2015-02-27', 'studyFirstSubmitQcDate': '2013-11-18', 'lastUpdatePostDateStruct': {'date': '2015-12-10', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-11-02', 'studyFirstPostDateStruct': {'date': '2013-11-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-12-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '1.Geometric Mean Titres (GMT) in Subjects After Receiving One Dose of Either QIVc, TIV1c or TIV2c', 'timeFrame': 'Three weeks post vaccination (Day 22)', 'description': 'Immunogenicity of QIVc to comparator TIVc (For H1N1, H3N2 and B1 strain, the comparison is between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison is between QIVc and TIV2c) was assessed in terms of GMT in subjects measured by hemagglutination inhibition (HI) assay, three weeks after vaccination with one dose of either QIVc or TIV1c and TIV2c.\n\nNon-inferiority was established if the upper bound of the two-sided 95% confidence interval (CI) for the ratio of GMTs (GMT TIV1c or TIV2c /GMT QIVc) for HI antibody does not exceed the non-inferiority margin of 1.5.'}, {'measure': '2. Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV1c or TIV2c', 'timeFrame': 'Three weeks post vaccination (Day 22)', 'description': 'Immunogenicity of QIVc to comparator TIVc (For H1N1, H3N2 and B1 strain, the comparison is between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison is between QIVc and TIV2c) was assessed in terms of percentages of subjects showing seroconversion or significant increase in HI antibody titers, three weeks (day 22) after vaccination with one dose of either QIVc,TIV1c or TIV2c Seroconversion is defined in subjects seronegative at baseline (i.e., HI titer \\<1:10 at Day 1) as post-vaccination HI titer ≥1:40, and defined in subjects sero-positive at baseline (i.e., HI titer ≥1:10 at Day 1) as a minimum of a 4-fold increase in post-vaccination HI titer'}], 'secondaryOutcomes': [{'measure': '3. Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV1c or TIV2c in 18 to <65 and ≥ 65 Years Age Cohorts', 'timeFrame': 'Three weeks post vaccination (Day 22)', 'description': 'Immunogenicity was assessed in terms of percentages of subjects showing seroconversion or significant increase in HI antibody titers, against each vaccine strains, three weeks (day 22) after vaccination with ether QIVc, TIV1c or TIV2c Seroconversion is defined in subjects seronegative at baseline (i.e., HI titer \\<1:10 at Day 1) as post-vaccination HI titer ≥1:40, and defined in subjects sero-positive at baseline (i.e., HI titer ≥1:10 at Day 1) as a minimum of a 4-fold increase in post-vaccination HI titer.The CBER criterion for 18 to \\<65 years age group is that the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroconversion for HI antibody should meet or exceed 40% and that for the ≥ 65 years age group should meet or exceed 30%'}, {'measure': '4. Percentages of Subjects Achieving HI Titer ≥1:40 After One Dose of Either QIVc, TIV1c or TIV2c in 18 to <65 and ≥ 65 Years Age-cohorts', 'timeFrame': 'Three weeks post vaccination (Day 22)', 'description': 'Immunogenicity was assessed in terms of percentages of subjects showing HI titer ≥1:40, three weeks (day 22) after vaccination with either QIVc, TIV1c or TIV2c The CBER criterion for 18 to \\<65 years age group is that the lower bound of the two-sided 95% CI for the percentage of subjects achieving an HI antibody titer ≥ 1:40 should meet or exceed 70% and that for the ≥ 65 years age group should meet or exceed 60%'}, {'measure': '5.Geometric Mean Ratios (GMR) in Subjects After One Dose of Either QIVc, TIV1c or TIV2c in 18 to ≤60 Years and ≥ 61 Years Age Cohorts', 'timeFrame': 'Three weeks post vaccination (Day 22)', 'description': 'Immunogenicity was measured as the geometric mean ratio (GMR). The ratio of post-vaccination to pre-vaccination HI GMTs, three weeks (day 22) after vaccination with either QIVc, TIV1c or TIV2c Committee for Medicinal Products for Human Use (CHMP) criterion for 18 to ≤60 years age group is \\>2.5 and that for ≥ 61 years age group is \\>2.0'}, {'measure': '6. Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV1c or TIV2c in 18 to ≤60 Years and ≥ 61 Years Age Cohorts', 'timeFrame': 'Three weeks post vaccination (Day 22)', 'description': 'Immunogenicity was assessed in terms of percentages of subjects showing seroconversion or significant increase in HI antibody titers, three weeks (day 22) after vaccination with either QIVc, TIV1c or TIV2c Seroconversion is defined in subjects seronegative at baseline (i.e., HI titer \\<1:10 at Day 1) as post-vaccination HI titer ≥1:40, and defined in subjects sero-positive at baseline (i.e., HI titer ≥1:10 at Day 1) as a minimum of a 4-fold increase in post-vaccination HI titer The CHMP criterion for 18 to ≤60 years age group is that the percentage of subjects achieving seroconversion or significant increase in HI titer is \\>40% and that for ≥ 61 years age group is \\>30%'}, {'measure': '7. Percentages of Subjects Achieving HI Titer ≥1:40 After One Dose of Either QIVc, TIV1c or TIV2c in 18 to ≤60 Years and ≥ 61 Years Age Cohorts', 'timeFrame': 'Three weeks post vaccination (Day 22)', 'description': 'Immunogenicity was assessed in terms of percentages of subjects showing HI titer ≥1:40, three weeks (day 22) after vaccination with either QIVc, TIV1c and TIV2c The CHMP criterion for 18 to ≤60 years age group is that the percentage of subjects achieving an HI titer ≥1:40 is \\>70% and that for ≥ 61 years age group is \\>60%'}, {'measure': '8.Geometric Mean Titres (GMT) in Subjects After Receiving One Dose of Either QIVc, TIV1c Against B2 Strain', 'timeFrame': 'Three weeks post vaccination (Day 22)', 'description': 'Immunogenicity of QIVc to TIV1c was assessed by GMT in subjects measured by HI assay, three weeks after vaccination with one dose of either QIVc or TIV1c.\n\nSuperiority was established if the upper bound of the two-sided 95% CI for the ratio of GMTs (GMT TIV1c /GMT QIVc) for HI antibody does not exceed the superiority margin of 1.'}, {'measure': '9.Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV1c Against B2 Strain', 'timeFrame': 'Three weeks post vaccination (Day 22)', 'description': 'Immunogenicity of QIVc to TIV1c was assessed in terms of percentages of subjects showing seroconversion or significant increase in HI antibody titers, against influenza strain B2, three weeks (day 22) after vaccination with QIVc or TIV1c Superiority was established if the upper bound of the two-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV1c - % seroconversion QIVc) for HI antibody in ≥ 18 years age group does not exceed the margin of 0 points'}, {'measure': '10.GMT in Subjects After Receiving One Dose of Either QIVc, TIV2c Against B1 Strain', 'timeFrame': 'Three weeks post vaccination (Day 22)', 'description': 'Immunogenicity of QIVc to TIV2c was assessed by GMT in subjects measured by HI assay, three weeks after vaccination with one dose of either QIVc or TIV2c.\n\nSuperiority was established if the upper bound of the two-sided 95% CI for the ratio of GMTs (GMT TIV2c /GMT QIVc) for HI antibody does not exceed the superiority margin of 1'}, {'measure': '11.Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV2c Against B1 Strain', 'timeFrame': 'Three weeks post vaccination (Day 22)', 'description': 'Immunogenicity of QIVc to TIV2c in terms of percentages of subjects showing seroconversion or significant increase in HI antibody titers, against influenza strain B1, three weeks (day 22) after vaccination with QIVc or TIV2c Superiority was established if the upper bound of the two-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV2c - % seroconversion QIVc) for HI antibody in ≥ 18 years age group does not exceed the margin of 0 points'}, {'measure': '12.Number of Subjects Reporting Solicited Adverse Events (AEs) After One Dose of Either QIVc, TIV1c or TIV2c by Overall Age Group', 'timeFrame': 'Day 1 to 7 post vaccination', 'description': 'Safety was assessed in terms of number (%) of subjects reporting solicited local and systemic reactions, day 1 to 7 after vaccination with one dose of either four (4) strain inactivated quadrivalent cell based influenza vaccine (QIVc) or trivalent inactivated influenza vaccine (TIV1c or TIV2c)'}, {'measure': '13.Number of Subjects Reporting Unsolicited Adverse Events (AEs) After One Dose of Either QIVc, TIV1c or TIV2c by Overall Age Group', 'timeFrame': 'Day 1 to 181 post vaccination', 'description': 'Safety was assessed in terms of number (%) of subjects reporting unsolicited AEs (day 1 to 22 after vaccination), serious adverse events (SAEs), medically attended AEs, AEs leading to withdrawal from the study, new onset of chronic diseases (NOCDs), and concomitant medications (day 1 to day 181 post vaccination) after receiving one dose of either four (4) strain inactivated quadrivalent cell based influenza vaccine (QIVc) or trivalent inactivated influenza vaccine (TIV1c or TIV2c)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Influenza', 'Influenza vaccine', 'Novartis', 'Adults'], 'conditions': ['Influenza']}, 'descriptionModule': {'briefSummary': 'Evaluate safety and immunogenicity of three influenza vaccines in adults 18 years of age and above.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 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Please contact the site for additional eligibility criteria'}, 'identificationModule': {'nctId': 'NCT01992094', 'briefTitle': 'Safety and Immunogenicity of Three Influenza Vaccines Adults Ages 18 and Older', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Phase III, Stratified, Randomized, Double-Blind, Multicenter, NonInferiority Study to Evaluate the Safety and Immunogenicity of a Cell-based Quadrivalent Subunit Influenza Virus Vaccine and Cell-based Trivalent Subunit Influenza Virus Vaccines in Adults Ages ≥18 Years of Age', 'orgStudyIdInfo': {'id': 'V130_01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'QIVc', 'description': 'Influenza vaccine', 'interventionNames': ['Biological: QIVc']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TIV1c', 'description': 'Influenza vaccine', 'interventionNames': ['Biological: TIV1c']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TIV2c', 'description': 'Influenza vaccine', 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