Ignite Creation Date:
2025-12-24 @ 3:37 PM
Ignite Modification Date:
2025-12-31 @ 12:36 AM
Study NCT ID:
NCT01346592
Status:
COMPLETED
Last Update Posted:
2015-03-26
First Post:
2011-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety, Tolerability, and Immunogenicity of the Adjuvanted Trivalent Subunit Influenza Vaccine and the Non-Adjuvanted Trivalent Subunit Influenza Vaccine Compared to the Non-Adjuvanted Trivalent Split Influenza Vaccine in Children 6 to < 72 Months of Age
Sponsor:
Organization:
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007252', 'term': 'Influenza Vaccines'}, {'id': 'C478243', 'term': 'fluad vaccine'}], 'ancestors': [{'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'RegistryContactVaccinesUS@novartis.com', 'title': 'Posting Director', 'organization': 'Novartis Vaccines and Diagnostics'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Solicited AEs collected from Day 1-7 after each vaccination, Unsolicited AEs, Adverse Events of Special Interest, New onset chronic disease, AEs leading to withdrawal and serious adverse events reported for through out the study (Day 1-Day 394)', 'description': 'Analysis was done on Full Safety Set - Subjects who received at least one study vaccination and provided post baseline safety data.', 'eventGroups': [{'id': 'EG000', 'title': 'ATIV (6 to <72 Months)', 'description': 'Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to \\<36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 \\& 29', 'otherNumAtRisk': 3123, 'otherNumAffected': 2106, 'seriousNumAtRisk': 3123, 'seriousNumAffected': 115}, {'id': 'EG001', 'title': 'TIV (6 to <72 Months)', 'description': 'Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to \\<36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 \\& 29', 'otherNumAtRisk': 1477, 'otherNumAffected': 905, 'seriousNumAtRisk': 1477, 'seriousNumAffected': 69}, {'id': 'EG002', 'title': 'Comparator TIV (6 to <72 Months)', 'description': 'Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to \\<36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 \\& 29', 'otherNumAtRisk': 1474, 'otherNumAffected': 917, 'seriousNumAtRisk': 1474, 'seriousNumAffected': 64}], 'otherEvents': [{'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 445}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 247}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 231}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 257}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 107}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 109}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Crying', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 186}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 105}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 124}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 204}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 43}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 31}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 312}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 109}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 102}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Injection site hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 191}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 72}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 86}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Injection site induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 258}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 62}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 67}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 851}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 177}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 189}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 217}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 34}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 43}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Irritability postvaccinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 290}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 165}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 191}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 795}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 279}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 260}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 112}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 70}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 84}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 291}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 151}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 175}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 452}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 237}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 246}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 437}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 197}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 206}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 216}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 43}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 25}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 286}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 48}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 40}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypersomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 229}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 150}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 153}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Coeliac Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Upper Gastrointestinal Disorder Hamorrage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Drowning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Type III Immune Complex Mediated Reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abscess Limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abscess Neck', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Amoebiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Arthritis Bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bacterial Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bronchopneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dengue Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diarrhoea Infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dysentery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Encephalitis Viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hepatitis A', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lower Respiratory Tract Infection Viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Mastoiditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Measles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Meningitis Pneumococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Otitis Media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Otitis Media Bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Otitis Media Chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Parasitic Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pharyngotonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumonia Bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumonia Viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pyelonephritis Acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Respiratory Syncytial Virus Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Respiratory Tract Infection Viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Septic Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Shigella Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Subcutaneous abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Tooth Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Thypoid Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Varicella', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Viral Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Viral Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Accidental Exposure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Animal Bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 14}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Animal Scratch', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Concussion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Craniocerebral Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Eye Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Femur Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Forearm Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Head Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Humerus Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Multiple Injuries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Radius Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Road Traffic Accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Skull Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Subdural Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Thermal Burn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Malnutrition', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Metabolic Acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Tetany', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Acute Lymphocytic Leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cholesteatoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Febrile Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Adenoidal Hypertrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Asthmatic Crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Atelectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bronchial Hyperreactivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bronchospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Tonsillary Hypertrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dermatitis Allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Swelling Face', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Finger Amputation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Roseola', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3123, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1477, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1474, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of Geometric Mean Titers (GMTs) Against Homologous Strains', 'denoms': [{'units': 'Participants', 'counts': [{'value': '682', 'groupId': 'OG000'}, {'value': '757', 'groupId': 'OG001'}, {'value': '765', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'aTIV (6 to <72 Months)', 'description': 'Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to \\<36 months received two doses (Day 1 \\& 29) while subjects aged ≥36 months received one dose (at Day 1) of the vaccine'}, {'id': 'OG001', 'title': 'Comparator TIV (6 to <72 Months)', 'description': 'Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to \\<36 months received two doses (Day 1 \\& 29) while subjects aged ≥36 months received one dose (at Day 1) of the vaccine'}, {'id': 'OG002', 'title': 'TIV (6 to <72 Months)', 'description': 'Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to \\<36 months received two doses (Day 1 \\& 29) while subjects aged ≥36 months received one dose (Day 1) of the vaccine'}], 'classes': [{'title': 'H1N1 - Day 1 (N=681,757,765)', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000', 'lowerLimit': '24', 'upperLimit': '33'}, {'value': '24', 'groupId': 'OG001', 'lowerLimit': '21', 'upperLimit': '28'}, {'value': '27', 'groupId': 'OG002', 'lowerLimit': '23', 'upperLimit': '31'}]}]}, {'title': 'H1N1 - Day 50 (N=681,757,765)', 'categories': [{'measurements': [{'value': '1537', 'groupId': 'OG000', 'lowerLimit': '1382', 'upperLimit': '1709'}, {'value': '629', 'groupId': 'OG001', 'lowerLimit': '567', 'upperLimit': '698'}, {'value': '480', 'groupId': 'OG002', 'lowerLimit': '433', 'upperLimit': '532'}]}]}, {'title': 'H3N2 - Day 1', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000', 'lowerLimit': '35', 'upperLimit': '47'}, {'value': '42', 'groupId': 'OG001', 'lowerLimit': '36', 'upperLimit': '49'}, {'value': '44', 'groupId': 'OG002', 'lowerLimit': '38', 'upperLimit': '51'}]}]}, {'title': 'H3N2 - Day 50', 'categories': [{'measurements': [{'value': '1908', 'groupId': 'OG000', 'lowerLimit': '1785', 'upperLimit': '2040'}, {'value': '1012', 'groupId': 'OG001', 'lowerLimit': '948', 'upperLimit': '1080'}, {'value': '803', 'groupId': 'OG002', 'lowerLimit': '752', 'upperLimit': '857'}]}]}, {'title': 'B strain Day 1', 'categories': [{'measurements': [{'value': '9.87', 'groupId': 'OG000', 'lowerLimit': '9.08', 'upperLimit': '11'}, {'value': '10', 'groupId': 'OG001', 'lowerLimit': '9.41', 'upperLimit': '11'}, {'value': '10', 'groupId': 'OG002', 'lowerLimit': '9.33', 'upperLimit': '11'}]}]}, {'title': 'B strain Day 50', 'categories': [{'measurements': [{'value': '492', 'groupId': 'OG000', 'lowerLimit': '450', 'upperLimit': '537'}, {'value': '160', 'groupId': 'OG001', 'lowerLimit': '147', 'upperLimit': '175'}, {'value': '157', 'groupId': 'OG002', 'lowerLimit': '144', 'upperLimit': '171'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT ratio (H1N1 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.6', 'paramValue': '2.44', 'ciLowerLimit': '2.06', 'ciUpperLimit': '2.9', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Noninferiority was established if the lower limit of the confidence interval of the day 50 ratio of GMTs was \\>0.667'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT ratio (H3N2 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.6', 'paramValue': '1.89', 'ciLowerLimit': '1.69', 'ciUpperLimit': '2.1', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Noninferiority was established if the lower limit of the confidence interval of the day 50 ratio of GMTs was \\>0.667'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT ratio (B strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.6', 'paramValue': '3.07', 'ciLowerLimit': '2.66', 'ciUpperLimit': '3.54', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Noninferiority was established if the lower limit of the confidence interval of the day 50 ratio of GMTs was \\>0.667'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'GMT ratio (H1N1 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.6', 'paramValue': '3.2', 'ciLowerLimit': '2.7', 'ciUpperLimit': '3.8', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Noninferiority was established if the lower limit of the confidence interval of the day 50 ratio of GMTs was \\>0.667'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'GMT ratio (H3N2 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.6', 'paramValue': '2.38', 'ciLowerLimit': '2.14', 'ciUpperLimit': '2.65', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Noninferiority was established if the lower limit of the confidence interval of the day 50 ratio of GMTs was \\>0.667'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'GMT ratio (B strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.6', 'paramValue': '3.14', 'ciLowerLimit': '2.72', 'ciUpperLimit': '3.62', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Noninferiority was established if the lower limit of the confidence interval of the day 50 ratio of GMTs was \\>0.667'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1, Day 50', 'description': 'The non-inferiority of Hemagglutination Inhibition (HI) antibody responses of aTIV compared to TIV and comparator TIV assessed in terms of post vaccination GMTs at three weeks after last vaccination against the three homologous vaccine strains.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on the Per Protocol Set (PPS) i.e all subjects in the enrolled population who correctly received the study vaccine, provided evaluable serum samples at relevant time-points and had no major protocol violations as defined prior to unblinding.'}, {'type': 'PRIMARY', 'title': 'Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of Percentage of Subjects Achieving Seroconversion or ≥4-fold Increase in HI Titers Against Homologous Strains', 'denoms': [{'units': 'Participants', 'counts': [{'value': '682', 'groupId': 'OG000'}, {'value': '757', 'groupId': 'OG001'}, {'value': '765', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'aTIV (6 to <72 Months)', 'description': 'Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to \\<36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 \\& 29'}, {'id': 'OG001', 'title': 'Comparator TIV (6 to <72 Months)', 'description': 'Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to \\<36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 \\& 29'}, {'id': 'OG002', 'title': 'TIV (6 to <72 Months)', 'description': 'Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to \\<36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 \\& 29'}], 'classes': [{'title': 'H1N1 - (N=680,757,765)', 'categories': [{'measurements': [{'value': '92.9', 'groupId': 'OG000', 'lowerLimit': '90.8', 'upperLimit': '94.8'}, {'value': '84.5', 'groupId': 'OG001', 'lowerLimit': '81.8', 'upperLimit': '87.1'}, {'value': '79.4', 'groupId': 'OG002', 'lowerLimit': '76.3', 'upperLimit': '82.2'}]}]}, {'title': 'H3N2', 'categories': [{'measurements': [{'value': '96.5', 'groupId': 'OG000', 'lowerLimit': '94.8', 'upperLimit': '97.7'}, {'value': '92.3', 'groupId': 'OG001', 'lowerLimit': '90.2', 'upperLimit': '94.1'}, {'value': '89.4', 'groupId': 'OG002', 'lowerLimit': '87', 'upperLimit': '91.5'}]}]}, {'title': 'B strain', 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000', 'lowerLimit': '96.6', 'upperLimit': '98.9'}, {'value': '86', 'groupId': 'OG001', 'lowerLimit': '83.3', 'upperLimit': '88.4'}, {'value': '84.6', 'groupId': 'OG002', 'lowerLimit': '81.8', 'upperLimit': '87.1'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Group difference (H1N1 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.6', 'paramValue': '9.09', 'ciLowerLimit': '5.48', 'ciUpperLimit': '12.69', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was established if the lower bound of the confidence interval for day 50 vaccine group difference was \\>-10%.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Group difference (H3N2 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.6', 'paramValue': '4.07', 'ciLowerLimit': '1.58', 'ciUpperLimit': '6.55', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was established if the lower bound of the confidence interval for day 50 vaccine group difference was \\>-10%'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Group difference (B strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.6', 'paramValue': '11.82', 'ciLowerLimit': '8.72', 'ciUpperLimit': '14.92', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was established if the lower bound of the confidence interval for day 50 vaccine group difference was \\> -10%'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Group difference (H1N1 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.6', 'paramValue': '14.21', 'ciLowerLimit': '10.3', 'ciUpperLimit': '18.13', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was established if the lower bound of the confidence interval for day 50 vaccine group difference was \\> -10%'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Group difference (H3N2 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.6', 'paramValue': '7.31', 'ciLowerLimit': '4.47', 'ciUpperLimit': '10.14', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was established if the lower bound of the confidence interval for day 50 vaccine group difference was \\> -10%'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Group difference (B strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.6', 'paramValue': '11.1', 'ciLowerLimit': '8.11', 'ciUpperLimit': '14.1', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was established if the lower bound of the confidence interval for day 50 vaccine group difference was \\> -10%'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 50', 'description': 'The non-inferiority of HI antibody responses of aTIV compared to TIV and comparator TIV assessed in terms of percentage of subjects achieving seroconversion or ≥4-fold increase in HI titers at three weeks after last vaccination against the three homologous vaccine strains.\n\nSeroconversion defined as prevaccination HI titer \\<10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10.', 'unitOfMeasure': 'Percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on the PPS.'}, {'type': 'PRIMARY', 'title': 'Comparison of Antibody Responses of TIV Versus Comparator TIV in Terms of Geometric Mean Titers (GMTs) Against Homologous Strains (6 to <36 Months)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '642', 'groupId': 'OG000'}, {'value': '635', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TIV (6 to <36months)', 'description': 'Subjects received two doses of 0.25 mL each, of investigational trivalent split influenza vaccine (TIV), at Days 1 \\& 29'}, {'id': 'OG001', 'title': 'Comparator TIV (6 to <36months)', 'description': 'Subjects received two doses of 0.25 mL each, of the licensed trivalent split influenza vaccine (comparator TIV), at Days 1 \\& 29'}], 'classes': [{'title': 'H1N1 - Day 1', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000', 'lowerLimit': '20', 'upperLimit': '27'}, {'value': '20', 'groupId': 'OG001', 'lowerLimit': '17', 'upperLimit': '23'}]}]}, {'title': 'H1N1 - Day 50', 'categories': [{'measurements': [{'value': '370', 'groupId': 'OG000', 'lowerLimit': '328', 'upperLimit': '419'}, {'value': '487', 'groupId': 'OG001', 'lowerLimit': '431', 'upperLimit': '551'}]}]}, {'title': 'H3N2 - Day 1', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000', 'lowerLimit': '24', 'upperLimit': '33'}, {'value': '28', 'groupId': 'OG001', 'lowerLimit': '24', 'upperLimit': '33'}]}]}, {'title': 'H3N2 - Day 50', 'categories': [{'measurements': [{'value': '698', 'groupId': 'OG000', 'lowerLimit': '650', 'upperLimit': '749'}, {'value': '912', 'groupId': 'OG001', 'lowerLimit': '849', 'upperLimit': '980'}]}]}, {'title': 'B strain Day 1', 'categories': [{'measurements': [{'value': '9.42', 'groupId': 'OG000', 'lowerLimit': '8.63', 'upperLimit': '10'}, {'value': '9.42', 'groupId': 'OG001', 'lowerLimit': '8.62', 'upperLimit': '10'}]}]}, {'title': 'B -strain Day 50', 'categories': [{'measurements': [{'value': '144', 'groupId': 'OG000', 'lowerLimit': '130', 'upperLimit': '159'}, {'value': '152', 'groupId': 'OG001', 'lowerLimit': '138', 'upperLimit': '168'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Group ratio (H1N1 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.4', 'paramValue': '0.76', 'ciLowerLimit': '0.62', 'ciUpperLimit': '0.93', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was established if the lower bound of the confidence interval for day 50 GMT group ratios was \\>0.667'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT ratio (H3N2 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.4', 'paramValue': '0.77', 'ciLowerLimit': '0.68', 'ciUpperLimit': '0.86', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was established if the lower bound of the confidence interval for day 50 GMT group ratios was \\>0.667'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT ratio (B strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.4', 'paramValue': '0.94', 'ciLowerLimit': '0.8', 'ciUpperLimit': '1.11', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was established if the lower bound of the confidence interval for day 50 GMT group ratios was \\>0.667'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1, Day 50', 'description': 'The non-inferiority of HI antibody responses of TIV to that of comparator TIV, in subjects aged 6 to \\<36 Months, assessed in terms of post vaccination GMTs at three weeks after last vaccination against the three homologous vaccine strains.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on the PPS.'}, {'type': 'PRIMARY', 'title': 'Comparison of Antibody Responses of TIV Versus Comparator TIV in Terms of Percentage of Subjects Achieving Seroconversion or ≥4-fold Increase in HI Titer Against Homologous Strains in Subjects 6 to <36 Months of Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '642', 'groupId': 'OG000'}, {'value': '635', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TIV (6 to <36months)', 'description': 'Subjects received two doses of 0.25 mL each, of investigational trivalent split influenza vaccine (TIV), at Days 1 \\& 29'}, {'id': 'OG001', 'title': 'Comparator TIV (6 to <36months)', 'description': 'Subjects received two doses of 0.25 mL each, of the licensed trivalent split influenza vaccine (comparator TIV), at Days 1 \\& 29'}], 'classes': [{'title': 'H1N1', 'categories': [{'measurements': [{'value': '78.8', 'groupId': 'OG000', 'lowerLimit': '75.5', 'upperLimit': '81.9'}, {'value': '84.1', 'groupId': 'OG001', 'lowerLimit': '81', 'upperLimit': '86.9'}]}]}, {'title': 'H3N2', 'categories': [{'measurements': [{'value': '89.9', 'groupId': 'OG000', 'lowerLimit': '87.3', 'upperLimit': '92.1'}, {'value': '92.6', 'groupId': 'OG001', 'lowerLimit': '90.3', 'upperLimit': '94.5'}]}]}, {'title': 'B strain', 'categories': [{'measurements': [{'value': '82.7', 'groupId': 'OG000', 'lowerLimit': '79.6', 'upperLimit': '85.6'}, {'value': '85.5', 'groupId': 'OG001', 'lowerLimit': '82.5', 'upperLimit': '88.2'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Group difference (H1N1 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.4', 'paramValue': '-5.3', 'ciLowerLimit': '-10.13', 'ciUpperLimit': '-0.47', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was established if the lower bound of the confidence interval for day 50 vaccine group differences was \\> -10%'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Group difference (H3N2 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.4', 'paramValue': '-2.84', 'ciLowerLimit': '-6.16', 'ciUpperLimit': '0.5', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was established if the lower bound of the confidence interval for day 50 vaccine group differences was \\> -10%'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Group difference (B strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.4', 'paramValue': '-2.49', 'ciLowerLimit': '-7.01', 'ciUpperLimit': '2', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was established if the lower bound of the confidence interval for day 50 vaccine group differences was \\> -10%'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 50', 'description': 'The non-inferiority of HI antibody responses of TIV to that of the licensed comparator TIV assessed in terms of percentage of subjects achieving seroconversion or ≥4-fold increase in HI titers at three weeks after last vaccination against the three homologous vaccine strains.', 'unitOfMeasure': 'Percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects aged 6 through \\<36 months of age - Per Protocol Set (PPS).'}, {'type': 'SECONDARY', 'title': 'Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains (6 to <24 Months)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '266', 'groupId': 'OG000'}, {'value': '389', 'groupId': 'OG001'}, {'value': '387', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'aTIV (6 to <24 Months)', 'description': 'Subjects received two doses of 0.25 mL each, of the investigational MF59-adjuvanted trivalent split influenza vaccine (aTIV), at Days 1 \\& 29'}, {'id': 'OG001', 'title': 'Comparator TIV (6 to <24 Months)', 'description': 'Subjects received two doses of 0.25 mL each, of the licensed comparator trivalent split influenza vaccine (comparator TIV), at Days 1 \\& 29'}, {'id': 'OG002', 'title': 'TIV (6 to <24 Months)', 'description': 'Subjects received two doses of 0.25 mL each, of the investigational trivalent split influenza vaccine (TIV), at Days 1 \\& 29'}], 'classes': [{'title': 'H1N1 - Day 1', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000', 'lowerLimit': '9.52', 'upperLimit': '14'}, {'value': '9.87', 'groupId': 'OG001', 'lowerLimit': '8.36', 'upperLimit': '12'}, {'value': '12', 'groupId': 'OG002', 'lowerLimit': '9.95', 'upperLimit': '14'}]}]}, {'title': 'H1N1 - Day 50', 'categories': [{'measurements': [{'value': '1080', 'groupId': 'OG000', 'lowerLimit': '899', 'upperLimit': '1297'}, {'value': '298', 'groupId': 'OG001', 'lowerLimit': '256', 'upperLimit': '347'}, {'value': '205', 'groupId': 'OG002', 'lowerLimit': '176', 'upperLimit': '238'}]}]}, {'title': 'H3N2 - Day 1', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000', 'lowerLimit': '12', 'upperLimit': '19'}, {'value': '15', 'groupId': 'OG001', 'lowerLimit': '12', 'upperLimit': '18'}, {'value': '17', 'groupId': 'OG002', 'lowerLimit': '14', 'upperLimit': '21'}]}]}, {'title': 'H3N2 - Day 50', 'categories': [{'measurements': [{'value': '1709', 'groupId': 'OG000', 'lowerLimit': '1536', 'upperLimit': '1903'}, {'value': '758', 'groupId': 'OG001', 'lowerLimit': '694', 'upperLimit': '828'}, {'value': '552', 'groupId': 'OG002', 'lowerLimit': '505', 'upperLimit': '603'}]}]}, {'title': 'B strain Day 1', 'categories': [{'measurements': [{'value': '7.75', 'groupId': 'OG000', 'lowerLimit': '6.83', 'upperLimit': '8.78'}, {'value': '8.18', 'groupId': 'OG001', 'lowerLimit': '7.37', 'upperLimit': '9.07'}, {'value': '7.92', 'groupId': 'OG002', 'lowerLimit': '7.14', 'upperLimit': '8.79'}]}]}, {'title': 'B strain Day 50', 'categories': [{'measurements': [{'value': '616', 'groupId': 'OG000', 'lowerLimit': '534', 'upperLimit': '711'}, {'value': '133', 'groupId': 'OG001', 'lowerLimit': '118', 'upperLimit': '149'}, {'value': '112', 'groupId': 'OG002', 'lowerLimit': '100', 'upperLimit': '127'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT ratio (H1N1 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.63', 'ciLowerLimit': '2.86', 'ciUpperLimit': '4.6', 'groupDescription': 'Superiority was concluded if the lower limit of the confidence interval for the day 50 vaccine group GMT ratios for at least 2 homologous strains was \\>1.5.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT ratio (H3N2 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.25', 'ciLowerLimit': '1.96', 'ciUpperLimit': '2.59', 'groupDescription': 'superiority was concluded if the lower limit of the confidence interval of the day 50 vaccine group GMT ratios for at least 2 homologous strains was \\>1.5', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT ratio (B strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.64', 'ciLowerLimit': '3.86', 'ciUpperLimit': '5.59', 'groupDescription': 'superiority was concluded if the lower limit of the confidence interval of the day 50 vaccine group GMT ratios for at least 2 homologous strains was \\>1.5', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'GMT ratio (H1N1 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.28', 'ciLowerLimit': '4.16', 'ciUpperLimit': '6.7', 'groupDescription': 'superiority was concluded if the lower limit of the confidence interval of the day 50 vaccine group GMT ratios for at least 2 homologous strains was \\>1.5', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'GMT ratio (H3N2 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.1', 'ciLowerLimit': '2.69', 'ciUpperLimit': '3.56', 'groupDescription': 'superiority was concluded if the lower limit of the confidence interval of the day 50 vaccine group GMT ratios for at least 2 homologous strains was \\>1.5', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'GMT ratio (B strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.64', 'ciLowerLimit': '3.86', 'ciUpperLimit': '5.59', 'groupDescription': 'superiority was concluded if the lower limit of the confidence interval of the day 50 vaccine group GMT ratios for at least 2 homologous strains was \\>1.5', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1, Day 50', 'description': 'The superiority of HI antibody responses, in subjects 6 to \\<24 months of age, of aTIV compared to TIV and comparator TIV assessed in terms of post vaccination GMTs at three weeks after last vaccination against the three homologous vaccine strains.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on the Full Analysis Set (FAS) i.e all enrolled subjects who received study vaccination and provided serum samples.'}, {'type': 'SECONDARY', 'title': 'Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms Percentage of Subjects Achieving Seroconversion or ≥4-fold Increase in HI Titer Against Homologous Strains (6 to <24 Months)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '266', 'groupId': 'OG000'}, {'value': '389', 'groupId': 'OG001'}, {'value': '387', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'aTIV (6 to <24 Months)', 'description': 'Subjects received two doses of 0.25 mL each, of the investigational MF59-adjuvanted trivalent split influenza vaccine (aTIV), at Days 1 \\& 29'}, {'id': 'OG001', 'title': 'Comparator TIV (6 to <24 Months)', 'description': 'Subjects received two doses of 0.25 mL each, of the licensed comparator trivalent split influenza vaccine (comparator TIV), at Days 1 \\& 29'}, {'id': 'OG002', 'title': 'TIV (6 to <24 Months)', 'description': 'Subjects received two doses of 0.25 mL each, of the investigational trivalent split influenza vaccine (TIV), at Days 1 \\& 29'}], 'classes': [{'title': 'H1N1', 'categories': [{'measurements': [{'value': '95.5', 'groupId': 'OG000', 'lowerLimit': '92.3', 'upperLimit': '97.7'}, {'value': '85.1', 'groupId': 'OG001', 'lowerLimit': '81.2', 'upperLimit': '88.5'}, {'value': '77.8', 'groupId': 'OG002', 'lowerLimit': '73.3', 'upperLimit': '81.8'}]}]}, {'title': 'H3N2', 'categories': [{'measurements': [{'value': '98.1', 'groupId': 'OG000', 'lowerLimit': '95.7', 'upperLimit': '99.4'}, {'value': '95.6', 'groupId': 'OG001', 'lowerLimit': '93.1', 'upperLimit': '97.4'}, {'value': '92.5', 'groupId': 'OG002', 'lowerLimit': '89.4', 'upperLimit': '94.9'}]}]}, {'title': 'B strain', 'categories': [{'measurements': [{'value': '98.1', 'groupId': 'OG000', 'lowerLimit': '95.7', 'upperLimit': '99.4'}, {'value': '85.4', 'groupId': 'OG001', 'lowerLimit': '81.4', 'upperLimit': '88.7'}, {'value': '79.3', 'groupId': 'OG002', 'lowerLimit': '75', 'upperLimit': '83.3'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Group difference (H1N1 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.4', 'ciLowerLimit': '6.1', 'ciUpperLimit': '14.7', 'groupDescription': 'superiority was concluded if the lower limit of the confidence interval of day 50 vaccine group difference,for at least 2 homologous strains, was \\>10%', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Group difference (H3N2 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.5', 'ciLowerLimit': '-0.12', 'ciUpperLimit': '5.1', 'groupDescription': 'superiority was concluded if the lower limit of the confidence interval of day 50 vaccine group difference,for at least 2 homologous strains, was \\>10%', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Group difference (B strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.8', 'ciLowerLimit': '8.9', 'ciUpperLimit': '16.7', 'groupDescription': 'superiority was concluded if the lower limit of the confidence interval of day 50 vaccine group difference,for at least 2 homologous strains, was \\>10%', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Group difference (H1N1 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '17.7', 'ciLowerLimit': '12.9', 'ciUpperLimit': '22.6', 'groupDescription': 'superiority was concluded if the lower limit of the confidence interval of day 50 vaccine group difference,for at least 2 homologous strains, was \\>10%', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Group difference (H3N2 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.6', 'ciLowerLimit': '2.5', 'ciUpperLimit': '8.7', 'groupDescription': 'superiority was concluded if the lower limit of the confidence interval of day 50 vaccine group difference,for at least 2 homologous strains, was \\>10%', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Group difference (B strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '18.8', 'ciLowerLimit': '14.4', 'ciUpperLimit': '23.1', 'groupDescription': 'superiority was concluded if the lower limit of the confidence interval of day 50 vaccine group difference,for at least 2 homologous strains, was \\>10%', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Day 50', 'description': 'The superiority of HI antibody responses, in subjects 6 to \\<24 months of age, of aTIV compared to TIV and comparator TIV assessed in terms of number of subjects achieving seroconversion at three weeks after last vaccination against the three homologous vaccine strains.', 'unitOfMeasure': 'Percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on the FAS'}, {'type': 'SECONDARY', 'title': 'Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains (6 to <72 Months)-FAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '747', 'groupId': 'OG000'}, {'value': '839', 'groupId': 'OG001'}, {'value': '849', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'aTIV (6 to <72 Months)', 'description': 'Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to \\<36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 \\& 29'}, {'id': 'OG001', 'title': 'Comparator TIV (6 to <72 Months)', 'description': 'Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to \\<36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 \\& 29'}, {'id': 'OG002', 'title': 'TIV (6 to <72 Months)', 'description': 'Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to \\<36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 \\& 29'}], 'classes': [{'title': 'H1N1 - Day 1 (N=746,839,849)', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000', 'lowerLimit': '25', 'upperLimit': '33'}, {'value': '24', 'groupId': 'OG001', 'lowerLimit': '21', 'upperLimit': '28'}, {'value': '27', 'groupId': 'OG002', 'lowerLimit': '23', 'upperLimit': '31'}]}]}, {'title': 'H1N1 - Day 50 (N=746,839,849)', 'categories': [{'measurements': [{'value': '1519', 'groupId': 'OG000', 'lowerLimit': '1372', 'upperLimit': '1683'}, {'value': '637', 'groupId': 'OG001', 'lowerLimit': '577', 'upperLimit': '704'}, {'value': '473', 'groupId': 'OG002', 'lowerLimit': '428', 'upperLimit': '522'}]}]}, {'title': 'H3N2 - Day 1', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000', 'lowerLimit': '36', 'upperLimit': '48'}, {'value': '42', 'groupId': 'OG001', 'lowerLimit': '37', 'upperLimit': '49'}, {'value': '44', 'groupId': 'OG002', 'lowerLimit': '38', 'upperLimit': '50'}]}]}, {'title': 'H3N2 - Day 50', 'categories': [{'measurements': [{'value': '1909', 'groupId': 'OG000', 'lowerLimit': '1791', 'upperLimit': '2035'}, {'value': '1016', 'groupId': 'OG001', 'lowerLimit': '954', 'upperLimit': '1081'}, {'value': '796', 'groupId': 'OG002', 'lowerLimit': '748', 'upperLimit': '847'}]}]}, {'title': 'B strain - Day 1', 'categories': [{'measurements': [{'value': '9.97', 'groupId': 'OG000', 'lowerLimit': '9.2', 'upperLimit': '11'}, {'value': '10', 'groupId': 'OG001', 'lowerLimit': '9.49', 'upperLimit': '11'}, {'value': '10', 'groupId': 'OG002', 'lowerLimit': '9.33', 'upperLimit': '11'}]}]}, {'title': 'B strain-Day 50', 'categories': [{'measurements': [{'value': '480', 'groupId': 'OG000', 'lowerLimit': '441', 'upperLimit': '523'}, {'value': '164', 'groupId': 'OG001', 'lowerLimit': '151', 'upperLimit': '178'}, {'value': '156', 'groupId': 'OG002', 'lowerLimit': '144', 'upperLimit': '169'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio (H1N1 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.38', 'ciLowerLimit': '2.07', 'ciUpperLimit': '2.75', 'groupDescription': 'superiority was concluded if the lower limit of the confidence interval of the day 50 vaccine group GMT ratios for at least 2 homologous strains was \\>1.5', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio (H3N2 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.88', 'ciLowerLimit': '1.72', 'ciUpperLimit': '2.06', 'groupDescription': 'superiority was concluded if the lower limit of the confidence interval of the day 50 vaccine group GMT ratios for at least 2 homologous strains was \\>1.5', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio (B strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.93', 'ciLowerLimit': '2.6', 'ciUpperLimit': '3.3', 'groupDescription': 'superiority was concluded if the lower limit of the confidence interval of the day 50 vaccine group GMT ratios for at least 2 homologous strains was \\>1.5', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'GMT Ratio (H1N1 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.21', 'ciLowerLimit': '2.79', 'ciUpperLimit': '3.71', 'groupDescription': 'superiority was concluded if the lower limit of the confidence interval of the day 50 vaccine group GMT ratios for at least 2 homologous strains was \\>1.5', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'GMT Ratio (H3N2 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.4', 'ciLowerLimit': '2.19', 'ciUpperLimit': '2.62', 'groupDescription': 'superiority was concluded if the lower limit of the confidence interval of the day 50 vaccine group GMT ratios for at least 2 homologous strains was \\>1.5', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'GMT Ratio (B strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.08', 'ciLowerLimit': '2.73', 'ciUpperLimit': '3.47', 'groupDescription': 'superiority was concluded if the lower limit of the confidence interval of the day 50 vaccine group GMT ratios for at least 2 homologous strains was \\>1.5', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1, Day 50', 'description': 'The superiority of HI antibody responses, in subjects 6 to \\<72 months of age, of aTIV compared to TIV and comparator TIV assessed in terms of post vaccination GMTs at three weeks after last vaccination against the three homologous vaccine strains.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on the FAS'}, {'type': 'SECONDARY', 'title': 'Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of Percentage of Subjects Achieving Seroconversion or ≥4 Fold Increase in HI Titers Against Homologous Strains (6 to <72 Months)-FAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '747', 'groupId': 'OG000'}, {'value': '839', 'groupId': 'OG001'}, {'value': '849', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'aTIV (6 to <72 Months)', 'description': 'Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to \\<36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 \\& 29'}, {'id': 'OG001', 'title': 'Comparator TIV (6 to <72 Months)', 'description': 'Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to \\<36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 \\& 29'}, {'id': 'OG002', 'title': 'TIV (6 to <72 Months)', 'description': 'Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to \\<36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 \\& 29'}], 'classes': [{'title': 'H1N1', 'categories': [{'measurements': [{'value': '92.8', 'groupId': 'OG000', 'lowerLimit': '90.7', 'upperLimit': '94.5'}, {'value': '83.7', 'groupId': 'OG001', 'lowerLimit': '81', 'upperLimit': '86.1'}, {'value': '78.8', 'groupId': 'OG002', 'lowerLimit': '75.9', 'upperLimit': '81.5'}]}]}, {'title': 'H3N2', 'categories': [{'measurements': [{'value': '96.4', 'groupId': 'OG000', 'lowerLimit': '94.8', 'upperLimit': '97.6'}, {'value': '92.3', 'groupId': 'OG001', 'lowerLimit': '90.2', 'upperLimit': '94'}, {'value': '89.8', 'groupId': 'OG002', 'lowerLimit': '87.5', 'upperLimit': '91.7'}]}]}, {'title': 'B strain', 'categories': [{'measurements': [{'value': '97.5', 'groupId': 'OG000', 'lowerLimit': '96.1', 'upperLimit': '98.5'}, {'value': '86.4', 'groupId': 'OG001', 'lowerLimit': '83.9', 'upperLimit': '88.7'}, {'value': '84.5', 'groupId': 'OG002', 'lowerLimit': '81.8', 'upperLimit': '86.8'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Group difference (H1N1 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.3', 'ciLowerLimit': '6.3', 'ciUpperLimit': '12.4', 'groupDescription': 'superiority was concluded if the lower limit of the confidence interval of day 50 vaccine group difference,for at least 2 homologous strains, was \\>10%', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Group difference (H3N2 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.9', 'ciLowerLimit': '1.8', 'ciUpperLimit': '5.9', 'groupDescription': 'superiority was concluded if the lower limit of the confidence interval of day 50 vaccine group difference,for at least 2 homologous strains, was \\>10%', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Group difference (B strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.7', 'ciLowerLimit': '8.1', 'ciUpperLimit': '13.3', 'groupDescription': 'superiority was concluded if the lower limit of the confidence interval of day 50 vaccine group difference,for at least 2 homologous strains, was \\>10%', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Group difference (H1N1 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '14.4', 'ciLowerLimit': '11.1', 'ciUpperLimit': '17.7', 'groupDescription': 'superiority was concluded if the lower limit of the confidence interval of day 50 vaccine group difference,for at least 2 homologous strains, was \\>10%', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Group difference (H3N2 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.8', 'ciLowerLimit': '4.5', 'ciUpperLimit': '9.1', 'groupDescription': 'superiority was concluded if the lower bound of 95% CI of day 50 vaccine group difference,for at least 2 homologous strains, was \\>10%', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Group difference (B strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.9', 'ciLowerLimit': '8.3', 'ciUpperLimit': '13.4', 'groupDescription': 'superiority was concluded if the lower limit of the confidence interval of day 50 vaccine group difference,for at least 2 homologous strains, was \\>10%', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Day 50', 'description': 'The superiority of HI antibody responses, in subjects 6 to \\<24 months of age, of aTIV compared to TIV and comparator TIV assessed in terms of number of subjects achieving seroconversion ≥4 fold increase in HI titers at three weeks after last vaccination against the three homologous vaccine strains.', 'unitOfMeasure': 'Percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on the FAS'}, {'type': 'SECONDARY', 'title': 'The HI GMTs Against Homologous Strains, by Vaccine Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '715', 'groupId': 'OG000'}, {'value': '822', 'groupId': 'OG001'}, {'value': '820', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'aTIV (6 to <72 Months)', 'description': 'Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to \\<36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 \\& 29'}, {'id': 'OG001', 'title': 'Comparator TIV (6 to <72 Months)', 'description': 'Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to \\<36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 \\& 29'}, {'id': 'OG002', 'title': 'TIV (6 to <72 Months)', 'description': 'Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to \\<36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 \\& 29'}], 'classes': [{'title': 'H1N1 - Day 1 (N=714,822,820)', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000', 'lowerLimit': '24', 'upperLimit': '32'}, {'value': '24', 'groupId': 'OG001', 'lowerLimit': '20', 'upperLimit': '27'}, {'value': '27', 'groupId': 'OG002', 'lowerLimit': '23', 'upperLimit': '31'}]}]}, {'title': 'H1N1 - Day 29', 'categories': [{'measurements': [{'value': '647', 'groupId': 'OG000', 'lowerLimit': '562', 'upperLimit': '745'}, {'value': '159', 'groupId': 'OG001', 'lowerLimit': '139', 'upperLimit': '182'}, {'value': '170', 'groupId': 'OG002', 'lowerLimit': '148', 'upperLimit': '194'}]}]}, {'title': 'H1N1 - Day 50 (N=714,822,820)', 'categories': [{'measurements': [{'value': '1507', 'groupId': 'OG000', 'lowerLimit': '1358', 'upperLimit': '1673'}, {'value': '635', 'groupId': 'OG001', 'lowerLimit': '575', 'upperLimit': '702'}, {'value': '475', 'groupId': 'OG002', 'lowerLimit': '429', 'upperLimit': '525'}]}]}, {'title': 'H1N1 - Day 209 (N=715,822,819)', 'categories': [{'measurements': [{'value': '276', 'groupId': 'OG000', 'lowerLimit': '246', 'upperLimit': '311'}, {'value': '97', 'groupId': 'OG001', 'lowerLimit': '87', 'upperLimit': '109'}, {'value': '107', 'groupId': 'OG002', 'lowerLimit': '96', 'upperLimit': '120'}]}]}, {'title': 'H3N2 - Day 1', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000', 'lowerLimit': '36', 'upperLimit': '48'}, {'value': '43', 'groupId': 'OG001', 'lowerLimit': '37', 'upperLimit': '49'}, {'value': '43', 'groupId': 'OG002', 'lowerLimit': '38', 'upperLimit': '50'}]}]}, {'title': 'H3N2 - Day 29', 'categories': [{'measurements': [{'value': '1087', 'groupId': 'OG000', 'lowerLimit': '1004', 'upperLimit': '1176'}, {'value': '558', 'groupId': 'OG001', 'lowerLimit': '517', 'upperLimit': '602'}, {'value': '453', 'groupId': 'OG002', 'lowerLimit': '420', 'upperLimit': '490'}]}]}, {'title': 'H3N2 - Day 50', 'categories': [{'measurements': [{'value': '1920', 'groupId': 'OG000', 'lowerLimit': '1799', 'upperLimit': '2050'}, {'value': '1013', 'groupId': 'OG001', 'lowerLimit': '952', 'upperLimit': '1079'}, {'value': '810', 'groupId': 'OG002', 'lowerLimit': '760', 'upperLimit': '862'}]}]}, {'title': 'H3N2 - Day 209', 'categories': [{'measurements': [{'value': '462', 'groupId': 'OG000', 'lowerLimit': '423', 'upperLimit': '505'}, {'value': '277', 'groupId': 'OG001', 'lowerLimit': '254', 'upperLimit': '301'}, {'value': '242', 'groupId': 'OG002', 'lowerLimit': '222', 'upperLimit': '263'}]}]}, {'title': 'B - Day 1', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000', 'lowerLimit': '9.29', 'upperLimit': '11'}, {'value': '10', 'groupId': 'OG001', 'lowerLimit': '9.57', 'upperLimit': '11'}, {'value': '10', 'groupId': 'OG002', 'lowerLimit': '9.34', 'upperLimit': '11'}]}]}, {'title': 'B - Day 29', 'categories': [{'measurements': [{'value': '119', 'groupId': 'OG000', 'lowerLimit': '106', 'upperLimit': '134'}, {'value': '58', 'groupId': 'OG001', 'lowerLimit': '52', 'upperLimit': '65'}, {'value': '61', 'groupId': 'OG002', 'lowerLimit': '54', 'upperLimit': '68'}]}]}, {'title': 'B - Day 50', 'categories': [{'measurements': [{'value': '488', 'groupId': 'OG000', 'lowerLimit': '447', 'upperLimit': '532'}, {'value': '166', 'groupId': 'OG001', 'lowerLimit': '153', 'upperLimit': '180'}, {'value': '159', 'groupId': 'OG002', 'lowerLimit': '146', 'upperLimit': '173'}]}]}, {'title': 'B- Day 209', 'categories': [{'measurements': [{'value': '125', 'groupId': 'OG000', 'lowerLimit': '114', 'upperLimit': '136'}, {'value': '57', 'groupId': 'OG001', 'lowerLimit': '53', 'upperLimit': '62'}, {'value': '61', 'groupId': 'OG002', 'lowerLimit': '56', 'upperLimit': '66'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1, Day 29, Day 50, Day 209', 'description': 'The HI antibody titers against the three homologous strains following vaccination with either aTIV, licensed comparator or TIV, at three weeks and at six months after vaccination are reported as GMTs.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on FAS (Persistence) i.e. all subjects in the enrolled population who actually received a study vaccination, and provided evaluable serum samples at all relevant timepoints and also at day 209.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination HI Titers Against Homologous Strains', 'denoms': [{'units': 'Participants', 'counts': [{'value': '715', 'groupId': 'OG000'}, {'value': '822', 'groupId': 'OG001'}, {'value': '820', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'aTIV (6 to <72 Months)', 'description': 'Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to \\<36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 \\& 29'}, {'id': 'OG001', 'title': 'Comparator TIV (6 to <72 Months)', 'description': 'Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to \\<36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 \\& 29'}, {'id': 'OG002', 'title': 'TIV (6 to <72 Months)', 'description': 'Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to \\<36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 \\& 29'}], 'classes': [{'title': 'H1N1, Day 29:Day 1 (N=714,822,820)', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000', 'lowerLimit': '23', 'upperLimit': '31'}, {'value': '6.81', 'groupId': 'OG001', 'lowerLimit': '5.94', 'upperLimit': '7.81'}, {'value': '7.13', 'groupId': 'OG002', 'lowerLimit': '6.22', 'upperLimit': '8.18'}]}]}, {'title': 'H1N1, Day 50:Day 1 (N=713,822,820)', 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000', 'lowerLimit': '51', 'upperLimit': '67'}, {'value': '27', 'groupId': 'OG001', 'lowerLimit': '24', 'upperLimit': '31'}, {'value': '19', 'groupId': 'OG002', 'lowerLimit': '17', 'upperLimit': '21'}]}]}, {'title': 'H1N1, Day 209:Day 1 (N=714,822,819)', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000', 'lowerLimit': '9.79', 'upperLimit': '13'}, {'value': '4.15', 'groupId': 'OG001', 'lowerLimit': '3.68', 'upperLimit': '4.69'}, {'value': '4.37', 'groupId': 'OG002', 'lowerLimit': '3.87', 'upperLimit': '4.94'}]}]}, {'title': 'H3N2, Day 29:Day 1', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000', 'lowerLimit': '26', 'upperLimit': '32'}, {'value': '15', 'groupId': 'OG001', 'lowerLimit': '14', 'upperLimit': '16'}, {'value': '12', 'groupId': 'OG002', 'lowerLimit': '11', 'upperLimit': '13'}]}]}, {'title': 'H3N2, Day 50:Day 1 (N=715,822,820)', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000', 'lowerLimit': '43', 'upperLimit': '54'}, {'value': '25', 'groupId': 'OG001', 'lowerLimit': '23', 'upperLimit': '28'}, {'value': '20', 'groupId': 'OG002', 'lowerLimit': '18', 'upperLimit': '22'}]}]}, {'title': 'H3N2, Day 209:Day 1', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000', 'lowerLimit': '10', 'upperLimit': '13'}, {'value': '6.93', 'groupId': 'OG001', 'lowerLimit': '6.14', 'upperLimit': '7.83'}, {'value': '6.02', 'groupId': 'OG002', 'lowerLimit': '5.33', 'upperLimit': '6.81'}]}]}, {'title': 'B strain, Day 29:Day 1', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000', 'lowerLimit': '11', 'upperLimit': '14'}, {'value': '6.18', 'groupId': 'OG001', 'lowerLimit': '5.49', 'upperLimit': '6.95'}, {'value': '6.38', 'groupId': 'OG002', 'lowerLimit': '5.66', 'upperLimit': '7.18'}]}]}, {'title': 'B strain, Day 50:Day 1', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000', 'lowerLimit': '45', 'upperLimit': '54'}, {'value': '17', 'groupId': 'OG001', 'lowerLimit': '15', 'upperLimit': '18'}, {'value': '16', 'groupId': 'OG002', 'lowerLimit': '15', 'upperLimit': '18'}]}]}, {'title': 'B strain, Day 209:Day 1', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000', 'lowerLimit': '12', 'upperLimit': '14'}, {'value': '5.76', 'groupId': 'OG001', 'lowerLimit': '5.26', 'upperLimit': '6.3'}, {'value': '6.15', 'groupId': 'OG002', 'lowerLimit': '5.62', 'upperLimit': '6.73'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 29, Day 50, Day 209', 'description': 'The GMR of post-vaccination versus pre-vaccination HI titers against homologous strains, three weeks (day 29/day 1; day 50/day 1)and six months (day 209/day 1) after vaccination with either aTIV, licensed comparator or TIV.', 'unitOfMeasure': 'Ratios', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on FAS (Persistence)'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects With HI Titers ≥40 Against Homologous Strains, by Vaccine Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '715', 'groupId': 'OG000'}, {'value': '822', 'groupId': 'OG001'}, {'value': '820', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'aTIV (6 to <72 Months)', 'description': 'Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to \\<36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 \\& 29'}, {'id': 'OG001', 'title': 'Comparator TIV (6 to <72 Months)', 'description': 'Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to \\<36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 \\& 29'}, {'id': 'OG002', 'title': 'TIV (6 to <72 Months)', 'description': 'Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to \\<36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 \\& 29'}], 'classes': [{'title': 'H1N1, Day 1 (N=714,822,820)', 'categories': [{'measurements': [{'value': '40.6', 'groupId': 'OG000', 'lowerLimit': '37', 'upperLimit': '44.3'}, {'value': '33.1', 'groupId': 'OG001', 'lowerLimit': '29.9', 'upperLimit': '36.4'}, {'value': '36.3', 'groupId': 'OG002', 'lowerLimit': '33', 'upperLimit': '39.7'}]}]}, {'title': 'H1N1, Day 29', 'categories': [{'measurements': [{'value': '89.8', 'groupId': 'OG000', 'lowerLimit': '87.3', 'upperLimit': '91.9'}, {'value': '55', 'groupId': 'OG001', 'lowerLimit': '51.5', 'upperLimit': '58.4'}, {'value': '57.9', 'groupId': 'OG002', 'lowerLimit': '54.5', 'upperLimit': '61.3'}]}]}, {'title': 'H1N1, Day 50 (N=714,822,820)', 'categories': [{'measurements': [{'value': '99.3', 'groupId': 'OG000', 'lowerLimit': '98.4', 'upperLimit': '99.8'}, {'value': '91.1', 'groupId': 'OG001', 'lowerLimit': '89', 'upperLimit': '93'}, {'value': '88.2', 'groupId': 'OG002', 'lowerLimit': '85.8', 'upperLimit': '90.3'}]}]}, {'title': 'H1N1, Day 209 (N=715, 822,819)', 'categories': [{'measurements': [{'value': '88.8', 'groupId': 'OG000', 'lowerLimit': '86.3', 'upperLimit': '91'}, {'value': '59.5', 'groupId': 'OG001', 'lowerLimit': '56', 'upperLimit': '62.9'}, {'value': '63.2', 'groupId': 'OG002', 'lowerLimit': '59.8', 'upperLimit': '66.6'}]}]}, {'title': 'H3N2, Day 1', 'categories': [{'measurements': [{'value': '52.6', 'groupId': 'OG000', 'lowerLimit': '48.9', 'upperLimit': '56.3'}, {'value': '45.5', 'groupId': 'OG001', 'lowerLimit': '42.1', 'upperLimit': '49'}, {'value': '44.6', 'groupId': 'OG002', 'lowerLimit': '41.2', 'upperLimit': '48.1'}]}]}, {'title': 'H3N2, Day 29', 'categories': [{'measurements': [{'value': '98.9', 'groupId': 'OG000', 'lowerLimit': '97.8', 'upperLimit': '99.5'}, {'value': '95.9', 'groupId': 'OG001', 'lowerLimit': '94.3', 'upperLimit': '97.1'}, {'value': '93.5', 'groupId': 'OG002', 'lowerLimit': '91.6', 'upperLimit': '95.1'}]}]}, {'title': 'H3N2, Day 50', 'categories': [{'measurements': [{'value': '99.7', 'groupId': 'OG000', 'lowerLimit': '99', 'upperLimit': '100'}, {'value': '99.5', 'groupId': 'OG001', 'lowerLimit': '98.8', 'upperLimit': '99.9'}, {'value': '99.4', 'groupId': 'OG002', 'lowerLimit': '98.6', 'upperLimit': '99.8'}]}]}, {'title': 'H3N2, Day 209', 'categories': [{'measurements': [{'value': '99.3', 'groupId': 'OG000', 'lowerLimit': '98.4', 'upperLimit': '99.8'}, {'value': '94.3', 'groupId': 'OG001', 'lowerLimit': '92.5', 'upperLimit': '95.8'}, {'value': '88.4', 'groupId': 'OG002', 'lowerLimit': '86', 'upperLimit': '90.5'}]}]}, {'title': 'B strain, Day 1', 'categories': [{'measurements': [{'value': '22.1', 'groupId': 'OG000', 'lowerLimit': '19.1', 'upperLimit': '25.3'}, {'value': '21.1', 'groupId': 'OG001', 'lowerLimit': '18.3', 'upperLimit': '24'}, {'value': '20.5', 'groupId': 'OG002', 'lowerLimit': '17.8', 'upperLimit': '23.4'}]}]}, {'title': 'B strain, Day 29', 'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000', 'lowerLimit': '65.4', 'upperLimit': '72.3'}, {'value': '48.2', 'groupId': 'OG001', 'lowerLimit': '44.7', 'upperLimit': '51.7'}, {'value': '45.6', 'groupId': 'OG002', 'lowerLimit': '42.2', 'upperLimit': '49.1'}]}]}, {'title': 'B strain, Day 50', 'categories': [{'measurements': [{'value': '98.9', 'groupId': 'OG000', 'lowerLimit': '97.8', 'upperLimit': '99.5'}, {'value': '89.1', 'groupId': 'OG001', 'lowerLimit': '86.7', 'upperLimit': '91.1'}, {'value': '87', 'groupId': 'OG002', 'lowerLimit': '84.5', 'upperLimit': '89.2'}]}]}, {'title': 'B strain, Day 209', 'categories': [{'measurements': [{'value': '93.4', 'groupId': 'OG000', 'lowerLimit': '91.4', 'upperLimit': '95.1'}, {'value': '67.9', 'groupId': 'OG001', 'lowerLimit': '64.6', 'upperLimit': '71.1'}, {'value': '67', 'groupId': 'OG002', 'lowerLimit': '63.6', 'upperLimit': '70.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1, Day 29, Day 50, Day 209', 'description': 'The percentage of subjects demonstrating HI titers ≥40,against homologous strains, at three weeks and six months after vaccination with aTIV or licensed comparator or TIV.', 'unitOfMeasure': 'Percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on FAS (Persistence)'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Achieving Seroconversion or ≥4 Fold Increase in HI Titers, Against Homologous Strains', 'denoms': [{'units': 'Participants', 'counts': [{'value': '715', 'groupId': 'OG000'}, {'value': '822', 'groupId': 'OG001'}, {'value': '820', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'aTIV (6 to <72 Months)', 'description': 'Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to \\<36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 \\& 29'}, {'id': 'OG001', 'title': 'Comparator TIV (6 to <72 Months)', 'description': 'Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to \\<36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 \\& 29'}, {'id': 'OG002', 'title': 'TIV (6 to <72 Months)', 'description': 'Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to \\<36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 \\& 29'}], 'classes': [{'title': 'H1N1, Day 29 (N=714,822,820)', 'categories': [{'measurements': [{'value': '83.6', 'groupId': 'OG000', 'lowerLimit': '80.7', 'upperLimit': '86.3'}, {'value': '48.5', 'groupId': 'OG001', 'lowerLimit': '45.1', 'upperLimit': '52.1'}, {'value': '51.5', 'groupId': 'OG002', 'lowerLimit': '48', 'upperLimit': '54.9'}]}]}, {'title': 'H1N1, Day 50 (N=713,822,820)', 'categories': [{'measurements': [{'value': '92.6', 'groupId': 'OG000', 'lowerLimit': '90.4', 'upperLimit': '94.4'}, {'value': '83.9', 'groupId': 'OG001', 'lowerLimit': '81.3', 'upperLimit': '86.4'}, {'value': '79', 'groupId': 'OG002', 'lowerLimit': '76.1', 'upperLimit': '81.8'}]}]}, {'title': 'H1N1, Day 209 (N=714,822,819)', 'categories': [{'measurements': [{'value': '71.7', 'groupId': 'OG000', 'lowerLimit': '68.3', 'upperLimit': '75'}, {'value': '39.5', 'groupId': 'OG001', 'lowerLimit': '36.2', 'upperLimit': '43'}, {'value': '41.9', 'groupId': 'OG002', 'lowerLimit': '38.5', 'upperLimit': '45.3'}]}]}, {'title': 'H3N2, Day 29', 'categories': [{'measurements': [{'value': '95.8', 'groupId': 'OG000', 'lowerLimit': '94.1', 'upperLimit': '97.2'}, {'value': '90.3', 'groupId': 'OG001', 'lowerLimit': '88', 'upperLimit': '92.2'}, {'value': '86.7', 'groupId': 'OG002', 'lowerLimit': '84.2', 'upperLimit': '89'}]}]}, {'title': 'H3N2, Day 50', 'categories': [{'measurements': [{'value': '96.5', 'groupId': 'OG000', 'lowerLimit': '94.9', 'upperLimit': '97.7'}, {'value': '92.1', 'groupId': 'OG001', 'lowerLimit': '90', 'upperLimit': '93.8'}, {'value': '90', 'groupId': 'OG002', 'lowerLimit': '87.7', 'upperLimit': '92'}]}]}, {'title': 'H3N2, Day 209', 'categories': [{'measurements': [{'value': '77.6', 'groupId': 'OG000', 'lowerLimit': '74.4', 'upperLimit': '80.6'}, {'value': '62.5', 'groupId': 'OG001', 'lowerLimit': '59.1', 'upperLimit': '65.9'}, {'value': '55.6', 'groupId': 'OG002', 'lowerLimit': '52.1', 'upperLimit': '59.1'}]}]}, {'title': 'B strain, Day 29', 'categories': [{'measurements': [{'value': '68.4', 'groupId': 'OG000', 'lowerLimit': '64.8', 'upperLimit': '71.8'}, {'value': '47', 'groupId': 'OG001', 'lowerLimit': '43.5', 'upperLimit': '50.4'}, {'value': '44', 'groupId': 'OG002', 'lowerLimit': '40.6', 'upperLimit': '47.5'}]}]}, {'title': 'B strain, Day 50', 'categories': [{'measurements': [{'value': '97.6', 'groupId': 'OG000', 'lowerLimit': '96.2', 'upperLimit': '98.6'}, {'value': '86.6', 'groupId': 'OG001', 'lowerLimit': '84.1', 'upperLimit': '88.9'}, {'value': '85', 'groupId': 'OG002', 'lowerLimit': '82.4', 'upperLimit': '87.4'}]}]}, {'title': 'B strain, Day 209', 'categories': [{'measurements': [{'value': '87.3', 'groupId': 'OG000', 'lowerLimit': '84.6', 'upperLimit': '89.6'}, {'value': '59.7', 'groupId': 'OG001', 'lowerLimit': '56.3', 'upperLimit': '63.1'}, {'value': '61.5', 'groupId': 'OG002', 'lowerLimit': '58', 'upperLimit': '64.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 29, Day 50, Day 209', 'description': 'The percentage of subjects achieving seroconversion ≥4 fold increase in HI titers from baseline, against homologous strains, at three weeks and six months after vaccination with ATIV or licensed comparator or TIV.', 'unitOfMeasure': 'Percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on FAS (Persistence)'}, {'type': 'SECONDARY', 'title': 'Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains, Subjects at Risk/Not at Risk, by Age Subgroup', 'denoms': [{'units': 'Participants', 'counts': [{'value': '660', 'groupId': 'OG000'}, {'value': '722', 'groupId': 'OG001'}, {'value': '739', 'groupId': 'OG002'}, {'value': '425', 'groupId': 'OG003'}, {'value': '612', 'groupId': 'OG004'}, {'value': '623', 'groupId': 'OG005'}, {'value': '235', 'groupId': 'OG006'}, {'value': '110', 'groupId': 'OG007'}, {'value': '116', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'aTIV (6 to <72 Months)', 'description': 'Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to \\<36 months received two doses (Day 1 \\& 29) while subjects aged ≥36 months received one dose (at Day 1) of the vaccine'}, {'id': 'OG001', 'title': 'Compartor TIV (6 to <72 Months)', 'description': 'Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to \\<36 months received two doses (Day 1 \\& 29) while subjects aged ≥36 months received one dose (at Day 1) of the vaccine'}, {'id': 'OG002', 'title': 'TIV (6 to <72 Months)', 'description': 'Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to \\<36 months received two doses (Day 1 \\& 29) while subjects aged ≥36 months received one dose (Day 1) of the vaccine'}, {'id': 'OG003', 'title': 'aTIV (6 to <36 Months)', 'description': 'Subjects received two doses (Day 1 \\& 29) of an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV)'}, {'id': 'OG004', 'title': 'Compartor TIV (6 to <36 Months)', 'description': 'Subjects received two doses (Day 1 \\& 29) of a licensed comparator trivalent split influenza vaccine (comparator TIV)'}, {'id': 'OG005', 'title': 'TIV (6 to <36 Months)', 'description': 'Subjects received two doses (Day 1 \\& 29) of an investigational trivalent split influenza vaccine (TIV)'}, {'id': 'OG006', 'title': 'aTIV (36 to <72 Months)', 'description': 'Subjects received one dose (Day 1) of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV)'}, {'id': 'OG007', 'title': 'Comparator TIV (36 to <72 Months)', 'description': 'Subjects received one dose (Day 1) of a licensed comparator trivalent split influenza vaccine (comparator TIV)'}, {'id': 'OG008', 'title': 'TIV (36 to <72 Months)', 'description': 'Subjects received one dose (Day 1) of an investigational trivalent split influenza vaccine (TIV)'}], 'classes': [{'title': 'H1N1nonrisk(N=659,722,739,425,612,623,234,110,116)', 'categories': [{'measurements': [{'value': '1516', 'groupId': 'OG000', 'lowerLimit': '1358', 'upperLimit': '1692'}, {'value': '566', 'groupId': 'OG001', 'lowerLimit': '509', 'upperLimit': '628'}, {'value': '431', 'groupId': 'OG002', 'lowerLimit': '388', 'upperLimit': '478'}, {'value': '1341', 'groupId': 'OG003', 'lowerLimit': '1165', 'upperLimit': '1544'}, {'value': '478', 'groupId': 'OG004', 'lowerLimit': '425', 'upperLimit': '537'}, {'value': '366', 'groupId': 'OG005', 'lowerLimit': '326', 'upperLimit': '411'}, {'value': '2111', 'groupId': 'OG006', 'lowerLimit': '1840', 'upperLimit': '2423'}, {'value': '1365', 'groupId': 'OG007', 'lowerLimit': '1117', 'upperLimit': '1668'}, {'value': '879', 'groupId': 'OG008', 'lowerLimit': '723', 'upperLimit': '1068'}]}]}, {'title': 'H3N2nonrisk(N=660,722,739,425,612,623,235,110,116)', 'categories': [{'measurements': [{'value': '1897', 'groupId': 'OG000', 'lowerLimit': '1772', 'upperLimit': '2030'}, {'value': '1014', 'groupId': 'OG001', 'lowerLimit': '950', 'upperLimit': '1082'}, {'value': '804', 'groupId': 'OG002', 'lowerLimit': '754', 'upperLimit': '857'}, {'value': '1863', 'groupId': 'OG003', 'lowerLimit': '1711', 'upperLimit': '2028'}, {'value': '912', 'groupId': 'OG004', 'lowerLimit': '849', 'upperLimit': '979'}, {'value': '695', 'groupId': 'OG005', 'lowerLimit': '648', 'upperLimit': '746'}, {'value': '2311', 'groupId': 'OG006', 'lowerLimit': '2080', 'upperLimit': '2568'}, {'value': '1526', 'groupId': 'OG007', 'lowerLimit': '1309', 'upperLimit': '1780'}, {'value': '1497', 'groupId': 'OG008', 'lowerLimit': '1289', 'upperLimit': '1739'}]}]}, {'title': 'B nonrisk(N=660,722,739,425,612,623,235,110,116)', 'categories': [{'measurements': [{'value': '492', 'groupId': 'OG000', 'lowerLimit': '450', 'upperLimit': '539'}, {'value': '162', 'groupId': 'OG001', 'lowerLimit': '148', 'upperLimit': '176'}, {'value': '157', 'groupId': 'OG002', 'lowerLimit': '144', 'upperLimit': '170'}, {'value': '559', 'groupId': 'OG003', 'lowerLimit': '498', 'upperLimit': '627'}, {'value': '149', 'groupId': 'OG004', 'lowerLimit': '136', 'upperLimit': '164'}, {'value': '141', 'groupId': 'OG005', 'lowerLimit': '128', 'upperLimit': '155'}, {'value': '431', 'groupId': 'OG006', 'lowerLimit': '380', 'upperLimit': '488'}, {'value': '226', 'groupId': 'OG007', 'lowerLimit': '188', 'upperLimit': '272'}, {'value': '254', 'groupId': 'OG008', 'lowerLimit': '212', 'upperLimit': '304'}]}]}, {'title': 'H1N1 at risk(N=22,35,26,12,23,19,10,12,7)', 'categories': [{'measurements': [{'value': '1706', 'groupId': 'OG000', 'lowerLimit': '990', 'upperLimit': '2939'}, {'value': '772', 'groupId': 'OG001', 'lowerLimit': '502', 'upperLimit': '1185'}, {'value': '631', 'groupId': 'OG002', 'lowerLimit': '383', 'upperLimit': '1041'}, {'value': '1414', 'groupId': 'OG003', 'lowerLimit': '658', 'upperLimit': '3040'}, {'value': '603', 'groupId': 'OG004', 'lowerLimit': '350', 'upperLimit': '1040'}, {'value': '519', 'groupId': 'OG005', 'lowerLimit': '283', 'upperLimit': '950'}, {'value': '2187', 'groupId': 'OG006', 'lowerLimit': '956', 'upperLimit': '5002'}, {'value': '1241', 'groupId': 'OG007', 'lowerLimit': '583', 'upperLimit': '2641'}, {'value': '1030', 'groupId': 'OG008', 'lowerLimit': '383', 'upperLimit': '2767'}]}]}, {'title': 'H3N2 at risk(N=22,35,26,12,23,19,10,12,7)', 'categories': [{'measurements': [{'value': '2306', 'groupId': 'OG000', 'lowerLimit': '1665', 'upperLimit': '3194'}, {'value': '941', 'groupId': 'OG001', 'lowerLimit': '727', 'upperLimit': '1220'}, {'value': '709', 'groupId': 'OG002', 'lowerLimit': '526', 'upperLimit': '955'}, {'value': '2323', 'groupId': 'OG003', 'lowerLimit': '1407', 'upperLimit': '3835'}, {'value': '794', 'groupId': 'OG004', 'lowerLimit': '552', 'upperLimit': '1140'}, {'value': '665', 'groupId': 'OG005', 'lowerLimit': '447', 'upperLimit': '988'}, {'value': '2319', 'groupId': 'OG006', 'lowerLimit': '1622', 'upperLimit': '3315'}, {'value': '1306', 'groupId': 'OG007', 'lowerLimit': '940', 'upperLimit': '1815'}, {'value': '826', 'groupId': 'OG008', 'lowerLimit': '538', 'upperLimit': '1267'}]}]}, {'title': 'B at risk(N=22,35,26,12,23,19,10,12,7)', 'categories': [{'measurements': [{'value': '495', 'groupId': 'OG000', 'lowerLimit': '307', 'upperLimit': '797'}, {'value': '143', 'groupId': 'OG001', 'lowerLimit': '98', 'upperLimit': '209'}, {'value': '179', 'groupId': 'OG002', 'lowerLimit': '116', 'upperLimit': '278'}, {'value': '694', 'groupId': 'OG003', 'lowerLimit': '367', 'upperLimit': '1316'}, {'value': '125', 'groupId': 'OG004', 'lowerLimit': '79', 'upperLimit': '199'}, {'value': '132', 'groupId': 'OG005', 'lowerLimit': '79', 'upperLimit': '220'}, {'value': '365', 'groupId': 'OG006', 'lowerLimit': '184', 'upperLimit': '724'}, {'value': '200', 'groupId': 'OG007', 'lowerLimit': '108', 'upperLimit': '372'}, {'value': '312', 'groupId': 'OG008', 'lowerLimit': '131', 'upperLimit': '743'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio (H1N1 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.68', 'ciLowerLimit': '2.3', 'ciUpperLimit': '3.12', 'groupDescription': 'No risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio (H3N2 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.87', 'ciLowerLimit': '1.7', 'ciUpperLimit': '2.05', 'groupDescription': 'No risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT ratio (B strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.04', 'ciLowerLimit': '2.68', 'ciUpperLimit': '3.44', 'groupDescription': 'No risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT ratio (H1N1 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.21', 'ciLowerLimit': '1.11', 'ciUpperLimit': '4.42', 'groupDescription': 'At risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT ratio (H3N2 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.45', 'ciLowerLimit': '1.61', 'ciUpperLimit': '3.72', 'groupDescription': 'At risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT ratio (B strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.46', 'ciLowerLimit': '1.88', 'ciUpperLimit': '6.34', 'groupDescription': 'At risk subjects', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'GMT ratios (H1N1 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.52', 'ciLowerLimit': '3.03', 'ciUpperLimit': '4.1', 'groupDescription': 'No risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'GMT ratio (H3N2 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.36', 'ciLowerLimit': '2.15', 'ciUpperLimit': '2.59', 'groupDescription': 'No risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'GMT ratio (B strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.14', 'ciLowerLimit': '2.78', 'ciUpperLimit': '3.56', 'groupDescription': 'No risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'GMT ratio (H1N1 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.7', 'ciLowerLimit': '1.28', 'ciUpperLimit': '5.68', 'groupDescription': 'At risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'GMT ratio (H3N2 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.25', 'ciLowerLimit': '2.09', 'ciUpperLimit': '5.06', 'groupDescription': 'At risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'GMT ratio (B strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.76', 'ciLowerLimit': '1.44', 'ciUpperLimit': '5.3', 'groupDescription': 'At risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.'}, {'groupIds': ['OG003', 'OG004'], 'paramType': 'GMT ratio (H1N1 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.81', 'ciLowerLimit': '2.34', 'ciUpperLimit': '3.37', 'groupDescription': 'No risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.'}, {'groupIds': ['OG003', 'OG004'], 'paramType': 'GMT ratio (H3N2 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.04', 'ciLowerLimit': '1.83', 'ciUpperLimit': '2.28', 'groupDescription': 'No risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.'}, {'groupIds': ['OG003', 'OG004'], 'paramType': 'GMT ratio (B strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.74', 'ciLowerLimit': '3.22', 'ciUpperLimit': '4.34', 'groupDescription': 'No risk subjects', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.'}, {'groupIds': ['OG003', 'OG004'], 'paramType': 'GMT ratio (H1N1 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.34', 'ciLowerLimit': '0.92', 'ciUpperLimit': '6', 'groupDescription': 'At risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.'}, {'groupIds': ['OG003', 'OG004'], 'paramType': 'GMT ratio (H3N2 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.93', 'ciLowerLimit': '1.57', 'ciUpperLimit': '5.45', 'groupDescription': 'At risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.'}, {'groupIds': ['OG003', 'OG004'], 'paramType': 'GMT ratio (B strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.55', 'ciLowerLimit': '2.52', 'ciUpperLimit': '12', 'groupDescription': 'At risk subjects', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.'}, {'groupIds': ['OG003', 'OG005'], 'paramType': 'GMT ratio (H1N1 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.66', 'ciLowerLimit': '3.05', 'ciUpperLimit': '4.39', 'groupDescription': 'No risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.'}, {'groupIds': ['OG003', 'OG005'], 'paramType': 'GMT ratio (H3N2 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.68', 'ciLowerLimit': '2.4', 'ciUpperLimit': '2.99', 'groupDescription': 'No risk subjects', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.'}, {'groupIds': ['OG003', 'OG005'], 'paramType': 'GMT ratio (B strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.97', 'ciLowerLimit': '3.42', 'ciUpperLimit': '4.61', 'groupDescription': 'No risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.'}, {'groupIds': ['OG003', 'OG005'], 'paramType': 'GMT ratio (H1N1 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.72', 'ciLowerLimit': '1.02', 'ciUpperLimit': '7.31', 'groupDescription': 'At risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.'}, {'groupIds': ['OG003', 'OG005'], 'paramType': 'GMT ratio (H3N2 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.5', 'ciLowerLimit': '1.85', 'ciUpperLimit': '6.62', 'groupDescription': 'At risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.'}, {'groupIds': ['OG003', 'OG005'], 'paramType': 'GMT ratio (B strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.26', 'ciLowerLimit': '2.32', 'ciUpperLimit': '12', 'groupDescription': 'At risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.'}, {'groupIds': ['OG006', 'OG007'], 'paramType': 'GMT ratio (H1N1 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.55', 'ciLowerLimit': '1.21', 'ciUpperLimit': '1.97', 'groupDescription': 'No risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.'}, {'groupIds': ['OG006', 'OG007'], 'paramType': 'GMT ratio (H3N2 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.51', 'ciLowerLimit': '1.26', 'ciUpperLimit': '1.82', 'groupDescription': 'No risk subjects', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.'}, {'groupIds': ['OG006', 'OG007'], 'paramType': 'GMT ratio (B strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.9', 'ciLowerLimit': '1.52', 'ciUpperLimit': '2.38', 'groupDescription': 'No risk subjects', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.'}, {'groupIds': ['OG006', 'OG007'], 'paramType': 'GMT ratio (H1N1 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.76', 'ciLowerLimit': '0.57', 'ciUpperLimit': '5.4', 'groupDescription': 'At risk subjects', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.'}, {'groupIds': ['OG006', 'OG007'], 'paramType': 'GMT ratio (H3N2 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.78', 'ciLowerLimit': '1.09', 'ciUpperLimit': '2.89', 'groupDescription': 'At risk subjects', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.'}, {'groupIds': ['OG006', 'OG007'], 'paramType': 'GMT ratio (B strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.82', 'ciLowerLimit': '0.73', 'ciUpperLimit': '4.54', 'groupDescription': 'At risk subjects', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.'}, {'groupIds': ['OG006', 'OG008'], 'paramType': 'GMT ratio (H1N1 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.4', 'ciLowerLimit': '1.89', 'ciUpperLimit': '3.05', 'groupDescription': 'No risk subjects', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.'}, {'groupIds': ['OG006', 'OG008'], 'paramType': 'GMT ratio (H3N2 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.54', 'ciLowerLimit': '1.29', 'ciUpperLimit': '1.85', 'groupDescription': 'No risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.'}, {'groupIds': ['OG006', 'OG008'], 'paramType': 'GMT ratio (B strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.7', 'ciLowerLimit': '1.36', 'ciUpperLimit': '2.11', 'groupDescription': 'No risk subjects', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.'}, {'groupIds': ['OG006', 'OG008'], 'paramType': 'GMT ratio (H1N1 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.12', 'ciLowerLimit': '0.58', 'ciUpperLimit': '7.71', 'groupDescription': 'At risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.'}, {'groupIds': ['OG006', 'OG008'], 'paramType': 'GMT ratio (H3N2 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.81', 'ciLowerLimit': '1.61', 'ciUpperLimit': '4.89', 'groupDescription': 'At risk subjects', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.'}, {'groupIds': ['OG006', 'OG008'], 'paramType': 'GMT ratio (B strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.17', 'ciLowerLimit': '0.37', 'ciUpperLimit': '3.67', 'groupDescription': 'At risk subjects', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 50', 'description': 'The non-inferiority of Hemagglutination Inhibition (HI) antibody responses of aTIV compared to TIV and comparator TIV assessed in terms of post vaccination GMTs at three weeks after last vaccination against the three homologous vaccine strains, in subjects with a defined set of underlying medical conditions (at risk) and healthy subjects (not at risk), by age sub group.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on the PPS.'}, {'type': 'SECONDARY', 'title': 'Comparison of Antibody Responses of aTIV Versus Comparator TIV and TIV in Terms of Percentage of Subjects Achieving Seroconversion or ≥4-fold Increase in HI Titer Against Homologous Strains in Subjects at Risk/Not at Risk, by Age Subgroup', 'denoms': [{'units': 'Participants', 'counts': [{'value': '660', 'groupId': 'OG000'}, {'value': '722', 'groupId': 'OG001'}, {'value': '739', 'groupId': 'OG002'}, {'value': '425', 'groupId': 'OG003'}, {'value': '612', 'groupId': 'OG004'}, {'value': '623', 'groupId': 'OG005'}, {'value': '235', 'groupId': 'OG006'}, {'value': '110', 'groupId': 'OG007'}, {'value': '116', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'aTIV (6 to <72 Months)', 'description': 'Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to \\<36 months received two doses (Day 1 \\& 29) while subjects aged ≥36 months received one dose (at Day 1) of the vaccine'}, {'id': 'OG001', 'title': 'Compartor TIV (6 to <72 Months)', 'description': 'Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to \\<36 months received two doses (Day 1 \\& 29) while subjects aged ≥36 months received one dose (at Day 1) of the vaccine'}, {'id': 'OG002', 'title': 'TIV (6 to <72 Months)', 'description': 'Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to \\<36 months received two doses (Day 1 \\& 29) while subjects aged ≥36 months received one dose (Day 1) of the vaccine'}, {'id': 'OG003', 'title': 'aTIV (6 to <36 Months)', 'description': 'Subjects received two doses (Day 1 \\& 29) of an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV)'}, {'id': 'OG004', 'title': 'Compartor TIV (6 to <36 Months)', 'description': 'Subjects received two doses (Day 1 \\& 29) of a licensed comparator trivalent split influenza vaccine (comparator TIV)'}, {'id': 'OG005', 'title': 'TIV (6 to <36 Months)', 'description': 'Subjects received two doses (Day 1 \\& 29) of an investigational trivalent split influenza vaccine (TIV)'}, {'id': 'OG006', 'title': 'aTIV (36 to <72 Months)', 'description': 'Subjects received one dose (Day 1) of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV)'}, {'id': 'OG007', 'title': 'Comparator TIV (36 to <72 Months)', 'description': 'Subjects received one dose (Day 1) of a licensed comparator trivalent split influenza vaccine (comparator TIV)'}, {'id': 'OG008', 'title': 'TIV (36 to <72 Months)', 'description': 'Subjects received one dose (Day 1) of an investigational trivalent split influenza vaccine (TIV)'}], 'classes': [{'title': 'H1N1 norisk(N=658,722,739,425,612,623,233,110,116)', 'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000', 'lowerLimit': '91', 'upperLimit': '95'}, {'value': '85', 'groupId': 'OG001', 'lowerLimit': '82', 'upperLimit': '87'}, {'value': '79', 'groupId': 'OG002', 'lowerLimit': '76', 'upperLimit': '82'}, {'value': '95', 'groupId': 'OG003', 'lowerLimit': '92', 'upperLimit': '97'}, {'value': '84', 'groupId': 'OG004', 'lowerLimit': '81', 'upperLimit': '87'}, {'value': '78', 'groupId': 'OG005', 'lowerLimit': '75', 'upperLimit': '82'}, {'value': '91', 'groupId': 'OG006', 'lowerLimit': '86', 'upperLimit': '94'}, {'value': '88', 'groupId': 'OG007', 'lowerLimit': '81', 'upperLimit': '94'}, {'value': '83', 'groupId': 'OG008', 'lowerLimit': '75', 'upperLimit': '89'}]}]}, {'title': 'H3N2 norisk(N=660,722,739,425,612,623,235,110,116)', 'categories': [{'measurements': [{'value': '97', 'groupId': 'OG000', 'lowerLimit': '95', 'upperLimit': '98'}, {'value': '93', 'groupId': 'OG001', 'lowerLimit': '91', 'upperLimit': '94'}, {'value': '90', 'groupId': 'OG002', 'lowerLimit': '87', 'upperLimit': '92'}, {'value': '98', 'groupId': 'OG003', 'lowerLimit': '96', 'upperLimit': '99'}, {'value': '93', 'groupId': 'OG004', 'lowerLimit': '91', 'upperLimit': '95'}, {'value': '90', 'groupId': 'OG005', 'lowerLimit': '88', 'upperLimit': '93'}, {'value': '94', 'groupId': 'OG006', 'lowerLimit': '91', 'upperLimit': '97'}, {'value': '90', 'groupId': 'OG007', 'lowerLimit': '83', 'upperLimit': '95'}, {'value': '86', 'groupId': 'OG008', 'lowerLimit': '79', 'upperLimit': '92'}]}]}, {'title': 'B norisk(N=660,722,739,425,612,623,235,110,116)', 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000', 'lowerLimit': '96', 'upperLimit': '99'}, {'value': '86', 'groupId': 'OG001', 'lowerLimit': '83', 'upperLimit': '88'}, {'value': '84', 'groupId': 'OG002', 'lowerLimit': '82', 'upperLimit': '87'}, {'value': '98', 'groupId': 'OG003', 'lowerLimit': '96', 'upperLimit': '99'}, {'value': '85', 'groupId': 'OG004', 'lowerLimit': '82', 'upperLimit': '88'}, {'value': '83', 'groupId': 'OG005', 'lowerLimit': '79', 'upperLimit': '86'}, {'value': '98', 'groupId': 'OG006', 'lowerLimit': '95', 'upperLimit': '99'}, {'value': '90', 'groupId': 'OG007', 'lowerLimit': '83', 'upperLimit': '95'}, {'value': '94', 'groupId': 'OG008', 'lowerLimit': '88', 'upperLimit': '98'}]}]}, {'title': 'H1N1 at risk (N=22,35,26,12,23,19,10,12,7)', 'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000', 'lowerLimit': '60', 'upperLimit': '95'}, {'value': '83', 'groupId': 'OG001', 'lowerLimit': '66', 'upperLimit': '93'}, {'value': '85', 'groupId': 'OG002', 'lowerLimit': '65', 'upperLimit': '96'}, {'value': '92', 'groupId': 'OG003', 'lowerLimit': '62', 'upperLimit': '100'}, {'value': '87', 'groupId': 'OG004', 'lowerLimit': '66', 'upperLimit': '97'}, {'value': '89', 'groupId': 'OG005', 'lowerLimit': '67', 'upperLimit': '99'}, {'value': '70', 'groupId': 'OG006', 'lowerLimit': '35', 'upperLimit': '93'}, {'value': '75', 'groupId': 'OG007', 'lowerLimit': '43', 'upperLimit': '95'}, {'value': '71', 'groupId': 'OG008', 'lowerLimit': '29', 'upperLimit': '96'}]}]}, {'title': 'H3N2 at risk(N=22,35,26,12,23,19,10,12,7)', 'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000', 'lowerLimit': '65', 'upperLimit': '97'}, {'value': '86', 'groupId': 'OG001', 'lowerLimit': '70', 'upperLimit': '95'}, {'value': '81', 'groupId': 'OG002', 'lowerLimit': '61', 'upperLimit': '93'}, {'value': '83', 'groupId': 'OG003', 'lowerLimit': '52', 'upperLimit': '98'}, {'value': '78', 'groupId': 'OG004', 'lowerLimit': '56', 'upperLimit': '93'}, {'value': '74', 'groupId': 'OG005', 'lowerLimit': '49', 'upperLimit': '91'}, {'value': '90', 'groupId': 'OG006', 'lowerLimit': '55', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG007', 'lowerLimit': '74', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG008', 'lowerLimit': '59', 'upperLimit': '100'}]}]}, {'title': 'B at risk(N=22,35,26,12,23,19,10,12,7)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '85', 'upperLimit': '100'}, {'value': '86', 'groupId': 'OG001', 'lowerLimit': '70', 'upperLimit': '98'}, {'value': '88', 'groupId': 'OG002', 'lowerLimit': '70', 'upperLimit': '98'}, {'value': '100', 'groupId': 'OG003', 'lowerLimit': '74', 'upperLimit': '100'}, {'value': '91', 'groupId': 'OG004', 'lowerLimit': '72', 'upperLimit': '99'}, {'value': '84', 'groupId': 'OG005', 'lowerLimit': '60', 'upperLimit': '97'}, {'value': '100', 'groupId': 'OG006', 'lowerLimit': '69', 'upperLimit': '100'}, {'value': '75', 'groupId': 'OG007', 'lowerLimit': '43', 'upperLimit': '95'}, {'value': '100', 'groupId': 'OG008', 'lowerLimit': '59', 'upperLimit': '100'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Group difference (H1N1 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9', 'ciLowerLimit': '5.4', 'ciUpperLimit': '12', 'groupDescription': 'No risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \\> -10%'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Group difference (H3N2 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4', 'ciLowerLimit': '1.8', 'ciUpperLimit': '6.6', 'groupDescription': 'No risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \\> -10%.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Group difference (B strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12', 'ciLowerLimit': '9.2', 'ciUpperLimit': '14.8', 'groupDescription': 'No risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \\> -10%.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Group difference (H1N1 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1', 'ciLowerLimit': '-24', 'ciUpperLimit': '18.7', 'groupDescription': 'At risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \\> -10%.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Group difference (H3N2 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1', 'ciLowerLimit': '-21.2', 'ciUpperLimit': '18.9', 'groupDescription': 'At risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \\> -10%.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Group difference (B strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '14', 'ciLowerLimit': '-1.6', 'ciUpperLimit': '29.5', 'groupDescription': 'At risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \\> -10%.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Group difference (H1N1 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '14', 'ciLowerLimit': '10.7', 'ciUpperLimit': '17.7', 'groupDescription': 'No risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \\> -10%.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Group difference (H3N2 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7', 'ciLowerLimit': '4.6', 'ciUpperLimit': '9.8', 'groupDescription': 'No risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \\> -10%.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Group difference (B strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13', 'ciLowerLimit': '10.7', 'ciUpperLimit': '16.4', 'groupDescription': 'No risk subjects', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \\> -10%.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Group difference (H1N1 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3', 'ciLowerLimit': '-26.1', 'ciUpperLimit': '19.2', 'groupDescription': 'At risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \\> -10%.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Group difference (H3N2 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6', 'ciLowerLimit': '-17.5', 'ciUpperLimit': '27.3', 'groupDescription': 'At risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \\> -10%.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Group difference (B strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12', 'ciLowerLimit': '-4.4', 'ciUpperLimit': '29.2', 'groupDescription': 'At risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \\> -10%.'}, {'groupIds': ['OG003', 'OG004'], 'paramType': 'Group difference (H1N1 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11', 'ciLowerLimit': '7.2', 'ciUpperLimit': '14.5', 'groupDescription': 'No risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \\> -10%.'}, {'groupIds': ['OG003', 'OG004'], 'paramType': 'Group difference (H3N2 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5', 'ciLowerLimit': '2.6', 'ciUpperLimit': '7.5', 'groupDescription': 'No risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \\> -10%.'}, {'groupIds': ['OG003', 'OG004'], 'paramType': 'Group difference (B strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13', 'ciLowerLimit': '9.5', 'ciUpperLimit': '15.8', 'groupDescription': 'No risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \\> -10%.'}, {'groupIds': ['OG003', 'OG004'], 'paramType': 'Group difference (H1N1 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5', 'ciLowerLimit': '-24.7', 'ciUpperLimit': '26.3', 'groupDescription': 'At risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \\> -10%.'}, {'groupIds': ['OG003', 'OG004'], 'paramType': 'Group difference (H3N2 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5', 'ciLowerLimit': '-26.9', 'ciUpperLimit': '30.3', 'groupDescription': 'At risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \\> -10%.'}, {'groupIds': ['OG003', 'OG004'], 'paramType': 'Group difference (B strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9', 'ciLowerLimit': '-16.9', 'ciUpperLimit': '27.1', 'groupDescription': 'At risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \\> -10%.'}, {'groupIds': ['OG003', 'OG005'], 'paramType': 'Group difference (H1N1 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '16', 'ciLowerLimit': '12.4', 'ciUpperLimit': '20.2', 'groupDescription': 'No risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \\> -10%.'}, {'groupIds': ['OG003', 'OG005'], 'paramType': 'Group difference (H3N2 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8', 'ciLowerLimit': '5.1', 'ciUpperLimit': '10.5', 'groupDescription': 'No risk subjects', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \\> -10%.'}, {'groupIds': ['OG003', 'OG005'], 'paramType': 'Group difference (B strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '15', 'ciLowerLimit': '12', 'ciUpperLimit': '18.6', 'groupDescription': 'No risk subjects', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \\> -10%.'}, {'groupIds': ['OG003', 'OG005'], 'paramType': 'Group difference (H1N1 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2', 'ciLowerLimit': '-27.1', 'ciUpperLimit': '25.5', 'groupDescription': 'At risk subjects', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \\> -10%.'}, {'groupIds': ['OG003', 'OG005'], 'paramType': 'Group difference (H3N2 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10', 'ciLowerLimit': '-23.5', 'ciUpperLimit': '37.2', 'groupDescription': 'At risk subjects', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \\> -10%.'}, {'groupIds': ['OG003', 'OG005'], 'paramType': 'Group difference (B strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '16', 'ciLowerLimit': '-10.7', 'ciUpperLimit': '38', 'groupDescription': 'At risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \\> -10%.'}, {'groupIds': ['OG006', 'OG007'], 'paramType': 'Group difference (H1N1 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2', 'ciLowerLimit': '-4.2', 'ciUpperLimit': '10.4', 'groupDescription': 'No risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \\> -10%.'}, {'groupIds': ['OG006', 'OG007'], 'paramType': 'Group difference (H3N2 subjects)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4', 'ciLowerLimit': '-1.2', 'ciUpperLimit': '11.9', 'groupDescription': 'No risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \\> -10%.'}, {'groupIds': ['OG006', 'OG007'], 'paramType': 'Group difference (B strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8', 'ciLowerLimit': '2.9', 'ciUpperLimit': '15.1', 'groupDescription': 'No risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \\> -10%.'}, {'groupIds': ['OG006', 'OG007'], 'paramType': 'Group difference (H1N1 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5', 'ciLowerLimit': '-42.4', 'ciUpperLimit': '32', 'groupDescription': 'At risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \\> -10%.'}, {'groupIds': ['OG006', 'OG007'], 'paramType': 'Group difference (H3N2 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-10', 'ciLowerLimit': '-41.2', 'ciUpperLimit': '16.6', 'groupDescription': 'At risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \\> -10%.'}, {'groupIds': ['OG006', 'OG007'], 'paramType': 'Group difference (B strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '25', 'ciLowerLimit': '-7.1', 'ciUpperLimit': '53.9', 'groupDescription': 'At risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \\> -10%.'}, {'groupIds': ['OG006', 'OG008'], 'paramType': 'Group difference (H1N1 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8', 'ciLowerLimit': '1', 'ciUpperLimit': '16.4', 'groupDescription': 'No risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \\> -10%.'}, {'groupIds': ['OG006', 'OG008'], 'paramType': 'Group difference (H3N2 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8', 'ciLowerLimit': '2', 'ciUpperLimit': '16.1', 'groupDescription': 'No risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \\> -10%.'}, {'groupIds': ['OG006', 'OG008'], 'paramType': 'Group difference (B strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4', 'ciLowerLimit': '0', 'ciUpperLimit': '10', 'groupDescription': 'No risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \\> -10%.'}, {'groupIds': ['OG006', 'OG008'], 'paramType': 'Group difference (H1N1 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1', 'ciLowerLimit': '-42.1', 'ciUpperLimit': '43', 'groupDescription': 'At risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \\> -10%.'}, {'groupIds': ['OG006', 'OG008'], 'paramType': 'Group difference (H3N2 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-10', 'ciLowerLimit': '-41.5', 'ciUpperLimit': '28.7', 'groupDescription': 'At risk subjects', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \\> -10%.'}, {'groupIds': ['OG006', 'OG008'], 'paramType': 'Group difference (B strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'ciLowerLimit': '-29', 'ciUpperLimit': '36.8', 'groupDescription': 'At risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \\> -10%.'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 50', 'description': 'The non-inferiority of HI antibody responses of aTIV to that of the licensed comparator TIV and to investigational TIV was assessed in terms of percentage of subjects achieving seroconversion or ≥4-fold increase in HI titers at three weeks after last vaccination against the three homologous vaccine strains in subjects with a defined set of underlying medical conditions (at risk) and in healthy subjects (not at risk) , by age sub group.', 'unitOfMeasure': 'Percentages of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on the Per Protocol Set.'}, {'type': 'SECONDARY', 'title': 'Comparison of Antibody Responses of TIV Versus Comparator TIV in Terms of Percentage of Subjects Achieving Seroconversion or ≥4-fold Increase in HI Titer Against Homologous Strains in Subjects at Risk/Not at Risk, by Age Sub Group-FAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '719', 'groupId': 'OG000'}, {'value': '799', 'groupId': 'OG001'}, {'value': '814', 'groupId': 'OG002'}, {'value': '459', 'groupId': 'OG003'}, {'value': '673', 'groupId': 'OG004'}, {'value': '688', 'groupId': 'OG005'}, {'value': '260', 'groupId': 'OG006'}, {'value': '126', 'groupId': 'OG007'}, {'value': '126', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'aTIV (6 to <72 Months)', 'description': 'Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to \\<36 months received two doses (Day 1 \\& 29) while subjects aged ≥36 months received one dose (at Day 1) of the vaccine'}, {'id': 'OG001', 'title': 'Compartor TIV (6 to <72 Months)', 'description': 'Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to \\<36 months received two doses (Day 1 \\& 29) while subjects aged ≥36 months received one dose (at Day 1) of the vaccine'}, {'id': 'OG002', 'title': 'TIV (6 to <72 Months)', 'description': 'Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to \\<36 months received two doses (Day 1 \\& 29) while subjects aged ≥36 months received one dose (Day 1) of the vaccine'}, {'id': 'OG003', 'title': 'aTIV (6 to <36 Months)', 'description': 'Subjects received two doses (Day 1 \\& 29) of an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV)'}, {'id': 'OG004', 'title': 'Compartor TIV (6 to <36 Months)', 'description': 'Subjects received two doses (Day 1 \\& 29) of a licensed comparator trivalent split influenza vaccine (comparator TIV)'}, {'id': 'OG005', 'title': 'TIV (6 to <36 Months)', 'description': 'Subjects received two doses (Day 1 \\& 29) of an investigational trivalent split influenza vaccine (TIV)'}, {'id': 'OG006', 'title': 'aTIV (36 to <72 Months)', 'description': 'Subjects received one dose (Day 1) of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV)'}, {'id': 'OG007', 'title': 'Comparator TIV (36 to <72 Months)', 'description': 'Subjects received one dose (Day 1) of a licensed comparator trivalent split influenza vaccine (comparator TIV)'}, {'id': 'OG008', 'title': 'TIV (36 to <72 Months)', 'description': 'Subjects received one dose (Day 1) of an investigational trivalent split influenza vaccine (TIV)'}], 'classes': [{'title': 'H1N1 norisk(N=717,799,814,459,673,688,258,126,126)', 'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000', 'lowerLimit': '91', 'upperLimit': '95'}, {'value': '84', 'groupId': 'OG001', 'lowerLimit': '81', 'upperLimit': '86'}, {'value': '79', 'groupId': 'OG002', 'lowerLimit': '76', 'upperLimit': '81'}, {'value': '95', 'groupId': 'OG003', 'lowerLimit': '92', 'upperLimit': '96'}, {'value': '83', 'groupId': 'OG004', 'lowerLimit': '80', 'upperLimit': '86'}, {'value': '78', 'groupId': 'OG005', 'lowerLimit': '75', 'upperLimit': '81'}, {'value': '91', 'groupId': 'OG006', 'lowerLimit': '87', 'upperLimit': '94'}, {'value': '89', 'groupId': 'OG007', 'lowerLimit': '82', 'upperLimit': '94'}, {'value': '81', 'groupId': 'OG008', 'lowerLimit': '73', 'upperLimit': '87'}]}]}, {'title': 'H3N2 norisk(N=719,799,814,459,673,688,260,126,126)', 'categories': [{'measurements': [{'value': '97', 'groupId': 'OG000', 'lowerLimit': '95', 'upperLimit': '98'}, {'value': '93', 'groupId': 'OG001', 'lowerLimit': '91', 'upperLimit': '94'}, {'value': '90', 'groupId': 'OG002', 'lowerLimit': '88', 'upperLimit': '92'}, {'value': '98', 'groupId': 'OG003', 'lowerLimit': '96', 'upperLimit': '99'}, {'value': '93', 'groupId': 'OG004', 'lowerLimit': '91', 'upperLimit': '95'}, {'value': '91', 'groupId': 'OG005', 'lowerLimit': '88', 'upperLimit': '93'}, {'value': '95', 'groupId': 'OG006', 'lowerLimit': '91', 'upperLimit': '97'}, {'value': '91', 'groupId': 'OG007', 'lowerLimit': '85', 'upperLimit': '96'}, {'value': '87', 'groupId': 'OG008', 'lowerLimit': '79', 'upperLimit': '92'}]}]}, {'title': 'B norisk(N=719,799,814,459,673,688,260,126,126)', 'categories': [{'measurements': [{'value': '97', 'groupId': 'OG000', 'lowerLimit': '96', 'upperLimit': '99'}, {'value': '86', 'groupId': 'OG001', 'lowerLimit': '84', 'upperLimit': '89'}, {'value': '84', 'groupId': 'OG002', 'lowerLimit': '82', 'upperLimit': '87'}, {'value': '98', 'groupId': 'OG003', 'lowerLimit': '96', 'upperLimit': '99'}, {'value': '85', 'groupId': 'OG004', 'lowerLimit': '83', 'upperLimit': '88'}, {'value': '83', 'groupId': 'OG005', 'lowerLimit': '80', 'upperLimit': '85'}, {'value': '97', 'groupId': 'OG006', 'lowerLimit': '95', 'upperLimit': '99'}, {'value': '91', 'groupId': 'OG007', 'lowerLimit': '85', 'upperLimit': '96'}, {'value': '94', 'groupId': 'OG008', 'lowerLimit': '88', 'upperLimit': '97'}]}]}, {'title': 'H1N1 at risk(N=28,40,35,17,26,26,11,14,9)', 'categories': [{'measurements': [{'value': '79', 'groupId': 'OG000', 'lowerLimit': '59', 'upperLimit': '92'}, {'value': '83', 'groupId': 'OG001', 'lowerLimit': '67', 'upperLimit': '93'}, {'value': '83', 'groupId': 'OG002', 'lowerLimit': '66', 'upperLimit': '93'}, {'value': '82', 'groupId': 'OG003', 'lowerLimit': '57', 'upperLimit': '96'}, {'value': '85', 'groupId': 'OG004', 'lowerLimit': '65', 'upperLimit': '96'}, {'value': '85', 'groupId': 'OG005', 'lowerLimit': '65', 'upperLimit': '96'}, {'value': '73', 'groupId': 'OG006', 'lowerLimit': '39', 'upperLimit': '94'}, {'value': '79', 'groupId': 'OG007', 'lowerLimit': '49', 'upperLimit': '95'}, {'value': '78', 'groupId': 'OG008', 'lowerLimit': '40', 'upperLimit': '97'}]}]}, {'title': 'H3N2 at risk(N=28,40,35,17,26,26,11,14,9)', 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000', 'lowerLimit': '72', 'upperLimit': '98'}, {'value': '85', 'groupId': 'OG001', 'lowerLimit': '70', 'upperLimit': '94'}, {'value': '83', 'groupId': 'OG002', 'lowerLimit': '66', 'upperLimit': '93'}, {'value': '88', 'groupId': 'OG003', 'lowerLimit': '64', 'upperLimit': '99'}, {'value': '77', 'groupId': 'OG004', 'lowerLimit': '56', 'upperLimit': '91'}, {'value': '77', 'groupId': 'OG005', 'lowerLimit': '56', 'upperLimit': '91'}, {'value': '91', 'groupId': 'OG006', 'lowerLimit': '59', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG007', 'lowerLimit': '77', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG008', 'lowerLimit': '66', 'upperLimit': '100'}]}]}, {'title': 'B at risk(N=28,40,35,17,26,26,11,14,9)', 'categories': [{'measurements': [{'value': '96', 'groupId': 'OG000', 'lowerLimit': '82', 'upperLimit': '100'}, {'value': '88', 'groupId': 'OG001', 'lowerLimit': '73', 'upperLimit': '96'}, {'value': '89', 'groupId': 'OG002', 'lowerLimit': '73', 'upperLimit': '97'}, {'value': '94', 'groupId': 'OG003', 'lowerLimit': '71', 'upperLimit': '100'}, {'value': '92', 'groupId': 'OG004', 'lowerLimit': '75', 'upperLimit': '99'}, {'value': '85', 'groupId': 'OG005', 'lowerLimit': '65', 'upperLimit': '96'}, {'value': '100', 'groupId': 'OG006', 'lowerLimit': '72', 'upperLimit': '100'}, {'value': '79', 'groupId': 'OG007', 'lowerLimit': '49', 'upperLimit': '95'}, {'value': '100', 'groupId': 'OG008', 'lowerLimit': '66', 'upperLimit': '100'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Group difference (H1N1 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10', 'ciLowerLimit': '6.4', 'ciUpperLimit': '12.8', 'groupDescription': 'No risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \\> -10%.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Group difference (H3N2 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4', 'ciLowerLimit': '1.8', 'ciUpperLimit': '6.4', 'groupDescription': 'No risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \\> -10%.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Group difference (B strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11', 'ciLowerLimit': '8.6', 'ciUpperLimit': '13.9', 'groupDescription': 'No risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \\> -10%.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Group difference (H1N1 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4', 'ciLowerLimit': '-24.7', 'ciUpperLimit': '14.9', 'groupDescription': 'At risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \\> -10%.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Group difference (H3N2 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4', 'ciLowerLimit': '-14.4', 'ciUpperLimit': '20.7', 'groupDescription': 'At risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \\> -10%.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Group difference (B strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9', 'ciLowerLimit': '-6.8', 'ciUpperLimit': '23.4', 'groupDescription': 'At risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \\> -10%.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Group difference (H1N1 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '15', 'ciLowerLimit': '11.3', 'ciUpperLimit': '18.1', 'groupDescription': 'No risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \\> -10%.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Group difference (H3N2 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7', 'ciLowerLimit': '4.2', 'ciUpperLimit': '9.1', 'groupDescription': 'No risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \\> -10%.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Group difference (B strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13', 'ciLowerLimit': '10.5', 'ciUpperLimit': '16.1', 'groupDescription': 'No risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \\> -10%.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Group difference (H1N1 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4', 'ciLowerLimit': '-25.3', 'ciUpperLimit': '15.4', 'groupDescription': 'At risk subjects', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \\> -10%.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Group difference (H3N2 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6', 'ciLowerLimit': '-12.7', 'ciUpperLimit': '24.2', 'groupDescription': 'At risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \\> -10%.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Group differences (B strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8', 'ciLowerLimit': '-7.8', 'ciUpperLimit': '23.2', 'groupDescription': 'At risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \\> -10%.'}, {'groupIds': ['OG003', 'OG004'], 'paramType': 'Group difference (H1N1 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12', 'ciLowerLimit': '8.2', 'ciUpperLimit': '15.3', 'groupDescription': 'No risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \\> -10%.'}, {'groupIds': ['OG003', 'OG004'], 'paramType': 'Group difference (H3N2 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5', 'ciLowerLimit': '2.5', 'ciUpperLimit': '7.4', 'groupDescription': 'No risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \\> -10%.'}, {'groupIds': ['OG003', 'OG004'], 'paramType': 'Group difference (B strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12', 'ciLowerLimit': '9.2', 'ciUpperLimit': '15.3', 'groupDescription': 'No risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \\> -10%.'}, {'groupIds': ['OG003', 'OG004'], 'paramType': 'Group difference (H1N1 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2', 'ciLowerLimit': '-28.5', 'ciUpperLimit': '20.2', 'groupDescription': 'At risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \\> -10%.'}, {'groupIds': ['OG003', 'OG004'], 'paramType': 'Group difference (H3N2 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11', 'ciLowerLimit': '-14.9', 'ciUpperLimit': '33.5', 'groupDescription': 'At risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \\> -10%.'}, {'groupIds': ['OG003', 'OG004'], 'paramType': 'Group difference (B strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2', 'ciLowerLimit': '-20.7', 'ciUpperLimit': '19.7', 'groupDescription': 'At risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \\> -10%.'}, {'groupIds': ['OG003', 'OG005'], 'paramType': 'Group difference (H1N1 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '16', 'ciLowerLimit': '12.6', 'ciUpperLimit': '20.1', 'groupDescription': 'No risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \\> -10%.'}, {'groupIds': ['OG003', 'OG005'], 'paramType': 'Group difference (H3N2 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7', 'ciLowerLimit': '4.6', 'ciUpperLimit': '9.8', 'groupDescription': 'No risk subjects', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \\> -10%.'}, {'groupIds': ['OG003', 'OG005'], 'paramType': 'Group difference (B strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '15', 'ciLowerLimit': '11.9', 'ciUpperLimit': '18.3', 'groupDescription': 'No risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \\> -10%.'}, {'groupIds': ['OG003', 'OG005'], 'paramType': 'Group difference (H1N1 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2', 'ciLowerLimit': '-28.5', 'ciUpperLimit': '20.2', 'groupDescription': 'At risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \\> -10%.'}, {'groupIds': ['OG003', 'OG005'], 'paramType': 'Group difference (H3N2 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11', 'ciLowerLimit': '-14.9', 'ciUpperLimit': '33.5', 'groupDescription': 'At risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \\> -10%.'}, {'groupIds': ['OG003', 'OG005'], 'paramType': 'Group difference (B strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10', 'ciLowerLimit': '-14', 'ciUpperLimit': '29.3', 'groupDescription': 'At risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \\> -10%.'}, {'groupIds': ['OG006', 'OG007'], 'paramType': 'Group difference (H1N1 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2', 'ciLowerLimit': '-3.8', 'ciUpperLimit': '9.5', 'groupDescription': 'No risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \\> -10%.'}, {'groupIds': ['OG006', 'OG007'], 'paramType': 'Group difference (H3N2 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3', 'ciLowerLimit': '-1.8', 'ciUpperLimit': '10', 'groupDescription': 'No risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \\> -10%.'}, {'groupIds': ['OG006', 'OG007'], 'paramType': 'Group difference (B strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6', 'ciLowerLimit': '1.5', 'ciUpperLimit': '12.5', 'groupDescription': 'No risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \\> -10%.'}, {'groupIds': ['OG006', 'OG007'], 'paramType': 'Group difference (H1N1 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6', 'ciLowerLimit': '-40.7', 'ciUpperLimit': '27.9', 'groupDescription': 'At risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \\> -10%.'}, {'groupIds': ['OG006', 'OG007'], 'paramType': 'Group difference (H3N2 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-9', 'ciLowerLimit': '-38.4', 'ciUpperLimit': '14.3', 'groupDescription': 'At risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \\> -10%.'}, {'groupIds': ['OG006', 'OG007'], 'paramType': 'Group difference (B strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '21', 'ciLowerLimit': '-7.9', 'ciUpperLimit': '48.1', 'groupDescription': 'At risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \\> -10%.'}, {'groupIds': ['OG006', 'OG008'], 'paramType': 'Group difference (H1N1 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10', 'ciLowerLimit': '3', 'ciUpperLimit': '18.5', 'groupDescription': 'No risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \\> -10%.'}, {'groupIds': ['OG006', 'OG008'], 'paramType': 'Group difference (H3N2 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8', 'ciLowerLimit': '2.2', 'ciUpperLimit': '15.6', 'groupDescription': 'No risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \\> -10%.'}, {'groupIds': ['OG006', 'OG008'], 'paramType': 'Group difference (B strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4', 'ciLowerLimit': '0', 'ciUpperLimit': '9.6', 'groupDescription': 'No risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \\> -10%.'}, {'groupIds': ['OG006', 'OG008'], 'paramType': 'Group difference (H1N1 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5', 'ciLowerLimit': '-41.7', 'ciUpperLimit': '35', 'groupDescription': 'At risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \\> -10%.'}, {'groupIds': ['OG006', 'OG008'], 'paramType': 'Group difference (H3N2 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-9', 'ciLowerLimit': '-38.6', 'ciUpperLimit': '23.4', 'groupDescription': 'At risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \\> -10%.'}, {'groupIds': ['OG006', 'OG008'], 'paramType': 'Group difference (B strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'ciLowerLimit': '-26.9', 'ciUpperLimit': '31', 'groupDescription': 'At risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \\> -10%.'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 50', 'description': 'The superiority of HI antibody responses of aTIV compared to TIV and comparator TIV assessed in terms of of percentage of subjects achieving seroconversion or ≥4-fold increase in HI Titer at three weeks after last vaccination against the three homologous vaccine strains in subjects with a defined set of underlying medical conditions (at risk) and healthy subjects (not at risk), by age sub group.', 'unitOfMeasure': 'Percentages of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on the Full Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains, at Risk/Not at Risk, by Age Sub Group-FAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '719', 'groupId': 'OG000'}, {'value': '799', 'groupId': 'OG001'}, {'value': '814', 'groupId': 'OG002'}, {'value': '459', 'groupId': 'OG003'}, {'value': '673', 'groupId': 'OG004'}, {'value': '688', 'groupId': 'OG005'}, {'value': '260', 'groupId': 'OG006'}, {'value': '126', 'groupId': 'OG007'}, {'value': '126', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'aTIV (6 to <72 Months)', 'description': 'Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to \\<36 months received two doses (Day 1 \\& 29) while subjects aged ≥36 months received one dose (at Day 1) of the vaccine'}, {'id': 'OG001', 'title': 'Compartor TIV (6 to <72 Months)', 'description': 'Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to \\<36 months received two doses (Day 1 \\& 29) while subjects aged ≥36 months received one dose (at Day 1) of the vaccine'}, {'id': 'OG002', 'title': 'TIV (6 to <72 Months)', 'description': 'Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to \\<36 months received two doses (Day 1 \\& 29) while subjects aged ≥36 months received one dose (Day 1) of the vaccine'}, {'id': 'OG003', 'title': 'aTIV (6 to <36 Months)', 'description': 'Subjects received two doses (Day 1 \\& 29) of an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV)'}, {'id': 'OG004', 'title': 'Compartor TIV (6 to <36 Months)', 'description': 'Subjects received two doses (Day 1 \\& 29) of a licensed comparator trivalent split influenza vaccine (comparator TIV)'}, {'id': 'OG005', 'title': 'TIV (6 to <36 Months)', 'description': 'Subjects received two doses (Day 1 \\& 29) of an investigational trivalent split influenza vaccine (TIV)'}, {'id': 'OG006', 'title': 'aTIV (36 to <72 Months)', 'description': 'Subjects received one dose (Day 1) of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV)'}, {'id': 'OG007', 'title': 'Comparator TIV (36 to <72 Months)', 'description': 'Subjects received one dose (Day 1) of a licensed comparator trivalent split influenza vaccine (comparator TIV)'}, {'id': 'OG008', 'title': 'TIV (36 to <72 Months)', 'description': 'Subjects received one dose (Day 1) of an investigational trivalent split influenza vaccine (TIV)'}], 'classes': [{'title': 'H1N1 norisk(N=718,799,814,459,673,688,259,126,126)', 'categories': [{'measurements': [{'value': '1509', 'groupId': 'OG000', 'lowerLimit': '1357', 'upperLimit': '1677'}, {'value': '569', 'groupId': 'OG001', 'lowerLimit': '515', 'upperLimit': '629'}, {'value': '422', 'groupId': 'OG002', 'lowerLimit': '382', 'upperLimit': '466'}, {'value': '1336', 'groupId': 'OG003', 'lowerLimit': '1166', 'upperLimit': '1530'}, {'value': '474', 'groupId': 'OG004', 'lowerLimit': '424', 'upperLimit': '530'}, {'value': '365', 'groupId': 'OG005', 'lowerLimit': '326', 'upperLimit': '407'}, {'value': '2077', 'groupId': 'OG006', 'lowerLimit': '1815', 'upperLimit': '2376'}, {'value': '1413', 'groupId': 'OG007', 'lowerLimit': '1165', 'upperLimit': '1713'}, {'value': '813', 'groupId': 'OG008', 'lowerLimit': '670', 'upperLimit': '986'}]}]}, {'title': 'H3N2 norisk(N=719,799,814,459,673,688,260,126,126)', 'categories': [{'measurements': [{'value': '1894', 'groupId': 'OG000', 'lowerLimit': '1775', 'upperLimit': '2022'}, {'value': '1015', 'groupId': 'OG001', 'lowerLimit': '954', 'upperLimit': '1080'}, {'value': '794', 'groupId': 'OG002', 'lowerLimit': '747', 'upperLimit': '844'}, {'value': '1851', 'groupId': 'OG003', 'lowerLimit': '1705', 'upperLimit': '2010'}, {'value': '905', 'groupId': 'OG004', 'lowerLimit': '845', 'upperLimit': '968'}, {'value': '686', 'groupId': 'OG005', 'lowerLimit': '641', 'upperLimit': '733'}, {'value': '2343', 'groupId': 'OG006', 'lowerLimit': '2120', 'upperLimit': '2589'}, {'value': '1582', 'groupId': 'OG007', 'lowerLimit': '1370', 'upperLimit': '1826'}, {'value': '1475', 'groupId': 'OG008', 'lowerLimit': '1278', 'upperLimit': '1703'}]}]}, {'title': 'B norisk(N=719,799,814,459,673,688,260,126,126)', 'categories': [{'measurements': [{'value': '484', 'groupId': 'OG000', 'lowerLimit': '444', 'upperLimit': '527'}, {'value': '164', 'groupId': 'OG001', 'lowerLimit': '151', 'upperLimit': '178'}, {'value': '155', 'groupId': 'OG002', 'lowerLimit': '143', 'upperLimit': '168'}, {'value': '545', 'groupId': 'OG003', 'lowerLimit': '487', 'upperLimit': '608'}, {'value': '150', 'groupId': 'OG004', 'lowerLimit': '137', 'upperLimit': '164'}, {'value': '139', 'groupId': 'OG005', 'lowerLimit': '127', 'upperLimit': '152'}, {'value': '432', 'groupId': 'OG006', 'lowerLimit': '383', 'upperLimit': '487'}, {'value': '243', 'groupId': 'OG007', 'lowerLimit': '205', 'upperLimit': '289'}, {'value': '253', 'groupId': 'OG008', 'lowerLimit': '212', 'upperLimit': '300'}]}]}, {'title': 'H1N1 at risk(N=28,40,35,17,26,26,11,14,9)', 'categories': [{'measurements': [{'value': '1541', 'groupId': 'OG000', 'lowerLimit': '948', 'upperLimit': '2504'}, {'value': '830', 'groupId': 'OG001', 'lowerLimit': '553', 'upperLimit': '1244'}, {'value': '586', 'groupId': 'OG002', 'lowerLimit': '380', 'upperLimit': '905'}, {'value': '1277', 'groupId': 'OG003', 'lowerLimit': '674', 'upperLimit': '2418'}, {'value': '617', 'groupId': 'OG004', 'lowerLimit': '370', 'upperLimit': '1028'}, {'value': '483', 'groupId': 'OG005', 'lowerLimit': '289', 'upperLimit': '808'}, {'value': '1982', 'groupId': 'OG006', 'lowerLimit': '929', 'upperLimit': '4228'}, {'value': '1478', 'groupId': 'OG007', 'lowerLimit': '756', 'upperLimit': '2891'}, {'value': '1028', 'groupId': 'OG008', 'lowerLimit': '445', 'upperLimit': '2372'}]}]}, {'title': 'H3N2 at risk(N=28,40,35,17,26,26,11,14,9)', 'categories': [{'measurements': [{'value': '2361', 'groupId': 'OG000', 'lowerLimit': '1743', 'upperLimit': '3197'}, {'value': '960', 'groupId': 'OG001', 'lowerLimit': '744', 'upperLimit': '1237'}, {'value': '763', 'groupId': 'OG002', 'lowerLimit': '582', 'upperLimit': '1001'}, {'value': '2517', 'groupId': 'OG003', 'lowerLimit': '1633', 'upperLimit': '3881'}, {'value': '820', 'groupId': 'OG004', 'lowerLimit': '578', 'upperLimit': '1164'}, {'value': '705', 'groupId': 'OG005', 'lowerLimit': '496', 'upperLimit': '1000'}, {'value': '2197', 'groupId': 'OG006', 'lowerLimit': '1514', 'upperLimit': '3187'}, {'value': '1286', 'groupId': 'OG007', 'lowerLimit': '925', 'upperLimit': '1788'}, {'value': '929', 'groupId': 'OG008', 'lowerLimit': '616', 'upperLimit': '1399'}]}]}, {'title': 'B at risk(N=28,40,35,17,26,26,11,14,9)', 'categories': [{'measurements': [{'value': '399', 'groupId': 'OG000', 'lowerLimit': '254', 'upperLimit': '628'}, {'value': '152', 'groupId': 'OG001', 'lowerLimit': '104', 'upperLimit': '222'}, {'value': '183', 'groupId': 'OG002', 'lowerLimit': '122', 'upperLimit': '274'}, {'value': '508', 'groupId': 'OG003', 'lowerLimit': '274', 'upperLimit': '939'}, {'value': '140', 'groupId': 'OG004', 'lowerLimit': '85', 'upperLimit': '231'}, {'value': '147', 'groupId': 'OG005', 'lowerLimit': '89', 'upperLimit': '242'}, {'value': '319', 'groupId': 'OG006', 'lowerLimit': '170', 'upperLimit': '596'}, {'value': '197', 'groupId': 'OG007', 'lowerLimit': '114', 'upperLimit': '341'}, {'value': '241', 'groupId': 'OG008', 'lowerLimit': '118', 'upperLimit': '493'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio (H1N1 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.29', 'ciLowerLimit': '1.91', 'ciUpperLimit': '2.76', 'groupDescription': 'No risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio (H3N2 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.6', 'ciLowerLimit': '1.35', 'ciUpperLimit': '1.89', 'groupDescription': 'No risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT ratio (B strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.92', 'ciLowerLimit': '2.57', 'ciUpperLimit': '3.31', 'groupDescription': 'No risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT ratio (H1N1 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.53', 'ciLowerLimit': '0.6', 'ciUpperLimit': '3.93', 'groupDescription': 'At risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT ratio (H3N2 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.02', 'ciLowerLimit': '0.89', 'ciUpperLimit': '4.61', 'groupDescription': 'At risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT ratio (B strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.5', 'ciLowerLimit': '1.34', 'ciUpperLimit': '4.67', 'groupDescription': 'At risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'GMT ratio (H1N1 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.33', 'ciLowerLimit': '2.77', 'ciUpperLimit': '4.01', 'groupDescription': 'No risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'GMT ratio (H3N2 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.07', 'ciLowerLimit': '1.75', 'ciUpperLimit': '2.45', 'groupDescription': 'No risk subjects', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'GMT ratio (B strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.08', 'ciLowerLimit': '2.72', 'ciUpperLimit': '3.49', 'groupDescription': 'No risk subjects', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'GMT ratio (H1N1 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.71', 'ciLowerLimit': '0.65', 'ciUpperLimit': '4.5', 'groupDescription': 'At risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'GMT ratio (H3N2 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.22', 'ciLowerLimit': '1.38', 'ciUpperLimit': '7.51', 'groupDescription': 'At risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'GMT ratio (B strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.1', 'ciLowerLimit': '1.1', 'ciUpperLimit': '3.98', 'groupDescription': 'At risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.'}, {'groupIds': ['OG003', 'OG004'], 'paramType': 'GMT ratio (H1N1 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.59', 'ciLowerLimit': '2.1', 'ciUpperLimit': '3.21', 'groupDescription': 'No risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \\> -10%.'}, {'groupIds': ['OG003', 'OG004'], 'paramType': 'GMT ratio (H3N2 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.08', 'ciLowerLimit': '1.71', 'ciUpperLimit': '2.52', 'groupDescription': 'No risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \\> -10%.'}, {'groupIds': ['OG003', 'OG004'], 'paramType': 'GMT ratio (B strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.73', 'ciLowerLimit': '3.22', 'ciUpperLimit': '4.33', 'groupDescription': 'No risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \\> -10%.'}, {'groupIds': ['OG003', 'OG004'], 'paramType': 'GMT ratio (H1N1 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.4', 'ciLowerLimit': '0.45', 'ciUpperLimit': '4.4', 'groupDescription': 'At risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \\> -10%.'}, {'groupIds': ['OG003', 'OG004'], 'paramType': 'GMT ratio (H3N2 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.86', 'ciLowerLimit': '0.94', 'ciUpperLimit': '8.66', 'groupDescription': 'At risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \\> -10%.'}, {'groupIds': ['OG003', 'OG004'], 'paramType': 'GMT ratio (B strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.4', 'ciLowerLimit': '0.45', 'ciUpperLimit': '4.4', 'groupDescription': 'At risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \\> -10%.'}, {'groupIds': ['OG003', 'OG005'], 'paramType': 'GMT ratio (H1N1 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.67', 'ciLowerLimit': '2.97', 'ciUpperLimit': '4.54', 'groupDescription': 'No risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \\> -10%.'}, {'groupIds': ['OG003', 'OG005'], 'paramType': 'GMT ratio (H3N2 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.78', 'ciLowerLimit': '2.29', 'ciUpperLimit': '3.37', 'groupDescription': 'No risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \\> -10%.'}, {'groupIds': ['OG003', 'OG005'], 'paramType': 'GMT ratio (B strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.01', 'ciLowerLimit': '3.46', 'ciUpperLimit': '4.65', 'groupDescription': 'No risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \\> -10%.'}, {'groupIds': ['OG003', 'OG005'], 'paramType': 'GMT ratio (H1N1 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.4', 'ciLowerLimit': '0.45', 'ciUpperLimit': '4.4', 'groupDescription': 'At risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \\> -10%.'}, {'groupIds': ['OG003', 'OG005'], 'paramType': 'GMT ratio (H3N2 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.32', 'ciLowerLimit': '1.43', 'ciUpperLimit': '13', 'groupDescription': 'At risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.'}, {'groupIds': ['OG003', 'OG005'], 'paramType': 'GMT ratio (B strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.69', 'ciLowerLimit': '1.67', 'ciUpperLimit': '8.15', 'groupDescription': 'At risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.'}, {'groupIds': ['OG006', 'OG007'], 'paramType': 'GMT ratio (H1N1 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.35', 'ciLowerLimit': '0.89', 'ciUpperLimit': '2.04', 'groupDescription': 'No risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.'}, {'groupIds': ['OG006', 'OG007'], 'paramType': 'GMT ratio (H3N2 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.59', 'ciLowerLimit': '1.14', 'ciUpperLimit': '2.22', 'groupDescription': 'No risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.'}, {'groupIds': ['OG006', 'OG007'], 'paramType': 'GMT ratio (B strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.68', 'ciLowerLimit': '1.3', 'ciUpperLimit': '2.15', 'groupDescription': 'No risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.'}, {'groupIds': ['OG006', 'OG007'], 'paramType': 'GMT ratio (H1N1 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.73', 'ciLowerLimit': '0.29', 'ciUpperLimit': '10', 'groupDescription': 'At risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.'}, {'groupIds': ['OG006', 'OG007'], 'paramType': 'GMT ratio (H3N2 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.16', 'ciLowerLimit': '0.33', 'ciUpperLimit': '4.01', 'groupDescription': 'At risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.'}, {'groupIds': ['OG006', 'OG007'], 'paramType': 'GMT ratio (B strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.45', 'ciLowerLimit': '0.53', 'ciUpperLimit': '3.94', 'groupDescription': 'At risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.'}, {'groupIds': ['OG006', 'OG008'], 'paramType': 'GMT ratio (H1N1 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.24', 'ciLowerLimit': '1.48', 'ciUpperLimit': '3.39', 'groupDescription': 'No risk subjects', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.'}, {'groupIds': ['OG006', 'OG008'], 'paramType': 'GMT ratio (H3N2 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.76', 'ciLowerLimit': '1.26', 'ciUpperLimit': '2.46', 'groupDescription': 'No risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.'}, {'groupIds': ['OG006', 'OG008'], 'paramType': 'GMT ratio (B strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.59', 'ciLowerLimit': '1.24', 'ciUpperLimit': '2.04', 'groupDescription': 'No risk subjects', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.'}, {'groupIds': ['OG006', 'OG008'], 'paramType': 'GMT ratio (H1N1 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.48', 'ciLowerLimit': '0.34', 'ciUpperLimit': '18', 'groupDescription': 'At risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.'}, {'groupIds': ['OG006', 'OG008'], 'paramType': 'GMT ratio (H3N2 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.98', 'ciLowerLimit': '0.49', 'ciUpperLimit': '7.92', 'groupDescription': 'At risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.'}, {'groupIds': ['OG006', 'OG008'], 'paramType': 'GMT ratio (B strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.71', 'ciLowerLimit': '0.23', 'ciUpperLimit': '2.16', 'groupDescription': 'At risk subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 50', 'description': 'The superiority of HI antibody responses of aTIV compared to TIV and comparator TIV assessed in terms of post vaccination GMTs at three weeks after last vaccination against the three homologous vaccine strains, in subjects with a defined set of underlying medical conditions (at risk) and in healthy subjects (not at risk), by age sub group.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on Full Analysis Set.'}, {'type': 'SECONDARY', 'title': 'The HI GMTs Against Heterologous Strains, by Vaccine Group (6 to <72 Months Age Group)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '380', 'groupId': 'OG000'}, {'value': '445', 'groupId': 'OG001'}, {'value': '431', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'aTIV (6 to <72 Months)', 'description': 'Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to \\<36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 \\& 29'}, {'id': 'OG001', 'title': 'Comparator TIV (6 to <72 Months)', 'description': 'Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to \\<36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 \\& 29'}, {'id': 'OG002', 'title': 'TIV (6 to <72 Months)', 'description': 'Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to \\<36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 \\& 29'}], 'classes': [{'title': 'H1N1/Jersey - Day 1 (N=380,445,430)', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000', 'lowerLimit': '9.37', 'upperLimit': '11'}, {'value': '9.75', 'groupId': 'OG001', 'lowerLimit': '8.85', 'upperLimit': '11'}, {'value': '10', 'groupId': 'OG002', 'lowerLimit': '9.07', 'upperLimit': '11'}]}]}, {'title': 'H1N1/Jersey - Day 50', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000', 'lowerLimit': '45', 'upperLimit': '58'}, {'value': '29', 'groupId': 'OG001', 'lowerLimit': '26', 'upperLimit': '33'}, {'value': '31', 'groupId': 'OG002', 'lowerLimit': '27', 'upperLimit': '36'}]}]}, {'title': 'H1N1/Jersey - Day 209', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000', 'lowerLimit': '19', 'upperLimit': '23'}, {'value': '17', 'groupId': 'OG001', 'lowerLimit': '16', 'upperLimit': '19'}, {'value': '18', 'groupId': 'OG002', 'lowerLimit': '16', 'upperLimit': '20'}]}]}, {'title': 'H3N2/Uruguay - Day 1 (N=380,445,430)', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000', 'lowerLimit': '15', 'upperLimit': '20'}, {'value': '18', 'groupId': 'OG001', 'lowerLimit': '16', 'upperLimit': '20'}, {'value': '17', 'groupId': 'OG002', 'lowerLimit': '15', 'upperLimit': '19'}]}]}, {'title': 'H3N2/Uruguay - Day 50', 'categories': [{'measurements': [{'value': '184', 'groupId': 'OG000', 'lowerLimit': '165', 'upperLimit': '206'}, {'value': '88', 'groupId': 'OG001', 'lowerLimit': '79', 'upperLimit': '98'}, {'value': '71', 'groupId': 'OG002', 'lowerLimit': '63', 'upperLimit': '79'}]}]}, {'title': 'H3N2/Uruguay- Day 209', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000', 'lowerLimit': '37', 'upperLimit': '47'}, {'value': '31', 'groupId': 'OG001', 'lowerLimit': '28', 'upperLimit': '34'}, {'value': '27', 'groupId': 'OG002', 'lowerLimit': '24', 'upperLimit': '30'}]}]}, {'title': 'B strain - Day 1', 'categories': [{'measurements': [{'value': '5.98', 'groupId': 'OG000', 'lowerLimit': '5.72', 'upperLimit': '6.25'}, {'value': '5.8', 'groupId': 'OG001', 'lowerLimit': '5.55', 'upperLimit': '6.05'}, {'value': '5.85', 'groupId': 'OG002', 'lowerLimit': '5.6', 'upperLimit': '6.11'}]}]}, {'title': 'B strain - Day 50', 'categories': [{'measurements': [{'value': '99', 'groupId': 'OG000', 'lowerLimit': '89', 'upperLimit': '111'}, {'value': '34', 'groupId': 'OG001', 'lowerLimit': '31', 'upperLimit': '38'}, {'value': '35', 'groupId': 'OG002', 'lowerLimit': '31', 'upperLimit': '39'}]}]}, {'title': 'B strain Day 209', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000', 'lowerLimit': '18', 'upperLimit': '22'}, {'value': '11', 'groupId': 'OG001', 'lowerLimit': '9.86', 'upperLimit': '12'}, {'value': '11', 'groupId': 'OG002', 'lowerLimit': '9.94', 'upperLimit': '12'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1, Day 50, Day 209', 'description': 'The HI antibody titers against the heterologous strains following vaccination with either aTIV, licensed comparator or TIV, at three weeks and at six months after vaccination are reported as GMTs.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on the FAS Persistence'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Achieving Seroconversion or ≥4 Fold Increase in HI Titers, Against Heterologous Strains', 'denoms': [{'units': 'Participants', 'counts': [{'value': '380', 'groupId': 'OG000'}, {'value': '445', 'groupId': 'OG001'}, {'value': '431', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'aTIV (6 to <72 Months)', 'description': 'Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to \\<36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 \\& 29'}, {'id': 'OG001', 'title': 'Comparator TIV (6 to <72 Months)', 'description': 'Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to \\<36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 \\& 29'}, {'id': 'OG002', 'title': 'TIV (6 to <72 Months)', 'description': 'Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to \\<36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 \\& 29'}], 'classes': [{'title': 'H1N1/Jersey, Day 50 (N=380,445,430)', 'categories': [{'measurements': [{'value': '53.16', 'groupId': 'OG000', 'lowerLimit': '48.00', 'upperLimit': '58.26'}, {'value': '36.85', 'groupId': 'OG001', 'lowerLimit': '32.36', 'upperLimit': '41.52'}, {'value': '36.05', 'groupId': 'OG002', 'lowerLimit': '31.50', 'upperLimit': '40.78'}]}]}, {'title': 'H1N1/Jersey, Day 209 (N=380,445,430)', 'categories': [{'measurements': [{'value': '33.95', 'groupId': 'OG000', 'lowerLimit': '29.20', 'upperLimit': '38.95'}, {'value': '19.33', 'groupId': 'OG001', 'lowerLimit': '15.76', 'upperLimit': '23.31'}, {'value': '20.70', 'groupId': 'OG002', 'lowerLimit': '16.96', 'upperLimit': '24.84'}]}]}, {'title': 'H3N2/Uruguay, Day 50 (N=380,445,430)', 'categories': [{'measurements': [{'value': '91.84', 'groupId': 'OG000', 'lowerLimit': '88.62', 'upperLimit': '94.39'}, {'value': '60.9', 'groupId': 'OG001', 'lowerLimit': '56.19', 'upperLimit': '65.46'}, {'value': '53.26', 'groupId': 'OG002', 'lowerLimit': '48.42', 'upperLimit': '58.05'}]}]}, {'title': 'H3N2/Uruguay, Day 209 (N=380,445,430)', 'categories': [{'measurements': [{'value': '40.26', 'groupId': 'OG000', 'lowerLimit': '35.29', 'upperLimit': '45.39'}, {'value': '23.82', 'groupId': 'OG001', 'lowerLimit': '19.94', 'upperLimit': '28.06'}, {'value': '19.07', 'groupId': 'OG002', 'lowerLimit': '15.46', 'upperLimit': '23.11'}]}]}, {'title': 'B strain, Day 50', 'categories': [{'measurements': [{'value': '92.63', 'groupId': 'OG000', 'lowerLimit': '89.53', 'upperLimit': '95.05'}, {'value': '53.71', 'groupId': 'OG001', 'lowerLimit': '48.95', 'upperLimit': '58.41'}, {'value': '52.90', 'groupId': 'OG002', 'lowerLimit': '48.07', 'upperLimit': '57.69'}]}]}, {'title': 'B strain, Day 209', 'categories': [{'measurements': [{'value': '30.0', 'groupId': 'OG000', 'lowerLimit': '25.43', 'upperLimit': '34.88'}, {'value': '13.93', 'groupId': 'OG001', 'lowerLimit': '10.85', 'upperLimit': '17.50'}, {'value': '17.63', 'groupId': 'OG002', 'lowerLimit': '14.15', 'upperLimit': '21.57'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 50, Day 209', 'description': 'The percentage of subjects achieving seroconversion or ≥4 fold increase in HI titers from baseline, against heterologous strains, at three weeks and six months after last vaccination with aTIV or licensed comparator or TIV.', 'unitOfMeasure': 'Percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects aged 6 through \\<72 months of age - Full Analyses Set (FAS) Persistence'}, {'type': 'SECONDARY', 'title': 'Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains, After One Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '715', 'groupId': 'OG000'}, {'value': '822', 'groupId': 'OG001'}, {'value': '820', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'aTIV (6 to <72 Months)', 'description': 'Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to \\<36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 \\& 29'}, {'id': 'OG001', 'title': 'Comparator TIV (6 to <72 Months)', 'description': 'Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to \\<36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 \\& 29'}, {'id': 'OG002', 'title': 'TIV (6 to <72 Months)', 'description': 'Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to \\<36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 \\& 29'}], 'classes': [{'title': 'H1N1- Day 1 (N=714,822,820)', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000', 'lowerLimit': '24', 'upperLimit': '32'}, {'value': '24', 'groupId': 'OG001', 'lowerLimit': '20', 'upperLimit': '27'}, {'value': '27', 'groupId': 'OG002', 'lowerLimit': '23', 'upperLimit': '31'}]}]}, {'title': 'H1N1- Day 29', 'categories': [{'measurements': [{'value': '647', 'groupId': 'OG000', 'lowerLimit': '562', 'upperLimit': '745'}, {'value': '159', 'groupId': 'OG001', 'lowerLimit': '139', 'upperLimit': '182'}, {'value': '170', 'groupId': 'OG002', 'lowerLimit': '148', 'upperLimit': '194'}]}]}, {'title': 'H3N2 - Day 1', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000', 'lowerLimit': '36', 'upperLimit': '48'}, {'value': '43', 'groupId': 'OG001', 'lowerLimit': '37', 'upperLimit': '49'}, {'value': '43', 'groupId': 'OG002', 'lowerLimit': '38', 'upperLimit': '50'}]}]}, {'title': 'H3N2 - Day 29', 'categories': [{'measurements': [{'value': '1087', 'groupId': 'OG000', 'lowerLimit': '1004', 'upperLimit': '1176'}, {'value': '558', 'groupId': 'OG001', 'lowerLimit': '517', 'upperLimit': '602'}, {'value': '453', 'groupId': 'OG002', 'lowerLimit': '420', 'upperLimit': '490'}]}]}, {'title': 'B strain Day 1', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000', 'lowerLimit': '9.29', 'upperLimit': '11'}, {'value': '10', 'groupId': 'OG001', 'lowerLimit': '9.57', 'upperLimit': '11'}, {'value': '10', 'groupId': 'OG002', 'lowerLimit': '9.34', 'upperLimit': '11'}]}]}, {'title': 'B strain Day 29', 'categories': [{'measurements': [{'value': '119', 'groupId': 'OG000', 'lowerLimit': '106', 'upperLimit': '134'}, {'value': '58', 'groupId': 'OG001', 'lowerLimit': '52', 'upperLimit': '65'}, {'value': '61', 'groupId': 'OG002', 'lowerLimit': '54', 'upperLimit': '68'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT ratio (H1N1 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.07', 'ciLowerLimit': '3.34', 'ciUpperLimit': '4.95', 'groupDescription': 'GMTs were considered to be statistically significantly higher if the lower bound of the 95% confidence interval around the vaccine group ratio was \\>1.0', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT ratio (H3N2 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.95', 'ciLowerLimit': '1.74', 'ciUpperLimit': '2.18', 'groupDescription': 'statistically significantly greater response was concluded if the lower bound of the 95% confidence interval around the vaccine group ratio is \\>1.0', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT ratio (B strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.03', 'ciLowerLimit': '1.73', 'ciUpperLimit': '2.39', 'groupDescription': 'statistically significantly greater response was concluded if the lower bound of the 95% CI around the vaccine group ratio was \\>1.0', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'GMT ratio (H1N1 strain)', 'ciPctValue': '95', 'paramValue': '3.82', 'ciLowerLimit': '3.14', 'ciUpperLimit': '4.64', 'groupDescription': 'statistically significantly greater response was concluded if the lower bound of the 95% CI around the vaccine group ratio was \\>1.0', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'GMT ratio (H3N2 strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.4', 'ciLowerLimit': '2.15', 'ciUpperLimit': '2.68', 'groupDescription': 'statistically significantly greater response was concluded if the lower bound of the 95% CI around the vaccine group ratio was \\>1.0', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'GMT ratio (B strain)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.95', 'ciLowerLimit': '1.65', 'ciUpperLimit': '2.29', 'groupDescription': 'statistically significantly greater response was concluded if the lower bound of the 95% CI around the vaccine group ratio was \\>1.0', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1, Day 29', 'description': "To demonstrate the GMTs at three weeks after one dose of aTIV are statistically significantly higher to the corresponding response's of comparator TIV and TIV.", 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on the FAS (Persistence).'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Solicited Adverse Events After Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3082', 'groupId': 'OG000'}, {'value': '1453', 'groupId': 'OG001'}, {'value': '1451', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'aTIV (6 to <72 Months)', 'description': 'Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to \\<36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 \\& 29'}, {'id': 'OG001', 'title': 'TIV (6 to <72 Months)', 'description': 'Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to \\<36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 \\& 29'}, {'id': 'OG002', 'title': 'Comparator TIV (6 to <72 Months)', 'description': 'Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to \\<36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 \\& 29'}], 'classes': [{'title': 'Any local', 'categories': [{'measurements': [{'value': '1082', 'groupId': 'OG000'}, {'value': '292', 'groupId': 'OG001'}, {'value': '311', 'groupId': 'OG002'}]}]}, {'title': 'Injection site ecchymosis(N=3075,1450,1446)', 'categories': [{'measurements': [{'value': '191', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}]}]}, {'title': 'Injection site erythema (N=3075,1450,1446)', 'categories': [{'measurements': [{'value': '312', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}, {'value': '101', 'groupId': 'OG002'}]}]}, {'title': 'Injection site induration (N=3075,1450,1446)', 'categories': [{'measurements': [{'value': '258', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}]}, {'title': 'Injection site tenderness (N=1495,1025,1012)', 'categories': [{'measurements': [{'value': '152', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}]}]}, {'title': 'Injection site swelling (N=3075,1450,1446)', 'categories': [{'measurements': [{'value': '217', 'groupId': 'OG000'}, {'value': '1450', 'groupId': 'OG001'}, {'value': '1446', 'groupId': 'OG002'}]}]}, {'title': 'Injection site pain (N=1580,422,429)', 'categories': [{'measurements': [{'value': '1580', 'groupId': 'OG000'}, {'value': '422', 'groupId': 'OG001'}, {'value': '429', 'groupId': 'OG002'}]}]}, {'title': 'Any systemic', 'categories': [{'measurements': [{'value': '1487', 'groupId': 'OG000'}, {'value': '604', 'groupId': 'OG001'}, {'value': '569', 'groupId': 'OG002'}]}]}, {'title': 'chills (N=1578,423,428)', 'categories': [{'measurements': [{'value': '154', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}]}, {'title': 'Myalgia (N=1578,423,429)', 'categories': [{'measurements': [{'value': '216', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}]}, {'title': 'Arthralgia (N=1578,423,429)', 'categories': [{'measurements': [{'value': '125', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}]}, {'title': 'Headache (N=1578,423,429)', 'categories': [{'measurements': [{'value': '282', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}]}, {'title': 'Fatigue (N=1578,423,430)', 'categories': [{'measurements': [{'value': '204', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}]}, {'title': 'Eating Habit (N=3076,1450,1446)', 'categories': [{'measurements': [{'value': '437', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}, {'value': '205', 'groupId': 'OG002'}]}]}, {'title': 'Diarrhea (N=3075,1450,1447)', 'categories': [{'measurements': [{'value': '423', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}, {'value': '220', 'groupId': 'OG002'}]}]}, {'title': 'Irritability (N=1496,1024,1013)', 'categories': [{'measurements': [{'value': '290', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}, {'value': '190', 'groupId': 'OG002'}]}]}, {'title': 'Crying (N=1463,1001,990)', 'categories': [{'measurements': [{'value': '186', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}]}]}, {'title': 'Sleepiness (N=1495,1024,1012)', 'categories': [{'measurements': [{'value': '229', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}, {'value': '153', 'groupId': 'OG002'}]}]}, {'title': 'Vomiting (N=3075,1451,1446)', 'categories': [{'measurements': [{'value': '249', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '104', 'groupId': 'OG002'}]}]}, {'title': 'Fever (≥38°C) (N=3074,1450,1446)', 'categories': [{'measurements': [{'value': '748', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}, {'value': '224', 'groupId': 'OG002'}]}]}, {'title': 'Any other', 'categories': [{'measurements': [{'value': '1047', 'groupId': 'OG000'}, {'value': '310', 'groupId': 'OG001'}, {'value': '317', 'groupId': 'OG002'}]}]}, {'title': 'Axillary Temperature (≥40°C) (N=3074,1450,1446)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Analgesic Antipyretic Med. used(N=3076,1448,1444)', 'categories': [{'measurements': [{'value': '984', 'groupId': 'OG000'}, {'value': '285', 'groupId': 'OG001'}, {'value': '282', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 through Day 7 after any vaccination', 'description': 'The number of subjects reporting any solicited local and systemic adverse events (AEs), following vaccination with aTIV or licensed comparator or TIV.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on solicited safety set i.e all subjects who had received at least one study vaccine and had provided data on post vaccination solicited AEs'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Unsolicited Adverse Events After Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3123', 'groupId': 'OG000'}, {'value': '1474', 'groupId': 'OG001'}, {'value': '1477', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'aTIV (6 to <72 Months)', 'description': 'Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to \\<36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 \\& 29'}, {'id': 'OG001', 'title': 'Comparator TIV (6 to <72 Months)', 'description': 'Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to \\<36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 \\& 29'}, {'id': 'OG002', 'title': 'TIV (6 to <72 Months)', 'description': 'Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to \\<36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 \\& 29'}], 'classes': [{'title': 'Any AEs (Day 1 to Day 50)', 'categories': [{'measurements': [{'value': '1541', 'groupId': 'OG000'}, {'value': '859', 'groupId': 'OG001'}, {'value': '808', 'groupId': 'OG002'}]}]}, {'title': 'Possibly/probably related AEs(Day 1 to Day 50)', 'categories': [{'measurements': [{'value': '158', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}]}]}, {'title': 'Any SAEs', 'categories': [{'measurements': [{'value': '115', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}]}]}, {'title': 'Possibly/probably related SAE', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'AE leading to WD', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'NOCD', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}]}, {'title': 'AESI', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Deaths', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 to Day 394', 'description': 'The number of subjects reporting any unsolicited adverse events (AEs) between Day 1 to Day 50, serious adverse events (SAEs), AE leading to withdrawal (WD), new onset of chronic disease(NOCD), adverse events of special interest following vaccination with aTIV or licensed comparator or TIV throughout the study (Day 1 to Day 394).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on the safety population i.e all subjects who had received at least one study vaccine and had postvaccination safety data'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'aTIV (6 to <72 Months)', 'description': 'Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to \\<36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 \\& 29'}, {'id': 'FG001', 'title': 'Comparator TIV (6 to <72 Months)', 'description': 'Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to \\<36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 \\& 29'}, {'id': 'FG002', 'title': 'TIV (6 to <72 Months)', 'description': 'Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to \\<36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 \\& 29'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3136'}, {'groupId': 'FG001', 'numSubjects': '1478'}, {'groupId': 'FG002', 'numSubjects': '1486'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2983'}, {'groupId': 'FG001', 'numSubjects': '1389'}, {'groupId': 'FG002', 'numSubjects': '1408'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '153'}, {'groupId': 'FG001', 'numSubjects': '89'}, {'groupId': 'FG002', 'numSubjects': '78'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '62'}, {'groupId': 'FG001', 'numSubjects': '29'}, {'groupId': 'FG002', 'numSubjects': '29'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '77'}, {'groupId': 'FG001', 'numSubjects': '51'}, {'groupId': 'FG002', 'numSubjects': '38'}]}, {'type': 'Inappropriate enrollment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Administrative reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Unable to Classify', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '6'}]}]}], 'recruitmentDetails': 'Participants were enrolled from 8 sites in Argentina, 5 sites in Australia, 2 sites in Chile, 12 sites in Philippines, and 5 sites in South Africa.', 'preAssignmentDetails': '4 of the enrolled subjects were not randomized hence were not included in the trial.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3136', 'groupId': 'BG000'}, {'value': '1478', 'groupId': 'BG001'}, {'value': '1486', 'groupId': 'BG002'}, {'value': '6100', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'aTIV (6 to <72 Months)', 'description': 'Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to \\<36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 \\& 29'}, {'id': 'BG001', 'title': 'Comparator TIV (6 to <72 Months)', 'description': 'Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to \\<36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 \\& 29'}, {'id': 'BG002', 'title': 'TIV (6 to <72 Months)', 'description': 'Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to \\<36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 \\& 29'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37.1', 'spread': '18.6', 'groupId': 'BG000'}, {'value': '30.0', 'spread': '16.9', 'groupId': 'BG001'}, {'value': '30.2', 'spread': '16.9', 'groupId': 'BG002'}, {'value': '33.7', 'spread': '18.1', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1545', 'groupId': 'BG000'}, {'value': '745', 'groupId': 'BG001'}, {'value': '731', 'groupId': 'BG002'}, {'value': '3021', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '1591', 'groupId': 'BG000'}, {'value': '733', 'groupId': 'BG001'}, {'value': '755', 'groupId': 'BG002'}, {'value': '3079', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6104}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'dispFirstSubmitDate': '2012-11-16', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-04', 'studyFirstSubmitDate': '2011-04-30', 'dispFirstSubmitQcDate': '2012-11-16', 'resultsFirstSubmitDate': '2014-01-27', 'studyFirstSubmitQcDate': '2011-05-02', 'dispFirstPostDateStruct': {'date': '2012-11-22', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2015-03-26', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-04-03', 'studyFirstPostDateStruct': {'date': '2011-05-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-05-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of Geometric Mean Titers (GMTs) Against Homologous Strains', 'timeFrame': 'Day 1, Day 50', 'description': 'The non-inferiority of Hemagglutination Inhibition (HI) antibody responses of aTIV compared to TIV and comparator TIV assessed in terms of post vaccination GMTs at three weeks after last vaccination against the three homologous vaccine strains.'}, {'measure': 'Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of Percentage of Subjects Achieving Seroconversion or ≥4-fold Increase in HI Titers Against Homologous Strains', 'timeFrame': 'Day 50', 'description': 'The non-inferiority of HI antibody responses of aTIV compared to TIV and comparator TIV assessed in terms of percentage of subjects achieving seroconversion or ≥4-fold increase in HI titers at three weeks after last vaccination against the three homologous vaccine strains.\n\nSeroconversion defined as prevaccination HI titer \\<10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10.'}, {'measure': 'Comparison of Antibody Responses of TIV Versus Comparator TIV in Terms of Geometric Mean Titers (GMTs) Against Homologous Strains (6 to <36 Months)', 'timeFrame': 'Day 1, Day 50', 'description': 'The non-inferiority of HI antibody responses of TIV to that of comparator TIV, in subjects aged 6 to \\<36 Months, assessed in terms of post vaccination GMTs at three weeks after last vaccination against the three homologous vaccine strains.'}, {'measure': 'Comparison of Antibody Responses of TIV Versus Comparator TIV in Terms of Percentage of Subjects Achieving Seroconversion or ≥4-fold Increase in HI Titer Against Homologous Strains in Subjects 6 to <36 Months of Age', 'timeFrame': 'Day 50', 'description': 'The non-inferiority of HI antibody responses of TIV to that of the licensed comparator TIV assessed in terms of percentage of subjects achieving seroconversion or ≥4-fold increase in HI titers at three weeks after last vaccination against the three homologous vaccine strains.'}], 'secondaryOutcomes': [{'measure': 'Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains (6 to <24 Months)', 'timeFrame': 'Day 1, Day 50', 'description': 'The superiority of HI antibody responses, in subjects 6 to \\<24 months of age, of aTIV compared to TIV and comparator TIV assessed in terms of post vaccination GMTs at three weeks after last vaccination against the three homologous vaccine strains.'}, {'measure': 'Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms Percentage of Subjects Achieving Seroconversion or ≥4-fold Increase in HI Titer Against Homologous Strains (6 to <24 Months)', 'timeFrame': 'Day 50', 'description': 'The superiority of HI antibody responses, in subjects 6 to \\<24 months of age, of aTIV compared to TIV and comparator TIV assessed in terms of number of subjects achieving seroconversion at three weeks after last vaccination against the three homologous vaccine strains.'}, {'measure': 'Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains (6 to <72 Months)-FAS', 'timeFrame': 'Day 1, Day 50', 'description': 'The superiority of HI antibody responses, in subjects 6 to \\<72 months of age, of aTIV compared to TIV and comparator TIV assessed in terms of post vaccination GMTs at three weeks after last vaccination against the three homologous vaccine strains.'}, {'measure': 'Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of Percentage of Subjects Achieving Seroconversion or ≥4 Fold Increase in HI Titers Against Homologous Strains (6 to <72 Months)-FAS', 'timeFrame': 'Day 50', 'description': 'The superiority of HI antibody responses, in subjects 6 to \\<24 months of age, of aTIV compared to TIV and comparator TIV assessed in terms of number of subjects achieving seroconversion ≥4 fold increase in HI titers at three weeks after last vaccination against the three homologous vaccine strains.'}, {'measure': 'The HI GMTs Against Homologous Strains, by Vaccine Group', 'timeFrame': 'Day 1, Day 29, Day 50, Day 209', 'description': 'The HI antibody titers against the three homologous strains following vaccination with either aTIV, licensed comparator or TIV, at three weeks and at six months after vaccination are reported as GMTs.'}, {'measure': 'Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination HI Titers Against Homologous Strains', 'timeFrame': 'Day 29, Day 50, Day 209', 'description': 'The GMR of post-vaccination versus pre-vaccination HI titers against homologous strains, three weeks (day 29/day 1; day 50/day 1)and six months (day 209/day 1) after vaccination with either aTIV, licensed comparator or TIV.'}, {'measure': 'Percentage of Subjects With HI Titers ≥40 Against Homologous Strains, by Vaccine Group', 'timeFrame': 'Day 1, Day 29, Day 50, Day 209', 'description': 'The percentage of subjects demonstrating HI titers ≥40,against homologous strains, at three weeks and six months after vaccination with aTIV or licensed comparator or TIV.'}, {'measure': 'Percentage of Subjects Achieving Seroconversion or ≥4 Fold Increase in HI Titers, Against Homologous Strains', 'timeFrame': 'Day 29, Day 50, Day 209', 'description': 'The percentage of subjects achieving seroconversion ≥4 fold increase in HI titers from baseline, against homologous strains, at three weeks and six months after vaccination with ATIV or licensed comparator or TIV.'}, {'measure': 'Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains, Subjects at Risk/Not at Risk, by Age Subgroup', 'timeFrame': 'Day 50', 'description': 'The non-inferiority of Hemagglutination Inhibition (HI) antibody responses of aTIV compared to TIV and comparator TIV assessed in terms of post vaccination GMTs at three weeks after last vaccination against the three homologous vaccine strains, in subjects with a defined set of underlying medical conditions (at risk) and healthy subjects (not at risk), by age sub group.'}, {'measure': 'Comparison of Antibody Responses of aTIV Versus Comparator TIV and TIV in Terms of Percentage of Subjects Achieving Seroconversion or ≥4-fold Increase in HI Titer Against Homologous Strains in Subjects at Risk/Not at Risk, by Age Subgroup', 'timeFrame': 'Day 50', 'description': 'The non-inferiority of HI antibody responses of aTIV to that of the licensed comparator TIV and to investigational TIV was assessed in terms of percentage of subjects achieving seroconversion or ≥4-fold increase in HI titers at three weeks after last vaccination against the three homologous vaccine strains in subjects with a defined set of underlying medical conditions (at risk) and in healthy subjects (not at risk) , by age sub group.'}, {'measure': 'Comparison of Antibody Responses of TIV Versus Comparator TIV in Terms of Percentage of Subjects Achieving Seroconversion or ≥4-fold Increase in HI Titer Against Homologous Strains in Subjects at Risk/Not at Risk, by Age Sub Group-FAS', 'timeFrame': 'Day 50', 'description': 'The superiority of HI antibody responses of aTIV compared to TIV and comparator TIV assessed in terms of of percentage of subjects achieving seroconversion or ≥4-fold increase in HI Titer at three weeks after last vaccination against the three homologous vaccine strains in subjects with a defined set of underlying medical conditions (at risk) and healthy subjects (not at risk), by age sub group.'}, {'measure': 'Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains, at Risk/Not at Risk, by Age Sub Group-FAS', 'timeFrame': 'Day 50', 'description': 'The superiority of HI antibody responses of aTIV compared to TIV and comparator TIV assessed in terms of post vaccination GMTs at three weeks after last vaccination against the three homologous vaccine strains, in subjects with a defined set of underlying medical conditions (at risk) and in healthy subjects (not at risk), by age sub group.'}, {'measure': 'The HI GMTs Against Heterologous Strains, by Vaccine Group (6 to <72 Months Age Group)', 'timeFrame': 'Day 1, Day 50, Day 209', 'description': 'The HI antibody titers against the heterologous strains following vaccination with either aTIV, licensed comparator or TIV, at three weeks and at six months after vaccination are reported as GMTs.'}, {'measure': 'Percentage of Subjects Achieving Seroconversion or ≥4 Fold Increase in HI Titers, Against Heterologous Strains', 'timeFrame': 'Day 50, Day 209', 'description': 'The percentage of subjects achieving seroconversion or ≥4 fold increase in HI titers from baseline, against heterologous strains, at three weeks and six months after last vaccination with aTIV or licensed comparator or TIV.'}, {'measure': 'Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains, After One Vaccination', 'timeFrame': 'Day 1, Day 29', 'description': "To demonstrate the GMTs at three weeks after one dose of aTIV are statistically significantly higher to the corresponding response's of comparator TIV and TIV."}, {'measure': 'Number of Subjects Reporting Solicited Adverse Events After Vaccination', 'timeFrame': 'Day 1 through Day 7 after any vaccination', 'description': 'The number of subjects reporting any solicited local and systemic adverse events (AEs), following vaccination with aTIV or licensed comparator or TIV.'}, {'measure': 'Number of Subjects Reporting Unsolicited Adverse Events After Vaccination', 'timeFrame': 'Day 1 to Day 394', 'description': 'The number of subjects reporting any unsolicited adverse events (AEs) between Day 1 to Day 50, serious adverse events (SAEs), AE leading to withdrawal (WD), new onset of chronic disease(NOCD), adverse events of special interest following vaccination with aTIV or licensed comparator or TIV throughout the study (Day 1 to Day 394).'}]}, 'conditionsModule': {'keywords': ['Adjuvanted Trivalent Subunit Influenza Vaccine', 'vaccine', 'influenza', 'adjuvant', 'MF-59', 'pediatric'], 'conditions': ['Influenza Disease']}, 'referencesModule': {'references': [{'pmid': '25223266', 'type': 'DERIVED', 'citation': 'Nolan T, Bravo L, Ceballos A, Mitha E, Gray G, Quiambao B, Patel SS, Bizjajeva S, Bock H, Nazaire-Bermal N, Forleo-Neto E, Cioppa GD, Narasimhan V. Enhanced and persistent antibody response against homologous and heterologous strains elicited by a MF59-adjuvanted influenza vaccine in infants and young children. Vaccine. 2014 Oct 21;32(46):6146-56. doi: 10.1016/j.vaccine.2014.08.068. Epub 2014 Sep 16.'}]}, 'descriptionModule': {'briefSummary': 'This Study Aims to Evaluate the Safety, Tolerability, and Immunogenicity of the Adjuvanted Trivalent Subunit Influenza Vaccine and the Non-Adjuvanted Trivalent Subunit Influenza Vaccine Compared to the Non-Adjuvanted Trivalent Split Influenza Vaccine in Children 6 to \\< 72 Months of Age.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '72 Months', 'minimumAge': '6 Months', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1.Children 6 months to 72 months of age.\n\nExclusion Criteria:Children\n\n1. Who had been hospitalized at the time of enrollment\n2. Who had any serious reaction or hypersensitivity to any vaccine component, eggs, or chicken protein\n3. Who had known impairment of the immune function\n4. Who had fever interfering with normal daily activities at the time of enrollment\n5. Who had received licensed vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrollment in the study\n6. Concomitant participation in another clinical study\n7. Who had surgery planned during the study period that in the investigator's opinion would have interfered with the study visits schedule."}, 'identificationModule': {'nctId': 'NCT01346592', 'briefTitle': 'Safety, Tolerability, and Immunogenicity of the Adjuvanted Trivalent Subunit Influenza Vaccine and the Non-Adjuvanted Trivalent Subunit Influenza Vaccine Compared to the Non-Adjuvanted Trivalent Split Influenza Vaccine in Children 6 to < 72 Months of Age', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Phase III, Observer-Blind, Randomized, Multi-center Study to Evaluate the Safety, Tolerability, and Immunogenicity of Fluad and Agriflu Compared to the Non-adjuvanted Trivalent Influenza Vaccine Fluzone in Children 6 to < 72 Months of Age', 'orgStudyIdInfo': {'id': 'V70_29'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'aTIV (6 to <72 months)', 'description': 'Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to \\<36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 \\& 29', 'interventionNames': ['Biological: MF59-adjuvanted trivalent influenza vaccine (aTIV)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Comparator TIV (6 to <72 months)', 'description': 'Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to \\<36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 \\& 29', 'interventionNames': ['Biological: Licensed comparator trivalent split influenza vaccine (comparator TIV)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TIV (6 to <72 months)', 'description': 'Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to \\<36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 \\& 29', 'interventionNames': ['Biological: Trivalent split influenza vaccine (TIV)']}], 'interventions': [{'name': 'Trivalent split influenza vaccine (TIV)', 'type': 'BIOLOGICAL', 'otherNames': ['Agriflu'], 'armGroupLabels': ['TIV (6 to <72 months)']}, {'name': 'MF59-adjuvanted trivalent influenza vaccine (aTIV)', 'type': 'BIOLOGICAL', 'otherNames': ['Fluad'], 'armGroupLabels': ['aTIV (6 to <72 months)']}, {'name': 'Licensed comparator trivalent split influenza vaccine (comparator TIV)', 'type': 'BIOLOGICAL', 'otherNames': ['Fluzone'], 'armGroupLabels': ['Comparator TIV (6 to <72 months)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Buenos Aires', 'country': 'Argentina', 'facility': '401 Paideia Jeronimo Salguero 2835 Piso 1', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'city': 'Buenos Aires', 'country': 'Argentina', 'facility': '402 Hospital de Ninos Gallo 130', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'city': 'Córdoba', 'country': 'Argentina', 'facility': '403 Instituto Medico Rio Cuarto Hipolito Yrigoyen 1020', 'geoPoint': {'lat': -31.40648, 'lon': -64.18853}}, {'city': 'Córdoba', 'country': 'Argentina', 'facility': '405 Hospital Pediatrico Nino Jesus Castro Barros 650', 'geoPoint': {'lat': -31.40648, 'lon': -64.18853}}, {'city': 'Córdoba', 'country': 'Argentina', 'facility': '406 Hospital Nostra Senora de la Misericordia Belgrano 1500', 'geoPoint': {'lat': -31.40648, 'lon': -64.18853}}, {'zip': '1406', 'city': 'Cuidad Automa de Beunos Aires', 'country': 'Argentina', 'facility': '407 Centro Pediatrico Caballito Directorio 1658'}, {'city': 'Mendoza', 'country': 'Argentina', 'facility': '408 Centro de Salud 31 Serpa y Republica del Libano', 'geoPoint': {'lat': -32.88946, 'lon': -68.84582}}, {'city': 'Villa Nueva', 'country': 'Argentina', 'facility': '409 Centro de Salud 16 Alpatacal y Chile', 'geoPoint': {'lat': -32.89737, 'lon': -68.7871}}, {'zip': '5006', 'city': 'Adelaide', 'country': 'Australia', 'facility': '206 Vaccine and Immunology Research Trials Unit University Department of Paediatrics 2nd floor Clarence Reiger Bldg Womens and Childrens Hospital', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'zip': '4029', 'city': 'Herston', 'country': 'Australia', 'facility': '201 Royal Children Hospital Department of Respiratory Medicine', 'geoPoint': {'lat': -27.44453, 'lon': 153.01852}}, {'city': 'Level 5 207 Bouverie Saint', 'country': 'Australia', 'facility': '205 Vaccine and Immunisation Research Group Murdoch Childrens Research Institute School Of Population Health'}, {'zip': '2031', 'city': 'Randwick', 'country': 'Australia', 'facility': '202 Sydney Children Hospital Department of Immunology and Infectious Diseases', 'geoPoint': {'lat': -33.91439, 'lon': 151.24895}}, {'zip': '2145', 'city': 'Westmead', 'country': 'Australia', 'facility': '204 National Centre for Immunisation Research and Surveillance Kids Research Institute The Childrens Hospital at Westmead', 'geoPoint': {'lat': -33.80383, 'lon': 150.98768}}, {'city': 'Santiago', 'country': 'Chile', 'facility': '502 Hospital Clinico Pontificia Universidad Catolica de Chile Marcoleta 357', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'city': 'Santiago', 'country': 'Chile', 'facility': '503 Clinica Tabancura Av Tabancura 1185', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'zip': '4114', 'city': 'Cavite', 'country': 'Philippines', 'facility': '111 DLSHI deCastro De La Salle Health Sciences Institute DBB B Dasmarinas', 'geoPoint': {'lat': 15.67785, 'lon': 120.76978}}, {'city': 'City of Muntinlupa', 'country': 'Philippines', 'facility': '106 Research Institute for Tropical Medicine Alabang Muntinlupa', 'geoPoint': {'lat': 14.39028, 'lon': 121.0475}}, {'city': 'City of Muntinlupa', 'country': 'Philippines', 'facility': '108 RITM Research Institute for Tropical Medicine Department of Health Compound FILINVEST Corporate City Alabang', 'geoPoint': {'lat': 14.39028, 'lon': 121.0475}}, {'zip': '4114', 'city': 'Dbbb Dasmarinas Cavite', 'country': 'Philippines', 'facility': '109 De La Salle Health Sciences Institute'}, {'zip': '4114', 'city': 'Dbbb Dasmarinas Cavite', 'country': 'Philippines', 'facility': '110 De La Salle Health Sciences Institute'}, {'zip': '1000', 'city': 'Manila', 'country': 'Philippines', 'facility': '103 Philippine General Hospital Taft Avenue', 'geoPoint': {'lat': 14.6042, 'lon': 120.9822}}, {'zip': '1000', 'city': 'Manila', 'country': 'Philippines', 'facility': '107 Philippine General Hospital Taft Avenue', 'geoPoint': {'lat': 14.6042, 'lon': 120.9822}}, {'zip': '1000', 'city': 'Manila', 'country': 'Philippines', 'facility': '112 PGH Lim Philippine General Hospital Taft Avenue', 'geoPoint': {'lat': 14.6042, 'lon': 120.9822}}, {'zip': '1000', 'city': 'Manila', 'country': 'Philippines', 'facility': '114 Philippine General Hospital Taft Avenue', 'geoPoint': {'lat': 14.6042, 'lon': 120.9822}}, {'zip': '1008', 'city': 'Manila', 'country': 'Philippines', 'facility': '105 Mary Chiles General Hospital 667 Gastambide St Sampaloc Manila', 'geoPoint': {'lat': 14.6042, 'lon': 120.9822}}, {'city': 'Quezon', 'country': 'Philippines', 'facility': '102 University of the East Ramon Magsaysay Memorial 64 Aurora Boulevard Barangay Dona Imelda', 'geoPoint': {'lat': 7.73028, 'lon': 125.09889}}, {'city': 'Quezon City', 'country': 'Philippines', 'facility': '101 Philippine Childrens Medical Center Quezon Avenue cor Agham Road Quezon City', 'geoPoint': {'lat': 14.6488, 'lon': 121.0509}}, {'city': 'Quezon City', 'country': 'Philippines', 'facility': '104 Philippine Childrens Medical Center Quezon Avenue cor Agham Road Quezon City', 'geoPoint': {'lat': 14.6488, 'lon': 121.0509}}, {'city': 'Quezon City', 'country': 'Philippines', 'facility': '113 Philippine Childrens Medical Center Quezon Avenue cor Agham Road Quezon City', 'geoPoint': {'lat': 14.6488, 'lon': 121.0509}}, {'zip': '1500', 'city': 'Benoni', 'country': 'South Africa', 'facility': '305 Worthwhile Clinical Trials Lakeview Hospital 1 Mowbray Avenue', 'geoPoint': {'lat': -26.18848, 'lon': 28.32078}}, {'zip': '2113', 'city': 'Johannesburg', 'country': 'South Africa', 'facility': '304 Newgate Centre Suite 3', 'geoPoint': {'lat': -26.20227, 'lon': 28.04363}}, {'zip': '0084', 'city': 'Pretoria', 'country': 'South Africa', 'facility': '303 Emmed Research', 'geoPoint': {'lat': -25.74486, 'lon': 28.18783}}, {'city': 'Soweto', 'country': 'South Africa', 'facility': '301 Perinatal HIV Research Unit, Baragwanath Hospital', 'geoPoint': {'lat': -26.26781, 'lon': 27.85849}}, {'city': 'Soweto', 'country': 'South Africa', 'facility': '302 Soweto Clinical Research', 'geoPoint': {'lat': -26.26781, 'lon': 27.85849}}], 'overallOfficials': [{'name': 'Novartis Vaccines', 'role': 'STUDY_CHAIR', 'affiliation': 'Novartis Vaccines'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Vaccines', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}