Viewing Study NCT00644059

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Ignite Creation Date: 2025-12-24 @ 3:02 PM
Ignite Modification Date: 2026-01-29 @ 4:02 PM
Study NCT ID: NCT00644059
Status: COMPLETED
Last Update Posted: 2015-09-18
First Post: 2008-03-20
Is Gene Therapy: True
Has Adverse Events: True
Brief Title: Study to Evaluate the Efficacy, Safety and Immunogenicity of Influenza Vaccine in Healthy Subjects (Aged 6 to <72 Months) Versus Control Vaccines
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007251', 'term': 'Influenza, Human'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009976', 'term': 'Orthomyxoviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C478243', 'term': 'fluad vaccine'}, {'id': 'C410218', 'term': 'serogroup C meningococcal conjugate vaccine'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'RegistryContactVaccinesUS@novartis.com', 'title': 'Posting Director', 'organization': 'Novartis Vaccines and Diagnostics'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '3 years (3 consecutive influenza seasons: 2007/08, 2008/09 and 2009/10).', 'description': '15 subjects were excluded from safety analysis either because the subjects did not receive any of the study vaccines or the subjects received wrong vaccine at one of the visits.', 'eventGroups': [{'id': 'EG000', 'title': 'TIV-adj_0.25', 'description': 'Subjects aged 6 to \\< 36 months received 0.25 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine', 'otherNumAtRisk': 1177, 'otherNumAffected': 1101, 'seriousNumAtRisk': 1177, 'seriousNumAffected': 91}, {'id': 'EG001', 'title': 'TIV-adj_0.5', 'description': 'Subjects aged 36 to \\< 72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine', 'otherNumAtRisk': 835, 'otherNumAffected': 769, 'seriousNumAtRisk': 835, 'seriousNumAffected': 31}, {'id': 'EG002', 'title': 'Flu-control_0.25', 'description': 'Subjects aged 6 to \\< 36 months received 0.25 mL of each injection of non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine', 'otherNumAtRisk': 1069, 'otherNumAffected': 989, 'seriousNumAtRisk': 1069, 'seriousNumAffected': 104}, {'id': 'EG003', 'title': 'Flu-control_0.5', 'description': 'Subjects aged 36 to \\< 72 months received 0.5 mL of each injection of non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine', 'otherNumAtRisk': 777, 'otherNumAffected': 686, 'seriousNumAtRisk': 777, 'seriousNumAffected': 65}, {'id': 'EG004', 'title': 'Non-Flu-control (TBE/Men C Vaccine)', 'description': 'Subjects aged 6 to \\<12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to \\<72 months received 2 doses of 0.25 mL of TBE vaccine', 'otherNumAtRisk': 607, 'otherNumAffected': 567, 'seriousNumAtRisk': 607, 'seriousNumAffected': 65}, {'id': 'EG005', 'title': 'Non-Flu-control (TBE Vaccine)', 'description': 'Subjects aged 6 to \\<12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to \\<72 months received 2 doses of 0.25 mL of TBE vaccine', 'otherNumAtRisk': 422, 'otherNumAffected': 375, 'seriousNumAtRisk': 422, 'seriousNumAffected': 45}], 'otherEvents': [{'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1177, 'numAffected': 164}, {'groupId': 'EG001', 'numAtRisk': 835, 'numAffected': 83}, {'groupId': 'EG002', 'numAtRisk': 1069, 'numAffected': 156}, {'groupId': 'EG003', 'numAtRisk': 777, 'numAffected': 65}, {'groupId': 'EG004', 'numAtRisk': 607, 'numAffected': 91}, {'groupId': 'EG005', 'numAtRisk': 422, 'numAffected': 45}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1177, 'numAffected': 309}, {'groupId': 'EG001', 'numAtRisk': 835, 'numAffected': 45}, {'groupId': 'EG002', 'numAtRisk': 1069, 'numAffected': 260}, {'groupId': 'EG003', 'numAtRisk': 777, 'numAffected': 35}, {'groupId': 'EG004', 'numAtRisk': 607, 'numAffected': 147}, {'groupId': 'EG005', 'numAtRisk': 422, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1177, 'numAffected': 188}, {'groupId': 'EG001', 'numAtRisk': 835, 'numAffected': 64}, {'groupId': 'EG002', 'numAtRisk': 1069, 'numAffected': 166}, {'groupId': 'EG003', 'numAtRisk': 777, 'numAffected': 70}, {'groupId': 'EG004', 'numAtRisk': 607, 'numAffected': 102}, {'groupId': 'EG005', 'numAtRisk': 422, 'numAffected': 23}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1177, 'numAffected': 77}, {'groupId': 'EG001', 'numAtRisk': 835, 'numAffected': 131}, {'groupId': 'EG002', 'numAtRisk': 1069, 'numAffected': 69}, {'groupId': 'EG003', 'numAtRisk': 777, 'numAffected': 51}, {'groupId': 'EG004', 'numAtRisk': 607, 'numAffected': 50}, {'groupId': 'EG005', 'numAtRisk': 422, 'numAffected': 37}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1177, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 835, 'numAffected': 338}, {'groupId': 'EG002', 'numAtRisk': 1069, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 777, 'numAffected': 224}, {'groupId': 'EG004', 'numAtRisk': 607, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 422, 'numAffected': 122}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1177, 'numAffected': 423}, {'groupId': 'EG001', 'numAtRisk': 835, 'numAffected': 321}, {'groupId': 'EG002', 'numAtRisk': 1069, 'numAffected': 325}, {'groupId': 'EG003', 'numAtRisk': 777, 'numAffected': 268}, {'groupId': 'EG004', 'numAtRisk': 607, 'numAffected': 240}, {'groupId': 'EG005', 'numAtRisk': 422, 'numAffected': 128}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Injection site haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1177, 'numAffected': 146}, {'groupId': 'EG001', 'numAtRisk': 835, 'numAffected': 131}, {'groupId': 'EG002', 'numAtRisk': 1069, 'numAffected': 107}, {'groupId': 'EG003', 'numAtRisk': 777, 'numAffected': 93}, {'groupId': 'EG004', 'numAtRisk': 607, 'numAffected': 69}, {'groupId': 'EG005', 'numAtRisk': 422, 'numAffected': 49}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Injection site induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1177, 'numAffected': 214}, {'groupId': 'EG001', 'numAtRisk': 835, 'numAffected': 169}, {'groupId': 'EG002', 'numAtRisk': 1069, 'numAffected': 131}, {'groupId': 'EG003', 'numAtRisk': 777, 'numAffected': 152}, {'groupId': 'EG004', 'numAtRisk': 607, 'numAffected': 154}, {'groupId': 'EG005', 'numAtRisk': 422, 'numAffected': 79}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1177, 'numAffected': 334}, {'groupId': 'EG001', 'numAtRisk': 835, 'numAffected': 478}, {'groupId': 'EG002', 'numAtRisk': 1069, 'numAffected': 250}, {'groupId': 'EG003', 'numAtRisk': 777, 'numAffected': 360}, {'groupId': 'EG004', 'numAtRisk': 607, 'numAffected': 173}, {'groupId': 'EG005', 'numAtRisk': 422, 'numAffected': 179}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1177, 'numAffected': 123}, {'groupId': 'EG001', 'numAtRisk': 835, 'numAffected': 156}, {'groupId': 'EG002', 'numAtRisk': 1069, 'numAffected': 90}, {'groupId': 'EG003', 'numAtRisk': 777, 'numAffected': 128}, {'groupId': 'EG004', 'numAtRisk': 607, 'numAffected': 83}, {'groupId': 'EG005', 'numAtRisk': 422, 'numAffected': 54}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1177, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 835, 'numAffected': 196}, {'groupId': 'EG002', 'numAtRisk': 1069, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 777, 'numAffected': 120}, {'groupId': 'EG004', 'numAtRisk': 607, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 422, 'numAffected': 64}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1177, 'numAffected': 482}, {'groupId': 'EG001', 'numAtRisk': 835, 'numAffected': 299}, {'groupId': 'EG002', 'numAtRisk': 1069, 'numAffected': 412}, {'groupId': 'EG003', 'numAtRisk': 777, 'numAffected': 183}, {'groupId': 'EG004', 'numAtRisk': 607, 'numAffected': 221}, {'groupId': 'EG005', 'numAtRisk': 422, 'numAffected': 125}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1177, 'numAffected': 169}, {'groupId': 'EG001', 'numAtRisk': 835, 'numAffected': 68}, {'groupId': 'EG002', 'numAtRisk': 1069, 'numAffected': 153}, {'groupId': 'EG003', 'numAtRisk': 777, 'numAffected': 66}, {'groupId': 'EG004', 'numAtRisk': 607, 'numAffected': 95}, {'groupId': 'EG005', 'numAtRisk': 422, 'numAffected': 50}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ear infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1177, 'numAffected': 131}, {'groupId': 'EG001', 'numAtRisk': 835, 'numAffected': 57}, {'groupId': 'EG002', 'numAtRisk': 1069, 'numAffected': 132}, {'groupId': 'EG003', 'numAtRisk': 777, 'numAffected': 49}, {'groupId': 'EG004', 'numAtRisk': 607, 'numAffected': 72}, {'groupId': 'EG005', 'numAtRisk': 422, 'numAffected': 22}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1177, 'numAffected': 178}, {'groupId': 'EG001', 'numAtRisk': 835, 'numAffected': 75}, {'groupId': 'EG002', 'numAtRisk': 1069, 'numAffected': 152}, {'groupId': 'EG003', 'numAtRisk': 777, 'numAffected': 85}, {'groupId': 'EG004', 'numAtRisk': 607, 'numAffected': 94}, {'groupId': 'EG005', 'numAtRisk': 422, 'numAffected': 36}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1177, 'numAffected': 153}, {'groupId': 'EG001', 'numAtRisk': 835, 'numAffected': 78}, {'groupId': 'EG002', 'numAtRisk': 1069, 'numAffected': 161}, {'groupId': 'EG003', 'numAtRisk': 777, 'numAffected': 74}, {'groupId': 'EG004', 'numAtRisk': 607, 'numAffected': 89}, {'groupId': 'EG005', 'numAtRisk': 422, 'numAffected': 36}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1177, 'numAffected': 250}, {'groupId': 'EG001', 'numAtRisk': 835, 'numAffected': 109}, {'groupId': 'EG002', 'numAtRisk': 1069, 'numAffected': 226}, {'groupId': 'EG003', 'numAtRisk': 777, 'numAffected': 110}, {'groupId': 'EG004', 'numAtRisk': 607, 'numAffected': 130}, {'groupId': 'EG005', 'numAtRisk': 422, 'numAffected': 62}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1177, 'numAffected': 76}, {'groupId': 'EG001', 'numAtRisk': 835, 'numAffected': 29}, {'groupId': 'EG002', 'numAtRisk': 1069, 'numAffected': 62}, {'groupId': 'EG003', 'numAtRisk': 777, 'numAffected': 37}, {'groupId': 'EG004', 'numAtRisk': 607, 'numAffected': 44}, {'groupId': 'EG005', 'numAtRisk': 422, 'numAffected': 17}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1177, 'numAffected': 260}, {'groupId': 'EG001', 'numAtRisk': 835, 'numAffected': 122}, {'groupId': 'EG002', 'numAtRisk': 1069, 'numAffected': 219}, {'groupId': 'EG003', 'numAtRisk': 777, 'numAffected': 97}, {'groupId': 'EG004', 'numAtRisk': 607, 'numAffected': 123}, {'groupId': 'EG005', 'numAtRisk': 422, 'numAffected': 57}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1177, 'numAffected': 64}, {'groupId': 'EG001', 'numAtRisk': 835, 'numAffected': 38}, {'groupId': 'EG002', 'numAtRisk': 1069, 'numAffected': 42}, {'groupId': 'EG003', 'numAtRisk': 777, 'numAffected': 38}, {'groupId': 'EG004', 'numAtRisk': 607, 'numAffected': 25}, {'groupId': 'EG005', 'numAtRisk': 422, 'numAffected': 25}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1177, 'numAffected': 362}, {'groupId': 'EG001', 'numAtRisk': 835, 'numAffected': 170}, {'groupId': 'EG002', 'numAtRisk': 1069, 'numAffected': 306}, {'groupId': 'EG003', 'numAtRisk': 777, 'numAffected': 156}, {'groupId': 'EG004', 'numAtRisk': 607, 'numAffected': 174}, {'groupId': 'EG005', 'numAtRisk': 422, 'numAffected': 85}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1177, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 835, 'numAffected': 183}, {'groupId': 'EG002', 'numAtRisk': 1069, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 777, 'numAffected': 102}, {'groupId': 'EG004', 'numAtRisk': 607, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 422, 'numAffected': 66}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Crying', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1177, 'numAffected': 373}, {'groupId': 'EG001', 'numAtRisk': 835, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 1069, 'numAffected': 325}, {'groupId': 'EG003', 'numAtRisk': 777, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 607, 'numAffected': 163}, {'groupId': 'EG005', 'numAtRisk': 422, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1177, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 835, 'numAffected': 201}, {'groupId': 'EG002', 'numAtRisk': 1069, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 777, 'numAffected': 120}, {'groupId': 'EG004', 'numAtRisk': 607, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 422, 'numAffected': 66}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1177, 'numAffected': 381}, {'groupId': 'EG001', 'numAtRisk': 835, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1069, 'numAffected': 315}, {'groupId': 'EG003', 'numAtRisk': 777, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 607, 'numAffected': 186}, {'groupId': 'EG005', 'numAtRisk': 422, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Eating disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1177, 'numAffected': 327}, {'groupId': 'EG001', 'numAtRisk': 835, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 1069, 'numAffected': 263}, {'groupId': 'EG003', 'numAtRisk': 777, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 607, 'numAffected': 161}, {'groupId': 'EG005', 'numAtRisk': 422, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1177, 'numAffected': 246}, {'groupId': 'EG001', 'numAtRisk': 835, 'numAffected': 176}, {'groupId': 'EG002', 'numAtRisk': 1069, 'numAffected': 210}, {'groupId': 'EG003', 'numAtRisk': 777, 'numAffected': 166}, {'groupId': 'EG004', 'numAtRisk': 607, 'numAffected': 119}, {'groupId': 'EG005', 'numAtRisk': 422, 'numAffected': 97}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dermatitis diaper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1177, 'numAffected': 76}, {'groupId': 'EG001', 'numAtRisk': 835, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 1069, 'numAffected': 62}, {'groupId': 'EG003', 'numAtRisk': 777, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 607, 'numAffected': 40}, {'groupId': 'EG005', 'numAtRisk': 422, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1177, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 835, 'numAffected': 69}, {'groupId': 'EG002', 'numAtRisk': 1069, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 777, 'numAffected': 42}, {'groupId': 'EG004', 'numAtRisk': 607, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 422, 'numAffected': 31}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1177, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 835, 'numAffected': 85}, {'groupId': 'EG002', 'numAtRisk': 1069, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 777, 'numAffected': 39}, {'groupId': 'EG004', 'numAtRisk': 607, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 422, 'numAffected': 26}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1177, 'numAffected': 63}, {'groupId': 'EG001', 'numAtRisk': 835, 'numAffected': 35}, {'groupId': 'EG002', 'numAtRisk': 1069, 'numAffected': 60}, {'groupId': 'EG003', 'numAtRisk': 777, 'numAffected': 28}, {'groupId': 'EG004', 'numAtRisk': 607, 'numAffected': 20}, {'groupId': 'EG005', 'numAtRisk': 422, 'numAffected': 19}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Enteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1177, 'numAffected': 54}, {'groupId': 'EG001', 'numAtRisk': 835, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 1069, 'numAffected': 60}, {'groupId': 'EG003', 'numAtRisk': 777, 'numAffected': 18}, {'groupId': 'EG004', 'numAtRisk': 607, 'numAffected': 33}, {'groupId': 'EG005', 'numAtRisk': 422, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}], 'seriousEvents': [{'term': 'Lymphadenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1177, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 835, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1069, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 777, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 607, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 422, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1177, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 835, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1069, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 777, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 607, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 422, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cyanosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1177, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 835, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1069, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 777, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 607, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 422, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1177, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 835, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1069, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 777, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 607, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 422, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hydrocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1177, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 835, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1069, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 777, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 607, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 422, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Autoimmune thyroiditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1177, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 835, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1069, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 777, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 607, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 422, 'numAffected': 0}], 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{'groupId': 'EG001', 'numAtRisk': 835, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1069, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 777, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 607, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 422, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1177, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 835, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1069, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 777, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 607, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 422, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Adenoidal hypertrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1177, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 835, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1069, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 777, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 607, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 422, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1177, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 835, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1069, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 777, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 607, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 422, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Exposure via ingestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1177, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 835, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1069, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 777, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 607, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 422, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Encephalitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1177, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 835, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1069, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 777, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 607, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 422, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Acquired epileptic aphasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1177, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 835, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1069, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 777, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 607, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 422, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Subjects (Unprimed) 6 to <36 Months Age With Local and Systemic Reactions After Any Vaccination for All Seasons, Comparison of Adjuvanted Trivalent Influenza Vaccine (aTIV) and Flu Vaccine Control.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1178', 'groupId': 'OG000'}, {'value': '1068', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TIV-adj (6 to <36 Months)', 'description': 'Subjects aged 6 to \\<36 months received 0.25 mL of each injection of Adjuvanted trivalent inactivated subunit influenza vaccine'}, {'id': 'OG001', 'title': 'Flu-control (6 to <36 Months)', 'description': 'Subjects aged 6 to \\<36 months received 0.25 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine'}], 'classes': [{'title': 'Any Local', 'categories': [{'measurements': [{'value': '625', 'groupId': 'OG000'}, {'value': '481', 'groupId': 'OG001'}]}]}, {'title': 'Injection Site Ecchymosis', 'categories': [{'measurements': [{'value': '147', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}]}, {'title': 'Injection Site Erythema', 'categories': [{'measurements': [{'value': '423', 'groupId': 'OG000'}, {'value': '322', 'groupId': 'OG001'}]}]}, {'title': 'Injection Site Induration', 'categories': [{'measurements': [{'value': '214', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}]}, {'title': 'Swelling', 'categories': [{'measurements': [{'value': '123', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}]}, {'title': 'Tender. at inj.site', 'categories': [{'measurements': [{'value': '330', 'groupId': 'OG000'}, {'value': '246', 'groupId': 'OG001'}]}]}, {'title': 'Any Systemic', 'categories': [{'measurements': [{'value': '785', 'groupId': 'OG000'}, {'value': '694', 'groupId': 'OG001'}]}]}, {'title': 'Change in eat. hab.', 'categories': [{'measurements': [{'value': '325', 'groupId': 'OG000'}, {'value': '261', 'groupId': 'OG001'}]}]}, {'title': 'Sleepiness', 'categories': [{'measurements': [{'value': '380', 'groupId': 'OG000'}, {'value': '312', 'groupId': 'OG001'}]}]}, {'title': 'Unusual crying', 'categories': [{'measurements': [{'value': '386', 'groupId': 'OG000'}, {'value': '345', 'groupId': 'OG001'}]}]}, {'title': 'Irritability', 'categories': [{'measurements': [{'value': '387', 'groupId': 'OG000'}, {'value': '353', 'groupId': 'OG001'}]}]}, {'title': 'Vomiting', 'categories': [{'measurements': [{'value': '131', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhea', 'categories': [{'measurements': [{'value': '258', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}]}]}, {'title': 'Shivering', 'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}]}, {'title': 'Any Other', 'categories': [{'measurements': [{'value': '358', 'groupId': 'OG000'}, {'value': '317', 'groupId': 'OG001'}]}]}, {'title': 'Fever (38-38.9°C) (N=1177,1068)', 'categories': [{'measurements': [{'value': '169', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}]}, {'title': 'Fever (39-39.9°C) (N=1177,1068)', 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}]}, {'title': 'Fever (>40.0°C) (N=1177,1068)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Analg.Antipyr.Used (N=1176,1068)', 'categories': [{'measurements': [{'value': '358', 'groupId': 'OG000'}, {'value': '317', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '7 days post-vaccination', 'description': 'Safety was assessed in terms of number of subjects experiencing each of the local and systemic reactions within 7-days after any vaccination for all seasons, comparison of adjuvanted Trivalent influenza vaccine (aTIV) and flu vaccine control.', 'unitOfMeasure': 'Number of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was done on Safety set - All subjects in the exposed population who provided post-baseline safety data.'}, {'type': 'PRIMARY', 'title': 'Percentage of Subjects (Unprimed) Aged 6 to <36 Months With Virus-Confirmed Influenza, Comparison of aTIV and Non-flu Vaccine Control (Men C/TBE Vaccine)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '916', 'groupId': 'OG000'}, {'value': '469', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TIV-adj (6 to <36 Months)', 'description': 'Subjects aged 6 to \\< 36 months received 0.25 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine'}, {'id': 'OG001', 'title': 'Non-flu Control (6 to <36 Months)', 'description': 'Subjects aged 6 to \\<12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to \\<72 months received 2 doses of 0.25 mL of TBE vaccine'}], 'classes': [{'title': 'Season 2007/2008, Matched strain,N=187,97', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Season 2008/2009, Matched strain', 'categories': [{'measurements': [{'value': '0.76', 'groupId': 'OG000'}, {'value': '4.05', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Vaccine Efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.66', 'paramValue': '81.36', 'ciLowerLimit': '49.24', 'ciUpperLimit': '93.16', 'groupDescription': 'Absolute vaccine efficacy (VE) was calculated as (1- the relative risk)100%. Relative Risk for virus-confirmed symptomatic influenza illness in the TIV-adj group vs. the non-flu control group. VE denotes the vaccine efficacy, i.e. 1-Itest/Inon-flu ctrl, where I stands for the population average incidence of influenza.\n\nAbsolute efficacy of TIV-adj is at most 40% (i.e. the probability of an influenza in the test group relative to that in the non-flu vaccine group is at least 0.6)', 'statisticalMethod': 'Poisson Regression Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '3 weeks after 2nd vaccination', 'description': 'Virus-confirmed influenza illnesses were assessed and compared between the adjuvanted influenza vaccine (TIV-adj) and non-influenza vaccines (Non-flu control) in 6 to \\<36 month unprimed subjects for Absolute Efficacy. This primary endpoint is only for homologous strains.', 'unitOfMeasure': 'Percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on Full Analysis Set (FAS) - All subjects in the enrolled set who received study vaccination and provided at least one evaluable serum sample both before and after baseline.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1178', 'groupId': 'OG000'}, {'value': '833', 'groupId': 'OG001'}, {'value': '1068', 'groupId': 'OG002'}, {'value': '778', 'groupId': 'OG003'}, {'value': '607', 'groupId': 'OG004'}, {'value': '422', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'TIV-adj (6 to <36 Months)', 'description': 'Subjects aged 6 to \\< 36 months received 0.25 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine'}, {'id': 'OG001', 'title': 'TIV-adj (36 to <72 Months)', 'description': 'Subjects aged 36 to \\< 72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine'}, {'id': 'OG002', 'title': 'Flu-control (6 to <36 Months)', 'description': 'Subjects aged 6 to \\< 36 months received 0.25 mL of each injection of non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine'}, {'id': 'OG003', 'title': 'Flu-control (36 to <72 Months)', 'description': 'Subjects aged 36 to \\< 72 months received 0.5 mL of each injection of non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine'}, {'id': 'OG004', 'title': 'Non-Flu-control (6 to <36 Months)', 'description': 'Subjects aged 6 to \\<12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to \\<72 months received 2 doses of 0.25 mL of TBE vaccine'}, {'id': 'OG005', 'title': 'Non-Flu-control (36 to <72 Months)', 'description': 'Subjects aged 6 to \\<12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to \\<72 months received 2 doses of 0.25 mL of TBE vaccine'}], 'classes': [{'title': 'Any Local', 'categories': [{'measurements': [{'value': '625', 'groupId': 'OG000'}, {'value': '569', 'groupId': 'OG001'}, {'value': '481', 'groupId': 'OG002'}, {'value': '466', 'groupId': 'OG003'}, {'value': '315', 'groupId': 'OG004'}, {'value': '232', 'groupId': 'OG005'}]}]}, {'title': 'Inj. site ecchymosis(N=1178,833,1068,777,607,422)', 'categories': [{'measurements': [{'value': '147', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}, {'value': '103', 'groupId': 'OG002'}, {'value': '93', 'groupId': 'OG003'}, {'value': '69', 'groupId': 'OG004'}, {'value': '49', 'groupId': 'OG005'}]}]}, {'title': 'Inj. site erythema(N=1178,833,1068,777,607,422)', 'categories': [{'measurements': [{'value': '423', 'groupId': 'OG000'}, {'value': '320', 'groupId': 'OG001'}, {'value': '322', 'groupId': 'OG002'}, {'value': '269', 'groupId': 'OG003'}, {'value': '239', 'groupId': 'OG004'}, {'value': '129', 'groupId': 'OG005'}]}]}, {'title': 'Inj. site induration(N=1178,833,1068,777,607,422)', 'categories': [{'measurements': [{'value': '214', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}, {'value': '131', 'groupId': 'OG002'}, {'value': '152', 'groupId': 'OG003'}, {'value': '153', 'groupId': 'OG004'}, {'value': '80', 'groupId': 'OG005'}]}]}, {'title': 'Inj. site swelling(N=1178,833,1068,777,607,422)', 'categories': [{'measurements': [{'value': '123', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}, {'value': '89', 'groupId': 'OG002'}, {'value': '128', 'groupId': 'OG003'}, {'value': '82', 'groupId': 'OG004'}, {'value': '55', 'groupId': 'OG005'}]}]}, {'title': 'Inj. site tenderness(N=1178,0,1068,0,607,0)', 'categories': [{'measurements': [{'value': '330', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '246', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '171', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Inj. site pain (N=0,833,0,777,0,422)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '477', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '360', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '180', 'groupId': 'OG005'}]}]}, {'title': 'Any Systemic', 'categories': [{'measurements': [{'value': '785', 'groupId': 'OG000'}, {'value': '523', 'groupId': 'OG001'}, {'value': '694', 'groupId': 'OG002'}, {'value': '341', 'groupId': 'OG003'}, {'value': '370', 'groupId': 'OG004'}, {'value': '211', 'groupId': 'OG005'}]}]}, {'title': 'Change in eat. hab.(N=1178,0,1068,0,607,0)', 'categories': [{'measurements': [{'value': '325', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '261', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '162', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Sleepiness (N=1178,0,1068,0,607,0)', 'categories': [{'measurements': [{'value': '380', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '312', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '186', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Unusual crying (N=1178,0,1068,0,607,0)', 'categories': [{'measurements': [{'value': '386', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '345', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '175', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Irritability (N=1178,0,1068,0,607,0)', 'categories': [{'measurements': [{'value': '387', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '353', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '187', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Vomiting (N=1178,0,1068,0,607,0)', 'categories': [{'measurements': [{'value': '131', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '66', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Diarrhea (N=1178,0,1068,0,607,0)', 'categories': [{'measurements': [{'value': '258', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '211', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '114', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Shivering (N=1178,0,1068,0,607,0)', 'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '50', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Chills shivering (N=0,833,0,777,0,422)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '37', 'groupId': 'OG005'}]}]}, {'title': 'Malaise (N=0,833,0,777,0,422)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '118', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '63', 'groupId': 'OG005'}]}]}, {'title': 'Myalgia (N=0,833,0,777,0,422)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '66', 'groupId': 'OG005'}]}]}, {'title': 'Arthralgia (N=0,833,0,777,0,422)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '27', 'groupId': 'OG005'}]}]}, {'title': 'Headache (N=0,833,0,777,0,422)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '54', 'groupId': 'OG005'}]}]}, {'title': 'Sweating (N=0,833,0,777,0,422)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '31', 'groupId': 'OG005'}]}]}, {'title': 'Fatigue (N=0,833,0,777,0,422)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '337', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '222', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '123', 'groupId': 'OG005'}]}]}, {'title': 'Any Other', 'categories': [{'measurements': [{'value': '358', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}, {'value': '317', 'groupId': 'OG002'}, {'value': '94', 'groupId': 'OG003'}, {'value': '159', 'groupId': 'OG004'}, {'value': '69', 'groupId': 'OG005'}]}]}, {'title': 'Fever(38-38.9C)(N=1177,833,1068,775,607,421)', 'categories': [{'measurements': [{'value': '169', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}, {'value': '143', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}, {'value': '62', 'groupId': 'OG004'}, {'value': '37', 'groupId': 'OG005'}]}]}, {'title': 'Fever(39-39.9C)(N=1177,833,1068,775,607,421)', 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}, {'value': '19', 'groupId': 'OG005'}]}]}, {'title': 'Fever(≥40.0C)(N=1177,833,1068,775,607,421)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': 'Analg.Antipyr.Used (N=1176,833,1068,777,607,422)', 'categories': [{'measurements': [{'value': '358', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}, {'value': '317', 'groupId': 'OG002'}, {'value': '94', 'groupId': 'OG003'}, {'value': '159', 'groupId': 'OG004'}, {'value': '69', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '7 days post-vaccination', 'description': 'Safety was assessed as the number of subjects aged 6 to \\<72 months who reported solicited local or systemic adverse events after any vaccination with TIV-adj for all seasons.', 'unitOfMeasure': 'Number of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was done on Safety set'}, {'type': 'SECONDARY', 'title': 'Number of Subjects (Unprimed) With Unsolicited Adverse Events Reported After Any Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1177', 'groupId': 'OG000'}, {'value': '1069', 'groupId': 'OG001'}, {'value': '607', 'groupId': 'OG002'}, {'value': '2012', 'groupId': 'OG003'}, {'value': '1846', 'groupId': 'OG004'}, {'value': '1029', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'TIV-adj (6 to <36 Months)', 'description': 'Subjects aged 6 to \\< 36 months received 0.25 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine'}, {'id': 'OG001', 'title': 'Flu-control (6 to <36 Months)', 'description': 'Subjects aged 6 to \\< 36 months received 0.25 mL of each injection of non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine'}, {'id': 'OG002', 'title': 'Non-Flu-control (6 to <36 Months)', 'description': 'Subjects aged 6 to \\<12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to \\<72 months received 2 doses of 0.25 mL of TBE vaccine'}, {'id': 'OG003', 'title': 'TIV-adj (6 to <72 Months )', 'description': 'Subjects aged 6 to \\< 36 months received 0.25 mL and those aged 36 to \\<72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine'}, {'id': 'OG004', 'title': 'Flu-control (6 to <72 Months)', 'description': 'Subjects aged 6 to \\< 36 months received 0.25 mL and those aged 36 to \\<72 months received 0.5 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine'}, {'id': 'OG005', 'title': 'Non-Flu-control (6 to <72 Months)', 'description': 'Subjects aged 6 to \\<12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to \\<72 months received 2 doses of 0.25 mL of TBE vaccine'}], 'classes': [{'title': 'Any AEs', 'categories': [{'measurements': [{'value': '1045', 'groupId': 'OG000'}, {'value': '938', 'groupId': 'OG001'}, {'value': '530', 'groupId': 'OG002'}, {'value': '1714', 'groupId': 'OG003'}, {'value': '1566', 'groupId': 'OG004'}, {'value': '867', 'groupId': 'OG005'}]}]}, {'title': 'At least possibly related AEs', 'categories': [{'measurements': [{'value': '152', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}, {'value': '262', 'groupId': 'OG003'}, {'value': '203', 'groupId': 'OG004'}, {'value': '137', 'groupId': 'OG005'}]}]}, {'title': 'Serious AEs', 'categories': [{'measurements': [{'value': '91', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}, {'value': '122', 'groupId': 'OG003'}, {'value': '169', 'groupId': 'OG004'}, {'value': '110', 'groupId': 'OG005'}]}]}, {'title': 'At least possibly related SAEs', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}]}, {'title': 'AEs leading to discontinuation', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Study day 1 to Study day 181', 'description': 'Number of subjects aged 6 to \\<36 months and in the overall age cohort (unprimed children aged 6 to \\<72 months) experiencing each of the unsolicited adverse events (AEs) throughout the study', 'unitOfMeasure': 'Number of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was done on Safety set'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects (Unprimed) Aged 6 to <72 Months With Virus-Confirmed Influenza, Comparison of aTIV to Non-flu Vaccine Control and Flu-vaccine Control (Matched Strains)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '916', 'groupId': 'OG000'}, {'value': '469', 'groupId': 'OG001'}, {'value': '902', 'groupId': 'OG002'}, {'value': '698', 'groupId': 'OG003'}, {'value': '360', 'groupId': 'OG004'}, {'value': '706', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'TIV-adj (6 to < 36 Months)', 'description': 'Subjects aged 6 to \\< 36 months received 0.25 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine'}, {'id': 'OG001', 'title': 'Non-flu Control (6 to <36 Months)', 'description': 'Subjects aged 6 to \\<12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to \\<72 months received 2 doses of 0.25 mL of TBE vaccine'}, {'id': 'OG002', 'title': 'Flu Control (6 to < 36 Months)', 'description': 'Subjects aged 6 to \\< 36 months received 0.25 mL of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine'}, {'id': 'OG003', 'title': 'TIV-adj (36 to < 72 Months)', 'description': 'Subjects aged 36 to \\< 72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine'}, {'id': 'OG004', 'title': 'Non-flu Control (36 to <72 Months)', 'description': 'Subjects aged 6 to \\<12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to \\<72 months received 2 doses of 0.25 mL of TBE vaccine'}, {'id': 'OG005', 'title': 'Flu Control (36 to < 72 Months)', 'description': 'Subjects aged 36 to \\< 72 months received 0.5 mL of each injection of non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine'}], 'classes': [{'title': 'Matched strain(Season2007/08)N=187,97,93,136,67,71', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Matched strain (Season2008/09)', 'categories': [{'measurements': [{'value': '0.76', 'groupId': 'OG000'}, {'value': '4.05', 'groupId': 'OG001'}, {'value': '2.44', 'groupId': 'OG002'}, {'value': '0.29', 'groupId': 'OG003'}, {'value': '6.11', 'groupId': 'OG004'}, {'value': '3.12', 'groupId': 'OG005'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Vaccine Efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '81.36', 'ciLowerLimit': '49.24', 'ciUpperLimit': '93.16', 'groupDescription': 'Absolute vaccine efficacy (VE) was calculated as (1- the relative risk)100%. Relative Risk for virus-confirmed symptomatic influenza illness in the TIV-adj group vs. the non-flu control group. VE denotes the vaccine efficacy, i.e. 1-Itest/Inon-flu ctrl, where I stands for the incidence of influenza.\n\nAbsolute efficacy of TIV-adj is at most 40% (i.e. the probability of an influenza in the test group relative to that in the non-flu vaccine group is at least 0.6)', 'statisticalMethod': 'Poisson Regression Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG003', 'OG004'], 'paramType': 'Vaccine Efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '95.5', 'ciLowerLimit': '80.92', 'ciUpperLimit': '98.94', 'groupDescription': 'Absolute vaccine efficacy (VE) was calculated as (1- the relative risk)100%. Relative Risk for virus-confirmed symptomatic influenza illness in the TIV-adj group vs. the non-flu control group. VE denotes the vaccine efficacy, i.e. 1-Itest/Inon-flu ctrl, where I stands for the incidence of influenza.\n\nAbsolute efficacy of TIV-adj is at most 40% (i.e. the probability of an influenza in the test group relative to that in the non-flu vaccine group is at least 0.6)', 'statisticalMethod': 'Poisson Regression Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Vaccine Efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.32', 'ciLowerLimit': '0.13', 'ciUpperLimit': '0.73', 'groupDescription': 'Relative efficacy for TIV-adj was to be calculated as VE = (1-Itest/Ictrl)100%, where I is the incidence of influenza, i.e. percentage of subjects with virus-confirmed symptomatic influenza A or B illness, in the investigational agent (TIV-adj) group or in the flu vaccine control group.', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG003', 'OG005'], 'paramType': 'Vaccine Efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.09', 'ciLowerLimit': '0.02', 'ciUpperLimit': '0.38', 'groupDescription': 'Relative efficacy for TIV-adj was to be calculated as VE = (1-Itest/Ictrl)100%, where I is the incidence of influenza, i.e. percentage of subjects with virus-confirmed symptomatic influenza A or B illness, in the investigational agent (TIV-adj) group or in the flu vaccine control group.', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '3 weeks after 2nd vaccination', 'description': 'Virus-confirmed influenza illnesses were assessed and compared between the adjuvanted influenza vaccine (TIV-adj) and non-influenza vaccines (Non-flu control) in subjects aged 6 to \\<72 months (unprimed) for Absolute Efficacy.\n\nFor Relative efficacy, the comparison was made between adjuvanted influenza vaccine (TIV-adj) and flu vaccine control.', 'unitOfMeasure': 'Percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was done on Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects (Unprimed) Aged 6 to <72 Months With Virus-Confirmed Influenza, Comparison of aTIV to Non-flu Vaccine Control and Flu Vaccine Control (Any Strains).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '916', 'groupId': 'OG000'}, {'value': '469', 'groupId': 'OG001'}, {'value': '902', 'groupId': 'OG002'}, {'value': '698', 'groupId': 'OG003'}, {'value': '360', 'groupId': 'OG004'}, {'value': '706', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'TIV-adj (6 to < 36 Months)', 'description': 'Subjects aged 6 to \\< 36 months received 0.25 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine'}, {'id': 'OG001', 'title': 'Non-flu Control (6 to < 36 Months)', 'description': 'Subjects aged 6 to \\<12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to \\<72 months received 2 doses of 0.25 mL of TBE vaccine'}, {'id': 'OG002', 'title': 'Flu Control (6 to < 36 Months)', 'description': 'Subjects aged 6 to \\< 36 months received 0.25 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine'}, {'id': 'OG003', 'title': 'TIV-adj (36 to <72 Months)', 'description': 'Subjects aged 36 to \\< 72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine'}, {'id': 'OG004', 'title': 'Non-flu Control (36 to < 72 Months)', 'description': 'Subjects aged 6 to \\<12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to \\<72 months received 2 doses of 0.25 mL of TBE vaccine'}, {'id': 'OG005', 'title': 'Flu Control (36 to < 72 Months)', 'description': 'Subjects aged 36 to \\< 72 months received 0.5 mL of each injection of non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine'}], 'classes': [{'title': 'Any Strain (Season 2007/08)N=187,97,93,136,67,71', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2.06', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0.74', 'groupId': 'OG003'}, {'value': '2.99', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Any Strain (Season 2008/09)', 'categories': [{'measurements': [{'value': '0.98', 'groupId': 'OG000'}, {'value': '4.26', 'groupId': 'OG001'}, {'value': '2.77', 'groupId': 'OG002'}, {'value': '0.43', 'groupId': 'OG003'}, {'value': '6.39', 'groupId': 'OG004'}, {'value': '3.54', 'groupId': 'OG005'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'vaccine Efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '79.18', 'ciLowerLimit': '54.78', 'ciUpperLimit': '90.42', 'groupDescription': 'Absolute vaccine efficacy (VE) was calculated as (1- the relative risk)100%. Relative Risk for virus-confirmed symptomatic influenza illness in the TIV-adj group vs. the non-flu control group. VE denotes the vaccine efficacy, i.e. 1-Itest/Inon-flu ctrl, where I stands for the population average incidence of influenza.\n\nAbsolute efficacy of TIV-adj is at most 40% (i.e. the probability of an influenza in the test group relative to that in the non-flu vaccine group is at least 0.6)', 'statisticalMethod': 'Poisson Regression Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG003', 'OG004'], 'paramType': 'Vaccine Efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '92.1', 'ciLowerLimit': '77.35', 'ciUpperLimit': '97.24', 'groupDescription': 'Absolute vaccine efficacy (VE) was calculated as (1- the relative risk)100%. Relative Risk for virus-confirmed symptomatic influenza illness in the TIV-adj group vs. the non-flu control group. VE denotes the vaccine efficacy, i.e. 1-Itest/Inon-flu ctrl, where I stands for the incidence of influenza. Absolute efficacy of TIV-adj is at most 40% (i.e. the probability of an influenza in the test group relative to that in the non-flu vaccine group is at least 0.6)', 'statisticalMethod': 'Poisson Regression Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Vaccine Efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '64.16', 'ciLowerLimit': '23.21', 'ciUpperLimit': '83.28', 'groupDescription': 'Relative efficacy for TIV-adj was to be calculated as VE = (1-Itest/Ictrl)100%, where I is the incidence of influenza, i.e. percentage of subjects with virus-confirmed symptomatic influenza A or B illness, in the investigational agent (TIV-adj) group or in the flu vaccine control group.', 'statisticalMethod': 'Poisson Regression Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG003', 'OG005'], 'paramType': 'Vaccine Efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '85.66', 'ciLowerLimit': '58.95', 'ciUpperLimit': '94.99', 'groupDescription': 'Relative efficacy for TIV-adj was to be calculated as VE = (1-Itest/Ictrl)100%, where I is the incidence of influenza, i.e. percentage of subjects with virus-confirmed symptomatic influenza A or B illness, in the investigational agent (TIV-adj) group or in the flu vaccine control group.', 'statisticalMethod': 'Poisson Regression Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '3 weeks after 2nd vaccination', 'description': 'Virus-confirmed influenza illnesses (regardless of antigenic match to those contained in the vaccine) were assessed and compared between the adjuvanted influenza vaccine (TIV-adj) and non-influenza vaccines (Non-flu control) in subjects aged 6 to \\<72 months (unprimed) for Absolute Efficacy.\n\nFor Relative efficacy, the comparison was made between adjuvanted influenza vaccine (TIV-adj) and flu vaccine control.', 'unitOfMeasure': 'Percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Number of Subjects (Unprimed) With Influenza Like Illnesses (ILIs) in the 6 to <72 Months Age Cohort for Combined Seasons 2007/08 and 2008/09', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1937', 'groupId': 'OG000'}, {'value': '1772', 'groupId': 'OG001'}, {'value': '993', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'TIV-adj', 'description': 'Subjects aged 6 to \\< 36 months received 0.25 mL and those aged 36 to \\<72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine'}, {'id': 'OG001', 'title': 'Flu-control', 'description': 'Subjects aged 6 to \\< 36 months received 0.25 mL and those aged 36 to \\<72 months received 0.5 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine'}, {'id': 'OG002', 'title': 'Non-flu Control', 'description': 'Subjects aged 6 to \\<12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to \\<72 months received 2 doses of 0.25 mL of TBE vaccine'}], 'classes': [{'title': 'Subjects with ILI', 'categories': [{'measurements': [{'value': '425', 'groupId': 'OG000'}, {'value': '436', 'groupId': 'OG001'}, {'value': '253', 'groupId': 'OG002'}]}]}, {'title': 'Outpatient visits', 'categories': [{'measurements': [{'value': '290', 'groupId': 'OG000'}, {'value': '293', 'groupId': 'OG001'}, {'value': '174', 'groupId': 'OG002'}]}]}, {'title': 'Inpatient visits', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}]}, {'title': 'Outcome (Recovered)', 'categories': [{'measurements': [{'value': '414', 'groupId': 'OG000'}, {'value': '431', 'groupId': 'OG001'}, {'value': '248', 'groupId': 'OG002'}]}]}, {'title': 'Outcome (Alive with sequelae)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Outcome (Lost to follow-up)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Outcome (ILI persisting)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Outcome (Not available)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 weeks after 2nd vaccination', 'description': 'Virus-confirmed influenza illnesses were assessed and trivalent adjuvanted influenza vaccine (TIV-adj) was compared with Non-flu control vaccine and Flu-control vaccine in 6 to \\<72 month old subjects for Influenza like illnesses for seasons 2007/08 and 2008/09.', 'unitOfMeasure': 'Number of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Influenza Like Illnesses (ILIs) in the 6 to <36 Months and in Overall Age Cohort (Unprimed Subjects Aged 6 to <72 Months) for Combined Seasons 2007/08 and 2008/09', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1103', 'groupId': 'OG000'}, {'value': '566', 'groupId': 'OG001'}, {'value': '995', 'groupId': 'OG002'}, {'value': '1937', 'groupId': 'OG003'}, {'value': '993', 'groupId': 'OG004'}, {'value': '1772', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'TIV-adj (6 to < 36 Months)', 'description': 'Subjects aged 6 to \\<36 months received 0.25 mL of each injection of Adjuvanted trivalent inactivated subunit influenza vaccine'}, {'id': 'OG001', 'title': 'Non-flu Control (6 to < 36 Months)', 'description': 'Subjects aged 6 to \\<12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to \\<72 months received 2 doses of 0.25 mL of TBE vaccine'}, {'id': 'OG002', 'title': 'Flu-control (6 to < 36 Months)', 'description': 'Subjects aged 6 to \\<36 months received 0.25 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine'}, {'id': 'OG003', 'title': 'TIV-adj (6 to < 72 Months)', 'description': 'Subjects aged 6 to \\< 36 months received 0.25 mL and those aged 36 to \\<72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine'}, {'id': 'OG004', 'title': 'Non-flu Control (6 to <72 Months)', 'description': 'Subjects aged 6 to \\<12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to \\<72 months received 2 doses of 0.25 mL of TBE vaccine'}, {'id': 'OG005', 'title': 'Flu Control (6 to < 72 Months)', 'description': 'Subjects aged 6 to \\< 36 months received 0.25 mL and those aged 36 to \\<72 months received 0.5 mL of each injection of non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine'}], 'classes': [{'title': 'Subjects with ILI', 'categories': [{'measurements': [{'value': '280', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}, {'value': '272', 'groupId': 'OG002'}, {'value': '425', 'groupId': 'OG003'}, {'value': '253', 'groupId': 'OG004'}, {'value': '436', 'groupId': 'OG005'}]}]}, {'title': 'Outpatient visits', 'categories': [{'measurements': [{'value': '192', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}, {'value': '183', 'groupId': 'OG002'}, {'value': '290', 'groupId': 'OG003'}, {'value': '174', 'groupId': 'OG004'}, {'value': '293', 'groupId': 'OG005'}]}]}, {'title': 'Inpatient visits', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}, {'value': '26', 'groupId': 'OG005'}]}]}, {'title': 'Outcome (Recovered)', 'categories': [{'measurements': [{'value': '269', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}, {'value': '267', 'groupId': 'OG002'}, {'value': '414', 'groupId': 'OG003'}, {'value': '248', 'groupId': 'OG004'}, {'value': '431', 'groupId': 'OG005'}]}]}, {'title': 'Outcome (Alive with sequelae)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}]}, {'title': 'Outcome (Lost to follow-up)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': 'Outcome (ILI persisting)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': 'Outcome (Not available)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 weeks after 2nd vaccination', 'description': 'Virus-confirmed influenza illnesses were assessed and trivalent adjuvanted influenza vaccine (TIV-adj) was compared with Non-flu control vaccine and Flu-control vaccine for Influenza like illnesses for seasons 2007/08 and 2008/09.', 'unitOfMeasure': 'Number of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Loss of Days of Usual Activity (Job, School, Day Care, Household/Family/Community Activities) Due to Influenza Like Illness (ILI) in Subjects in Aged 6 to <72 and 6 to <36 Months and in Direct Caregivers Living in the Household.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '425', 'groupId': 'OG000'}, {'value': '253', 'groupId': 'OG001'}, {'value': '436', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'TIV-adj', 'description': 'Subjects aged 6 to \\< 36 months received 0.25 mL and those aged 36 to \\<72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine'}, {'id': 'OG001', 'title': 'Non-flu Control', 'description': 'Subjects aged 6 to \\<12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to \\<72 months received 2 doses of 0.25 mL of TBE vaccine'}, {'id': 'OG002', 'title': 'Flu-control', 'description': 'Subjects aged 6 to \\< 36 months received 0.25 mL and those aged 36 to \\<72 months received 0.5 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine'}], 'classes': [{'title': 'Mean bed days (6 to <72 mths)(N=419,250,426)', 'categories': [{'measurements': [{'value': '1.9', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '2.3', 'spread': '2.7', 'groupId': 'OG001'}, {'value': '1.9', 'spread': '2.4', 'groupId': 'OG002'}]}]}, {'title': 'Mean bed days (6 to <36 mths)(N=274,160,263)', 'categories': [{'measurements': [{'value': '2.0', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '2.4', 'groupId': 'OG001'}, {'value': '1.8', 'spread': '2.4', 'groupId': 'OG002'}]}]}, {'title': 'Mean inactive days(6 to <72 mths)(N=417,249,427)', 'categories': [{'measurements': [{'value': '3.1', 'spread': '3.3', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '3.5', 'groupId': 'OG001'}, {'value': '2.9', 'spread': '3.7', 'groupId': 'OG002'}]}]}, {'title': 'Mean inactive days(6 to <36 mths)(N=273,160,264)', 'categories': [{'measurements': [{'value': '2.9', 'spread': '3.3', 'groupId': 'OG000'}, {'value': '3.0', 'spread': '3.6', 'groupId': 'OG001'}, {'value': '2.6', 'spread': '3.3', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 weeks after 2nd vaccination', 'description': 'Virus-confirmed influenza illnesses were assessed and trivalent adjuvanted influenza vaccine (TIV-adj) was compared with Non-flu control vaccine and Flu-control vaccine for Influenza like illnesses for seasons 2007/08 and 2008/09.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was done on Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Number of Events of Influenza Like Illness for Combined Seasons 2007/08 and 2008/09.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '425', 'groupId': 'OG000'}, {'value': '253', 'groupId': 'OG001'}, {'value': '436', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'TIV-adj', 'description': 'Subjects aged 6 to \\< 36 months received 0.25 mL and those aged 36 to \\<72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine'}, {'id': 'OG001', 'title': 'Non-flu Control', 'description': 'Subjects aged 6 to \\<12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to \\<72 months received 2 doses of 0.25 mL of TBE vaccine'}, {'id': 'OG002', 'title': 'Flu-control', 'description': 'Subjects aged 6 to \\< 36 months received 0.25 mL and those aged 36 to \\<72 months received 0.5 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine'}], 'classes': [{'title': 'Mean ILI events (6 to <72 mths)(N=425,253,436)', 'categories': [{'measurements': [{'value': '1.2', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '0.6', 'groupId': 'OG001'}, {'value': '1.2', 'spread': '0.5', 'groupId': 'OG002'}]}]}, {'title': 'Mean ILI events (6 to <36 mths)(N=280,163,272)', 'categories': [{'measurements': [{'value': '1.3', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '0.6', 'groupId': 'OG001'}, {'value': '1.3', 'spread': '0.5', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 weeks after 2nd vaccination', 'description': 'The number of events of Influenza like Illness reported by subjects aged 6 to \\<72 months was assessed for combined seasons 2007/08 and 2008/09', 'unitOfMeasure': 'Events', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was done on Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of GMRs, in Unprimed Subjects Aged 6 to <36 Months or Season 2008/09 (Homologous and Heterologous Strains)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}, {'value': '165', 'groupId': 'OG001'}, {'value': '83', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'TIV-adj', 'description': 'Subjects aged 6 to \\< 36 months received 0.25 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine'}, {'id': 'OG001', 'title': 'Flu-control', 'description': 'Subjects aged 6 to \\< 36 months received 0.25 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine'}, {'id': 'OG002', 'title': 'Non-flu-control', 'description': 'Subjects aged 6 to \\<12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to \\<72 months received 2 doses of 0.25 mL of TBE vaccine'}], 'classes': [{'title': 'Day 29:1 A/Brisbane/2007 (A/H1N1) (N=165,163,82)', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000', 'lowerLimit': '15', 'upperLimit': '20'}, {'value': '1.83', 'groupId': 'OG001', 'lowerLimit': '1.57', 'upperLimit': '2.13'}, {'value': '1.03', 'groupId': 'OG002', 'lowerLimit': '0.83', 'upperLimit': '1.27'}]}]}, {'title': 'Day 50:1 A/Brisbane/2007 (A/H1N1) (N=160,162,78)', 'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000', 'lowerLimit': '70', 'upperLimit': '98'}, {'value': '4.55', 'groupId': 'OG001', 'lowerLimit': '3.84', 'upperLimit': '5.39'}, {'value': '1.11', 'groupId': 'OG002', 'lowerLimit': '0.87', 'upperLimit': '1.4'}]}]}, {'title': 'Day 181:1 A/Brisbane/2007 (A/H1N1) (N=161,163,80)', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000', 'lowerLimit': '17', 'upperLimit': '21'}, {'value': '2.4', 'groupId': 'OG001', 'lowerLimit': '2.11', 'upperLimit': '2.73'}, {'value': '1.02', 'groupId': 'OG002', 'lowerLimit': '0.85', 'upperLimit': '1.22'}]}]}, {'title': 'Day 29:1 A/Brisbane/2007 (A/H3N2) (N=165,163,82)', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000', 'lowerLimit': '13', 'upperLimit': '18'}, {'value': '1.58', 'groupId': 'OG001', 'lowerLimit': '1.38', 'upperLimit': '1.81'}, {'value': '1.07', 'groupId': 'OG002', 'lowerLimit': '0.88', 'upperLimit': '1.29'}]}]}, {'title': 'Day 50:1 A/Brisbane/2007 (A/H3N2) (N=160,162,78)', 'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000', 'lowerLimit': '73', 'upperLimit': '102'}, {'value': '5.57', 'groupId': 'OG001', 'lowerLimit': '4.73', 'upperLimit': '6.55'}, {'value': '1.04', 'groupId': 'OG002', 'lowerLimit': '0.83', 'upperLimit': '1.32'}]}]}, {'title': 'Day 181:1 A/Brisbane/2007 (A/H3N1) (N=161,163,80)', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000', 'lowerLimit': '24', 'upperLimit': '37'}, {'value': '6.16', 'groupId': 'OG001', 'lowerLimit': '4.97', 'upperLimit': '7.63'}, {'value': '2.1', 'groupId': 'OG002', 'lowerLimit': '1.55', 'upperLimit': '2.83'}]}]}, {'title': 'Day 29:1 B/Florida/2006 (N=165,163,82)', 'categories': [{'measurements': [{'value': '2.11', 'groupId': 'OG000', 'lowerLimit': '1.86', 'upperLimit': '2.39'}, {'value': '1.41', 'groupId': 'OG001', 'lowerLimit': '1.24', 'upperLimit': '1.6'}, {'value': '1.06', 'groupId': 'OG002', 'lowerLimit': '0.89', 'upperLimit': '1.26'}]}]}, {'title': 'Day 50:1 B/Florida/2006 (N=160,162,78)', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '13', 'upperLimit': '16'}, {'value': '2.05', 'groupId': 'OG001', 'lowerLimit': '1.81', 'upperLimit': '2.31'}, {'value': '1.02', 'groupId': 'OG002', 'lowerLimit': '0.86', 'upperLimit': '1.22'}]}]}, {'title': 'Day 181:1 B/Florida/2006 (N=161,163,80)', 'categories': [{'measurements': [{'value': '4.22', 'groupId': 'OG000', 'lowerLimit': '3.79', 'upperLimit': '4.68'}, {'value': '1.45', 'groupId': 'OG001', 'lowerLimit': '1.31', 'upperLimit': '1.61'}, {'value': '1.05', 'groupId': 'OG002', 'lowerLimit': '0.91', 'upperLimit': '1.22'}]}]}, {'title': 'Day 29:1A/SolomonIsland/2006(A/H1N1)(N=165,163,82)', 'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000', 'lowerLimit': '1.81', 'upperLimit': '2.42'}, {'value': '1.41', 'groupId': 'OG001', 'lowerLimit': '1.22', 'upperLimit': '1.62'}, {'value': '0.97', 'groupId': 'OG002', 'lowerLimit': '0.79', 'upperLimit': '1.18'}]}]}, {'title': 'Day 50:1A/SolomonIsland/2006(A/H1N1)(N=160,162,78)', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000', 'lowerLimit': '16', 'upperLimit': '21'}, {'value': '1.96', 'groupId': 'OG001', 'lowerLimit': '1.7', 'upperLimit': '2.25'}, {'value': '0.98', 'groupId': 'OG002', 'lowerLimit': '0.8', 'upperLimit': '1.19'}]}]}, {'title': 'Day181:1A/SolomonIsland/2006(A/H1N1)(N=161,163,80)', 'categories': [{'measurements': [{'value': '6.52', 'groupId': 'OG000', 'lowerLimit': '5.79', 'upperLimit': '7.34'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.42', 'upperLimit': '1.8'}, {'value': '0.99', 'groupId': 'OG002', 'lowerLimit': '0.84', 'upperLimit': '1.16'}]}]}, {'title': 'Day 29:1 A/Wisconsin/2009 (A/H3N2)(N=165,163,82)', 'categories': [{'measurements': [{'value': '4.56', 'groupId': 'OG000', 'lowerLimit': '4.07', 'upperLimit': '5.11'}, {'value': '1.17', 'groupId': 'OG001', 'lowerLimit': '1.05', 'upperLimit': '1.31'}, {'value': '0.95', 'groupId': 'OG002', 'lowerLimit': '0.81', 'upperLimit': '1.11'}]}]}, {'title': 'Day 50:1 A/Wisconsin/2009 (A/H3N2)(N=160,162,78)', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000', 'lowerLimit': '37', 'upperLimit': '50'}, {'value': '3.01', 'groupId': 'OG001', 'lowerLimit': '2.59', 'upperLimit': '3.51'}, {'value': '1.04', 'groupId': 'OG002', 'lowerLimit': '0.84', 'upperLimit': '1.29'}]}]}, {'title': 'Day181:1 A/Wisconsin/2009 (A/H3N2)(N=161,163,80)', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000', 'lowerLimit': '16', 'upperLimit': '25'}, {'value': '5.06', 'groupId': 'OG001', 'lowerLimit': '4.03', 'upperLimit': '6.37'}, {'value': '2.22', 'groupId': 'OG002', 'lowerLimit': '1.61', 'upperLimit': '3.06'}]}]}, {'title': 'Day 29:1 B/Brisbane/2008 (N=164,163,82)', 'categories': [{'measurements': [{'value': '1.08', 'groupId': 'OG000', 'lowerLimit': '1.04', 'upperLimit': '1.11'}, {'value': '1.02', 'groupId': 'OG001', 'lowerLimit': '0.098', 'upperLimit': '1.05'}, {'value': '1', 'groupId': 'OG002', 'lowerLimit': '0.96', 'upperLimit': '1.05'}]}]}, {'title': 'Day 50:1 B/Brisbane/2008 (N=159,162,78)', 'categories': [{'measurements': [{'value': '1.94', 'groupId': 'OG000', 'lowerLimit': '1.8', 'upperLimit': '2.08'}, {'value': '1.11', 'groupId': 'OG001', 'lowerLimit': '1.03', 'upperLimit': '1.19'}, {'value': '1.02', 'groupId': 'OG002', 'lowerLimit': '0.93', 'upperLimit': '1.14'}]}]}, {'title': 'Day181:1 B/Brisbane/2008 (N=160,163,80)', 'categories': [{'measurements': [{'value': '1.04', 'groupId': 'OG000', 'lowerLimit': '0.98', 'upperLimit': '1.11'}, {'value': '1.05', 'groupId': 'OG001', 'lowerLimit': '0.98', 'upperLimit': '1.11'}, {'value': '1.26', 'groupId': 'OG002', 'lowerLimit': '1.15', 'upperLimit': '1.37'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'On study days 1, 29, 50 and 181', 'description': 'The immunogenicity was assessed in terms of Geometric mean titer ratios (GMRs) of study day 29/study day 1, study day 50/study day 1, study day 181/study day 1 were evaluated.\n\nThe criteria for evaluation is GMR \\>2.5', 'unitOfMeasure': 'Ratios', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was done on Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of Geometric Mean Titers (GMTs), in Unprimed Subjects Aged 6 to <36 Months for Season 2008/09 (Homologous and Heterologous Strains)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}, {'value': '165', 'groupId': 'OG001'}, {'value': '83', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'TIV-adj', 'description': 'Subjects aged 6 to \\< 36 months received 0.25 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine'}, {'id': 'OG001', 'title': 'Flu-control', 'description': 'Subjects aged 6 to \\< 36 months received 0.25 mL of each injection of non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine'}, {'id': 'OG002', 'title': 'Non-flu-control', 'description': 'Subjects aged 6 to \\<12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to \\<72 months received 2 doses of 0.25 mL of TBE vaccine'}], 'classes': [{'title': 'Day 1 A/Brisbane/2007 (A/H1N1)', 'categories': [{'measurements': [{'value': '6.21', 'groupId': 'OG000', 'lowerLimit': '5.33', 'upperLimit': '7.24'}, {'value': '7.52', 'groupId': 'OG001', 'lowerLimit': '6.45', 'upperLimit': '8.76'}, {'value': '5.93', 'groupId': 'OG002', 'lowerLimit': '4.8', 'upperLimit': '7.33'}]}]}, {'title': 'Day 29 A/Brisbane/2007 (A/H1N1) (N=165,163,82)', 'categories': [{'measurements': [{'value': '105', 'groupId': 'OG000', 'lowerLimit': '82', 'upperLimit': '136'}, {'value': '14', 'groupId': 'OG001', 'lowerLimit': '11', 'upperLimit': '18'}, {'value': '6.13', 'groupId': 'OG002', 'lowerLimit': '4.33', 'upperLimit': '8.69'}]}]}, {'title': 'Day 50 A/Brisbane/2007 (A/H1N1) (N=160,162,78)', 'categories': [{'measurements': [{'value': '513', 'groupId': 'OG000', 'lowerLimit': '405', 'upperLimit': '652'}, {'value': '35', 'groupId': 'OG001', 'lowerLimit': '27', 'upperLimit': '44'}, {'value': '6.57', 'groupId': 'OG002', 'lowerLimit': '4.71', 'upperLimit': '9.16'}]}]}, {'title': 'Day 181 A/Brisbane/2007 (A/H1N1) (N=161,163,80)', 'categories': [{'measurements': [{'value': '118', 'groupId': 'OG000', 'lowerLimit': '95', 'upperLimit': '146'}, {'value': '18', 'groupId': 'OG001', 'lowerLimit': '15', 'upperLimit': '22'}, {'value': '6.1', 'groupId': 'OG002', 'lowerLimit': '4.51', 'upperLimit': '8.25'}]}]}, {'title': 'Day 1 A/Brisbane/2007 (A/H3N2)', 'categories': [{'measurements': [{'value': '5.85', 'groupId': 'OG000', 'lowerLimit': '5.13', 'upperLimit': '6.67'}, {'value': '5.8', 'groupId': 'OG001', 'lowerLimit': '5.09', 'upperLimit': '6.6'}, {'value': '5.66', 'groupId': 'OG002', 'lowerLimit': '4.73', 'upperLimit': '6.77'}]}]}, {'title': 'Day 29 A/Brisbane/2007 (A/H3N2) (N=165,163,82)', 'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000', 'lowerLimit': '76', 'upperLimit': '107'}, {'value': '9.17', 'groupId': 'OG001', 'lowerLimit': '7.71', 'upperLimit': '11'}, {'value': '6.04', 'groupId': 'OG002', 'lowerLimit': '4.75', 'upperLimit': '7.69'}]}]}, {'title': 'Day 50 A/Brisbane/2007 (A/H3N2) (N=160,162,78)', 'categories': [{'measurements': [{'value': '510', 'groupId': 'OG000', 'lowerLimit': '426', 'upperLimit': '609'}, {'value': '32', 'groupId': 'OG001', 'lowerLimit': '27', 'upperLimit': '39'}, {'value': '6', 'groupId': 'OG002', 'lowerLimit': '4.68', 'upperLimit': '7.68'}]}]}, {'title': 'Day 181 A/Brisbane/2007 (A/H3N2) (N=161,163,80)', 'categories': [{'measurements': [{'value': '176', 'groupId': 'OG000', 'lowerLimit': '141', 'upperLimit': '220'}, {'value': '36', 'groupId': 'OG001', 'lowerLimit': '29', 'upperLimit': '45'}, {'value': '12', 'groupId': 'OG002', 'lowerLimit': '8.74', 'upperLimit': '16'}]}]}, {'title': 'Day 1 B/Florida/2006', 'categories': [{'measurements': [{'value': '6.01', 'groupId': 'OG000', 'lowerLimit': '5.59', 'upperLimit': '6.45'}, {'value': '6', 'groupId': 'OG001', 'lowerLimit': '5.59', 'upperLimit': '6.44'}, {'value': '5.87', 'groupId': 'OG002', 'lowerLimit': '5.32', 'upperLimit': '6.47'}]}]}, {'title': 'Day 29 B/Florida/2006 (N=165,163,82)', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000', 'lowerLimit': '11', 'upperLimit': '15'}, {'value': '8.45', 'groupId': 'OG001', 'lowerLimit': '7.11', 'upperLimit': '10'}, {'value': '6.19', 'groupId': 'OG002', 'lowerLimit': '4.87', 'upperLimit': '7.87'}]}]}, {'title': 'Day 50 B/Florida/2006 (N=160,162,78)', 'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000', 'lowerLimit': '74', 'upperLimit': '100'}, {'value': '12', 'groupId': 'OG001', 'lowerLimit': '11', 'upperLimit': '14'}, {'value': '6.09', 'groupId': 'OG002', 'lowerLimit': '4.95', 'upperLimit': '7.49'}]}]}, {'title': 'Day 181 B/Florida/2006 (N=161,163,80)', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000', 'lowerLimit': '22', 'upperLimit': '29'}, {'value': '8.72', 'groupId': 'OG001', 'lowerLimit': '7.65', 'upperLimit': '9.95'}, {'value': '6.21', 'groupId': 'OG002', 'lowerLimit': '5.16', 'upperLimit': '7.48'}]}]}, {'title': 'Day 1 A/SolomonIslands/2006(A/H1N1)', 'categories': [{'measurements': [{'value': '6.66', 'groupId': 'OG000', 'lowerLimit': '5.56', 'upperLimit': '7.98'}, {'value': '8.19', 'groupId': 'OG001', 'lowerLimit': '6.85', 'upperLimit': '9.8'}, {'value': '6.24', 'groupId': 'OG002', 'lowerLimit': '4.87', 'upperLimit': '8'}]}]}, {'title': 'Day 29 A/SolomonIslands/2006(A/H1N1)(N=165,163,82)', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '11', 'upperLimit': '19'}, {'value': '12', 'groupId': 'OG001', 'lowerLimit': '8.69', 'upperLimit': '15'}, {'value': '6.08', 'groupId': 'OG002', 'lowerLimit': '4.12', 'upperLimit': '8.98'}]}]}, {'title': 'Day 50 A/SolomonIslands/2006(A/H1N1)(N=160,162,78)', 'categories': [{'measurements': [{'value': '122', 'groupId': 'OG000', 'lowerLimit': '94', 'upperLimit': '157'}, {'value': '16', 'groupId': 'OG001', 'lowerLimit': '13', 'upperLimit': '21'}, {'value': '6.1', 'groupId': 'OG002', 'lowerLimit': '4.27', 'upperLimit': '8.73'}]}]}, {'title': 'Day181 A/SolomonIslands/2006(A/H1N1)(N=161,163,80)', 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000', 'lowerLimit': '34', 'upperLimit': '55'}, {'value': '13', 'groupId': 'OG001', 'lowerLimit': '10', 'upperLimit': '17'}, {'value': '6.2', 'groupId': 'OG002', 'lowerLimit': '4.46', 'upperLimit': '8.61'}]}]}, {'title': 'Day 1 A/Wisconsin/2009 (A/H3N2)', 'categories': [{'measurements': [{'value': '6.09', 'groupId': 'OG000', 'lowerLimit': '5.26', 'upperLimit': '7.06'}, {'value': '6.74', 'groupId': 'OG001', 'lowerLimit': '5.83', 'upperLimit': '7.8'}, {'value': '6.16', 'groupId': 'OG002', 'lowerLimit': '5.03', 'upperLimit': '7.53'}]}]}, {'title': 'Day 29 A/Wisconsin/2009 (A/H3N2)(N=165,163,82)', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000', 'lowerLimit': '23', 'upperLimit': '33'}, {'value': '7.86', 'groupId': 'OG001', 'lowerLimit': '6.57', 'upperLimit': '9.39'}, {'value': '5.87', 'groupId': 'OG002', 'lowerLimit': '4.59', 'upperLimit': '7.52'}]}]}, {'title': 'Day 50 A/Wisconsin/2009 (A/H3N2)(N=160,162,78)', 'categories': [{'measurements': [{'value': '261', 'groupId': 'OG000', 'lowerLimit': '218', 'upperLimit': '313'}, {'value': '20', 'groupId': 'OG001', 'lowerLimit': '17', 'upperLimit': '24'}, {'value': '6.47', 'groupId': 'OG002', 'lowerLimit': '5.03', 'upperLimit': '8.32'}]}]}, {'title': 'Day181 A/Wisconsin/2009 (A/H3N2)(N=161,163,80)', 'categories': [{'measurements': [{'value': '123', 'groupId': 'OG000', 'lowerLimit': '97', 'upperLimit': '156'}, {'value': '34', 'groupId': 'OG001', 'lowerLimit': '27', 'upperLimit': '43'}, {'value': '14', 'groupId': 'OG002', 'lowerLimit': '9.81', 'upperLimit': '19'}]}]}, {'title': 'Day 1 B/Brisbane/2008 (N=165,165,83)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '5'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '5'}, {'value': '5', 'groupId': 'OG002', 'lowerLimit': '5', 'upperLimit': '5'}]}]}, {'title': 'Day 29 B/Brisbane/2008 (N=165,163,82)', 'categories': [{'measurements': [{'value': '5.38', 'groupId': 'OG000', 'lowerLimit': '5.21', 'upperLimit': '5.56'}, {'value': '5.08', 'groupId': 'OG001', 'lowerLimit': '4.91', 'upperLimit': '5.24'}, {'value': '5', 'groupId': 'OG002', 'lowerLimit': '4.78', 'upperLimit': '5.23'}]}]}, {'title': 'Day 50 B/Brisbane/2008 (N=160,162,78)', 'categories': [{'measurements': [{'value': '9.64', 'groupId': 'OG000', 'lowerLimit': '8.96', 'upperLimit': '10'}, {'value': '5.55', 'groupId': 'OG001', 'lowerLimit': '5.16', 'upperLimit': '5.97'}, {'value': '5.12', 'groupId': 'OG002', 'lowerLimit': '4.63', 'upperLimit': '5.68'}]}]}, {'title': 'Day181 B/Brisbane/2008 (N=161,163,80)', 'categories': [{'measurements': [{'value': '5.21', 'groupId': 'OG000', 'lowerLimit': '4.89', 'upperLimit': '5.54'}, {'value': '5.23', 'groupId': 'OG001', 'lowerLimit': '4.92', 'upperLimit': '5.56'}, {'value': '6.28', 'groupId': 'OG002', 'lowerLimit': '5.75', 'upperLimit': '6.84'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT[A/Brisbane/2007 (A/H1N1)]', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.83', 'ciLowerLimit': '0.67', 'ciUpperLimit': '1.02', 'groupDescription': 'To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 1 for strain A/Brisbane/2007 (A/H1N1) in terms of GMTs in subjects aged 6 to \\<36 months by HI assay.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT[A/Brisbane/2007 (A/H1N1)]', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.63', 'ciLowerLimit': '5.42', 'ciUpperLimit': '11', 'groupDescription': 'To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 29 for strain A/Brisbane/2007 (A/H1N1) in terms of GMTs in subjects aged 6 to \\<36 months by HI assay.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT[A/Brisbane/2007 (A/H1N1)]', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '15', 'ciLowerLimit': '11', 'ciUpperLimit': '21', 'groupDescription': 'To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 50 for strain A/Brisbane/2007 (A/H1N1) in terms of GMTs in subjects aged 6 to \\<36 months by HI assay', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT[A/Brisbane/2007 (A/H1N1)]', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.48', 'ciLowerLimit': '4.83', 'ciUpperLimit': '8.68', 'groupDescription': 'To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 181 for strain A/Brisbane/2007 (A/H1N1) in terms of GMTs in subjects aged 6 to \\<36 months by HI assay', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT[A/Brisbane/2007 (A/H3N2)]', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.01', 'ciLowerLimit': '0.85', 'ciUpperLimit': '1.21', 'groupDescription': 'To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 1 for strain A/Brisbane/2007 (A/H3N2) in terms of GMTs in subjects aged 6 to \\<36 months by HI assay.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT[A/Brisbane/2007 (A/H3N2)]', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.82', 'ciLowerLimit': '7.76', 'ciUpperLimit': '12', 'groupDescription': 'To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 29 for strain A/Brisbane/2007 (A/H3N2) in terms of GMTs in subjects aged 6 to \\<36 months by HI assay.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT[A/Brisbane/2007 (A/H3N2)]', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '16', 'ciLowerLimit': '12', 'ciUpperLimit': '20', 'groupDescription': 'To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 50 for strain A/Brisbane/2007 (A/H3N2) in terms of GMTs in subjects aged 6 to \\<36 months by HI assay.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT[A/Brisbane/2007 (A/H3N2)]', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.92', 'ciLowerLimit': '3.64', 'ciUpperLimit': '6.65', 'groupDescription': 'To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 181 for strain A/Brisbane/2007 (A/H3N2) in terms of GMTs in subjects aged 6 to \\<36 months by HI assay.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT[B/Florida/2006]', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1', 'ciLowerLimit': '0.91', 'ciUpperLimit': '1.1', 'groupDescription': 'To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 1 for strain B/Florida/2006 in terms of GMTs in subjects aged 6 to \\<36 months by HI assay.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT[B/Florida/2006]', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.5', 'ciLowerLimit': '1.19', 'ciUpperLimit': '1.9', 'groupDescription': 'To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 29 for strain B/Florida/2006 in terms of GMTs in subjects aged 6 to \\<36 months by HI assay.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT[B/Florida/2006]', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.99', 'ciLowerLimit': '5.72', 'ciUpperLimit': '8.53', 'groupDescription': 'To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 50 for strain B/Florida/2006 in terms of GMTs in subjects aged 6 to \\<36 months by HI assay.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT[B/Florida/2006]', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.92', 'ciLowerLimit': '2.44', 'ciUpperLimit': '3.5', 'groupDescription': 'To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 181 for strain B/Florida/2006 in terms of GMTs in subjects aged 6 to \\<36 months by HI assay.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT [A/Solomon Islands/2006 (A/H1N1)]', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.81', 'ciLowerLimit': '0.64', 'ciUpperLimit': '1.04', 'groupDescription': 'To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 1 for strain A/Solomon Islands/2006 (A/H1N1) in terms of GMTs in subjects aged 6 to \\<36 months by HI assay.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT[A/Solomon Islands/2006 (A/H1N1)]', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.21', 'ciLowerLimit': '0.83', 'ciUpperLimit': '1.78', 'groupDescription': 'To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 29 for strain A/Solomon Islands/2006 (A/H1N1) in terms of GMTs in subjects aged 6 to \\<36 months by HI assay.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT [A/Solomon Islands/2006 (A/H1N1]', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.54', 'ciLowerLimit': '5.33', 'ciUpperLimit': '11', 'groupDescription': 'To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 50 for strain A/Solomon Islands/2006 (A/H1N1) in terms of GMTs in subjects aged 6 to \\<36 months by HI assay.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT[A/Solomon Islands/2006 (A/H1N1)]', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.31', 'ciLowerLimit': '2.4', 'ciUpperLimit': '4.55', 'groupDescription': 'To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 181 for strain A/Solomon Islands/2006 (A/H1N1) in terms of GMTs in subjects aged 6 to \\<36 months by HI assay.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT [A/Wisconsin/2009 (A/H3N2)]', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.9', 'ciLowerLimit': '0.74', 'ciUpperLimit': '1.1', 'groupDescription': 'To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 1 for strain A/Wisconsin/2009 (A/H3N2) in terms of GMTs in subjects aged 6 to \\<36 months by HI assay.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT[A/Wisconsin/2009 (A/H3N2)]', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.54', 'ciLowerLimit': '2.78', 'ciUpperLimit': '4.51', 'groupDescription': 'To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 29 for strain A/Wisconsin/2009 (A/H3N2) in terms of GMTs in subjects aged 6 to \\<36 months by HI assay.', 'statisticalMethod': 'GMT', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT [A/Wisconsin/2009 (A/H3N2)]', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13', 'ciLowerLimit': '10', 'ciUpperLimit': '16', 'groupDescription': 'To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 50 for strain A/Wisconsin/2009 (A/H3N2) in terms of GMTs in subjects aged 6 to \\<36 months by HI assay.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT [A/Wisconsin/2009 (A/H3N2)]', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.6', 'ciLowerLimit': '2.61', 'ciUpperLimit': '4.95', 'groupDescription': 'To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 181 for strain A/Wisconsin/2009 (A/H3N2) in terms of GMTs in subjects aged 6 to \\<36 months by HI assay.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT [B/Brisbane/2008]', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1', 'ciLowerLimit': '1', 'ciUpperLimit': '1', 'groupDescription': 'To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 1 for strain B/Brisbane/2008 in terms of GMTs in subjects aged 6 to \\<36 months by HI assay.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT [B/Brisbane/2008]', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.06', 'ciLowerLimit': '1.02', 'ciUpperLimit': '1.11', 'groupDescription': 'To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 29 for strain B/Brisbane/2008 in terms of GMTs in subjects aged 6 to \\<36 months by HI assay.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT [B/Brisbane/2008]', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.74', 'ciLowerLimit': '1.57', 'ciUpperLimit': '1.92', 'groupDescription': 'To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 50 for strain B/Brisbane/2008 in terms of GMTs in subjects aged 6 to \\<36 months by HI assay.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT [B/Brisbane/2008]', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1', 'ciLowerLimit': '0.92', 'ciUpperLimit': '1.08', 'groupDescription': 'To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 181 for strain B/Brisbane/2008 in terms of GMTs in subjects aged 6 to \\<36 months by HI assay.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'On study days 1, 29, 50 and 181', 'description': 'Immunogenicity was analyzed in terms of Geometric Mean Titers (GMTs) as measured by hemagglutination inhibition (HI) assay. For each strain and each vaccine group, least squares GMTs, associated 2-sided 95% confidence interval were determined for all time points.\n\nSuperiority analysis: GMT-TIV-adj/GMT-Flu-control \\>1 should be elicited to show that GMT-TIV-adj is superior to GMT-Flu-control', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was done on Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With HI Titer ≥1:40 in Season 2008/09 HI Assay(Homologous and Heterologous Strains)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}, {'value': '165', 'groupId': 'OG001'}, {'value': '83', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'TIV-adj', 'description': 'Subjects aged 6 to \\< 36 months received 0.25 mL of each injection of Adjuvanted trivalent inactivated subunit influenza vaccine'}, {'id': 'OG001', 'title': 'Flu-control', 'description': 'Subjects aged 6 to \\< 36 months received 0.25 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine'}, {'id': 'OG002', 'title': 'Non-flu-control', 'description': 'Subjects aged 6 to \\<12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to \\<72 months received 2 doses of 0.25 mL of TBE vaccine'}], 'classes': [{'title': 'Day 1 A/Brisbane/2007 (A/H1N1)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '10'}, {'value': '11', 'groupId': 'OG001', 'lowerLimit': '7', 'upperLimit': '17'}, {'value': '5', 'groupId': 'OG002', 'lowerLimit': '1', 'upperLimit': '12'}]}]}, {'title': 'Day29 A/Brisbane/2007(A/H1N1)(N=165,163,82)', 'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000', 'lowerLimit': '86', 'upperLimit': '95'}, {'value': '20', 'groupId': 'OG001', 'lowerLimit': '14', 'upperLimit': '27'}, {'value': '6', 'groupId': 'OG002', 'lowerLimit': '2', 'upperLimit': '14'}]}]}, {'title': 'Day 50 A/Brisbane/2007 (A/H1N1) (N=160,162,78)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '98', 'upperLimit': '100'}, {'value': '38', 'groupId': 'OG001', 'lowerLimit': '31', 'upperLimit': '46'}, {'value': '6', 'groupId': 'OG002', 'lowerLimit': '2', 'upperLimit': '14'}]}]}, {'title': 'Day181A/Brisbane/2007(A/H1N1)(N=161,163,80)', 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000', 'lowerLimit': '94', 'upperLimit': '99'}, {'value': '25', 'groupId': 'OG001', 'lowerLimit': '19', 'upperLimit': '33'}, {'value': '6', 'groupId': 'OG002', 'lowerLimit': '2', 'upperLimit': '14'}]}]}, {'title': 'Day1 A/Brisbane/2007(A/H3N2)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '8'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '8'}, {'value': '2', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '8'}]}]}, {'title': 'Day29 A/Brisbane/2007(A/H3N2)(N=165,163,82)', 'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000', 'lowerLimit': '90', 'upperLimit': '97'}, {'value': '12', 'groupId': 'OG001', 'lowerLimit': '7', 'upperLimit': '18'}, {'value': '4', 'groupId': 'OG002', 'lowerLimit': '1', 'upperLimit': '10'}]}]}, {'title': 'Day50 A/Brisbane/2007(A/H3N2)(N=160,162,78)', 'categories': [{'measurements': [{'value': '99', 'groupId': 'OG000', 'lowerLimit': '97', 'upperLimit': '100'}, {'value': '45', 'groupId': 'OG001', 'lowerLimit': '37', 'upperLimit': '53'}, {'value': '4', 'groupId': 'OG002', 'lowerLimit': '1', 'upperLimit': '11'}]}]}, {'title': 'Day181A/Brisbane/2007(A/H3N2)(N=161,163,80)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '98', 'upperLimit': '100'}, {'value': '45', 'groupId': 'OG001', 'lowerLimit': '37', 'upperLimit': '53'}, {'value': '21', 'groupId': 'OG002', 'lowerLimit': '13', 'upperLimit': '32'}]}]}, {'title': 'Day 1 B/Florida/2006', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '6'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '5'}, {'value': '1', 'groupId': 'OG002', 'lowerLimit': '0.03', 'upperLimit': '7'}]}]}, {'title': 'Day29 B/Florida/2006 (N=165,163,82)', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000', 'lowerLimit': '8', 'upperLimit': '18'}, {'value': '12', 'groupId': 'OG001', 'lowerLimit': '8', 'upperLimit': '18'}, {'value': '4', 'groupId': 'OG002', 'lowerLimit': '1', 'upperLimit': '10'}]}]}, {'title': 'Day50 B/Florida/2006 (N=160,162,78)', 'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000', 'lowerLimit': '81', 'upperLimit': '92'}, {'value': '19', 'groupId': 'OG001', 'lowerLimit': '13', 'upperLimit': '25'}, {'value': '3', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '9'}]}]}, {'title': 'Day181B/Florida/2006 (N=161,163,80)', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000', 'lowerLimit': '33', 'upperLimit': '48'}, {'value': '13', 'groupId': 'OG001', 'lowerLimit': '9', 'upperLimit': '20'}, {'value': '3', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '9'}]}]}, {'title': 'Day 1 A/SolomonIslands/2006(A/H1N1)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '10'}, {'value': '11', 'groupId': 'OG001', 'lowerLimit': '7', 'upperLimit': '17'}, {'value': '5', 'groupId': 'OG002', 'lowerLimit': '1', 'upperLimit': '12'}]}]}, {'title': 'Day29A/Sol.Islands/2006(A/H1N1)(N=165,163,82)', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000', 'lowerLimit': '10', 'upperLimit': '21'}, {'value': '13', 'groupId': 'OG001', 'lowerLimit': '9', 'upperLimit': '20'}, {'value': '5', 'groupId': 'OG002', 'lowerLimit': '1', 'upperLimit': '12'}]}]}, {'title': 'Day50A/Sol.Islands/2006(A/H1N1) (N=160,162,78)', 'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000', 'lowerLimit': '90', 'upperLimit': '98'}, {'value': '24', 'groupId': 'OG001', 'lowerLimit': '18', 'upperLimit': '31'}, {'value': '5', 'groupId': 'OG002', 'lowerLimit': '1', 'upperLimit': '13'}]}]}, {'title': 'D181A/Sol.Islands/2006(A/H1N1) (N=161,163,80)', 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000', 'lowerLimit': '53', 'upperLimit': '68'}, {'value': '19', 'groupId': 'OG001', 'lowerLimit': '13', 'upperLimit': '26'}, {'value': '5', 'groupId': 'OG002', 'lowerLimit': '1', 'upperLimit': '12'}]}]}, {'title': 'Day 1 A/Wisconsin/2009 (A/H3N2)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '8'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '9'}, {'value': '2', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '8'}]}]}, {'title': 'Day29 A/Wisconsin/2009(A/H3N2) (N=165,163,82)', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000', 'lowerLimit': '30', 'upperLimit': '45'}, {'value': '6', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '10'}, {'value': '2', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '9'}]}]}, {'title': 'Day50 A/Wisconsin/2009(A/H3N2) (N=160,162,78)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '98', 'upperLimit': '100'}, {'value': '30', 'groupId': 'OG001', 'lowerLimit': '23', 'upperLimit': '37'}, {'value': '4', 'groupId': 'OG002', 'lowerLimit': '1', 'upperLimit': '11'}]}]}, {'title': 'Day181A/Wisconsin/2009(A/H3N2) (N=161,163,80)', 'categories': [{'measurements': [{'value': '99', 'groupId': 'OG000', 'lowerLimit': '97', 'upperLimit': '100'}, {'value': '42', 'groupId': 'OG001', 'lowerLimit': '34', 'upperLimit': '50'}, {'value': '23', 'groupId': 'OG002', 'lowerLimit': '14', 'upperLimit': '33'}]}]}, {'title': 'Day 1 B/Brisbane/2008', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '4'}]}]}, {'title': 'Day29 B/Brisbane/2008 (N=165,163,82)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '0.015', 'upperLimit': '3'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '4'}]}]}, {'title': 'Day50 B/Brisbane/2008 (N=160,162,78)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '10'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '5'}]}]}, {'title': 'Day181 B/Brisbane/2008 (N=161,163,80)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '0.016', 'upperLimit': '3'}, {'value': '6', 'groupId': 'OG002', 'lowerLimit': '2', 'upperLimit': '14'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'On study days 1, 29, 50, 181', 'description': 'Percentage of subjects achieving seroprotection (i.e., with HI titer ≥1:40) at study day 1, study day 29, study day 50 and a study day 181 and associated 95% CI. The lower bound of the two-sided 95% CI for the percentage of subjects achieving an HI antibody titer ≥1:40 should meet or exceed 70%.', 'unitOfMeasure': 'Percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was done on Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With Seroconversion From Baseline, for Season 2008/09 (Homologous and Heterologous Strains)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'TIV-adj', 'description': 'Subjects aged 6 to \\< 36 months received 0.25 mL of each injection of Adjuvanted trivalent inactivated subunit influenza vaccine'}, {'id': 'OG001', 'title': 'Flu-control', 'description': 'Subjects aged 6 to \\< 36 months received 0.25 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine'}, {'id': 'OG002', 'title': 'Non-flu-control', 'description': 'Subjects aged 6 to \\<12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to \\<72 months received 2 doses of 0.25 mL of TBE vaccine'}], 'classes': [{'title': 'Day29 A/Brisbane/2007(A/H1N1)', 'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000', 'lowerLimit': '86', 'upperLimit': '95'}, {'value': '19', 'groupId': 'OG001', 'lowerLimit': '13', 'upperLimit': '26'}, {'value': '1', 'groupId': 'OG002', 'lowerLimit': '0.031', 'upperLimit': '7'}]}]}, {'title': 'Day50 A/Brisbane/2007(A/H1N1)(N=160,162,78)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '98', 'upperLimit': '100'}, {'value': '38', 'groupId': 'OG001', 'lowerLimit': '30', 'upperLimit': '46'}, {'value': '1', 'groupId': 'OG002', 'lowerLimit': '0.032', 'upperLimit': '7'}]}]}, {'title': 'Day181A/Brisbane/2007(A/H1N1)(N=161,163,80)', 'categories': [{'measurements': [{'value': '97', 'groupId': 'OG000', 'lowerLimit': '93', 'upperLimit': '99'}, {'value': '24', 'groupId': 'OG001', 'lowerLimit': '18', 'upperLimit': '31'}, {'value': '1', 'groupId': 'OG002', 'lowerLimit': '0.032', 'upperLimit': '7'}]}]}, {'title': 'Day29 A/Brisbane/2007(A/H3N2)', 'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000', 'lowerLimit': '88', 'upperLimit': '97'}, {'value': '10', 'groupId': 'OG001', 'lowerLimit': '6', 'upperLimit': '16'}, {'value': '1', 'groupId': 'OG002', 'lowerLimit': '0.031', 'upperLimit': '7'}]}]}, {'title': 'Day50 A/Brisbane/2007(A/H3N2)(N=160,162,78)', 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000', 'lowerLimit': '95', 'upperLimit': '100'}, {'value': '44', 'groupId': 'OG001', 'lowerLimit': '36', 'upperLimit': '52'}, {'value': '1', 'groupId': 'OG002', 'lowerLimit': '0.032', 'upperLimit': '7'}]}]}, {'title': 'Day181A/Brisbane/2007(A/H3N2)(N=161,163,80)', 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000', 'lowerLimit': '94', 'upperLimit': '99'}, {'value': '42', 'groupId': 'OG001', 'lowerLimit': '35', 'upperLimit': '50'}, {'value': '19', 'groupId': 'OG002', 'lowerLimit': '11', 'upperLimit': '29'}]}]}, {'title': 'Day29 B/Florida/2006', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000', 'lowerLimit': '8', 'upperLimit': '18'}, {'value': '12', 'groupId': 'OG001', 'lowerLimit': '8', 'upperLimit': '18'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '4'}]}]}, {'title': 'Day50 B/Florida/2006 (N=160,162,78)', 'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000', 'lowerLimit': '81', 'upperLimit': '92'}, {'value': '19', 'groupId': 'OG001', 'lowerLimit': '13', 'upperLimit': '25'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '5'}]}]}, {'title': 'Day181B/Florida/2006 (N=161,163,80)', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000', 'lowerLimit': '31', 'upperLimit': '46'}, {'value': '12', 'groupId': 'OG001', 'lowerLimit': '7', 'upperLimit': '18'}, {'value': '1', 'groupId': 'OG002', 'lowerLimit': '0.032', 'upperLimit': '7'}]}]}, {'title': 'Day29A/Sol.Islands/2006(A/H1N1)', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '9', 'upperLimit': '20'}, {'value': '13', 'groupId': 'OG001', 'lowerLimit': '8', 'upperLimit': '19'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '4'}]}]}, {'title': 'Day50A/Sol.Islands/2006(A/H1N1)(N=160,162,78)', 'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000', 'lowerLimit': '89', 'upperLimit': '97'}, {'value': '23', 'groupId': 'OG001', 'lowerLimit': '17', 'upperLimit': '30'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '5'}]}]}, {'title': 'Day181A/Sol.Islands/2006(A/H1N1)(N=161,163,80)', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000', 'lowerLimit': '52', 'upperLimit': '68'}, {'value': '18', 'groupId': 'OG001', 'lowerLimit': '12', 'upperLimit': '25'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '5'}]}]}, {'title': 'Day29 A/Wisconsin/2009(A/H3N2)', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000', 'lowerLimit': '28', 'upperLimit': '44'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '8'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '4'}]}]}, {'title': 'Day50 A/Wisconsin/2009(A/H3N2)(N=160,162,78)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '98', 'upperLimit': '100'}, {'value': '27', 'groupId': 'OG001', 'lowerLimit': '20', 'upperLimit': '35'}, {'value': '1', 'groupId': 'OG002', 'lowerLimit': '0.032', 'upperLimit': '7'}]}]}, {'title': 'Day181A/Wisconsin/2009(A/H3N2)(N=161,163,80)', 'categories': [{'measurements': [{'value': '97', 'groupId': 'OG000', 'lowerLimit': '93', 'upperLimit': '99'}, {'value': '39', 'groupId': 'OG001', 'lowerLimit': '31', 'upperLimit': '47'}, {'value': '20', 'groupId': 'OG002', 'lowerLimit': '12', 'upperLimit': '30'}]}]}, {'title': 'Day29 B/Brisbane/2008', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '0.015', 'upperLimit': '3'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '4'}]}]}, {'title': 'Day 50:1 B/Brisbane/2008 (N=160,162,78)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '12'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '5'}]}]}, {'title': 'Day181 B/Brisbane/2008 (N=161,163,80)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '0.016', 'upperLimit': '3'}, {'value': '6', 'groupId': 'OG002', 'lowerLimit': '2', 'upperLimit': '14'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'On study days 1, 29, 50, 181', 'description': 'HI assay was used for the analysis. Seroconversion is defined as negative pre-vaccination serum (\\<10)/ post-vaccination HI titer ≥1:40.\n\nSeroconversion is defined as either pre-vaccination HI titer \\<10 and a post-vaccination HI titer ≥1:40 or a prevaccination HI titer ≥10 and a minimum four-fold rise in post-vaccination HI antibody titer.\n\nThe lower bound of the two-sided 95% confidence interval (CI) for the percentage of subjects achieving seroconversion for HI antibody should meet or exceed 40%.', 'unitOfMeasure': 'Percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was done on Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of GMTs, in Unprimed Subjects Aged 6 to <72 Months for Season 2008/09 (Homologous and Heterologous Strains)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '319', 'groupId': 'OG000'}, {'value': '316', 'groupId': 'OG001'}, {'value': '158', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'TIV-adj', 'description': 'Subjects aged 6 to \\< 36 months received 0.25 mL and those aged 36 to \\<72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine'}, {'id': 'OG001', 'title': 'Flu-control', 'description': 'Subjects aged 6 to \\< 36 months received 0.25 mL and those aged 36 to \\<72 months received 0.5 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine'}, {'id': 'OG002', 'title': 'Non-flu-control', 'description': 'Subjects aged 6 to \\<12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to \\<72 months received 2 doses of 0.25 mL of TBE vaccine'}], 'classes': [{'title': 'Day 1 A/Brisbane/2007 (A/H1N1)', 'categories': [{'measurements': [{'value': '9.63', 'groupId': 'OG000', 'lowerLimit': '8.28', 'upperLimit': '11'}, {'value': '10', 'groupId': 'OG001', 'lowerLimit': '8.59', 'upperLimit': '12'}, {'value': '9.48', 'groupId': 'OG002', 'lowerLimit': '7.67', 'upperLimit': '12'}]}]}, {'title': 'Day29A/Brisbane/2007(A/H1N1) (N=316,313,15', 'categories': [{'measurements': [{'value': '232', 'groupId': 'OG000', 'lowerLimit': '185', 'upperLimit': '291'}, {'value': '36', 'groupId': 'OG001', 'lowerLimit': '29', 'upperLimit': '45'}, {'value': '9.42', 'groupId': 'OG002', 'lowerLimit': '6.85', 'upperLimit': '13'}]}]}, {'title': 'Day50A/Brisbane/2007(A/H1N1) (N=310,309,150)', 'categories': [{'measurements': [{'value': '735', 'groupId': 'OG000', 'lowerLimit': '608', 'upperLimit': '888'}, {'value': '89', 'groupId': 'OG001', 'lowerLimit': '74', 'upperLimit': '108'}, {'value': '9.91', 'groupId': 'OG002', 'lowerLimit': '7.58', 'upperLimit': '13'}]}]}, {'title': 'Day181A/Brisbane/2007(A/H1N1) (N=309,310,151)', 'categories': [{'measurements': [{'value': '186', 'groupId': 'OG000', 'lowerLimit': '155', 'upperLimit': '225'}, {'value': '43', 'groupId': 'OG001', 'lowerLimit': '35', 'upperLimit': '51'}, {'value': '9.65', 'groupId': 'OG002', 'lowerLimit': '7.41', 'upperLimit': '13'}]}]}, {'title': 'Day1A/Brisbane/2007(A/H3N2)', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000', 'lowerLimit': '10', 'upperLimit': '15'}, {'value': '12', 'groupId': 'OG001', 'lowerLimit': '9.83', 'upperLimit': '14'}, {'value': '12', 'groupId': 'OG002', 'lowerLimit': '8.98', 'upperLimit': '15'}]}]}, {'title': 'Day 29 A/Brisbane/2007 (A/H3N2) (N=316,313,156)', 'categories': [{'measurements': [{'value': '209', 'groupId': 'OG000', 'lowerLimit': '167', 'upperLimit': '261'}, {'value': '33', 'groupId': 'OG001', 'lowerLimit': '26', 'upperLimit': '41'}, {'value': '12', 'groupId': 'OG002', 'lowerLimit': '8.83', 'upperLimit': '17'}]}]}, {'title': 'Day 50 A/Brisbane/2007 (A/H3N2) (N=310,309,150)', 'categories': [{'measurements': [{'value': '762', 'groupId': 'OG000', 'lowerLimit': '634', 'upperLimit': '915'}, {'value': '95', 'groupId': 'OG001', 'lowerLimit': '79', 'upperLimit': '115'}, {'value': '12', 'groupId': 'OG002', 'lowerLimit': '9.18', 'upperLimit': '15'}]}]}, {'title': 'Day 181 A/Brisbane/2007 (A/H3N2) (N=309,310,151)', 'categories': [{'measurements': [{'value': '295', 'groupId': 'OG000', 'lowerLimit': '245', 'upperLimit': '356'}, {'value': '94', 'groupId': 'OG001', 'lowerLimit': '78', 'upperLimit': '114'}, {'value': '26', 'groupId': 'OG002', 'lowerLimit': '20', 'upperLimit': '34'}]}]}, {'title': 'Day 1 B/Florida/2006', 'categories': [{'measurements': [{'value': '6.37', 'groupId': 'OG000', 'lowerLimit': '6.01', 'upperLimit': '6.75'}, {'value': '6.57', 'groupId': 'OG001', 'lowerLimit': '6.2', 'upperLimit': '6.96'}, {'value': '6.41', 'groupId': 'OG002', 'lowerLimit': '5.92', 'upperLimit': '6.95'}]}]}, {'title': 'Day 29 B/Florida/2006 (N=316,313,156)', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000', 'lowerLimit': '18', 'upperLimit': '25'}, {'value': '14', 'groupId': 'OG001', 'lowerLimit': '12', 'upperLimit': '16'}, {'value': '6.54', 'groupId': 'OG002', 'lowerLimit': '5.26', 'upperLimit': '8.13'}]}]}, {'title': 'Day 50 B/Florida/2006 (N=310,309,150)', 'categories': [{'measurements': [{'value': '109', 'groupId': 'OG000', 'lowerLimit': '97', 'upperLimit': '123'}, {'value': '22', 'groupId': 'OG001', 'lowerLimit': '19', 'upperLimit': '25'}, {'value': '6.67', 'groupId': 'OG002', 'lowerLimit': '5.64', 'upperLimit': '7.88'}]}]}, {'title': 'Day 181 B/Florida/2006 (N=309,310,151)', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000', 'lowerLimit': '29', 'upperLimit': '36'}, {'value': '13', 'groupId': 'OG001', 'lowerLimit': '11', 'upperLimit': '14'}, {'value': '6.92', 'groupId': 'OG002', 'lowerLimit': '6.01', 'upperLimit': '7.98'}]}]}, {'title': 'Day 1 A/SolomonIslands/2006(A/H1N1)', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000', 'lowerLimit': '9.47', 'upperLimit': '14'}, {'value': '12', 'groupId': 'OG001', 'lowerLimit': '9.89', 'upperLimit': '14'}, {'value': '10', 'groupId': 'OG002', 'lowerLimit': '8.16', 'upperLimit': '13'}]}]}, {'title': 'Day29 A/SolomonIslands/2006(A/H1N1)(N=316,313,150)', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000', 'lowerLimit': '30', 'upperLimit': '53'}, {'value': '23', 'groupId': 'OG001', 'lowerLimit': '18', 'upperLimit': '31'}, {'value': '10', 'groupId': 'OG002', 'lowerLimit': '7.12', 'upperLimit': '15'}]}]}, {'title': 'Day50 A/SolomonIslands/2006(A/H1N1)(N=310,309,150)', 'categories': [{'measurements': [{'value': '228', 'groupId': 'OG000', 'lowerLimit': '182', 'upperLimit': '287'}, {'value': '41', 'groupId': 'OG001', 'lowerLimit': '33', 'upperLimit': '51'}, {'value': '11', 'groupId': 'OG002', 'lowerLimit': '7.63', 'upperLimit': '15'}]}]}, {'title': 'Day181A/SolomonIslands/2006(A/H1N1)(N=309,310,151)', 'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000', 'lowerLimit': '70', 'upperLimit': '109'}, {'value': '28', 'groupId': 'OG001', 'lowerLimit': '23', 'upperLimit': '35'}, {'value': '11', 'groupId': 'OG002', 'lowerLimit': '7.76', 'upperLimit': '14'}]}]}, {'title': 'Day 1 A/Wisconsin/2009 (A/H3N2)', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000', 'lowerLimit': '12', 'upperLimit': '18'}, {'value': '15', 'groupId': 'OG001', 'lowerLimit': '12', 'upperLimit': '19'}, {'value': '13', 'groupId': 'OG002', 'lowerLimit': '9.97', 'upperLimit': '18'}]}]}, {'title': 'Day 29 A/Wisconsin/2009 (A/H3N2) (N=316,313,156)', 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000', 'lowerLimit': '75', 'upperLimit': '127'}, {'value': '31', 'groupId': 'OG001', 'lowerLimit': '24', 'upperLimit': '40'}, {'value': '13', 'groupId': 'OG002', 'lowerLimit': '8.74', 'upperLimit': '18'}]}]}, {'title': 'Day 50 A/Wisconsin/2009 (A/H3N2) (N=310,309,150)', 'categories': [{'measurements': [{'value': '518', 'groupId': 'OG000', 'lowerLimit': '420', 'upperLimit': '639'}, {'value': '70', 'groupId': 'OG001', 'lowerLimit': '57', 'upperLimit': '87'}, {'value': '14', 'groupId': 'OG002', 'lowerLimit': '10', 'upperLimit': '19'}]}]}, {'title': 'Day181 A/Wisconsin/2009 (A/H3N2) (N=309,310,151)', 'categories': [{'measurements': [{'value': '261', 'groupId': 'OG000', 'lowerLimit': '212', 'upperLimit': '322'}, {'value': '98', 'groupId': 'OG001', 'lowerLimit': '79', 'upperLimit': '121'}, {'value': '34', 'groupId': 'OG002', 'lowerLimit': '26', 'upperLimit': '46'}]}]}, {'title': 'Day 1 B/Brisbane/2008', 'categories': [{'measurements': [{'value': '5.05', 'groupId': 'OG000', 'lowerLimit': '4.99', 'upperLimit': '5.11'}, {'value': '5.05', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '5.11'}, {'value': '5.08', 'groupId': 'OG002', 'lowerLimit': '5', 'upperLimit': '5.16'}]}]}, {'title': 'Day 29 B/Brisbane/2008 (N=316,313,156)', 'categories': [{'measurements': [{'value': '6.31', 'groupId': 'OG000', 'lowerLimit': '5.97', 'upperLimit': '6.66'}, {'value': '5.57', 'groupId': 'OG001', 'lowerLimit': '5.28', 'upperLimit': '5.89'}, {'value': '5.11', 'groupId': 'OG002', 'lowerLimit': '4.74', 'upperLimit': '5.52'}]}]}, {'title': 'Day 50 B/Brisbane/2008 (N=310,309,150)', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000', 'lowerLimit': '11', 'upperLimit': '13'}, {'value': '6.69', 'groupId': 'OG001', 'lowerLimit': '6.23', 'upperLimit': '7.17'}, {'value': '5.2', 'groupId': 'OG002', 'lowerLimit': '4.71', 'upperLimit': '5.75'}]}]}, {'title': 'Day181 B/Brisbane/2008 (N=309,310,151)', 'categories': [{'measurements': [{'value': '6.12', 'groupId': 'OG000', 'lowerLimit': '5.77', 'upperLimit': '6.49'}, {'value': '5.67', 'groupId': 'OG001', 'lowerLimit': '5.35', 'upperLimit': '6.01'}, {'value': '6.12', 'groupId': 'OG002', 'lowerLimit': '5.64', 'upperLimit': '6.65'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT [A/Brisbane/2007 (A/H1N1)]', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.96', 'ciLowerLimit': '0.78', 'ciUpperLimit': '1.19', 'groupDescription': 'To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 1 for strain A/Brisbane/2007 (A/H1N1) in terms of GMTs in subjects aged 6 to \\<72 months by HI assay.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT [A/Brisbane/2007 (A/H1N1)]', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.41', 'ciLowerLimit': '4.69', 'ciUpperLimit': '8.76', 'groupDescription': 'To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 29 for strain A/Brisbane/2007 (A/H1N1) in terms of GMTs in subjects aged 6 to \\<72 months by HI assay.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT [A/Brisbane/2007 (A/H1N1)]', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.26', 'ciLowerLimit': '6.36', 'ciUpperLimit': '11', 'groupDescription': 'To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 50 for strain A/Brisbane/2007 (A/H1N1) in terms of GMTs in subjects aged 6 to \\<72 months by HI assay.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT [A/Brisbane/2007 (A/H1N1)]', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.37', 'ciLowerLimit': '3.38', 'ciUpperLimit': '5.65', 'groupDescription': 'To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 181 for strain A/Brisbane/2007 (A/H1N1) in terms of GMTs in subjects aged 6 to \\<72 months by HI assay.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT [A/Brisbane/2007 (A/H3N2)]', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.05', 'ciLowerLimit': '0.82', 'ciUpperLimit': '1.35', 'groupDescription': 'To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 1 for strain A/Brisbane/2007 (A/H3N2) in terms of Geometric Mean Titers GMTs in subjects aged 6 to \\<72 months by HI assay.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT [A/Brisbane/2007 (A/H3N2)]', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.42', 'ciLowerLimit': '4.72', 'ciUpperLimit': '8.73', 'groupDescription': 'To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 29 for strain A/Brisbane/2007 (A/H3N2) in terms of GMTs in subjects aged 6 to \\<72 months by HI assay.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT [A/Brisbane/2007 (A/H3N2)]', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.98', 'ciLowerLimit': '6.2', 'ciUpperLimit': '10', 'groupDescription': 'To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 50 for strain A/Brisbane/2007 (A/H3N2) in terms of GMTs in subjects aged 6 to \\<72 months by HI assay.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT [A/Brisbane/2007 (A/H3N2)]', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.13', 'ciLowerLimit': '2.42', 'ciUpperLimit': '4.05', 'groupDescription': 'To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 181 for strain A/Brisbane/2007 (A/H3N2) in terms of GMTs in subjects aged 6 to \\<72 months by HI assay.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT [B/Florida/2006]', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.97', 'ciLowerLimit': '0.9', 'ciUpperLimit': '1.05', 'groupDescription': 'To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 1 for strain B/Florida/2006 in terms of GMTs in subjects aged 6 to \\<72 months by HI assay.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT [B/Florida/2006]', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.56', 'ciLowerLimit': '1.26', 'ciUpperLimit': '1.93', 'groupDescription': 'To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 29 for strain B/Florida/2006 in terms of GMTs in subjects aged 6 to \\<72 months by HI assay.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT [B/Florida/2006]', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5', 'ciLowerLimit': '4.25', 'ciUpperLimit': '5.88', 'groupDescription': 'To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 50 for strain B/Florida/2006 in terms of GMTs in subjects aged 6 to \\<72 months by HI assay.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT [B/Florida/2006]', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.55', 'ciLowerLimit': '2.22', 'ciUpperLimit': '2.93', 'groupDescription': 'To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 181 for strain B/Florida/2006 in terms of GMTs in subjects aged 6 to \\<72 months by HI assay.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT [A/Solomon Islands/2006 (A/H1N1)]', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.96', 'ciLowerLimit': '0.75', 'ciUpperLimit': '1.22', 'groupDescription': 'To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day1 for strain A/Solomon Islands/2006 (A/H1N1) in terms of GMTs in subjects aged 6 to \\<72 months by HI assay.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT [A/Solomon Islands/2006 (A/H1N1)]', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.72', 'ciLowerLimit': '1.17', 'ciUpperLimit': '2.51', 'groupDescription': 'To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 29 for strain A/Solomon Islands/2006 (A/H1N1) in terms of GMTs in subjects aged 6 to \\<72 months by HI assay.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT [A/Solomon Islands/2006 (A/H1N1)]', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.58', 'ciLowerLimit': '4.08', 'ciUpperLimit': '7.63', 'groupDescription': 'To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 50 for strain A/Solomon Islands/2006 (A/H1N1) in terms of GMTs in subjects aged 6 to \\<72 months by HI assay.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT [A/Solomon Islands/2006 (A/H1N1)]', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.11', 'ciLowerLimit': '2.3', 'ciUpperLimit': '4.2', 'groupDescription': 'To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 181 for strain A/Solomon Islands/2006 (A/H1N1) in terms of GMTs in subjects aged 6 to \\<72 months by HI assay.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT [A/Wisconsin/2009 (A/H3N2)]', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.98', 'ciLowerLimit': '0.74', 'ciUpperLimit': '1.3', 'groupDescription': 'To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 1 for strain A/Wisconsin/2009 (A/H3N2) in terms of GMTs in subjects aged 6 to \\<72 months by HI assay.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT [A/Wisconsin/2009 (A/H3N2)]', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.14', 'ciLowerLimit': '2.19', 'ciUpperLimit': '4.49', 'groupDescription': 'To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 29 for strain A/Wisconsin/2009 (A/H3N2) in terms of GMTs in subjects aged 6 to \\<72 months by HI assay.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT [A/Wisconsin/2009 (A/H3N2)]', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.36', 'ciLowerLimit': '5.51', 'ciUpperLimit': '9.82', 'groupDescription': 'To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 50 for strain A/Wisconsin/2009 (A/H3N2) in terms of GMTs in subjects aged 6 to \\<72 months by HI assay.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT [A/Wisconsin/2009 (A/H3N2)]', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.66', 'ciLowerLimit': '2', 'ciUpperLimit': '3.55', 'groupDescription': 'To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 181 for strain A/Wisconsin/2009 (A/H3N2) in terms of GMTs in subjects aged 6 to \\<72 months by HI assay.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT [B/Brisbane/2008]', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1', 'ciLowerLimit': '0.98', 'ciUpperLimit': '1.01', 'groupDescription': 'To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 1 for strain B/Brisbane/2008 in terms of GMTs in subjects aged 6 to \\<72 months by HI assay.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT [B/Brisbane/2008]', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.13', 'ciLowerLimit': '1.05', 'ciUpperLimit': '1.22', 'groupDescription': 'To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 29 for strain B/Brisbane/2008 in terms of GMTs in subjects aged 6 to \\<72 months by HI assay.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT [B/Brisbane/2008]', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.79', 'ciLowerLimit': '1.63', 'ciUpperLimit': '1.97', 'groupDescription': 'To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 50 for strain B/Brisbane/2008 in terms of GMTs in subjects aged 6 to \\<72 months by HI assay.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT [B/Brisbane/2008]', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.08', 'ciLowerLimit': '1', 'ciUpperLimit': '1.17', 'groupDescription': 'To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 181 for strain B/Brisbane/2008 in terms of GMTs in subjects aged 6 to \\<72 months by HI assay.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'On study days 1, 29, 50 , 181', 'description': 'Immunogenicity was analyzed in terms of Geometric Mean Titers (GMTs) as measured by hemagglutination inhibition (HI) assay. For each strain and each vaccine group, least squares GMTs, associated 2-sided 95% confidence interval were determined for all time points Superiority analysis: GMT-TIV-adj/GMT-Flu-control \\>1 and GMT-TIV-adj/GMT-Non Flu-control \\>1 should be elicited to show that GMT-TIV-adj is superior to GMT-Flu-control/Non Flu-control.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was done on Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of GMRs, in Unprimed Subjects Aged 6 to <72 Months for Season 2008/09 (Homologous and Heterologous Strains)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '319', 'groupId': 'OG000'}, {'value': '316', 'groupId': 'OG001'}, {'value': '158', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'TIV-adj', 'description': 'Subjects aged 6 to \\< 36 months received 0.25 mL and those aged 36 to \\<72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine'}, {'id': 'OG001', 'title': 'Flu-control', 'description': 'Subjects aged 6 to \\< 36 months received 0.25 mL and those aged 36 to \\<72 months received 0.5 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine'}, {'id': 'OG002', 'title': 'Non-flu-control', 'description': 'Subjects aged 6 to \\<12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to \\<72 months received 2 doses of 0.25 mL of TBE vaccine'}], 'classes': [{'title': 'Day 29:1A/Brisbane/2007(A/H1N1;N=316,313,156)', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000', 'lowerLimit': '21', 'upperLimit': '27'}, {'value': '3.6', 'groupId': 'OG001', 'lowerLimit': '3.17', 'upperLimit': '4.08'}, {'value': '0.99', 'groupId': 'OG002', 'lowerLimit': '0.83', 'upperLimit': '1.18'}]}]}, {'title': 'Day 50:1A/Brisbane/2007(A/H1N1;N=10,309,150)', 'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000', 'lowerLimit': '67', 'upperLimit': '86'}, {'value': '9', 'groupId': 'OG001', 'lowerLimit': '7.89', 'upperLimit': '10'}, {'value': '1.02', 'groupId': 'OG002', 'lowerLimit': '0.84', 'upperLimit': '1.22'}]}]}, {'title': 'Day 181:1A/Brisbane/2007(A/H1N1;N=309,310,151)', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000', 'lowerLimit': '17', 'upperLimit': '21'}, {'value': '4.31', 'groupId': 'OG001', 'lowerLimit': '3.89', 'upperLimit': '4.77'}, {'value': '1.02', 'groupId': 'OG002', 'lowerLimit': '0.88', 'upperLimit': '1.17'}]}]}, {'title': 'Day 29:1A/Brisbane/2007(A/H3N2;N=316,313,156)', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000', 'lowerLimit': '15', 'upperLimit': '19'}, {'value': '2.73', 'groupId': 'OG001', 'lowerLimit': '2.4', 'upperLimit': '3.09'}, {'value': '1.03', 'groupId': 'OG002', 'lowerLimit': '0.86', 'upperLimit': '1.23'}]}]}, {'title': 'D50:1A/Brisbane/2007(A/H3N2;N=310,309,150)', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000', 'lowerLimit': '52', 'upperLimit': '69'}, {'value': '8.03', 'groupId': 'OG001', 'lowerLimit': '6.93', 'upperLimit': '9.3'}, {'value': '0.98', 'groupId': 'OG002', 'lowerLimit': '0.8', 'upperLimit': '1.21'}]}]}, {'title': 'Day 181:1A/Brisbane/2007(A/H3N2;N=309,310,151)', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000', 'lowerLimit': '20', 'upperLimit': '28'}, {'value': '7.96', 'groupId': 'OG001', 'lowerLimit': '6.71', 'upperLimit': '9.44'}, {'value': '2.21', 'groupId': 'OG002', 'lowerLimit': '1.73', 'upperLimit': '2.81'}]}]}, {'title': 'Day 29:1B/Florida/2006(N=316,313,156)', 'categories': [{'measurements': [{'value': '3.32', 'groupId': 'OG000', 'lowerLimit': '2.94', 'upperLimit': '3.75'}, {'value': '2.06', 'groupId': 'OG001', 'lowerLimit': '1.83', 'upperLimit': '2.33'}, {'value': '1.03', 'groupId': 'OG002', 'lowerLimit': '0.87', 'upperLimit': '1.22'}]}]}, {'title': 'Day 50:1B/Florida/2006(N=310,309,150)', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000', 'lowerLimit': '15', 'upperLimit': '19'}, {'value': '3.29', 'groupId': 'OG001', 'lowerLimit': '2.98', 'upperLimit': '3.63'}, {'value': '1.03', 'groupId': 'OG002', 'lowerLimit': '0.9', 'upperLimit': '1.18'}]}]}, {'title': 'Day 181:1B/Florida/2006(N=309,310,151)', 'categories': [{'measurements': [{'value': '5.05', 'groupId': 'OG000', 'lowerLimit': '4.67', 'upperLimit': '5.46'}, {'value': '1.92', 'groupId': 'OG001', 'lowerLimit': '1.78', 'upperLimit': '2.08'}, {'value': '1.06', 'groupId': 'OG002', 'lowerLimit': '0.95', 'upperLimit': '1.19'}]}]}, {'title': 'Day 29:1A/Sol.Island/2006(A/H1N1;N=316,313,156)', 'categories': [{'measurements': [{'value': '3.51', 'groupId': 'OG000', 'lowerLimit': '3.09', 'upperLimit': '3.98'}, {'value': '1.96', 'groupId': 'OG001', 'lowerLimit': '1.72', 'upperLimit': '2.22'}, {'value': '0.99', 'groupId': 'OG002', 'lowerLimit': '0.83', 'upperLimit': '1.18'}]}]}, {'title': 'Day 50:1A/Sol.Island/2006A/H1N1;N=310,309,150)', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000', 'lowerLimit': '18', 'upperLimit': '22'}, {'value': '3.49', 'groupId': 'OG001', 'lowerLimit': '3.12', 'upperLimit': '3.89'}, {'value': '0.97', 'groupId': 'OG002', 'lowerLimit': '0.83', 'upperLimit': '1.14'}]}]}, {'title': 'Day 181:1A/Sol.Island/2006A/H1N1;N=309,310,151)', 'categories': [{'measurements': [{'value': '7.63', 'groupId': 'OG000', 'lowerLimit': '6.98', 'upperLimit': '8.34'}, {'value': '2.41', 'groupId': 'OG001', 'lowerLimit': '2.2', 'upperLimit': '2.63'}, {'value': '1.01', 'groupId': 'OG002', 'lowerLimit': '0.89', 'upperLimit': '1.14'}]}]}, {'title': 'Day 29:1A/Wisconsin/2009(A/H3N2;N=316,313,156)', 'categories': [{'measurements': [{'value': '6.59', 'groupId': 'OG000', 'lowerLimit': '5.92', 'upperLimit': '7.34'}, {'value': '2.04', 'groupId': 'OG001', 'lowerLimit': '1.83', 'upperLimit': '2.27'}, {'value': '0.93', 'groupId': 'OG002', 'lowerLimit': '0.8', 'upperLimit': '1.09'}]}]}, {'title': 'Day 50:1A/Wisconsin/2009(A/H3N2;N=310,309,150)', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000', 'lowerLimit': '30', 'upperLimit': '38'}, {'value': '4.6', 'groupId': 'OG001', 'lowerLimit': '4.07', 'upperLimit': '5.2'}, {'value': '0.98', 'groupId': 'OG002', 'lowerLimit': '0.83', 'upperLimit': '1.17'}]}]}, {'title': 'Day 181:1A/Wisconsin/2009(A/H3N2;N=309,310,151)', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000', 'lowerLimit': '15', 'upperLimit': '21'}, {'value': '6.39', 'groupId': 'OG001', 'lowerLimit': '5.36', 'upperLimit': '7.6'}, {'value': '2.59', 'groupId': 'OG002', 'lowerLimit': '2', 'upperLimit': '3.29'}]}]}, {'title': 'Day 29:1B/Brisbane/2008(N=315,313,156)', 'categories': [{'measurements': [{'value': '1.25', 'groupId': 'OG000', 'lowerLimit': '1.19', 'upperLimit': '1.31'}, {'value': '1.1', 'groupId': 'OG001', 'lowerLimit': '1.05', 'upperLimit': '1.16'}, {'value': '1.01', 'groupId': 'OG002', 'lowerLimit': '0.94', 'upperLimit': '1.08'}]}]}, {'title': 'Day 50:1B/Brisbane/2008(N=309,309,150)', 'categories': [{'measurements': [{'value': '2.38', 'groupId': 'OG000', 'lowerLimit': '2.23', 'upperLimit': '2.55'}, {'value': '1.32', 'groupId': 'OG001', 'lowerLimit': '1.24', 'upperLimit': '1.42'}, {'value': '1.02', 'groupId': 'OG002', 'lowerLimit': '0.93', 'upperLimit': '1.13'}]}]}, {'title': 'Day 181:1B/Brisbane/2008(N=308,310,151)', 'categories': [{'measurements': [{'value': '1.21', 'groupId': 'OG000', 'lowerLimit': '1.15', 'upperLimit': '1.28'}, {'value': '1.12', 'groupId': 'OG001', 'lowerLimit': '1.06', 'upperLimit': '1.19'}, {'value': '1.21', 'groupId': 'OG002', 'lowerLimit': '1.11', 'upperLimit': '1.31'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'On study days 1, 29, 50, 181', 'description': 'Hemagglutination Inhibition (HI) assay was used for the analysis. Geometric mean titer ratios (GMRs) of study day 29/study day 1, study day 50/study day 1, study day 181/study day 1 were evaluated.\n\nThe criteria for evaluation is GMR \\>2.5', 'unitOfMeasure': 'Ratios', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was done on Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Percentages of Subjects With HI Titers ≥ 1:40 in Unprimed Subjects 6 to <72 Months of Age for Season 2008/09 Homologous and Heterologous Strains', 'denoms': [{'units': 'Participants', 'counts': [{'value': '319', 'groupId': 'OG000'}, {'value': '316', 'groupId': 'OG001'}, {'value': '158', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'TIV-adj', 'description': 'Subjects aged 6 to \\< 36 months received 0.25 mL and those aged 36 to \\<72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine'}, {'id': 'OG001', 'title': 'Flu-control', 'description': 'Subjects aged 6 to \\< 36 months received 0.25 mL and those aged 36 to \\<72 months received 0.5 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine'}, {'id': 'OG002', 'title': 'Non-flu-control', 'description': 'Subjects aged 6 to \\<12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to \\<72 months received 2 doses of 0.25 mL of TBE vaccine'}], 'classes': [{'title': 'Day1 A/Brisbane/2007(A/H1N1)', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000', 'lowerLimit': '16', 'upperLimit': '25'}, {'value': '21', 'groupId': 'OG001', 'lowerLimit': '17', 'upperLimit': '26'}, {'value': '16', 'groupId': 'OG002', 'lowerLimit': '11', 'upperLimit': '23'}]}]}, {'title': 'Day29A/Brisbane/2007(A/H1N1;N=316,313,156)', 'categories': [{'measurements': [{'value': '96', 'groupId': 'OG000', 'lowerLimit': '93', 'upperLimit': '98'}, {'value': '40', 'groupId': 'OG001', 'lowerLimit': '35', 'upperLimit': '46'}, {'value': '17', 'groupId': 'OG002', 'lowerLimit': '11', 'upperLimit': '23'}]}]}, {'title': 'Day50A/Brisbane/2007(A/H1N1;N=310,309,150)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '99', 'upperLimit': '100'}, {'value': '59', 'groupId': 'OG001', 'lowerLimit': '54', 'upperLimit': '65'}, {'value': '17', 'groupId': 'OG002', 'lowerLimit': '12', 'upperLimit': '24'}]}]}, {'title': 'Day181A/Brisbane/2007(A/H1N1;N=309,310,151)', 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000', 'lowerLimit': '96', 'upperLimit': '99'}, {'value': '49', 'groupId': 'OG001', 'lowerLimit': '43', 'upperLimit': '54'}, {'value': '18', 'groupId': 'OG002', 'lowerLimit': '12', 'upperLimit': '25'}]}]}, {'title': 'Day1A/Brisbane/2007(A/H3N2)', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000', 'lowerLimit': '18', 'upperLimit': '28'}, {'value': '22', 'groupId': 'OG001', 'lowerLimit': '17', 'upperLimit': '27'}, {'value': '20', 'groupId': 'OG002', 'lowerLimit': '14', 'upperLimit': '27'}]}]}, {'title': 'Day29A/Brisbane/2007(A/H3N2;N=316,313,156)', 'categories': [{'measurements': [{'value': '96', 'groupId': 'OG000', 'lowerLimit': '93', 'upperLimit': '98'}, {'value': '35', 'groupId': 'OG001', 'lowerLimit': '30', 'upperLimit': '40'}, {'value': '21', 'groupId': 'OG002', 'lowerLimit': '15', 'upperLimit': '28'}]}]}, {'title': 'Day50A/Brisbane/2007(A/H3N2;N=310,309,150)', 'categories': [{'measurements': [{'value': '99', 'groupId': 'OG000', 'lowerLimit': '97', 'upperLimit': '100'}, {'value': '65', 'groupId': 'OG001', 'lowerLimit': '60', 'upperLimit': '71'}, {'value': '21', 'groupId': 'OG002', 'lowerLimit': '14', 'upperLimit': '28'}]}]}, {'title': 'Day181A/Brisbane/2007(A/H3N2;N=309,310,151)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '98', 'upperLimit': '100'}, {'value': '65', 'groupId': 'OG001', 'lowerLimit': '60', 'upperLimit': '70'}, {'value': '41', 'groupId': 'OG002', 'lowerLimit': '33', 'upperLimit': '49'}]}]}, {'title': 'Day1B/Florida/2006', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '4'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '5'}, {'value': '4', 'groupId': 'OG002', 'lowerLimit': '1', 'upperLimit': '8'}]}]}, {'title': 'Day29B/Florida/2006(N=316,313,156)', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000', 'lowerLimit': '23', 'upperLimit': '33'}, {'value': '26', 'groupId': 'OG001', 'lowerLimit': '21', 'upperLimit': '31'}, {'value': '4', 'groupId': 'OG002', 'lowerLimit': '1', 'upperLimit': '8'}]}]}, {'title': 'Day50B/Florida/2006(N=310,309,150)', 'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000', 'lowerLimit': '89', 'upperLimit': '95'}, {'value': '38', 'groupId': 'OG001', 'lowerLimit': '33', 'upperLimit': '44'}, {'value': '3', 'groupId': 'OG002', 'lowerLimit': '1', 'upperLimit': '8'}]}]}, {'title': 'Day181B/Florida/2006(N=309,310,151)', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000', 'lowerLimit': '46', 'upperLimit': '57'}, {'value': '23', 'groupId': 'OG001', 'lowerLimit': '18', 'upperLimit': '28'}, {'value': '4', 'groupId': 'OG002', 'lowerLimit': '1', 'upperLimit': '8'}]}]}, {'title': 'Day1A/Sol.Islands/2006(A/H1N1)', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000', 'lowerLimit': '16', 'upperLimit': '26'}, {'value': '22', 'groupId': 'OG001', 'lowerLimit': '17', 'upperLimit': '27'}, {'value': '18', 'groupId': 'OG002', 'lowerLimit': '12', 'upperLimit': '25'}]}]}, {'title': 'D29A/Sol.Islands/2006(A/H1N1;N=316,313,156)', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000', 'lowerLimit': '27', 'upperLimit': '38'}, {'value': '24', 'groupId': 'OG001', 'lowerLimit': '20', 'upperLimit': '29'}, {'value': '18', 'groupId': 'OG002', 'lowerLimit': '12', 'upperLimit': '25'}]}]}, {'title': 'D50A/Sol.islands/2006(A/H1N1;N=310,309,150)', 'categories': [{'measurements': [{'value': '96', 'groupId': 'OG000', 'lowerLimit': '94', 'upperLimit': '98'}, {'value': '45', 'groupId': 'OG001', 'lowerLimit': '39', 'upperLimit': '51'}, {'value': '18', 'groupId': 'OG002', 'lowerLimit': '12', 'upperLimit': '25'}]}]}, {'title': 'D181A/Sol.Islands/2006(A/H1N1;N=309,310,151)', 'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000', 'lowerLimit': '67', 'upperLimit': '77'}, {'value': '34', 'groupId': 'OG001', 'lowerLimit': '29', 'upperLimit': '40'}, {'value': '18', 'groupId': 'OG002', 'lowerLimit': '12', 'upperLimit': '25'}]}]}, {'title': 'Day1A/Wisconsin/2009(A/H3N2)', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000', 'lowerLimit': '21', 'upperLimit': '31'}, {'value': '25', 'groupId': 'OG001', 'lowerLimit': '20', 'upperLimit': '30'}, {'value': '21', 'groupId': 'OG002', 'lowerLimit': '15', 'upperLimit': '28'}]}]}, {'title': 'Day29A/Wisconsin/2009(A/H3N2;N=316,313,156)', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000', 'lowerLimit': '54', 'upperLimit': '66'}, {'value': '29', 'groupId': 'OG001', 'lowerLimit': '24', 'upperLimit': '34'}, {'value': '21', 'groupId': 'OG002', 'lowerLimit': '14', 'upperLimit': '28'}]}]}, {'title': 'Day50A/Wisconsin/2009(A/H3N2;N=310,309,150)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '98', 'upperLimit': '100'}, {'value': '54', 'groupId': 'OG001', 'lowerLimit': '48', 'upperLimit': '59'}, {'value': '21', 'groupId': 'OG002', 'lowerLimit': '15', 'upperLimit': '29'}]}]}, {'title': 'D181A/Wisconsin/2009(A/H3N2;N=309,310,151)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '98', 'upperLimit': '100'}, {'value': '63', 'groupId': 'OG001', 'lowerLimit': '57', 'upperLimit': '68'}, {'value': '43', 'groupId': 'OG002', 'lowerLimit': '35', 'upperLimit': '51'}]}]}, {'title': 'Day1B/Brisbane/2008', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '1'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '1'}, {'value': '1', 'groupId': 'OG002', 'lowerLimit': '0.016', 'upperLimit': '3'}]}]}, {'title': 'Day29B/Brisbane/2008(N=316,313,156)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '6'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '3'}, {'value': '1', 'groupId': 'OG002', 'lowerLimit': '0.016', 'upperLimit': '4'}]}]}, {'title': 'Day50B/Brisbane/2008(N=310,309,150)', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000', 'lowerLimit': '7', 'upperLimit': '14'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '5'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '2'}]}]}, {'title': 'Day181B/Brisbane/2008(N=309,310,151)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '5'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '5'}, {'value': '5', 'groupId': 'OG002', 'lowerLimit': '2', 'upperLimit': '10'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'On study days 1, 29, 50, 181', 'description': 'Hemagglutination Inhibition (HI) assay was used for the analysis.\n\nPercentage of subjects achieving seroprotection (i.e., with HI titer ≥1:40) at study day 1, study day 29, study day 50 and a study day 181 and associated 95% Confidence Intervals. The lower bound of the two-sided 95% CI for the percentage of subjects achieving an HI antibody titer ≥1:40 should meet or exceed 70%.', 'unitOfMeasure': 'Percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was done on Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Percentages of Subjects With Seroconversion and Vaccine Group Differences in Unprimed Subjects 6 to <72 Months of Age for Season 2008/09 (Homologous and Heterologous Strains)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '319', 'groupId': 'OG000'}, {'value': '316', 'groupId': 'OG001'}, {'value': '158', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'TIV-adj', 'description': 'Subjects aged 6 to \\< 36 months received 0.25 mL and those aged 36 to \\<72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine'}, {'id': 'OG001', 'title': 'Flu-control', 'description': 'Subjects aged 6 to \\< 36 months received 0.25 mL and those aged 36 to \\<72 months received 0.5 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine'}, {'id': 'OG002', 'title': 'Non-flu-control', 'description': 'Subjects aged 6 to \\<12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to \\<72 months received 2 doses of 0.25 mL of TBE vaccine'}], 'classes': [{'title': 'Day 29:1 A/Brisbane/2007 (A/H1N1; N=316,313,156)', 'categories': [{'measurements': [{'value': '96', 'groupId': 'OG000', 'lowerLimit': '93', 'upperLimit': '98'}, {'value': '40', 'groupId': 'OG001', 'lowerLimit': '34', 'upperLimit': '45'}, {'value': '1', 'groupId': 'OG002', 'lowerLimit': '0.016', 'upperLimit': '4'}]}]}, {'title': 'Day 50:1 A/Brisbane/2007 (A/H1N1; N=310,309,150)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '99', 'upperLimit': '100'}, {'value': '59', 'groupId': 'OG001', 'lowerLimit': '53', 'upperLimit': '64'}, {'value': '1', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '5'}]}]}, {'title': 'Day 181:1 A/Brisbane/2007 (A/H1N1; N=309,310,151)', 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000', 'lowerLimit': '96', 'upperLimit': '99'}, {'value': '48', 'groupId': 'OG001', 'lowerLimit': '42', 'upperLimit': '53'}, {'value': '1', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '5'}]}]}, {'title': 'Day 29:1 A/Brisbane/2007 (A/H3N2; N=316,313,156)', 'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000', 'lowerLimit': '91', 'upperLimit': '97'}, {'value': '31', 'groupId': 'OG001', 'lowerLimit': '26', 'upperLimit': '37'}, {'value': '1', 'groupId': 'OG002', 'lowerLimit': '0.016', 'upperLimit': '4'}]}]}, {'title': 'Day 50:1 A/Brisbane/2007 (A/H3N2; N=310,309,150)', 'categories': [{'measurements': [{'value': '97', 'groupId': 'OG000', 'lowerLimit': '95', 'upperLimit': '99'}, {'value': '63', 'groupId': 'OG001', 'lowerLimit': '57', 'upperLimit': '68'}, {'value': '2', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '6'}]}]}, {'title': 'Day 181:1 A/Brisbane/2007 (A/H3N2; N=309,310,151)', 'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000', 'lowerLimit': '90', 'upperLimit': '96'}, {'value': '56', 'groupId': 'OG001', 'lowerLimit': '51', 'upperLimit': '62'}, {'value': '23', 'groupId': 'OG002', 'lowerLimit': '17', 'upperLimit': '31'}]}]}, {'title': 'Day 29:1 B/Florida/2006 (N=316,313,156)', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000', 'lowerLimit': '23', 'upperLimit': '33'}, {'value': '26', 'groupId': 'OG001', 'lowerLimit': '21', 'upperLimit': '31'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '2'}]}]}, {'title': 'Day 50:1 B/Florida/2006 (N=310,309,150)', 'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000', 'lowerLimit': '89', 'upperLimit': '95'}, {'value': '38', 'groupId': 'OG001', 'lowerLimit': '32', 'upperLimit': '43'}, {'value': '1', 'groupId': 'OG002', 'lowerLimit': '0.017', 'upperLimit': '4'}]}]}, {'title': 'Day 181:1 B/Florida/2006 (N=309,310,151)', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000', 'lowerLimit': '44', 'upperLimit': '56'}, {'value': '19', 'groupId': 'OG001', 'lowerLimit': '15', 'upperLimit': '24'}, {'value': '1', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '5'}]}]}, {'title': 'Day 29:1A/SolomonIsland/2006(A/H1N1;N=316,313,156)', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000', 'lowerLimit': '27', 'upperLimit': '37'}, {'value': '24', 'groupId': 'OG001', 'lowerLimit': '19', 'upperLimit': '29'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '2'}]}]}, {'title': 'Day 50:1A/SolomonIsland/2006(A/H1N1;N=310,309,150)', 'categories': [{'measurements': [{'value': '96', 'groupId': 'OG000', 'lowerLimit': '93', 'upperLimit': '98'}, {'value': '44', 'groupId': 'OG001', 'lowerLimit': '39', 'upperLimit': '50'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '2'}]}]}, {'title': 'Day181:1A/SolomonIsland/2006(A/H1N1;N=309,310,151)', 'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000', 'lowerLimit': '66', 'upperLimit': '76'}, {'value': '33', 'groupId': 'OG001', 'lowerLimit': '27', 'upperLimit': '38'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '2'}]}]}, {'title': 'Day 29:1 A/Wisconsin/2009 (A/H3N2; N=316,313,156)', 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000', 'lowerLimit': '53', 'upperLimit': '64'}, {'value': '23', 'groupId': 'OG001', 'lowerLimit': '19', 'upperLimit': '28'}, {'value': '1', 'groupId': 'OG002', 'lowerLimit': '0.016', 'upperLimit': '4'}]}]}, {'title': 'Day 50:1 A/Wisconsin/2009 (A/H3N2; N=310,309,150)', 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000', 'lowerLimit': '96', 'upperLimit': '99'}, {'value': '49', 'groupId': 'OG001', 'lowerLimit': '43', 'upperLimit': '54'}, {'value': '2', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '6'}]}]}, {'title': 'Day181:1 A/Wisconsin/2009 (A/H3N2;N=309,310,151)', 'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000', 'lowerLimit': '89', 'upperLimit': '95'}, {'value': '52', 'groupId': 'OG001', 'lowerLimit': '46', 'upperLimit': '58'}, {'value': '25', 'groupId': 'OG002', 'lowerLimit': '18', 'upperLimit': '33'}]}]}, {'title': 'Day 29:1 B/Brisbane/2008 (N=316,313,156)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '6'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '3'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '2'}]}]}, {'title': 'Day 50:1 B/Brisbane/2008 (N=310,309,150)', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000', 'lowerLimit': '7', 'upperLimit': '14'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '5'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '2'}]}]}, {'title': 'Day181:1 B/Brisbane/2008 (N=309,310,151)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '5'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '5'}, {'value': '5', 'groupId': 'OG002', 'lowerLimit': '2', 'upperLimit': '10'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'On study days 1, 29, 50, 181', 'description': 'HI assay was used for the analysis. Seroconversion is defined as negative pre-vaccination serum (\\<10)/ post-vaccination HI titer ≥1:40.\n\nSeroconversion is defined as either pre-vaccination HI titer \\<10 and a post-vaccination HI titer ≥1:40 or a prevaccination HI titer ≥10 and a minimum 4-fold rise in post-vaccination HI antibody titer. The lower bound of the two-sided 95% confidence interval (CI) for the percentage of subjects achieving seroconversion for HI antibody should meet or exceed 40%.', 'unitOfMeasure': 'Percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was done on Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Local and Systemic Reactions for Egg and Cell Derived Inactivated Novel Swine Origin A/H1N1 Subunit Influenza Vaccines After Each Vaccination for All Seasons', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'TIV-adj', 'description': 'Subjects aged 6 to \\< 36 months received 0.25 mL and those aged 36 to \\<72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine'}, {'id': 'OG001', 'title': 'Flu-control', 'description': 'Subjects aged 6 to \\< 36 months received 0.25 mL and those aged 36 to \\<72 months received 0.5 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine'}, {'id': 'OG002', 'title': 'Non-flu Control', 'description': 'Subjects aged 6 to \\< 36 months received 0.25 mL and those aged 36 to \\<72 months received 0.5 mL of each injection of Novartis meningococcal C conjugate vaccine or tick-borne encephalitis vaccine'}], 'timeFrame': '7 days post-vaccination', 'reportingStatus': 'POSTED', 'populationDescription': 'Adequate data was not available to conduct this analysis.'}, {'type': 'SECONDARY', 'title': 'Indirect Protective Effect of Fluad (NH Composition 2007/2008), Compared to Non-flu Control and Flu Control, in Connection to Household-contact Persons Via a Questioning of the Parents About ILI of Persons Living in the Same Household as the Study Child', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'TIV-adj', 'description': 'Subjects aged 6 to \\< 36 months received 0.25 mL and those aged 36 to \\<72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine'}, {'id': 'OG001', 'title': 'Non-flu Control', 'description': 'Subjects aged 6 to \\<12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to \\<72 months received 2 doses of 0.25 mL of TBE vaccine'}, {'id': 'OG002', 'title': 'Flu-Control', 'description': 'Subjects aged 6 to \\< 36 months received 0.25 mL and those aged 36 to \\<72 months received 0.5 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine'}], 'timeFrame': '3 weeks after 2nd vaccination', 'reportingStatus': 'POSTED', 'populationDescription': 'As per an amendment to the protocol, the Secondary efficacy endpoints were evaluated in enrolled subjects only and the household members were not included in the trial for the evaluation of indirect vaccine efficacy.'}, {'type': 'SECONDARY', 'title': 'Incidence Rate of the 2009-2010 H1N1 Swine Pandemic Caused by a Novel Influenza A (H1N1) Virus of Swine Origin in Unprimed Children Aged 6 to <36 and 6 to <72 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'TIV-adj', 'description': 'Subjects aged 6 to \\< 36 months received 0.25 mL and those aged 36 to \\<72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine'}, {'id': 'OG001', 'title': 'Non-flu Control', 'description': 'Subjects aged 6 to \\<12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to \\<72 months received 2 doses of 0.25 mL of TBE vaccine'}, {'id': 'OG002', 'title': 'Flu-Control', 'description': 'Subjects aged 6 to \\< 36 months received 0.25 mL and those aged 36 to \\<72 months received 0.5 mL of each injection of'}], 'timeFrame': '3 weeks after 2nd vaccination', 'reportingStatus': 'POSTED', 'populationDescription': 'Adequate data was not available for assessing the incidence rates of the 2009-2010 swine pandemic caused by a novel influenza A (H1N1) virus of swine origin.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'TIV-adj', 'description': 'Subjects aged 6 to \\< 36 months received 0.25 mL and those aged 36 to \\<72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine'}, {'id': 'FG001', 'title': 'Flu-control', 'description': 'Subjects aged 6 to \\< 36 months received 0.25 mL and those aged 36 to \\<72 months received 0.5 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine'}, {'id': 'FG002', 'title': 'Non-flu Control', 'description': 'Subjects aged 6 to \\<12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to \\<72 months received 2 doses of 0.25 mL of Tick-borne encephalitis (TBE) vaccine'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2019'}, {'groupId': 'FG001', 'numSubjects': '1849'}, {'groupId': 'FG002', 'numSubjects': '1034'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1895'}, {'groupId': 'FG001', 'numSubjects': '1726'}, {'groupId': 'FG002', 'numSubjects': '969'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '124'}, {'groupId': 'FG001', 'numSubjects': '123'}, {'groupId': 'FG002', 'numSubjects': '65'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '34'}, {'groupId': 'FG002', 'numSubjects': '16'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '60'}, {'groupId': 'FG002', 'numSubjects': '30'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Inappropriate Enrollment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Protocol Deviation/violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '15'}]}, {'type': 'Unable to classify', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'Participants were enrolled as follows:\n\nIn season 2007/08: 28 active sites in Germany (Excluding Site 023); In season 2008/09: 83 active sites+ 1 coordinating site in Germany, 15 sites in Finland; In season 2009/10: 15 sites in Finland, 2 sites in Italy', 'preAssignmentDetails': 'All subjects enrolled were included in the trial. The data entered is for the overall study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2019', 'groupId': 'BG000'}, {'value': '1849', 'groupId': 'BG001'}, {'value': '1034', 'groupId': 'BG002'}, {'value': '4902', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'TIV-adj', 'description': 'Subjects aged 6 to \\< 36 months received 0.25 mL and those aged 36 to \\<72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine'}, {'id': 'BG001', 'title': 'Flu-control', 'description': 'Subjects aged 6 to \\< 36 months received 0.25 mL and those aged 36 to \\<72 months received 0.5 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine'}, {'id': 'BG002', 'title': 'Non-flu Control', 'description': 'Subjects aged 6 to \\<12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to \\<72 months received 2 doses of 0.25 mL of TBE vaccine'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '31.9', 'spread': '19.8', 'groupId': 'BG000'}, {'value': '32.6', 'spread': '20.1', 'groupId': 'BG001'}, {'value': '32.2', 'spread': '19.8', 'groupId': 'BG002'}, {'value': '32.2', 'spread': '19.9', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '962', 'groupId': 'BG000'}, {'value': '903', 'groupId': 'BG001'}, {'value': '484', 'groupId': 'BG002'}, {'value': '2349', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '1057', 'groupId': 'BG000'}, {'value': '946', 'groupId': 'BG001'}, {'value': '550', 'groupId': 'BG002'}, {'value': '2553', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4902}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-31', 'studyFirstSubmitDate': '2008-03-20', 'resultsFirstSubmitDate': '2011-10-06', 'studyFirstSubmitQcDate': '2008-03-25', 'lastUpdatePostDateStruct': {'date': '2015-09-18', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-10-13', 'studyFirstPostDateStruct': {'date': '2008-03-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-10-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Subjects (Unprimed) 6 to <36 Months Age With Local and Systemic Reactions After Any Vaccination for All Seasons, Comparison of Adjuvanted Trivalent Influenza Vaccine (aTIV) and Flu Vaccine Control.', 'timeFrame': '7 days post-vaccination', 'description': 'Safety was assessed in terms of number of subjects experiencing each of the local and systemic reactions within 7-days after any vaccination for all seasons, comparison of adjuvanted Trivalent influenza vaccine (aTIV) and flu vaccine control.'}, {'measure': 'Percentage of Subjects (Unprimed) Aged 6 to <36 Months With Virus-Confirmed Influenza, Comparison of aTIV and Non-flu Vaccine Control (Men C/TBE Vaccine)', 'timeFrame': '3 weeks after 2nd vaccination', 'description': 'Virus-confirmed influenza illnesses were assessed and compared between the adjuvanted influenza vaccine (TIV-adj) and non-influenza vaccines (Non-flu control) in 6 to \\<36 month unprimed subjects for Absolute Efficacy. This primary endpoint is only for homologous strains.'}], 'secondaryOutcomes': [{'measure': 'Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination', 'timeFrame': '7 days post-vaccination', 'description': 'Safety was assessed as the number of subjects aged 6 to \\<72 months who reported solicited local or systemic adverse events after any vaccination with TIV-adj for all seasons.'}, {'measure': 'Number of Subjects (Unprimed) With Unsolicited Adverse Events Reported After Any Vaccination', 'timeFrame': 'Study day 1 to Study day 181', 'description': 'Number of subjects aged 6 to \\<36 months and in the overall age cohort (unprimed children aged 6 to \\<72 months) experiencing each of the unsolicited adverse events (AEs) throughout the study'}, {'measure': 'Percentage of Subjects (Unprimed) Aged 6 to <72 Months With Virus-Confirmed Influenza, Comparison of aTIV to Non-flu Vaccine Control and Flu-vaccine Control (Matched Strains)', 'timeFrame': '3 weeks after 2nd vaccination', 'description': 'Virus-confirmed influenza illnesses were assessed and compared between the adjuvanted influenza vaccine (TIV-adj) and non-influenza vaccines (Non-flu control) in subjects aged 6 to \\<72 months (unprimed) for Absolute Efficacy.\n\nFor Relative efficacy, the comparison was made between adjuvanted influenza vaccine (TIV-adj) and flu vaccine control.'}, {'measure': 'Percentage of Subjects (Unprimed) Aged 6 to <72 Months With Virus-Confirmed Influenza, Comparison of aTIV to Non-flu Vaccine Control and Flu Vaccine Control (Any Strains).', 'timeFrame': '3 weeks after 2nd vaccination', 'description': 'Virus-confirmed influenza illnesses (regardless of antigenic match to those contained in the vaccine) were assessed and compared between the adjuvanted influenza vaccine (TIV-adj) and non-influenza vaccines (Non-flu control) in subjects aged 6 to \\<72 months (unprimed) for Absolute Efficacy.\n\nFor Relative efficacy, the comparison was made between adjuvanted influenza vaccine (TIV-adj) and flu vaccine control.'}, {'measure': 'Number of Subjects (Unprimed) With Influenza Like Illnesses (ILIs) in the 6 to <72 Months Age Cohort for Combined Seasons 2007/08 and 2008/09', 'timeFrame': '3 weeks after 2nd vaccination', 'description': 'Virus-confirmed influenza illnesses were assessed and trivalent adjuvanted influenza vaccine (TIV-adj) was compared with Non-flu control vaccine and Flu-control vaccine in 6 to \\<72 month old subjects for Influenza like illnesses for seasons 2007/08 and 2008/09.'}, {'measure': 'Number of Subjects With Influenza Like Illnesses (ILIs) in the 6 to <36 Months and in Overall Age Cohort (Unprimed Subjects Aged 6 to <72 Months) for Combined Seasons 2007/08 and 2008/09', 'timeFrame': '3 weeks after 2nd vaccination', 'description': 'Virus-confirmed influenza illnesses were assessed and trivalent adjuvanted influenza vaccine (TIV-adj) was compared with Non-flu control vaccine and Flu-control vaccine for Influenza like illnesses for seasons 2007/08 and 2008/09.'}, {'measure': 'Loss of Days of Usual Activity (Job, School, Day Care, Household/Family/Community Activities) Due to Influenza Like Illness (ILI) in Subjects in Aged 6 to <72 and 6 to <36 Months and in Direct Caregivers Living in the Household.', 'timeFrame': '3 weeks after 2nd vaccination', 'description': 'Virus-confirmed influenza illnesses were assessed and trivalent adjuvanted influenza vaccine (TIV-adj) was compared with Non-flu control vaccine and Flu-control vaccine for Influenza like illnesses for seasons 2007/08 and 2008/09.'}, {'measure': 'Number of Events of Influenza Like Illness for Combined Seasons 2007/08 and 2008/09.', 'timeFrame': '3 weeks after 2nd vaccination', 'description': 'The number of events of Influenza like Illness reported by subjects aged 6 to \\<72 months was assessed for combined seasons 2007/08 and 2008/09'}, {'measure': 'Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of GMRs, in Unprimed Subjects Aged 6 to <36 Months or Season 2008/09 (Homologous and Heterologous Strains)', 'timeFrame': 'On study days 1, 29, 50 and 181', 'description': 'The immunogenicity was assessed in terms of Geometric mean titer ratios (GMRs) of study day 29/study day 1, study day 50/study day 1, study day 181/study day 1 were evaluated.\n\nThe criteria for evaluation is GMR \\>2.5'}, {'measure': 'Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of Geometric Mean Titers (GMTs), in Unprimed Subjects Aged 6 to <36 Months for Season 2008/09 (Homologous and Heterologous Strains)', 'timeFrame': 'On study days 1, 29, 50 and 181', 'description': 'Immunogenicity was analyzed in terms of Geometric Mean Titers (GMTs) as measured by hemagglutination inhibition (HI) assay. For each strain and each vaccine group, least squares GMTs, associated 2-sided 95% confidence interval were determined for all time points.\n\nSuperiority analysis: GMT-TIV-adj/GMT-Flu-control \\>1 should be elicited to show that GMT-TIV-adj is superior to GMT-Flu-control'}, {'measure': 'Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With HI Titer ≥1:40 in Season 2008/09 HI Assay(Homologous and Heterologous Strains)', 'timeFrame': 'On study days 1, 29, 50, 181', 'description': 'Percentage of subjects achieving seroprotection (i.e., with HI titer ≥1:40) at study day 1, study day 29, study day 50 and a study day 181 and associated 95% CI. The lower bound of the two-sided 95% CI for the percentage of subjects achieving an HI antibody titer ≥1:40 should meet or exceed 70%.'}, {'measure': 'Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With Seroconversion From Baseline, for Season 2008/09 (Homologous and Heterologous Strains)', 'timeFrame': 'On study days 1, 29, 50, 181', 'description': 'HI assay was used for the analysis. Seroconversion is defined as negative pre-vaccination serum (\\<10)/ post-vaccination HI titer ≥1:40.\n\nSeroconversion is defined as either pre-vaccination HI titer \\<10 and a post-vaccination HI titer ≥1:40 or a prevaccination HI titer ≥10 and a minimum four-fold rise in post-vaccination HI antibody titer.\n\nThe lower bound of the two-sided 95% confidence interval (CI) for the percentage of subjects achieving seroconversion for HI antibody should meet or exceed 40%.'}, {'measure': 'Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of GMTs, in Unprimed Subjects Aged 6 to <72 Months for Season 2008/09 (Homologous and Heterologous Strains)', 'timeFrame': 'On study days 1, 29, 50 , 181', 'description': 'Immunogenicity was analyzed in terms of Geometric Mean Titers (GMTs) as measured by hemagglutination inhibition (HI) assay. For each strain and each vaccine group, least squares GMTs, associated 2-sided 95% confidence interval were determined for all time points Superiority analysis: GMT-TIV-adj/GMT-Flu-control \\>1 and GMT-TIV-adj/GMT-Non Flu-control \\>1 should be elicited to show that GMT-TIV-adj is superior to GMT-Flu-control/Non Flu-control.'}, {'measure': 'Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of GMRs, in Unprimed Subjects Aged 6 to <72 Months for Season 2008/09 (Homologous and Heterologous Strains)', 'timeFrame': 'On study days 1, 29, 50, 181', 'description': 'Hemagglutination Inhibition (HI) assay was used for the analysis. Geometric mean titer ratios (GMRs) of study day 29/study day 1, study day 50/study day 1, study day 181/study day 1 were evaluated.\n\nThe criteria for evaluation is GMR \\>2.5'}, {'measure': 'Percentages of Subjects With HI Titers ≥ 1:40 in Unprimed Subjects 6 to <72 Months of Age for Season 2008/09 Homologous and Heterologous Strains', 'timeFrame': 'On study days 1, 29, 50, 181', 'description': 'Hemagglutination Inhibition (HI) assay was used for the analysis.\n\nPercentage of subjects achieving seroprotection (i.e., with HI titer ≥1:40) at study day 1, study day 29, study day 50 and a study day 181 and associated 95% Confidence Intervals. The lower bound of the two-sided 95% CI for the percentage of subjects achieving an HI antibody titer ≥1:40 should meet or exceed 70%.'}, {'measure': 'Percentages of Subjects With Seroconversion and Vaccine Group Differences in Unprimed Subjects 6 to <72 Months of Age for Season 2008/09 (Homologous and Heterologous Strains)', 'timeFrame': 'On study days 1, 29, 50, 181', 'description': 'HI assay was used for the analysis. Seroconversion is defined as negative pre-vaccination serum (\\<10)/ post-vaccination HI titer ≥1:40.\n\nSeroconversion is defined as either pre-vaccination HI titer \\<10 and a post-vaccination HI titer ≥1:40 or a prevaccination HI titer ≥10 and a minimum 4-fold rise in post-vaccination HI antibody titer. The lower bound of the two-sided 95% confidence interval (CI) for the percentage of subjects achieving seroconversion for HI antibody should meet or exceed 40%.'}, {'measure': 'Number of Subjects With Local and Systemic Reactions for Egg and Cell Derived Inactivated Novel Swine Origin A/H1N1 Subunit Influenza Vaccines After Each Vaccination for All Seasons', 'timeFrame': '7 days post-vaccination'}, {'measure': 'Indirect Protective Effect of Fluad (NH Composition 2007/2008), Compared to Non-flu Control and Flu Control, in Connection to Household-contact Persons Via a Questioning of the Parents About ILI of Persons Living in the Same Household as the Study Child', 'timeFrame': '3 weeks after 2nd vaccination'}, {'measure': 'Incidence Rate of the 2009-2010 H1N1 Swine Pandemic Caused by a Novel Influenza A (H1N1) Virus of Swine Origin in Unprimed Children Aged 6 to <36 and 6 to <72 Months', 'timeFrame': '3 weeks after 2nd vaccination'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Influenza', 'vaccine', 'children'], 'conditions': ['Influenza, Human']}, 'referencesModule': {'references': [{'pmid': '21995388', 'type': 'RESULT', 'citation': 'Vesikari T, Knuf M, Wutzler P, Karvonen A, Kieninger-Baum D, Schmitt HJ, Baehner F, Borkowski A, Tsai TF, Clemens R. Oil-in-water emulsion adjuvant with influenza vaccine in young children. N Engl J Med. 2011 Oct 13;365(15):1406-16. doi: 10.1056/NEJMoa1010331.'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the efficacy, safety and immunogenicity of one or two 0.25 mL or 0.5 mL intramuscular injections of an adjuvanted influenza vaccine compared with non-influenza and non-adjuvanted influenza control vaccines in subjects 6 to \\<72 months of age.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '71 Months', 'minimumAge': '6 Months', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Children whose parents/legal guardians have given written informed consent prior to study entry: a) aged 6 to \\<72 months (Part I and II of the study; influenza seasons 2007/2008 and 2008/2009) b) aged 6 to \\<36 months (Part III of the study; influenza season 2009/2010)\n* In good health as determined by: a) medical history, b) physical examination, c) clinical judgment of the investigator\n\nExclusion criteria:\n\n* Administration of licensed vaccines (including H1N1sw vaccines) within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrollment in this study. Routine vaccines, according to local recommendations, or any other vaccines not foreseen in the protocol could be given after the active trial phase (i.e., 21 days after last vaccination) has been concluded.\n* Receipt of another investigational vaccine or any investigational agent within 30 days prior to enrollment in the study or before completion of the safety follow-up period in another study, whichever is longer, and participation in another clinical trial during the present study.\n* Experience of a severe acute infectious disease in the month prior to study start or experience of a mild acute infection disease in the week prior the study start (untreated common cold is acceptable). The severity of the infectious disease occurred will be based on the investigator's judgment.\n* Any severe acute respiratory disease and infection requiring systemic antibiotic or antiviral therapy ongoing or resolved within 2 days prior to study start.\n* Experience an axillary temperature equal to or greater than 37.8°C (rectal temperature equal to or greater than 38.3°C) within the 2 days before enrollment.\n* Any serious disease in the opinion of the investigator including, for example: a) cancer, b) autoimmune disease (including rheumatoid arthritis under immunosuppressive therapy), c) insulin dependent diabetes mellitus, d) chronic pulmonary disease, asthma under inhalative therapy only is acceptable, e) acute or progressive hepatic disease, f) acute or progressive renal disease.\n* Known or suspected impairment/alteration of immune function, for example, resulting from: a) receipt of immunosuppressive therapy (corticosteroid -except topical or inhaled steroids- or cancer chemotherapy), b) receipt of immunostimulants, c) receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within the past 90 days and for the full length of the study, d) high risk for developing an immunocompromising disease (suspected or known HIV infection or HIV-related disease).\n* Bleeding diathesis.\n* History of hypersensitivity to any component of the study medication or chemically related substances.\n* History of any anaphylaxis, serious vaccine reactions, or allergy to eggs, egg products or any other vaccine component.\n* Laboratory confirmed influenza disease.\n* History of neurological disorder or seizures (febrile seizures allowed).\n* Received any influenza vaccine.\n* Major surgery planned during the study period.\n* Any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives, e.g., planned travel or relocation of residence that would interfere with completion of study."}, 'identificationModule': {'nctId': 'NCT00644059', 'briefTitle': 'Study to Evaluate the Efficacy, Safety and Immunogenicity of Influenza Vaccine in Healthy Subjects (Aged 6 to <72 Months) Versus Control Vaccines', 'nctIdAliases': ['NCT01015885'], 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Phase III, Randomized, Observer-blind, Controlled, Multi-center Clinical Trial to Evaluate the Efficacy, Safety and Immunogenicity of One and Two Intramuscular Doses of Influenza Vaccine Versus Control Vaccines in Healthy Subject Aged 6 to <72 Months', 'orgStudyIdInfo': {'id': 'V70P5'}, 'secondaryIdInfos': [{'id': 'Eudract number 2007-003786-41'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TIV-adj', 'description': 'Adjuvanted trivalent inactivated subunit influenza vaccine', 'interventionNames': ['Biological: Adjuvanted trivalent inactivated subunit influenza vaccine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Flu-control', 'description': 'Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine', 'interventionNames': ['Biological: Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine']}, {'type': 'SHAM_COMPARATOR', 'label': 'Non-flu Control', 'description': 'Novartis meningococcal C conjugate vaccine or tick-borne encephalitis vaccine', 'interventionNames': ['Biological: Meningococcal C conjugate vaccine or tick-borne encephalitis vaccine']}], 'interventions': [{'name': 'Adjuvanted trivalent inactivated subunit influenza vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['Fluad'], 'description': 'Either two intramuscular (IM) injections of half dose or one IM injection of full dose, depending on age of subject, were administered in the deltoid muscle preferably of the non-dominant arm.', 'armGroupLabels': ['TIV-adj']}, {'name': 'Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['1) Agrippal', '2) Influsplit SSW'], 'description': 'For both vaccines, either two intramuscular (IM) injections of half dose or one IM injection of full dose, depending on age of subject, were administered in the deltoid muscle preferably of the non-dominant arm.', 'armGroupLabels': ['Flu-control']}, {'name': 'Meningococcal C conjugate vaccine or tick-borne encephalitis vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['1. Menjugate', '2. Encepur Children'], 'description': '1. Meningococcal vaccine: two IM injections\n2. Tick-borne encephalitis vaccine: two IM injections', 'armGroupLabels': ['Non-flu Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01300', 'city': 'East Vaanta', 'country': 'Finland', 'facility': 'East Vantaa Clinic'}, {'zip': '02100', 'city': 'Espoo', 'country': 'Finland', 'facility': 'Espoo Vaccine Research Clinic', 'geoPoint': {'lat': 60.2052, 'lon': 24.6522}}, {'zip': '00100', 'city': 'Helsinki', 'country': 'Finland', 'facility': 'Helsinki South Vaccine Research Clinic', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}, {'zip': '00930', 'city': 'Helsinki', 'country': 'Finland', 'facility': 'Helsinki East Vaccine Research Clinic', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}, {'zip': '04400', 'city': 'Järvenpää', 'country': 'Finland', 'facility': 'Jarvenpaa Vaccine Research Clinic', 'geoPoint': {'lat': 60.47369, 'lon': 25.08992}}, {'zip': '67100', 'city': 'Kokkola', 'country': 'Finland', 'facility': 'Kokkola Vaccine Research Clinic', 'geoPoint': {'lat': 63.83847, 'lon': 23.13066}}, {'zip': '48600', 'city': 'Kotka', 'country': 'Finland', 'facility': 'Kotka Clinic', 'geoPoint': {'lat': 60.4664, 'lon': 26.94582}}, {'zip': '70100', 'city': 'Kuopio', 'country': 'Finland', 'facility': 'Kuopio Vaccine Clinic', 'geoPoint': {'lat': 62.89238, 'lon': 27.67703}}, {'zip': '70211', 'city': 'Kuopio', 'country': 'Finland', 'facility': 'Kuopio Vaccine Research Clinic', 'geoPoint': {'lat': 62.89238, 'lon': 27.67703}}, {'zip': '15140', 'city': 'Lahti', 'country': 'Finland', 'facility': 'Lahti vaccine research Clinic', 'geoPoint': {'lat': 60.98267, 'lon': 25.66151}}, {'zip': '90200', 'city': 'Oulu', 'country': 'Finland', 'facility': 'Oulu Vaccine Research Clini', 'geoPoint': {'lat': 65.01236, 'lon': 25.46816}}, {'zip': '28100', 'city': 'Pori', 'country': 'Finland', 'facility': 'Pori Vaccine Research Clinic', 'geoPoint': {'lat': 61.48072, 'lon': 21.78518}}, {'zip': '60100', 'city': 'Seinäjoki', 'country': 'Finland', 'facility': 'Seinajoki Clinic', 'geoPoint': {'lat': 62.79446, 'lon': 22.82822}}, {'zip': '33100', 'city': 'Tampere', 'country': 'Finland', 'facility': 'Tampere Vaccine Research Clinic', 'geoPoint': {'lat': 61.49911, 'lon': 23.78712}}, {'zip': '20520', 'city': 'Turku', 'country': 'Finland', 'facility': 'Turku Clinic', 'geoPoint': {'lat': 60.45148, 'lon': 22.26869}}, {'zip': '01600', 'city': 'Vantaa', 'country': 'Finland', 'facility': 'Vantaa West Vaccine Research Clinic', 'geoPoint': {'lat': 60.29414, 'lon': 25.04099}}, {'zip': '01600', 'city': 'West Vantaa', 'country': 'Finland', 'facility': 'West Vantaa Clinic'}, {'zip': '55101', 'city': 'Mainz', 'state': 'Mainz', 'country': 'Germany', 'facility': 'Johannes Gutenberg-University', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'zip': '73433', 'city': 'Aalen Wasseralfingen', 'country': 'Germany', 'facility': 'Praxis Dr med Thilo Heising'}, {'zip': '10315', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Praxis Dr med Ursula Hornlein', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '10551', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Praxis Dr med Thomas Richter', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '10559', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Praxis Dipl med Andreas Muhmer', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '10627', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Praxis Dr med Mechthild Vocks-Hauck', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '10999', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Praxis Dr med Klaus-Peter Falkowski', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '12165', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Praxis Dr med Eva Brand', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '12209', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Praxis Dr med Dorothea Budde', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '12589', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Praxis Dr. med. 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