Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2026-03-18 @ 1:31 PM
Study NCT ID:
NCT02583256
Status:
COMPLETED
Last Update Posted:
2019-04-24
First Post:
2015-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Study to Evaluate Safety, Immunogenicity of Investigational Flu Vaccine Compared to an Approved Flu Vaccine in Children Previously Vaccinated in Trial V118_05 (NCT01964989)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D007251', 'term': 'Influenza, Human'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009976', 'term': 'Orthomyxoviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Seqirus.ClinicalTrials@Seqirus.com', 'phone': 'Phone: 1-855-358-8966', 'title': 'Seqirus Clinical Trial Disclosure Manager', 'organization': 'Seqirus'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Day 1 - Day 366', 'description': 'The overall safety set included all subjects who were in the solicited safety set and/or in the unsolicited safety set.\n\nAssessment of revaccination safety included:\n\nSAEs collected between Day 1 to Day 366 Non-serious AEs included solicited AEs collected between Day 1 to Day 7 after last vaccination, and unsolicited AEs collected between Day 1 to Day 366 after last vaccination', 'eventGroups': [{'id': 'EG000', 'title': 'aQIV-aQIV', 'description': 'Subjects previously vaccinated with aQIV followed one year later by aQIV\n\nAdjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)', 'otherNumAtRisk': 403, 'deathsNumAtRisk': 403, 'otherNumAffected': 289, 'seriousNumAtRisk': 403, 'deathsNumAffected': 0, 'seriousNumAffected': 10}, {'id': 'EG001', 'title': 'aQIV-QIV', 'description': 'Subjects previously vaccinated with aQIV followed one year later by QIV\n\nNon-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)', 'otherNumAtRisk': 403, 'deathsNumAtRisk': 403, 'otherNumAffected': 269, 'seriousNumAtRisk': 403, 'deathsNumAffected': 0, 'seriousNumAffected': 11}, {'id': 'EG002', 'title': 'QIV-aQIV', 'description': 'Subjects previously vaccinated with QIV followed one year later by aQIV\n\nAdjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)', 'otherNumAtRisk': 402, 'deathsNumAtRisk': 402, 'otherNumAffected': 274, 'seriousNumAtRisk': 402, 'deathsNumAffected': 0, 'seriousNumAffected': 7}, {'id': 'EG003', 'title': 'QIV-QIV', 'description': 'Subjects previously vaccinated with QIV followed one year later by QIV\n\nNon-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)', 'otherNumAtRisk': 393, 'deathsNumAtRisk': 393, 'otherNumAffected': 229, 'seriousNumAtRisk': 393, 'deathsNumAffected': 0, 'seriousNumAffected': 8}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 403, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 402, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 393, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 403, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 402, 'numAffected': 19}, {'groupId': 'EG003', 'numAtRisk': 393, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'Influenza Like Illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 403, 'numAffected': 41}, {'groupId': 'EG002', 'numAtRisk': 402, 'numAffected': 37}, {'groupId': 'EG003', 'numAtRisk': 393, 'numAffected': 31}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'Injection Site Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numAffected': 81}, {'groupId': 'EG001', 'numAtRisk': 403, 'numAffected': 57}, {'groupId': 'EG002', 'numAtRisk': 402, 'numAffected': 51}, {'groupId': 'EG003', 'numAtRisk': 393, 'numAffected': 39}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'Injection Site Induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numAffected': 62}, {'groupId': 'EG001', 'numAtRisk': 403, 'numAffected': 55}, {'groupId': 'EG002', 'numAtRisk': 402, 'numAffected': 38}, {'groupId': 'EG003', 'numAtRisk': 393, 'numAffected': 24}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'Injection Site Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numAffected': 163}, {'groupId': 'EG001', 'numAtRisk': 403, 'numAffected': 137}, {'groupId': 'EG002', 'numAtRisk': 402, 'numAffected': 134}, {'groupId': 'EG003', 'numAtRisk': 393, 'numAffected': 120}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numAffected': 96}, {'groupId': 'EG001', 'numAtRisk': 403, 'numAffected': 46}, {'groupId': 'EG002', 'numAtRisk': 402, 'numAffected': 72}, {'groupId': 'EG003', 'numAtRisk': 393, 'numAffected': 51}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 403, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 402, 'numAffected': 26}, {'groupId': 'EG003', 'numAtRisk': 393, 'numAffected': 16}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numAffected': 78}, {'groupId': 'EG001', 'numAtRisk': 403, 'numAffected': 100}, {'groupId': 'EG002', 'numAtRisk': 402, 'numAffected': 99}, {'groupId': 'EG003', 'numAtRisk': 393, 'numAffected': 73}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numAffected': 79}, {'groupId': 'EG001', 'numAtRisk': 403, 'numAffected': 45}, {'groupId': 'EG002', 'numAtRisk': 402, 'numAffected': 55}, {'groupId': 'EG003', 'numAtRisk': 393, 'numAffected': 25}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'Eating Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numAffected': 66}, {'groupId': 'EG001', 'numAtRisk': 403, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 402, 'numAffected': 52}, {'groupId': 'EG003', 'numAtRisk': 393, 'numAffected': 24}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numAffected': 60}, {'groupId': 'EG001', 'numAtRisk': 403, 'numAffected': 44}, {'groupId': 'EG002', 'numAtRisk': 402, 'numAffected': 50}, {'groupId': 'EG003', 'numAtRisk': 393, 'numAffected': 36}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}], 'seriousEvents': [{'term': 'Iron Deficiency Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 393, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'Lymphadenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 393, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'Spina Bifida Occulta', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 393, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 403, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 393, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'Aphthous Ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 393, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 403, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 393, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 403, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 393, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'Anaphylactic Reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 393, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'Amoebic Dysentery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 403, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 393, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'Appendiceal Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 402, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 393, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 402, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 393, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'Dengue Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 403, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 393, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'External Ear Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 402, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 393, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 402, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 393, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'Herpangina', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 393, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 403, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 402, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 393, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 402, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 393, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 393, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 403, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 393, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'Animal Bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 403, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 402, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 393, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 402, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 393, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'Jaw Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 403, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 393, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'Wound Secretion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 402, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 393, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'Febrile Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 403, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 393, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': "Kawasaki's Disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 393, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Immunogenicity Endpoint: Geometric Mean Titer (GMT) and GMT Ratio as Determined by Hemagglutination Inhibition (HI) Assay on Day 22 Against Homologous Strains (aQIV-primed Comparison), Noninferiority Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '403', 'groupId': 'OG000'}, {'value': '398', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'aQIV/aQIV', 'description': 'Subjects previously vaccinated with aQIV followed one year later by aQIV\n\nAdjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)'}, {'id': 'OG001', 'title': 'aQIV/QIV', 'description': 'Subjects previously vaccinated with aQIV followed one year later by QIV\n\nNon-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)'}], 'classes': [{'title': 'A/H1N1', 'categories': [{'measurements': [{'value': '1219.00', 'groupId': 'OG000', 'lowerLimit': '1137.35', 'upperLimit': '1306.52'}, {'value': '1020.89', 'groupId': 'OG001', 'lowerLimit': '953.22', 'upperLimit': '1093.36'}]}]}, {'title': 'A/H3N2', 'categories': [{'measurements': [{'value': '2355.52', 'groupId': 'OG000', 'lowerLimit': '2226.19', 'upperLimit': '2492.35'}, {'value': '2529.83', 'groupId': 'OG001', 'lowerLimit': '2392.90', 'upperLimit': '2674.59'}]}]}, {'title': 'B/Yamagata', 'categories': [{'measurements': [{'value': '276.23', 'groupId': 'OG000', 'lowerLimit': '252.73', 'upperLimit': '301.92'}, {'value': '232.82', 'groupId': 'OG001', 'lowerLimit': '213.25', 'upperLimit': '254.19'}]}]}, {'title': 'B/Victoria', 'categories': [{'measurements': [{'value': '388.35', 'groupId': 'OG000', 'lowerLimit': '355.33', 'upperLimit': '424.44'}, {'value': '328.42', 'groupId': 'OG001', 'lowerLimit': '300.76', 'upperLimit': '358.63'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.19', 'ciLowerLimit': '1.1', 'ciUpperLimit': '1.3', 'groupDescription': 'Comparison performed for strain A/H1N1.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Lower bound of two-sided 95% CI on the ratio of aQIV-aQIV/aQIV-QIV HI GMT should not fall below 0.667.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.93', 'ciLowerLimit': '0.9', 'ciUpperLimit': '1.0', 'groupDescription': 'Comparison performed for strain A/H3N2.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Lower bound of two-sided 95% CI on the ratio of aQIV-aQIV/aQIV-QIV HI GMT should not fall below 0.667.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.19', 'ciLowerLimit': '1.1', 'ciUpperLimit': '1.3', 'groupDescription': 'Comparison performed for strain B/Yamagata.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Lower bound of two-sided 95% CI on the ratio of aQIV-aQIV/aQIV-QIV HI GMT should not fall below 0.667.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.18', 'ciLowerLimit': '1.1', 'ciUpperLimit': '1.3', 'groupDescription': 'Comparison performed for strain B/Victoria.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Lower bound of two-sided 95% CI on the ratio of aQIV-aQIV/aQIV-QIV HI GMT should not fall below 0.667.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 22', 'description': 'GMT and 95% confidence interval (CI) were analyzed for Day 22 against homologous strains using ANCOVA with study specific covariates.\n\nStrains tested: A/H1N1 California/07/2009; A/H3N2 Switzerland/9715293/2013; B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013.', 'unitOfMeasure': 'titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Immunogenicity per protocol set (PPS) consisting of all subjects who received a study vaccination and provided immunogenicity data, and who correctly received the study vaccine, had no major protocol deviations, and did not develop reverse transcription polymerase chain reaction(RT-PCR) confirmed influenza infection between baseline and Visit 2.'}, {'type': 'PRIMARY', 'title': 'Immunogenicity Endpoint: GMT and GMT Ratio as Determined by HI Assay on Day 22 Against Homologous Strains (aQIV-primed Comparison), Superiority Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '403', 'groupId': 'OG000'}, {'value': '403', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'aQIV/aQIV', 'description': 'Subjects previously vaccinated with aQIV followed one year later by aQIV\n\nAdjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)'}, {'id': 'OG001', 'title': 'aQIV/QIV', 'description': 'Subjects previously vaccinated with aQIV followed one year later by QIV\n\nNon-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)'}], 'classes': [{'title': 'A/H1N1', 'categories': [{'measurements': [{'value': '1218.91', 'groupId': 'OG000', 'lowerLimit': '1137.02', 'upperLimit': '1306.70'}, {'value': '1023.37', 'groupId': 'OG001', 'lowerLimit': '955.72', 'upperLimit': '1095.81'}]}]}, {'title': 'A/H3N2', 'categories': [{'measurements': [{'value': '2345.71', 'groupId': 'OG000', 'lowerLimit': '2216.84', 'upperLimit': '2482.07'}, {'value': '2521.60', 'groupId': 'OG001', 'lowerLimit': '2385.43', 'upperLimit': '2665.56'}]}]}, {'title': 'B/Yamagata', 'categories': [{'measurements': [{'value': '274.75', 'groupId': 'OG000', 'lowerLimit': '251.09', 'upperLimit': '300.65'}, {'value': '230.51', 'groupId': 'OG001', 'lowerLimit': '210.97', 'upperLimit': '251.86'}]}]}, {'title': 'B/Victoria', 'categories': [{'measurements': [{'value': '387.35', 'groupId': 'OG000', 'lowerLimit': '354.15', 'upperLimit': '423.66'}, {'value': '326.68', 'groupId': 'OG001', 'lowerLimit': '299.10', 'upperLimit': '356.81'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.19', 'ciLowerLimit': '1.1', 'ciUpperLimit': '1.3', 'groupDescription': 'Comparison performed for strain A/H1N1.', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Superiority criterion for the GMT ratio: Lower bound of two-sided 95% CI on the ratio of aQIV-aQIV/aQIV-QIV HI GMT should exceed 1.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.93', 'ciLowerLimit': '0.9', 'ciUpperLimit': '1.0', 'groupDescription': 'Comparison performed for strain A/H3N2.', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Lower bound of two-sided 95% CI on the ratio of aQIV-aQIV/aQIV-QIV HI GMT should exceed 1.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.19', 'ciLowerLimit': '1.1', 'ciUpperLimit': '1.3', 'groupDescription': 'Comparison performed for strain B/Yamagata.', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Lower bound of two-sided 95% CI on the ratio of aQIV-aQIV/aQIV-QIV HI GMT should exceed 1.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.19', 'ciLowerLimit': '1.1', 'ciUpperLimit': '1.3', 'groupDescription': 'Comparison performed for strain B/Victoria.', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Lower bound of two-sided 95% CI on the ratio of aQIV-aQIV/aQIV-QIV HI GMT should exceed 1.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 22', 'description': 'GMT and 95% CI were analyzed for Day 22 against homologous strains using ANCOVA with study specific covariates.\n\nStrains tested: A/H1N1 California/07/2009; A/H3N2 Switzerland/9715293/2013; B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013.', 'unitOfMeasure': 'titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The immunogenicity full analysis set (FAS) consisting of all subjects who received a study vaccination and provided immunogenicity data at both Visit 1 (baseline) and at least one post-vaccination visit.'}, {'type': 'SECONDARY', 'title': 'Immunogenicity Endpoint: GMT and GMT Ratio as Determined by HI Assay on Day 22 Against Homologous Strains (QIV-primed Comparison)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '397', 'groupId': 'OG000'}, {'value': '389', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QIV/aQIV', 'description': 'Subjects previously vaccinated with QIV followed one year later by aQIV\n\nAdjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)'}, {'id': 'OG001', 'title': 'QIV/QIV', 'description': 'Subjects previously vaccinated with QIV followed one year later by QIV\n\nNon-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)'}], 'classes': [{'title': 'A/H1N1', 'categories': [{'measurements': [{'value': '1206.20', 'groupId': 'OG000', 'lowerLimit': '1123.80', 'upperLimit': '1294.65'}, {'value': '866.51', 'groupId': 'OG001', 'lowerLimit': '807.30', 'upperLimit': '930.06'}]}]}, {'title': 'A/H3N2', 'categories': [{'measurements': [{'value': '2369.95', 'groupId': 'OG000', 'lowerLimit': '2236.39', 'upperLimit': '2511.48'}, {'value': '2229.48', 'groupId': 'OG001', 'lowerLimit': '2103.42', 'upperLimit': '2363.10'}]}]}, {'title': 'B/Yamagata', 'categories': [{'measurements': [{'value': '221.54', 'groupId': 'OG000', 'lowerLimit': '202.12', 'upperLimit': '242.82'}, {'value': '156.01', 'groupId': 'OG001', 'lowerLimit': '142.32', 'upperLimit': '171.02'}]}]}, {'title': 'B/Victoria', 'categories': [{'measurements': [{'value': '330.94', 'groupId': 'OG000', 'lowerLimit': '302.38', 'upperLimit': '362.21'}, {'value': '244.03', 'groupId': 'OG001', 'lowerLimit': '222.84', 'upperLimit': '267.24'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.39', 'ciLowerLimit': '1.28', 'ciUpperLimit': '1.51', 'groupDescription': 'Comparison performed for strain A/H1N1.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Lower bound of two-sided 95% CI on the ratio of QIV-aQIV/QIV-QIV HI GMT should not fall below 0.667.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.06', 'ciLowerLimit': '0.99', 'ciUpperLimit': '1.14', 'groupDescription': 'Comparison performed for strain A/H3N2', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Lower bound of two-sided 95% CI on the ratio of QIV-aQIV/QIV-QIV HI GMT should not fall below 0.667.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.42', 'ciLowerLimit': '1.27', 'ciUpperLimit': '1.58', 'groupDescription': 'Comparison performed for strain B/Yamagata.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Lower bound of two-sided 95% CI on the ratio of QIV-aQIV/QIV-QIV HI GMT should not fall below 0.667.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.36', 'ciLowerLimit': '1.22', 'ciUpperLimit': '1.51', 'groupDescription': 'Comparison performed for strain B/Victoria.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Lower bound of two-sided 95% CI on the ratio of QIV-aQIV/QIV-QIV HI GMT should not fall below 0.667.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 22', 'description': 'GMT and 95% CI were analyzed for Day 22 against homologous strains using ANCOVA with study specific covariates.\n\nStrains tested: A/H1N1 California/07/2009; A/H3N2 Switzerland/9715293/2013; B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013.', 'unitOfMeasure': 'titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The immunogenicity PPS consisting of all subjects who received a study vaccination and provided immunogenicity data, and who correctly received the study vaccine, had no major protocol deviations, and did not develop RT-PCR-confirmed influenza infection between baseline and Visit 2.'}, {'type': 'SECONDARY', 'title': 'Immunogenicity Endpoint: GMT and GMT Ratio as Determined by HI Assay on Day 181 Against Homologous Strains (aQIV-primed and QIV-primed Comparison)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '403', 'groupId': 'OG000'}, {'value': '398', 'groupId': 'OG001'}, {'value': '397', 'groupId': 'OG002'}, {'value': '389', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'aQIV/aQIV', 'description': 'Subjects previously vaccinated with aQIV followed one year later by aQIV\n\nAdjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)'}, {'id': 'OG001', 'title': 'aQIV/QIV', 'description': 'Subjects previously vaccinated with aQIV followed one year later by QIV\n\nNon-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)'}, {'id': 'OG002', 'title': 'QIV/aQIV', 'description': 'Subjects previously vaccinated with QIV followed one year later by aQIV\n\nAdjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)'}, {'id': 'OG003', 'title': 'QIV/QIV', 'description': 'Subjects previously vaccinated with QIV followed one year later by QIV\n\nNon-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)'}], 'classes': [{'title': 'A/H1N1', 'categories': [{'measurements': [{'value': '489.45', 'groupId': 'OG000', 'lowerLimit': '449.93', 'upperLimit': '532.45'}, {'value': '411.72', 'groupId': 'OG001', 'lowerLimit': '378.83', 'upperLimit': '447.46'}, {'value': '429.06', 'groupId': 'OG002', 'lowerLimit': '393.73', 'upperLimit': '467.57'}, {'value': '307.36', 'groupId': 'OG003', 'lowerLimit': '282.02', 'upperLimit': '334.98'}]}]}, {'title': 'A/H3N2', 'categories': [{'measurements': [{'value': '1423.38', 'groupId': 'OG000', 'lowerLimit': '1310.04', 'upperLimit': '1546.52'}, {'value': '1438.40', 'groupId': 'OG001', 'lowerLimit': '1325.53', 'upperLimit': '1560.89'}, {'value': '1233.84', 'groupId': 'OG002', 'lowerLimit': '1133.08', 'upperLimit': '1343.56'}, {'value': '1222.21', 'groupId': 'OG003', 'lowerLimit': '1121.92', 'upperLimit': '1331.46'}]}]}, {'title': 'B/Yamagata', 'categories': [{'measurements': [{'value': '97.01', 'groupId': 'OG000', 'lowerLimit': '88.67', 'upperLimit': '106.13'}, {'value': '86.43', 'groupId': 'OG001', 'lowerLimit': '79.09', 'upperLimit': '94.45'}, {'value': '73.37', 'groupId': 'OG002', 'lowerLimit': '66.88', 'upperLimit': '80.49'}, {'value': '56.57', 'groupId': 'OG003', 'lowerLimit': '51.56', 'upperLimit': '62.08'}]}]}, {'title': 'B/Victoria', 'categories': [{'measurements': [{'value': '128.32', 'groupId': 'OG000', 'lowerLimit': '115.17', 'upperLimit': '142.97'}, {'value': '115.26', 'groupId': 'OG001', 'lowerLimit': '103.57', 'upperLimit': '128.26'}, {'value': '104.93', 'groupId': 'OG002', 'lowerLimit': '94.02', 'upperLimit': '117.10'}, {'value': '79.76', 'groupId': 'OG003', 'lowerLimit': '71.41', 'upperLimit': '89.09'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.19', 'ciLowerLimit': '1.07', 'ciUpperLimit': '1.32', 'groupDescription': 'Comparison performed for strain A/H1N1.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Lower bound of two-sided 95% CI on the ratio of aQIV-aQIV/aQIV-QIV HI GMT should not fall below 0.667.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.99', 'ciLowerLimit': '0.90', 'ciUpperLimit': '1.09', 'groupDescription': 'Comparison performed for strain A/H3N2.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Lower bound of two-sided 95% CI on the ratio of aQIV-aQIV/aQIV-QIV HI GMT should not fall below 0.667.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.12', 'ciLowerLimit': '1.01', 'ciUpperLimit': '1.25', 'groupDescription': 'Comparison performed for strain B/Yamagata.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Lower bound of two-sided 95% CI on the ratio of aQIV-aQIV/aQIV-QIV HI GMT should not fall below 0.667.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.11', 'ciLowerLimit': '0.98', 'ciUpperLimit': '1.27', 'groupDescription': 'Comparison performed for strain B/Victoria.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Lower bound of two-sided 95% CI on the ratio of aQIV-aQIV/aQIV-QIV HI GMT should not fall below 0.667.'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'GMT ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.4', 'ciLowerLimit': '1.3', 'ciUpperLimit': '1.5', 'groupDescription': 'Comparison performed for strain A/H1N1.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Lower bound of two-sided 95% CI on the ratio of QIV-aQIV/QIV-QIV HI GMT should not fall below 0.667.'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'GMT ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.01', 'ciLowerLimit': '0.9', 'ciUpperLimit': '1.1', 'groupDescription': 'Comparison performed for strain A/H3N2.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Lower bound of two-sided 95% CI on the ratio of QIV-aQIV/QIV-QIV HI GMT should not fall below 0.667.'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'GMT ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.30', 'ciLowerLimit': '1.2', 'ciUpperLimit': '1.4', 'groupDescription': 'Comparison performed for strain B/Yamagata.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Lower bound of two-sided 95% CI on the ratio of QIV-aQIV/QIV-QIV HI GMT should not fall below 0.667.'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'GMT ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.32', 'ciLowerLimit': '1.2', 'ciUpperLimit': '1.5', 'groupDescription': 'Comparison performed for strain B/Victoria.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Lower bound of two-sided 95% CI on the ratio of QIV-aQIV/QIV-QIV HI GMT should not fall below 0.667.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 181', 'description': 'GMT and 95% CI were analyzed for Day 181 against homologous strains using ANCOVA with study specific covariates.\n\nStrains tested: A/H1N1 California/07/2009; A/H3N2 Switzerland/9715293/2013; B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013.', 'unitOfMeasure': 'titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Immunogenicity PPS consisting of all subjects who received a study vaccination and provided immunogenicity data, and who correctly received the study vaccine, had no major protocol deviations, and did not develop RT-PCR-confirmed influenza infection between baseline and Visit 2.'}, {'type': 'SECONDARY', 'title': 'Immunogenicity Endpoint: Seroconversion Rate (SCR) on Day 22 Against Homologous Strains (aQIV-primed and QIV-primed Comparison)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '403', 'groupId': 'OG000'}, {'value': '398', 'groupId': 'OG001'}, {'value': '397', 'groupId': 'OG002'}, {'value': '389', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'aQIV/aQIV', 'description': 'Subjects previously vaccinated with aQIV followed one year later by aQIV\n\nAdjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)'}, {'id': 'OG001', 'title': 'aQIV/QIV', 'description': 'Subjects previously vaccinated with aQIV followed one year later by QIV\n\nNon-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)'}, {'id': 'OG002', 'title': 'QIV/aQIV', 'description': 'Subjects previously vaccinated with QIV followed one year later by aQIV\n\nAdjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)'}, {'id': 'OG003', 'title': 'QIV/QIV', 'description': 'Subjects previously vaccinated with QIV followed one year later by QIV\n\nNon-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)'}], 'classes': [{'title': 'A/H1N1', 'categories': [{'measurements': [{'value': '62.7', 'groupId': 'OG000', 'lowerLimit': '57.8', 'upperLimit': '67.4'}, {'value': '60.9', 'groupId': 'OG001', 'lowerLimit': '55.9', 'upperLimit': '65.7'}, {'value': '72.04', 'groupId': 'OG002', 'lowerLimit': '67.35', 'upperLimit': '76.40'}, {'value': '62.37', 'groupId': 'OG003', 'lowerLimit': '57.34', 'upperLimit': '67.21'}]}]}, {'title': 'A/H3N2', 'categories': [{'measurements': [{'value': '68.9', 'groupId': 'OG000', 'lowerLimit': '64.1', 'upperLimit': '73.4'}, {'value': '68.0', 'groupId': 'OG001', 'lowerLimit': '63.2', 'upperLimit': '72.6'}, {'value': '72.80', 'groupId': 'OG002', 'lowerLimit': '68.13', 'upperLimit': '77.12'}, {'value': '76.74', 'groupId': 'OG003', 'lowerLimit': '72.21', 'upperLimit': '80.86'}]}]}, {'title': 'B/Yamagata', 'categories': [{'measurements': [{'value': '76.4', 'groupId': 'OG000', 'lowerLimit': '71.9', 'upperLimit': '80.4'}, {'value': '72.0', 'groupId': 'OG001', 'lowerLimit': '67.4', 'upperLimit': '76.4'}, {'value': '79.44', 'groupId': 'OG002', 'lowerLimit': '75.11', 'upperLimit': '83.32'}, {'value': '66.49', 'groupId': 'OG003', 'lowerLimit': '61.51', 'upperLimit': '71.21'}]}]}, {'title': 'B/Victoria', 'categories': [{'measurements': [{'value': '77.4', 'groupId': 'OG000', 'lowerLimit': '73.0', 'upperLimit': '81.4'}, {'value': '74.8', 'groupId': 'OG001', 'lowerLimit': '70.2', 'upperLimit': '79.0'}, {'value': '77.92', 'groupId': 'OG002', 'lowerLimit': '73.49', 'upperLimit': '81.92'}, {'value': '69.55', 'groupId': 'OG003', 'lowerLimit': '64.66', 'upperLimit': '74.14'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'SCR difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.8', 'ciLowerLimit': '-4.9', 'ciUpperLimit': '8.6', 'groupDescription': 'Comparison performed for strain A/H1N1.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The lower bound of two-sided 95% CI on the difference between SCR should not be below -10%.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'SCR difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.9', 'ciLowerLimit': '-5.6', 'ciUpperLimit': '7.3', 'groupDescription': 'Comparison performed for strain A/H3N2.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The lower bound of two-sided 95% CI on the difference between SCR should not be below -10%.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'SCR difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.3', 'ciLowerLimit': '-1.8', 'ciUpperLimit': '10.4', 'groupDescription': 'Comparison performed for strain B/Yamagata.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The lower bound of two-sided 95% CI on the difference between SCR should not be below -10%.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'SCR difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.6', 'ciLowerLimit': '-3.3', 'ciUpperLimit': '8.5', 'groupDescription': 'Comparison performed for strain B/Victoria.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The lower bound of two-sided 95% CI on the difference between SCR should not be below -10%.'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'SCR difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.67', 'ciLowerLimit': '3.11', 'ciUpperLimit': '16.17', 'groupDescription': 'Comparison performed for strain A/H1N1.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The lower bound of two-sided 95% CI on the difference between SCR should not be below -10%.'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'SCR difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.95', 'ciLowerLimit': '-10.02', 'ciUpperLimit': '2.15', 'groupDescription': 'Comparison performed for strain A/H3N2.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The lower bound of two-sided 95% CI on the difference between SCR should not be below -10%.'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'SCR difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.95', 'ciLowerLimit': '6.73', 'ciUpperLimit': '19.12', 'groupDescription': 'Comparison performed for strain B/Yamagata.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The lower bound of two-sided 95% CI on the difference between SCR should not be below -10%.'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'SCR difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.36', 'ciLowerLimit': '2.17', 'ciUpperLimit': '14.54', 'groupDescription': 'Comparison performed for strain B/Victoria.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The lower bound of two-sided 95% CI on the difference between SCR should not be below -10%.'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1, Day 22', 'description': 'The percentage of subjects achieving seroconversion at Day 22 after vaccination is reported against homologous strains. Seroconversion was defined in subjects seronegative at baseline (i.e. HI titer \\<1:10 on Day 1) as postvaccination HI titer ≥1:40 and defined in subjects seropositive at baseline (i.e. HI titer ≥1:10 on Day 1) as a minimum of a 4-fold increase in post-vaccination HI titer.\n\nStrains tested: A/H1N1 California/07/2009; A/H3N2 Switzerland/9715293/2013; B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013.', 'unitOfMeasure': 'percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Immunogenicity PPS consisting of all subjects who received a study vaccination and provided immunogenicity data, and who correctly received the study vaccine, had no major protocol deviations, and did not develop RT-PCR-confirmed influenza infection between baseline and Visit 2.'}, {'type': 'SECONDARY', 'title': 'Immunogenicity Endpoint: Geometric Mean Ratio (GMR) as Determined by HI Assay for Day 22/Day 1 and Day 181/Day 1 for Against Homologous Strains', 'denoms': [{'units': 'Participants', 'counts': [{'value': '403', 'groupId': 'OG000'}, {'value': '398', 'groupId': 'OG001'}, {'value': '397', 'groupId': 'OG002'}, {'value': '389', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'aQIV/aQIV', 'description': 'Subjects previously vaccinated with aQIV followed one year later by aQIV\n\nAdjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)'}, {'id': 'OG001', 'title': 'aQIV/QIV', 'description': 'Subjects previously vaccinated with aQIV followed one year later by QIV\n\nNon-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)'}, {'id': 'OG002', 'title': 'QIV/aQIV', 'description': 'Subjects previously vaccinated with QIV followed one year later by aQIV\n\nAdjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)'}, {'id': 'OG003', 'title': 'QIV/QIV', 'description': 'Subjects previously vaccinated with QIV followed one year later by QIV\n\nNon-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)'}], 'classes': [{'title': 'A/H1N1 (Day 22/Day 1)', 'categories': [{'measurements': [{'value': '7.69', 'groupId': 'OG000', 'lowerLimit': '7.17', 'upperLimit': '8.24'}, {'value': '6.44', 'groupId': 'OG001', 'lowerLimit': '6.01', 'upperLimit': '6.90'}, {'value': '7.61', 'groupId': 'OG002', 'lowerLimit': '7.09', 'upperLimit': '8.17'}, {'value': '5.47', 'groupId': 'OG003', 'lowerLimit': '5.09', 'upperLimit': '5.87'}]}]}, {'title': 'A/H1N1 (Day 181/Day 1)', 'categories': [{'measurements': [{'value': '3.11', 'groupId': 'OG000', 'lowerLimit': '2.86', 'upperLimit': '3.38'}, {'value': '2.61', 'groupId': 'OG001', 'lowerLimit': '2.40', 'upperLimit': '2.84'}, {'value': '2.72', 'groupId': 'OG002', 'lowerLimit': '2.50', 'upperLimit': '2.97'}, {'value': '1.95', 'groupId': 'OG003', 'lowerLimit': '1.79', 'upperLimit': '2.13'}]}]}, {'title': 'A/H3N2 (Day 22/Day 1)', 'categories': [{'measurements': [{'value': '9.02', 'groupId': 'OG000', 'lowerLimit': '8.53', 'upperLimit': '9.55'}, {'value': '9.69', 'groupId': 'OG001', 'lowerLimit': '9.17', 'upperLimit': '10.25'}, {'value': '9.08', 'groupId': 'OG002', 'lowerLimit': '8.57', 'upperLimit': '9.62'}, {'value': '8.54', 'groupId': 'OG003', 'lowerLimit': '8.06', 'upperLimit': '9.05'}]}]}, {'title': 'A/H3N2 (Day 181/Day 1)', 'categories': [{'measurements': [{'value': '5.44', 'groupId': 'OG000', 'lowerLimit': '5.01', 'upperLimit': '5.91'}, {'value': '5.50', 'groupId': 'OG001', 'lowerLimit': '5.07', 'upperLimit': '5.97'}, {'value': '4.72', 'groupId': 'OG002', 'lowerLimit': '4.33', 'upperLimit': '5.14'}, {'value': '4.67', 'groupId': 'OG003', 'lowerLimit': '4.29', 'upperLimit': '5.09'}]}]}, {'title': 'B/Yamagata (Day 22/Day 1)', 'categories': [{'measurements': [{'value': '7.81', 'groupId': 'OG000', 'lowerLimit': '7.14', 'upperLimit': '8.54'}, {'value': '6.58', 'groupId': 'OG001', 'lowerLimit': '6.03', 'upperLimit': '7.19'}, {'value': '6.26', 'groupId': 'OG002', 'lowerLimit': '5.71', 'upperLimit': '6.86'}, {'value': '4.41', 'groupId': 'OG003', 'lowerLimit': '4.02', 'upperLimit': '4.83'}]}]}, {'title': 'B/Yamagata (Day 181/Day 1)', 'categories': [{'measurements': [{'value': '2.74', 'groupId': 'OG000', 'lowerLimit': '2.50', 'upperLimit': '3.00'}, {'value': '2.44', 'groupId': 'OG001', 'lowerLimit': '2.23', 'upperLimit': '2.67'}, {'value': '2.07', 'groupId': 'OG002', 'lowerLimit': '1.89', 'upperLimit': '2.27'}, {'value': '1.60', 'groupId': 'OG003', 'lowerLimit': '1.46', 'upperLimit': '1.75'}]}]}, {'title': 'B/Victoria (Day 22/Day 1)', 'categories': [{'measurements': [{'value': '7.86', 'groupId': 'OG000', 'lowerLimit': '7.19', 'upperLimit': '8.59'}, {'value': '6.64', 'groupId': 'OG001', 'lowerLimit': '6.09', 'upperLimit': '7.26'}, {'value': '6.70', 'groupId': 'OG002', 'lowerLimit': '6.12', 'upperLimit': '7.33'}, {'value': '4.94', 'groupId': 'OG003', 'lowerLimit': '4.51', 'upperLimit': '5.41'}]}]}, {'title': 'B/Victoria (Day 181/Day 1)', 'categories': [{'measurements': [{'value': '2.59', 'groupId': 'OG000', 'lowerLimit': '2.33', 'upperLimit': '2.89'}, {'value': '2.33', 'groupId': 'OG001', 'lowerLimit': '2.09', 'upperLimit': '2.59'}, {'value': '2.12', 'groupId': 'OG002', 'lowerLimit': '1.90', 'upperLimit': '2.36'}, {'value': '1.61', 'groupId': 'OG003', 'lowerLimit': '1.44', 'upperLimit': '1.80'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 22, Day 181', 'description': 'The GMR is the geometric mean of the fold increase in HI titer from Day 1 to Day 22 or Day 181. GMR and 95% CI were analyzed against homologous strains using ANCOVA with study specific covariates.\n\nStrains tested: A/H1N1 California/07/2009; A/H3N2 Switzerland/9715293/2013; B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013.', 'unitOfMeasure': 'ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The immunogenicity PPS consisting of all subjects who received a study vaccination and provided immunogenicity data, and who correctly received the study vaccine, had no major protocol deviations, and did not develop RT-PCR-confirmed influenza infection between baseline and Visit 2.'}, {'type': 'SECONDARY', 'title': 'Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 on Day 22 and Day 181 Against Homologous Strains', 'denoms': [{'units': 'Participants', 'counts': [{'value': '403', 'groupId': 'OG000'}, {'value': '398', 'groupId': 'OG001'}, {'value': '397', 'groupId': 'OG002'}, {'value': '389', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'aQIV/aQIV', 'description': 'Subjects previously vaccinated with aQIV followed one year later by aQIV\n\nAdjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)'}, {'id': 'OG001', 'title': 'aQIV/QIV', 'description': 'Subjects previously vaccinated with aQIV followed one year later by QIV\n\nNon-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)'}, {'id': 'OG002', 'title': 'QIV/aQIV', 'description': 'Subjects previously vaccinated with QIV followed one year later by aQIV\n\nAdjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)'}, {'id': 'OG003', 'title': 'QIV/QIV', 'description': 'Subjects previously vaccinated with QIV followed one year later by QIV\n\nNon-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)'}], 'classes': [{'title': 'A/H1N1 (Day 22)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '99.1', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '99.1', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG002', 'lowerLimit': '99.1', 'upperLimit': '100'}, {'value': '99.7', 'groupId': 'OG003', 'lowerLimit': '98.6', 'upperLimit': '100'}]}]}, {'title': 'A/H1N1 (Day 181)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '99.1', 'upperLimit': '100'}, {'value': '99.2', 'groupId': 'OG001', 'lowerLimit': '97.8', 'upperLimit': '99.8'}, {'value': '99.2', 'groupId': 'OG002', 'lowerLimit': '97.8', 'upperLimit': '99.8'}, {'value': '95.9', 'groupId': 'OG003', 'lowerLimit': '93.4', 'upperLimit': '97.6'}]}]}, {'title': 'A/H3N2 (Day 22)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '99.1', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '99.1', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG002', 'lowerLimit': '99.1', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG003', 'lowerLimit': '99.1', 'upperLimit': '100'}]}]}, {'title': 'A/H3N2 (Day 181)', 'categories': [{'measurements': [{'value': '99.8', 'groupId': 'OG000', 'lowerLimit': '98.6', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '99.1', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG002', 'lowerLimit': '99.1', 'upperLimit': '100'}, {'value': '98.7', 'groupId': 'OG003', 'lowerLimit': '97.0', 'upperLimit': '99.6'}]}]}, {'title': 'B/Yamagata (Day 22)', 'categories': [{'measurements': [{'value': '98.5', 'groupId': 'OG000', 'lowerLimit': '96.8', 'upperLimit': '99.5'}, {'value': '98.7', 'groupId': 'OG001', 'lowerLimit': '97.1', 'upperLimit': '99.6'}, {'value': '98.5', 'groupId': 'OG002', 'lowerLimit': '96.7', 'upperLimit': '99.4'}, {'value': '96.6', 'groupId': 'OG003', 'lowerLimit': '94.3', 'upperLimit': '98.2'}]}]}, {'title': 'B/Yamagata (Day 181)', 'categories': [{'measurements': [{'value': '94.3', 'groupId': 'OG000', 'lowerLimit': '91.5', 'upperLimit': '96.3'}, {'value': '93.9', 'groupId': 'OG001', 'lowerLimit': '91.1', 'upperLimit': '96.1'}, {'value': '83.9', 'groupId': 'OG002', 'lowerLimit': '79.9', 'upperLimit': '87.4'}, {'value': '76.1', 'groupId': 'OG003', 'lowerLimit': '71.5', 'upperLimit': '80.3'}]}]}, {'title': 'B/Victoria (Day 22)', 'categories': [{'measurements': [{'value': '99.9', 'groupId': 'OG000', 'lowerLimit': '98.6', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '99.1', 'upperLimit': '100'}, {'value': '99.5', 'groupId': 'OG002', 'lowerLimit': '98.2', 'upperLimit': '99.9'}, {'value': '97.9', 'groupId': 'OG003', 'lowerLimit': '95.9', 'upperLimit': '99.1'}]}]}, {'title': 'B/Victoria (Day 181)', 'categories': [{'measurements': [{'value': '95.3', 'groupId': 'OG000', 'lowerLimit': '92.7', 'upperLimit': '97.1'}, {'value': '93.9', 'groupId': 'OG001', 'lowerLimit': '91.1', 'upperLimit': '96.1'}, {'value': '86.7', 'groupId': 'OG002', 'lowerLimit': '83.0', 'upperLimit': '89.9'}, {'value': '76.9', 'groupId': 'OG003', 'lowerLimit': '72.2', 'upperLimit': '80.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 22, Day 181', 'description': 'The percentage of subjects achieving HI titer ≥1:40 at Day 22 and Day 181 after vaccination is reported against homologous strains.\n\nStrains tested: A/H1N1 California/07/2009; A/H3N2 Switzerland/9715293/2013; B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013.', 'unitOfMeasure': 'percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Immunogenicity PPS consisting of all subjects who received a study vaccination and provided immunogenicity data, and who correctly received the study vaccine, had no major protocol deviations, and did not develop RT-PCR-confirmed influenza infection between baseline and Visit 2.'}, {'type': 'SECONDARY', 'title': 'Immunogenicity Endpoints: Percentage of Subjects With HI Titer ≥1:110, ≥1:151, ≥1:215, ≥1:330 and ≥1:629 on Day 22 Against Homologous Strains', 'denoms': [{'units': 'Participants', 'counts': [{'value': '403', 'groupId': 'OG000'}, {'value': '398', 'groupId': 'OG001'}, {'value': '397', 'groupId': 'OG002'}, {'value': '389', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'aQIV/aQIV', 'description': 'Subjects previously vaccinated with aQIV followed one year later by aQIV\n\nAdjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)'}, {'id': 'OG001', 'title': 'aQIV/QIV', 'description': 'Subjects previously vaccinated with aQIV followed one year later by QIV\n\nNon-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)'}, {'id': 'OG002', 'title': 'QIV/aQIV', 'description': 'Subjects previously vaccinated with QIV followed one year later by aQIV\n\nAdjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)'}, {'id': 'OG003', 'title': 'QIV/QIV', 'description': 'Subjects previously vaccinated with QIV followed one year later by QIV\n\nNon-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)'}], 'classes': [{'title': 'A/H1N1, HI ≥1:110', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '99.1', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '99.1', 'upperLimit': '100.0'}, {'value': '99.7', 'groupId': 'OG002', 'lowerLimit': '98.6', 'upperLimit': '100.0'}, {'value': '97.7', 'groupId': 'OG003', 'lowerLimit': '95.6', 'upperLimit': '98.9'}]}]}, {'title': 'A/H1N1, HI ≥1:151', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '99.1', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '99.1', 'upperLimit': '100.0'}, {'value': '99.5', 'groupId': 'OG002', 'lowerLimit': '98.2', 'upperLimit': '99.9'}, {'value': '97.4', 'groupId': 'OG003', 'lowerLimit': '95.3', 'upperLimit': '98.8'}]}]}, {'title': 'A/H1N1, HI ≥1:215', 'categories': [{'measurements': [{'value': '99.8', 'groupId': 'OG000', 'lowerLimit': '98.6', 'upperLimit': '100.0'}, {'value': '99.2', 'groupId': 'OG001', 'lowerLimit': '97.8', 'upperLimit': '99.8'}, {'value': '97.5', 'groupId': 'OG002', 'lowerLimit': '95.4', 'upperLimit': '98.8'}, {'value': '93.8', 'groupId': 'OG003', 'lowerLimit': '90.9', 'upperLimit': '96.0'}]}]}, {'title': 'A/H1N1, HI ≥1:330', 'categories': [{'measurements': [{'value': '97.3', 'groupId': 'OG000', 'lowerLimit': '95.2', 'upperLimit': '98.6'}, {'value': '93.7', 'groupId': 'OG001', 'lowerLimit': '90.8', 'upperLimit': '95.9'}, {'value': '93.2', 'groupId': 'OG002', 'lowerLimit': '90.3', 'upperLimit': '95.5'}, {'value': '82.5', 'groupId': 'OG003', 'lowerLimit': '78.3', 'upperLimit': '86.1'}]}]}, {'title': 'A/ H1N1 ≥1:629', 'categories': [{'measurements': [{'value': '94.8', 'groupId': 'OG000', 'lowerLimit': '92.1', 'upperLimit': '96.7'}, {'value': '87.6', 'groupId': 'OG001', 'lowerLimit': '84.0', 'upperLimit': '90.7'}, {'value': '87.9', 'groupId': 'OG002', 'lowerLimit': '84.3', 'upperLimit': '91.0'}, {'value': '74.2', 'groupId': 'OG003', 'lowerLimit': '69.6', 'upperLimit': '78.5'}]}]}, {'title': 'A/H3N2, HI ≥1:110', 'categories': [{'measurements': [{'value': '99.8', 'groupId': 'OG000', 'lowerLimit': '98.6', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '99.1', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '99.1', 'upperLimit': '100.0'}, {'value': '99.5', 'groupId': 'OG003', 'lowerLimit': '98.1', 'upperLimit': '99.9'}]}]}, {'title': 'A/H3N2, HI ≥1:151', 'categories': [{'measurements': [{'value': '99.8', 'groupId': 'OG000', 'lowerLimit': '98.6', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '99.1', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '99.1', 'upperLimit': '100.0'}, {'value': '99.5', 'groupId': 'OG003', 'lowerLimit': '98.1', 'upperLimit': '99.9'}]}]}, {'title': 'A/H3N2, HI ≥1:215', 'categories': [{'measurements': [{'value': '99.5', 'groupId': 'OG000', 'lowerLimit': '98.2', 'upperLimit': '99.9'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '99.1', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '99.1', 'upperLimit': '100.0'}, {'value': '97.7', 'groupId': 'OG003', 'lowerLimit': '95.6', 'upperLimit': '98.9'}]}]}, {'title': 'A/H3N2, HI ≥1:330', 'categories': [{'measurements': [{'value': '99.3', 'groupId': 'OG000', 'lowerLimit': '97.8', 'upperLimit': '99.8'}, {'value': '99.7', 'groupId': 'OG001', 'lowerLimit': '98.6', 'upperLimit': '100.0'}, {'value': '99.5', 'groupId': 'OG002', 'lowerLimit': '98.2', 'upperLimit': '99.9'}, {'value': '95.9', 'groupId': 'OG003', 'lowerLimit': '93.4', 'upperLimit': '97.6'}]}]}, {'title': 'A/H3N2, HI ≥1:629', 'categories': [{'measurements': [{'value': '99.0', 'groupId': 'OG000', 'lowerLimit': '97.5', 'upperLimit': '99.7'}, {'value': '99.7', 'groupId': 'OG001', 'lowerLimit': '98.6', 'upperLimit': '100.0'}, {'value': '99.2', 'groupId': 'OG002', 'lowerLimit': '97.8', 'upperLimit': '99.8'}, {'value': '95.1', 'groupId': 'OG003', 'lowerLimit': '92.4', 'upperLimit': '97.0'}]}]}, {'title': 'B/Yamagata, HI ≥1:110', 'categories': [{'measurements': [{'value': '90.8', 'groupId': 'OG000', 'lowerLimit': '87.5', 'upperLimit': '93.4'}, {'value': '88.4', 'groupId': 'OG001', 'lowerLimit': '84.8', 'upperLimit': '91.4'}, {'value': '82.7', 'groupId': 'OG002', 'lowerLimit': '78.6', 'upperLimit': '86.3'}, {'value': '68.3', 'groupId': 'OG003', 'lowerLimit': '63.4', 'upperLimit': '73.0'}]}]}, {'title': 'B/Yamagata, HI ≥1:151', 'categories': [{'measurements': [{'value': '87.6', 'groupId': 'OG000', 'lowerLimit': '83.9', 'upperLimit': '90.6'}, {'value': '81.6', 'groupId': 'OG001', 'lowerLimit': '77.4', 'upperLimit': '85.3'}, {'value': '75.9', 'groupId': 'OG002', 'lowerLimit': '71.4', 'upperLimit': '80.0'}, {'value': '59.9', 'groupId': 'OG003', 'lowerLimit': '54.8', 'upperLimit': '64.9'}]}]}, {'title': 'B/Yamagata, HI ≥1:215', 'categories': [{'measurements': [{'value': '69.9', 'groupId': 'OG000', 'lowerLimit': '65.2', 'upperLimit': '74.3'}, {'value': '64.2', 'groupId': 'OG001', 'lowerLimit': '59.3', 'upperLimit': '69.0'}, {'value': '53.3', 'groupId': 'OG002', 'lowerLimit': '48.2', 'upperLimit': '58.3'}, {'value': '38.5', 'groupId': 'OG003', 'lowerLimit': '33.6', 'upperLimit': '43.6'}]}]}, {'title': 'B/Yamagata, HI ≥1:330', 'categories': [{'measurements': [{'value': '44.0', 'groupId': 'OG000', 'lowerLimit': '39.1', 'upperLimit': '49.0'}, {'value': '34.3', 'groupId': 'OG001', 'lowerLimit': '29.6', 'upperLimit': '39.2'}, {'value': '25.1', 'groupId': 'OG002', 'lowerLimit': '20.9', 'upperLimit': '29.7'}, {'value': '14.9', 'groupId': 'OG003', 'lowerLimit': '11.5', 'upperLimit': '18.9'}]}]}, {'title': 'B/Yamagata, HI ≥1:629', 'categories': [{'measurements': [{'value': '27.9', 'groupId': 'OG000', 'lowerLimit': '23.5', 'upperLimit': '32.5'}, {'value': '20.9', 'groupId': 'OG001', 'lowerLimit': '17.0', 'upperLimit': '25.2'}, {'value': '14.2', 'groupId': 'OG002', 'lowerLimit': '10.9', 'upperLimit': '18.1'}, {'value': '7.3', 'groupId': 'OG003', 'lowerLimit': '4.9', 'upperLimit': '10.4'}]}]}, {'title': 'B/Victoria, HI ≥1:110', 'categories': [{'measurements': [{'value': '93.0', 'groupId': 'OG000', 'lowerLimit': '90.1', 'upperLimit': '95.3'}, {'value': '89.9', 'groupId': 'OG001', 'lowerLimit': '86.5', 'upperLimit': '92.7'}, {'value': '86.0', 'groupId': 'OG002', 'lowerLimit': '82.8', 'upperLimit': '89.8'}, {'value': '76.1', 'groupId': 'OG003', 'lowerLimit': '71.5', 'upperLimit': '80.3'}]}]}, {'title': 'B/Victoria, HI ≥1:151', 'categories': [{'measurements': [{'value': '91.3', 'groupId': 'OG000', 'lowerLimit': '88.1', 'upperLimit': '93.9'}, {'value': '87.9', 'groupId': 'OG001', 'lowerLimit': '84.3', 'upperLimit': '90.9'}, {'value': '83.0', 'groupId': 'OG002', 'lowerLimit': '78.9', 'upperLimit': '86.6'}, {'value': '70.6', 'groupId': 'OG003', 'lowerLimit': '65.8', 'upperLimit': '75.1'}]}]}, {'title': 'B/Victoria, HI ≥1:215', 'categories': [{'measurements': [{'value': '79.6', 'groupId': 'OG000', 'lowerLimit': '75.3', 'upperLimit': '83.4'}, {'value': '73.4', 'groupId': 'OG001', 'lowerLimit': '69.1', 'upperLimit': '78.0'}, {'value': '67.5', 'groupId': 'OG002', 'lowerLimit': '62.6', 'upperLimit': '72.1'}, {'value': '53.0', 'groupId': 'OG003', 'lowerLimit': '47.9', 'upperLimit': '58.1'}]}]}, {'title': 'B/Victoria, HI ≥1:330', 'categories': [{'measurements': [{'value': '58.7', 'groupId': 'OG000', 'lowerLimit': '53.7', 'upperLimit': '63.6'}, {'value': '48.7', 'groupId': 'OG001', 'lowerLimit': '43.8', 'upperLimit': '53.8'}, {'value': '41.9', 'groupId': 'OG002', 'lowerLimit': '37.0', 'upperLimit': '46.9'}, {'value': '32.0', 'groupId': 'OG003', 'lowerLimit': '27.4', 'upperLimit': '37.0'}]}]}, {'title': 'B/Victoria, HI ≥1:629', 'categories': [{'measurements': [{'value': '45.3', 'groupId': 'OG000', 'lowerLimit': '40.3', 'upperLimit': '50.3'}, {'value': '37.6', 'groupId': 'OG001', 'lowerLimit': '32.8', 'upperLimit': '42.6'}, {'value': '34.3', 'groupId': 'OG002', 'lowerLimit': '29.6', 'upperLimit': '39.2'}, {'value': '24.1', 'groupId': 'OG003', 'lowerLimit': '19.9', 'upperLimit': '28.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 22', 'description': 'The percentage of subjects achieving HI Titers ≥1:110, ≥1:151, ≥1:215, ≥1:330 and ≥1:629 at Day 22 after vaccination is reported against homologous strains.\n\nStrains tested: A/H1N1 California/07/2009; A/H3N2 Switzerland/9715293/2013; B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013.', 'unitOfMeasure': 'percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Immunogenicity PPS consisting of all subjects who received a study vaccination and provided immunogenicity data, and who correctly received the study vaccine, had no major protocol deviations, and did not develop RT-PCR-confirmed influenza infection between baseline and Visit 2.'}, {'type': 'SECONDARY', 'title': 'Immunogenicity Endpoint: GMT as Determined by HI Assay on Day 1, Day 22, and Day 181 Against Heterologous Strains', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '58', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'aQIV/aQIV', 'description': 'Subjects previously vaccinated with aQIV followed one year later by aQIV\n\nAdjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)'}, {'id': 'OG001', 'title': 'aQIV/QIV', 'description': 'Subjects previously vaccinated with aQIV followed one year later by QIV\n\nNon-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)'}, {'id': 'OG002', 'title': 'QIV/aQIV', 'description': 'Subjects previously vaccinated with QIV followed one year later by aQIV\n\nAdjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)'}, {'id': 'OG003', 'title': 'QIV/QIV', 'description': 'Subjects previously vaccinated with QIV followed one year later by QIV\n\nNon-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)'}], 'classes': [{'title': 'A/H3N2 (Day 1)', 'categories': [{'measurements': [{'value': '97.7', 'groupId': 'OG000', 'lowerLimit': '59.4', 'upperLimit': '160.6'}, {'value': '156.6', 'groupId': 'OG001', 'lowerLimit': '96.1', 'upperLimit': '255.1'}, {'value': '40.9', 'groupId': 'OG002', 'lowerLimit': '25.3', 'upperLimit': '66.0'}, {'value': '91.6', 'groupId': 'OG003', 'lowerLimit': '55.6', 'upperLimit': '150.8'}]}]}, {'title': 'A/H3N2 (Day 22)', 'categories': [{'measurements': [{'value': '2436.1', 'groupId': 'OG000', 'lowerLimit': '2058.0', 'upperLimit': '2883.6'}, {'value': '2415.2', 'groupId': 'OG001', 'lowerLimit': '2049.9', 'upperLimit': '2845.5'}, {'value': '2225.1', 'groupId': 'OG002', 'lowerLimit': '1872.6', 'upperLimit': '2643.8'}, {'value': '2097.2', 'groupId': 'OG003', 'lowerLimit': '1769.7', 'upperLimit': '2485.2'}]}]}, {'title': 'A/H3N2 (Day 181)', 'categories': [{'measurements': [{'value': '898.1', 'groupId': 'OG000', 'lowerLimit': '707.5', 'upperLimit': '1139.9'}, {'value': '917.6', 'groupId': 'OG001', 'lowerLimit': '728.2', 'upperLimit': '1156.3'}, {'value': '953.2', 'groupId': 'OG002', 'lowerLimit': '746.7', 'upperLimit': '1216.6'}, {'value': '791.7', 'groupId': 'OG003', 'lowerLimit': '621.5', 'upperLimit': '1008.3'}]}]}, {'title': 'B/Victoria (Day 1)', 'categories': [{'measurements': [{'value': '33.4', 'groupId': 'OG000', 'lowerLimit': '24.6', 'upperLimit': '45.3'}, {'value': '23.8', 'groupId': 'OG001', 'lowerLimit': '17.6', 'upperLimit': '32.2'}, {'value': '15.8', 'groupId': 'OG002', 'lowerLimit': '11.8', 'upperLimit': '21.2'}, {'value': '15.9', 'groupId': 'OG003', 'lowerLimit': '11.7', 'upperLimit': '21.6'}]}]}, {'title': 'B/Victoria (Day 22)', 'categories': [{'measurements': [{'value': '327.1', 'groupId': 'OG000', 'lowerLimit': '255.7', 'upperLimit': '418.4'}, {'value': '248.4', 'groupId': 'OG001', 'lowerLimit': '195.3', 'upperLimit': '316.0'}, {'value': '283.2', 'groupId': 'OG002', 'lowerLimit': '222.8', 'upperLimit': '359.8'}, {'value': '204.8', 'groupId': 'OG003', 'lowerLimit': '159.6', 'upperLimit': '262.8'}]}]}, {'title': 'B/Victoria (Day 181)', 'categories': [{'measurements': [{'value': '107.1', 'groupId': 'OG000', 'lowerLimit': '79.3', 'upperLimit': '144.6'}, {'value': '85.6', 'groupId': 'OG001', 'lowerLimit': '63.9', 'upperLimit': '114.7'}, {'value': '77.5', 'groupId': 'OG002', 'lowerLimit': '57.9', 'upperLimit': '103.9'}, {'value': '56.0', 'groupId': 'OG003', 'lowerLimit': '41.2', 'upperLimit': '76.0'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1, Day 22, Day 181', 'description': 'GMT and 95% CI were analyzed for Day 22 for the heterologous strains using ANCOVA with study specific covariates.\n\nThe two heterologous strains selected for HI testing in this study were the H3N2 strain, A/Hong Kong/4801/2014 (X-263B), and the B/ Victoria lineage strain, B/Malaysia/2506/2004.', 'unitOfMeasure': 'titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Immunogenicity PPS consisting of all subjects who received a study vaccination and provided immunogenicity data, and who correctly received the study vaccine, had no major protocol deviations, and did not develop RT-PCR-confirmed influenza infection between baseline and Visit 2.'}, {'type': 'SECONDARY', 'title': 'Immunogenicity Endpoint: GMR as Determined by HI Assay for Day 22/Day 1 and Day 181/Day 1 Against Heterologous Strains', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '58', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'aQIV/aQIV', 'description': 'Subjects previously vaccinated with aQIV followed one year later by aQIV\n\nAdjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)'}, {'id': 'OG001', 'title': 'aQIV/QIV', 'description': 'Subjects previously vaccinated with aQIV followed one year later by QIV\n\nNon-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)'}, {'id': 'OG002', 'title': 'QIV/aQIV', 'description': 'Subjects previously vaccinated with QIV followed one year later by aQIV\n\nAdjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)'}, {'id': 'OG003', 'title': 'QIV/QIV', 'description': 'Subjects previously vaccinated with QIV followed one year later by QIV\n\nNon-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)'}], 'classes': [{'title': 'A/H3N2 (Day 22/Day 1)', 'categories': [{'measurements': [{'value': '14.67', 'groupId': 'OG000', 'lowerLimit': '12.4', 'upperLimit': '17.4'}, {'value': '14.55', 'groupId': 'OG001', 'lowerLimit': '12.3', 'upperLimit': '17.1'}, {'value': '13.40', 'groupId': 'OG002', 'lowerLimit': '11.3', 'upperLimit': '15.9'}, {'value': '12.63', 'groupId': 'OG003', 'lowerLimit': '10.7', 'upperLimit': '15.0'}]}]}, {'title': 'A/H3N2 (Day 181/Day 1)', 'categories': [{'measurements': [{'value': '5.31', 'groupId': 'OG000', 'lowerLimit': '4.2', 'upperLimit': '6.7'}, {'value': '5.42', 'groupId': 'OG001', 'lowerLimit': '4.3', 'upperLimit': '6.8'}, {'value': '5.63', 'groupId': 'OG002', 'lowerLimit': '4.4', 'upperLimit': '7.2'}, {'value': '4.68', 'groupId': 'OG003', 'lowerLimit': '3.7', 'upperLimit': '6.0'}]}]}, {'title': 'B/Victoria (Day 22/Day 1)', 'categories': [{'measurements': [{'value': '13.40', 'groupId': 'OG000', 'lowerLimit': '10.5', 'upperLimit': '17.1'}, {'value': '10.18', 'groupId': 'OG001', 'lowerLimit': '8.0', 'upperLimit': '13.0'}, {'value': '11.60', 'groupId': 'OG002', 'lowerLimit': '9.1', 'upperLimit': '14.7'}, {'value': '8.39', 'groupId': 'OG003', 'lowerLimit': '6.5', 'upperLimit': '10.8'}]}]}, {'title': 'B/Victoria (Day 181/Day 1)', 'categories': [{'measurements': [{'value': '4.38', 'groupId': 'OG000', 'lowerLimit': '3.2', 'upperLimit': '5.9'}, {'value': '3.50', 'groupId': 'OG001', 'lowerLimit': '2.6', 'upperLimit': '4.7'}, {'value': '3.17', 'groupId': 'OG002', 'lowerLimit': '2.4', 'upperLimit': '4.3'}, {'value': '2.29', 'groupId': 'OG003', 'lowerLimit': '1.7', 'upperLimit': '3.1'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 22/Day 1 and Day 181/Day 1', 'description': 'The GMR is the geometric mean of the fold increase in HI titer from Day 1 to Day 22 or Day 181. GMR and 95% CI were analyzed for the heterologous strains using ANCOVA with study specific covariates.\n\nThe two heterologous strains selected for HI testing in this study were the H3N2 strain, A/Hong Kong/4801/2014 (X-263B), and the B Victoria lineage strain, B/Malaysia/2506/2004.', 'unitOfMeasure': 'ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Immunogenicity PPS consisting of all subjects who received a study vaccination and provided immunogenicity data, and who correctly received the study vaccine, had no major protocol deviations, and did not develop RT-PCR-confirmed influenza infection between baseline and Visit 2.'}, {'type': 'SECONDARY', 'title': 'Immunogenicity Endpoint: Percentage of Subjects Achieving SCR and HI Titer ≥1:40 on Day 22 and Day 181 Against Heterologous Strains', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '58', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'aQIV/aQIV', 'description': 'Subjects previously vaccinated with aQIV followed one year later by aQIV\n\nAdjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)'}, {'id': 'OG001', 'title': 'aQIV/QIV', 'description': 'Subjects previously vaccinated with aQIV followed one year later by QIV\n\nNon-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)'}, {'id': 'OG002', 'title': 'QIV/aQIV', 'description': 'Subjects previously vaccinated with QIV followed one year later by aQIV\n\nAdjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)'}, {'id': 'OG003', 'title': 'QIV/QIV', 'description': 'Subjects previously vaccinated with QIV followed one year later by QIV\n\nNon-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)'}], 'classes': [{'title': 'A/H3N2, SCR (Day 22)', 'categories': [{'measurements': [{'value': '78.3', 'groupId': 'OG000', 'lowerLimit': '65.8', 'upperLimit': '87.9'}, {'value': '73.7', 'groupId': 'OG001', 'lowerLimit': '60.3', 'upperLimit': '84.5'}, {'value': '83.1', 'groupId': 'OG002', 'lowerLimit': '71.0', 'upperLimit': '91.6'}, {'value': '69.0', 'groupId': 'OG003', 'lowerLimit': '55.5', 'upperLimit': '80.5'}]}]}, {'title': 'A/ H3N2, HI titer ≥1:40 (Day 22)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '94.0', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '93.7', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG002', 'lowerLimit': '93.9', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG003', 'lowerLimit': '93.8', 'upperLimit': '100'}]}]}, {'title': 'A/ H3N2, HI titer ≥1:40 (Day 181)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '93.8', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '93.68', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG002', 'lowerLimit': '93.8', 'upperLimit': '100'}, {'value': '98.2', 'groupId': 'OG003', 'lowerLimit': '90.4', 'upperLimit': '100'}]}]}, {'title': 'B/Victoria, SCR (Day 22)', 'categories': [{'measurements': [{'value': '75.0', 'groupId': 'OG000', 'lowerLimit': '62.1', 'upperLimit': '85.3'}, {'value': '82.1', 'groupId': 'OG001', 'lowerLimit': '69.6', 'upperLimit': '91.1'}, {'value': '81.4', 'groupId': 'OG002', 'lowerLimit': '69.1', 'upperLimit': '90.3'}, {'value': '77.6', 'groupId': 'OG003', 'lowerLimit': '64.7', 'upperLimit': '87.5'}]}]}, {'title': 'B/Victoria, HI titer ≥1:40 (Day 22)', 'categories': [{'measurements': [{'value': '98.3', 'groupId': 'OG000', 'lowerLimit': '91.1', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '93.6', 'upperLimit': '100'}, {'value': '96.6', 'groupId': 'OG002', 'lowerLimit': '88.3', 'upperLimit': '99.6'}, {'value': '98.3', 'groupId': 'OG003', 'lowerLimit': '90.8', 'upperLimit': '100'}]}]}, {'title': 'B/ Victoria, HI titer ≥1:40 (Day 181)', 'categories': [{'measurements': [{'value': '91.4', 'groupId': 'OG000', 'lowerLimit': '81.0', 'upperLimit': '97.1'}, {'value': '83.6', 'groupId': 'OG001', 'lowerLimit': '71.2', 'upperLimit': '92.2'}, {'value': '74.1', 'groupId': 'OG002', 'lowerLimit': '61.0', 'upperLimit': '84.7'}, {'value': '64.3', 'groupId': 'OG003', 'lowerLimit': '50.4', 'upperLimit': '76.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 22, Day 181', 'description': 'The percentage of subjects achieving HI titer ≥1:40 at Day 22 and Day 181 after vaccination and the percentage of subject who experienced seroconversion is reported for homologous strains. Seroconversion was defined in subjects seronegative at baseline (i.e. HI titer \\<1:10 on Day 1) as post-vaccination HI titer ≥1:40 and defined in subjects seropositive at baseline (i.e. HI titer ≥1:10 on Day 1) as a minimum of a 4-fold increase in post-vaccination HI titer.\n\nThe two heterologous strains selected for HI testing in this study were the H3N2 strain, A/Hong Kong/4801/2014 (X-263B), and the B/Victoria lineage strain, B/Malaysia/2506/2004.', 'unitOfMeasure': 'percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Immunogenicity PPS consisting of all subjects who received a study vaccination and provided immunogenicity data, and who correctly received the study vaccine, had no major protocol deviations, and did not develop RT-PCR-confirmed influenza infection between baseline and Visit 2.'}, {'type': 'SECONDARY', 'title': 'Immunogenicity Endpoint: GMT as Determined by Microneutralization (MN) Assay on Day 1, Day 22, and Day 181 Against Homologous Strains', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'aQIV/aQIV', 'description': 'Subjects previously vaccinated with aQIV followed one year later by aQIV\n\nAdjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)'}, {'id': 'OG001', 'title': 'aQIV/QIV', 'description': 'Subjects previously vaccinated with aQIV followed one year later by QIV\n\nNon-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)'}, {'id': 'OG002', 'title': 'QIV/aQIV', 'description': 'Subjects previously vaccinated with QIV followed one year later by aQIV\n\nAdjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)'}, {'id': 'OG003', 'title': 'QIV/QIV', 'description': 'Subjects previously vaccinated with QIV followed one year later by QIV\n\nNon-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)'}], 'classes': [{'title': 'A/H1N1 (Day 1)', 'categories': [{'measurements': [{'value': '264.36', 'groupId': 'OG000', 'lowerLimit': '173.8', 'upperLimit': '402.1'}, {'value': '198.13', 'groupId': 'OG001', 'lowerLimit': '127.8', 'upperLimit': '307.0'}, {'value': '104.28', 'groupId': 'OG002', 'lowerLimit': '67.0', 'upperLimit': '162.3'}, {'value': '140.38', 'groupId': 'OG003', 'lowerLimit': '90.0', 'upperLimit': '219.1'}]}]}, {'title': 'A/H1N1 (Day 22)', 'categories': [{'measurements': [{'value': '2253.81', 'groupId': 'OG000', 'lowerLimit': '1713.5', 'upperLimit': '2964.5'}, {'value': '2295.46', 'groupId': 'OG001', 'lowerLimit': '1729.5', 'upperLimit': '3046.7'}, {'value': '2992.29', 'groupId': 'OG002', 'lowerLimit': '2238.5', 'upperLimit': '3999.9'}, {'value': '1543.54', 'groupId': 'OG003', 'lowerLimit': '1156.5', 'upperLimit': '20660.1'}]}]}, {'title': 'A/H1N1 (Day 181)', 'categories': [{'measurements': [{'value': '727.04', 'groupId': 'OG000', 'lowerLimit': '568.6', 'upperLimit': '929.6'}, {'value': '725.35', 'groupId': 'OG001', 'lowerLimit': '560.7', 'upperLimit': '938.4'}, {'value': '686.98', 'groupId': 'OG002', 'lowerLimit': '527.2', 'upperLimit': '895.2'}, {'value': '412.34', 'groupId': 'OG003', 'lowerLimit': '317.2', 'upperLimit': '536.0'}]}]}, {'title': 'A/H3N2 (Day 1)', 'categories': [{'measurements': [{'value': '160.88', 'groupId': 'OG000', 'lowerLimit': '103.6', 'upperLimit': '249.7'}, {'value': '113.74', 'groupId': 'OG001', 'lowerLimit': '71.9', 'upperLimit': '180.0'}, {'value': '133.25', 'groupId': 'OG002', 'lowerLimit': '83.8', 'upperLimit': '211.8'}, {'value': '97.47', 'groupId': 'OG003', 'lowerLimit': '61.1', 'upperLimit': '155.6'}]}]}, {'title': 'A/H3N2 (Day 22)', 'categories': [{'measurements': [{'value': '5532.06', 'groupId': 'OG000', 'lowerLimit': '4441.7', 'upperLimit': '6890.0'}, {'value': '6649.94', 'groupId': 'OG001', 'lowerLimit': '5275.3', 'upperLimit': '8382.7'}, {'value': '5019.51', 'groupId': 'OG002', 'lowerLimit': '3978.6', 'upperLimit': '6332.8'}, {'value': '4696.37', 'groupId': 'OG003', 'lowerLimit': '3699.4', 'upperLimit': '5962.1'}]}]}, {'title': 'A/H3N2 (Day 181)', 'categories': [{'measurements': [{'value': '2069.22', 'groupId': 'OG000', 'lowerLimit': '1488.8', 'upperLimit': '2875.9'}, {'value': '2127.88', 'groupId': 'OG001', 'lowerLimit': '1500.4', 'upperLimit': '3017.8'}, {'value': '2138.80', 'groupId': 'OG002', 'lowerLimit': '1505.0', 'upperLimit': '3039.5'}, {'value': '1696.57', 'groupId': 'OG003', 'lowerLimit': '1178.4', 'upperLimit': '2442.5'}]}]}, {'title': 'B/Yamagata (Day 1)', 'categories': [{'measurements': [{'value': '29.82', 'groupId': 'OG000', 'lowerLimit': '22.2', 'upperLimit': '40.1'}, {'value': '37.99', 'groupId': 'OG001', 'lowerLimit': '27.9', 'upperLimit': '51.7'}, {'value': '21.57', 'groupId': 'OG002', 'lowerLimit': '15.8', 'upperLimit': '29.5'}, {'value': '21.07', 'groupId': 'OG003', 'lowerLimit': '15.4', 'upperLimit': '28.9'}]}]}, {'title': 'B/Yamagata (Day 22)', 'categories': [{'measurements': [{'value': '388.29', 'groupId': 'OG000', 'lowerLimit': '299.1', 'upperLimit': '504.0'}, {'value': '301.39', 'groupId': 'OG001', 'lowerLimit': '229.0', 'upperLimit': '396.7'}, {'value': '247.31', 'groupId': 'OG002', 'lowerLimit': '187.6', 'upperLimit': '326.0'}, {'value': '197.51', 'groupId': 'OG003', 'lowerLimit': '149.3', 'upperLimit': '261.4'}]}]}, {'title': 'B/Yamagata (Day 181)', 'categories': [{'measurements': [{'value': '107.05', 'groupId': 'OG000', 'lowerLimit': '81.4', 'upperLimit': '140.8'}, {'value': '103.59', 'groupId': 'OG001', 'lowerLimit': '77.5', 'upperLimit': '138.5'}, {'value': '82.90', 'groupId': 'OG002', 'lowerLimit': '61.9', 'upperLimit': '111.0'}, {'value': '56.03', 'groupId': 'OG003', 'lowerLimit': '41.5', 'upperLimit': '75.6'}]}]}, {'title': 'B/Victoria (Day 1)', 'categories': [{'measurements': [{'value': '43.66', 'groupId': 'OG000', 'lowerLimit': '33.1', 'upperLimit': '57.6'}, {'value': '43.13', 'groupId': 'OG001', 'lowerLimit': '32.3', 'upperLimit': '57.6'}, {'value': '27.96', 'groupId': 'OG002', 'lowerLimit': '20.9', 'upperLimit': '37.4'}, {'value': '33.14', 'groupId': 'OG003', 'lowerLimit': '24.7', 'upperLimit': '44.4'}]}]}, {'title': 'B/Victoria (Day 22)', 'categories': [{'measurements': [{'value': '355.63', 'groupId': 'OG000', 'lowerLimit': '271.8', 'upperLimit': '465.4'}, {'value': '346.99', 'groupId': 'OG001', 'lowerLimit': '262.6', 'upperLimit': '458.5'}, {'value': '338.49', 'groupId': 'OG002', 'lowerLimit': '255.0', 'upperLimit': '449.4'}, {'value': '193.09', 'groupId': 'OG003', 'lowerLimit': '145.5', 'upperLimit': '256.3'}]}]}, {'title': 'B/Victoria (Day 181)', 'categories': [{'measurements': [{'value': '124.31', 'groupId': 'OG000', 'lowerLimit': '95.3', 'upperLimit': '162.1'}, {'value': '106.08', 'groupId': 'OG001', 'lowerLimit': '80.2', 'upperLimit': '140.3'}, {'value': '95.87', 'groupId': 'OG002', 'lowerLimit': '72.1', 'upperLimit': '127.5'}, {'value': '60.54', 'groupId': 'OG003', 'lowerLimit': '45.4', 'upperLimit': '80.7'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1, Day 22, Day 181', 'description': 'To further characterize immune response, MN GMT and 95% CI were analyzed for Day 1, Day 22, and Day 181 against homologous strains.\n\nStrains tested: A/H1N1 California/07/2009; A/H3N2 Switzerland/9715293/2013; B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013.', 'unitOfMeasure': 'titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Immunogenicity PPS consisting of all subjects who received a study vaccination and provided immunogenicity data, and who correctly received the study vaccine, had no major protocol deviations, and did not develop RT-PCR-confirmed influenza infection between baseline and Visit 2.'}, {'type': 'SECONDARY', 'title': 'Immunogenicity Endpoint: GMR as Determined by MN Assay for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'aQIV/aQIV', 'description': 'Subjects previously vaccinated with aQIV followed one year later by aQIV\n\nAdjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)'}, {'id': 'OG001', 'title': 'aQIV/QIV', 'description': 'Subjects previously vaccinated with aQIV followed one year later by QIV\n\nNon-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)'}, {'id': 'OG002', 'title': 'QIV/aQIV', 'description': 'Subjects previously vaccinated with QIV followed one year later by aQIV\n\nAdjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)'}, {'id': 'OG003', 'title': 'QIV/QIV', 'description': 'Subjects previously vaccinated with QIV followed one year later by QIV\n\nNon-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)'}], 'classes': [{'title': 'A/H1N1 (Day 22/Day 1)', 'categories': [{'measurements': [{'value': '11.85', 'groupId': 'OG000', 'lowerLimit': '9.0', 'upperLimit': '15.6'}, {'value': '12.07', 'groupId': 'OG001', 'lowerLimit': '9.1', 'upperLimit': '16.0'}, {'value': '15.73', 'groupId': 'OG002', 'lowerLimit': '11.8', 'upperLimit': '21.0'}, {'value': '8.11', 'groupId': 'OG003', 'lowerLimit': '6.1', 'upperLimit': '10.8'}]}]}, {'title': 'A/H1N1 (Day 181/Day 1)', 'categories': [{'measurements': [{'value': '3.67', 'groupId': 'OG000', 'lowerLimit': '2.9', 'upperLimit': '4.7'}, {'value': '3.66', 'groupId': 'OG001', 'lowerLimit': '2.8', 'upperLimit': '4.7'}, {'value': '3.47', 'groupId': 'OG002', 'lowerLimit': '2.7', 'upperLimit': '4.5'}, {'value': '2.08', 'groupId': 'OG003', 'lowerLimit': '1.6', 'upperLimit': '2.7'}]}]}, {'title': 'A/H3N2 (Day 22/Day 1)', 'categories': [{'measurements': [{'value': '28.19', 'groupId': 'OG000', 'lowerLimit': '22.6', 'upperLimit': '35.1'}, {'value': '33.88', 'groupId': 'OG001', 'lowerLimit': '26.9', 'upperLimit': '42.7'}, {'value': '25.57', 'groupId': 'OG002', 'lowerLimit': '20.3', 'upperLimit': '32.3'}, {'value': '23.93', 'groupId': 'OG003', 'lowerLimit': '18.8', 'upperLimit': '30.4'}]}]}, {'title': 'A/H3N2 (Day 181/Day 1)', 'categories': [{'measurements': [{'value': '10.63', 'groupId': 'OG000', 'lowerLimit': '7.6', 'upperLimit': '14.8'}, {'value': '10.93', 'groupId': 'OG001', 'lowerLimit': '7.7', 'upperLimit': '15.5'}, {'value': '10.99', 'groupId': 'OG002', 'lowerLimit': '7.7', 'upperLimit': '15.6'}, {'value': '8.72', 'groupId': 'OG003', 'lowerLimit': '6.1', 'upperLimit': '12.5'}]}]}, {'title': 'B/Yamagata (Day 22/Day 1)', 'categories': [{'measurements': [{'value': '14.11', 'groupId': 'OG000', 'lowerLimit': '10.9', 'upperLimit': '18.3'}, {'value': '10.95', 'groupId': 'OG001', 'lowerLimit': '8.3', 'upperLimit': '14.4'}, {'value': '8.99', 'groupId': 'OG002', 'lowerLimit': '6.8', 'upperLimit': '11.8'}, {'value': '7.18', 'groupId': 'OG003', 'lowerLimit': '5.4', 'upperLimit': '9.5'}]}]}, {'title': 'B/Yamagata (Day 181/Day 1)', 'categories': [{'measurements': [{'value': '3.97', 'groupId': 'OG000', 'lowerLimit': '3.0', 'upperLimit': '5.2'}, {'value': '3.84', 'groupId': 'OG001', 'lowerLimit': '2.9', 'upperLimit': '5.1'}, {'value': '3.07', 'groupId': 'OG002', 'lowerLimit': '2.3', 'upperLimit': '4.1'}, {'value': '2.08', 'groupId': 'OG003', 'lowerLimit': '1.5', 'upperLimit': '2.8'}]}]}, {'title': 'B/Victoria (Day 22/Day 1)', 'categories': [{'measurements': [{'value': '9.43', 'groupId': 'OG000', 'lowerLimit': '7.2', 'upperLimit': '12.3'}, {'value': '9.20', 'groupId': 'OG001', 'lowerLimit': '7.0', 'upperLimit': '12.2'}, {'value': '8.97', 'groupId': 'OG002', 'lowerLimit': '6.8', 'upperLimit': '11.9'}, {'value': '5.12', 'groupId': 'OG003', 'lowerLimit': '3.9', 'upperLimit': '6.8'}]}]}, {'title': 'B/Victoria (Day 181/Day 1)', 'categories': [{'measurements': [{'value': '3.25', 'groupId': 'OG000', 'lowerLimit': '2.5', 'upperLimit': '4.2'}, {'value': '2.77', 'groupId': 'OG001', 'lowerLimit': '2.1', 'upperLimit': '3.7'}, {'value': '2.51', 'groupId': 'OG002', 'lowerLimit': '1.9', 'upperLimit': '3.3'}, {'value': '1.58', 'groupId': 'OG003', 'lowerLimit': '1.2', 'upperLimit': '2.1'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 22/Day 1 and Day 181/Day 1', 'description': 'The GMR is the geometric mean of the fold increase in MN titer from Day 1 to Day 22 or Day 181. GMR and 95% CI were analyzed for the homologous strains using ANCOVA with study specific covariates.\n\nStrains tested: A/H1N1 California/07/2009; A/H3N2 Switzerland/9715293/2013; B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013.', 'unitOfMeasure': 'ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Immunogenicity PPS consisting of all subjects who received a study vaccination and provided immunogenicity data, and who correctly received the study vaccine, had no major protocol deviations, and did not develop RT-PCR-confirmed influenza infection between baseline and Visit 2.'}, {'type': 'SECONDARY', 'title': 'Immunogenicity Endpoint: Anti-neuraminidase (NA) GMTs on Day 1, Day 22, and Day 181 Against Homologous Strains', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'aQIV/aQIV', 'description': 'Subjects previously vaccinated with aQIV followed one year later by aQIV\n\nAdjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)'}, {'id': 'OG001', 'title': 'aQIV/QIV', 'description': 'Subjects previously vaccinated with aQIV followed one year later by QIV\n\nNon-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)'}, {'id': 'OG002', 'title': 'QIV/aQIV', 'description': 'Subjects previously vaccinated with QIV followed one year later by aQIV\n\nAdjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)'}, {'id': 'OG003', 'title': 'QIV/QIV', 'description': 'Subjects previously vaccinated with QIV followed one year later by QIV\n\nNon-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)'}], 'classes': [{'title': 'N1 (Day 1)', 'categories': [{'measurements': [{'value': '1174.69', 'groupId': 'OG000', 'lowerLimit': '767.8', 'upperLimit': '1797.3'}, {'value': '1209.21', 'groupId': 'OG001', 'lowerLimit': '815.7', 'upperLimit': '1792.6'}, {'value': '230.09', 'groupId': 'OG002', 'lowerLimit': '154.7', 'upperLimit': '342.2'}, {'value': '182.80', 'groupId': 'OG003', 'lowerLimit': '122.7', 'upperLimit': '272.2'}]}]}, {'title': 'N1 (Day 22)', 'categories': [{'measurements': [{'value': '3403.72', 'groupId': 'OG000', 'lowerLimit': '2821.4', 'upperLimit': '4106.2'}, {'value': '3161.01', 'groupId': 'OG001', 'lowerLimit': '2654.7', 'upperLimit': '3763.9'}, {'value': '3588.43', 'groupId': 'OG002', 'lowerLimit': '2994.0', 'upperLimit': '4300.9'}, {'value': '2410.65', 'groupId': 'OG003', 'lowerLimit': '2001.2', 'upperLimit': '2903.9'}]}]}, {'title': 'N1 (Day 181)', 'categories': [{'measurements': [{'value': '2477.65', 'groupId': 'OG000', 'lowerLimit': '1958.9', 'upperLimit': '3133.7'}, {'value': '1649.89', 'groupId': 'OG001', 'lowerLimit': '1324.9', 'upperLimit': '2054.5'}, {'value': '2018.32', 'groupId': 'OG002', 'lowerLimit': '1610.4', 'upperLimit': '2529.5'}, {'value': '870.73', 'groupId': 'OG003', 'lowerLimit': '691.0', 'upperLimit': '1097.2'}]}]}, {'title': 'N2 (Day 1)', 'categories': [{'measurements': [{'value': '204.59', 'groupId': 'OG000', 'lowerLimit': '121.3', 'upperLimit': '345.2'}, {'value': '289.86', 'groupId': 'OG001', 'lowerLimit': '178.6', 'upperLimit': '470.4'}, {'value': '86.08', 'groupId': 'OG002', 'lowerLimit': '52.8', 'upperLimit': '140.3'}, {'value': '86.34', 'groupId': 'OG003', 'lowerLimit': '52.9', 'upperLimit': '140.9'}]}]}, {'title': 'N2 (Day 22)', 'categories': [{'measurements': [{'value': '915.19', 'groupId': 'OG000', 'lowerLimit': '753.5', 'upperLimit': '1111.6'}, {'value': '1050.44', 'groupId': 'OG001', 'lowerLimit': '876.7', 'upperLimit': '1258.7'}, {'value': '1242.36', 'groupId': 'OG002', 'lowerLimit': '1031.4', 'upperLimit': '1496.5'}, {'value': '980.87', 'groupId': 'OG003', 'lowerLimit': '813.8', 'upperLimit': '1182.2'}]}]}, {'title': 'N2 (Day 181)', 'categories': [{'measurements': [{'value': '505.91', 'groupId': 'OG000', 'lowerLimit': '375.2', 'upperLimit': '682.2'}, {'value': '565.69', 'groupId': 'OG001', 'lowerLimit': '426.7', 'upperLimit': '749.9'}, {'value': '516.51', 'groupId': 'OG002', 'lowerLimit': '388.6', 'upperLimit': '686.4'}, {'value': '369.04', 'groupId': 'OG003', 'lowerLimit': '277.5', 'upperLimit': '490.8'}]}]}, {'title': 'B/Victoria (Day 1)', 'categories': [{'measurements': [{'value': '497.11', 'groupId': 'OG000', 'lowerLimit': '344.3', 'upperLimit': '717.7'}, {'value': '548.92', 'groupId': 'OG001', 'lowerLimit': '390.7', 'upperLimit': '771.2'}, {'value': '306.48', 'groupId': 'OG002', 'lowerLimit': '217.6', 'upperLimit': '431.7'}, {'value': '237.96', 'groupId': 'OG003', 'lowerLimit': '168.7', 'upperLimit': '335.6'}]}]}, {'title': 'B/Victoria (Day 22)', 'categories': [{'measurements': [{'value': '3175.99', 'groupId': 'OG000', 'lowerLimit': '2736.5', 'upperLimit': '3686.0'}, {'value': '3336.65', 'groupId': 'OG001', 'lowerLimit': '2906.2', 'upperLimit': '3830.8'}, {'value': '3331.87', 'groupId': 'OG002', 'lowerLimit': '2894.6', 'upperLimit': '3835.2'}, {'value': '2418.50', 'groupId': 'OG003', 'lowerLimit': '2094.6', 'upperLimit': '2792.74'}]}]}, {'title': 'B/Victoria (Day 181)', 'categories': [{'measurements': [{'value': '1424.38', 'groupId': 'OG000', 'lowerLimit': '1108.1', 'upperLimit': '1831.0'}, {'value': '1587.86', 'groupId': 'OG001', 'lowerLimit': '1256.5', 'upperLimit': '2006.6'}, {'value': '1443.37', 'groupId': 'OG002', 'lowerLimit': '1140.1', 'upperLimit': '1827.3'}, {'value': '1030.77', 'groupId': 'OG003', 'lowerLimit': '810.3', 'upperLimit': '1311.3'}]}]}, {'title': 'B/Yamagata (Day 1)', 'categories': [{'measurements': [{'value': '290.06', 'groupId': 'OG000', 'lowerLimit': '202.3', 'upperLimit': '415.8'}, {'value': '282.17', 'groupId': 'OG001', 'lowerLimit': '201.7', 'upperLimit': '394.8'}, {'value': '148.35', 'groupId': 'OG002', 'lowerLimit': '106.0', 'upperLimit': '207.6'}, {'value': '126.07', 'groupId': 'OG003', 'lowerLimit': '90.0', 'upperLimit': '176.6'}]}]}, {'title': 'B/Yamagata (Day 22)', 'categories': [{'measurements': [{'value': '1288.67', 'groupId': 'OG000', 'lowerLimit': '1094.6', 'upperLimit': '1517.2'}, {'value': '1250.88', 'groupId': 'OG001', 'lowerLimit': '1074.3', 'upperLimit': '1456.5'}, {'value': '1275.06', 'groupId': 'OG002', 'lowerLimit': '1093.5', 'upperLimit': '1486.7'}, {'value': '883.66', 'groupId': 'OG003', 'lowerLimit': '756.1', 'upperLimit': '1032.7'}]}]}, {'title': 'B/Yamagata (Day 181)', 'categories': [{'measurements': [{'value': '727.17', 'groupId': 'OG000', 'lowerLimit': '560.2', 'upperLimit': '943.9'}, {'value': '596.62', 'groupId': 'OG001', 'lowerLimit': '467.2', 'upperLimit': '762.0'}, {'value': '511.73', 'groupId': 'OG002', 'lowerLimit': '400.7', 'upperLimit': '653.5'}, {'value': '391.23', 'groupId': 'OG003', 'lowerLimit': '305.3', 'upperLimit': '501.3'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1, Day 22, Day 181', 'description': 'To further characterize immune response, adjusted anti-NA GMT and 95% CI were analyzed for Day 1, Day 22, and Day 181 against homologous strains.\n\nStrains tested: N1 (PR8 H6N1 California/07/2009), N2 (PR8 H6N2 Switzerl/9715293/2013); B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013.', 'unitOfMeasure': 'titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Immunogenicity PPS consisting of all subjects who received a study vaccination and provided immunogenicity data, and who correctly received the study vaccine, had no major protocol deviations, and did not develop RT-PCR-confirmed influenza infection between baseline and Visit 2.'}, {'type': 'SECONDARY', 'title': 'Immunogenicity Endpoint: Anti-NA GMR for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'aQIV/aQIV', 'description': 'Subjects previously vaccinated with aQIV followed one year later by aQIV\n\nAdjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)'}, {'id': 'OG001', 'title': 'aQIV/QIV', 'description': 'Subjects previously vaccinated with aQIV followed one year later by QIV\n\nNon-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)'}, {'id': 'OG002', 'title': 'QIV/aQIV', 'description': 'Subjects previously vaccinated with QIV followed one year later by aQIV\n\nAdjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)'}, {'id': 'OG003', 'title': 'QIV/QIV', 'description': 'Subjects previously vaccinated with QIV followed one year later by QIV\n\nNon-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)'}], 'classes': [{'title': 'N1 (Day 22/Day 1)', 'categories': [{'measurements': [{'value': '5.40', 'groupId': 'OG000', 'lowerLimit': '4.5', 'upperLimit': '6.5'}, {'value': '5.02', 'groupId': 'OG001', 'lowerLimit': '4.2', 'upperLimit': '6.0'}, {'value': '5.70', 'groupId': 'OG002', 'lowerLimit': '4.8', 'upperLimit': '6.8'}, {'value': '3.83', 'groupId': 'OG003', 'lowerLimit': '3.2', 'upperLimit': '4.6'}]}]}, {'title': 'N1 (Day 181/Day 1)', 'categories': [{'measurements': [{'value': '3.95', 'groupId': 'OG000', 'lowerLimit': '3.1', 'upperLimit': '5.0'}, {'value': '2.63', 'groupId': 'OG001', 'lowerLimit': '2.1', 'upperLimit': '3.3'}, {'value': '3.22', 'groupId': 'OG002', 'lowerLimit': '2.6', 'upperLimit': '4.0'}, {'value': '1.39', 'groupId': 'OG003', 'lowerLimit': '1.1', 'upperLimit': '1.8'}]}]}, {'title': 'N2 (Day 22/Day 1)', 'categories': [{'measurements': [{'value': '4.51', 'groupId': 'OG000', 'lowerLimit': '3.7', 'upperLimit': '5.5'}, {'value': '5.18', 'groupId': 'OG001', 'lowerLimit': '4.3', 'upperLimit': '6.2'}, {'value': '6.13', 'groupId': 'OG002', 'lowerLimit': '5.1', 'upperLimit': '7.4'}, {'value': '4.84', 'groupId': 'OG003', 'lowerLimit': '4.0', 'upperLimit': '5.8'}]}]}, {'title': 'N2 (Day 181/Day 1)', 'categories': [{'measurements': [{'value': '2.45', 'groupId': 'OG000', 'lowerLimit': '1.8', 'upperLimit': '3.3'}, {'value': '2.74', 'groupId': 'OG001', 'lowerLimit': '2.1', 'upperLimit': '3.6'}, {'value': '2.50', 'groupId': 'OG002', 'lowerLimit': '1.9', 'upperLimit': '3.3'}, {'value': '1.79', 'groupId': 'OG003', 'lowerLimit': '1.3', 'upperLimit': '2.4'}]}]}, {'title': 'B/Yamagata (Day 22/Day 1)', 'categories': [{'measurements': [{'value': '5.75', 'groupId': 'OG000', 'lowerLimit': '4.9', 'upperLimit': '6.8'}, {'value': '5.59', 'groupId': 'OG001', 'lowerLimit': '4.8', 'upperLimit': '6.5'}, {'value': '5.69', 'groupId': 'OG002', 'lowerLimit': '4.9', 'upperLimit': '6.6'}, {'value': '3.95', 'groupId': 'OG003', 'lowerLimit': '3.4', 'upperLimit': '4.6'}]}]}, {'title': 'B/Yamagata (Day 181/Day 1)', 'categories': [{'measurements': [{'value': '3.29', 'groupId': 'OG000', 'lowerLimit': '2.5', 'upperLimit': '4.3'}, {'value': '2.70', 'groupId': 'OG001', 'lowerLimit': '2.1', 'upperLimit': '3.4'}, {'value': '2.32', 'groupId': 'OG002', 'lowerLimit': '1.81', 'upperLimit': '3.0'}, {'value': '1.77', 'groupId': 'OG003', 'lowerLimit': '1.4', 'upperLimit': '2.3'}]}]}, {'title': 'B/Victoria (Day 22/Day 1)', 'categories': [{'measurements': [{'value': '6.81', 'groupId': 'OG000', 'lowerLimit': '5.9', 'upperLimit': '7.9'}, {'value': '7.15', 'groupId': 'OG001', 'lowerLimit': '6.2', 'upperLimit': '8.2'}, {'value': '7.14', 'groupId': 'OG002', 'lowerLimit': '6.2', 'upperLimit': '8.2'}, {'value': '5.18', 'groupId': 'OG003', 'lowerLimit': '4.5', 'upperLimit': '6.0'}]}]}, {'title': 'B/Victoria (Day 181/Day 1)', 'categories': [{'measurements': [{'value': '3.05', 'groupId': 'OG000', 'lowerLimit': '2.4', 'upperLimit': '3.9'}, {'value': '3.40', 'groupId': 'OG001', 'lowerLimit': '2.7', 'upperLimit': '4.3'}, {'value': '3.09', 'groupId': 'OG002', 'lowerLimit': '2.4', 'upperLimit': '3.9'}, {'value': '2.21', 'groupId': 'OG003', 'lowerLimit': '1.7', 'upperLimit': '2.8'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 22/Day 1 and Day 181/Day 1', 'description': 'The GMR is the geometric mean of the fold increase in anti-NA titer from Day 1 to Day 22 or Day 181. GMR and 95% CI were analyzed against homologous strains using ANCOVA with study specific covariates.\n\nStrains tested: N1 (PR8 H6N1 California/07/2009), N2 (PR8 H6N2 Switzerl/9715293/2013); B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013.', 'unitOfMeasure': 'ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Immunogenicity PPS consisting of all subjects who received a study vaccination and provided immunogenicity data, and who correctly received the study vaccine, had no major protocol deviations, and did not develop RT-PCR-confirmed influenza infection between baseline and Visit 2.'}, {'type': 'SECONDARY', 'title': 'Safety Endpoint: Percentage of Subjects With Solicited AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '403', 'groupId': 'OG000'}, {'value': '403', 'groupId': 'OG001'}, {'value': '402', 'groupId': 'OG002'}, {'value': '393', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'aQIV/aQIV', 'description': 'Subjects previously vaccinated with aQIV followed one year later by aQIV\n\nAdjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)'}, {'id': 'OG001', 'title': 'aQIV/QIV', 'description': 'Subjects previously vaccinated with aQIV followed one year later by QIV\n\nNon-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)'}, {'id': 'OG002', 'title': 'QIV/aQIV', 'description': 'Subjects previously vaccinated with QIV followed one year later by aQIV\n\nAdjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)'}, {'id': 'OG003', 'title': 'QIV/QIV', 'description': 'Subjects previously vaccinated with QIV followed one year later by QIV\n\nNon-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)'}], 'classes': [{'title': 'Any Solicited AE', 'categories': [{'measurements': [{'value': '64.76', 'groupId': 'OG000'}, {'value': '50.12', 'groupId': 'OG001'}, {'value': '53.48', 'groupId': 'OG002'}, {'value': '40.71', 'groupId': 'OG003'}]}]}, {'title': 'Solicited Local AE', 'categories': [{'measurements': [{'value': '44.67', 'groupId': 'OG000'}, {'value': '37.97', 'groupId': 'OG001'}, {'value': '36.82', 'groupId': 'OG002'}, {'value': '29.52', 'groupId': 'OG003'}]}]}, {'title': 'Solicited Systemic AE', 'categories': [{'measurements': [{'value': '39.21', 'groupId': 'OG000'}, {'value': '24.81', 'groupId': 'OG001'}, {'value': '30.85', 'groupId': 'OG002'}, {'value': '18.83', 'groupId': 'OG003'}]}]}, {'title': 'Other (analgesic/antipyretic use)', 'categories': [{'measurements': [{'value': '27.54', 'groupId': 'OG000'}, {'value': '10.17', 'groupId': 'OG001'}, {'value': '16.92', 'groupId': 'OG002'}, {'value': '10.43', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 to Day 7 after vaccination', 'description': 'Safety of revaccination was assessed in terms of percentage of subjects reporting solicited AEs up to 7 days after vaccination.', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The solicited safety set consisting of all subjects who received a study vaccination with evaluable solicited AE data recorded on a diary card.'}, {'type': 'SECONDARY', 'title': 'Safety Endpoint: Percentage of Subjects With Unsolicited AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '403', 'groupId': 'OG000'}, {'value': '403', 'groupId': 'OG001'}, {'value': '402', 'groupId': 'OG002'}, {'value': '393', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'aQIV/aQIV', 'description': 'Subjects previously vaccinated with aQIV followed one year later by aQIV\n\nAdjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)'}, {'id': 'OG001', 'title': 'aQIV/QIV', 'description': 'Subjects previously vaccinated with aQIV followed one year later by QIV\n\nNon-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)'}, {'id': 'OG002', 'title': 'QIV/aQIV', 'description': 'Subjects previously vaccinated with QIV followed one year later by aQIV\n\nAdjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)'}, {'id': 'OG003', 'title': 'QIV/QIV', 'description': 'Subjects previously vaccinated with QIV followed one year later by QIV\n\nNon-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)'}], 'classes': [{'title': 'Any Unsolicited AE', 'categories': [{'measurements': [{'value': '54.09', 'groupId': 'OG000'}, {'value': '55.33', 'groupId': 'OG001'}, {'value': '55.97', 'groupId': 'OG002'}, {'value': '52.16', 'groupId': 'OG003'}]}]}, {'title': 'Related Unsolicited AE', 'categories': [{'measurements': [{'value': '6.20', 'groupId': 'OG000'}, {'value': '3.97', 'groupId': 'OG001'}, {'value': '5.72', 'groupId': 'OG002'}, {'value': '3.82', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 to Day 366', 'description': 'Safety of revaccination was assessed in terms of percentage of subjects reporting unsolicited AEs during the overall study period (Day 1 to Day 366).', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred).'}, {'type': 'SECONDARY', 'title': 'Safety Endpoint: Percentage of Subjects With Serious Adverse Events (SAE), AEs Leading to Withdrawal, New Onset of Chronic Disease (NOCD), AE of Special Interest (AESI), and Medically Attended AE.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '403', 'groupId': 'OG000'}, {'value': '403', 'groupId': 'OG001'}, {'value': '402', 'groupId': 'OG002'}, {'value': '393', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'aQIV/aQIV', 'description': 'Subjects previously vaccinated with aQIV followed one year later by aQIV\n\nAdjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)'}, {'id': 'OG001', 'title': 'aQIV/QIV', 'description': 'Subjects previously vaccinated with aQIV followed one year later by QIV\n\nNon-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)'}, {'id': 'OG002', 'title': 'QIV/aQIV', 'description': 'Subjects previously vaccinated with QIV followed one year later by aQIV\n\nAdjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)'}, {'id': 'OG003', 'title': 'QIV/QIV', 'description': 'Subjects previously vaccinated with QIV followed one year later by QIV\n\nNon-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)'}], 'classes': [{'title': 'SAE', 'categories': [{'measurements': [{'value': '2.48', 'groupId': 'OG000'}, {'value': '2.73', 'groupId': 'OG001'}, {'value': '1.74', 'groupId': 'OG002'}, {'value': '2.04', 'groupId': 'OG003'}]}]}, {'title': 'AE leading to withdrawal', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'NOCD', 'categories': [{'measurements': [{'value': '0.50', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'AESI', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0.25', 'groupId': 'OG003'}]}]}, {'title': 'Medically attended AE', 'categories': [{'measurements': [{'value': '51.61', 'groupId': 'OG000'}, {'value': '54.34', 'groupId': 'OG001'}, {'value': '53.98', 'groupId': 'OG002'}, {'value': '48.60', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 to Day 366', 'description': 'Safety of revaccination was assessed in terms of percentage of subjects reporting SAEs, AEs leading to withdrawal, NOCD, AESI and medically attended AE. Each subject was followed for a period of 12 months after receipt of the study vaccine.\n\nNOCDs include AEs that represents a new diagnosis of a chronic medical condition that was not present or suspected in a subject prior to study enrollment. AESIs include potentially immune-mediated disorders which were reported by the investigators.', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited adverse event (AE) data (including those where it was reported/confirmed that no events had occurred).'}, {'type': 'SECONDARY', 'title': 'Safety Endpoint: Percentage of Subjects With Diagnosis of Failure to Thrive or Short Stature', 'denoms': [{'units': 'Participants', 'counts': [{'value': '403', 'groupId': 'OG000'}, {'value': '403', 'groupId': 'OG001'}, {'value': '402', 'groupId': 'OG002'}, {'value': '393', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'aQIV/aQIV', 'description': 'Subjects previously vaccinated with aQIV followed one year later by aQIV\n\nAdjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)'}, {'id': 'OG001', 'title': 'aQIV/QIV', 'description': 'Subjects previously vaccinated with aQIV followed one year later by QIV\n\nNon-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)'}, {'id': 'OG002', 'title': 'QIV/aQIV', 'description': 'Subjects previously vaccinated with QIV followed one year later by aQIV\n\nAdjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)'}, {'id': 'OG003', 'title': 'QIV/QIV', 'description': 'Subjects previously vaccinated with QIV followed one year later by QIV\n\nNon-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.25', 'groupId': 'OG000'}, {'value': '0.74', 'groupId': 'OG001'}, {'value': '0.25', 'groupId': 'OG002'}, {'value': '0.76', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 to Day 366', 'description': 'Safety of revaccination was assessed in terms of percentage of subjects reporting diagnosis of failure to thrive or short stature up to 12 months after last vaccination.', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred).'}, {'type': 'SECONDARY', 'title': 'Safety Endpoint: Percentage of Subjects With Otitis Media, or Pneumonia, or Influenza-like Illness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '403', 'groupId': 'OG000'}, {'value': '403', 'groupId': 'OG001'}, {'value': '402', 'groupId': 'OG002'}, {'value': '393', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'aQIV/aQIV', 'description': 'Subjects previously vaccinated with aQIV followed one year later by aQIV\n\nAdjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)'}, {'id': 'OG001', 'title': 'aQIV/QIV', 'description': 'Subjects previously vaccinated with aQIV followed one year later by QIV\n\nNon-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)'}, {'id': 'OG002', 'title': 'QIV/aQIV', 'description': 'Subjects previously vaccinated with QIV followed one year later by aQIV\n\nAdjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)'}, {'id': 'OG003', 'title': 'QIV/QIV', 'description': 'Subjects previously vaccinated with QIV followed one year later by QIV\n\nNon-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)'}], 'classes': [{'title': 'otitis media, any event', 'categories': [{'measurements': [{'value': '3.23', 'groupId': 'OG000'}, {'value': '3.47', 'groupId': 'OG001'}, {'value': '3.73', 'groupId': 'OG002'}, {'value': '2.80', 'groupId': 'OG003'}]}]}, {'title': 'pneumonia, any event', 'categories': [{'measurements': [{'value': '1.49', 'groupId': 'OG000'}, {'value': '1.49', 'groupId': 'OG001'}, {'value': '0.75', 'groupId': 'OG002'}, {'value': '1.78', 'groupId': 'OG003'}]}]}, {'title': 'influenza-like illness', 'categories': [{'measurements': [{'value': '7.94', 'groupId': 'OG000'}, {'value': '10.17', 'groupId': 'OG001'}, {'value': '9.20', 'groupId': 'OG002'}, {'value': '7.89', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 to Day 366', 'description': 'Safety of revaccination was assessed in terms of percentage of subjects reporting otitis media, or pneumonia, or influenza-like illness up to 12 months after last vaccination.', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred).'}, {'type': 'SECONDARY', 'title': 'Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'aQIV/aQIV', 'description': 'Subjects previously vaccinated with aQIV followed one year later by aQIV\n\nAdjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)'}, {'id': 'OG001', 'title': 'aQIV/QIV', 'description': 'Subjects previously vaccinated with aQIV followed one year later by QIV\n\nNon-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)'}, {'id': 'OG002', 'title': 'QIV/aQIV', 'description': 'Subjects previously vaccinated with QIV followed one year later by aQIV\n\nAdjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)'}, {'id': 'OG003', 'title': 'QIV/QIV', 'description': 'Subjects previously vaccinated with QIV followed one year later by QIV\n\nNon-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)'}], 'classes': [{'title': 'A/ H1N1, ≥1:20 (Day 22)', 'categories': [{'measurements': [{'value': '100.00', 'groupId': 'OG000', 'lowerLimit': '93.94', 'upperLimit': '100.00'}, {'value': '100.00', 'groupId': 'OG001', 'lowerLimit': '93.94', 'upperLimit': '100.00'}, {'value': '100.00', 'groupId': 'OG002', 'lowerLimit': '94.04', 'upperLimit': '100.00'}, {'value': '100.00', 'groupId': 'OG003', 'lowerLimit': '93.94', 'upperLimit': '100.00'}]}]}, {'title': 'A/ H1N1, ≥1:40 (Day 22)', 'categories': [{'measurements': [{'value': '98.31', 'groupId': 'OG000', 'lowerLimit': '90.91', 'upperLimit': '99.96'}, {'value': '100.00', 'groupId': 'OG001', 'lowerLimit': '93.94', 'upperLimit': '100.00'}, {'value': '100.00', 'groupId': 'OG002', 'lowerLimit': '94.04', 'upperLimit': '100.00'}, {'value': '100.00', 'groupId': 'OG003', 'lowerLimit': '93.94', 'upperLimit': '100.00'}]}]}, {'title': 'A/H1N1, ≥1:80 (Day 22)', 'categories': [{'measurements': [{'value': '98.31', 'groupId': 'OG000', 'lowerLimit': '90.91', 'upperLimit': '99.96'}, {'value': '100.00', 'groupId': 'OG001', 'lowerLimit': '93.94', 'upperLimit': '100.00'}, {'value': '100.00', 'groupId': 'OG002', 'lowerLimit': '94.04', 'upperLimit': '100.00'}, {'value': '98.31', 'groupId': 'OG003', 'lowerLimit': '90.91', 'upperLimit': '99.96'}]}]}, {'title': 'A/H1N1, ≥1:160 (Day 22)', 'categories': [{'measurements': [{'value': '98.31', 'groupId': 'OG000', 'lowerLimit': '90.91', 'upperLimit': '99.96'}, {'value': '100.00', 'groupId': 'OG001', 'lowerLimit': '93.94', 'upperLimit': '100.00'}, {'value': '100.00', 'groupId': 'OG002', 'lowerLimit': '94.04', 'upperLimit': '100.00'}, {'value': '94.92', 'groupId': 'OG003', 'lowerLimit': '85.85', 'upperLimit': '98.94'}]}]}, {'title': 'A/H1N1, ≥1:320 (Day 22)', 'categories': [{'measurements': [{'value': '96.61', 'groupId': 'OG000', 'lowerLimit': '88.29', 'upperLimit': '99.59'}, {'value': '100.00', 'groupId': 'OG001', 'lowerLimit': '93.94', 'upperLimit': '100.00'}, {'value': '100.00', 'groupId': 'OG002', 'lowerLimit': '94.04', 'upperLimit': '100.00'}, {'value': '94.92', 'groupId': 'OG003', 'lowerLimit': '85.85', 'upperLimit': '98.94'}]}]}, {'title': 'A/H1N1, ≥1:640 (Day 22)', 'categories': [{'measurements': [{'value': '96.61', 'groupId': 'OG000', 'lowerLimit': '88.29', 'upperLimit': '99.59'}, {'value': '98.31', 'groupId': 'OG001', 'lowerLimit': '90.91', 'upperLimit': '99.96'}, {'value': '91.67', 'groupId': 'OG002', 'lowerLimit': '81.61', 'upperLimit': '97.24'}, {'value': '81.36', 'groupId': 'OG003', 'lowerLimit': '69.09', 'upperLimit': '90.31'}]}]}, {'title': 'A/H1N1, ≥1:20 (Day 181)', 'categories': [{'measurements': [{'value': '100.00', 'groupId': 'OG000', 'lowerLimit': '94.04', 'upperLimit': '100.00'}, {'value': '100.00', 'groupId': 'OG001', 'lowerLimit': '93.84', 'upperLimit': '100.00'}, {'value': '100.00', 'groupId': 'OG002', 'lowerLimit': '93.84', 'upperLimit': '100.00'}, {'value': '98.28', 'groupId': 'OG003', 'lowerLimit': '90.76', 'upperLimit': '99.96'}]}]}, {'title': 'A/H1N1, ≥1:40 (Day 181)', 'categories': [{'measurements': [{'value': '100.00', 'groupId': 'OG000', 'lowerLimit': '94.04', 'upperLimit': '100.00'}, {'value': '100.00', 'groupId': 'OG001', 'lowerLimit': '93.84', 'upperLimit': '100.00'}, {'value': '100.00', 'groupId': 'OG002', 'lowerLimit': '93.84', 'upperLimit': '100.00'}, {'value': '96.55', 'groupId': 'OG003', 'lowerLimit': '88.09', 'upperLimit': '99.58'}]}]}, {'title': 'A/H1N1, ≥1:80 (Day 181)', 'categories': [{'measurements': [{'value': '100.00', 'groupId': 'OG000', 'lowerLimit': '94.04', 'upperLimit': '100.00'}, {'value': '100.00', 'groupId': 'OG001', 'lowerLimit': '93.84', 'upperLimit': '100.00'}, {'value': '100.00', 'groupId': 'OG002', 'lowerLimit': '93.84', 'upperLimit': '100.00'}, {'value': '93.10', 'groupId': 'OG003', 'lowerLimit': '83.27', 'upperLimit': '98.09'}]}]}, {'title': 'A/H1N1, ≥1:160 (Day 181)', 'categories': [{'measurements': [{'value': '96.67', 'groupId': 'OG000', 'lowerLimit': '88.47', 'upperLimit': '99.59'}, {'value': '98.28', 'groupId': 'OG001', 'lowerLimit': '90.76', 'upperLimit': '99.96'}, {'value': '94.83', 'groupId': 'OG002', 'lowerLimit': '85.62', 'upperLimit': '98.92'}, {'value': '81.03', 'groupId': 'OG003', 'lowerLimit': '68.59', 'upperLimit': '90.13'}]}]}, {'title': 'A/H1N1, ≥1:320 (Day 181)', 'categories': [{'measurements': [{'value': '91.67', 'groupId': 'OG000', 'lowerLimit': '81.61', 'upperLimit': '97.24'}, {'value': '91.38', 'groupId': 'OG001', 'lowerLimit': '81.02', 'upperLimit': '97.14'}, {'value': '84.48', 'groupId': 'OG002', 'lowerLimit': '72.58', 'upperLimit': '92.65'}, {'value': '63.79', 'groupId': 'OG003', 'lowerLimit': '50.12', 'upperLimit': '76.01'}]}]}, {'title': 'A/H1N1, ≥1:640 (Day 181)', 'categories': [{'measurements': [{'value': '80.00', 'groupId': 'OG000', 'lowerLimit': '67.67', 'upperLimit': '89.22'}, {'value': '63.79', 'groupId': 'OG001', 'lowerLimit': '50.12', 'upperLimit': '76.01'}, {'value': '55.17', 'groupId': 'OG002', 'lowerLimit': '41.54', 'upperLimit': '68.26'}, {'value': '48.28', 'groupId': 'OG003', 'lowerLimit': '34.95', 'upperLimit': '61.78'}]}]}, {'title': 'A/H3N2, ≥1:20 (Day 22)', 'categories': [{'measurements': [{'value': '100.00', 'groupId': 'OG000', 'lowerLimit': '94.04', 'upperLimit': '100.00'}, {'value': '100.00', 'groupId': 'OG001', 'lowerLimit': '93.94', 'upperLimit': '100.00'}, {'value': '100.00', 'groupId': 'OG002', 'lowerLimit': '94.04', 'upperLimit': '100.00'}, {'value': '98.28', 'groupId': 'OG003', 'lowerLimit': '90.76', 'upperLimit': '99.96'}]}]}, {'title': 'A/H3N2, ≥1:40 (Day 22)', 'categories': [{'measurements': [{'value': '100.00', 'groupId': 'OG000', 'lowerLimit': '94.04', 'upperLimit': '100.00'}, {'value': '100.00', 'groupId': 'OG001', 'lowerLimit': '93.94', 'upperLimit': '100.00'}, {'value': '100.00', 'groupId': 'OG002', 'lowerLimit': '94.04', 'upperLimit': '100.00'}, {'value': '98.28', 'groupId': 'OG003', 'lowerLimit': '90.76', 'upperLimit': '99.96'}]}]}, {'title': 'A/H3N2, ≥1:80 (Day 22)', 'categories': [{'measurements': [{'value': '100.00', 'groupId': 'OG000', 'lowerLimit': '94.04', 'upperLimit': '100.00'}, {'value': '100.00', 'groupId': 'OG001', 'lowerLimit': '93.94', 'upperLimit': '100.00'}, {'value': '100.00', 'groupId': 'OG002', 'lowerLimit': '94.04', 'upperLimit': '100.00'}, {'value': '98.28', 'groupId': 'OG003', 'lowerLimit': '90.76', 'upperLimit': '99.96'}]}]}, {'title': 'A/H3N2, ≥1:160 (Day 22)', 'categories': [{'measurements': [{'value': '100.00', 'groupId': 'OG000', 'lowerLimit': '94.04', 'upperLimit': '100.00'}, {'value': '100.00', 'groupId': 'OG001', 'lowerLimit': '93.94', 'upperLimit': '100.00'}, {'value': '100.00', 'groupId': 'OG002', 'lowerLimit': '94.04', 'upperLimit': '100.00'}, {'value': '98.28', 'groupId': 'OG003', 'lowerLimit': '90.76', 'upperLimit': '99.96'}]}]}, {'title': 'A/H3N2, ≥1:320 (Day 22)', 'categories': [{'measurements': [{'value': '100.00', 'groupId': 'OG000', 'lowerLimit': '94.04', 'upperLimit': '100.00'}, {'value': '100.00', 'groupId': 'OG001', 'lowerLimit': '93.94', 'upperLimit': '100.00'}, {'value': '100.00', 'groupId': 'OG002', 'lowerLimit': '94.04', 'upperLimit': '100.00'}, {'value': '98.28', 'groupId': 'OG003', 'lowerLimit': '90.76', 'upperLimit': '99.96'}]}]}, {'title': 'A/H3N2, ≥1:640 (Day 22)', 'categories': [{'measurements': [{'value': '100.00', 'groupId': 'OG000', 'lowerLimit': '94.04', 'upperLimit': '100.00'}, {'value': '100.00', 'groupId': 'OG001', 'lowerLimit': '93.94', 'upperLimit': '100.00'}, {'value': '100.00', 'groupId': 'OG002', 'lowerLimit': '94.04', 'upperLimit': '100.00'}, {'value': '98.28', 'groupId': 'OG003', 'lowerLimit': '90.76', 'upperLimit': '99.96'}]}]}, {'title': 'A/H3N2, ≥1:20 (Day 181)', 'categories': [{'measurements': [{'value': '100.00', 'groupId': 'OG000', 'lowerLimit': '94.04', 'upperLimit': '100.00'}, {'value': '98.28', 'groupId': 'OG001', 'lowerLimit': '90.76', 'upperLimit': '99.96'}, {'value': '100.00', 'groupId': 'OG002', 'lowerLimit': '93.84', 'upperLimit': '100.00'}, {'value': '98.21', 'groupId': 'OG003', 'lowerLimit': '90.45', 'upperLimit': '99.95'}]}]}, {'title': 'A/H3N2, ≥1:40 (Day 181)', 'categories': [{'measurements': [{'value': '100.00', 'groupId': 'OG000', 'lowerLimit': '94.04', 'upperLimit': '100.00'}, {'value': '98.28', 'groupId': 'OG001', 'lowerLimit': '90.76', 'upperLimit': '99.96'}, {'value': '100.00', 'groupId': 'OG002', 'lowerLimit': '93.84', 'upperLimit': '100.00'}, {'value': '96.43', 'groupId': 'OG003', 'lowerLimit': '87.69', 'upperLimit': '99.56'}]}]}, {'title': 'A/H3N2, ≥1:80 (Day 181)', 'categories': [{'measurements': [{'value': '100.00', 'groupId': 'OG000', 'lowerLimit': '94.04', 'upperLimit': '100.00'}, {'value': '98.28', 'groupId': 'OG001', 'lowerLimit': '90.76', 'upperLimit': '99.96'}, {'value': '100.00', 'groupId': 'OG002', 'lowerLimit': '93.84', 'upperLimit': '100.00'}, {'value': '91.07', 'groupId': 'OG003', 'lowerLimit': '80.38', 'upperLimit': '97.04'}]}]}, {'title': 'A/H3N2, ≥1:160 (Day 181)', 'categories': [{'measurements': [{'value': '96.67', 'groupId': 'OG000', 'lowerLimit': '88.47', 'upperLimit': '99.59'}, {'value': '98.28', 'groupId': 'OG001', 'lowerLimit': '90.76', 'upperLimit': '99.96'}, {'value': '96.55', 'groupId': 'OG002', 'lowerLimit': '88.09', 'upperLimit': '99.58'}, {'value': '89.29', 'groupId': 'OG003', 'lowerLimit': '78.12', 'upperLimit': '95.97'}]}]}, {'title': 'A/H3N2, ≥1:320 (Day 181)', 'categories': [{'measurements': [{'value': '91.67', 'groupId': 'OG000', 'lowerLimit': '81.61', 'upperLimit': '97.24'}, {'value': '94.83', 'groupId': 'OG001', 'lowerLimit': '85.62', 'upperLimit': '98.92'}, {'value': '93.10', 'groupId': 'OG002', 'lowerLimit': '83.27', 'upperLimit': '98.09'}, {'value': '85.71', 'groupId': 'OG003', 'lowerLimit': '73.78', 'upperLimit': '93.62'}]}]}, {'title': 'A/H3N2, ≥1:640 (Day 181)', 'categories': [{'measurements': [{'value': '86.67', 'groupId': 'OG000', 'lowerLimit': '75.41', 'upperLimit': '94.06'}, {'value': '86.21', 'groupId': 'OG001', 'lowerLimit': '74.62', 'upperLimit': '93.85'}, {'value': '84.48', 'groupId': 'OG002', 'lowerLimit': '72.58', 'upperLimit': '92.65'}, {'value': '83.93', 'groupId': 'OG003', 'lowerLimit': '71.67', 'upperLimit': '92.38'}]}]}, {'title': 'B/Yamagata, ≥1:20 (Day 22)', 'categories': [{'measurements': [{'value': '100.00', 'groupId': 'OG000', 'lowerLimit': '94.04', 'upperLimit': '100.00'}, {'value': '100.00', 'groupId': 'OG001', 'lowerLimit': '93.94', 'upperLimit': '100.00'}, {'value': '96.67', 'groupId': 'OG002', 'lowerLimit': '88.47', 'upperLimit': '99.59'}, {'value': '96.55', 'groupId': 'OG003', 'lowerLimit': '88.09', 'upperLimit': '99.58'}]}]}, {'title': 'B/Yamagata, ≥1:40 (Day 22)', 'categories': [{'measurements': [{'value': '98.33', 'groupId': 'OG000', 'lowerLimit': '91.06', 'upperLimit': '99.96'}, {'value': '98.31', 'groupId': 'OG001', 'lowerLimit': '90.91', 'upperLimit': '99.96'}, {'value': '96.67', 'groupId': 'OG002', 'lowerLimit': '88.47', 'upperLimit': '99.59'}, {'value': '93.10', 'groupId': 'OG003', 'lowerLimit': '83.27', 'upperLimit': '98.09'}]}]}, {'title': 'B/Yamagata, ≥1:80 (Day 22)', 'categories': [{'measurements': [{'value': '95.00', 'groupId': 'OG000', 'lowerLimit': '86.08', 'upperLimit': '98.96'}, {'value': '96.61', 'groupId': 'OG001', 'lowerLimit': '88.29', 'upperLimit': '99.59'}, {'value': '95.00', 'groupId': 'OG002', 'lowerLimit': '86.08', 'upperLimit': '98.96'}, {'value': '89.66', 'groupId': 'OG003', 'lowerLimit': '78.83', 'upperLimit': '96.11'}]}]}, {'title': 'B/Yamagata, ≥1:160 (Day 22)', 'categories': [{'measurements': [{'value': '91.67', 'groupId': 'OG000', 'lowerLimit': '81.61', 'upperLimit': '97.24'}, {'value': '86.44', 'groupId': 'OG001', 'lowerLimit': '75.02', 'upperLimit': '93.96'}, {'value': '78.33', 'groupId': 'OG002', 'lowerLimit': '65.80', 'upperLimit': '87.93'}, {'value': '70.69', 'groupId': 'OG003', 'lowerLimit': '57.27', 'upperLimit': '81.91'}]}]}, {'title': 'B/Yamagata, ≥1:320 (Day 22)', 'categories': [{'measurements': [{'value': '75.00', 'groupId': 'OG000', 'lowerLimit': '62.14', 'upperLimit': '85.28'}, {'value': '72.88', 'groupId': 'OG001', 'lowerLimit': '59.73', 'upperLimit': '83.64'}, {'value': '65.00', 'groupId': 'OG002', 'lowerLimit': '51.60', 'upperLimit': '76.87'}, {'value': '50.00', 'groupId': 'OG003', 'lowerLimit': '36.58', 'upperLimit': '63.42'}]}]}, {'title': 'B/Yamagata, ≥1:640 (Day 22)', 'categories': [{'measurements': [{'value': '58.33', 'groupId': 'OG000', 'lowerLimit': '44.88', 'upperLimit': '70.93'}, {'value': '47.46', 'groupId': 'OG001', 'lowerLimit': '34.30', 'upperLimit': '60.88'}, {'value': '31.67', 'groupId': 'OG002', 'lowerLimit': '20.26', 'upperLimit': '44.96'}, {'value': '24.14', 'groupId': 'OG003', 'lowerLimit': '13.87', 'upperLimit': '37.17'}]}]}, {'title': 'B/Yamagata, ≥1:20 (Day 181)', 'categories': [{'measurements': [{'value': '98.33', 'groupId': 'OG000', 'lowerLimit': '91.06', 'upperLimit': '99.96'}, {'value': '96.55', 'groupId': 'OG001', 'lowerLimit': '88.09', 'upperLimit': '99.58'}, {'value': '93.10', 'groupId': 'OG002', 'lowerLimit': '83.27', 'upperLimit': '98.09'}, {'value': '80.36', 'groupId': 'OG003', 'lowerLimit': '67.57', 'upperLimit': '89.77'}]}]}, {'title': 'B/Yamagata, ≥1:40 (Day 181)', 'categories': [{'measurements': [{'value': '93.33', 'groupId': 'OG000', 'lowerLimit': '83.80', 'upperLimit': '98.15'}, {'value': '93.10', 'groupId': 'OG001', 'lowerLimit': '83.27', 'upperLimit': '98.09'}, {'value': '79.31', 'groupId': 'OG002', 'lowerLimit': '66.65', 'upperLimit': '88.83'}, {'value': '71.43', 'groupId': 'OG003', 'lowerLimit': '57.79', 'upperLimit': '82.70'}]}]}, {'title': 'B/Yamagata, ≥1:80 (Day 181)', 'categories': [{'measurements': [{'value': '71.67', 'groupId': 'OG000', 'lowerLimit': '58.56', 'upperLimit': '82.55'}, {'value': '72.41', 'groupId': 'OG001', 'lowerLimit': '59.10', 'upperLimit': '83.34'}, {'value': '56.90', 'groupId': 'OG002', 'lowerLimit': '42.23', 'upperLimit': '69.84'}, {'value': '46.43', 'groupId': 'OG003', 'lowerLimit': '32.99', 'upperLimit': '60.26'}]}]}, {'title': 'B/Yamagata, ≥1:160 (Day 181)', 'categories': [{'measurements': [{'value': '45.00', 'groupId': 'OG000', 'lowerLimit': '32.12', 'upperLimit': '58.39'}, {'value': '48.28', 'groupId': 'OG001', 'lowerLimit': '34.95', 'upperLimit': '61.78'}, {'value': '32.76', 'groupId': 'OG002', 'lowerLimit': '21.01', 'upperLimit': '46.34'}, {'value': '17.86', 'groupId': 'OG003', 'lowerLimit': '8.91', 'upperLimit': '30.40'}]}]}, {'title': 'B/Yamagata, ≥1:320 (Day 181)', 'categories': [{'measurements': [{'value': '25.00', 'groupId': 'OG000', 'lowerLimit': '14.72', 'upperLimit': '37.86'}, {'value': '24.14', 'groupId': 'OG001', 'lowerLimit': '13.87', 'upperLimit': '37.17'}, {'value': '15.52', 'groupId': 'OG002', 'lowerLimit': '7.35', 'upperLimit': '27.42'}, {'value': '7.14', 'groupId': 'OG003', 'lowerLimit': '1.98', 'upperLimit': '17.29'}]}]}, {'title': 'B/Yamagata, ≥1:640 (Day 181)', 'categories': [{'measurements': [{'value': '3.33', 'groupId': 'OG000', 'lowerLimit': '0.41', 'upperLimit': '11.53'}, {'value': '8.62', 'groupId': 'OG001', 'lowerLimit': '2.86', 'upperLimit': '18.98'}, {'value': '5.17', 'groupId': 'OG002', 'lowerLimit': '1.08', 'upperLimit': '14.38'}, {'value': '3.57', 'groupId': 'OG003', 'lowerLimit': '0.44', 'upperLimit': '12.31'}]}]}, {'title': 'B/Victoria, ≥1:20 (Day 22)', 'categories': [{'measurements': [{'value': '98.31', 'groupId': 'OG000', 'lowerLimit': '90.91', 'upperLimit': '99.96'}, {'value': '100.00', 'groupId': 'OG001', 'lowerLimit': '93.94', 'upperLimit': '100.00'}, {'value': '100.00', 'groupId': 'OG002', 'lowerLimit': '94.04', 'upperLimit': '100.00'}, {'value': '98.31', 'groupId': 'OG003', 'lowerLimit': '90.91', 'upperLimit': '99.96'}]}]}, {'title': 'B/Victoria, ≥1:40 (Day 22)', 'categories': [{'measurements': [{'value': '94.92', 'groupId': 'OG000', 'lowerLimit': '85.85', 'upperLimit': '98.94'}, {'value': '100.00', 'groupId': 'OG001', 'lowerLimit': '93.94', 'upperLimit': '100.00'}, {'value': '96.67', 'groupId': 'OG002', 'lowerLimit': '88.47', 'upperLimit': '99.59'}, {'value': '93.22', 'groupId': 'OG003', 'lowerLimit': '83.54', 'upperLimit': '98.12'}]}]}, {'title': 'B/Victoria, ≥1:80 (Day 22)', 'categories': [{'measurements': [{'value': '91.53', 'groupId': 'OG000', 'lowerLimit': '81.32', 'upperLimit': '97.19'}, {'value': '96.61', 'groupId': 'OG001', 'lowerLimit': '88.29', 'upperLimit': '99.59'}, {'value': '90.00', 'groupId': 'OG002', 'lowerLimit': '79.49', 'upperLimit': '96.24'}, {'value': '84.75', 'groupId': 'OG003', 'lowerLimit': '73.01', 'upperLimit': '92.78'}]}]}, {'title': 'B/Victoria, ≥1:160 (Day 22)', 'categories': [{'measurements': [{'value': '86.44', 'groupId': 'OG000', 'lowerLimit': '75.02', 'upperLimit': '93.96'}, {'value': '86.44', 'groupId': 'OG001', 'lowerLimit': '75.02', 'upperLimit': '93.96'}, {'value': '81.67', 'groupId': 'OG002', 'lowerLimit': '69.56', 'upperLimit': '90.48'}, {'value': '69.49', 'groupId': 'OG003', 'lowerLimit': '56.13', 'upperLimit': '80.81'}]}]}, {'title': 'B/Victoria, ≥1:320 (Day 22)', 'categories': [{'measurements': [{'value': '74.58', 'groupId': 'OG000', 'lowerLimit': '61.56', 'upperLimit': '85.02'}, {'value': '67.80', 'groupId': 'OG001', 'lowerLimit': '54.36', 'upperLimit': '79.38'}, {'value': '58.33', 'groupId': 'OG002', 'lowerLimit': '44.88', 'upperLimit': '70.93'}, {'value': '35.59', 'groupId': 'OG003', 'lowerLimit': '23.55', 'upperLimit': '49.13'}]}]}, {'title': 'B/Victoria, ≥1:640 (Day 22)', 'categories': [{'measurements': [{'value': '49.15', 'groupId': 'OG000', 'lowerLimit': '35.89', 'upperLimit': '62.50'}, {'value': '42.37', 'groupId': 'OG001', 'lowerLimit': '29.61', 'upperLimit': '55.93'}, {'value': '33.33', 'groupId': 'OG002', 'lowerLimit': '21.69', 'upperLimit': '46.69'}, {'value': '22.03', 'groupId': 'OG003', 'lowerLimit': '12.29', 'upperLimit': '34.73'}]}]}, {'title': 'B/Victoria, ≥1:20 (Day 181)', 'categories': [{'measurements': [{'value': '100.00', 'groupId': 'OG000', 'lowerLimit': '94.04', 'upperLimit': '100.00'}, {'value': '100.00', 'groupId': 'OG001', 'lowerLimit': '93.84', 'upperLimit': '100.00'}, {'value': '98.28', 'groupId': 'OG002', 'lowerLimit': '90.76', 'upperLimit': '99.96'}, {'value': '96.43', 'groupId': 'OG003', 'lowerLimit': '87.69', 'upperLimit': '99.56'}]}]}, {'title': 'B/Victoria, ≥1:40 (Day 181)', 'categories': [{'measurements': [{'value': '86.67', 'groupId': 'OG000', 'lowerLimit': '75.41', 'upperLimit': '94.06'}, {'value': '87.93', 'groupId': 'OG001', 'lowerLimit': '76.70', 'upperLimit': '95.01'}, {'value': '74.14', 'groupId': 'OG002', 'lowerLimit': '60.96', 'upperLimit': '84.74'}, {'value': '60.71', 'groupId': 'OG003', 'lowerLimit': '46.75', 'upperLimit': '73.50'}]}]}, {'title': 'B/Victoria, ≥1:80 (Day 181)', 'categories': [{'measurements': [{'value': '78.33', 'groupId': 'OG000', 'lowerLimit': '65.80', 'upperLimit': '87.93'}, {'value': '63.79', 'groupId': 'OG001', 'lowerLimit': '50.12', 'upperLimit': '76.01'}, {'value': '44.83', 'groupId': 'OG002', 'lowerLimit': '31.74', 'upperLimit': '58.46'}, {'value': '41.07', 'groupId': 'OG003', 'lowerLimit': '28.10', 'upperLimit': '55.02'}]}]}, {'title': 'B/Victoria, ≥1:160 (Day 181)', 'categories': [{'measurements': [{'value': '58.33', 'groupId': 'OG000', 'lowerLimit': '44.88', 'upperLimit': '70.93'}, {'value': '43.10', 'groupId': 'OG001', 'lowerLimit': '30.16', 'upperLimit': '56.77'}, {'value': '27.59', 'groupId': 'OG002', 'lowerLimit': '16.66', 'upperLimit': '40.90'}, {'value': '23.21', 'groupId': 'OG003', 'lowerLimit': '12.98', 'upperLimit': '36.42'}]}]}, {'title': 'B/Victoria, ≥1:320 (Day 181)', 'categories': [{'measurements': [{'value': '31.67', 'groupId': 'OG000', 'lowerLimit': '20.26', 'upperLimit': '44.96'}, {'value': '20.69', 'groupId': 'OG001', 'lowerLimit': '11.17', 'upperLimit': '33.35'}, {'value': '18.97', 'groupId': 'OG002', 'lowerLimit': '9.87', 'upperLimit': '31.41'}, {'value': '8.93', 'groupId': 'OG003', 'lowerLimit': '2.96', 'upperLimit': '19.62'}]}]}, {'title': 'B/Victoria, ≥1:640 (Day 181)', 'categories': [{'measurements': [{'value': '8.33', 'groupId': 'OG000', 'lowerLimit': '2.76', 'upperLimit': '18.39'}, {'value': '15.52', 'groupId': 'OG001', 'lowerLimit': '7.35', 'upperLimit': '27.42'}, {'value': '12.07', 'groupId': 'OG002', 'lowerLimit': '4.99', 'upperLimit': '23.30'}, {'value': '5.36', 'groupId': 'OG003', 'lowerLimit': '1.12', 'upperLimit': '14.87'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 22, Day 181', 'description': 'The percentage of subjects achieving MN titer ≥1:20, ≥1:40, ≥1:80 ≥1:160, ≥1:320 and ≥1:640 at Day 22 and Day 181 after vaccination is reported against homologous strains.\n\nStrains tested: A/H1N1 California/07/2009; A/H3N2 Switzerland/9715293/2013; B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013.', 'unitOfMeasure': 'percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Immunogenicity PPS consisting of all subjects who received a study vaccination and provided immunogenicity data (MN titer ≥1:20, ≥1:40, ≥1:80, \\>four-fold rise), and who correctly received the study vaccine, had no major protocol deviations, and did not develop RT-PCR-confirmed influenza infection between baseline and Visit 2.'}, {'type': 'SECONDARY', 'title': 'Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'aQIV/aQIV', 'description': 'Subjects previously vaccinated with aQIV followed one year later by aQIV\n\nAdjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)'}, {'id': 'OG001', 'title': 'aQIV/QIV', 'description': 'Subjects previously vaccinated with aQIV followed one year later by QIV\n\nNon-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)'}, {'id': 'OG002', 'title': 'QIV/aQIV', 'description': 'Subjects previously vaccinated with QIV followed one year later by aQIV\n\nAdjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)'}, {'id': 'OG003', 'title': 'QIV/QIV', 'description': 'Subjects previously vaccinated with QIV followed one year later by QIV\n\nNon-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)'}], 'classes': [{'title': 'N1, ≥1:20 (Day 22)', 'categories': [{'measurements': [{'value': '100.00', 'groupId': 'OG000', 'lowerLimit': '93.62', 'upperLimit': '100.00'}, {'value': '100.00', 'groupId': 'OG001', 'lowerLimit': '94.22', 'upperLimit': '100.00'}, {'value': '100.00', 'groupId': 'OG002', 'lowerLimit': '93.94', 'upperLimit': '100.00'}, {'value': '100.00', 'groupId': 'OG003', 'lowerLimit': '94.04', 'upperLimit': '100.00'}]}]}, {'title': 'N1, ≥1:40 (Day 22)', 'categories': [{'measurements': [{'value': '100.00', 'groupId': 'OG000', 'lowerLimit': '93.62', 'upperLimit': '100.00'}, {'value': '100.00', 'groupId': 'OG001', 'lowerLimit': '94.22', 'upperLimit': '100.00'}, {'value': '100.00', 'groupId': 'OG002', 'lowerLimit': '93.94', 'upperLimit': '100.00'}, {'value': '98.33', 'groupId': 'OG003', 'lowerLimit': '91.06', 'upperLimit': '99.96'}]}]}, {'title': 'N1, ≥1:80 (Day 22)', 'categories': [{'measurements': [{'value': '100.00', 'groupId': 'OG000', 'lowerLimit': '93.62', 'upperLimit': '100.00'}, {'value': '100.00', 'groupId': 'OG001', 'lowerLimit': '94.22', 'upperLimit': '100.00'}, {'value': '100.00', 'groupId': 'OG002', 'lowerLimit': '93.94', 'upperLimit': '100.00'}, {'value': '98.33', 'groupId': 'OG003', 'lowerLimit': '91.06', 'upperLimit': '99.96'}]}]}, {'title': 'N1, ≥1:160 (Day 22)', 'categories': [{'measurements': [{'value': '100.00', 'groupId': 'OG000', 'lowerLimit': '93.62', 'upperLimit': '100.00'}, {'value': '100.00', 'groupId': 'OG001', 'lowerLimit': '94.22', 'upperLimit': '100.00'}, {'value': '100.00', 'groupId': 'OG002', 'lowerLimit': '93.94', 'upperLimit': '100.00'}, {'value': '93.33', 'groupId': 'OG003', 'lowerLimit': '83.80', 'upperLimit': '98.15'}]}]}, {'title': 'N1, ≥1:320 (Day 22)', 'categories': [{'measurements': [{'value': '100.00', 'groupId': 'OG000', 'lowerLimit': '93.62', 'upperLimit': '100.00'}, {'value': '100.00', 'groupId': 'OG001', 'lowerLimit': '94.22', 'upperLimit': '100.00'}, {'value': '100.00', 'groupId': 'OG002', 'lowerLimit': '93.94', 'upperLimit': '100.00'}, {'value': '88.33', 'groupId': 'OG003', 'lowerLimit': '77.43', 'upperLimit': '95.18'}]}]}, {'title': 'N1,≥1:640 (Day 22)', 'categories': [{'measurements': [{'value': '100.00', 'groupId': 'OG000', 'lowerLimit': '93.62', 'upperLimit': '100.00'}, {'value': '100.00', 'groupId': 'OG001', 'lowerLimit': '94.22', 'upperLimit': '100.00'}, {'value': '98.31', 'groupId': 'OG002', 'lowerLimit': '90.91', 'upperLimit': '99.96'}, {'value': '85.00', 'groupId': 'OG003', 'lowerLimit': '73.43', 'upperLimit': '92.90'}]}]}, {'title': 'N1, ≥1:20 (Day 181)', 'categories': [{'measurements': [{'value': '100.00', 'groupId': 'OG000', 'lowerLimit': '93.51', 'upperLimit': '100.00'}, {'value': '100.00', 'groupId': 'OG001', 'lowerLimit': '94.13', 'upperLimit': '100.00'}, {'value': '100.00', 'groupId': 'OG002', 'lowerLimit': '93.84', 'upperLimit': '100.00'}, {'value': '93.33', 'groupId': 'OG003', 'lowerLimit': '83.80', 'upperLimit': '98.15'}]}]}, {'title': 'N1, ≥1:40 (Day 181)', 'categories': [{'measurements': [{'value': '100.00', 'groupId': 'OG000', 'lowerLimit': '93.51', 'upperLimit': '100.00'}, {'value': '100.00', 'groupId': 'OG001', 'lowerLimit': '94.13', 'upperLimit': '100.00'}, {'value': '100.00', 'groupId': 'OG002', 'lowerLimit': '93.84', 'upperLimit': '100.00'}, {'value': '91.67', 'groupId': 'OG003', 'lowerLimit': '81.61', 'upperLimit': '97.24'}]}]}, {'title': 'N1, ≥1:80 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'groupId': 'OG001', 'lowerLimit': '88.65', 'upperLimit': '99.60'}, {'value': '93.10', 'groupId': 'OG002', 'lowerLimit': '83.27', 'upperLimit': '98.09'}, {'value': '70.00', 'groupId': 'OG003', 'lowerLimit': '56.79', 'upperLimit': '81.15'}]}]}, {'title': 'N1, ≥1:640 (Day 181)', 'categories': [{'measurements': [{'value': '100.00', 'groupId': 'OG000', 'lowerLimit': '93.51', 'upperLimit': '100.00'}, {'value': '93.44', 'groupId': 'OG001', 'lowerLimit': '84.05', 'upperLimit': '98.18'}, {'value': '72.41', 'groupId': 'OG002', 'lowerLimit': '59.10', 'upperLimit': '83.34'}, {'value': '51.67', 'groupId': 'OG003', 'lowerLimit': '38.39', 'upperLimit': '64.77'}]}]}, {'title': 'N2, ≥1:20 (Day 22)', 'categories': [{'measurements': [{'value': '100.00', 'groupId': 'OG000', 'lowerLimit': '93.62', 'upperLimit': '100.00'}, {'value': '100.00', 'groupId': 'OG001', 'lowerLimit': '94.22', 'upperLimit': '100.00'}, {'value': '100.00', 'groupId': 'OG002', 'lowerLimit': '93.94', 'upperLimit': '100.00'}, {'value': 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'91.80', 'groupId': 'OG001', 'lowerLimit': '81.90', 'upperLimit': '97.28'}, {'value': '89.83', 'groupId': 'OG002', 'lowerLimit': '79.17', 'upperLimit': '96.18'}, {'value': '66.67', 'groupId': 'OG003', 'lowerLimit': '53.31', 'upperLimit': '78.31'}]}]}, {'title': 'B/Yamagata, ≥1:20 (Day 181)', 'categories': [{'measurements': [{'value': '100.00', 'groupId': 'OG000', 'lowerLimit': '93.51', 'upperLimit': '100.00'}, {'value': '98.33', 'groupId': 'OG001', 'lowerLimit': '91.06', 'upperLimit': '99.96'}, {'value': '100.00', 'groupId': 'OG002', 'lowerLimit': '93.84', 'upperLimit': '100.00'}, {'value': '100.00', 'groupId': 'OG003', 'lowerLimit': '94.04', 'upperLimit': '100.00'}]}]}, {'title': 'B/Yamagata, ≥1:40 (Day 181)', 'categories': [{'measurements': [{'value': '100.00', 'groupId': 'OG000', 'lowerLimit': '93.51', 'upperLimit': '100.00'}, {'value': '98.33', 'groupId': 'OG001', 'lowerLimit': '91.06', 'upperLimit': '99.96'}, {'value': '98.28', 'groupId': 'OG002', 'lowerLimit': '90.76', 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'groupId': 'OG001', 'lowerLimit': '94.22', 'upperLimit': '100.00'}, {'value': '100.00', 'groupId': 'OG002', 'lowerLimit': '93.94', 'upperLimit': '100.00'}, {'value': '100.00', 'groupId': 'OG003', 'lowerLimit': '94.04', 'upperLimit': '100.00'}]}]}, {'title': 'B/Victoria, ≥1:40 (Day 22)', 'categories': [{'measurements': [{'value': '100.00', 'groupId': 'OG000', 'lowerLimit': '93.62', 'upperLimit': '100.00'}, {'value': '100.00', 'groupId': 'OG001', 'lowerLimit': '94.22', 'upperLimit': '100.00'}, {'value': '100.00', 'groupId': 'OG002', 'lowerLimit': '93.94', 'upperLimit': '100.00'}, {'value': '100.00', 'groupId': 'OG003', 'lowerLimit': '94.04', 'upperLimit': '100.00'}]}]}, {'title': 'B/Victoria, ≥1:80 (Day 22)', 'categories': [{'measurements': [{'value': '100.00', 'groupId': 'OG000', 'lowerLimit': '93.62', 'upperLimit': '100.00'}, {'value': '100.00', 'groupId': 'OG001', 'lowerLimit': '94.22', 'upperLimit': '100.00'}, {'value': '100.00', 'groupId': 'OG002', 'lowerLimit': '93.94', 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{'value': '100.00', 'groupId': 'OG001', 'lowerLimit': '94.13', 'upperLimit': '100.00'}, {'value': '100.00', 'groupId': 'OG002', 'lowerLimit': '93.84', 'upperLimit': '100.00'}, {'value': '100.00', 'groupId': 'OG003', 'lowerLimit': '94.04', 'upperLimit': '100.00'}]}]}, {'title': 'B/Victoria, ≥1:80 (Day 181)', 'categories': [{'measurements': [{'value': '100.00', 'groupId': 'OG000', 'lowerLimit': '93.51', 'upperLimit': '100.00'}, {'value': '100.00', 'groupId': 'OG001', 'lowerLimit': '94.13', 'upperLimit': '100.00'}, {'value': '100.00', 'groupId': 'OG002', 'lowerLimit': '93.84', 'upperLimit': '100.00'}, {'value': '100.00', 'groupId': 'OG003', 'lowerLimit': '94.04', 'upperLimit': '100.00'}]}]}, {'title': 'B/Victoria, ≥1:160 (Day 181)', 'categories': [{'measurements': [{'value': '100.00', 'groupId': 'OG000', 'lowerLimit': '93.51', 'upperLimit': '100.00'}, {'value': '100.00', 'groupId': 'OG001', 'lowerLimit': '94.13', 'upperLimit': '100.00'}, {'value': '96.55', 'groupId': 'OG002', 'lowerLimit': '88.09', 'upperLimit': '99.58'}, {'value': '96.67', 'groupId': 'OG003', 'lowerLimit': '88.47', 'upperLimit': '99.59'}]}]}, {'title': 'B/Victoria, ≥1:320 (Day 181)', 'categories': [{'measurements': [{'value': '94.55', 'groupId': 'OG000', 'lowerLimit': '84.88', 'upperLimit': '98.86'}, {'value': '100.00', 'groupId': 'OG001', 'lowerLimit': '94.13', 'upperLimit': '100.00'}, {'value': '95.55', 'groupId': 'OG002', 'lowerLimit': '88.09', 'upperLimit': '99.58'}, {'value': '83.33', 'groupId': 'OG003', 'lowerLimit': '71.48', 'upperLimit': '91.71'}]}]}, {'title': 'B/Victoria, ≥1:640 (Day 181)', 'categories': [{'measurements': [{'value': '89.09', 'groupId': 'OG000', 'lowerLimit': '77.75', 'upperLimit': '95.89'}, {'value': '95.08', 'groupId': 'OG001', 'lowerLimit': '86.29', 'upperLimit': '98.97'}, {'value': '81.03', 'groupId': 'OG002', 'lowerLimit': '68.59', 'upperLimit': '90.13'}, {'value': '70.00', 'groupId': 'OG003', 'lowerLimit': '56.79', 'upperLimit': '81.15'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 22, Day 181', 'description': 'The percentage of subjects achieving anti-NA titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 after vaccination is reported against homologous strains\n\nStrains tested: N1 (PR8 H6N1 California/07/2009), N2 (PR8 H6N2 Switzerl/9715293/2013); B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013.', 'unitOfMeasure': 'percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Immunogenicity PPS consisting of all subjects who received a study vaccination and provided immunogenicity data, and who correctly received the study vaccine, had no major protocol deviations, and did not develop RT-PCR-confirmed influenza infection between baseline and Visit 2.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'aQIV/aQIV', 'description': 'Subjects previously vaccinated with aQIV followed one year later by aQIV\n\nAdjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)'}, {'id': 'FG001', 'title': 'aQIV/QIV', 'description': 'Subjects previously vaccinated with aQIV followed one year later by QIV\n\nNon-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)'}, {'id': 'FG002', 'title': 'QIV/aQIV', 'description': 'Subjects previously vaccinated with QIV followed one year later by aQIV\n\nAdjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)'}, {'id': 'FG003', 'title': 'QIV/QIV', 'description': 'Subjects previously vaccinated with QIV followed one year later by QIV\n\nNon-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '403'}, {'groupId': 'FG001', 'numSubjects': '403'}, {'groupId': 'FG002', 'numSubjects': '402'}, {'groupId': 'FG003', 'numSubjects': '393'}]}, {'type': 'Exposed', 'achievements': [{'groupId': 'FG000', 'numSubjects': '403'}, {'groupId': 'FG001', 'numSubjects': '403'}, {'groupId': 'FG002', 'numSubjects': '402'}, {'groupId': 'FG003', 'numSubjects': '393'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '400'}, {'groupId': 'FG001', 'numSubjects': '401'}, {'groupId': 'FG002', 'numSubjects': '400'}, {'groupId': 'FG003', 'numSubjects': '390'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Administrative/Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'This study was conducted at 17 sites in total; 9 sites in Finland, 4 sites in the Philippines and 4 sites in Thailand.', 'preAssignmentDetails': 'All enrolled subjects were included in the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '403', 'groupId': 'BG000'}, {'value': '403', 'groupId': 'BG001'}, {'value': '402', 'groupId': 'BG002'}, {'value': '393', 'groupId': 'BG003'}, {'value': '1601', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'aQIV/aQIV', 'description': 'Subjects previously vaccinated with aQIV followed one year later by aQIV\n\nAdjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)'}, {'id': 'BG001', 'title': 'aQIV/QIV', 'description': 'Subjects previously vaccinated with aQIV followed one year later by QIV\n\nNon-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)'}, {'id': 'BG002', 'title': 'QIV/aQIV', 'description': 'Subjects previously vaccinated with QIV followed one year later by aQIV\n\nAdjuvanted QIV (aQIV): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)'}, {'id': 'BG003', 'title': 'QIV/QIV', 'description': 'Subjects previously vaccinated with QIV followed one year later by QIV\n\nNon-adjuvanted QIV: Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.4', 'spread': '17.12', 'groupId': 'BG000'}, {'value': '52.3', 'spread': '17.02', 'groupId': 'BG001'}, {'value': '53.4', 'spread': '17.32', 'groupId': 'BG002'}, {'value': '53.3', 'spread': '17.30', 'groupId': 'BG003'}, {'value': '53.0', 'spread': '16.91', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '197', 'groupId': 'BG000'}, {'value': '189', 'groupId': 'BG001'}, {'value': '206', 'groupId': 'BG002'}, {'value': '178', 'groupId': 'BG003'}, {'value': '770', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '206', 'groupId': 'BG000'}, {'value': '214', 'groupId': 'BG001'}, {'value': '196', 'groupId': 'BG002'}, {'value': '215', 'groupId': 'BG003'}, {'value': '831', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '402', 'groupId': 'BG000'}, {'value': '403', 'groupId': 'BG001'}, {'value': '402', 'groupId': 'BG002'}, {'value': '392', 'groupId': 'BG003'}, {'value': '1599', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '364', 'groupId': 'BG000'}, {'value': '364', 'groupId': 'BG001'}, {'value': '362', 'groupId': 'BG002'}, {'value': '355', 'groupId': 'BG003'}, {'value': '1445', 'groupId': 'BG004'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}, {'value': '146', 'groupId': 'BG004'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Philippines', 'categories': [{'measurements': [{'value': '210', 'groupId': 'BG000'}, {'value': '211', 'groupId': 'BG001'}, {'value': '213', 'groupId': 'BG002'}, {'value': '212', 'groupId': 'BG003'}, {'value': '846', 'groupId': 'BG004'}]}]}, {'title': 'Finland', 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}, {'value': '38', 'groupId': 'BG003'}, {'value': '155', 'groupId': 'BG004'}]}]}, {'title': 'Thailand', 'categories': [{'measurements': [{'value': '154', 'groupId': 'BG000'}, {'value': '153', 'groupId': 'BG001'}, {'value': '150', 'groupId': 'BG002'}, {'value': '143', 'groupId': 'BG003'}, {'value': '600', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Risk Status', 'classes': [{'categories': [{'title': 'At risk', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '61', 'groupId': 'BG004'}]}, {'title': 'Not at risk', 'measurements': [{'value': '393', 'groupId': 'BG000'}, {'value': '383', 'groupId': 'BG001'}, {'value': '384', 'groupId': 'BG002'}, {'value': '380', 'groupId': 'BG003'}, {'value': '1540', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Subjects with underlying conditions that posed high risk of influenza complications (at risk/not at risk)', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1601}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'dispFirstSubmitDate': '2017-09-30', 'completionDateStruct': {'date': '2017-05-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-23', 'studyFirstSubmitDate': '2015-10-16', 'dispFirstSubmitQcDate': '2017-10-16', 'resultsFirstSubmitDate': '2019-02-25', 'studyFirstSubmitQcDate': '2015-10-20', 'dispFirstPostDateStruct': {'date': '2017-10-19', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2019-04-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-04-23', 'studyFirstPostDateStruct': {'date': '2015-10-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-11-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Immunogenicity Endpoint: Geometric Mean Titer (GMT) and GMT Ratio as Determined by Hemagglutination Inhibition (HI) Assay on Day 22 Against Homologous Strains (aQIV-primed Comparison), Noninferiority Analysis', 'timeFrame': 'Day 22', 'description': 'GMT and 95% confidence interval (CI) were analyzed for Day 22 against homologous strains using ANCOVA with study specific covariates.\n\nStrains tested: A/H1N1 California/07/2009; A/H3N2 Switzerland/9715293/2013; B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013.'}, {'measure': 'Immunogenicity Endpoint: GMT and GMT Ratio as Determined by HI Assay on Day 22 Against Homologous Strains (aQIV-primed Comparison), Superiority Analysis', 'timeFrame': 'Day 22', 'description': 'GMT and 95% CI were analyzed for Day 22 against homologous strains using ANCOVA with study specific covariates.\n\nStrains tested: A/H1N1 California/07/2009; A/H3N2 Switzerland/9715293/2013; B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013.'}], 'secondaryOutcomes': [{'measure': 'Immunogenicity Endpoint: GMT and GMT Ratio as Determined by HI Assay on Day 22 Against Homologous Strains (QIV-primed Comparison)', 'timeFrame': 'Day 22', 'description': 'GMT and 95% CI were analyzed for Day 22 against homologous strains using ANCOVA with study specific covariates.\n\nStrains tested: A/H1N1 California/07/2009; A/H3N2 Switzerland/9715293/2013; B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013.'}, {'measure': 'Immunogenicity Endpoint: GMT and GMT Ratio as Determined by HI Assay on Day 181 Against Homologous Strains (aQIV-primed and QIV-primed Comparison)', 'timeFrame': 'Day 181', 'description': 'GMT and 95% CI were analyzed for Day 181 against homologous strains using ANCOVA with study specific covariates.\n\nStrains tested: A/H1N1 California/07/2009; A/H3N2 Switzerland/9715293/2013; B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013.'}, {'measure': 'Immunogenicity Endpoint: Seroconversion Rate (SCR) on Day 22 Against Homologous Strains (aQIV-primed and QIV-primed Comparison)', 'timeFrame': 'Day 1, Day 22', 'description': 'The percentage of subjects achieving seroconversion at Day 22 after vaccination is reported against homologous strains. Seroconversion was defined in subjects seronegative at baseline (i.e. HI titer \\<1:10 on Day 1) as postvaccination HI titer ≥1:40 and defined in subjects seropositive at baseline (i.e. HI titer ≥1:10 on Day 1) as a minimum of a 4-fold increase in post-vaccination HI titer.\n\nStrains tested: A/H1N1 California/07/2009; A/H3N2 Switzerland/9715293/2013; B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013.'}, {'measure': 'Immunogenicity Endpoint: Geometric Mean Ratio (GMR) as Determined by HI Assay for Day 22/Day 1 and Day 181/Day 1 for Against Homologous Strains', 'timeFrame': 'Day 22, Day 181', 'description': 'The GMR is the geometric mean of the fold increase in HI titer from Day 1 to Day 22 or Day 181. GMR and 95% CI were analyzed against homologous strains using ANCOVA with study specific covariates.\n\nStrains tested: A/H1N1 California/07/2009; A/H3N2 Switzerland/9715293/2013; B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013.'}, {'measure': 'Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 on Day 22 and Day 181 Against Homologous Strains', 'timeFrame': 'Day 22, Day 181', 'description': 'The percentage of subjects achieving HI titer ≥1:40 at Day 22 and Day 181 after vaccination is reported against homologous strains.\n\nStrains tested: A/H1N1 California/07/2009; A/H3N2 Switzerland/9715293/2013; B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013.'}, {'measure': 'Immunogenicity Endpoints: Percentage of Subjects With HI Titer ≥1:110, ≥1:151, ≥1:215, ≥1:330 and ≥1:629 on Day 22 Against Homologous Strains', 'timeFrame': 'Day 22', 'description': 'The percentage of subjects achieving HI Titers ≥1:110, ≥1:151, ≥1:215, ≥1:330 and ≥1:629 at Day 22 after vaccination is reported against homologous strains.\n\nStrains tested: A/H1N1 California/07/2009; A/H3N2 Switzerland/9715293/2013; B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013.'}, {'measure': 'Immunogenicity Endpoint: GMT as Determined by HI Assay on Day 1, Day 22, and Day 181 Against Heterologous Strains', 'timeFrame': 'Day 1, Day 22, Day 181', 'description': 'GMT and 95% CI were analyzed for Day 22 for the heterologous strains using ANCOVA with study specific covariates.\n\nThe two heterologous strains selected for HI testing in this study were the H3N2 strain, A/Hong Kong/4801/2014 (X-263B), and the B/ Victoria lineage strain, B/Malaysia/2506/2004.'}, {'measure': 'Immunogenicity Endpoint: GMR as Determined by HI Assay for Day 22/Day 1 and Day 181/Day 1 Against Heterologous Strains', 'timeFrame': 'Day 22/Day 1 and Day 181/Day 1', 'description': 'The GMR is the geometric mean of the fold increase in HI titer from Day 1 to Day 22 or Day 181. GMR and 95% CI were analyzed for the heterologous strains using ANCOVA with study specific covariates.\n\nThe two heterologous strains selected for HI testing in this study were the H3N2 strain, A/Hong Kong/4801/2014 (X-263B), and the B Victoria lineage strain, B/Malaysia/2506/2004.'}, {'measure': 'Immunogenicity Endpoint: Percentage of Subjects Achieving SCR and HI Titer ≥1:40 on Day 22 and Day 181 Against Heterologous Strains', 'timeFrame': 'Day 22, Day 181', 'description': 'The percentage of subjects achieving HI titer ≥1:40 at Day 22 and Day 181 after vaccination and the percentage of subject who experienced seroconversion is reported for homologous strains. Seroconversion was defined in subjects seronegative at baseline (i.e. HI titer \\<1:10 on Day 1) as post-vaccination HI titer ≥1:40 and defined in subjects seropositive at baseline (i.e. HI titer ≥1:10 on Day 1) as a minimum of a 4-fold increase in post-vaccination HI titer.\n\nThe two heterologous strains selected for HI testing in this study were the H3N2 strain, A/Hong Kong/4801/2014 (X-263B), and the B/Victoria lineage strain, B/Malaysia/2506/2004.'}, {'measure': 'Immunogenicity Endpoint: GMT as Determined by Microneutralization (MN) Assay on Day 1, Day 22, and Day 181 Against Homologous Strains', 'timeFrame': 'Day 1, Day 22, Day 181', 'description': 'To further characterize immune response, MN GMT and 95% CI were analyzed for Day 1, Day 22, and Day 181 against homologous strains.\n\nStrains tested: A/H1N1 California/07/2009; A/H3N2 Switzerland/9715293/2013; B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013.'}, {'measure': 'Immunogenicity Endpoint: GMR as Determined by MN Assay for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains', 'timeFrame': 'Day 22/Day 1 and Day 181/Day 1', 'description': 'The GMR is the geometric mean of the fold increase in MN titer from Day 1 to Day 22 or Day 181. GMR and 95% CI were analyzed for the homologous strains using ANCOVA with study specific covariates.\n\nStrains tested: A/H1N1 California/07/2009; A/H3N2 Switzerland/9715293/2013; B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013.'}, {'measure': 'Immunogenicity Endpoint: Anti-neuraminidase (NA) GMTs on Day 1, Day 22, and Day 181 Against Homologous Strains', 'timeFrame': 'Day 1, Day 22, Day 181', 'description': 'To further characterize immune response, adjusted anti-NA GMT and 95% CI were analyzed for Day 1, Day 22, and Day 181 against homologous strains.\n\nStrains tested: N1 (PR8 H6N1 California/07/2009), N2 (PR8 H6N2 Switzerl/9715293/2013); B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013.'}, {'measure': 'Immunogenicity Endpoint: Anti-NA GMR for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains', 'timeFrame': 'Day 22/Day 1 and Day 181/Day 1', 'description': 'The GMR is the geometric mean of the fold increase in anti-NA titer from Day 1 to Day 22 or Day 181. GMR and 95% CI were analyzed against homologous strains using ANCOVA with study specific covariates.\n\nStrains tested: N1 (PR8 H6N1 California/07/2009), N2 (PR8 H6N2 Switzerl/9715293/2013); B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013.'}, {'measure': 'Safety Endpoint: Percentage of Subjects With Solicited AEs', 'timeFrame': 'Day 1 to Day 7 after vaccination', 'description': 'Safety of revaccination was assessed in terms of percentage of subjects reporting solicited AEs up to 7 days after vaccination.'}, {'measure': 'Safety Endpoint: Percentage of Subjects With Unsolicited AEs', 'timeFrame': 'Day 1 to Day 366', 'description': 'Safety of revaccination was assessed in terms of percentage of subjects reporting unsolicited AEs during the overall study period (Day 1 to Day 366).'}, {'measure': 'Safety Endpoint: Percentage of Subjects With Serious Adverse Events (SAE), AEs Leading to Withdrawal, New Onset of Chronic Disease (NOCD), AE of Special Interest (AESI), and Medically Attended AE.', 'timeFrame': 'Day 1 to Day 366', 'description': 'Safety of revaccination was assessed in terms of percentage of subjects reporting SAEs, AEs leading to withdrawal, NOCD, AESI and medically attended AE. Each subject was followed for a period of 12 months after receipt of the study vaccine.\n\nNOCDs include AEs that represents a new diagnosis of a chronic medical condition that was not present or suspected in a subject prior to study enrollment. AESIs include potentially immune-mediated disorders which were reported by the investigators.'}, {'measure': 'Safety Endpoint: Percentage of Subjects With Diagnosis of Failure to Thrive or Short Stature', 'timeFrame': 'Day 1 to Day 366', 'description': 'Safety of revaccination was assessed in terms of percentage of subjects reporting diagnosis of failure to thrive or short stature up to 12 months after last vaccination.'}, {'measure': 'Safety Endpoint: Percentage of Subjects With Otitis Media, or Pneumonia, or Influenza-like Illness', 'timeFrame': 'Day 1 to Day 366', 'description': 'Safety of revaccination was assessed in terms of percentage of subjects reporting otitis media, or pneumonia, or influenza-like illness up to 12 months after last vaccination.'}, {'measure': 'Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains', 'timeFrame': 'Day 22, Day 181', 'description': 'The percentage of subjects achieving MN titer ≥1:20, ≥1:40, ≥1:80 ≥1:160, ≥1:320 and ≥1:640 at Day 22 and Day 181 after vaccination is reported against homologous strains.\n\nStrains tested: A/H1N1 California/07/2009; A/H3N2 Switzerland/9715293/2013; B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013.'}, {'measure': 'Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains', 'timeFrame': 'Day 22, Day 181', 'description': 'The percentage of subjects achieving anti-NA titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 after vaccination is reported against homologous strains\n\nStrains tested: N1 (PR8 H6N1 California/07/2009), N2 (PR8 H6N2 Switzerl/9715293/2013); B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Influenza Vaccine', 'MF59 adjuvant'], 'conditions': ['Influenza']}, 'descriptionModule': {'briefSummary': 'Safety, Immunogenicity of an Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine Compared to Non-Adjuvanted Comparator Influenza Vaccine in Children Previously vaccinated in Trial V118\\_05. Subjects will receive either the Same or Alternate Type of Vaccine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Years', 'minimumAge': '12 Months', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nIn order to participate in this study, all subjects must meet ALL of the inclusion criteria described.\n\n* Subject's parent/legal guardian has voluntarily given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry.\n* Male or female subject who has completed their Visit 13 (Study Day 366 for non-naïve subjects) or clinic Visit 15 (Day 390 for naïve subjects) in parent trial V118\\_05.\n* For naïve subjects in parent trial V118\\_05 to have received two doses of the same study vaccine (i.e. 2 doses of aQIV or 2 doses of QIV).\n\nExclusion Criteria:\n\n* Previous immunization with any influenza vaccine (licensed or investigational) within 6 months prior to enrollment.\n* Subjects with a clinical condition representing a contraindication to intramuscular vaccination or blood draws.\n* Unwillingness of the parent(s)/ legal guardian(s) of the subject to refuse to participate in another clinical trial while enrolled in V118-05E3.\n\nAdditional eligibility criteria may be discussed by contacting the site."}, 'identificationModule': {'nctId': 'NCT02583256', 'briefTitle': 'Clinical Study to Evaluate Safety, Immunogenicity of Investigational Flu Vaccine Compared to an Approved Flu Vaccine in Children Previously Vaccinated in Trial V118_05 (NCT01964989)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Seqirus'}, 'officialTitle': 'A Phase III, Randomized, Observer Blind, Multicenter Study to Evaluate the Safety and Immunogenicity of Repeated Exposure to Either the Same or Alternate Type of Vaccine, Adjuvanted or Non-adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV or QIV), Administered to Subjects Previously Vaccinated in Trial V118_05 (NCT01964989)', 'orgStudyIdInfo': {'id': 'V118_05E3'}, 'secondaryIdInfos': [{'id': '2015-002973-39', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'aQIV/aQIV', 'description': 'Subjects previously vaccinated with aQIV followed one year later by aQIV', 'interventionNames': ['Biological: Adjuvanted QIV (aQIV)']}, {'type': 'EXPERIMENTAL', 'label': 'aQIV/QIV', 'description': 'Subjects previously vaccinated with aQIV followed one year later by QIV', 'interventionNames': ['Biological: Non-adjuvanted QIV']}, {'type': 'EXPERIMENTAL', 'label': 'QIV/aQIV', 'description': 'Subjects previously vaccinated with QIV followed one year later by aQIV', 'interventionNames': ['Biological: Adjuvanted QIV (aQIV)']}, {'type': 'EXPERIMENTAL', 'label': 'QIV/QIV', 'description': 'Subjects previously vaccinated with QIV followed one year later by QIV', 'interventionNames': ['Biological: Non-adjuvanted QIV']}], 'interventions': [{'name': 'Adjuvanted QIV (aQIV)', 'type': 'BIOLOGICAL', 'description': 'Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)', 'armGroupLabels': ['QIV/aQIV', 'aQIV/aQIV']}, {'name': 'Non-adjuvanted QIV', 'type': 'BIOLOGICAL', 'description': 'Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)', 'armGroupLabels': ['QIV/QIV', 'aQIV/QIV']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02230', 'city': 'Espoo', 'state': 'Etelä-Suomen Lääni', 'country': 'Finland', 'facility': 'Investigational Site- 001', 'geoPoint': {'lat': 60.2052, 'lon': 24.6522}}, {'zip': '00100', 'city': 'Helsinki', 'state': 'Etelä-Suomen Lääni', 'country': 'Finland', 'facility': 'Investigational Site- 002', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}, {'zip': '00100', 'city': 'Helsinki', 'state': 'Etelä-Suomen Lääni', 'country': 'Finland', 'facility': 'Investigational Site- 003', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}, {'zip': '04400', 'city': 'Järvenpää', 'state': 'Etelä-Suomen Lääni', 'country': 'Finland', 'facility': 'Investigational Site- 004', 'geoPoint': {'lat': 60.47369, 'lon': 25.08992}}, {'zip': '67100', 'city': 'Kokkola', 'state': 'Länsi-Suomen Lääni', 'country': 'Finland', 'facility': 'Investigational Site- 005', 'geoPoint': {'lat': 63.83847, 'lon': 23.13066}}, {'zip': '28100', 'city': 'Pori', 'state': 'Länsi-Suomen Lääni', 'country': 'Finland', 'facility': 'Investigational Site- 007', 'geoPoint': {'lat': 61.48072, 'lon': 21.78518}}, {'zip': '33100', 'city': 'Tampere', 'state': 'Länsi-Suomen Lääni', 'country': 'Finland', 'facility': 'Investigational Site- 009', 'geoPoint': {'lat': 61.49911, 'lon': 23.78712}}, {'zip': '20520', 'city': 'Turku', 'state': 'Länsi-Suomen Lääni', 'country': 'Finland', 'facility': 'Investigational Site- 010', 'geoPoint': {'lat': 60.45148, 'lon': 22.26869}}, {'zip': '90220', 'city': 'Oulu', 'country': 'Finland', 'facility': 'Investigational Site- 006', 'geoPoint': {'lat': 65.01236, 'lon': 25.46816}}, {'zip': '1781', 'city': 'Laguna', 'state': 'Matro Manila', 'country': 'Philippines', 'facility': 'Investigational Site- 303', 'geoPoint': {'lat': 12.31667, 'lon': 123.7}}, {'zip': '1781', 'city': 'Muntinlupa', 'state': 'National Capital Region', 'country': 'Philippines', 'facility': 'Investigational Site- 304'}, {'zip': '1781', 'city': 'Muntinlupa', 'state': 'National Capital Region', 'country': 'Philippines', 'facility': 'Investigational Site- 305'}, {'zip': '4114', 'city': 'Cavite', 'country': 'Philippines', 'facility': 'Investigational Site- 306', 'geoPoint': {'lat': 15.67785, 'lon': 120.76978}}, {'zip': '12120', 'city': 'Pathum Thani', 'state': 'Bangkok', 'country': 'Thailand', 'facility': 'Investigational Site- 325'}, {'zip': '10400', 'city': 'Bangkok', 'state': 'Changwat Samut Prakan', 'country': 'Thailand', 'facility': 'Investigational Site- 320'}, {'zip': '10400', 'city': 'Bangkok', 'state': 'Krung Thep Maha Nakhon [Bangko', 'country': 'Thailand', 'facility': 'Investigational Site- 327', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'zip': '10330', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Investigational Site- 323', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'overallOfficials': [{'name': 'Clinical Program Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Seqirus'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seqirus', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}