Ignite Creation Date:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2025-12-26 @ 4:17 AM
Study NCT ID:
NCT00976027
Status:
TERMINATED
Last Update Posted:
2012-08-01
First Post:
2009-09-11
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Multi-Year Study of Fluzone High-Dose Influenza Vaccine Compared With Fluzone® Vaccine in Adults Aged 65 Years and Older
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007251', 'term': 'Influenza, Human'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D009976', 'term': 'Orthomyxoviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007252', 'term': 'Influenza Vaccines'}], 'ancestors': [{'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'RegistryContactUs@sanofipasteur.com', 'title': 'Medical Director', 'organization': 'Sanofi Pasteur Inc.'}, 'certainAgreement': {'otherDetails': 'Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The study was terminated due to lack of primary endpoint cases in 2009-2010 influenza season (coincided with the H1N1 Pandemic). There were no safety concerns; enrolled subjects were followed per-protocol.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.', 'eventGroups': [{'id': 'EG000', 'title': 'Fluzone® High Dose', 'description': 'All participants received a single dose of Fluzone High Dose vaccine on Day 0.', 'otherNumAtRisk': 6108, 'otherNumAffected': 0, 'seriousNumAtRisk': 6108, 'seriousNumAffected': 493}, {'id': 'EG001', 'title': 'Fluzone®', 'description': 'All subjects received a single dose of Fluzone vaccine on Day 0.', 'otherNumAtRisk': 3050, 'otherNumAffected': 0, 'seriousNumAtRisk': 3050, 'seriousNumAffected': 236}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6108, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 3050, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Coagulopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6108, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3050, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Iron Deficiency Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6108, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3050, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Splenomegaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6108, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3050, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6108, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3050, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Acute Coronary Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6108, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3050, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Acute Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6108, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3050, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Angina Pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6108, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3050, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Angina Unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6108, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 3050, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Aortic Valve Incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6108, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3050, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6108, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3050, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6108, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 3050, 'numAffected': 7}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Atrioventricular Block Complete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6108, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3050, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Atrioventricular Block First Degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6108, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3050, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Atrioventricular Block Second Degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6108, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3050, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Bradyarrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6108, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3050, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6108, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 3050, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Cardiac Arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6108, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3050, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Cardiac Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6108, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3050, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Cardiac Failure Acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6108, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3050, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Cardiac Failure Chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6108, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3050, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Cardiac Failure Congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6108, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 3050, 'numAffected': 11}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Cardiac Valve Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6108, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3050, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Cardiomegaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6108, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3050, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6108, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3050, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Coronary Artery Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6108, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 3050, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Coronary Artery Occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6108, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3050, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Coronary Artery Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6108, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3050, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Ischaemic Cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6108, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3050, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Mitral Valve Incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6108, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3050, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6108, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 3050, 'numAffected': 8}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Myocardial Ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6108, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3050, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pericardial Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6108, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3050, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6108, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3050, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Sick Sinus Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6108, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 3050, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Sinus Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6108, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3050, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Arteriovenous Malformation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6108, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3050, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Atrial Septal Defect', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6108, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3050, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6108, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3050, 'numAffected': 3}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Retinal Artery Occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6108, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3050, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Abdominal Hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6108, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3050, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6108, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3050, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Abdominal Pain Upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6108, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3050, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6108, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3050, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Colitis Ischaemic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6108, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3050, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Colitis Ulcerative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6108, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3050, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6108, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3050, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6108, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 3050, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Diverticular Perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6108, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3050, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Diverticulitis Intestinal Haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6108, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3050, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Diverticulum Intestinal Haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6108, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3050, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Duodenal Ulcer Haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6108, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3050, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Duodenal Ulcer Perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6108, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3050, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6108, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3050, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Faecaloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6108, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3050, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Faeces Discolored', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6108, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3050, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Food Poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6108, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3050, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Gastric Ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6108, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3050, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Gastric Ulcer Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6108, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3050, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6108, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3050, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Gastrointestinal Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6108, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 3050, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Gastrooesophageal Reflux Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6108, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3050, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6108, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3050, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Hiatus Hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6108, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3050, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Ileus Paralytic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6108, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3050, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Inguinal Hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6108, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3050, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Intestinal Ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6108, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3050, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Intestinal Obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6108, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3050, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Intestinal Ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6108, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3050, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Intra Abdominal Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6108, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3050, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Large Intestine Perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6108, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3050, 'numAffected': 1}], 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1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': "Hodgkin's disease stage IV", 'stats': [{'groupId': 'EG000', 'numAtRisk': 6108, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3050, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Intraocular melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6108, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3050, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Large cell lung cancer stage II', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6108, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3050, 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{'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6108, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 3050, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Cervicobrachial syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6108, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3050, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Drug withdrawal convulsions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6108, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3050, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6108, 'numAffected': 1}, {'groupId': 'EG001', 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'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Vascular rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6108, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3050, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6108, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 3050, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6108, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3050, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6108, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3050, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Kidney infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6108, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3050, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Klebsiella infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6108, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3050, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Lobar pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6108, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3050, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Orchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6108, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3050, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6108, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3050, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6108, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3050, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Perineal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6108, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3050, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6108, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 3050, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pneumonia staphylococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6108, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3050, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Post procedural infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6108, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3050, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6108, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3050, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6108, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3050, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}], 'frequencyThreshold': '5.00'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Efficacy of Fluzone High Dose Relative to Fluzone in the Prevention of Laboratory Confirmed Influenza Caused by Viral Types and Subtypes That Are Antigenically Similar to Those Contained in the Respective Annual Vaccine Formulations.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6013', 'groupId': 'OG000'}, {'value': '3008', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluzone® High Dose', 'description': 'All participants received a single dose of Fluzone High Dose vaccine on Day 0.'}, {'id': 'OG001', 'title': 'Fluzone®', 'description': 'All subjects received a single dose of Fluzone vaccine on Day 0.'}], 'classes': [{'title': 'Laboratory Confirmed Cases of ILI', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Culture Confirmed Cases of ILI', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'PCR Confirmed Cases of ILI', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0 (pre-vaccination) up to Year 1 post-vaccination', 'description': 'The presence (and specific identification) of influenza virus in the respiratory tract of vaccinated individuals with influenza like illness (ILI) was confirmed by tissue culture (for infectious virus) and molecular techniques (polymerase chain reaction based assays), with results reported for cases cause by any viral type or subtype.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy was assessed in all participants who met all study inclusion criteria and none of the exclusion criteria, received the vaccine to which they were randomized, and had no protocol violations that might have interfered with evaluation of primary endpoints (Per Protocol Analysis Set).'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants Reporting Events Associated With All Cases of Protocol Defined Influenza-Like Illness (ILI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6013', 'groupId': 'OG000'}, {'value': '3008', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluzone® High Dose', 'description': 'All participants received a single dose of Fluzone High Dose vaccine on Day 0.'}, {'id': 'OG001', 'title': 'Fluzone®', 'description': 'All subjects received a single dose of Fluzone vaccine on Day 0.'}], 'classes': [{'title': 'Pneumonia', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Cardio Respiratory Conditions', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Any Health Care Visit', 'categories': [{'measurements': [{'value': '478', 'groupId': 'OG000'}, {'value': '245', 'groupId': 'OG001'}]}]}, {'title': 'Hospitalization', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Emergency Room Visit', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'Non Routine Medical Office Visits', 'categories': [{'measurements': [{'value': '439', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}]}]}, {'title': 'Any Medication Use (Taken or Prescribed)', 'categories': [{'measurements': [{'value': '781', 'groupId': 'OG000'}, {'value': '402', 'groupId': 'OG001'}]}]}, {'title': 'Antipyretics, NSAIDs, Analgesics Use', 'categories': [{'measurements': [{'value': '552', 'groupId': 'OG000'}, {'value': '289', 'groupId': 'OG001'}]}]}, {'title': 'Antiviral Use', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Antibiotic Use', 'categories': [{'measurements': [{'value': '374', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0 (pre-vaccination) up to the end of the influenza season', 'description': 'Events associated with Protocol defined influenza-like Illnesses (ILI) were defined as pneumonia, new onset or exacerbation of pre-existing cardio respiratory conditions, health care visits, and medication use (including nonsteroidal anti-inflammatory drugs, NSAIDs).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The occurrence of events associated with ILI was assessed in all participants who met all study inclusion and exclusion criteria, received the vaccine to which they were randomized, and had no protocol violations that might have interfered with evaluation of primary endpoints (Per-Protocol Analysis Set).'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants Reporting Events Associated With All Cases of CDC Defined Influenza-Like Illness (ILI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6013', 'groupId': 'OG000'}, {'value': '3008', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluzone® High Dose', 'description': 'All participants received a single dose of Fluzone High Dose vaccine on Day 0.'}, {'id': 'OG001', 'title': 'Fluzone®', 'description': 'All subjects received a single dose of Fluzone vaccine on Day 0.'}], 'classes': [{'title': 'Pneumonia', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'New Onset or Exacerbation of Cardio Respiratory', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Any Health Care Visit', 'categories': [{'measurements': [{'value': '145', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}]}, {'title': 'Hospitalization', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Emergency Room Visit', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Non Routine Medical Office Visits', 'categories': [{'measurements': [{'value': '129', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}]}, {'title': 'Any Medication Use (Taken or Prescribed)', 'categories': [{'measurements': [{'value': '220', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}]}, {'title': 'Antipyretics, NSAIDs, Analgesics Use', 'categories': [{'measurements': [{'value': '153', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}]}]}, {'title': 'Antiviral Use', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Antibiotic Use', 'categories': [{'measurements': [{'value': '123', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 14 (post-vaccination) up to 12 Months post-vaccination', 'description': 'Events associated with CDC defined influenza-like Illnesses (ILI) were defined as pneumonia, new onset or exacerbation of pre existing cardio respiratory conditions, health care visits, and medication use (including nonsteroidal anti-inflammatory drugs, NSAIDs).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The occurrence of events associated with CDC defined ILI was assessed in all participants who met all study inclusion and exclusion criteria, received the vaccine to which they were randomized, and had no protocol violations that might have interfered with evaluation of primary endpoints (Per-Protocol Analysis Set).'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants Reporting Adverse Events of Special Interest (AESIs) and Serious Adverse Events Post-vaccination With Either Fluzone High-Dose and Fluzone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6108', 'groupId': 'OG000'}, {'value': '3008', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluzone® High Dose', 'description': 'All participants received a single dose of Fluzone High Dose vaccine on Day 0.'}, {'id': 'OG001', 'title': 'Fluzone®', 'description': 'All subjects received a single dose of Fluzone vaccine on Day 0.'}], 'classes': [{'title': 'Serious Adverse Events (SAE)', 'categories': [{'measurements': [{'value': '493', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}]}, {'title': 'Death', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Guillain Barre Syndrome', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': "Bell's Palsy", 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Encephalitis or Myelitis', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Optic Neuritis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Stevens Johnson Syndrome', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Toxic Epidermal Necrolysis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'SAE Leading to Study Discontinuation', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Related SAE', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Related SAE Leading to Study Discontinuation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0 before vaccination to Day 180 after vaccination', 'description': "Adverse events of special interest: new onset of Guillain Barre Syndrome (GBS), Bell's Palsy, encephalitis or myelitis, optic neuritis, Stevens Johnson Syndrome, and toxic epidermal necrolysis", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Adverse events of special interest were assessed in all participants who received study vaccine (Full Analysis Set).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Fluzone® High Dose', 'description': 'All participants received a single dose of Fluzone High Dose vaccine on Day 0.'}, {'id': 'FG001', 'title': 'Fluzone®', 'description': 'All subjects received a single dose of Fluzone vaccine on Day 0.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6108'}, {'groupId': 'FG001', 'numSubjects': '3050'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5697'}, {'groupId': 'FG001', 'numSubjects': '2835'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '411'}, {'groupId': 'FG001', 'numSubjects': '215'}]}], 'dropWithdraws': [{'type': 'Serious Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '208'}, {'groupId': 'FG001', 'numSubjects': '103'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '107'}, {'groupId': 'FG001', 'numSubjects': '66'}]}]}], 'recruitmentDetails': 'Participants were enrolled in the study from 22 September 2009 to 07 November 2009 at 99 clinical centers in the US.', 'preAssignmentDetails': 'A total of 9158 of the 9172 participants that were randomized were vaccinated, evaluated, and reported in this report.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6108', 'groupId': 'BG000'}, {'value': '3050', 'groupId': 'BG001'}, {'value': '9158', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Fluzone® High Dose', 'description': 'All participants received a single dose of Fluzone High Dose vaccine on Day 0.'}, {'id': 'BG001', 'title': 'Fluzone®', 'description': 'All subjects received a single dose of Fluzone vaccine on Day 0.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '6108', 'groupId': 'BG000'}, {'value': '3050', 'groupId': 'BG001'}, {'value': '9158', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '72.8', 'spread': '6.0', 'groupId': 'BG000'}, {'value': '72.8', 'spread': '5.9', 'groupId': 'BG001'}, {'value': '72.8', 'spread': '6.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3268', 'groupId': 'BG000'}, {'value': '1647', 'groupId': 'BG001'}, {'value': '4915', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2840', 'groupId': 'BG000'}, {'value': '1403', 'groupId': 'BG001'}, {'value': '4243', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '6108', 'groupId': 'BG000'}, {'value': '3050', 'groupId': 'BG001'}, {'value': '9158', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', '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': 9172}}, 'statusModule': {'whyStopped': 'No safety concerns, study terminated due to lack of primary endpoint cases in 2009-2010 Flu season (coincided with H1N1 Pandemic) Subjects followed per-protocol', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-24', 'studyFirstSubmitDate': '2009-09-11', 'resultsFirstSubmitDate': '2012-06-19', 'studyFirstSubmitQcDate': '2009-09-11', 'lastUpdatePostDateStruct': {'date': '2012-08-01', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-06-19', 'studyFirstPostDateStruct': {'date': '2009-09-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-07-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Participants Reporting Events Associated With All Cases of Protocol Defined Influenza-Like Illness (ILI)', 'timeFrame': 'Day 0 (pre-vaccination) up to the end of the influenza season', 'description': 'Events associated with Protocol defined influenza-like Illnesses (ILI) were defined as pneumonia, new onset or exacerbation of pre-existing cardio respiratory conditions, health care visits, and medication use (including nonsteroidal anti-inflammatory drugs, NSAIDs).'}, {'measure': 'Number of Participants Reporting Events Associated With All Cases of CDC Defined Influenza-Like Illness (ILI)', 'timeFrame': 'Day 14 (post-vaccination) up to 12 Months post-vaccination', 'description': 'Events associated with CDC defined influenza-like Illnesses (ILI) were defined as pneumonia, new onset or exacerbation of pre existing cardio respiratory conditions, health care visits, and medication use (including nonsteroidal anti-inflammatory drugs, NSAIDs).'}, {'measure': 'Number of Participants Reporting Adverse Events of Special Interest (AESIs) and Serious Adverse Events Post-vaccination With Either Fluzone High-Dose and Fluzone', 'timeFrame': 'Day 0 before vaccination to Day 180 after vaccination', 'description': "Adverse events of special interest: new onset of Guillain Barre Syndrome (GBS), Bell's Palsy, encephalitis or myelitis, optic neuritis, Stevens Johnson Syndrome, and toxic epidermal necrolysis"}], 'primaryOutcomes': [{'measure': 'Efficacy of Fluzone High Dose Relative to Fluzone in the Prevention of Laboratory Confirmed Influenza Caused by Viral Types and Subtypes That Are Antigenically Similar to Those Contained in the Respective Annual Vaccine Formulations.', 'timeFrame': 'Day 0 (pre-vaccination) up to Year 1 post-vaccination', 'description': 'The presence (and specific identification) of influenza virus in the respiratory tract of vaccinated individuals with influenza like illness (ILI) was confirmed by tissue culture (for infectious virus) and molecular techniques (polymerase chain reaction based assays), with results reported for cases cause by any viral type or subtype.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Influenza', 'Respiratory Tract Infections', 'Influenza-like illness', 'Elderly', 'Fluzone®', 'Efficacy'], 'conditions': ['Influenza']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.sanofipasteur.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to determine the efficacy of Fluzone High Dose vaccine and that of Fluzone® vaccine in the elderly.\n\nPrimary objective:\n\nTo measure the efficacy of the vaccine, defined as the prevention of laboratory-confirmed influenza caused by viral types/subtypes that are antigenically similar to those contained in the respective annual vaccine formulations.\n\nSecondary objectives:\n\n* To compare the clinical efficacy of Fluzone High Dose vaccine with that of Fluzone® vaccine in elderly adults, with respect to laboratory-confirmed influenza illness caused by any type or subtype of influenza virus.\n* To compare the clinical efficacy of Fluzone High Dose vaccine with that of Fluzone® vaccine in elderly adults, in preventing culture-confirmed influenza illness caused by viral types/subtypes antigenically similar to those contained in the respective annual vaccine formulations.', 'detailedDescription': 'The occurrence of influenza-like illness (ILI) will be determined in elderly participants vaccinated with either Fluzone High Dose or Fluzone® vaccine.\n\nThe presence of influenza virus in the respiratory tract of vaccinated individuals with ILI will be confirmed by two methods.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria :\n\n* Aged ≥ 65 years on the day of vaccination\n* Informed consent form signed and dated.\n* Able to attend all scheduled visits and to comply with all trial procedures.\n\nExclusion Criteria :\n\n* Participation in another interventional clinical trial investigating a vaccine, drug, medical device, herbal supplement, or a medical procedure in the 4 weeks preceding the trial vaccination or planned participation in another clinical trial investigating a vaccine, drug, medical device, herbal supplement, or a medical procedure during each year of participation in the study trial.\n* Vaccination against influenza in the 6 months preceding the trial vaccination.\n* Systemic hypersensitivity to eggs, chicken proteins, or any of the vaccine components, or a history of a life-threatening reaction to Fluzone vaccine or to a vaccine containing any of the same substances.\n* Personal history of Guillain-Barré syndrome.\n* Dementia or any other cognitive condition at a stage that could interfere with following the trial procedures.\n* Thrombocytopenia, bleeding disorder, or anticoagulation therapy contraindicating intramuscular (IM) vaccination.\n* Known or suspected human immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg), or Hepatitis C seropositivity.\n* Alcohol abuse or drug addiction that could interfere with the subject's ability to comply with trial procedures.\n* Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.\n* Bedridden subjects."}, 'identificationModule': {'nctId': 'NCT00976027', 'briefTitle': 'Multi-Year Study of Fluzone High-Dose Influenza Vaccine Compared With Fluzone® Vaccine in Adults Aged 65 Years and Older', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Multi-Year Efficacy Study of Fluzone High-Dose Trivalent Vaccine Compared With Fluzone® Vaccine In Adults ≥ 65 Years of Age', 'orgStudyIdInfo': {'id': 'FIM07'}, 'secondaryIdInfos': [{'id': 'UTN: U1111-1111-4478', 'type': 'OTHER', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fluzone® High Dose Group', 'interventionNames': ['Biological: Trivalent inactivated influenza vaccine High Dose']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fluzone® Group', 'interventionNames': ['Biological: Trivalent inactivated influenza vaccine']}], 'interventions': [{'name': 'Trivalent inactivated influenza vaccine High Dose', 'type': 'BIOLOGICAL', 'otherNames': ['Fluzone® High Dose'], 'description': '0.5 mL, Intramuscular', 'armGroupLabels': ['Fluzone® High Dose Group']}, {'name': 'Trivalent inactivated influenza vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['Fluzone®'], 'description': '0.5 mL, Intramuscular', 'armGroupLabels': ['Fluzone® Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35209', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85308', 'city': 'Glendale', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.53865, 'lon': -112.18599}}, {'zip': '85203', 'city': 'Mesa', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.42227, 'lon': -111.82264}}, {'zip': '85028', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85050', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 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