Ignite Creation Date:
2025-12-24 @ 5:17 PM
Ignite Modification Date:
2025-12-28 @ 10:14 PM
Study NCT ID:
NCT00775450
Status:
COMPLETED
Last Update Posted:
2013-12-31
First Post:
2008-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Influenza Vaccine Revaccination in Ambulatory Elderly Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007251', 'term': 'Influenza, Human'}, {'id': 'D009976', 'term': 'Orthomyxoviridae Infections'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': '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}}, 'adverseEventsModule': {'timeFrame': 'Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination', 'eventGroups': [{'id': 'EG000', 'title': 'Group 1a: Fluzone ID After Fluzone ID', 'description': 'Participants who received a dose (0.1 mL) of Fluzone intradermal (ID) after receiving Fluzone ID in Study FID29 (NCT00551031)', 'otherNumAtRisk': 292, 'otherNumAffected': 239, 'seriousNumAtRisk': 295, 'seriousNumAffected': 10}, {'id': 'EG001', 'title': 'Group 1b: Fluzone IM After Fluzone ID', 'description': 'Participants who received a dose (0.5 mL) of Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID29 (NCT00551031)', 'otherNumAtRisk': 98, 'otherNumAffected': 42, 'seriousNumAtRisk': 98, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'Group 2a: Fluzone IM After Fluzone IM', 'description': 'Participants who received a dose (0.5 mL) Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID29 NCT00551031)', 'otherNumAtRisk': 105, 'otherNumAffected': 54, 'seriousNumAtRisk': 105, 'seriousNumAffected': 6}, {'id': 'EG003', 'title': 'Group 2b: Fluzone ID After Fluzone IM', 'description': 'Participants who received a dose (0.1 )Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID29 (NCT00551031)', 'otherNumAtRisk': 107, 'otherNumAffected': 86, 'seriousNumAtRisk': 108, 'seriousNumAffected': 3}, {'id': 'EG004', 'title': 'Group 3: Fluzone HD After Fluzone HD', 'description': 'Participants who received a dose (0.5 mL) of Fluzone High Dose (HD) vaccine after receiving Fluzone HD vaccine in Study FID29 (NCT00551031)', 'otherNumAtRisk': 200, 'otherNumAffected': 123, 'seriousNumAtRisk': 201, 'seriousNumAffected': 10}], 'otherEvents': [{'term': 'Injection Site Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 68, 'numAffected': 68}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 18, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 105, 'numEvents': 23, 'numAffected': 23}, {'groupId': 'EG003', 'numAtRisk': 107, 'numEvents': 31, 'numAffected': 31}, {'groupId': 'EG004', 'numAtRisk': 200, 'numEvents': 91, 'numAffected': 91}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Injection Site Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 207, 'numAffected': 207}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 18, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 105, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 107, 'numEvents': 71, 'numAffected': 71}, {'groupId': 'EG004', 'numAtRisk': 200, 'numEvents': 34, 'numAffected': 34}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Injection Site Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 127, 'numAffected': 127}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 105, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 107, 'numEvents': 44, 'numAffected': 44}, {'groupId': 'EG004', 'numAtRisk': 200, 'numEvents': 23, 'numAffected': 23}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Injection Site Induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 133, 'numAffected': 133}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 105, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 107, 'numEvents': 50, 'numAffected': 50}, {'groupId': 'EG004', 'numAtRisk': 200, 'numEvents': 18, 'numAffected': 18}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Injection Site Ecchymosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 27, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 105, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 107, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG004', 'numAtRisk': 200, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Injection Site Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 99, 'numAffected': 99}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 105, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 107, 'numEvents': 38, 'numAffected': 38}, {'groupId': 'EG004', 'numAtRisk': 200, 'numEvents': 20, 'numAffected': 20}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 31, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 105, 'numEvents': 18, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 107, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG004', 'numAtRisk': 200, 'numEvents': 36, 'numAffected': 36}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Shivering', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 105, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 107, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 200, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 35, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 18, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 105, 'numEvents': 25, 'numAffected': 25}, {'groupId': 'EG003', 'numAtRisk': 107, 'numEvents': 22, 'numAffected': 22}, {'groupId': 'EG004', 'numAtRisk': 200, 'numEvents': 48, 'numAffected': 48}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 39, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 105, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 107, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG004', 'numAtRisk': 200, 'numEvents': 45, 'numAffected': 45}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}], 'seriousEvents': [{'term': 'Acute Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 105, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Retroperitoneal Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Small Intestinal Obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Umbilical Hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Umbilical Hernia, Obstructive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Non Cardiac Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Cholecystitis Acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Bacterial Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Infective Exacerbation of Chronic Obstructive Airways Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Lobar Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Otitis Media Chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Humerus Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pelvic Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Subdural Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Tibia Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Acute Myeloid Leukemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Breast Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Prostate Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Cerebral Cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Cerebrovascular Accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Subarachnoid Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Renal Failure Acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Endometrial Hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pulmonary Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Cholecystectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 201, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 295, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}], 'frequencyThreshold': '5.0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '105', 'groupId': 'OG002'}, {'value': '107', 'groupId': 'OG003'}, {'value': '200', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1a: Fluzone ID After Fluzone ID', 'description': 'Participants who received a dose (0.1 mL) of Fluzone intradermal (ID) after receiving Fluzone ID in Study FID29 (NCT00551031)'}, {'id': 'OG001', 'title': 'Group 1b: Fluzone IM After Fluzone ID', 'description': 'Participants who received a dose (0.5 mL) of Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID29 (NCT00551031)'}, {'id': 'OG002', 'title': 'Group 2a: Fluzone IM After Fluzone IM', 'description': 'Participants who received a dose (0.5 mL) Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID29 NCT00551031)'}, {'id': 'OG003', 'title': 'Group 2b: Fluzone ID After Fluzone IM', 'description': 'Participants who received a dose (0.1 )Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID29 (NCT00551031)'}, {'id': 'OG004', 'title': 'Group 3: Fluzone HD After Fluzone HD', 'description': 'Participants who received a dose (0.5 mL) of Fluzone High Dose (HD) vaccine after receiving Fluzone HD vaccine in Study FID29 (NCT00551031)'}], 'classes': [{'title': 'Any Solicited Injection site Pain', 'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}, {'value': '91', 'groupId': 'OG004'}]}]}, {'title': 'Grade 3 Pain (Incapacitating)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Any Solicited Injection site Erythema', 'categories': [{'measurements': [{'value': '207', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '71', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}]}]}, {'title': 'Grade 3 Erythema (≥ 5 cm)', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}]}, {'title': 'Any Solicited Injection site Swelling', 'categories': [{'measurements': [{'value': '127', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}, {'value': '23', 'groupId': 'OG004'}]}]}, {'title': 'Grade 3 Swelling (≥ 5 cm)', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}]}, {'title': 'Any Solicited Injection site Induration', 'categories': [{'measurements': [{'value': '133', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}]}]}, {'title': 'Grade 3 Induration (≥ 5 cm)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Any Solicited Injection site Ecchymosis', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}]}, {'title': 'Grade 3 Ecchymosis (≥ 5 cm)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Any Solicited Injection site Pruritus', 'categories': [{'measurements': [{'value': '99', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}]}]}, {'title': 'Grade 3 Pruritus (Incapacitating)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Any Fever', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}]}, {'title': 'Grade 3 Fever (>102.2 ºF)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Any Headache', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '45', 'groupId': 'OG004'}]}]}, {'title': 'Grade 3 Headache (Prevents daily activities)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Any Malaise', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}]}]}, {'title': 'Grade 3 Malaise (Prevents daily activities)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}, {'title': 'Any Myalgia', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '48', 'groupId': 'OG004'}]}]}, {'title': 'Grade 3 Myalgia (Prevents daily activities)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}, {'title': 'Any Shivering', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}]}, {'title': 'Grade 3 Shivering (Prevents daily activities)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 0 through 7 post vaccination', 'description': 'Solicited injection site reactions: Pain, Erythema (redness), Swelling, Induration, Ecchymosis, Pruritus. Solicited systemic reactions: Fever, (Temperature), Headache, Malaise, Myalgia, and Shivering.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis was on all enrolled and vaccinated subjects with available reaction data, intent-to-treat population.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '273', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '102', 'groupId': 'OG003'}, {'value': '187', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1a: Fluzone ID After Fluzone ID', 'description': 'Participants who received a dose (0.1 mL) of Fluzone intradermal (ID) after receiving Fluzone ID in Study FID29 (NCT00551031)'}, {'id': 'OG001', 'title': 'Group 1b: Fluzone IM After Fluzone ID', 'description': 'Participants who received a dose (0.5 mL) of Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID29 (NCT00551031)'}, {'id': 'OG002', 'title': 'Group 2a: Fluzone IM After Fluzone IM', 'description': 'Participants who received a dose (0.5 mL) Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID29 NCT00551031)'}, {'id': 'OG003', 'title': 'Group 2b: Fluzone ID After Fluzone IM', 'description': 'Participants who received a dose (0.1 )Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID29 (NCT00551031)'}, {'id': 'OG004', 'title': 'Group 3: Fluzone HD After Fluzone HD', 'description': 'Participants who received a dose (0.5 mL) of Fluzone High Dose (HD) vaccine after receiving Fluzone HD vaccine in Study FID29 (NCT00551031)'}], 'classes': [{'title': 'A/H1N1 Pre-dose (Day 0,N = 273, 94, 100, 102, 186)', 'categories': [{'measurements': [{'value': '28.7', 'groupId': 'OG000', 'lowerLimit': '25.3', 'upperLimit': '32.5'}, {'value': '23.5', 'groupId': 'OG001', 'lowerLimit': '19.3', 'upperLimit': '28.6'}, {'value': '27.3', 'groupId': 'OG002', 'lowerLimit': '22.0', 'upperLimit': '33.9'}, {'value': '20.8', 'groupId': 'OG003', 'lowerLimit': '17.1', 'upperLimit': '25.2'}, {'value': '28.7', 'groupId': 'OG004', 'lowerLimit': '24.5', 'upperLimit': '33.6'}]}]}, {'title': 'A/H1N1 Post -dose (Day 0 = 273, 94, 100, 102, 185)', 'categories': [{'measurements': [{'value': '75.0', 'groupId': 'OG000', 'lowerLimit': '66.4', 'upperLimit': '84.7'}, {'value': '59.6', 'groupId': 'OG001', 'lowerLimit': '48.4', 'upperLimit': '73.2'}, {'value': '72.4', 'groupId': 'OG002', 'lowerLimit': '58.7', 'upperLimit': '89.2'}, {'value': '73.5', 'groupId': 'OG003', 'lowerLimit': '60.4', 'upperLimit': '89.5'}, {'value': '113', 'groupId': 'OG004', 'lowerLimit': '96.2', 'upperLimit': '133'}]}]}, {'title': 'A/H2N3 Pre-dose (Day 0, N= 273, 94, 100, 102, 186)', 'categories': [{'measurements': [{'value': '30.8', 'groupId': 'OG000', 'lowerLimit': '26.3', 'upperLimit': '36.2'}, {'value': '28.7', 'groupId': 'OG001', 'lowerLimit': '22.1', 'upperLimit': '37.3'}, {'value': '24.5', 'groupId': 'OG002', 'lowerLimit': '19.6', 'upperLimit': '30.7'}, {'value': '28.1', 'groupId': 'OG003', 'lowerLimit': '21.8', 'upperLimit': '36.2'}, {'value': '36.6', 'groupId': 'OG004', 'lowerLimit': '30.2', 'upperLimit': '44.4'}]}]}, {'title': 'A/H2N3 Post Dose (n = 273, 94, 100, 102, 187)', 'categories': [{'measurements': [{'value': '244', 'groupId': 'OG000', 'lowerLimit': '205', 'upperLimit': '289'}, {'value': '212', 'groupId': 'OG001', 'lowerLimit': '156', 'upperLimit': '288'}, {'value': '257', 'groupId': 'OG002', 'lowerLimit': '197', 'upperLimit': '336'}, {'value': '273', 'groupId': 'OG003', 'lowerLimit': '208', 'upperLimit': '358'}, {'value': '454', 'groupId': 'OG004', 'lowerLimit': '380', 'upperLimit': '543'}]}]}, {'title': 'B Pre Dose (n = 273, 94, 100, 102, 186', 'categories': [{'measurements': [{'value': '22.8', 'groupId': 'OG000', 'lowerLimit': '20.2', 'upperLimit': '25.6'}, {'value': '18.9', 'groupId': 'OG001', 'lowerLimit': '15.5', 'upperLimit': '22.9'}, {'value': '21.8', 'groupId': 'OG002', 'lowerLimit': '18.0', 'upperLimit': '26.5'}, {'value': '21.9', 'groupId': 'OG003', 'lowerLimit': '17.9', 'upperLimit': '26.8'}, {'value': '22.3', 'groupId': 'OG004', 'lowerLimit': '19.6', 'upperLimit': '25.4'}]}]}, {'title': 'B Post Dose (n = 273, 94, 100, 102, 185)', 'categories': [{'measurements': [{'value': '54.3', 'groupId': 'OG000', 'lowerLimit': '48.3', 'upperLimit': '61.0'}, {'value': '51.4', 'groupId': 'OG001', 'lowerLimit': '42.4', 'upperLimit': '62.3'}, {'value': '60.4', 'groupId': 'OG002', 'lowerLimit': '49.6', 'upperLimit': '73.6'}, {'value': '51.1', 'groupId': 'OG003', 'lowerLimit': '42.9', 'upperLimit': '60.9'}, {'value': '78.2', 'groupId': 'OG004', 'lowerLimit': '68.5', 'upperLimit': '89.3'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 0 and Day 28 post-vaccination', 'description': 'Serum antibody titers for the influenza vaccine serogroups A/H1N1, A/H3N2, and B were assessed by the hemagglutinin inhibition (HAI) assay.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Serum antibody titers were assessed in the per-protocol population.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieved Seroprotection Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '273', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '102', 'groupId': 'OG003'}, {'value': '187', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1a: Fluzone ID After Fluzone ID', 'description': 'Participants who received a dose (0.1 mL) of Fluzone intradermal (ID) after receiving Fluzone ID in Study FID29 (NCT00551031)'}, {'id': 'OG001', 'title': 'Group 1b: Fluzone IM After Fluzone ID', 'description': 'Participants who received a dose (0.5 mL) of Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID29 (NCT00551031)'}, {'id': 'OG002', 'title': 'Group 2a: Fluzone IM After Fluzone IM', 'description': 'Participants who received a dose (0.5 mL) Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID29 NCT00551031)'}, {'id': 'OG003', 'title': 'Group 2b: Fluzone ID After Fluzone IM', 'description': 'Participants who received a dose (0.1 )Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID29 (NCT00551031)'}, {'id': 'OG004', 'title': 'Group 3: Fluzone HD After Fluzone HD', 'description': 'Participants who received a dose (0.5 mL) of Fluzone High Dose (HD) vaccine after receiving Fluzone HD vaccine in Study FID29 (NCT00551031)'}], 'classes': [{'title': 'A/H1N1 Serogroup - (Day 0, Pre-dose)', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}, {'value': '41', 'groupId': 'OG004'}]}]}, {'title': 'A/H1N1 Serogroup - (Day 28, Post-dose)', 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}, {'value': '88', 'groupId': 'OG004'}]}]}, {'title': 'A/H3N2 Serogroup - (Day 0, Pre-dose)', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '50', 'groupId': 'OG004'}]}]}, {'title': 'A/H3N2 Serogroup - (Day 28, Post-dose)', 'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '94', 'groupId': 'OG002'}, {'value': '91', 'groupId': 'OG003'}, {'value': '98', 'groupId': 'OG004'}]}]}, {'title': 'B Serogroup - (Day 0, Pre-dose)', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}]}]}, {'title': 'B Serogroup - (Day 28, Post-dose)', 'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}, {'value': '66', 'groupId': 'OG003'}, {'value': '83', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 0 and 28 post-vaccination', 'description': 'Seroprotection was defined as hemagglutinin inhibition (HAI) titer ≥ 1:40 at Day 28.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Serum antibody titers were assessed in the per-protocol population.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieved Seroconversion Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '273', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '102', 'groupId': 'OG003'}, {'value': '186', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1a: Fluzone ID After Fluzone ID', 'description': 'Participants who received a dose (0.1 mL) of Fluzone intradermal (ID) after receiving Fluzone ID in Study FID29 (NCT00551031)'}, {'id': 'OG001', 'title': 'Group 1b: Fluzone IM After Fluzone ID', 'description': 'Participants who received a dose (0.5 mL) of Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID29 (NCT00551031)'}, {'id': 'OG002', 'title': 'Group 2a: Fluzone IM After Fluzone IM', 'description': 'Participants who received a dose (0.5 mL) Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID29 NCT00551031)'}, {'id': 'OG003', 'title': 'Group 2b: Fluzone ID After Fluzone IM', 'description': 'Participants who received a dose (0.1 )Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID29 (NCT00551031)'}, {'id': 'OG004', 'title': 'Group 3: Fluzone HD After Fluzone HD', 'description': 'Participants who received a dose (0.5 mL) of Fluzone High Dose (HD) vaccine after receiving Fluzone HD vaccine in Study FID29 (NCT00551031)'}], 'classes': [{'title': 'A/H1N1 (N = 273, 94, 100, 102, 185)', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}, {'value': '47', 'groupId': 'OG004'}]}]}, {'title': 'A/H2N3 (N = 273, 94, 100, 102, 186)', 'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}, {'value': '75', 'groupId': 'OG003'}, {'value': '84', 'groupId': 'OG004'}]}]}, {'title': 'B (N = 273, 94, 100, 102, 185)', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}, {'value': '41', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 28 post vaccination', 'description': 'Seroconversion was defined as either a pre-vaccination hemagglutinin inhibition (HAI) titer \\< 1:10 and a post-vaccination titer ≥ 1:40 or a pre- vaccination titer ≥ 1:10 and a minimum 4 fold increase at 28 days post vaccination.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Serum antibody titers were assessed in the per-protocol population.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group 1a: Fluzone ID After Fluzone ID', 'description': 'Participants who received a dose (0.1 mL) of Fluzone intradermal (ID) after receiving Fluzone ID in Study FID29 (NCT00551031)'}, {'id': 'FG001', 'title': 'Group 1b: Fluzone IM After Fluzone ID', 'description': 'Participants who received a dose (0.5 mL) of Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID29 (NCT00551031)'}, {'id': 'FG002', 'title': 'Group 2a: Fluzone IM After Fluzone IM', 'description': 'Participants who received a dose (0.5 mL) Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID29 NCT00551031)'}, {'id': 'FG003', 'title': 'Group 2b: Fluzone ID After Fluzone IM', 'description': 'Participants who received a dose (0.1 )Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID29 (NCT00551031)'}, {'id': 'FG004', 'title': 'Group 3: Fluzone HD After Fluzone HD', 'description': 'Participants who received a dose (0.5 mL) of Fluzone High Dose (HD) vaccine after receiving Fluzone HD vaccine in Study FID29 (NCT00551031)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '295'}, {'groupId': 'FG001', 'numSubjects': '98'}, {'groupId': 'FG002', 'numSubjects': '105'}, {'groupId': 'FG003', 'numSubjects': '108'}, {'groupId': 'FG004', 'numSubjects': '201'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '292'}, {'groupId': 'FG001', 'numSubjects': '98'}, {'groupId': 'FG002', 'numSubjects': '105'}, {'groupId': 'FG003', 'numSubjects': '108'}, {'groupId': 'FG004', 'numSubjects': '199'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Serious Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants were enrolled from 14 October to 20 November 2008 in 27 medical centers in the US.', 'preAssignmentDetails': 'A total of 807 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '295', 'groupId': 'BG000'}, {'value': '98', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}, {'value': '108', 'groupId': 'BG003'}, {'value': '201', 'groupId': 'BG004'}, {'value': '807', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Group 1a: Fluzone ID After Fluzone ID', 'description': 'Participants who received a dose (0.1 mL) of Fluzone intradermal (ID) after receiving Fluzone ID in Study FID29 (NCT00551031)'}, {'id': 'BG001', 'title': 'Group 1b: Fluzone IM After Fluzone ID', 'description': 'Participants who received a dose (0.5 mL) of Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID29 (NCT00551031)'}, {'id': 'BG002', 'title': 'Group 2a: Fluzone IM After Fluzone IM', 'description': 'Participants who received a dose (0.5 mL) Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID29 NCT00551031)'}, {'id': 'BG003', 'title': 'Group 2b: Fluzone ID After Fluzone IM', 'description': 'Participants who received a dose (0.1 )Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID29 (NCT00551031)'}, {'id': 'BG004', 'title': 'Group 3: Fluzone HD After Fluzone HD', 'description': 'Participants who received a dose (0.5 mL) of Fluzone High Dose (HD) vaccine after receiving Fluzone HD vaccine in Study FID29 (NCT00551031)'}, {'id': 'BG005', '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'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': '>=65 years', 'measurements': [{'value': '295', 'groupId': 'BG000'}, {'value': '98', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}, {'value': '108', 'groupId': 'BG003'}, {'value': '201', 'groupId': 'BG004'}, {'value': '807', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '73.9', 'spread': '5.99', 'groupId': 'BG000'}, {'value': '74.2', 'spread': '5.97', 'groupId': 'BG001'}, {'value': '73.0', 'spread': '5.37', 'groupId': 'BG002'}, {'value': '74.3', 'spread': '5.11', 'groupId': 'BG003'}, {'value': '73.5', 'spread': '5.74', 'groupId': 'BG004'}, {'value': '73.8', 'spread': '5.74', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '169', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '61', 'groupId': 'BG003'}, {'value': '117', 'groupId': 'BG004'}, {'value': '459', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '126', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}, {'value': '47', 'groupId': 'BG003'}, {'value': '84', 'groupId': 'BG004'}, {'value': '348', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '295', 'groupId': 'BG000'}, {'value': '98', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}, {'value': '108', 'groupId': 'BG003'}, {'value': '201', 'groupId': 'BG004'}, {'value': '807', 'groupId': 'BG005'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 807}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'dispFirstSubmitDate': '2010-03-31', 'completionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-05', 'studyFirstSubmitDate': '2008-10-16', 'dispFirstSubmitQcDate': '2010-03-31', 'resultsFirstSubmitDate': '2011-07-14', 'studyFirstSubmitQcDate': '2008-10-16', 'dispFirstPostDateStruct': {'date': '2010-04-02', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2013-12-31', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-07-14', 'studyFirstPostDateStruct': {'date': '2008-10-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-08-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection', 'timeFrame': 'Days 0 through 7 post vaccination', 'description': 'Solicited injection site reactions: Pain, Erythema (redness), Swelling, Induration, Ecchymosis, Pruritus. Solicited systemic reactions: Fever, (Temperature), Headache, Malaise, Myalgia, and Shivering.'}], 'secondaryOutcomes': [{'measure': 'Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection', 'timeFrame': 'Day 0 and Day 28 post-vaccination', 'description': 'Serum antibody titers for the influenza vaccine serogroups A/H1N1, A/H3N2, and B were assessed by the hemagglutinin inhibition (HAI) assay.'}, {'measure': 'Percentage of Participants Who Achieved Seroprotection Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine', 'timeFrame': 'Days 0 and 28 post-vaccination', 'description': 'Seroprotection was defined as hemagglutinin inhibition (HAI) titer ≥ 1:40 at Day 28.'}, {'measure': 'Percentage of Participants Who Achieved Seroconversion Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine', 'timeFrame': 'Day 28 post vaccination', 'description': 'Seroconversion was defined as either a pre-vaccination hemagglutinin inhibition (HAI) titer \\< 1:10 and a post-vaccination titer ≥ 1:40 or a pre- vaccination titer ≥ 1:10 and a minimum 4 fold increase at 28 days post vaccination.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Influenza', 'Orthomyxovirus Infection', 'Inactivated Split-virion influenza vaccine', 'Elderly'], 'conditions': ['Influenza', 'Orthomyxovirus Infection', 'Myxovirus Infection']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.sanofipasteur.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This is a multi-center study designed to evaluate the safety and immunogenicity of a Fluzone revaccination in elderly adults aged ≥ 65 years.\n\nPrimary Objective:\n\nTo describe the safety profile for all subjects.\n\nSecondary Objective:\n\nTo describe immunogenicity 28 days following revaccination with one of three Fluzone formulations.', 'detailedDescription': 'Subjects who previously participated in study FID29 will be invited to participate in this revaccination study. They will be assigned to 1 of 3 groups based on the group they were previously randomized to and the vaccine received in study FID29.'}, '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* Enrolled in and completed study FID29 and received the correct vaccine for the group to which they were randomized\n* Informed consent form signed and dated\n* Able to attend all scheduled visits and to comply with all trial procedures\n* Subject is medically stable.\n\nExclusion Criteria :\n\n* Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances\n* Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the four weeks preceding the trial vaccination\n* Planned participation in another clinical trial during the present trial period\n* Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy\n* Chronic illness, at a stage that could interfere with trial conduct or completion, in the opinion of the investigator\n* Current alcohol abuse or drug addiction that may interfere with the subject's ability to comply with trial procedures\n* Receipt of blood or blood-derived products in the past 3 months, that might interfere with the assessment of immune response\n* Receipt of any vaccination in the 4 weeks preceding the trial vaccination\n* Planned receipt of any vaccine in the 4 weeks following the trial vaccination\n* Known human immunodeficiency virus (HIV), hepatitis B (HBs) antigen, or Hepatitis C seropositivity.\n* Previous vaccination against influenza in the past 6 months with the trial vaccine or another vaccine\n* Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating intramuscular (IM) vaccination\n* Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent\n* Neoplastic disease or any hematologic malignancy, (except localized skin or prostate cancer that is stable at the time of vaccination in the absence of therapy, as well as subjects who have a history of neoplastic disease and who have been disease free for ≥ 5 years).\n* Personal or family history of Guillain-Barré Syndrome."}, 'identificationModule': {'nctId': 'NCT00775450', 'briefTitle': 'Influenza Vaccine Revaccination in Ambulatory Elderly Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Safety and Immunogenicity of Revaccination With Influenza Vaccine in Ambulatory Elderly Subjects Previously Vaccinated With Fluzone ID, Fluzone HD, and Fluzone® IM', 'orgStudyIdInfo': {'id': 'FID21'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1a: Fluzone ID After Fluzone ID', 'interventionNames': ['Biological: Influenza Virus Vaccine USP Trivalent Types A and B']}, {'type': 'EXPERIMENTAL', 'label': 'Group 1b: Fluzone IM After Fluzone ID', 'interventionNames': ['Biological: Influenza Virus Vaccine USP Trivalent Types A and B']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2a: Fluzone IM After Fluzone IM', 'interventionNames': ['Biological: Influenza Virus Vaccine USP Trivalent Types A and B']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2b: Fluzone ID After Fluzone IM', 'interventionNames': ['Biological: Influenza Virus Vaccine USP Trivalent Types A and B']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 3: Fluzone HD After Fluzone HD', 'interventionNames': ['Biological: Influenza Virus Vaccine USP Trivalent Types A and B']}], 'interventions': [{'name': 'Influenza Virus Vaccine USP Trivalent Types A and B', 'type': 'BIOLOGICAL', 'otherNames': ['Fluzone'], 'description': '0.1 mL, Intradermal', 'armGroupLabels': ['Group 1a: Fluzone ID After Fluzone ID']}, {'name': 'Influenza Virus Vaccine USP Trivalent Types A and B', 'type': 'BIOLOGICAL', 'otherNames': ['Fluzone'], 'description': '0.5 mL, Intramuscular', 'armGroupLabels': ['Group 1b: Fluzone IM After Fluzone ID']}, {'name': 'Influenza Virus Vaccine USP Trivalent Types A and B', 'type': 'BIOLOGICAL', 'otherNames': ['Fluzone'], 'description': '0.5 mL, Intramuscular', 'armGroupLabels': ['Group 2a: Fluzone IM After Fluzone IM']}, {'name': 'Influenza Virus Vaccine USP Trivalent Types A and B', 'type': 'BIOLOGICAL', 'otherNames': ['Fluzone'], 'description': '0.1 mL, Intradermal', 'armGroupLabels': ['Group 2b: Fluzone ID After Fluzone IM']}, {'name': 'Influenza Virus Vaccine USP Trivalent Types A and B', 'type': 'BIOLOGICAL', 'otherNames': ['Fluzone'], 'description': '0.5 mL, Intramuscular', 'armGroupLabels': ['Group 3: Fluzone HD After Fluzone HD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35216', 'city': 'Hoover', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 33.40539, 'lon': -86.81138}}, {'zip': '36608', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '85224', 'city': 'Chandler', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.30616, 'lon': -111.84125}}, {'zip': '85213', 'city': 'Mesa', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.42227, 'lon': -111.82264}}, {'zip': '85014', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85710', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '92708', 'city': 'Fountain Valley', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 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{'zip': '65802', 'city': 'Springfield', 'state': 'Missouri', 'country': 'United States', 'geoPoint': {'lat': 37.21533, 'lon': -93.29824}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '27518', 'city': 'Cary', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.79154, 'lon': -78.78112}}, {'zip': '27609', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '45249', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '19020', 'city': 'Bensalem', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 40.10455, 'lon': -74.95128}}, {'zip': '02886', 'city': 'Warwick', 'state': 'Rhode Island', 'country': 'United States', 'geoPoint': {'lat': 41.7001, 'lon': -71.41617}}, {'zip': '29464', 'city': 'Mt. Pleasant', 'state': 'South Carolina', 'country': 'United States', 'geoPoint': {'lat': 32.79407, 'lon': -79.86259}}, {'zip': '76107', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '77555', 'city': 'Galveston', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.30135, 'lon': -94.7977}}, {'zip': '84109', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '84121', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '84088', 'city': 'West Jordan', 'state': 'Utah', 'country': 'United States', 'geoPoint': {'lat': 40.60967, 'lon': -111.9391}}, {'zip': '54449', 'city': 'Marshfield', 'state': 'Wisconsin', 'country': 'United States', 'geoPoint': {'lat': 44.66885, 'lon': -90.1718}}], 'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi Pasteur Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi Pasteur, a Sanofi Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}