Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2026-03-04 @ 5:58 AM
Study NCT ID:
NCT02258334
Status:
COMPLETED
Last Update Posted:
2015-10-19
First Post:
2014-10-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose, Influenza Vaccines in Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007251', 'term': 'Influenza, Human'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009976', 'term': 'Orthomyxoviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007252', 'term': 'Influenza Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}], 'ancestors': [{'id': 'D014765', 'term': 'Viral 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 event data were collected from Day 0 (post-vaccination) up to Day 21 post-vaccination.', 'eventGroups': [{'id': 'EG000', 'title': 'Group 1', 'description': 'Adults 18 to \\< 65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.', 'otherNumAtRisk': 49, 'otherNumAffected': 26, 'seriousNumAtRisk': 49, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Group 2', 'description': 'Adults 18 to \\< 65 years of age randomly assigned to receive an intradermal dose of Fluzone Intradermal vaccine.', 'otherNumAtRisk': 54, 'otherNumAffected': 28, 'seriousNumAtRisk': 54, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Group 3', 'description': 'Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.', 'otherNumAtRisk': 52, 'otherNumAffected': 19, 'seriousNumAtRisk': 52, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Group 4', 'description': 'Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone High Dose vaccine.', 'otherNumAtRisk': 52, 'otherNumAffected': 21, 'seriousNumAtRisk': 52, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Injection site Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 26, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 28, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 19, 'numAffected': 19}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 21, 'numAffected': 21}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Injection site Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 19, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Injection site Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Injection site Induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Injection site Ecchymosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Shivering', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}], 'seriousEvents': [{'term': 'Haematochezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}], 'frequencyThreshold': '5.00'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1', 'description': 'Adults 18 to \\< 65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.'}, {'id': 'OG001', 'title': 'Group 2', 'description': 'Adults 18 to \\< 65 years of age randomly assigned to receive an intradermal dose of Fluzone Intradermal vaccine.'}, {'id': 'OG002', 'title': 'Group 3', 'description': 'Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.'}, {'id': 'OG003', 'title': 'Group 4', 'description': 'Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone High-Dose vaccine.'}], 'classes': [{'title': 'Injection-site Pain', 'categories': [{'measurements': [{'value': '53.1', 'groupId': 'OG000'}, {'value': '51.9', 'groupId': 'OG001'}, {'value': '36.5', 'groupId': 'OG002'}, {'value': '40.4', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Injection-site Pain', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.9', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Injection-site Erythema', 'categories': [{'measurements': [{'value': '6.1', 'groupId': 'OG000'}, {'value': '35.2', 'groupId': 'OG001'}, {'value': '3.8', 'groupId': 'OG002'}, {'value': '7.7', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Injection site Erythema', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Injection-site Swelling', 'categories': [{'measurements': [{'value': '4.1', 'groupId': 'OG000'}, {'value': '22.2', 'groupId': 'OG001'}, {'value': '5.8', 'groupId': 'OG002'}, {'value': '5.8', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Injection-site Swelling', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Injection-site Induration', 'categories': [{'measurements': [{'value': '6.1', 'groupId': 'OG000'}, {'value': '18.5', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1.9', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Injection-site Induration', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Injection-site Ecchymosis', 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000'}, {'value': '5.6', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1.9', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Injection-site Ecchymosis', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Fever', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Fever', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Headache', 'categories': [{'measurements': [{'value': '28.6', 'groupId': 'OG000'}, {'value': '18.5', 'groupId': 'OG001'}, {'value': '17.3', 'groupId': 'OG002'}, {'value': '25.0', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Headache', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1.9', 'groupId': 'OG003'}]}]}, {'title': 'Malaise', 'categories': [{'measurements': [{'value': '16.3', 'groupId': 'OG000'}, {'value': '27.8', 'groupId': 'OG001'}, {'value': '9.6', 'groupId': 'OG002'}, {'value': '15.4', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Malaise', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.9', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1.9', 'groupId': 'OG003'}]}]}, {'title': 'Myalgia', 'categories': [{'measurements': [{'value': '26.5', 'groupId': 'OG000'}, {'value': '25.9', 'groupId': 'OG001'}, {'value': '23.1', 'groupId': 'OG002'}, {'value': '28.8', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Myalgia', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.9', 'groupId': 'OG001'}, {'value': '1.9', 'groupId': 'OG002'}, {'value': '1.9', 'groupId': 'OG003'}]}]}, {'title': 'Shivering', 'categories': [{'measurements': [{'value': '4.1', 'groupId': 'OG000'}, {'value': '9.3', 'groupId': 'OG001'}, {'value': '1.9', 'groupId': 'OG002'}, {'value': '1.9', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Shivering', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0 up to Day 7 post-vaccination', 'description': 'Injection-site reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering. Grade 3 Injection-site reactions: Pain, Significant, prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis, \\>100 mm. Grade 3 Systemic reactions: Fever, ≥39.0°C or ≥102.1°F; Headache, Malaise, Myalgia, and Shivering, Significant, prevents daily activity.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Solicited injection-site and systemic reactions were assessed in the Safety Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Titers (GMTs) of Antibodies to the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine Antigens Before and Following Vaccination With the Respective Vaccine.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1', 'description': 'Adults 18 to \\< 65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.'}, {'id': 'OG001', 'title': 'Group 2', 'description': 'Adults 18 to \\< 65 years of age randomly assigned to receive an intradermal dose of Fluzone Intradermal vaccine.'}, {'id': 'OG002', 'title': 'Group 3', 'description': 'Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.'}, {'id': 'OG003', 'title': 'Group 4', 'description': 'Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone High-Dose vaccine.'}], 'classes': [{'title': 'A/H1N1; Pre-vaccination (N=49,52,52,52)', 'categories': [{'measurements': [{'value': '153', 'groupId': 'OG000', 'lowerLimit': '90.6', 'upperLimit': '260'}, {'value': '148', 'groupId': 'OG001', 'lowerLimit': '94.3', 'upperLimit': '231'}, {'value': '148', 'groupId': 'OG002', 'lowerLimit': '96.7', 'upperLimit': '226'}, {'value': '171', 'groupId': 'OG003', 'lowerLimit': '124', 'upperLimit': '237'}]}]}, {'title': 'A/H1N1; Post-vaccination (N=49,53,52,52)', 'categories': [{'measurements': [{'value': '707', 'groupId': 'OG000', 'lowerLimit': '490', 'upperLimit': '1020'}, {'value': '632', 'groupId': 'OG001', 'lowerLimit': '459', 'upperLimit': '870'}, {'value': '288', 'groupId': 'OG002', 'lowerLimit': '200', 'upperLimit': '414'}, {'value': '386', 'groupId': 'OG003', 'lowerLimit': '294', 'upperLimit': '506'}]}]}, {'title': 'A/H3N2; Pre-vaccination (N=49,53,52,52)', 'categories': [{'measurements': [{'value': '139', 'groupId': 'OG000', 'lowerLimit': '90.9', 'upperLimit': '212'}, {'value': '147', 'groupId': 'OG001', 'lowerLimit': '97.6', 'upperLimit': '221'}, {'value': '168', 'groupId': 'OG002', 'lowerLimit': '119', 'upperLimit': '237'}, {'value': '275', 'groupId': 'OG003', 'lowerLimit': '193', 'upperLimit': '390'}]}]}, {'title': 'A/H3N2; Post-vaccination (N=49,53,52,52)', 'categories': [{'measurements': [{'value': '613', 'groupId': 'OG000', 'lowerLimit': '439', 'upperLimit': '857'}, {'value': '648', 'groupId': 'OG001', 'lowerLimit': '470', 'upperLimit': '894'}, {'value': '349', 'groupId': 'OG002', 'lowerLimit': '244', 'upperLimit': '499'}, {'value': '680', 'groupId': 'OG003', 'lowerLimit': '490', 'upperLimit': '942'}]}]}, {'title': 'B (Yamagata); Pre-vaccination (N=49,53,52,52)', 'categories': [{'measurements': [{'value': '596', 'groupId': 'OG000', 'lowerLimit': '400', 'upperLimit': '888'}, {'value': '471', 'groupId': 'OG001', 'lowerLimit': '324', 'upperLimit': '684'}, {'value': '471', 'groupId': 'OG002', 'lowerLimit': '342', 'upperLimit': '649'}, {'value': '465', 'groupId': 'OG003', 'lowerLimit': '340', 'upperLimit': '635'}]}]}, {'title': 'B (Yamagata); Post-vaccination (N=49,53,52,52)', 'categories': [{'measurements': [{'value': '1836', 'groupId': 'OG000', 'lowerLimit': '1376', 'upperLimit': '2449'}, {'value': '1272', 'groupId': 'OG001', 'lowerLimit': '906', 'upperLimit': '1785'}, {'value': '864', 'groupId': 'OG002', 'lowerLimit': '651', 'upperLimit': '1146'}, {'value': '994', 'groupId': 'OG003', 'lowerLimit': '777', 'upperLimit': '1270'}]}]}, {'title': 'B (Victoria); Pre-vaccination (N=49,0,52,0)', 'categories': [{'measurements': [{'value': '252', 'groupId': 'OG000', 'lowerLimit': '164', 'upperLimit': '385'}, {'value': 'NA', 'comment': 'B (Victoria) antigen was not in the administered vaccine', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '273', 'groupId': 'OG002', 'lowerLimit': '195', 'upperLimit': '382'}, {'value': 'NA', 'comment': 'B (Victoria) antigen was not in the administered vaccine', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'B (Victoria); Post-vaccination (N=49,0,52,0)', 'categories': [{'measurements': [{'value': '1119', 'groupId': 'OG000', 'lowerLimit': '838', 'upperLimit': '1495'}, {'value': 'NA', 'comment': 'B (Victoria) antigen was not in the administered vaccine', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '568', 'groupId': 'OG002', 'lowerLimit': '430', 'upperLimit': '750'}, {'value': 'NA', 'comment': 'B (Victoria) antigen was not in the administered vaccine', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 0 (pre-vaccination) and Day 21 post-vaccination', 'description': 'Geometric mean titers of antibodies to Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose vaccine antigens were assessed using the hemagglutination inhibition (HAI) assay.', 'unitOfMeasure': 'Titers (1/dilution)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Geometric mean titers were assessed in the Per-Protocol Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Seroprotection Before and Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1', 'description': 'Adults 18 to \\< 65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.'}, {'id': 'OG001', 'title': 'Group 2', 'description': 'Adults 18 to \\< 65 years of age randomly assigned to receive an intradermal of Fluzone Intradermal vaccine.'}, {'id': 'OG002', 'title': 'Group 3', 'description': 'Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.'}, {'id': 'OG003', 'title': 'Group 4', 'description': 'Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone High-Dose vaccine.'}], 'classes': [{'title': 'A/H1N1; Pre-vaccination (N=49,52,52,52)', 'categories': [{'measurements': [{'value': '77.6', 'groupId': 'OG000'}, {'value': '84.6', 'groupId': 'OG001'}, {'value': '82.7', 'groupId': 'OG002'}, {'value': '90.4', 'groupId': 'OG003'}]}]}, {'title': 'A/H1N1; Post-vaccination (N=49,53,52,52)', 'categories': [{'measurements': [{'value': '98.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}, {'value': '92.3', 'groupId': 'OG002'}, {'value': '100.0', 'groupId': 'OG003'}]}]}, {'title': 'A/H3N2; Pre-vaccination (N=49,53,52,52)', 'categories': [{'measurements': [{'value': '81.6', 'groupId': 'OG000'}, {'value': '83.0', 'groupId': 'OG001'}, {'value': '90.4', 'groupId': 'OG002'}, {'value': '96.2', 'groupId': 'OG003'}]}]}, {'title': 'A/H3N2; Post-vaccination (N=49,53,52,52)', 'categories': [{'measurements': [{'value': '98.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}, {'value': '94.2', 'groupId': 'OG002'}, {'value': '100.0', 'groupId': 'OG003'}]}]}, {'title': 'B (Yamagata); Pre-vaccination (N=49,53,52,52)', 'categories': [{'measurements': [{'value': '98.0', 'groupId': 'OG000'}, {'value': '98.1', 'groupId': 'OG001'}, {'value': '96.2', 'groupId': 'OG002'}, {'value': '100.0', 'groupId': 'OG003'}]}]}, {'title': 'B (Yamagata); Post-vaccination (N=49,53,52,52)', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}, {'value': '100.0', 'groupId': 'OG002'}, {'value': '100.0', 'groupId': 'OG003'}]}]}, {'title': 'B (Victoria); Pre-vaccination (n=49,0,52,0)', 'categories': [{'measurements': [{'value': '91.8', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'B (Victoria) antigen was not in the administered vaccine', 'groupId': 'OG001'}, {'value': '94.2', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'B (Victoria) antigen was not in the administered vaccine', 'groupId': 'OG003'}]}]}, {'title': 'B (Victoria); Post-vaccination (N=49,0,52,0)', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'B (Victoria) antigen was not in the administered vaccine', 'groupId': 'OG001'}, {'value': '100.0', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'B (Victoria) antigen was not in the administered vaccine', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0 (pre-vaccination) and Day 21 post-vaccination', 'description': 'Antibodies to Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose vaccine antigens were assessed using the hemagglutination inhibition (HAI) assay. Seroprotection was defined as a titer ≥40 (l/dilution \\[dil\\]) at pre-vaccination and 21 days after vaccination.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Seroprotection was assessed in the Per-Protocol Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Seroconversion Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1', 'description': 'Adults 18 to \\< 65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.'}, {'id': 'OG001', 'title': 'Group 2', 'description': 'Adults 18 to \\< 65 years of age randomly assigned to receive an intradermal dose of Fluzone Intradermal vaccine.'}, {'id': 'OG002', 'title': 'Group 3', 'description': 'Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.'}, {'id': 'OG003', 'title': 'Group 4', 'description': 'Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone High Dose vaccine.'}], 'classes': [{'title': 'A/H1N1 (N=49,52,52,52)', 'categories': [{'measurements': [{'value': '34.7', 'groupId': 'OG000'}, {'value': '42.3', 'groupId': 'OG001'}, {'value': '15.4', 'groupId': 'OG002'}, {'value': '28.8', 'groupId': 'OG003'}]}]}, {'title': 'A/H3N2 (N=49,53,52,52)', 'categories': [{'measurements': [{'value': '38.8', 'groupId': 'OG000'}, {'value': '39.6', 'groupId': 'OG001'}, {'value': '23.1', 'groupId': 'OG002'}, {'value': '26.9', 'groupId': 'OG003'}]}]}, {'title': 'B (Yamagata) (N=49,53,52,52)', 'categories': [{'measurements': [{'value': '28.6', 'groupId': 'OG000'}, {'value': '28.3', 'groupId': 'OG001'}, {'value': '15.4', 'groupId': 'OG002'}, {'value': '21.2', 'groupId': 'OG003'}]}]}, {'title': 'B (Victoria) (N=49,0,52,0)', 'categories': [{'measurements': [{'value': '51.0', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'B (Victoria) antigen was not in the administered vaccine', 'groupId': 'OG001'}, {'value': '23.1', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'B (Victoria) antigen was not in the administered vaccine', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 21 post-vaccination', 'description': 'Antibodies to Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose vaccine antigens were assessed using the hemagglutination inhibition (HAI) assay. Seroconversion was defined as either a pre-vaccination titer \\< 10 (1/dil) and a post-vaccination titer ≥ 40 (1/dil) or a pre-vaccination titer ≥ 10 (1/dil) and a ≥ 4-fold increase in post-vaccination titer 21 days after vaccination.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Seroconversion was assessed in the Per-Protocol Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Titer Ratios (GMTRs) of Antibodies to the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine Antigens Following Vaccination With the Respective Vaccine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1', 'description': 'Adults 18 to \\< 65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.'}, {'id': 'OG001', 'title': 'Group 2', 'description': 'Adults 18 to \\< 65 years of age randomly assigned to receive an intradermal dose of Fluzone Intradermal vaccine.'}, {'id': 'OG002', 'title': 'Group 3', 'description': 'Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.'}, {'id': 'OG003', 'title': 'Group 4', 'description': 'Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone High Dose vaccine.'}], 'classes': [{'title': 'A/H1N1 (N=49,52,52,52)', 'categories': [{'measurements': [{'value': '4.32', 'groupId': 'OG000', 'lowerLimit': '2.66', 'upperLimit': '7.04'}, {'value': '3.92', 'groupId': 'OG001', 'lowerLimit': '2.54', 'upperLimit': '6.06'}, {'value': '1.91', 'groupId': 'OG002', 'lowerLimit': '1.53', 'upperLimit': '2.38'}, {'value': '2.25', 'groupId': 'OG003', 'lowerLimit': '1.79', 'upperLimit': '2.83'}]}]}, {'title': 'A/H3N2 (N=49,53,52,52)', 'categories': [{'measurements': [{'value': '4.26', 'groupId': 'OG000', 'lowerLimit': '2.83', 'upperLimit': '6.42'}, {'value': '4.24', 'groupId': 'OG001', 'lowerLimit': '2.93', 'upperLimit': '6.14'}, {'value': '2.08', 'groupId': 'OG002', 'lowerLimit': '1.65', 'upperLimit': '2.62'}, {'value': '2.48', 'groupId': 'OG003', 'lowerLimit': '1.97', 'upperLimit': '3.12'}]}]}, {'title': 'B (Yamagata) (N=49,53,52,52)', 'categories': [{'measurements': [{'value': '3.08', 'groupId': 'OG000', 'lowerLimit': '2.21', 'upperLimit': '4.29'}, {'value': '2.70', 'groupId': 'OG001', 'lowerLimit': '1.95', 'upperLimit': '3.74'}, {'value': '1.83', 'groupId': 'OG002', 'lowerLimit': '1.48', 'upperLimit': '2.28'}, {'value': '2.14', 'groupId': 'OG003', 'lowerLimit': '1.72', 'upperLimit': '2.65'}]}]}, {'title': 'B (Victoria) (N=49,0,52,0)', 'categories': [{'measurements': [{'value': '4.39', 'groupId': 'OG000', 'lowerLimit': '3.05', 'upperLimit': '6.30'}, {'value': 'NA', 'comment': 'B (Victoria) antigen was not in the administered vaccine', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '2.08', 'groupId': 'OG002', 'lowerLimit': '1.62', 'upperLimit': '2.68'}, {'value': 'NA', 'comment': 'B (Victoria) antigen was not in the administered vaccine', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 21 post-vaccination', 'description': 'Geometric mean titer ratios of antibodies to Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose vaccine antigens were assessed using the hemagglutination inhibition (HAI) assay.', 'unitOfMeasure': 'Titer ratios', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Geometric mean titer ratios were assessed in the Per-Protocol Analysis Set.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group 1', 'description': 'Adults 18 to \\< 65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.'}, {'id': 'FG001', 'title': 'Group 2', 'description': 'Adults 18 to \\< 65 years of age randomly assigned to receive an intradermal dose of Fluzone Intradermal vaccine.'}, {'id': 'FG002', 'title': 'Group 3', 'description': 'Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.'}, {'id': 'FG003', 'title': 'Group 4', 'description': 'Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone High-Dose vaccine.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '54'}, {'groupId': 'FG002', 'numSubjects': '52'}, {'groupId': 'FG003', 'numSubjects': '52'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '54'}, {'groupId': 'FG002', 'numSubjects': '52'}, {'groupId': 'FG003', 'numSubjects': '52'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Study participants were enrolled from 01 October 2014 to 07 November 2014 at 4 clinical sites in the United States.', 'preAssignmentDetails': 'A total of 208 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled and vaccinated in this study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}, {'value': '208', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Group 1', 'description': 'Adults 18 to \\< 65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.'}, {'id': 'BG001', 'title': 'Group 2', 'description': 'Adults 18 to \\< 65 years of age randomly assigned to receive an intradermal dose of Fluzone Intradermal vaccine.'}, {'id': 'BG002', 'title': 'Group 3', 'description': 'Adults ≥ 65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.'}, {'id': 'BG003', 'title': 'Group 4', 'description': 'Adults ≥ 65 years of age randomly assigned to receive an intramuscular dose of Fluzone High-Dose vaccine.'}, {'id': 'BG004', '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'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '104', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}, {'value': '104', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'title': 'Age Continuous', 'categories': [{'measurements': [{'value': '44.8', 'spread': '14.9', 'groupId': 'BG000'}, {'value': '48.0', 'spread': '12.1', 'groupId': 'BG001'}, {'value': '73.9', 'spread': '5.0', 'groupId': 'BG002'}, {'value': '72.2', 'spread': '5.4', 'groupId': 'BG003'}, {'value': '59.8', 'spread': '16.8', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}, {'value': '127', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '81', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}, {'value': '208', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 208}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-16', 'studyFirstSubmitDate': '2014-10-02', 'resultsFirstSubmitDate': '2015-09-16', 'studyFirstSubmitQcDate': '2014-10-02', 'lastUpdatePostDateStruct': {'date': '2015-10-19', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-09-16', 'studyFirstPostDateStruct': {'date': '2014-10-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-10-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine', 'timeFrame': 'Day 0 up to Day 7 post-vaccination', 'description': 'Injection-site reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering. Grade 3 Injection-site reactions: Pain, Significant, prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis, \\>100 mm. Grade 3 Systemic reactions: Fever, ≥39.0°C or ≥102.1°F; Headache, Malaise, Myalgia, and Shivering, Significant, prevents daily activity.'}], 'secondaryOutcomes': [{'measure': 'Geometric Mean Titers (GMTs) of Antibodies to the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine Antigens Before and Following Vaccination With the Respective Vaccine.', 'timeFrame': 'Day 0 (pre-vaccination) and Day 21 post-vaccination', 'description': 'Geometric mean titers of antibodies to Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose vaccine antigens were assessed using the hemagglutination inhibition (HAI) assay.'}, {'measure': 'Percentage of Participants With Seroprotection Before and Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine.', 'timeFrame': 'Day 0 (pre-vaccination) and Day 21 post-vaccination', 'description': 'Antibodies to Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose vaccine antigens were assessed using the hemagglutination inhibition (HAI) assay. Seroprotection was defined as a titer ≥40 (l/dilution \\[dil\\]) at pre-vaccination and 21 days after vaccination.'}, {'measure': 'Percentage of Participants With Seroconversion Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine', 'timeFrame': 'Day 21 post-vaccination', 'description': 'Antibodies to Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose vaccine antigens were assessed using the hemagglutination inhibition (HAI) assay. Seroconversion was defined as either a pre-vaccination titer \\< 10 (1/dil) and a post-vaccination titer ≥ 40 (1/dil) or a pre-vaccination titer ≥ 10 (1/dil) and a ≥ 4-fold increase in post-vaccination titer 21 days after vaccination.'}, {'measure': 'Geometric Mean Titer Ratios (GMTRs) of Antibodies to the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine Antigens Following Vaccination With the Respective Vaccine', 'timeFrame': 'Day 21 post-vaccination', 'description': 'Geometric mean titer ratios of antibodies to Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose vaccine antigens were assessed using the hemagglutination inhibition (HAI) assay.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Influenza', 'Fluzone® Quadrivalent, Influenza Vaccine', 'Fluzone® Intradermal, Influenza Vaccine', 'Fluzone® High-Dose, Influenza Vaccine'], 'conditions': ['Influenza']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.sanofipasteur.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The aim of this trial is to evaluate the safety and immunogenicity of the 2014-2015 formulations of Fluzone® Quadrivalent and Fluzone® Intradermal vaccines in adults 18 to \\< 65 years or age, and of the 2014-2015 formulations of Fluzone® Quadrivalent and Fluzone® High-Dose vaccines in adults ≥ 65 years of age.\n\nObjectives:\n\n* To describe the safety of the 2014-2015 formulations of Fluzone Quadrivalent and Fluzone Intradermal vaccines in adults 18 to \\< 65 years of age and the safety of the 2014-2015 formulations of Fluzone® Quadrivalent and Fluzone® High-Dose vaccines in adults ≥ 65 years of age.\n\nObservational objectives:\n\n* To describe the immunogenicity of the 2014-2015 formulations of Fluzone® Quadrivalent and Fluzone® Intradermal vaccines in adults 18 to \\< 65 years of age and the immunogenicity of the 2014-2015 formulations of Fluzone® Quadrivalent and Fluzone ®High-Dose vaccines in adults ≥ 65 years of age.\n* To evaluate the compliance, in terms of immunogenicity, of each study vaccine (Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose) in the applicable age group with the historical requirements of the Committee for Human Medicinal Products (CHMP) Note for Guidance (NfG) CPMP/BWP/214/96.', 'detailedDescription': 'Adults 18 to \\< 65 years of age will be randomly assigned in a 1:1 ratio to receive either Fluzone® Quadrivalent or Fluzone® Intradermal vaccine. Adults ≥ 65 years of age will also be randomly assigned in a 1:1 ratio to receive either Fluzone® Quadrivalent or Fluzone® High-Dose vaccine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject is ≥ 18 years of age on the day of inclusion.\n* Informed consent form has been signed and dated.\n* Able to attend all scheduled visits and to comply with all trial procedures.\n\nExclusion Criteria:\n\n* History of serious adverse reaction to any influenza vaccine.\n* Receipt of any vaccine within 30 days before receiving study vaccine, or plans to receive another vaccine before Visit 2.\n* Participation in another interventional clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 30 days preceding the first study vaccination or during the course of the study, unless no intervention for the other study occurred within the 30 days prior to the first study vaccination and none are planned before the subject would complete safety surveillance for the present study.\n* Thrombocytopenia, which may be a contraindication for intramuscular vaccination, at the discretion of the Investigator.\n* Prior vaccination with any 2014-2015 formulation of influenza vaccine.\n* Known systemic hypersensitivity to eggs, chicken proteins, or any of the vaccine components, or a history of a life-threatening reaction to Fluzone Quadrivalent, Fluzone Intradermal, or Fluzone High-Dose vaccine or to a vaccine containing any of the same substances (the complete list of vaccine components is included in the Prescribing Information).\n* Receipt of immune globulins, blood, or blood-derived products in the past 3 months.\n* Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion, which may be a contraindication for intramuscular vaccination, at the discretion of the Investigator.\n* Subject is pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be pre-menarche or post-menopausal for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination and until at least 4 weeks after vaccination).\n* Any condition that in the opinion of the Investigator would pose a health risk to the subject if enrolled or could interfere with the evaluation of the vaccine.\n* Personal history of Guillain-Barré syndrome.\n* Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).\n* Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion.\n* Seropositivity for human immunodeficiency virus, hepatitis B, or hepatitis C, as reported by the subject.\n* Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.\n* Current alcohol or drug addiction that, in the opinion of the Investigator, might interfere with the ability to comply with trial procedures.\n* Moderate or severe acute illness/infection (according to Investigator judgment) or febrile illness (temperature ≥ 100.4°F) on the day of vaccination. A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided.\n* Identified as an Investigator or employee of an Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of an Investigator or employee with direct involvement in the proposed study.'}, 'identificationModule': {'nctId': 'NCT02258334', 'briefTitle': 'Study of Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose, Influenza Vaccines in Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Safety and Immunogenicity Among Adults of Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose, Influenza Vaccines, 2014-2015 Formulations', 'orgStudyIdInfo': {'id': 'GRC55'}, 'secondaryIdInfos': [{'id': 'U1111-1143-8931', 'type': 'OTHER', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fluzone® Quadrivalent vaccine Group 1', 'description': 'Adults 18 to \\< 65 years of age randomly assigned to receive an intramuscular injection of Fluzone® Quadrivalent vaccine', 'interventionNames': ['Biological: Fluzone® Quadrivalent vaccine, 2014-2015 formulation']}, {'type': 'EXPERIMENTAL', 'label': 'Fluzone® Intradermal vaccine Group 2', 'description': 'Adults 18 to \\< 65 years of age randomly assigned to receive an intradermal injection of Fluzone® Intradermal vaccine', 'interventionNames': ['Biological: Fluzone I®ntradermal vaccine, 2014-2015 formulation']}, {'type': 'EXPERIMENTAL', 'label': 'Fluzone® Quadrivalent vaccine Group 3', 'description': 'Adults ≥ 65 years of age randomly assigned to receive an intramuscular injection of Fluzone® Quadrivalent vaccine', 'interventionNames': ['Biological: Fluzone® Quadrivalent vaccine, 2014-2015 formulation']}, {'type': 'EXPERIMENTAL', 'label': 'Fluzone® High-Dose vaccine Group 4', 'description': 'Adults ≥ 65 years of age randomly assigned to receive an intramuscular injection of Fluzone® High-Dose vaccine', 'interventionNames': ['Biological: Fluzone High Dose vaccine, 2014-2015 formulation']}], 'interventions': [{'name': 'Fluzone® Quadrivalent vaccine, 2014-2015 formulation', 'type': 'BIOLOGICAL', 'otherNames': ['Fluzone® Quadrivalent vaccine'], 'description': '0.5 mL, Intramuscular', 'armGroupLabels': ['Fluzone® Quadrivalent vaccine Group 1']}, {'name': 'Fluzone I®ntradermal vaccine, 2014-2015 formulation', 'type': 'BIOLOGICAL', 'otherNames': ['Fluzone® Intradermal vaccine'], 'description': '0.1 mL, Intradermal', 'armGroupLabels': ['Fluzone® Intradermal vaccine Group 2']}, {'name': 'Fluzone® Quadrivalent vaccine, 2014-2015 formulation', 'type': 'BIOLOGICAL', 'otherNames': ['Fluzone® Quadrivalent vaccine'], 'description': '0.5 mL, Intramuscular', 'armGroupLabels': ['Fluzone® Quadrivalent vaccine Group 3']}, {'name': 'Fluzone High Dose vaccine, 2014-2015 formulation', 'type': 'BIOLOGICAL', 'otherNames': ['Fluzone® High Dose, vaccine'], 'description': '0.5 mL, Intramuscular', 'armGroupLabels': ['Fluzone® High-Dose vaccine Group 4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95405', 'city': 'Santa Rosa', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 38.44047, 'lon': -122.71443}}, {'zip': '51503', 'city': 'Council Bluffs', 'state': 'Iowa', 'country': 'United States', 'geoPoint': {'lat': 41.26194, 'lon': -95.86083}}, {'zip': '70006', 'city': 'Metairie', 'state': 'Louisiana', 'country': 'United States', 'geoPoint': {'lat': 29.98409, 'lon': -90.15285}}, {'zip': '45249', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi Pasteur Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi Pasteur, a Sanofi Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}