Ignite Creation Date:
2025-12-24 @ 1:21 PM
Ignite Modification Date:
2026-02-23 @ 12:21 PM
Study NCT ID:
NCT01258595
Status:
COMPLETED
Last Update Posted:
2016-05-16
First Post:
2010-12-10
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of High-Dose Trivalent Inactivated Influenza Vaccine in Adults 50 to 64 Years of Age
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'}], '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 through 28 days post-vaccination.', 'eventGroups': [{'id': 'EG000', 'title': 'Fluzone® High-Dose Vaccine Group', 'description': 'Participants who received a single dose of Fluzone® High-Dose vaccine, containing 60 µg hemagglutinin on Day 0', 'otherNumAtRisk': 148, 'otherNumAffected': 130, 'seriousNumAtRisk': 148, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Fluzone® Vaccine Group', 'description': 'Participants who received a single dose of Fluzone® vaccine, containing 15 µg hemagglutinin on Day 0', 'otherNumAtRisk': 152, 'otherNumAffected': 110, 'seriousNumAtRisk': 152, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Solicited Injection Site Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 112, 'numAffected': 112}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 85, 'numAffected': 85}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Solicited Injection Site Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Solicited Injection Site Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Solicited Injection Site Induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Solicited Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numEvents': 44, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 38, 'numAffected': 38}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Solicited Shivering', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numEvents': 29, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 21, 'numAffected': 21}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Solicited Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numEvents': 70, 'numAffected': 70}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 46, 'numAffected': 46}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Solicited Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numEvents': 46, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 40, 'numAffected': 40}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}], 'frequencyThreshold': '5.00'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Geometric Mean Titers (GMTs) of Vaccine Antibodies Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluzone® High-Dose Vaccine Group', 'description': 'Participants who received a single dose of Fluzone® High-Dose vaccine, containing 60 µg hemagglutinin on Day 0'}, {'id': 'OG001', 'title': 'Fluzone® Vaccine Group', 'description': 'Participants who received a single dose of Fluzone® vaccine, containing 15 µg hemagglutinin on Day 0'}], 'classes': [{'title': 'A/H1N1: California - Pre-vaccination (N=147, 152)', 'categories': [{'measurements': [{'value': '40.5', 'groupId': 'OG000', 'lowerLimit': '30.0', 'upperLimit': '54.5'}, {'value': '28.8', 'groupId': 'OG001', 'lowerLimit': '21.8', 'upperLimit': '38.1'}]}]}, {'title': 'A/H3N2: Victoria - Pre-vaccination (N=147, 152)', 'categories': [{'measurements': [{'value': '36.4', 'groupId': 'OG000', 'lowerLimit': '28.0', 'upperLimit': '47.4'}, {'value': '41.4', 'groupId': 'OG001', 'lowerLimit': '31.4', 'upperLimit': '54.6'}]}]}, {'title': 'B: Brisbane - Pre-vaccination (N=147, 152)', 'categories': [{'measurements': [{'value': '27.4', 'groupId': 'OG000', 'lowerLimit': '22.4', 'upperLimit': '33.6'}, {'value': '28.9', 'groupId': 'OG001', 'lowerLimit': '23.5', 'upperLimit': '35.5'}]}]}, {'title': 'A/H1N1: California - Post-vaccination (N=145, 151)', 'categories': [{'measurements': [{'value': '1067', 'groupId': 'OG000', 'lowerLimit': '868', 'upperLimit': '1312'}, {'value': '745', 'groupId': 'OG001', 'lowerLimit': '585', 'upperLimit': '948'}]}]}, {'title': 'A/H3N2: Victoria - Post-vaccination (N = 145, 151)', 'categories': [{'measurements': [{'value': '936', 'groupId': 'OG000', 'lowerLimit': '745', 'upperLimit': '1176'}, {'value': '567', 'groupId': 'OG001', 'lowerLimit': '459', 'upperLimit': '699'}]}]}, {'title': 'B: Brisbane - Post-vaccination (N=145, 151)', 'categories': [{'measurements': [{'value': '203', 'groupId': 'OG000', 'lowerLimit': '171', 'upperLimit': '241'}, {'value': '127', 'groupId': 'OG001', 'lowerLimit': '104', 'upperLimit': '154'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 0 and Day 28 post-vaccination', 'description': 'Serum antibody titers to vaccine antigens were assessed by means of the hemagglutination inhibition (HAI) assay method.', 'unitOfMeasure': '1/dilution (1/dil)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Serum antibody titers to vaccine antigens were assessed in the full analysis set population.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean of Individual Titer Ratios (GMTRs) of Vaccine Antibodies Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluzone® High-Dose Vaccine Group', 'description': 'Participants who received a single dose of Fluzone® High-Dose vaccine, containing 60 µg hemagglutinin on Day 0'}, {'id': 'OG001', 'title': 'Fluzone® Vaccine Group', 'description': 'Participants who received a single dose of Fluzone® vaccine, containing 15 µg hemagglutinin on Day 0'}], 'classes': [{'title': 'A/H1N1: California', 'categories': [{'measurements': [{'value': '21.8', 'groupId': 'OG000', 'lowerLimit': '16.1', 'upperLimit': '29.6'}, {'value': '21.2', 'groupId': 'OG001', 'lowerLimit': '15.8', 'upperLimit': '28.4'}]}]}, {'title': 'A/H3N2: Victoria', 'categories': [{'measurements': [{'value': '22.0', 'groupId': 'OG000', 'lowerLimit': '17.2', 'upperLimit': '28.1'}, {'value': '12.0', 'groupId': 'OG001', 'lowerLimit': '9.21', 'upperLimit': '15.5'}]}]}, {'title': 'B: Brisbane', 'categories': [{'measurements': [{'value': '6.27', 'groupId': 'OG000', 'lowerLimit': '5.16', 'upperLimit': '7.62'}, {'value': '3.91', 'groupId': 'OG001', 'lowerLimit': '3.17', 'upperLimit': '4.83'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 0 and Day 28 Post-vaccination', 'description': 'Serum antibody titers to vaccine antigens were assessed by means of the hemagglutination inhibition (HAI) assay method.', 'unitOfMeasure': '1/dilution (1/dil)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Serum antibody titers to vaccine antigens were assessed in the full analysis set population.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Seroconversion After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluzone® High-Dose Vaccine Group', 'description': 'Participants who received a single dose of Fluzone® High-Dose vaccine, containing 60 µg hemagglutinin on Day 0'}, {'id': 'OG001', 'title': 'Fluzone® Vaccine Group', 'description': 'Participants who received a single dose of Fluzone® vaccine, containing 15 µg hemagglutinin on Day 0'}], 'classes': [{'title': 'A/H1N1: California', 'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}]}, {'title': 'A/H3N2: Victoria', 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}]}, {'title': 'B: Brisbane', 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0 and Day 28 post-vaccination', 'description': 'Seroconversion: For participants with a Day 0 (pre-vaccination) titer \\< 10 (1/dilution \\[1/dil\\]) a titer ≥ 40 (1/dil), and for participants with a Day 0 titer ≥ 10 (1/dil) a ≥ 4 fold increase of titer on Day 28.\n\nSerum antibody titers were assessed by means of the hemagglutination inhibition (HAI) assay method.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Seroconversion to the vaccine antigens was assessed in the full analysis set population.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Seroprotection Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluzone® High-Dose Vaccine Group', 'description': 'Participants who received a single dose of Fluzone® High-Dose vaccine, containing 60 µg hemagglutinin on Day 0'}, {'id': 'OG001', 'title': 'Fluzone® Vaccine Group', 'description': 'Participants who received a single dose of Fluzone® vaccine, containing 15 µg hemagglutinin on Day 0'}], 'classes': [{'title': 'A/H1N1: California - Pre-vaccination (N=147, 152)', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}]}, {'title': 'A/H3N2: Victoria - Pre-vaccination (N=147, 152)', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}]}, {'title': 'B: Brisbane - Pre-vaccination (N=147, 152)', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}, {'title': 'A/H1N1: California - Post-vaccination (N=145, 151)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}]}, {'title': 'A/H3N2: Victoria - Post-vaccination (N=145, 151)', 'categories': [{'measurements': [{'value': '99', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}]}, {'title': 'B: Brisbane - Post-vaccination (N=145, 151)', 'categories': [{'measurements': [{'value': '97', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0 and Day 28 post vaccination', 'description': 'Seroprotection was defined as a titer ≥ 40 (1/dilution \\[1/dil\\]). Serum antibody titers were assessed by means of the hemagglutination inhibition (HAI) assay method.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Seroprotection was assessed in the full analysis set population.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluzone® High-Dose Vaccine Group', 'description': 'Participants who received a single dose of Fluzone® High-Dose vaccine, containing 60 µg hemagglutinin on Day 0'}, {'id': 'OG001', 'title': 'Fluzone® Vaccine Group', 'description': 'Participants who received a single dose of Fluzone® vaccine, containing 15 µg hemagglutinin on Day 0'}], 'classes': [{'title': 'Any Injection Site Pain', 'categories': [{'measurements': [{'value': '112', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}]}, {'title': 'Grad 3 Injection site Pain-Prevents daily activity', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Injection Site Erythema', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Injection Site Erythema (>100 mm)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Injection Site Swelling', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Injection Site Swelling (>100 mm)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Injection Site Ecchymosis', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Injection Site Ecchymosis (>100 mm)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Injection Site Induration', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Injection Site Induration (>100 mm)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Fever', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Fever (≥ 39.0 ºC or ≥ 102.1 ºF)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Headache', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Headache (Prevents daily activity)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Any Malaise', 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Malaise (Prevents daily activity)', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Any Myalgia', 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Myalgia (Prevents daily activity)', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Any Shivering', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Shivering (Prevents daily activity)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0 through Day 7 post-vaccination', 'description': 'Solicited Injection Site Reactions: Pain, Erythema, Swelling, Ecchymosis, and Induration. Solicited Systemic Reactions: Fever, Headache, Malaise, Myalgia, and Shivering', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis was on all enrolled and vaccinated subjects with available reaction data, safety analysis set population.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Fluzone® High-Dose Vaccine Group', 'description': 'Participants who received a single dose of Fluzone® High-Dose vaccine, containing 60 µg hemagglutinin on Day 0'}, {'id': 'FG001', 'title': 'Fluzone® Vaccine Group', 'description': 'Participants who received a single dose of Fluzone® vaccine, containing 15 µg hemagglutinin on Day 0'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '148'}, {'groupId': 'FG001', 'numSubjects': '152'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '147'}, {'groupId': 'FG001', 'numSubjects': '151'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants were enrolled from 15 November to 10 December 2010 in 4 clinical centers in the US.', 'preAssignmentDetails': 'A total of 300 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'BG000'}, {'value': '152', 'groupId': 'BG001'}, {'value': '300', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Fluzone® High-Dose Vaccine Group', 'description': 'Participants who received a single dose of Fluzone® High-Dose vaccine, containing 60 µg hemagglutinin on Day 0'}, {'id': 'BG001', 'title': 'Fluzone® Vaccine Group', 'description': 'Participants who received a single dose of Fluzone® vaccine, containing 15 µg hemagglutinin on Day 0'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '148', 'groupId': 'BG000'}, {'value': '152', 'groupId': 'BG001'}, {'value': '300', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.6', 'spread': '4.38', 'groupId': 'BG000'}, {'value': '57.7', 'spread': '4.14', 'groupId': 'BG001'}, {'value': '57.7', 'spread': '4.25', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '98', 'groupId': 'BG000'}, {'value': '96', 'groupId': 'BG001'}, {'value': '194', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '148', 'groupId': 'BG000'}, {'value': '152', 'groupId': 'BG001'}, {'value': '300', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-12', 'studyFirstSubmitDate': '2010-12-10', 'resultsFirstSubmitDate': '2011-09-19', 'studyFirstSubmitQcDate': '2010-12-10', 'lastUpdatePostDateStruct': {'date': '2016-05-16', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-09-19', 'studyFirstPostDateStruct': {'date': '2010-12-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-10-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Geometric Mean Titers (GMTs) of Vaccine Antibodies Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine.', 'timeFrame': 'Day 0 and Day 28 post-vaccination', 'description': 'Serum antibody titers to vaccine antigens were assessed by means of the hemagglutination inhibition (HAI) assay method.'}, {'measure': 'Geometric Mean of Individual Titer Ratios (GMTRs) of Vaccine Antibodies Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine', 'timeFrame': 'Day 0 and Day 28 Post-vaccination', 'description': 'Serum antibody titers to vaccine antigens were assessed by means of the hemagglutination inhibition (HAI) assay method.'}, {'measure': 'Percentage of Participants With Seroconversion After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine', 'timeFrame': 'Day 0 and Day 28 post-vaccination', 'description': 'Seroconversion: For participants with a Day 0 (pre-vaccination) titer \\< 10 (1/dilution \\[1/dil\\]) a titer ≥ 40 (1/dil), and for participants with a Day 0 titer ≥ 10 (1/dil) a ≥ 4 fold increase of titer on Day 28.\n\nSerum antibody titers were assessed by means of the hemagglutination inhibition (HAI) assay method.'}, {'measure': 'Percentage of Participants With Seroprotection Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine', 'timeFrame': 'Day 0 and Day 28 post vaccination', 'description': 'Seroprotection was defined as a titer ≥ 40 (1/dilution \\[1/dil\\]). Serum antibody titers were assessed by means of the hemagglutination inhibition (HAI) assay method.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine', 'timeFrame': 'Day 0 through Day 7 post-vaccination', 'description': 'Solicited Injection Site Reactions: Pain, Erythema, Swelling, Ecchymosis, and Induration. Solicited Systemic Reactions: Fever, Headache, Malaise, Myalgia, and Shivering'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Influenza', 'Trivalent Inactivated Influenza Vaccine', 'High-Dose Trivalent Inactivated Influenza Vaccine', 'Influenza vaccines'], 'conditions': ['Influenza']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.sanofipasteur.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to generate data on key parameters associated with assessment of influenza vaccines in individuals 50-64 years of age\n\nPrimary Objective:\n\n* To describe the immunogenicity of High-Dose Trivalent Inactivated Influenza Vaccine (TIV) compared to TIV.\n* To describe the safety profile of High-Dose Trivalent Inactivated Influenza Vaccine, as assessed by solicited adverse reactions collected for 7 days post-vaccination, and unsolicited adverse events (including Serious Adverse Events and Adverse Events of Special Interests) collected between Visit 1 and Visit 2', 'detailedDescription': 'Participants will be randomized to receive one dose of either High-Dose Trivalent Inactivated Influenza Vaccine or Trivalent Inactivated Influenza Vaccine. They will be followed up for safety for one month post-vaccination.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 50 to 64 years (inclusive) on the day of vaccination\n* Informed consent form has been signed and dated\n* Medically stable\n* Able to attend all scheduled visits and to comply with all trial procedures\n* For a woman of childbearing potential, use of an effective method of contraception or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination\n\nExclusion Criteria:\n\n* Known pregnancy, or a positive urine pregnancy test\n* Currently breastfeeding a child\n* Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the trial vaccination\n* Planned participation in another clinical trial during the present trial period\n* Planned receipt of any vaccine in the 4 weeks following the trial vaccination (prior to the Visit 2 blood draw)\n* Receipt of seasonal or pandemic influenza vaccine in the past 6 months\n* Receipt of blood or blood-derived products in the past 3 months\n* Systemic hypersensitivity to eggs, chicken proteins, or any of the vaccine components, or a history of a life-threatening reaction to the standard-dose Trivalent Inactivated Influenza Vaccine or a vaccine containing any of the same substances\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\n* Neoplastic disease or any hematologic malignancy\n* Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination\n* Personal history of Guillain-Barré Syndrome\n* Self-reported seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C\n* Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily\n* Current alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures\n* Identified as employees of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as family members (i.e., immediate, husband, wife and their children, adopted or natural) of the employees or the Investigator'}, 'identificationModule': {'nctId': 'NCT01258595', 'briefTitle': 'A Study of High-Dose Trivalent Inactivated Influenza Vaccine in Adults 50 to 64 Years of Age', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Safety and Immunogenicity of High-Dose Trivalent Inactivated Influenza Vaccine in Adults 50 to 64 Years of Age', 'orgStudyIdInfo': {'id': 'FIM09'}, 'secondaryIdInfos': [{'id': 'UTN: U1111-1113-3648', 'type': 'OTHER', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High-Dose Trivalent Inactivated Influenza Vaccine', 'interventionNames': ['Biological: High-Dose Trivalent Inactivated Influenza Vaccine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Trivalent Inactivated Influenza Vaccine', 'interventionNames': ['Biological: Trivalent Inactivated Influenza Vaccine']}], 'interventions': [{'name': 'High-Dose Trivalent Inactivated Influenza Vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['Fluzone® High-Dose'], 'description': '0.5 mL Intramuscular', 'armGroupLabels': ['High-Dose Trivalent Inactivated Influenza Vaccine']}, {'name': 'Trivalent Inactivated Influenza Vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['Fluzone®'], 'description': '0.5 mL, Intramuscular', 'armGroupLabels': ['Trivalent Inactivated Influenza Vaccine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '83404', 'city': 'Idaho Falls', 'state': 'Idaho', 'country': 'United States', 'geoPoint': {'lat': 43.46658, 'lon': -112.03414}}, {'zip': '21045', 'city': 'Columbia', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 39.24038, 'lon': -76.83942}}, {'zip': '21042', 'city': 'Ellicott City', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 39.26733, 'lon': -76.79831}}, {'zip': '59802', 'city': 'Missoula', 'state': 'Montana', 'country': 'United States', 'geoPoint': {'lat': 46.87215, 'lon': -113.994}}, {'zip': '44122', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi Pasteur Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi Pasteur, a Sanofi Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}