Ignite Creation Date:
2025-12-24 @ 12:03 PM
Ignite Modification Date:
2025-12-27 @ 9:34 PM
Study NCT ID:
NCT03179761
Status:
COMPLETED
Last Update Posted:
2024-12-04
First Post:
2017-06-01
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
High vs. Standard Dose Flu Vaccine in Adult Stem Cell Transplant Recipients
Sponsor:
Organization:
Raw JSON
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'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Fever', 'notes': 'Temperature of 100.4 degrees Fahrenheit or greater Systemic solicited reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'notes': 'Systemic solicited reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 24, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 23, 'numAffected': 23}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'notes': 'Systemic solicited reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 18, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 20, 'numAffected': 20}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'notes': 'Systemic solicited reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 16, 'numAffected': 16}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Myalgia/ Body aches', 'notes': 'Systemic solicited reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 18, 'numAffected': 18}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Decreased general activity', 'notes': 'Systemic solicited reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 26, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 25, 'numAffected': 25}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'notes': 'Systemic solicited reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain', 'notes': 'Solicited injection-site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 21, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tenderness', 'notes': 'Solicited injection-site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 33, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 23, 'numAffected': 23}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Swelling', 'notes': 'Solicited injection-site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Redness/ Erythema', 'notes': 'Injection-site reaction of at least 0.5 cm in diameter Solicited injection-site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Viral illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'HD-TIV Compared With SD-QIV (Influenza A) - Immunogenicity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 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{'title': 'A/H1N1 Visit 2 GMFR ≥ 4-Fold Rise', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.23', 'groupId': 'OG000', 'lowerLimit': '0.14', 'upperLimit': '0.35'}, {'value': '0.25', 'groupId': 'OG001', 'lowerLimit': '0.16', 'upperLimit': '0.37'}]}]}, {'title': 'A/H1N1 Visit 3 GMT ≥1:40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.75', 'groupId': 'OG000', 'lowerLimit': '0.63', 'upperLimit': '0.84'}, {'value': '0.73', 'groupId': 'OG001', 'lowerLimit': '0.61', 'upperLimit': '0.84'}]}]}, {'title': 'A/H1N1 Visit 3 GMFR ≥ 4-Fold Rise', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.41', 'groupId': 'OG000', 'lowerLimit': 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'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.65', 'groupId': 'OG000', 'lowerLimit': '0.52', 'upperLimit': '0.76'}, {'value': '0.60', 'groupId': 'OG001', 'lowerLimit': '0.48', 'upperLimit': '0.72'}]}]}, {'title': 'A/H3N2 Visit 2 GMFR ≥ 4-Fold Rise', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.32', 'groupId': 'OG000', 'lowerLimit': '0.21', 'upperLimit': '0.44'}, {'value': '0.19', 'groupId': 'OG001', 'lowerLimit': '0.11', 'upperLimit': '0.30'}]}]}, {'title': 'A/H3N2 Visit 3 GMT ≥1:40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.78', 'groupId': 'OG000', 'lowerLimit': '0.66', 'upperLimit': '0.87'}, {'value': '0.73', 'groupId': 'OG001', 'lowerLimit': '0.61', 'upperLimit': '0.84'}]}]}, {'title': 'A/H3N2 Visit 3 GMFR ≥ 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{'value': '0.27', 'groupId': 'OG001', 'lowerLimit': '0.16', 'upperLimit': '0.40'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Visit 1 titers (baseline) were measured on day 0; visit 2 titers were measured 28-42 days after visit 1; visit 3 titers were measured 28-42 days after visit 2; and visit 4 titers were measured 138-222 days after visit 2.', 'description': 'Point estimates and 95% confidence intervals for proportion of subjects achieving seroprotection (≥1:40 HAI titer) and seroconversion (4-fold or greater rise in HAI titers from visit 1) for Influenza A antigens.', 'unitOfMeasure': 'proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The number analyzed for each row represents the number of participants that completed the indicated visit and had a recorded HAI titer for the indicated antigen and visit.'}, {'type': 'SECONDARY', 'title': 'HD-TIV Compared With SD-QIV (Influenza B) - Immunogenicity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group I (HD-TIV)', 'description': 'Patients received HD-TIV intramuscularly once at baseline (day 0) and again between 28-42 days later.\n\nTrivalent Influenza Vaccine: High Dose Trivalent Influenza Vaccine given intramuscularly\n\nLaboratory Biomarker Analysis: Correlative studies'}, {'id': 'OG001', 'title': 'Group 2 (SD-QIV)', 'description': 'Patients received SD-QIV intramuscularly once at baseline (day 0) and again between 28-42 days later.\n\nQuadrivalent Inactivated Influenza Vaccine: Standard Dose Quadrivalent Influenza Vaccine given intramuscularly\n\nLaboratory Biomarker Analysis: Correlative studies'}], 'classes': [{'title': 'B/Victoria Visit 2 GMT ≥1:40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.73', 'groupId': 'OG000', 'lowerLimit': '0.61', 'upperLimit': '0.83'}, {'value': '0.79', 'groupId': 'OG001', 'lowerLimit': '0.68', 'upperLimit': '0.88'}]}]}, {'title': 'B/Victoria Visit 2 GMFR ≥ 4-Fold Rise', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.25', 'groupId': 'OG000', 'lowerLimit': '0.15', 'upperLimit': '0.37'}, {'value': '0.17', 'groupId': 'OG001', 'lowerLimit': '0.09', 'upperLimit': '0.28'}]}]}, {'title': 'B/Victoria Visit 3 GMT ≥1:40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.92', 'groupId': 'OG000', 'lowerLimit': '0.83', 'upperLimit': '0.97'}, {'value': '0.86', 'groupId': 'OG001', 'lowerLimit': '0.75', 'upperLimit': '0.93'}]}]}, {'title': 'B/Victoria Visit 3 GMFR ≥ 4-Fold Rise', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.44', 'groupId': 'OG000', 'lowerLimit': '0.32', 'upperLimit': '0.57'}, {'value': '0.29', 'groupId': 'OG001', 'lowerLimit': '0.18', 'upperLimit': '0.41'}]}]}, {'title': 'B/Victoria Visit 4 GMT ≥1:40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.83', 'groupId': 'OG000', 'lowerLimit': '0.71', 'upperLimit': '0.91'}, {'value': '0.73', 'groupId': 'OG001', 'lowerLimit': '0.60', 'upperLimit': '0.84'}]}]}, {'title': 'B/Victoria Visit 4 GMFR ≥ 4-Fold Rise', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.34', 'groupId': 'OG000', 'lowerLimit': '0.22', 'upperLimit': '0.47'}, {'value': '0.18', 'groupId': 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the number of participants that completed the indicated visit and had a recorded HAI titer for the indicated antigen and visit.'}, {'type': 'SECONDARY', 'title': 'Solicited Local Injection Site Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group I (HD-TIV)', 'description': 'Patients received HD-TIV intramuscularly once at baseline (day 0) and again between 28-42 days later.\n\nTrivalent Influenza Vaccine: High Dose Trivalent Influenza Vaccine given intramuscularly\n\nLaboratory Biomarker Analysis: Correlative studies'}, {'id': 'OG001', 'title': 'Group 2 (SD-QIV)', 'description': 'Patients received SD-QIV intramuscularly once at baseline (day 0) and again between 28-42 days later.\n\nQuadrivalent Inactivated Influenza Vaccine: Standard Dose Quadrivalent Influenza Vaccine given intramuscularly\n\nLaboratory Biomarker Analysis: Correlative studies'}], 'classes': [{'title': 'Vaccine 1 - Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.250', 'groupId': 'OG000', 'lowerLimit': '0.147', 'upperLimit': '0.379'}, {'value': '0.156', 'groupId': 'OG001', 'lowerLimit': '0.078', 'upperLimit': '0.269'}]}]}, {'title': 'Vaccine 1 - Tenderness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.383', 'groupId': 'OG000', 'lowerLimit': '0.261', 'upperLimit': '0.518'}, {'value': '0.297', 'groupId': 'OG001', 'lowerLimit': '0.189', 'upperLimit': '0.424'}]}]}, {'title': 'Vaccine 1 - Redness size', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.067', 'groupId': 'OG000', 'lowerLimit': '0.018', 'upperLimit': '0.162'}, {'value': '0.047', 'groupId': 'OG001', 'lowerLimit': '0.010', 'upperLimit': '0.131'}]}]}, {'title': 'Vaccine 1 - Swelling', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.117', 'groupId': 'OG000', 'lowerLimit': '0.048', 'upperLimit': '0.226'}, {'value': '0.094', 'groupId': 'OG001', 'lowerLimit': '0.035', 'upperLimit': '0.193'}]}]}, {'title': 'Vaccine 1 - Swelling size', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.100', 'groupId': 'OG000', 'lowerLimit': '0.038', 'upperLimit': '0.205'}, {'value': '0.063', 'groupId': 'OG001', 'lowerLimit': '0.017', 'upperLimit': '0.152'}]}]}, {'title': 'Vaccine 2 - Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.254', 'groupId': 'OG000', 'lowerLimit': '0.150', 'upperLimit': '0.384'}, {'value': '0.169', 'groupId': 'OG001', 'lowerLimit': '0.084', 'upperLimit': '0.290'}]}]}, {'title': 'Vaccine 2 - Tenderness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.458', 'groupId': 'OG000', 'lowerLimit': '0.327', 'upperLimit': '0.592'}, {'value': '0.288', 'groupId': 'OG001', 'lowerLimit': '0.178', 'upperLimit': '0.421'}]}]}, {'title': 'Vaccine 2 - Redness size', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.102', 'groupId': 'OG000', 'lowerLimit': '0.038', 'upperLimit': '0.208'}, {'value': '0.000', 'groupId': 'OG001', 'lowerLimit': '0.000', 'upperLimit': '0.061'}]}]}, {'title': 'Vaccine 2 - Swelling', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.136', 'groupId': 'OG000', 'lowerLimit': '0.060', 'upperLimit': '0.250'}, {'value': '0.102', 'groupId': 'OG001', 'lowerLimit': '0.038', 'upperLimit': '0.208'}]}]}, {'title': 'Vaccine 2 - Swelling size', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.119', 'groupId': 'OG000', 'lowerLimit': '0.049', 'upperLimit': '0.229'}, {'value': '0.034', 'groupId': 'OG001', 'lowerLimit': '0.004', 'upperLimit': '0.117'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Adverse events were recorded for 7 days following each vaccination or until resolution, up to study conclusion.', 'description': 'The proportion of subjects in each group experiencing at least one solicited AE with 95% posterior credible intervals, separated by vaccine number and adverse event type. AEs were assessed by clinicians using Tables 4 and 5 within section C16 of the protocol.\n\nSolicited injection site AEs included: pain, tenderness, erythema/redness, and swelling/induration. The diameter of any erythema/redness and swelling/induration was measured to evaluate "redness size" and "swelling size."', 'unitOfMeasure': 'proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of subjects analyzed for Vaccine 1 represents the number of subjects who attended Visit 1 and received the first vaccine. The number of subjects analyzed for Vaccine 2 represents the number of subjects who attended Visit 2 and received the second vaccine.'}, {'type': 'SECONDARY', 'title': 'Solicited Systemic Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group I (HD-TIV)', 'description': 'Patients received HD-TIV intramuscularly once at baseline (day 0) and again between 28-42 days later.\n\nTrivalent Influenza Vaccine: High Dose Trivalent Influenza Vaccine given intramuscularly\n\nLaboratory Biomarker Analysis: Correlative studies'}, {'id': 'OG001', 'title': 'Group 2 (SD-QIV)', 'description': 'Patients received SD-QIV intramuscularly once at baseline (day 0) and again between 28-42 days later.\n\nQuadrivalent Inactivated Influenza Vaccine: Standard Dose Quadrivalent Influenza Vaccine given intramuscularly\n\nLaboratory Biomarker Analysis: Correlative studies'}], 'classes': [{'title': 'Vaccine 1 - Fever', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.033', 'groupId': 'OG000', 'lowerLimit': '0.004', 'upperLimit': '0.115'}, {'value': '0.031', 'groupId': 'OG001', 'lowerLimit': '0.004', 'upperLimit': '0.108'}]}]}, {'title': 'Vaccine 1 - Fatigue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.350', 'groupId': 'OG000', 'lowerLimit': '0.231', 'upperLimit': '0.484'}, {'value': '0.313', 'groupId': 'OG001', 'lowerLimit': '0.202', 'upperLimit': '0.441'}]}]}, {'title': 'Vaccine 1 - Headache', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.267', 'groupId': 'OG000', 'lowerLimit': '0.161', 'upperLimit': '0.397'}, {'value': '0.188', 'groupId': 'OG001', 'lowerLimit': '0.101', 'upperLimit': '0.305'}]}]}, {'title': 'Vaccine 1 - Nausea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.083', 'groupId': 'OG000', 'lowerLimit': '0.028', 'upperLimit': '0.184'}, {'value': '0.172', 'groupId': 'OG001', 'lowerLimit': '0.089', 'upperLimit': '0.287'}]}]}, {'title': 'Vaccine 1 - Myalgia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.200', 'groupId': 'OG000', 'lowerLimit': '0.108', 'upperLimit': '0.323'}, {'value': '0.172', 'groupId': 'OG001', 'lowerLimit': '0.089', 'upperLimit': '0.287'}]}]}, {'title': 'Vaccine 1 - General Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.300', 'groupId': 'OG000', 'lowerLimit': '0.188', 'upperLimit': '0.432'}, {'value': '0.297', 'groupId': 'OG001', 'lowerLimit': '0.189', 'upperLimit': '0.424'}]}]}, {'title': 'Vaccine 1 - Vomiting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.017', 'groupId': 'OG000', 'lowerLimit': '0.000', 'upperLimit': '0.089'}, {'value': '0.063', 'groupId': 'OG001', 'lowerLimit': '0.017', 'upperLimit': '0.152'}]}]}, {'title': 'Vaccine 2 - Fever', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.034', 'groupId': 'OG000', 'lowerLimit': '0.004', 'upperLimit': '0.117'}, {'value': '0.068', 'groupId': 'OG001', 'lowerLimit': '0.019', 'upperLimit': '0.165'}]}]}, {'title': 'Vaccine 2 - Fatigue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.254', 'groupId': 'OG000', 'lowerLimit': '0.150', 'upperLimit': '0.384'}, {'value': '0.254', 'groupId': 'OG001', 'lowerLimit': '0.150', 'upperLimit': '0.384'}]}]}, {'title': 'Vaccine 2 - Headache', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.203', 'groupId': 'OG000', 'lowerLimit': '0.110', 'upperLimit': '0.328'}, {'value': '0.203', 'groupId': 'OG001', 'lowerLimit': '0.110', 'upperLimit': '0.328'}]}]}, {'title': 'Vaccine 2 - Nausea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.119', 'groupId': 'OG000', 'lowerLimit': '0.049', 'upperLimit': '0.229'}, {'value': '0.186', 'groupId': 'OG001', 'lowerLimit': '0.097', 'upperLimit': '0.309'}]}]}, {'title': 'Vaccine 2 - Myalgia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.153', 'groupId': 'OG000', 'lowerLimit': '0.072', 'upperLimit': '0.270'}, {'value': '0.153', 'groupId': 'OG001', 'lowerLimit': '0.072', 'upperLimit': '0.270'}]}]}, {'title': 'Vaccine 2 - General Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.305', 'groupId': 'OG000', 'lowerLimit': '0.192', 'upperLimit': '0.439'}, {'value': '0.220', 'groupId': 'OG001', 'lowerLimit': '0.123', 'upperLimit': '0.347'}]}]}, {'title': 'Vaccine 2 - Vomiting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.000', 'groupId': 'OG000', 'lowerLimit': '0.000', 'upperLimit': '0.061'}, {'value': '0.017', 'groupId': 'OG001', 'lowerLimit': '0.000', 'upperLimit': '0.091'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Adverse events were recorded for 7 days following each vaccination or until resolution, up to study conclusion.', 'description': 'The proportion of subjects in each group experiencing at least one solicited AE with 95% posterior credible intervals, separated by vaccine number and adverse event type. AEs were assessed by clinicians using Tables 4 and 5 within section C16 of the protocol.\n\nSolicited systemic AEs included: fevers, fatigue/malaise, headache, nausea, body ache/myalgia, generally activity, and vomiting.', 'unitOfMeasure': 'proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of subjects analyzed for Vaccine 1 represents the number of subjects who attended Visit 1 and received the first vaccine. The number of subjects analyzed for Vaccine 2 represents the number of subjects who attended Visit 2 and received the second vaccine.'}, {'type': 'SECONDARY', 'title': 'Percentage of Individuals in Each Group That Test Positive for Influenza by PCR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group I (HD-TIV)', 'description': 'Patients received HD-TIV intramuscularly once at baseline (day 0) and again between 28-42 days later.\n\nTrivalent Influenza Vaccine: High Dose Trivalent Influenza Vaccine given intramuscularly\n\nLaboratory Biomarker Analysis: Correlative studies'}, {'id': 'OG001', 'title': 'Group 2 (SD-QIV)', 'description': 'Patients received SD-QIV intramuscularly once at baseline (day 0) and again between 28-42 days later.\n\nQuadrivalent Inactivated Influenza Vaccine: Standard Dose Quadrivalent Influenza Vaccine given intramuscularly\n\nLaboratory Biomarker Analysis: Correlative studies'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Nasal swabs were collected at each study visit or within 48 hours if a subject presented with influenza-like symptoms throughout the duration of the study.', 'description': 'The percentage of breakthrough flu in vaccinated participants, separated by treatment group.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'B Cell Response Assessed by Mass Cytometry and In-vitro Functionality Assays', 'timeFrame': 'Visit 1 cell counts (baseline) were measured on day 0; visit 2 cell counts were measured 28-42 days after visit 1; visit 3 cell counts were measured 28-42 days after visit 2; and visit 4 cell counts were measured 138-222 days after visit 2.', 'description': 'The total number of B cells will be measured prior to each vaccination and compared to each group.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2025-08'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'T Cell Response Assessed by Mass Cytometry and In-vitro Functionality Assays', 'timeFrame': 'Visit 1 cell counts (baseline) were measured on day 0; visit 2 cell counts were measured 28-42 days after visit 1; visit 3 cell counts were measured 28-42 days after visit 2; and visit 4 cell counts were measured 138-222 days after visit 2.', 'description': 'The total number of T cells will be measured prior to each vaccination and compared to each group.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2025-08'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group I (HD-TIV)', 'description': 'Patients received HD-TIV intramuscularly once at baseline (day 0) and again between 28-42 days later.\n\nTrivalent Influenza Vaccine: High Dose Trivalent Influenza Vaccine given intramuscularly\n\nLaboratory Biomarker Analysis: Correlative studies'}, {'id': 'FG001', 'title': 'Group 2 (SD-QIV)', 'description': 'Patients received SD-QIV intramuscularly once at baseline (day 0) and again between 28-42 days later.\n\nQuadrivalent Inactivated Influenza Vaccine: Standard Dose Quadrivalent Influenza Vaccine given intramuscularly\n\nLaboratory Biomarker Analysis: Correlative studies'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '64'}]}, {'type': 'Visit 1', 'comment': 'Study vaccine was administered.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '64'}]}, {'type': 'Visit 2', 'comment': 'Study vaccine was administered.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}, {'groupId': 'FG001', 'numSubjects': '59'}]}, {'type': 'Visit 3', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}, {'groupId': 'FG001', 'numSubjects': '59'}]}, {'type': 'Visit 4', 'achievements': [{'groupId': 'FG000', 'numSubjects': '54'}, {'groupId': 'FG001', 'numSubjects': '51'}]}, {'type': 'Visit 1 Repeat', 'comment': 'This visit was attended by subjects who enrolled for a second year following their first year of enrollment, and the study vaccine was administered. See protocol for criteria.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'Visit 2 Repeat', 'comment': 'This visit was attended by subjects who enrolled for a second year following their first year of enrollment, and the study vaccine was administered. See protocol for criteria.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'Visit 3 Repeat', 'comment': 'This visit was attended by subjects who enrolled for a second year following their first year of enrollment. See protocol for criteria.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'Visit 4 Repeat', 'comment': 'This visit was attended by subjects who enrolled for a second year following their first year of enrollment. See protocol for criteria.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'comment': 'This includes subjects who completed all four visits for their first year of enrollment. This does not account for those who participated in a "repeater" year.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '54'}, {'groupId': 'FG001', 'numSubjects': '51'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '13'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Investigator Request', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'A total of 138 adults were targeted with the expectation of a 20% drop out rate, as described in Section C17 in the protocol. We were able to enroll 124 subjects with a 15% dropout rate between Visit 1 and Visit 4.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '124', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Group I (HD-TIV)', 'description': 'Patients received HD-TIV intramuscularly once at baseline (day 0) and again between 28-42 days later.\n\nTrivalent Influenza Vaccine: High Dose Trivalent Influenza Vaccine given intramuscularly\n\nLaboratory Biomarker Analysis: Correlative studies'}, {'id': 'BG001', 'title': 'Group 2 (SD-QIV)', 'description': 'Patients received SD-QIV intramuscularly once at baseline (day 0) and again between 28-42 days later.\n\nQuadrivalent Inactivated Influenza Vaccine: Standard Dose Quadrivalent Influenza Vaccine given intramuscularly\n\nLaboratory Biomarker Analysis: Correlative studies'}, {'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': '53', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52.657', 'groupId': 'BG000', 'lowerLimit': '34.448', 'upperLimit': '61.643'}, {'value': '59.986', 'groupId': 'BG001', 'lowerLimit': '51.397', 'upperLimit': '66.943'}, {'value': '57.815', 'groupId': 'BG002', 'lowerLimit': '42.358', 'upperLimit': '64.101'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '111', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '124', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'All participants who received at least one dose of their assigned vaccine'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-08-12', 'size': 904449, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-01-11T12:57', 'hasProtocol': True}, {'date': '2019-08-12', 'size': 206420, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-12-20T17:42', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 124}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-13', 'studyFirstSubmitDate': '2017-06-01', 'resultsFirstSubmitDate': '2022-10-24', 'studyFirstSubmitQcDate': '2017-06-05', 'lastUpdatePostDateStruct': {'date': '2024-12-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-12-19', 'studyFirstPostDateStruct': {'date': '2017-06-07', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-01-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'B Cell Response Assessed by Mass Cytometry and In-vitro Functionality Assays', 'timeFrame': 'Visit 1 cell counts (baseline) were measured on day 0; visit 2 cell counts were measured 28-42 days after visit 1; visit 3 cell counts were measured 28-42 days after visit 2; and visit 4 cell counts were measured 138-222 days after visit 2.', 'description': 'The total number of B cells will be measured prior to each vaccination and compared to each group.'}, {'measure': 'T Cell Response Assessed by Mass Cytometry and In-vitro Functionality Assays', 'timeFrame': 'Visit 1 cell counts (baseline) were measured on day 0; visit 2 cell counts were measured 28-42 days after visit 1; visit 3 cell counts were measured 28-42 days after visit 2; and visit 4 cell counts were measured 138-222 days after visit 2.', 'description': 'The total number of T cells will be measured prior to each vaccination and compared to each group.'}], 'primaryOutcomes': [{'measure': 'HD-TIV Compared With SD-QIV (Influenza A) - Immunogenicity', 'timeFrame': 'Visit 1 titers (baseline) were measured on day 0; visit 2 titers were measured 28-42 days after visit 1; visit 3 titers were measured 28-42 days after visit 2; and visit 4 titers were measured 138-222 days after visit 2.', 'description': 'Point estimates and 95% confidence intervals for proportion of subjects achieving seroprotection (≥1:40 HAI titer) and seroconversion (4-fold or greater rise in HAI titers from visit 1) for Influenza A antigens.'}], 'secondaryOutcomes': [{'measure': 'HD-TIV Compared With SD-QIV (Influenza B) - Immunogenicity', 'timeFrame': 'Visit 1 titers (baseline) were measured on day 0; visit 2 titers were measured 28-42 days after visit 1; visit 3 titers were measured 28-42 days after visit 2; and visit 4 titers were measured 138-222 days after visit 2.', 'description': 'Point estimates and 95% confidence intervals for proportion of subjects achieving seroprotection (≥1:40 HAI titer) and seroconversion (4-fold or greater rise in HAI titers from visit 1) for Influenza B antigens.'}, {'measure': 'Solicited Local Injection Site Adverse Events', 'timeFrame': 'Adverse events were recorded for 7 days following each vaccination or until resolution, up to study conclusion.', 'description': 'The proportion of subjects in each group experiencing at least one solicited AE with 95% posterior credible intervals, separated by vaccine number and adverse event type. AEs were assessed by clinicians using Tables 4 and 5 within section C16 of the protocol.\n\nSolicited injection site AEs included: pain, tenderness, erythema/redness, and swelling/induration. The diameter of any erythema/redness and swelling/induration was measured to evaluate "redness size" and "swelling size."'}, {'measure': 'Solicited Systemic Adverse Events', 'timeFrame': 'Adverse events were recorded for 7 days following each vaccination or until resolution, up to study conclusion.', 'description': 'The proportion of subjects in each group experiencing at least one solicited AE with 95% posterior credible intervals, separated by vaccine number and adverse event type. AEs were assessed by clinicians using Tables 4 and 5 within section C16 of the protocol.\n\nSolicited systemic AEs included: fevers, fatigue/malaise, headache, nausea, body ache/myalgia, generally activity, and vomiting.'}, {'measure': 'Percentage of Individuals in Each Group That Test Positive for Influenza by PCR', 'timeFrame': 'Nasal swabs were collected at each study visit or within 48 hours if a subject presented with influenza-like symptoms throughout the duration of the study.', 'description': 'The percentage of breakthrough flu in vaccinated participants, separated by treatment group.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hematopoietic Cell Transplantation']}, 'descriptionModule': {'briefSummary': "This randomized phase II studies the side effects of high-dose trivalent influenza vaccine or standard-dose quadrivalent inactivated influenza and how well they work in treating adult patients undergoing stem cell transplant. Season influenza can cause more severe infections in patients who have had a stem cell transplant since their immune system doesn't work as well. Influenza vaccine may provide better protection against flu in adults.", 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To determine whether high dose (HD)-trivalent influenza vaccine (TIV) compared with standard dose (SD)-quadrivalent inactivated influenza vaccine (QIV) will increase the probability of achieving a \\>= 4-fold rise in hemagglutination inhibition assay (HAI) titer, \\>= 1:40 HAI titer, or a higher geometric mean titer (GMT) titer to influenza A antigens in adult hematopoietic cell transplantation (HSCT) recipients.\n\nSECONDARY OBJECTIVES:\n\nI. To determine whether HD-TIV compared with SD-QIV will increase the probability of achieving a \\>= 4-fold rise in HAI titers, \\>= 1:40 HAI titer, or higher GMT titers to influenza B antigens in adult HSCT recipients.\n\nII. To determine the frequency and severity of solicited local injection site adverse events (e.g. pain/tenderness, redness, and swelling at injection site) with HD-TIV compared to SD-QIV in adult HSCT recipients.\n\nIII. To determine the frequency and severity of solicited systemic adverse events (e.g. fevers, headache, fatigue/malaise, nausea, body ache/myalgia, general activity level, and vomiting) with HD-TIV compared to SD-QIV in adult HSCT recipients.\n\nIV. To define the relationship between HAI titers, in vivo T and B cell phenotype, and in vitro influenza-specific T and B cell response in adult HSCT recipients receiving either HD-TIV or SD-QIV.\n\nV. To correlate HAI responses to microneutralization responses. VI. To compare the persistent HAI and microneutralization assay (MN) titers for all four antigen seven months after the last vaccine dose to assess for persistence of antibody titers.\n\nVII. To compare influenza detection by polymerase chain reaction (PCR) during influenza season in adult HSCT recipients receiving either HD-TIV or standard dose QIV.\n\nOUTLINE: Patients are randomized into 1 of 2 groups.\n\nGROUP I: Patients receive HD-TIV intramuscularly once at baseline and once between 28-42 days.\n\nGROUP II: Patients receive SD-QIV intramuscularly once at baseline and once between 28-42 days.\n\nAfter completion of study treatment, patients are contacted at 1-3 and 8-10 days after each vaccination visit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\n1. Allogeneic HSCT recipients who are 3-23 months post-transplant;\n2. ≥ 18 years of age;\n3. Available for duration of study;\n4. Patients with stable GVHD for at least 4 weeks will be eligible (stable is defined as no major change in systemic immunosuppressive therapy for worsening GVHD; adjustment of actual dose to obtain a stable target level is acceptable).\n5. Can be reached by telephone and/or electronic communication\n6. Subjects must have a platelet count of ≥30,000 to receive the immunizations. Patients requiring platelet transfusions are eligible to enroll and must have a platelet count ≥30,000 within 72 hours prior to their immunization, or platelet count ≥75,000 without transfusion documented within 30 days for subjects \\<12 months post- transplant and within 90 days for subjects 12-23 months post-transplant.\n\nExclusion criteria\n\n1. History of hypersensitivity to previous influenza vaccination or severe hypersensitivity to eggs/egg protein;\n2. History of Guillain-Barre syndrome;\n3. Evidence of hematologic malignancy or disease relapse post-transplant (stable mixed chimerism is permitted);\n4. History of receiving current seasonal influenza vaccine post-transplant;\n5. Pregnant female;\n6. History of proven influenza disease after September 1, 2018 prior to enrollment;\n7. Non-allogeneic (e.g. autologous) or syngeneic hematopoietic SCT recipients;\n8. History of known active infection with HIV\n9. History of cirrhosis\n10. History of known latex hypersensitivity;\n11. Subjects who have received stem cell boost or delayed donor lymphocyte infusion within 90 days of enrollment, including day of enrollment\n12. Receipt of. IVIG/SCIG \\<28 days prior to vaccination\n\nCriteria for temporarily delaying vaccine administration: The following conditions are temporary or self-limiting, and a subject may be included in the study once the condition has resolved, provided that the subject is otherwise eligible:\n\n1. Fever ≥100.4ºF/38.0ºC (oral measurement), or an acute illness within 48 hours of enrollment\n2. Receipt of any live vaccines within four weeks or any inactivated vaccines within two weeks prior to potential study vaccination.\n\nNote: if patients were eligible for vaccine 1, they will be eligible to receive vaccine 2 regardless of any changes on their GVHD status, unless it is deemed not medically safe to receive influenza vaccine.\n\nFor subjects who were enrolled and vaccinated in 2017-18, and 2018-19, the goal is to enroll these same subjects who participated the previous influenza season year and then administer the same vaccination as the previous year. These subjects are referred to as repeaters. For example, subjects enrolled in 2017-18 year were eligible to enroll again in 2018-19 as repeaters. For subjects enrolled in 2018-19 year and received at least one vaccine, will be eligible to be enrolled as repeaters for 2019-2020 season.'}, 'identificationModule': {'nctId': 'NCT03179761', 'briefTitle': 'High vs. Standard Dose Flu Vaccine in Adult Stem Cell Transplant Recipients', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt-Ingram Cancer Center'}, 'officialTitle': 'High vs. Standard Dose Flu Vaccine in Adult Stem Cell Transplant Recipients', 'orgStudyIdInfo': {'id': 'VICC CTT 1733'}, 'secondaryIdInfos': [{'id': 'NCI-2017-00466', 'type': 'REGISTRY', 'domain': 'NCI, Clinical Trials Reporting Program'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group I (HD-TIV)', 'description': 'Patients received HD-TIV intramuscularly once at baseline (day 0) and again between 28-42 days later.', 'interventionNames': ['Other: Laboratory Biomarker Analysis', 'Biological: Trivalent Influenza Vaccine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2(SD-QIV)', 'description': 'Patients received SD-QIV intramuscularly once at baseline (day 0) and again between 28-42 days later.', 'interventionNames': ['Biological: Quadrivalent Inactivated Influenza Vaccine', 'Other: Laboratory Biomarker Analysis']}], 'interventions': [{'name': 'Quadrivalent Inactivated Influenza Vaccine', 'type': 'BIOLOGICAL', 'description': 'Standard Dose Quadrivalent Influenza Vaccine given intramuscularly', 'armGroupLabels': ['Group 2(SD-QIV)']}, {'name': 'Laboratory Biomarker Analysis', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Group 2(SD-QIV)', 'Group I (HD-TIV)']}, {'name': 'Trivalent Influenza Vaccine', 'type': 'BIOLOGICAL', 'description': 'High Dose Trivalent Influenza Vaccine given intramuscularly', 'armGroupLabels': ['Group I (HD-TIV)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt-Ingram Cancer Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '98109', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Fred Hutchinson Cancer Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt-Ingram Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Natasha Halasa, MD', 'investigatorAffiliation': 'Vanderbilt-Ingram Cancer Center'}}}}