Ignite Creation Date:
2025-12-24 @ 9:45 PM
Ignite Modification Date:
2026-01-01 @ 1:13 PM
Study NCT ID:
NCT01216332
Status:
COMPLETED
Last Update Posted:
2019-05-03
First Post:
2010-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Standard Versus High-Dose Trivalent Inactivated Flu Vaccine in Pediatric Acute Lymphoblastic Leukemia Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'natasha.halasa@vanderbilt.edu', 'phone': '6153223346', 'title': 'Dr. Natasha Halasa', 'organization': 'Vanderbilt'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'AEs were collected for 28 days after last vaccination, and SAEs were collected through 180 days after their final vaccination via phone call and medical chart review.', 'eventGroups': [{'id': 'EG000', 'title': 'High-Dose Trivalent Inactivated Influenza Vaccine', 'description': '0.5 mL of high-dose trivalent inactivated influenza vaccine, either one dose or 2 based on whether the patient has previously received standard dose trivalent inactivated influenza vaccine.\n\nHigh-dose trivalent inactivated influenza vaccine: 0.5 mL of high-dose trivalent inactivated influenza vaccine, either one dose or 2 based on whether the patient has previously received standard dose trivalent inactivated influenza vaccine.', 'otherNumAtRisk': 34, 'deathsNumAtRisk': 34, 'otherNumAffected': 21, 'seriousNumAtRisk': 34, 'deathsNumAffected': 0, 'seriousNumAffected': 9}, {'id': 'EG001', 'title': 'Standard Dose Trivalent Inactivated Influenza Vaccine', 'description': '0.5 mL standard dose trivalent inactivated influenza vaccine, either one dose or 2 based on whether the patient has previously received standard dose trivalent inactivated influenza vaccine\n\nStandard dose trivalent inactivated influenza vaccine: 0.5 mL standard dose trivalent inactivated influenza vaccine', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 14, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Redness at injection site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Pain at Injection Site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Tenderness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Intense Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Decrease in Activity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Body Aches', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}], 'seriousEvents': [{'term': 'Acute Otitis Media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Influenza B', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Coronavirus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Viral Illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'New Onset Seizures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Local Reactions After Each Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High-Dose Trivalent Inactivated Influenza Vaccine', 'description': '0.5 mL of high-dose trivalent inactivated influenza vaccine, either one dose or 2 based on whether the patient has previously received standard dose trivalent inactivated influenza vaccine.\n\nHigh-dose trivalent inactivated influenza vaccine: 0.5 mL of high-dose trivalent inactivated influenza vaccine, either one dose or 2 based on whether the patient has previously received standard dose trivalent inactivated influenza vaccine.'}, {'id': 'OG001', 'title': 'Standard Dose Trivalent Inactivated Influenza Vaccine', 'description': '0.5 mL standard dose trivalent inactivated influenza vaccine, either one dose or 2 based on whether the patient has previously received standard dose trivalent inactivated influenza vaccine\n\nStandard dose trivalent inactivated influenza vaccine: 0.5 mL standard dose trivalent inactivated influenza vaccine'}], 'classes': [{'title': 'Pain', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Tenderness', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Intense Swelling', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Redness', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From baseline to 7 days after each vaccination', 'description': 'Number of participants with local reactions after each vaccination', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Systemic Reaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High-Dose Trivalent Inactivated Influenza Vaccine', 'description': '0.5 mL of high-dose trivalent inactivated influenza vaccine, either one dose or 2 based on whether the patient has previously received standard dose trivalent inactivated influenza vaccine.\n\nHigh-dose trivalent inactivated influenza vaccine: 0.5 mL of high-dose trivalent inactivated influenza vaccine, either one dose or 2 based on whether the patient has previously received standard dose trivalent inactivated influenza vaccine.'}, {'id': 'OG001', 'title': 'Standard Dose Trivalent Inactivated Influenza Vaccine', 'description': '0.5 mL standard dose trivalent inactivated influenza vaccine, either one dose or 2 based on whether the patient has previously received standard dose trivalent inactivated influenza vaccine\n\nStandard dose trivalent inactivated influenza vaccine: 0.5 mL standard dose trivalent inactivated influenza vaccine'}], 'classes': [{'title': 'Fatigue', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Decrease in Activity', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Fever', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Headache', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Nausea', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Body aches', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Vomiting', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From baseline to 7 days after each vaccination', 'description': 'Number of participants with systemic reactions after each vaccination', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Immunogenicity: Number of Participants With a Post-titer Greater Than or Equal to a Fourfold Titer Rise', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High-Dose Trivalent Inactivated Influenza Vaccine', 'description': '0.5 mL of high-dose trivalent inactivated influenza vaccine, either one dose or 2 based on whether the patient has previously received standard dose trivalent inactivated influenza vaccine.\n\nHigh-dose trivalent inactivated influenza vaccine: 0.5 mL of high-dose trivalent inactivated influenza vaccine, either one dose or 2 based on whether the patient has previously received standard dose trivalent inactivated influenza vaccine.'}, {'id': 'OG001', 'title': 'Standard Dose Trivalent Inactivated Influenza Vaccine', 'description': '0.5 mL standard dose trivalent inactivated influenza vaccine, either one dose or 2 based on whether the patient has previously received standard dose trivalent inactivated influenza vaccine\n\nStandard dose trivalent inactivated influenza vaccine: 0.5 mL standard dose trivalent inactivated influenza vaccine'}], 'classes': [{'title': 'A/California/7/09 H1N1', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'A/Perth/16/2009 H3N2', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'B/Brisbane/60/2008', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'About 6 months after last dose of vaccine.', 'description': 'Greater than or equal to a Fourfold titer rise three strains (A/California/7/09/H1N1, A/Perth/16/2009/ H3N2, B/Brisbane/60/2008)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants that receive only 1 dose of vaccine. In addition, two subjects were excluded due to lack of complete immunogenicity data'}, {'type': 'SECONDARY', 'title': 'Immunogenicity:Number of Participants With a Pre-titer ≥1:40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High-Dose Trivalent Inactivated Influenza Vaccine', 'description': '0.5 mL of high-dose trivalent inactivated influenza vaccine, either one dose or 2 based on whether the patient has previously received standard dose trivalent inactivated influenza vaccine.\n\nHigh-dose trivalent inactivated influenza vaccine: 0.5 mL of high-dose trivalent inactivated influenza vaccine, either one dose or 2 based on whether the patient has previously received standard dose trivalent inactivated influenza vaccine.'}, {'id': 'OG001', 'title': 'Standard Dose Trivalent Inactivated Influenza Vaccine', 'description': '0.5 mL standard dose trivalent inactivated influenza vaccine, either one dose or 2 based on whether the patient has previously received standard dose trivalent inactivated influenza vaccine\n\nStandard dose trivalent inactivated influenza vaccine: 0.5 mL standard dose trivalent inactivated influenza vaccine'}], 'classes': [{'title': 'A/California/7/09 H1N1', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'A/Perth/16/2009 H3N2', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'B/Brisbane/60/2008', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'About 6 months after last dose of vaccine.', 'description': 'Pre-titer ≥1:40 for three strains (A/California/7/09/H1N1, A/Perth/16/2009/ H3N2, B/Brisbane/60/2008)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants that receive only 1 dose of vaccine. In addition, two subjects were excluded due to lack of complete immunogenicity data'}, {'type': 'SECONDARY', 'title': 'Immunogenicity: Number of Participants With a Post-titer ≥1:40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High-Dose Trivalent Inactivated Influenza Vaccine', 'description': '0.5 mL of high-dose trivalent inactivated influenza vaccine, either one dose or 2 based on whether the patient has previously received standard dose trivalent inactivated influenza vaccine.\n\nHigh-dose trivalent inactivated influenza vaccine: 0.5 mL of high-dose trivalent inactivated influenza vaccine, either one dose or 2 based on whether the patient has previously received standard dose trivalent inactivated influenza vaccine.'}, {'id': 'OG001', 'title': 'Standard Dose Trivalent Inactivated Influenza Vaccine', 'description': '0.5 mL standard dose trivalent inactivated influenza vaccine, either one dose or 2 based on whether the patient has previously received standard dose trivalent inactivated influenza vaccine\n\nStandard dose trivalent inactivated influenza vaccine: 0.5 mL standard dose trivalent inactivated influenza vaccine'}], 'classes': [{'title': 'A/California/7/09 H1N1', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'A/Perth/16/2009 H3N2', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'B/Brisbane/60/2008', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'About 6 months after last dose of vaccine.', 'description': 'Post-titer ≥1:40 for three strains (A/California/7/09/H1N1, A/Perth/16/2009/ H3N2, B/Brisbane/60/2008)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants that receive only 1 dose of vaccine. In addition, two subjects were excluded due to lack of complete immunogenicity data'}, {'type': 'SECONDARY', 'title': 'Immunogenicity: The Geometric Mean Titers Pre-vaccine in Study Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High-Dose Trivalent Inactivated Influenza Vaccine', 'description': '0.5 mL of high-dose trivalent inactivated influenza vaccine, either one dose or 2 based on whether the patient has previously received standard dose trivalent inactivated influenza vaccine.\n\nHigh-dose trivalent inactivated influenza vaccine: 0.5 mL of high-dose trivalent inactivated influenza vaccine, either one dose or 2 based on whether the patient has previously received standard dose trivalent inactivated influenza vaccine.'}, {'id': 'OG001', 'title': 'Standard Dose Trivalent Inactivated Influenza Vaccine', 'description': '0.5 mL standard dose trivalent inactivated influenza vaccine, either one dose or 2 based on whether the patient has previously received standard dose trivalent inactivated influenza vaccine\n\nStandard dose trivalent inactivated influenza vaccine: 0.5 mL standard dose trivalent inactivated influenza vaccine'}], 'classes': [{'title': 'A/California/7/09 H1N1', 'categories': [{'measurements': [{'value': '46.2', 'groupId': 'OG000', 'lowerLimit': '27.4', 'upperLimit': '75.7'}, {'value': '87.4', 'groupId': 'OG001', 'lowerLimit': '37.9', 'upperLimit': '209.1'}]}]}, {'title': 'A/Perth/16/2009 H3N2', 'categories': [{'measurements': [{'value': '28.3', 'groupId': 'OG000', 'lowerLimit': '18.7', 'upperLimit': '43.3'}, {'value': '28.8', 'groupId': 'OG001', 'lowerLimit': '18.1', 'upperLimit': '46.5'}]}]}, {'title': 'B/Brisbane/60/2008', 'categories': [{'measurements': [{'value': '66.5', 'groupId': 'OG000', 'lowerLimit': '51.8', 'upperLimit': '82.2'}, {'value': '56.1', 'groupId': 'OG001', 'lowerLimit': '43.9', 'upperLimit': '69.4'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'baseline', 'description': 'Geometric mean titers pre-vaccine (A/California/7/09/H1N1, A/Perth/16/2009/ H3N2, B/Brisbane/60/2008)', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants that receive only 1 dose of vaccine. In addition, two subjects were excluded due to lack of complete immunogenicity data'}, {'type': 'SECONDARY', 'title': 'Immunogenicity: Geometric Mean Titers Post-vaccine in Study Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High-Dose Trivalent Inactivated Influenza Vaccine', 'description': '0.5 mL of high-dose trivalent inactivated influenza vaccine, either one dose or 2 based on whether the patient has previously received standard dose trivalent inactivated influenza vaccine.\n\nHigh-dose trivalent inactivated influenza vaccine: 0.5 mL of high-dose trivalent inactivated influenza vaccine, either one dose or 2 based on whether the patient has previously received standard dose trivalent inactivated influenza vaccine.'}, {'id': 'OG001', 'title': 'Standard Dose Trivalent Inactivated Influenza Vaccine', 'description': '0.5 mL standard dose trivalent inactivated influenza vaccine, either one dose or 2 based on whether the patient has previously received standard dose trivalent inactivated influenza vaccine\n\nStandard dose trivalent inactivated influenza vaccine: 0.5 mL standard dose trivalent inactivated influenza vaccine'}], 'classes': [{'title': 'A/California/7/09 H1N1', 'categories': [{'measurements': [{'value': '97.9', 'groupId': 'OG000', 'lowerLimit': '61.1', 'upperLimit': '166.3'}, {'value': '322.9', 'groupId': 'OG001', 'lowerLimit': '141.3', 'upperLimit': '792.1'}]}]}, {'title': 'A/Perth/16/2009 H3N2', 'categories': [{'measurements': [{'value': '62.9', 'groupId': 'OG000', 'lowerLimit': '34.6', 'upperLimit': '122.2'}, {'value': '76.5', 'groupId': 'OG001', 'lowerLimit': '36', 'upperLimit': '176.5'}]}]}, {'title': 'B/Brisbane/60/2008', 'categories': [{'measurements': [{'value': '74.4', 'groupId': 'OG000', 'lowerLimit': '49.9', 'upperLimit': '111.6'}, {'value': '50.6', 'groupId': 'OG001', 'lowerLimit': '35.3', 'upperLimit': '67.3'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'About 6 months after last dose of vaccine.', 'description': 'Geometric mean titers post-vaccine (A/California/7/09/H1N1, A/Perth/16/2009/ H3N2, B/Brisbane/60/2008)', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants that receive only 1 dose of vaccine. In addition, two subjects were excluded due to lack of complete immunogenicity data'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'High-Dose Trivalent Inactivated Influenza Vaccine', 'description': '0.5 mL of high-dose trivalent inactivated influenza vaccine, either one dose or 2 based on whether the patient has previously received standard dose trivalent inactivated influenza vaccine.'}, {'id': 'FG001', 'title': 'Standard Dose Trivalent Inactivated Influenza Vaccine', 'description': '0.5 mL standard dose trivalent inactivated influenza vaccine, either one dose or 2 based on whether the patient has previously received standard dose trivalent inactivated influenza vaccine'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Four subjects (from the high dose group) were excluded from the data analysis , because they were given the second dose of TIV outside the study window period. These four subjects were included in the adverse event reporting.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'High-Dose Trivalent Inactivated Influenza Vaccine', 'description': '0.5 mL of high-dose trivalent inactivated influenza vaccine, either one dose or 2 based on whether the patient has previously received standard dose trivalent inactivated influenza vaccine.\n\nHigh-dose trivalent inactivated influenza vaccine: 0.5 mL of high-dose trivalent inactivated influenza vaccine, either one dose or 2 based on whether the patient has previously received standard dose trivalent inactivated influenza vaccine.'}, {'id': 'BG001', 'title': 'Standard Dose Trivalent Inactivated Influenza Vaccine', 'description': '0.5 mL standard dose trivalent inactivated influenza vaccine, either one dose or 2 based on whether the patient has previously received standard dose trivalent inactivated influenza vaccine\n\nStandard dose trivalent inactivated influenza vaccine: 0.5 mL standard dose trivalent inactivated influenza vaccine'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex/Gender, Customized', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', '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': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Four subjects were excluded from the data analysis (from the high dose group), because they were given the second dose of TIV outside the study window period'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-29', 'studyFirstSubmitDate': '2010-10-05', 'resultsFirstSubmitDate': '2016-08-12', 'studyFirstSubmitQcDate': '2010-10-05', 'lastUpdatePostDateStruct': {'date': '2019-05-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-04-29', 'studyFirstPostDateStruct': {'date': '2010-10-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Local Reactions After Each Vaccination', 'timeFrame': 'From baseline to 7 days after each vaccination', 'description': 'Number of participants with local reactions after each vaccination'}, {'measure': 'Systemic Reaction', 'timeFrame': 'From baseline to 7 days after each vaccination', 'description': 'Number of participants with systemic reactions after each vaccination'}], 'secondaryOutcomes': [{'measure': 'Immunogenicity: Number of Participants With a Post-titer Greater Than or Equal to a Fourfold Titer Rise', 'timeFrame': 'About 6 months after last dose of vaccine.', 'description': 'Greater than or equal to a Fourfold titer rise three strains (A/California/7/09/H1N1, A/Perth/16/2009/ H3N2, B/Brisbane/60/2008)'}, {'measure': 'Immunogenicity:Number of Participants With a Pre-titer ≥1:40', 'timeFrame': 'About 6 months after last dose of vaccine.', 'description': 'Pre-titer ≥1:40 for three strains (A/California/7/09/H1N1, A/Perth/16/2009/ H3N2, B/Brisbane/60/2008)'}, {'measure': 'Immunogenicity: Number of Participants With a Post-titer ≥1:40', 'timeFrame': 'About 6 months after last dose of vaccine.', 'description': 'Post-titer ≥1:40 for three strains (A/California/7/09/H1N1, A/Perth/16/2009/ H3N2, B/Brisbane/60/2008)'}, {'measure': 'Immunogenicity: The Geometric Mean Titers Pre-vaccine in Study Participants', 'timeFrame': 'baseline', 'description': 'Geometric mean titers pre-vaccine (A/California/7/09/H1N1, A/Perth/16/2009/ H3N2, B/Brisbane/60/2008)'}, {'measure': 'Immunogenicity: Geometric Mean Titers Post-vaccine in Study Participants', 'timeFrame': 'About 6 months after last dose of vaccine.', 'description': 'Geometric mean titers post-vaccine (A/California/7/09/H1N1, A/Perth/16/2009/ H3N2, B/Brisbane/60/2008)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Pediatric Patients With Acute Lymphoblastic Leukemia']}, 'descriptionModule': {'briefSummary': 'This is a phase I safety and immunogenicity trial comparing high-dose (HD)trivalent inactivated influenza vaccine (TIV) to standard dose (SD) TIV in pediatric patients with Acute Lymphoblastic Leukemia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pediatric patients with standard or high risk Acute Lymphoblastic Leukemia.\n* Must be in 1st complete remission.\n* Must be 4 weeks into maintenance therapy.\n* 17 years of age, inclusive.\n* Available for duration of study.\n\nExclusion Criteria:\n\n* History of hypersensitivity to previous influenza vaccination or hypersensitivity to eggs/egg protein.\n* History of Guillain-Barre syndrome.\n* Evidence of relapsed disease.\n* Have any condition that would, in the opinion of the site investigator, place them at an unacceptable risk of injury or render them unable to meet the requirements of the protocol.\n* Have any condition that the investigator believes may interfere with successful completion of the study.\n* History of receiving 2010 - 2011 influenza vaccine.\n* Pregnant female.\n* History of proven influenza disease after September 1, 2010.'}, 'identificationModule': {'nctId': 'NCT01216332', 'briefTitle': 'Standard Versus High-Dose Trivalent Inactivated Flu Vaccine in Pediatric Acute Lymphoblastic Leukemia Patients', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University Medical Center'}, 'officialTitle': 'Randomized, Double Blind, Comparison of Standard Dose Trivalent Inactivated Influenza Vaccine Versus High Dose Trivalent Inactivated Influenza Vaccine in Pediatric Patients With Acute Lymphoblastic Leukemia', 'orgStudyIdInfo': {'id': 'VICC PED 1067'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High-Dose trivalent inactivated influenza vaccine', 'description': '0.5 mL of high-dose trivalent inactivated influenza vaccine, either one dose or 2 based on whether the patient has previously received standard dose trivalent inactivated influenza vaccine.', 'interventionNames': ['Drug: High-dose trivalent inactivated influenza vaccine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard dose trivalent inactivated influenza vaccine', 'description': '0.5 mL standard dose trivalent inactivated influenza vaccine, either one dose or 2 based on whether the patient has previously received standard dose trivalent inactivated influenza vaccine', 'interventionNames': ['Drug: Standard dose trivalent inactivated influenza vaccine']}], 'interventions': [{'name': 'High-dose trivalent inactivated influenza vaccine', 'type': 'DRUG', 'description': '0.5 mL of high-dose trivalent inactivated influenza vaccine, either one dose or 2 based on whether the patient has previously received standard dose trivalent inactivated influenza vaccine.', 'armGroupLabels': ['High-Dose trivalent inactivated influenza vaccine']}, {'name': 'Standard dose trivalent inactivated influenza vaccine', 'type': 'DRUG', 'description': '0.5 mL standard dose trivalent inactivated influenza vaccine', 'armGroupLabels': ['Standard dose trivalent inactivated influenza vaccine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': "Monroe Carell Jr. Children's Hospital at Vanderbilt", 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Natasha Halasa, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt Universtiy Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Natasha Halasa', 'investigatorAffiliation': 'Vanderbilt University'}}}}