Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2026-02-24 @ 1:15 AM
Study NCT ID:
NCT02461758
Status:
COMPLETED
Last Update Posted:
2019-10-02
First Post:
2015-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Trial of High Dose vs. Standard Dose Influenza Vaccine in Inflammatory Bowel Disease Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal 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': 'fcaldera@medicine.wisc.edu', 'phone': '(608) 263-1995', 'title': 'FREDDY CALDERA, ASST PROFESSOR , GASTROENTEROLOGY', 'organization': 'University of Wisconsin School of Medicine and Public Health'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 7 days', 'description': 'AEs were recorded after administration of the vaccine from days 0-6 using the adverse event dairy. Adverse event data is reported for 24 participants in the HDIV arm as 1 participant did not submit the diary card for adverse event reporting. Adverse event are reported just for anti-TNF monotherapy group HDIV and SDIV since these were the primary outcome.No AEs were collected for vedolizumab group and control group as they were secondary outcomes which were dependent on primary outcomes.', 'eventGroups': [{'id': 'EG000', 'title': 'High Dose Influenza Vaccine (HDIV)', 'description': 'This arm will be a double blind randomized controlled trial of High dose influenza vaccine (HDIV) for IBD patients on TNF monotherapy.\n\n40 patients will be enrolled and randomized in a 5:3 fashion to HDIV or SDIV. Randomization will generated by a random number generator and investigator will be blinded to randomization scheme.', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 25, 'otherNumAffected': 13, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Standard Dose Influenza Vaccine (SDIV)', 'description': 'This arm will be a double blind randomized controlled trial of standard dose influenza vaccine (SDIV) for IBD patients on TNF monotherapy.\n\n40 patients will be enrolled and randomized in a 5:3 fashion to HDIV or SDIV. Randomization will generated by a random number generator and investigator will be blinded to randomization scheme.', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 8, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Local reactions: Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Local reaction: Redness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Muscle Aches', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Measure Antibody Concentrations in Immunosuppressed IBD Patients Who Receive High Dose and Standard of Care Dose Influenza Vaccine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'High Dose of Influenza Vaccine (HDIV) Group', 'description': 'This arm will be a double blind randomized controlled trial of high dose influenza vaccine (HDIV) for IBD patients on TNF monotherapy.\n\n40 patients will be enrolled and randomized in a 5:3 fashion to HDIV or SDIV. Randomization will generated by a random number generator and investigator will be blinded to randomization scheme.'}, {'id': 'OG001', 'title': 'Standard Dose Influenza Vaccine (SDIV) Group', 'description': 'This arm will be a double blind randomized controlled trial of standard dose influenza vaccine (SDIV) for IBD patients on TNF monotherapy.\n\n40 patients will be enrolled and randomized in a 5:3 fashion to HDIV or SDIV. Randomization will generated by a random number generator and investigator will be blinded to randomization scheme.'}, {'id': 'OG002', 'title': 'Vedolizumab Group', 'description': 'A group of 20 patients who are currently on vedolizumab. All individuals in this group will receive SDIV'}, {'id': 'OG003', 'title': 'Control Group', 'description': 'A group of 20 healthy individuals without IBD, other chronic diseases, or immunosuppressive therapy will be enrolled. All healthy individuals will receive standard dose influenza vaccine SDIV.'}], 'classes': [{'title': 'Influenza A H1N1, pre-immunization', 'categories': [{'measurements': [{'value': '160', 'groupId': 'OG000', 'lowerLimit': '80', 'upperLimit': '240'}, {'value': '160', 'groupId': 'OG001', 'lowerLimit': '80', 'upperLimit': '160'}, {'value': '160', 'groupId': 'OG002', 'lowerLimit': '80', 'upperLimit': '320'}, {'value': '160', 'groupId': 'OG003', 'lowerLimit': '80', 'upperLimit': '160'}]}]}, {'title': 'Influenza A H1N1, 2-4 weeks post immunization', 'categories': [{'measurements': [{'value': '320', 'groupId': 'OG000', 'lowerLimit': '150', 'upperLimit': '320'}, {'value': '160', 'groupId': 'OG001', 'lowerLimit': '80', 'upperLimit': '320'}, {'value': '320', 'groupId': 'OG002', 'lowerLimit': '160', 'upperLimit': '640'}, {'value': '320', 'groupId': 'OG003', 'lowerLimit': '160', 'upperLimit': '320'}]}]}, {'title': 'Influenza A H3N2, Pre-immunization', 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000', 'lowerLimit': '40', 'upperLimit': '160'}, {'value': '40', 'groupId': 'OG001', 'lowerLimit': '20', 'upperLimit': '40'}, {'value': '80', 'groupId': 'OG002', 'lowerLimit': '80', 'upperLimit': '160'}, {'value': '80', 'groupId': 'OG003', 'lowerLimit': '40', 'upperLimit': '80'}]}]}, {'title': 'Influenza A H3N2, 2-4 weeks post immunization', 'categories': [{'measurements': [{'value': '160', 'groupId': 'OG000', 'lowerLimit': '80', 'upperLimit': '320'}, {'value': '80', 'groupId': 'OG001', 'lowerLimit': '40', 'upperLimit': '160'}, {'value': '320', 'groupId': 'OG002', 'lowerLimit': '160', 'upperLimit': '320'}, {'value': '160', 'groupId': 'OG003', 'lowerLimit': '160', 'upperLimit': '160'}]}]}, {'title': 'Influenza B Victoria,Pre-immunization', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000', 'lowerLimit': '10', 'upperLimit': '20'}, {'value': '10', 'groupId': 'OG001', 'lowerLimit': '10', 'upperLimit': '20'}, {'value': '20', 'groupId': 'OG002', 'lowerLimit': '10', 'upperLimit': '20'}, {'value': '20', 'groupId': 'OG003', 'lowerLimit': '20', 'upperLimit': '35'}]}]}, {'title': 'Influenza B Victoria, 2-4 weeks post immunization', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000', 'lowerLimit': '15', 'upperLimit': '20'}, {'value': '20', 'groupId': 'OG001', 'lowerLimit': '20', 'upperLimit': '40'}, {'value': '20', 'groupId': 'OG002', 'lowerLimit': '20', 'upperLimit': '40'}, {'value': '20', 'groupId': 'OG003', 'lowerLimit': '20', 'upperLimit': '40'}]}]}, {'title': 'Influenza B Yamagata, Pre-immunization', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000', 'lowerLimit': '10', 'upperLimit': '20'}, {'value': '10', 'groupId': 'OG001', 'lowerLimit': '10', 'upperLimit': '20'}, {'value': '20', 'groupId': 'OG002', 'lowerLimit': '10', 'upperLimit': '40'}, {'value': '20', 'groupId': 'OG003', 'lowerLimit': '10', 'upperLimit': '35'}]}]}, {'title': 'Influenza B Yamagata, 2-4 weeks post immunization', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000', 'lowerLimit': '10', 'upperLimit': '20'}, {'value': '20', 'groupId': 'OG001', 'lowerLimit': '10', 'upperLimit': '20'}, {'value': '40', 'groupId': 'OG002', 'lowerLimit': '20', 'upperLimit': '40'}, {'value': '20', 'groupId': 'OG003', 'lowerLimit': '13', 'upperLimit': '40'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-immunization and 2-4 weeks post immunization', 'description': 'Influenza vaccine antibody concentration will be measured in immunosuppressed IBD patients who receive high dose and standard of care dose influenza vaccine.\n\nHigher antibody concentrations are associated with better protection from infection.', 'unitOfMeasure': 'Antibody Titer', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Response Rate Against Influenza Vaccine in Patients With Inflammatory Bowel Disease: Number of Participants Positive for Seroconversion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Dose Influenza Vaccine (SDIV) Group', 'description': 'This arm will be a double blind randomized controlled trial of standard dose influenza vaccine (SDIV) for IBD patients on TNF monotherapy.\n\n40 patients will be enrolled and randomized in a 5:3 fashion to HDIV or SDIV. Randomization will generated by a random number generator and investigator will be blinded to randomization scheme.'}, {'id': 'OG001', 'title': 'High Dose of Influenza Vaccine(HDIV) Group', 'description': 'This arm will be a double blind randomized controlled trial of high dose influenza vaccine (HDIV) for IBD patients on TNF monotherapy.\n\n40 patients will be enrolled and randomized in a 5:3 fashion to HDIV or SDIV. Randomization will generated by a random number generator and investigator will be blinded to randomization scheme.'}, {'id': 'OG002', 'title': 'Vedolizumab Group', 'description': 'A group of 20 patients who are currently on vedolizumab. All individuals in this group will receive SDIV'}, {'id': 'OG003', 'title': 'Contorl Group', 'description': 'A group of 20 healthy individuals without IBD, other chronic diseases, or immunosuppressive therapy will be enrolled. All healthy individuals will receive standard dose influenza vaccine SDIV.'}], 'classes': [{'title': 'Influenza A H1N1', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'Influenza A H3N2', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}, {'title': 'Influenza B Victoria', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Influenza B Yamagata', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'At least one virus', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}]}, {'title': 'At least two viruses', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Three viruses', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 weeks', 'description': 'Vaccine response rates for influenza vaccines in patients with inflammatory bowel disease will be accessed by number of patients who has shown significant seroconversion. Seroconversion is defined as a four fold increase in antibody concentration from preimmunization to 4 weeks post immunization.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Seroprotection: Number of Participants With Antibody Concentration at Least 1:40 at Week 4 Postimmunization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Dose Influenza Vaccine (SDIV) Group', 'description': 'This arm will be a double blind randomized controlled trial of standard dose influenza vaccine (SDIV) for IBD patients on TNF monotherapy.\n\n40 patients will be enrolled and randomized in a 5:3 fashion to HDIV or SDIV. Randomization will generated by a random number generator and investigator will be blinded to randomization scheme.\n\n.'}, {'id': 'OG001', 'title': 'High Dose of Influenza Vaccine(HDIV) Group', 'description': 'This arm will be a double blind randomized controlled trial of high dose influenza vaccine (HDIV) for IBD patients on TNF monotherapy.\n\n40 patients will be enrolled and randomized in a 5:3 fashion to HDIV or SDIV. Randomization will generated by a random number generator and investigator will be blinded to randomization scheme.'}, {'id': 'OG002', 'title': 'Vedolizumab Group', 'description': 'A group of 20 patients who are currently on Vedolizumab. All individuals in this group will receive SDIV'}, {'id': 'OG003', 'title': 'Control Group', 'description': 'A group of 20 healthy individuals without IBD, other chronic diseases, or immunosuppressive therapy will be enrolled. All healthy individuals will receive standard dose influenza vaccine SDIV.'}], 'classes': [{'title': 'Influenza A H1N1', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}]}, {'title': 'Influenza A H3N2', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}]}, {'title': 'Influenza B Victoria', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}]}, {'title': 'Influenza B Yamagata', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}]}, {'title': 'At least one virus', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}]}, {'title': 'At least two virus', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}]}, {'title': 'Three viruses', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 weeks', 'description': 'Seroprotection is defined as an antibody concentration of at least 1:40 at 4 weeks post-immunization which confers protection from infection in about 50% of individuals', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Seroprotection: Number of Participants With Antibody Titer of 160 at Week 4 Post-immunization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Dose Influenza Vaccine (SDIV) Group', 'description': 'This arm will be a double blind randomized controlled trial of standard dose influenza vaccine (SDIV) for IBD patients on TNF monotherapy.\n\n40 patients will be enrolled and randomized in a 5:3 fashion to HDIV or SDIV. Randomization will generated by a random number generator and investigator will be blinded to randomization scheme.\n\n.'}, {'id': 'OG001', 'title': 'High Dose of Influenza Vaccine(HDIV) Group', 'description': 'This arm will be a double blind randomized controlled trial of high dose influenza vaccine (HDIV) for IBD patients on TNF monotherapy.\n\n40 patients will be enrolled and randomized in a 5:3 fashion to HDIV or SDIV. Randomization will generated by a random number generator and investigator will be blinded to randomization scheme.'}, {'id': 'OG002', 'title': 'Vedolizumab Group', 'description': 'A group of 20 patients who are currently on Vedolizumab. All individuals in this group will receive SDIV'}, {'id': 'OG003', 'title': 'Control Group', 'description': 'A group of 20 healthy individuals without IBD, other chronic diseases, or immunosuppressive therapy will be enrolled. All healthy individuals will receive standard dose influenza vaccine SDIV.'}], 'classes': [{'title': 'Influenza A H1N1', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}]}, {'title': 'Influenza A H3N2', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}]}, {'title': 'Influenza B Victoria', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Influenza B Yamagata', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'At least one virus', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}]}, {'title': 'At least two virus', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}]}, {'title': 'Three viruses', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 weeks', 'description': 'Seroprotection is defined by the FDA as post-immunization concentration of 1:160 that confers protection from infection to 95% of the population.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Measure Antibody Concentrations in Immunosuppressed IBD Patients Who Receive High Dose and Standard of Care Dose Influenza Vaccine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'High Dose of Influenza Vaccine (HDIV) Group', 'description': 'This arm will be a double blind randomized controlled trial of high dose influenza vaccine (HDIV) for IBD patients on TNF monotherapy.\n\n40 patients will be enrolled and randomized in a 5:3 fashion to HDIV or SDIV. Randomization will generated by a random number generator and investigator will be blinded to randomization scheme.'}, {'id': 'OG001', 'title': 'Standard Dose Influenza Vaccine (SDIV) Group', 'description': 'This arm will be a double blind randomized controlled trial of standard dose influenza vaccine (SDIV) for IBD patients on TNF monotherapy.\n\n40 patients will be enrolled and randomized in a 5:3 fashion to HDIV or SDIV. Randomization will generated by a random number generator and investigator will be blinded to randomization scheme.'}, {'id': 'OG002', 'title': 'Vedolizumab Group', 'description': 'A group of 20 patients who are currently on vedolizumab. All individuals in this group will receive SDIV'}, {'id': 'OG003', 'title': 'Control Group', 'description': 'A group of 20 healthy individuals without IBD, other chronic diseases, or immunosuppressive therapy will be enrolled. All healthy individuals will receive standard dose influenza vaccine SDIV.'}], 'classes': [{'title': 'Influenza A H1N1, 6 months post immunization', 'categories': [{'measurements': [{'value': '160', 'groupId': 'OG000', 'lowerLimit': '80', 'upperLimit': '320'}, {'value': '160', 'groupId': 'OG001', 'lowerLimit': '80', 'upperLimit': '320'}, {'value': '160', 'groupId': 'OG002', 'lowerLimit': '160', 'upperLimit': '320'}, {'value': '160', 'groupId': 'OG003', 'lowerLimit': '80', 'upperLimit': '320'}]}]}, {'title': 'Influenza A H3N2, 6 months post immunization', 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000', 'lowerLimit': '40', 'upperLimit': '80'}, {'value': '80', 'groupId': 'OG001', 'lowerLimit': '40', 'upperLimit': '160'}, {'value': '160', 'groupId': 'OG002', 'lowerLimit': '80', 'upperLimit': '160'}, {'value': '80', 'groupId': 'OG003', 'lowerLimit': '80', 'upperLimit': '160'}]}]}, {'title': 'Influenza B Victoria, 6 months post immunization', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000', 'lowerLimit': '10', 'upperLimit': '20'}, {'value': '20', 'groupId': 'OG001', 'lowerLimit': '18', 'upperLimit': '40'}, {'value': '40', 'groupId': 'OG002', 'lowerLimit': '20', 'upperLimit': '40'}, {'value': '20', 'groupId': 'OG003', 'lowerLimit': '20', 'upperLimit': '40'}]}]}, {'title': 'Influenza B Yamagata, 6 months post immunization', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000', 'lowerLimit': '10', 'upperLimit': '20'}, {'value': '20', 'groupId': 'OG001', 'lowerLimit': '10', 'upperLimit': '20'}, {'value': '20', 'groupId': 'OG002', 'lowerLimit': '20', 'upperLimit': '40'}, {'value': '20', 'groupId': 'OG003', 'lowerLimit': '20', 'upperLimit': '40'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 months post-immunization', 'description': 'Influenza vaccine antibody concentration will be measured in immunosuppressed IBD patients who receive high dose and standard of care dose influenza vaccine.\n\nHigher antibody concentrations are associated with better protection from infection.', 'unitOfMeasure': 'Antibody Titer', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control Group', 'description': 'A group of 20 healthy individuals without IBD, other chronic diseases, or immunosuppressive therapy will be enrolled. All healthy individuals will receive standard dose influenza vaccine SDIV.'}, {'id': 'FG001', 'title': 'Vedolizumab Group', 'description': 'A group of 20 patients who are currently on vedolizumab. All individuals in this group will receive SDIV'}, {'id': 'FG002', 'title': 'High Dose Influenza Vaccine (HDIV)', 'description': 'This arm will be a double blind randomized controlled trial of High dose influenza vaccine (HDIV) for IBD patients on TNF monotherapy.\n\n40 patients will be enrolled and randomized in a 5:3 fashion to HDIV or SDIV. Randomization will generated by a random number generator and investigator will be blinded to randomization scheme.'}, {'id': 'FG003', 'title': 'Standard Dose Influenza Vaccine (SDIV)', 'description': 'This arm will be a double blind randomized controlled trial of standard dose influenza vaccine (SDIV) for IBD patients on TNF monotherapy.\n\n40 patients will be enrolled and randomized in a 5:3 fashion to HDIV or SDIV. Randomization will generated by a random number generator and investigator will be blinded to randomization scheme.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '26'}, {'groupId': 'FG003', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '25'}, {'groupId': 'FG003', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '79', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Control Group', 'description': 'A group of 20 healthy individuals without IBD, other chronic diseases, or immunosuppressive therapy will be enrolled. All healthy individuals will receive standard dose influenza vaccine SDIV.'}, {'id': 'BG001', 'title': 'Vedolizumab Group', 'description': 'A group of 20 patients who are currently on vedolizumab. All individuals in this group will receive SDIV'}, {'id': 'BG002', 'title': 'High Dose Influenza Vaccine (HDIV)', 'description': 'This arm will be a double blind randomized controlled trial of high dose influenza vaccine (HDIV) for IBD patients on TNF monotherapy.\n\n40 patients will be enrolled and randomized in a 5:3 fashion to HDIV or SDIV. Randomization will generated by a random number generator and investigator will be blinded to randomization scheme.'}, {'id': 'BG003', 'title': 'Standard Dose Influenza Vaccine (SDIV)', 'description': 'This arm will be a double blind randomized controlled trial of standard dose influenza vaccine (SDIV) for IBD patients on TNF monotherapy.\n\n40 patients will be enrolled and randomized in a 5:3 fashion to HDIV or SDIV. Randomization will generated by a random number generator and investigator will be blinded to randomization scheme.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40.35', 'spread': '9.89', 'groupId': 'BG000'}, {'value': '36.57', 'spread': '16.16', 'groupId': 'BG001'}, {'value': '34.96', 'spread': '12.92', 'groupId': 'BG002'}, {'value': '39.35', 'spread': '11.98', 'groupId': 'BG003'}, {'value': '37.81', 'spread': '12.74', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '36', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '43', 'groupId': 'BG004'}]}]}], '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'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '77', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '79', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-01-27', 'size': 293465, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-06-18T15:27', 'hasProtocol': True}, {'date': '2015-08-13', 'size': 76642, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-08-08T14:30', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 81}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2018-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-18', 'studyFirstSubmitDate': '2015-05-26', 'resultsFirstSubmitDate': '2019-06-26', 'studyFirstSubmitQcDate': '2015-05-29', 'lastUpdatePostDateStruct': {'date': '2019-10-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-09-11', 'studyFirstPostDateStruct': {'date': '2015-06-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-09-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measure Antibody Concentrations in Immunosuppressed IBD Patients Who Receive High Dose and Standard of Care Dose Influenza Vaccine', 'timeFrame': 'Pre-immunization and 2-4 weeks post immunization', 'description': 'Influenza vaccine antibody concentration will be measured in immunosuppressed IBD patients who receive high dose and standard of care dose influenza vaccine.\n\nHigher antibody concentrations are associated with better protection from infection.'}], 'secondaryOutcomes': [{'measure': 'Response Rate Against Influenza Vaccine in Patients With Inflammatory Bowel Disease: Number of Participants Positive for Seroconversion', 'timeFrame': '4 weeks', 'description': 'Vaccine response rates for influenza vaccines in patients with inflammatory bowel disease will be accessed by number of patients who has shown significant seroconversion. Seroconversion is defined as a four fold increase in antibody concentration from preimmunization to 4 weeks post immunization.'}, {'measure': 'Seroprotection: Number of Participants With Antibody Concentration at Least 1:40 at Week 4 Postimmunization', 'timeFrame': '4 weeks', 'description': 'Seroprotection is defined as an antibody concentration of at least 1:40 at 4 weeks post-immunization which confers protection from infection in about 50% of individuals'}, {'measure': 'Seroprotection: Number of Participants With Antibody Titer of 160 at Week 4 Post-immunization', 'timeFrame': '4 weeks', 'description': 'Seroprotection is defined by the FDA as post-immunization concentration of 1:160 that confers protection from infection to 95% of the population.'}, {'measure': 'Measure Antibody Concentrations in Immunosuppressed IBD Patients Who Receive High Dose and Standard of Care Dose Influenza Vaccine', 'timeFrame': '6 months post-immunization', 'description': 'Influenza vaccine antibody concentration will be measured in immunosuppressed IBD patients who receive high dose and standard of care dose influenza vaccine.\n\nHigher antibody concentrations are associated with better protection from infection.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Inflammatory Bowel Disease (IBD)']}, 'referencesModule': {'references': [{'pmid': '31504526', 'type': 'RESULT', 'citation': 'Caldera F, Hillman L, Saha S, Wald A, Grimes I, Zhang Y, Sharpe AR, Reichelderfer M, Hayney MS. Immunogenicity of High Dose Influenza Vaccine for Patients with Inflammatory Bowel Disease on Anti-TNF Monotherapy: A Randomized Clinical Trial. Inflamm Bowel Dis. 2020 Mar 4;26(4):593-602. doi: 10.1093/ibd/izz164.'}]}, 'descriptionModule': {'briefSummary': "Inflammatory bowel disease (IBD) is a chronic inflammatory disorder of the gastrointestinal tract which includes Crohn's disease (CD) and ulcerative colitis (UC). A recent epidemiological investigation estimates that nearly 4 million people worldwide are affected and approximately 1.4 million of these cases occur in the United States. IBD can lead to debilitating symptoms, hospitalizations, decreased quality of life, frequent procedures and/or surgery. Treatment options consist of immunosuppressive therapy, such as systemic corticosteroids, immunomodulators (thiopurines and methotrexate) and/or biologics, such as tumor necrosis factor alpha (TNF) agents or an integrin inhibitor, vedolizumab. They can achieve clinical remission and decrease the risk of complications, but also increase the risk for opportunistic infections, including influenza.\n\nMultiple studies have shown lower influenza vaccine responses in patients with IBD compared to healthy individuals; IBD patients treated with TNF agents or combination therapy (TNF inhibitors and immunomodulators) are very likely to mount a poor immune response. Influenza serum antibody concentration correlates with protection from infection following vaccination. Therefore, increasing influenza antibody responses in patients with IBD would appear to be critical to improving protection from influenza. A high dose (HD) influenza vaccine containing four times more hemagglutinin was licensed based on its ability to induce higher antibody concentrations compared to standard dose (SD) in adults 65 years or older."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "CASES Specific Aim #1 Inclusion Criteria\n\n* A history of chronic (greater than 3 month) ulcerative colitis or Crohn's disease diagnosed and documented by the standard clinical, radiographic, endoscopic and histopathologic criteria.\n* Ages 18-64\n* Currently taking anti-TNF therapy (infliximab, golilumab, adalimumab, or certolizumab) for at least 3 months\n* Exclusion Criteria\n* Received season's influenza vaccine\n* Allergy to eggs or influenza vaccine\n* Currently use of systemic steroids in the past 3 months\n\nSpecific Aim #2 Inclusion criteria\n\n* A history of chronic (greater than 3 month) ulcerative colitis or Crohn's disease diagnosed and documented by the standard clinical, radiographic, endoscopic and histopathologic criteria.\n* Ages 18-64\n* Currently on vedolizumab therapy\n\nExclusion Criteria\n\n* Received season's influenza vaccine\n* Allergy to eggs or influenza vaccine\n* Currently use of systemic steroids in the past 3 months\n\nControl group Inclusion criteria\n\n* Age 18-64\n* Willing to participate in study\n\nControl group Exclusion criteria\n\n* Currently on immunosuppressive therapy\n* Has a chronic health condition that may have an impact on vaccine antibody concentrations as deemed by the investigators, including chronic liver disease, celiac disease, history of solid organ or bone marrow transplantation.\n* Older than age 65 years\n* Unconfirmed Measles, Mumps, and Rubella (MMR) vaccination status\n* Patients in whom venipuncture are not feasible due to poor tolerability or lack of easy access."}, 'identificationModule': {'nctId': 'NCT02461758', 'briefTitle': 'Trial of High Dose vs. Standard Dose Influenza Vaccine in Inflammatory Bowel Disease Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Wisconsin, Madison'}, 'officialTitle': 'Randomized Trial of High Dose vs. Standard Dose Influenza Vaccine in Inflammatory Bowel Disease Patients', 'orgStudyIdInfo': {'id': '2015-0813'}, 'secondaryIdInfos': [{'id': 'Influenza in IBD', 'type': 'OTHER', 'domain': 'Study Team'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Control Group', 'description': 'A group of 20 healthy individuals without IBD, other chronic diseases, or immunosuppressive therapy will be enrolled. All healthy individuals will receive standard dose influenza vaccine SDIV.', 'interventionNames': ['Biological: Standard dose Influenza vaccine (SDIV)']}, {'type': 'OTHER', 'label': 'Vedolizumab Group + standard dose influenza vaccine (SDIV)', 'description': 'A group of 20 patients who are currently on vedolizumab. All individuals in this group will receive SDIV', 'interventionNames': ['Biological: Standard dose Influenza vaccine (SDIV)']}, {'type': 'OTHER', 'label': 'High dose influenza vaccine (HDIV)', 'description': 'This arm will be a double blind randomized controlled trial of High dose influenza vaccine (HDIV) for IBD patients on TNF monotherapy.\n\n40 patients will be enrolled and randomized in a 5:3 fashion to HDIV or SDIV. Randomization will generated by a random number generator and investigator will be blinded to randomization scheme.', 'interventionNames': ['Biological: High dose influenza vaccine (HDIV)']}, {'type': 'OTHER', 'label': 'Standard dose influenza vaccine (SDIV)', 'description': 'This arm will be a double blind randomized controlled trial of standard dose influenza vaccine (SDIV) for IBD patients on TNF monotherapy.\n\n40 patients will be enrolled and randomized in a 5:3 fashion to HDIV or SDIV. Randomization will generated by a random number generator and investigator will be blinded to randomization scheme.', 'interventionNames': ['Biological: Standard dose Influenza vaccine (SDIV)']}], 'interventions': [{'name': 'Standard dose Influenza vaccine (SDIV)', 'type': 'BIOLOGICAL', 'armGroupLabels': ['Control Group', 'Standard dose influenza vaccine (SDIV)', 'Vedolizumab Group + standard dose influenza vaccine (SDIV)']}, {'name': 'High dose influenza vaccine (HDIV)', 'type': 'BIOLOGICAL', 'armGroupLabels': ['High dose influenza vaccine (HDIV)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin Hospital & Clinics', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Freddy Caldera', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Wisconsin School of Medicine and Public Health, Madison'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}