Ignite Creation Date:
2025-12-24 @ 10:19 PM
Ignite Modification Date:
2025-12-26 @ 8:14 PM
Study NCT ID:
NCT01666535
Status:
COMPLETED
Last Update Posted:
2016-05-09
First Post:
2012-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Infliximab IBD Influenza Vaccine Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D007251', 'term': 'Influenza, Human'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009976', 'term': 'Orthomyxoviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007252', 'term': 'Influenza Vaccines'}], 'ancestors': [{'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 137}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-05', 'studyFirstSubmitDate': '2012-08-08', 'studyFirstSubmitQcDate': '2012-08-10', 'lastUpdatePostDateStruct': {'date': '2016-05-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of participants with serious adverse events', 'timeFrame': '3 days post vaccination', 'description': 'To evaluate the number of participants with early serious adverse reactions (≤ 3 days post-vaccination)'}, {'measure': 'Change in disease activity from baseline', 'timeFrame': 'Four week post-vaccination', 'description': "To evaluate the change in disease activity score from baseline using the validated instruments of the Pediatric Ulcerative Colitis Activity Index for participants with Ulcerative Coltiis and the Harvey Bradshaw Index for participants with Crohn's Disease"}], 'primaryOutcomes': [{'measure': 'Serologic protection', 'timeFrame': '28 days ± 3 days after influenza vaccination', 'description': 'To compare the proportion of IBD patients on maintenance infliximab who mount serologic protection to each component of the influenza vaccination between patients vaccinated on day of infliximab infusion (Day 0 to 4) and patients vaccinated at the mid-point between infliximab infusions (Day 21 to 28). Serologic protection will be defined by a hemagglutination-inhibition titer ≥ 1:40.'}], 'secondaryOutcomes': [{'measure': 'Immunogenic response', 'timeFrame': '28 days ± 3 days after influenza vaccination', 'description': 'To compare the proportion of IBD patients on maintenance infliximab who mount an immunogenic response to each component of the influenza vaccination between patients vaccinated on day of infliximab infusion (Day 0 to 4) and patients vaccinated at the mid-point between infliximab infusions (Day 21 to 28). Immunogenicity will be defined as a fourfold or greater differences in titer between pre and post-vaccination sera.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Influenza vaccine', 'Immune response', 'Remicade (infliximab)', 'Inflammatory bowel disease'], 'conditions': ['Inflammatory Bowel Disease']}, 'descriptionModule': {'briefSummary': 'The investigators will compare the immunogenicity of influenza vaccine in adults and children with inflammatory bowel disease by timing of vaccine in relation to maintenance infliximab dosing. The primary objective is to compare the proportion of IBD patients on maintenance infliximab who mount serologic protection to each component of the influenza vaccination between patients vaccinated on day of infliximab infusion (Day 0 to 4) and patients vaccinated at the mid-point between infliximab infusions (Day 21 to 28). Serologic protection will be defined by a hemagglutination-inhibition titer ≥ 1:40. The secondary objective is to compare the proportion of IBD patients who mount an immunogenic response (≥ 4-fold increase from pre to post-vaccination titer) to each component of the influenza vaccination between patients vaccinated on day of infliximab infusion and those vaccinated at the mid-point.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '9 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of IBD established by accepted criteria\n* On maintenance infliximab administered every 6 to 8 weeks (already received at least 6 weeks of infliximab)\n* Between ages 9 and 60 years\n\nExclusion Criteria:\n\n1. Pregnancy\n2. Hypersensitivity reaction to previous dose of influenza vaccine\n3. Known hypersensitivity to eggs or chicken or other components of influenza vaccine'}, 'identificationModule': {'nctId': 'NCT01666535', 'briefTitle': 'Infliximab IBD Influenza Vaccine Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Calgary'}, 'officialTitle': 'Effect of Influenza Vaccination Timing on Immune Response in Patients With Inflammatory Bowel Disease on Infliximab Therapy: A Randomized Equivalence Trial', 'orgStudyIdInfo': {'id': 'REMICADEIBD4010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Influenza vaccination Timing #1', 'description': 'Influenza vaccination administered on the same day as infliximab administration (Day 0 to 4).', 'interventionNames': ['Biological: Influenza vaccination']}, {'type': 'OTHER', 'label': 'Influenza vaccination Timing #2', 'description': 'Influenza vaccination administered at the mid-point between infliximab infusions (Day 21 to 28)', 'interventionNames': ['Biological: Influenza vaccination']}], 'interventions': [{'name': 'Influenza vaccination', 'type': 'BIOLOGICAL', 'armGroupLabels': ['Influenza vaccination Timing #1', 'Influenza vaccination Timing #2']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T3B 6A8', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'University of Calgary', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}], 'overallOfficials': [{'name': 'Jennifer deBruyn, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Calgary'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Calgary', 'class': 'OTHER'}, 'collaborators': [{'name': 'Janssen Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Jennifer deBruyn', 'investigatorAffiliation': 'University of Calgary'}}}}