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Effect of Influenza Vaccination Timing on Immune Response in Patients With Inflammatory Bowel Disease on Infliximab Therapy: A Randomized Equivalence Trial
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.
Age
9 - 60 years
Sex
ALL
Healthy Volunteers
No
University of Calgary
Calgary, Alberta, Canada
Start Date
September 1, 2012
Primary Completion Date
March 1, 2013
Completion Date
August 1, 2013
Last Updated
May 9, 2016
137
ACTUAL participants
Influenza vaccination
BIOLOGICAL
Lead Sponsor
University of Calgary
Collaborators
NCT06226883
NCT07207200
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07245394