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Infliximab IBD Influenza Vaccine Study

This study is not yet open for participant recruitment.
Verified August 2012 by University of Calgary
Sponsor:
Collaborator:
Janssen Inc.
Information provided by (Responsible Party):
Jennifer deBruyn, University of Calgary
ClinicalTrials.gov Identifier:
NCT01666535
First received: August 8, 2012
Last updated: August 10, 2012
Last verified: August 2012
History of Changes

August 8, 2012
August 10, 2012
August 2012
March 2013   (final data collection date for primary outcome measure)
Serologic protection [ Time Frame: 28 days ± 3 days after influenza vaccination ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01666535 on ClinicalTrials.gov Archive Site
Immunogenic response [ Time Frame: 28 days ± 3 days after influenza vaccination ] [ Designated as safety issue: No ]
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.
Same as current
  • Number of participants with serious adverse events [ Time Frame: 3 days post vaccination ] [ Designated as safety issue: Yes ]
    To evaluate the number of participants with early serious adverse reactions (≤ 3 days post-vaccination)
  • Change in disease activity from baseline [ Time Frame: Four week post-vaccination ] [ Designated as safety issue: No ]
    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
Same as current
 
Infliximab IBD Influenza Vaccine Study
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Inflammatory Bowel Disease
Biological: Influenza vaccination
  • Influenza vaccination Timing #1
    Influenza vaccination administered on the same day as infliximab administration (Day 0 to 4).
    Intervention: Biological: Influenza vaccination
  • Influenza vaccination Timing #2
    Influenza vaccination administered at the mid-point between infliximab infusions (Day 21 to 28)
    Intervention: Biological: Influenza vaccination
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
180
August 2013
March 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of IBD established by accepted criteria
  • On maintenance infliximab administered every 6 to 8 weeks (already received at least 6 weeks of infliximab)
  • Between ages 9 and 60 years

Exclusion Criteria:

  1. Pregnancy
  2. Hypersensitivity reaction to previous dose of influenza vaccine
  3. Known hypersensitivity to eggs or chicken or other components of influenza vaccine
Both
9 Years to 60 Years
No
Contact: Jennifer deBruyn jennifer.debruyn@albertahealthservices.ca
Canada
 
NCT01666535
REMICADEIBD4010
No
Jennifer deBruyn, University of Calgary
University of Calgary
Janssen Inc.
Principal Investigator: Jennifer deBruyn, MD University of Calgary
University of Calgary
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP