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Trial record 21 of 1632 for:    influenza vaccination

Infliximab IBD Influenza Vaccine Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01666535
Recruitment Status : Completed
First Posted : August 16, 2012
Last Update Posted : May 9, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Inflammatory Bowel Disease Biological: Influenza vaccination

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 137 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effect of Influenza Vaccination Timing on Immune Response in Patients With Inflammatory Bowel Disease on Infliximab Therapy: A Randomized Equivalence Trial
Study Start Date : September 2012
Primary Completion Date : March 2013
Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Influenza vaccination Timing #1
Influenza vaccination administered on the same day as infliximab administration (Day 0 to 4).
Biological: Influenza vaccination
Influenza vaccination Timing #2
Influenza vaccination administered at the mid-point between infliximab infusions (Day 21 to 28)
Biological: Influenza vaccination


Outcome Measures

Primary Outcome Measures :
  1. Serologic protection [ Time Frame: 28 days ± 3 days after influenza vaccination ]
    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.


Secondary Outcome Measures :
  1. Immunogenic response [ Time Frame: 28 days ± 3 days after influenza vaccination ]
    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.


Other Outcome Measures:
  1. Number of participants with serious adverse events [ Time Frame: 3 days post vaccination ]
    To evaluate the number of participants with early serious adverse reactions (≤ 3 days post-vaccination)

  2. Change in disease activity from baseline [ Time Frame: Four week post-vaccination ]
    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


Eligibility Criteria

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Ages Eligible for Study:   9 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01666535


Locations
Canada, Alberta
University of Calgary
Calgary, Alberta, Canada, T3B 6A8
Sponsors and Collaborators
University of Calgary
Janssen Inc.
Investigators
Principal Investigator: Jennifer deBruyn, MD University of Calgary
More Information

Responsible Party: Jennifer deBruyn, Assistant Professor, University of Calgary
ClinicalTrials.gov Identifier: NCT01666535     History of Changes
Other Study ID Numbers: REMICADEIBD4010
First Posted: August 16, 2012    Key Record Dates
Last Update Posted: May 9, 2016
Last Verified: May 2016

Keywords provided by Jennifer deBruyn, University of Calgary:
Influenza vaccine
Immune response
Remicade (infliximab)
Inflammatory bowel disease

Additional relevant MeSH terms:
Influenza, Human
Vaccines
Intestinal Diseases
Inflammatory Bowel Diseases
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Infliximab
Immunologic Factors
Physiological Effects of Drugs
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents