Infliximab IBD Influenza Vaccine Study

• Register: ClinicalTrials.gov
• Last refreshed on: 17 May 2016
• Main ID: NCT01666535
• Date of registration: 08/08/2012
• Prospective Registration: Yes
• Primary sponsor: University of Calgary
• Public title: Infliximab IBD Influenza Vaccine Study
• Scientific title: Effect of Influenza Vaccination Timing on Immune Response in Patients With Inflammatory Bowel Disease on Infliximab Therapy: A Randomized Equivalence Trial
• Date of first enrolment: September 2012
• Target sample size: 137
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01666535
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
• Phase: N/A

Countries of recruitment

Canada

Contacts

• Name: Jennifer deBruyn, MD
• Affiliation: University of Calgary

Key inclusion & exclusion 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



Age minimum: 9 Years
Age maximum: 60 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Inflammatory Bowel Disease

Intervention(s)

Biological: Influenza vaccination

Primary Outcome(s)

Serologic protection [Time Frame: 28 days ± 3 days after influenza vaccination]

Secondary Outcome(s)

Immunogenic response [Time Frame: 28 days ± 3 days after influenza vaccination]

Secondary ID(s)

REMICADEIBD4010

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Janssen Inc.