Completed

Effect of Influenza Vaccination Timing on Immune Response in Patients With Inflammatory Bowel Disease on Infliximab Therapy: A Randomized Equivalence Trial

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What is being tested

Influenza vaccination

+ Influenza vaccination

Biological
Who is being recruted

Digestive System Diseases+9

+ Gastroenteritis

+ Gastrointestinal Diseases

From 9 to 60 Years
+6 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Interventional
Study Start: September 2012
See protocol details

Summary

Principal SponsorUniversity of Calgary
Last updated: May 9, 2016
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2012

Actual date on which the first participant was enrolled.

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.

NCT01666535
Principal SponsorUniversity of Calgary
Last updated: May 9, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

137 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 9 to 60 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Digestive System DiseasesGastroenteritisGastrointestinal DiseasesInfectionsIntestinal DiseasesOrthomyxoviridae InfectionsRespiratory Tract DiseasesRespiratory Tract InfectionsRNA Virus InfectionsVirus DiseasesInfluenza, HumanInflammatory Bowel Diseases

Criteria

3 inclusion criteria required to participate
Between ages 9 and 60 years
Diagnosis of IBD established by accepted criteria
On maintenance infliximab administered every 6 to 8 weeks (already received at least 6 weeks of infliximab)
3 exclusion criteria prevent from participating
Hypersensitivity reaction to previous dose of influenza vaccine
Known hypersensitivity to eggs or chicken or other components of influenza vaccine
Pregnancy

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Influenza vaccination administered on the same day as infliximab administration (Day 0 to 4).

Group II

Influenza vaccination administered at the mid-point between infliximab infusions (Day 21 to 28)

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

University of Calgary

Calgary, CanadaOpen University of Calgary in Google Maps
CompletedOne Study Center