Infliximab IBD Influenza Vaccine Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

137 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2013-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Inflammatory Bowel Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Influenza vaccination Timing #1

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

Group Type OTHER

Influenza vaccination

Intervention Type BIOLOGICAL

Influenza vaccination Timing #2

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

Group Type OTHER

Influenza vaccination

Intervention Type BIOLOGICAL

Interventions

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Influenza vaccination

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

9 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No