NCT01666535

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
137

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 8, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 16, 2012

Completed
16 days until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

May 9, 2016

Status Verified

May 1, 2016

Enrollment Period

6 months

First QC Date

August 8, 2012

Last Update Submit

May 5, 2016

Conditions

Inflammatory Bowel Disease

Keywords

Influenza vaccineImmune responseRemicade (infliximab)Inflammatory bowel disease

Outcome Measures

Primary Outcomes (1)

  • Serologic protection

    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.

    28 days ± 3 days after influenza vaccination

Secondary Outcomes (1)

  • Immunogenic response

    28 days ± 3 days after influenza vaccination

Other Outcomes (2)

  • Number of participants with serious adverse events

    3 days post vaccination

  • Change in disease activity from baseline

    Four week post-vaccination

Study Arms (2)

Influenza vaccination Timing #1

OTHER

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

Biological: Influenza vaccination

Influenza vaccination Timing #2

OTHER

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

Biological: Influenza vaccination

Interventions

Influenza vaccinationBIOLOGICAL
Influenza vaccination Timing #1Influenza vaccination Timing #2

Eligibility Criteria

Age9 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Pregnancy
  • Hypersensitivity reaction to previous dose of influenza vaccine
  • Known hypersensitivity to eggs or chicken or other components of influenza vaccine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Calgary

Calgary, Alberta, T3B 6A8, Canada

Location

MeSH Terms

Conditions

Inflammatory Bowel DiseasesInfluenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesRespiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Jennifer deBruyn, MD

    University of Calgary

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 8, 2012

First Posted

August 16, 2012

Study Start

September 1, 2012

Primary Completion

March 1, 2013

Study Completion

August 1, 2013

Last Updated

May 9, 2016

Record last verified: 2016-05

Locations

CA(1)