Infliximab IBD Influenza Vaccine Study

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01666535
Study type	Interventional
Source	University of Calgary
Contact
Status	Completed
Phase	N/A
Start date	September 2012
Completion date	August 2013

View Details

See also
Status	Clinical Trial	Phase
Withdrawn	`NCT03278912` - Natural History of Intestinal Inflammation in People With Primary Immune Dysregulations
Terminated	`NCT00061282` - Clotrimazole Enemas for Pouchitis in Children and Adults	Phase 1/Phase 2
Recruiting	`NCT05579392` - A Randomized Crossover Trial of Bright Light Therapy in Crohn's Disease on Intestinal Barrier Homeostasis	N/A
Completed	`NCT03264690` - Study to Observe the Change in Microbiome in Human Derived Sample and the Relation With Clinical Response Before and After the Anti-TNF Treatment in IBD Patients
Recruiting	`NCT02861053` - Inflammatory Bowel Disease : Could a Regular Physical Activity Reduce Patients Fatigue ?	N/A
Recruiting	`NCT02275676` - Resting Energy Expenditure and Nutritional Status in IBD	N/A
Completed	`NCT02197780` - Head-to-head Comparison of Two Fecal Biomarkers to Screen Children for IBD	N/A
Completed	`NCT02161640` - Vascular Dysfunction in Paediatric IBD	N/A
Completed	`NCT02503696` - Sample Collection Study to Evaluate DNA Markers in Subjects With Inflammatory Bowel Disease (IBD)	N/A
Completed	`NCT01852760` - Assessment of Disease Activity in Ulcerative Colitis by Endoscopic Ultrasound	N/A
Completed	`NCT01933867` - Water-aided Colonoscopy in Inflammatory Bowel Disease Patients	N/A
Completed	`NCT01860651` - Web-based Monitoring in Children and Adolescents With Inflammatory Bowel Disease	N/A
Completed	`NCT01676324` - FOCUS: The Future of Fecal Calprotectin Utility Study for the Diagnosis and Management of Inflammatory Bowel Disease (IBD)	N/A
Completed	`NCT01688557` - Trial on Innovative Technologies in Colonoscopy	N/A
Completed	`NCT01692743` - Telemedicine in Patients With Inflammatory Bowel Disease (TELE-IBD)	Phase 3
Completed	`NCT01981616` - Immune Response to Systemic and Mucosal Antigenic Challenge in the Presence of Vedolizumab	Phase 1
Completed	`NCT01557387` - Real-time Diagnosis of Pseudopolyps During Colonoscopy
Completed	`NCT01476995` - Prognostic Indicators as Provided by the EPIC ClearView	N/A
Completed	`NCT01221818` - A Randomized, Double-Blind, Placebo-Controlled, Ascending Single Dose Study of E6007 in Healthy Subjects	Phase 1
Completed	`NCT02322008` - Anti-TNF Therapy in Danish Patients With Inflammatory Bowel Diseases in Clinical Practice	N/A