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NCT01584908 Clinical Trial

Adjuvanted Influenza Vaccine Evaluation in Kidney Transplant Recipients

Influenza Clinical Trial

Official title:
Adjuvanted Influenza Vaccine Evaluation in Kidney Transplant Recipients(AdVEnTR)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01584908
Other study ID # UofA - AdVEnTR
Secondary ID
Status Completed
Phase Phase 4
First received April 23, 2012
Last updated December 31, 2014
Start date August 2012
Est. completion date November 2014

Study information
Verified date December 2014
Source University of Alberta
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Observational

Clinical Trial Summary

Influenza is an important public health problem. Organ transplant patients are particularly susceptible to severe disease. Also, they shed higher quantities of virus for longer durations, leading to greater contagious potential, thereby potentially serving as nodes of spread in the community. Therefore, improved strategies to prevent influenza in this population is an important public health concern. Standard vaccination is poorly immunogenic post-transplant and new vaccine strategies are needed. Adjuvanted vaccines contain molecules that create a strong local inflammatory response and they attract immune cells to the site of injection, increasing the immunogenicity of the vaccine antigen. Recently seasonal influenza vaccines containing adjuvants have become available in Canada but have only limited information in transplant patients. This randomized trial is designed to assess the immunogenicity of an adjuvanted vaccination strategy compared to a standard vaccine for seasonal influenza in a cohort of adult organ transplant recipients.

Recruitment information / eligibility
Status Completed
Enrollment 68
Est. completion date November 2014
Est. primary completion date April 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

Adult kidney transplant recipients Greater than 3 months post-transplant

Exclusion Criteria:

Has already received influenza vaccination for 2012-2013 season Egg allergy Previous life-threatening reaction to influenza vaccine (i.e. Guillain Barre Syndrome) Ongoing therapy for rejection Febrile illness in the past two weeks Unable to provide informed consent Unable to comply with study protocol

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Canada University of Alberta Hospital Edmonton Alberta

Sponsors (1)
Lead Sponsor Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

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