NCT01584908

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2012

Typical duration for all trials

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

April 23, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 25, 2012

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

January 1, 2015

Status Verified

December 1, 2014

Enrollment Period

1.7 years

First QC Date

April 23, 2012

Last Update Submit

December 31, 2014

Conditions

Influenza

Keywords

kidney transplant recipients

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

adult kidney tranplant recipients

You may qualify if:

  • Adult kidney transplant recipients Greater than 3 months post-transplant

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alberta Hospital

Edmonton, Alberta, Canada

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Deepali Kumar, MD

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2012

First Posted

April 25, 2012

Study Start

August 1, 2012

Primary Completion

April 1, 2014

Study Completion

November 1, 2014

Last Updated

January 1, 2015

Record last verified: 2014-12

Locations

CA(1)