Adjuvanted Influenza Vaccine Evaluation in Kidney Transplant Recipients

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

68 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-08-31

Study Completion Date

2014-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Intradermal Versus Intramuscular Trivalent Influenza Vaccine in Adult Solid Organ Transplant Recipients

NCT01180699

Influenza Vaccine

COMPLETED NA

Influenza A/H1N1/2009-adjuvanted Vaccine in Renal Disease Patients

NCT01298102

Decreased Immunologic Activity [PE] Influenza Rejection

COMPLETED PHASE4

Immune Response to Influenza Vaccine in Islet Cell Transplant Recipients

NCT01149382

Transplant

COMPLETED

Influenza Vaccination in Hemodialysis Patients and Renal Transplant Recipients

NCT00776750

Hemodialysis Renal Transplantation

COMPLETED PHASE4

Efficacy of Different Doses of Influenza Vaccine in Chronic Hemodialysis Patients

NCT05070494

ESRD Influenza Vaccine Seroprotection

UNKNOWN PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Influenza

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No