drugset / Trial / NCT01180699

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

NCT01180699

Completed 229 enrolled University of Alberta
RandomizedParallel-groupSingle-blindPrevention

Summary

Influenza virus is an important cause of morbidity in the transplant population and can lead to viral and bacterial pneumonia and contribute to the development of rejection. Although the annual influenza vaccine is recommended for transplant patients, studies have shown that a single intramuscular dose has poor immunogenicity. There are no studies that define the effect of intradermal doses in this population. We plan to study the immunogenicity of two different administration routes of the influenza vaccine in 200 solid organ transplant patients during the 2010-2011 season. Patients will be randomized to receive influenza vaccine either intradermally or intramuscularly. We hypothesize that the patients who receive the intradermal influenza vaccine will significantly reach a higher response to the vaccine. This study advances research on the prevention of serious viral infections in transplant recipients. Results from this study have the potential to directly improve patient care. If the use of the intradermal influenza vaccine is successful, this strategy may lead to a significant reduction in burden of disease, hospitalizations, and long-term morbidity.

Timeline

Start
2010-10
Primary completion
2012-08
Completion
2012-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Fluviral Vaccine 0.5 ml Intramuscular
Subject Influenza Virus Vaccine Vaccine 0.5 ml Intramuscular
Subject Intanza Vaccine 0.1 ml Intrathecal

Indications

No indication recorded.