drugset / Trial / NCT02560909

Adjuvanted Influenza Vaccine in Stem Cell Transplant

NCT02560909

Phase 4 Completed 73 enrolled University Health Network, Toronto
RandomizedParallel-groupQuadruple-blindPrevention

Summary

Influenza virus is an important cause of morbidity in the transplant population and can lead to viral and bacterial pneumonia. Although the annual influenza vaccine is recommended for transplant patients, studies have shown that nonadjuvanted vaccine has poor immunogenicity. There are no studies that define the effect of adjuvanted vaccine in this population. The purpose of this study is to determine if a vaccination with FLUAD® results in improved immunogenicity as compared to standard vaccine in allo-HSCT recipients. Immunogenicity will be assessed by standard quantitative antibody titer assessments and using cell-mediated immunity measurements.

Timeline

Start
2015-10
Primary completion
2016-02
Completion
2016-08

Drugs

EvaluationDrugModalityDoseRoute
Subject FLUAD® influenza vaccine Vaccine 0.5 ml Intramuscular
Comparator Fluviral Vaccine 0.5 ml Intramuscular