INfluenza Vaccine to Effectively Stop Cardio Thoracic Events and Decompensated heart failure (INVESTED)
Project Summary: pending
PaTH Protocol PI(s):
Purpose: Influenza leads to significant morbidity and mortality, particularly in patients with cardiovascular disease. High-dose influenza vaccine is FDA approved for use in medically stable adults over the age of 65 but has not been studied, nor is it indicated, for patients under the age of 65 or in those with chronic conditions.
Goal(s): To assess whether high-dose influenza vaccine compared with standard dose vaccine will reduce cardiopulmonary events in a high-risk cardiovascular population.
Study Design: Randomized Active-Control Double-Blind Comparative Multicenter Clinical Trial. The study sample will consist of adult patients without a previous history of intolerance to a standard dose of influenza vaccine. One group will receive standard dose trivalent, inactivated influenza vaccine (15 μg/strain, TIV), one group will receive a four-fold dose of TIV (60μg/strain). Each season, the same vaccine will be administered according to each participant’s assigned randomized therapy. Patients will be followed up to 12 months.
PCORnet Partners: pending
Sponsor: Barbara Wells, National Heart, Lung, and Blood Institute
Coordinating Center: University of Wisconsin-Madison, Harvard Medical School, University of Toronto, Clinical Sciences Center, Madison, Wisconsin
Fact Sheet: pending
How to Participate: Participants will be recruited from sites in the United States and Canada through electronic health systems over three influenza seasons.