INVESTED Study of Flu Vaccine in Patients with Heart Disease - Clinical Trial
What is the Purpose of this Study?
We are doing this study to learn if an investigational high-dose flu vaccine is able to safely reduce heart- or lung-related problems compared to the standard-dose flu vaccine because getting the flu puts people at higher risk for heart problems.
Flu vaccine in people with heart disease
Who Can Participate in the Study?
- With a history of EITHER a heart attack in the past 12 months (1 year) OR a hospitalization for heart failure in the past 24 months (2 years)
- With no known allergy or hypersensitivity to the flu vaccine
- With no history of Guillain-Barre Syndrome (GBS) within 6 weeks after getting a flu vaccine
- With no severe allergy to egg protein
For more information about who can participate in this study, please contact the study team.
What is Involved?
If you choose to join this study, you will:
- Be randomized (like flipping a coin) to get a high dose or standard dose flu vaccine
- Have 1 in-person clinic visit for a flu vaccine at the start of the flu season (this visit will take about 90 minutes)
- Receive 3 telephone calls over the course of the flu season (about 10 minutes each) to see how you're tolerating the vaccine and how you're feeling.
- Depending on the year you start in the study, you may have the initial visit, study flu vaccine, and telephone calls described above each year for up to 3 years.