INVESTED Trial

STUDY BASICS

Do you have heart disease? Have you either been hospitalized for heart failure in the past 2 years, or have you had a heart attack in the past year? If so, you may be able to participate in a research study to help find out if a high-dose flu vaccine can reduce the rate of death or hospitalization from heart- or lung-related causes. Vaccination provided at no cost to participants.

STUDY PURPOSE

People with heart disease who get the flu (influenza) have a higher risk of being hospitalized or dying due to flu-related complications. Getting a yearly flu shot can reduce this risk. The flu vaccine is available in different formulations. Most people receive the standard-dose vaccine. A high-dose vaccine is also FDA-approved for use in adults 65 years of age or older, but it is considered investigational when used with younger adults. Some research suggests that receiving a high-dose vaccine can decrease the likelihood of getting the flu for people with heart disease. The purpose of this study is to help researchers find out if the high-dose flu vaccine is more effective than the standard-dose flu vaccine at reducing the rate of hospitalization or death in people with heart disease.

COULD THIS STUDY BE RIGHT FOR YOU?

• Age 18 and up
• Hospitalized for a heart attack in the past year, or hospitalized for heart failure in the past 2 years
• Have at least one heart disease risk factor, such as obesity, smoking, high blood pressure, diabetes, or high cholesterol
• Have NOT received a flu shot this season

WHAT PARTICIPANTS CAN EXPECT

Participation involves 3 visits lasting about 90 minutes-2 hours. Researchers will collect your medical record information and randomly (like the flip of a coin) assign you to receive either the high-dose flu shot (which is investigational in adults under 65), or the standard-dose flu shot. After receiving the shot (which may be done on a different day if desired) participants must stay in the clinic for 20 minutes so the study team can watch for any vaccine-related reactions. Participants will also be asked to record any side effects they experience from the vaccination for 7 days, and will receive 3 follow-up phone calls from the study team. You may also choose to continue in the study and receive a study flu shot in years 2 and 3. Follow-up reporting and calls will be the same as in year 1. The flu shot is provided to participants at no cost.