The purpose of this study is to see if an investigational high-dose influenza (“flu”) vaccine is able to safely reduce heart or lung-related problems compared to the standard-dose flu vaccine. Both the high dose and standard dose flu vaccines called Fluzone® are being provided for use in the study by Sanofi Pasteur, which manufactures the vaccines. The standard dose vaccine is approved by the Food and Drug Administration (FDA) for protecting against influenza disease caused by influenza A and influenza B viruses. The high dose vaccine is approved by the FDA for the same reason, but only for adults who are at least 65 years old. Thus its use with adults younger than 65 in this study is investigational.
|Effective start/end date||2/1/17 → 1/31/20|
- Brigham and Women's Hospital (SUB 5.22.17//5U01HL130163-02)
- National Heart, Lung, and Blood Institute (SUB 5.22.17//5U01HL130163-02)
United States Food and Drug Administration
Influenza B virus