The main purpose of this Phase II study is to assess the safety and immunogenicity of a dose of Fluzone High-Dose Quadrivalent vaccine and a third dose or booster dose of Moderna COVID-19 Vaccine administered concomitantly or singly in 300 adults 65 years of age and older who have received their second dose of the 2-dose schedule of Moderna COVID-19 Vaccine at least 5 months before enrollment in the study.
Results
October 20, 2021 - The CDC presented the interim results for this trial. Of the 296 participants, the study results demonstrate that QIV-HD and SpikeVax (100µg) can be administered safely together without evidence of immunogenicity interference, supporting existing co-administration recommendations of COVID-19 and influenza vaccines.