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Clinical Trial Summary

This study is a prospective, randomized clinical trial. During this study, participants will be randomly assigned to either receive quadrivalent inactivated influenza vaccine (IIV4) or saline placebo simultaneously with mRNA COVID-19 vaccine at Visit 1. Participants receiving IIV4 will receive saline placebo and participants receiving placebo will receive IIV4 14 days later at Visit 2. A second dose of mRNA COVID-19 vaccine will be administered either 3 or 4 weeks following the first dose at Visit 3, depending upon the mRNA COVID-19 vaccine received. Study staff and participants will be blinded with respect to the timing of receipt of their influenza vaccine. Solicited symptoms of reactogenicity will be assessed on vaccination day and daily during the 7 days following each Vaccination Visit using either electronic or paper symptoms diaries, depending on study participant preference. Quality of life data will be collected using electronic or paper diaries on day of Visit 1 and daily during the 7 days following the initial vaccination visit. Serious adverse events and adverse events of special interest will be collected at designated time points during the study. Serum samples from participants will be collected for determination of COVID-19 seropositivity at baseline. Serum samples will be taken at designated time points to determine IIV4 immunogenicity and for potential future studies.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT05028361
Study type Interventional
Source Duke University
Contact Emmanual B Walter, MD, MPH
Phone 919-620-5346
Email [email protected]
Status Not yet recruiting
Phase Phase 4
Start date September 15, 2021
Completion date July 14, 2022

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