CISA Simultaneous mRNA COVID-19 and IIV4 Vaccination Study - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find out how COVID-19 vaccines and the flu vaccine work in your body when they are given at the same time. This study is important because people may want to get the COVID-19 and flu vaccine at the same time.

What is the Condition Being Studied?

Combined COVID-19 and Flu Vaccination

Who Can Participate in the Study?

Adults or adolescents ages 12 and older who:
- Have an interest in receiving the COVID-19 vaccine (or booster shot) and flu vaccine

For more information about who can be in this study, please contact the study team at covidflu@duke.edu or 919-971-5649.

What is Involved?

If you or your child choose to join the study, you or your child will:
- Visit our clinic 5 or 6 times
- Answer questionnaires about your health and your reactions to the vaccines
- Be randomly assigned (like a coin flip) to 1 of 2 groups
-- Group 1 will get a COVID-19 vaccine and flu vaccine on the same day and get a placebo (inactive substance) shot 2 weeks later
-- Group 2 will get a COVID-19 vaccine and placebo the same day and get a flu vaccine 2 weeks later

If this is your or your child's first vaccination against COVID-19, you will need to visit our clinic 6 times. If you are vaccinated against COVID-19 and get your booster shot as part of this study, you only need to visit our clinic 5 times.

If you are interested or would like to speak to a team member, please fill out our contact form: https://duke.qualtrics.com/jfe/form/SV_6ih4mKY3HSwhX0y

Study Details

Full Title
Safety of Simultaneous versus Sequential Administration of mRNA COVID-19 Vaccines and Quadrivalent Inactivated Influenza (IIV4) in Adults and Adolescents: A Randomized Observer Blinded Study
Principal Investigator
Protocol Number
IRB: PRO00109102
NCT: NCT05028361
Phase
Phase IV
ClinicalTrials.gov
Enrollment Status
Open for Enrollment
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698