What will happen in the study?

If you decide you want to be in the study, you will come to Cincinnati Children’s main campus up to four times during the study. You will have up to six phone call visits. These are the things that will happen while you are in the study:

You will:

• Answer questions about your health, medications you are taking, vaccination history and symptoms following vaccination.
• Have vital signs taken.
• Have blood samples drawn.
• Be randomly (like flipping a coin) assigned to receive the flu vaccine and the COVID-19 vaccine either on the same day or one to two weeks apart.
• Receive a licensed, approved mRNA COVID-19 vaccine.
• Receive a licensed, approved flu vaccine.
• Complete an online or paper symptom diary after being vaccinated.
• Be assessed for any immediate symptoms after vaccination.
• Sign a medical release form so the study staff can review medical information related to your delivery.
• Sign a medical release form so the study staff can review medical information about the health of your baby after birth.
• Consent to allow the collection of cord blood from your placenta after birth.
• Return for an unscheduled visit, if needed, to assess an adverse reaction to the vaccine(s).

You will be given a consent form that explains all the details of the study. A member of the study staff will review the consent form with you and answer all your questions before you agree to be in the study.