Clinical Trials / Research Studies
Clinical Trials / Research Studies

COVID-19 Vaccine or COVID-19 Booster and Flu Vaccine Study for Children at Least 5 Years Old and Adults

Why are we doing this research?

Cincinnati Children’s is conducting a research study, sometimes known as a clinical trial or clinical study, to learn more about the safety of giving the annual flu vaccine and a COVID-19 vaccine or COVID-19 booster (Pfizer or Moderna) at the same time or two weeks apart.

Who can participate?

Healthy children at least 5 years old and adults who have not yet received the annual flu vaccine this year and qualify to receive a Pfizer or Moderna COVID-19 vaccine under current Food and Drug Administration (FDA) approval and Centers for Disease Control (CDC) guidelines may be eligible to participate.

Conditions

  • COVID-19/Coronavirus
  • Vaccines
  • Healthy Adults

What will happen in the study?

There are five or six study visits over about 4 months. Here are some of the things that will happen in this study:

You as an adult participant, or your child will:

  • Answer questions about your or your child’s health, current medications, demographics and your or your child’s flu and COVID-19 vaccination history.
  • Have vital signs taken.
  • Be asked about your or your child’s quality of life.
  • Have blood samples drawn.
  • Be randomly (like flipping a coin) assigned to receive either the flu vaccine or a placebo with a Pfizer or Moderna COVID-19 vaccine.
  • Receive a Pfizer or Moderna COVID-19 vaccine.
  • Receive either a flu vaccine or a placebo at the first visit, then return two weeks later. Those given a placebo at the first visit will get the flu vaccine. Those given a flu vaccine will get a placebo at the second visit.
  • Receive the second COVID-19 vaccine if getting the first COVID-19 vaccine in the study.
  • Complete an online or paper symptom diary daily for seven days after each vaccine dose and Quality of Life assessment daily for seven days after the first vaccine dose.
  • Be assessed for any immediate symptoms after vaccination.
  • 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 or allow your child to be in the study.

What are the good things that can happen from this research?

If you agree to take part in this study, there may be direct medical benefits to you or your child. You or your child will receive the recommended flu and COVID-19 vaccinations. The flu and COVID-19 vaccines have been shown to prevent flu and COVID-19 infection. As with any licensed vaccine, protection may not occur in 100% of vaccinated persons. However, you or your child may develop protective antibodies against the flu and COVID-19.

Also, information learned from this study may help researchers understand more about the safety and effectiveness of the flu and mRNA COVID-19 vaccines when given on the same day.

What are the bad things that can happen from this research?

There may be some risks and discomforts from being in the study which will be discussed with you. If you choose, you can discuss these risks with your regular health care provider or with the study doctor.

Will you/your child be paid to be in this research study?

Participants will receive up to $350 for time and effort.

Contact

Contact Us.

For more information or to see if you qualify:
Contact:
Study Team
513-332-8796
IDStudies@cchmc.org

Study Doctor

Contact Us.

Elizabeth Schlaudecker, MD, MPH
Mary Staat, MD, MPH
Division of Infectious Diseases