Clinical Trials / Research Studies
COVID-19 Omicron Vaccine Study for Infants and Children 6 Months through 23 months
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 about the safety and duration of protection of BNT162b Omicron KP.2 vaccine in children 6 months through 23 months to protect against COVID-19.
COVID-19 is a respiratory disease discovered in 2020 that can make children very sick. The Pfizer-BioNTech COVID-19 vaccine has been FDA approved for children ages 6 months through 11 years. The vaccine has been updated to target current strains of COVID-19. The current Omicron KP.2 vaccine is approved for emergency use. The purpose of this study is to assess the safety of the vaccine is when given as part of a 2-dose series of BNT162b (Omicron KP.2) at the selected 10 microgram dose in children 6 months to less than 2 years of age.
Who can participate?
Children 6 months through 23 months and are generally healthy and:
- Interested in participating in a COVID-19 vaccine study
- Have not previously received a COVID-19 vaccine
Conditions
- Healthy Infants, Children and Adolescent Studies
- Vaccines
What will happen in the study?
Your child will have about 2 in-person study visits (2 vaccine visits), and 3 phone-call follow-up visits. We may request that you come into our study center for visits outside of your scheduled visits if you have any severe symptoms. Here are some of the things that will happen in this study.
You will:
- Be given a consent form that thoroughly explains all the details of the study. A member of the study staff will review the consent form with you and will be sure that all your questions are answered.
- Have a physical exam and tell us about your child’s medical history
- Receive 2 vaccine doses about 1 month apart.
- Complete a symptom diary to record any symptoms which occur on the day
of vaccination and each day for 7 days after vaccination of your infant
What are the good things that can happen from this research?
These study products have been licensed by the US FDA and have already been proven to reduce severe COVID-19.
If you participate in this study, your child will likely have a lower risk of severe COVID-19.
This study will look at giving the approved Omicron Kp.2 vaccine to children. Knowledge gained from this study may be used to inform future policy recommendations about future COVID-19 vaccines in children.
What are the bad things that can happen from this research?
As with any vaccine, you may have side effects. Common side effects from vaccines include injection site redness, swelling or pain. You may also have discomfort from nasal swabs. We will discuss possible risks and discomforts with you prior to the start of the study.
Will you/your child be paid to be in this research study?
Participants will receive up to $420 for time and effort to complete the study.
Contact
Go to https://redcap.link/omicronkidsOr contact:
Gamble Program for Clinical Studies
513-636-7699
gamble.program@cchmc.org
Cincinnati Children’s Hospital Medical Center
3333 Burnet Ave.
Cincinnati, OH 45229-3039
Study Doctor
Grant Paulsen, MD
Infectious Diseases
Find More
3333 Burnet Avenue, Cincinnati, Ohio 45229-3026
© 1999-2025 Cincinnati Children's Hospital Medical Center. All rights reserved.
