Clinical Trials / Research Studies
Pfizer C4591082 Peds High Risk Covid
Why are we doing this research?
Cincinnati Children's is doing a research study, also known as a clinical trial or clinical study, to learn if an already approved COVID-19 vaccine is safe and could offer protection against severe COVID-19 in children 5 through 11 years old who are at high risk for this.
The virus that causes COVID-19, called SARS-CoV-2, keeps changing over time. These changes create new versions of the virus, called variants. Some of these variants can spread more easily or might be harder for our bodies to fight off. One group of these variants, known as the Omicron family, has similar changes in a part of the virus. Right now, most COVID-19 cases are still being caused by Omicron variants. This is why scientists keep studying the virus and working on new vaccines. These updated vaccines help train the body's immune system to recognize and fight off versions of the virus that have changed.
Who can participate?
Children who are 5-11 years old, with at least one medical condition that puts them at higher risk of becoming sick from COVID-19 and:
- Interested in being in a COVID-19 vaccine study
- Able and willing to complete all scheduled visits and comply with all study
procedures
Conditions
- Healthy Infants, Children and Adolescent Studies
- Vaccines
What will happen in the study?
The study includes up to 2 planned study visits over 6 months (1 vaccine clinic visit, 1 follow-up clinic visit, and 1 contact follow-up). Your child may be asked to come to our study center for visits outside of their scheduled visits.
Here are some of the things that will happen in this study:
- You will be given a consent form that thoroughly explains all of the details of the study. A member of the study staff will review the consent form with you and will be sure that all of your questions are answered.
- You will be asked about your child’s health and any medications they take.
- Your child will have a physical exam including temperature, heart rate, breathing rate, blood pressure, height, and weight.
- Your child will receive 1 dose of the study vaccine. Cincinnati Children’s Research Foundation Office for Clinical and Translational Research (OCTR)
- You will be asked to complete a diary to record any symptoms your child may have after receiving vaccination. starting the day of study vaccine and for 7 days after (or longer if symptoms are ongoing).
- Your child will have blood samples collected at 2 of the study visits.
What are the good things that can happen from this research?
Your child may or may not benefit from being in this study. However, by taking part, your child may help to provide new scientific information that may help doctors to the development of COVID-19 vaccines.
What are the bad things that can happen from this research?
Possible risks and discomforts will be discussed with you and your child prior to the start of the study.
Will you/your child be paid to be in this research study?
Participants will receive up to $250.00 for time and effort to complete the study. If you do not complete all visits/contacts, you will be paid for those you have completed.
Contact
Go to Pediatric High Risk Covid-19 eScreenerOr contact:
The Vaccine Research Center at Cincinnati Children's
513-636-7699
VaccineResearch@cchmc.org
Cincinnati Children’s Hospital Medical Center
3333 Burnet Ave.
Cincinnati, OH 45229-3039
NCT07222384
Study Doctor
Grant Paulsen, MD
Infectious Diseases
3333 Burnet Avenue, Cincinnati, Ohio 45229-3026
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