Clinical Trials / Research Studies
COVID-19 Vaccine Study for Infants and Children 6 Months to 4 Years Old
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 how often children develop a fever when they receive a COVID-19 vaccine on the same day with their other routine childhood vaccines versus when they receive it 1 to 3 weeks later.
Who can participate?
Infants and children 6 months to 4 years old may be eligible to participate.
Conditions
- Healthy Infants, Children and Adolescent Studies
- Vaccines
What will happen in the study?
The study includes 1 to 2 study visits in person and a few phone calls and text messages. Here are some of the things that will happen in this study:
Participants in this study will be randomly assigned (like flipping a coin) to one of two groups.
- Participants in Group 1 will receive their routine vaccines and the mRNA COVID-19 vaccine on the same day at their regular pediatrician visit.
- Participants in Group 2 will receive other routine vaccines on the same day at their regular pediatrician visit and the mRNA COVID-19 vaccine 1 to 3 weeks after the other vaccines.
You, as the parent or guardian, will:
- Answer questions about your child’s demographics, health history, vaccine history and current medications, etc.
- Record your child’s temperature and other symptoms for 7 days in a study diary following each vaccination. You will be given a thermometer to help you complete the diary entries.
- Let the study team know if your child has a reaction to the vaccine(s) so that they can be assessed by the study team.
You will be given a consent form that thoroughly explains the details of the study. A member of the study staff will review the consent form with you and will answer all your questions.
What are the good things that can happen from this research?
Your infant/child may or may not personally benefit from their participation in this study. However, the information learned from this study may benefit other children who receive childhood vaccines in the future.
What are the bad things that can happen from this research?
The study team will discuss possible risks and discomforts with you prior to the start of the study. If you choose, you should discuss these risks with your child’s regular health care provider or with the study doctor.
Will you/your child be paid to be in this research study?
Families will receive $175 for time and effort to complete the study.
Contact
Go to https://redcap.link/COVIDBabiesOr contact:
The Study Team
513-926-7799
IDStudies@cchmc.org
Cincinnati Children’s Hospital Medical Center
3333 Burnet Ave.
Cincinnati, OH 45229-3039
3333 Burnet Avenue, Cincinnati, Ohio 45229-3026
© 1999-2024 Cincinnati Children's Hospital Medical Center. All rights reserved.
