GETTING A SHOT IS
CHANGING THE WORLD IS
Your child could be part of important pediatric research for a COVID-19 vaccine for kids.
The University of Kentucky is a testing site for a research study to test whether the Moderna vaccine safely protects children between the ages of 6 months through 11 years old from getting sick with COVID-19 (also known as coronavirus).
Parents/guardians interested in enrolling their child can answer a confidential screening survey to help us determine if they qualify. Taking the survey does not obligate you/your child to participate.
A vaccine that prevents COVID-19 disease and SARS-CoV-2 virus transmission in children is a crucial public health tool to curb the pandemic.
Moderna is committed to researching a safe and effective vaccine that protects people of all backgrounds and ages, including children less than 12 years old.
KidCOVE is a Phase 2/3 clinical study is to test the safety and effectiveness of the Moderna study vaccine, called mRNA-1273, that may protect children between the ages of 6 months through 11 years old from getting sick if they come into contact with SARS-CoV-2, which causes COVID-19.
Additional eligibility requirements will be assessed by the study team.
Insurance is not needed to join this clinical trial, and compensation for your family's time will be available.
Please note that it may take several weeks before you hear back from the study team about your child's eligibility. Enrollment for this study is staggered by age group, and we expect that interest will exceed our enrollment capacity. If your child can't be enrolled in this study due to eligibility or capacity, we will be happy to contact you about any future study opportunities. Just be sure to indicate in the screening survey that you agree to be contacted.
Clinical research studies include scientifically evaluated plans, or protocols, that outline how to test if a potential new medication or vaccine is safe and/or effective in people. All investigational medications and vaccines must be tested in clinical research studies before they can be submitted for approval by regulatory authorities. A clinical research study is conducted by doctors and researchers who follow strict guidelines to ensure the safety and wellbeing of the study volunteers who participate. Although side effects can occur in any clinical trial, the study is designed to minimize the risk and you will be monitored closely.
Clinical trials are conducted in phases. The trials at each phase have a different purpose and help scientists answer different questions:
This study is a phase 2/3 trial. Phase 2/3 trials may provide more information about the safety and side effects of the new vaccine. Combining phases 2 and 3 may allow research questions to be answered more quickly or with fewer study volunteers.
Clinical research studies and study volunteers are vital to creating a vaccine that will protect people of all ages and from all backgrounds against this devastating disease.
Given that certain populations and ages can respond differently to medical therapies, it is extremely important that this clinical research study include children of all ages, genders, races and ethnicities to ensure the vaccine is safe and effective for everyone to use.
Yes, compensation for your family's time will be available. We realize it takes time to come for study visits, so we want to make sure this is not too much of a burden for you and your child. The study site will review these details with you.
Normally vaccines for viruses are made from a weakened or inactive (not live) virus, but the mRNA-1273 study vaccine is different. It is made from an instructional molecule called mRNA that tells your cells how to make protein. In this case, the protein is a small part of the virus that is thought to help the body's immune system protect itself if you ever come in contact with the coronavirus.
Your child cannot get infected with SARS-CoV-2 or get COVID-19 illness from the mRNA-1273 study vaccine.
In order to understand if the study vaccine works, medical researchers are comparing the mRNA-1273 study vaccine to a saltwater placebo. A placebo looks like the study vaccine being tested but does not contain the study vaccine.
Each study volunteer will be closely monitored by the study doctor and medical staff for symptoms of COVID-19 while in the KidCOVE Study. If a study volunteer is diagnosed with COVID-19 during the trial, the study team will notify the child's primary care physician and the study team will continue to monitor the child's well-being closely.
You can check if your child is potentially eligible for this trial be completing a set of screening questions. Click on the blue "Take Screening Survey Now" button at the top or bottom of this page. The survey is confidential, and answering it does not obligate you or your child to participate in the study.
Study volunteers have the right to drop out of the study at any time for any reason, or no reason at all. The study doctor or sponsor also has the right to discontinue a study volunteer at any time for the volunteer's safety, or if the study volunteer no longer meets the study requirements.