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GETTING A SHOT IS
BRAVE.
CHANGING THE WORLD IS
HEROIC.

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.

Purpose of The Study

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.

Enrollment Requirements:

Your child might qualify to participate if they are:

Children are not eligible to participate if they:

6 months through 11 years old
Have received an investigational or approved vaccine for COVID-19
In good/stable health. Children with chronic disease (e.g., asthma, diabetes mellitus, cystic fibrosis) may be eligible if their disease is stable.
Are currently taking any investigational or approved treatments for COVID-19
Have tested positive for COVID-19 or been in contact with anyone diagnosed with COVID-19 within two weeks prior to receiving the vaccine
Have participated in another COVID-19 trial in the past month

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.

What is a clinical research study?

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.


What are the phases of clinical research and what is a phase 2/3 trial?

Clinical trials are conducted in phases. The trials at each phase have a different purpose and help scientists answer different questions:

  • In Phase 1 trials, researchers test a new vaccine, drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
  • In Phase 2 trials, the study vaccine, drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
  • In Phase 3 trials, the study vaccine, drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
  • In Phase 4 trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

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.

Reference: https://www.ciscrp.org/education-center/important-information/#faq


Why is diversity important in clinical trials?

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.


Will compensation for time be available as part of this clinical trial?

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.


Does the mRNA-1273 study vaccine contain a live virus?

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.


Can my child get COVID-19 from the study vaccine being researched?

Your child cannot get infected with SARS-CoV-2 or get COVID-19 illness from the mRNA-1273 study vaccine.


What is a placebo?

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.


What happens if my child is diagnosed with COVID-19 while in this trial?

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.


How can I check to see if my child is eligible for this trial?

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.


Can my child quit the trial at any time?

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.