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KidCOVE Study Participation Overview

The coronavirus (COVID-19) pandemic is like nothing we’ve seen in more than a century, and it has altered each and every one of our lives. Parents and caregivers just like you are waiting on a vaccine so children can return to school, the playground, and afterschool activities. And now, your child could be a part of important research on a COVID-19 vaccine.

By enrolling your child in the KidCOVE Study, your family is contributing to a potential solution that could solve this global health crisis.

The purpose of the study

The purpose of the KidCOVE Study is to test a vaccine that may protect children from getting sick if they come into contact with SARS-CoV-2, which causes COVID-19. The KidCOVE Study is evaluating:

  • The safety of the study vaccine (called mRNA-1273), which is given to your child in two doses 28 days apart
  • The effectiveness of the study injection at preventing illness after exposure to SARS-CoV-2
  • The occurrence of COVID-19 infection after injection with the study vaccine or the placebo

Participation in the study

In order to participate, your child must:

  • Be between six months old and less than 12 years old and in good health
  • Not have a positive COVID-19 test within two weeks prior to receiving the first vaccination
  • Be free from exposure to someone with SARS-CoV-2 infection or COVID-19 within two weeks prior to receiving the first vaccination
  • Not have received an investigational vaccine or treatment for COVID-19
  • Be willing and able to comply with all study requirements *There are additional eligibility requirements, which the study doctor can explain to you. *Participation in the KidCOVE Study is completely voluntary. You may withdraw your child from the study at any time, for any reason.

About the KidCOVE study

This study lasts approximately 14 months and includes phone calls, telemedicine visits, and up to seven visits to the study site.

  • Your child will have two injection visits, which will be about 28 days apart.
  • You and your child will be asked to return to the study site three to four times, depending on their enrollment assignment. These visits will occur 15 days, one month, six months, and 12 months after the second injection.
  • Your child will have two telemedicine visits – about one week after each injection – where the study team will call to check how your child is feeling. The study team will also call you once a month after that, during the months your child does not have a study site visit, to discuss safety-related information.
  • You will also be asked to complete electronic diary (eDiary) entries for the duration of the study to report any COVID-19 symptoms your child experiences.
  • Your child will be closely monitored by the study team if any symptoms of COVID-19 are reported at any time throughout their participation.

How your child will feel after the vaccinations

All vaccines have some side effects, and your child may experience side effects in this study. This is the first time that the investigational vaccine will be tested in children less than 12 years of age. In other studies of people receiving vaccines similar to mRNA-1273, the most common side effects were fever, headache, muscle aches or pain, joint aches or pain, tiredness, nausea/vomiting, and chills.

After each injection, your child may have pain or redness and hardness of the skin at the injection site. If the injection was given in the arm, underarm gland swelling may also occur on the arm where the study vaccination was given.

Most side effects go away within a few days after the injection, and your child should still be able to go about their daily activities. Not everyone has side effects, and these side effects may not be experienced after every dose.

This is a randomized study. Neither participants nor their parents will know if they received the study vaccine or a placebo injection. 

Withdrawing from the KidCOVE study

Study participants have the right to drop out of the study at any time and for any reason. You do not have to give a reason for withdrawing to the study doctor. The study doctor also has the right to discontinue a study participant at any time for the participant’s safety or if the participant no longer meets the study requirements.

To learn more, visit KidCOVEStudy.com or contact the participating site listed here.

We understand that any decision regarding your child’s health is important. By taking part in this study, your child could make a difference for your family, your community, and people everywhere. More information can be obtained here:

Need More Information?

For more information or enrollment questions, please contact the Henry Ford Health System Moderna KidCOVE Vaccination Study Team.
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If you are having symptoms of COVID-19, for your safety, please select a MyChart video visit on demand or call your primary care provider. For symptoms of COVID-19, please visit our website www.henryford.com/coronavirus.

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