Moderna

A COVID-19 vaccine study for children

A research study conducted by Moderna is testing an investigational vaccine that may protect children who are between the ages of 6 months to < 12 years from getting sick if they come into contact with SARS-COV-2, which causes COVID-19; also known as coronavirus.

Trial ID: NCT04796896

A vaccine that prevents COVID-19 disease and SARS-CoV-2 transmission in children would be a crucial public health tool to help curb the pandemic. Moderna is committed to researching a safe and effective vaccine that protects people of all ages and from all backgrounds against COVID-19, including those that are less than 12 years of age.

Trial Details

The primary purpose of the KidCOVE Study is to test the safety and effectiveness of the study vaccine, called mRNA-1273, that may protect children between the ages of 6 months to < 12 years from getting sick if they come into contact with SARS-CoV-2, which causes COVID-19.

Moderna plans to enroll this study in two parts, staggering the recruitment of three different age groups. The first age group will start in children between the ages of 6 years to less than 12 years old. The second age group, recruiting later on, will be for children between the ages of 2 years to less than 6 years old. Finally, the third, and last group to start, will be for children ages 6 months to less than 2 years old. Please be aware that it may be several months before your child’s age group and/or a site near you opens.

Estimated Enrollment

13,275 Participants

Phase

2/3

Eligibility Criteria

Participants must:
  • Be between 6 months to < 12 years old
  • Be in good health
Participants must not:
  • Have received an investigational or approved vaccine for COVID-19
  • Be 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 2 weeks prior to vaccine administration
  • Have participated in another COVID-19 trial in the past month

Check Your Child's Eligibility

We’ll check to see if your child is eligible by asking you some questions.

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What to Expect

Participation in the KidCOVE Study lasts approximately 14 months and includes phone calls, telemedicine visits, and up to seven visits to the study site.

  • Your child will be given two injections in the upper arm – about 28 days apart. Your child has a chance of receiving either the mRNA-1273 study vaccine or the placebo. By using a placebo, medical researchers are able to understand if the study vaccine is effective in preventing COVID-19.

  • You and your child will be asked to return to the study site up to six times depending on their enrollment assignment.

  • You and your child will have two telemedicine visits with the study doctor after each injection, and then monthly after that to monitor for COVID-19 symptoms. During these phone calls, the study doctor and medical staff will check how your child is feeling and ask for updates on their health.

  • You will be asked to use an eDiary app on your smartphone or a provided smartphone 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.

The study doctor and medical staff will talk to you and your child about additional medical support that your child will receive if he/she experiences COVID-19 symptoms at any time while in this clinical trial. Insurance is not needed to join this clinical trial, and compensation for your family’s time will be available.

Frequently Asked Questions (FAQs)

Check Your Child's Eligibility

We’ll check to see if your child is eligible by asking you some questions.

Get Started