This trial is not actively recruiting.

This trial has completed recruitment on this platform, and is no longer accepting new referrals.

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

Often 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.

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 will be recruiting multiple age groups from 6 months to < 12 years and staggering the recruitment of each group. The goal of this study is to evaluate the safety and effectiveness of different dose amounts and regimens, including a three-dose regimen in children 6 to < 12 years. Please be aware that there may be a delay in hearing from a study site, or the site near you may no longer be recruiting in a specific age group.

Estimated Enrollment

13,275 Participants



Eligibility Criteria

Participants must:
  • Be between 6 months to < 2 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

Study Participation

Participation in the KidCOVE Study lasts up to 17 months and includes phone calls, telemedicine visits, and up to eight visits to the study site.

  • In Part 1 and 2 of the study, participants will be given two injections in the upper arm or thigh—about 28 days apart. Participants in these groups have 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.
  • In Part 3 of the study, participants ages 6 years to < 12 years will be given three injections in the upper arm — the first two doses will be about 28 days apart, and the third dose will be given approximately 4 months after the second dose. All participants in this group will receive the mRNA-1273 investigational vaccine.
  • Each part of the study may run in parallel or may close at different times, meaning eligibility may vary based on age and location.
  • Participants and their caregivers will be asked to return to the study site up to seven times depending on their enrollment assignment.
  • Participants and their caregivers 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 the participant is feeling and ask for updates on their health.
  • Caregivers of participants will be asked to use an eDiary app on your smartphone or a provided smartphone to report any COVID-19 symptoms the participants experience.
  • Participants 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 participants and their caregivers about additional medical support that they will receive if they experience COVID-19 symptoms at any time while in this clinical trial. Insurance is not needed to join this clinical trial, and compensation for your time will be available.

You will need to bring your child to one of the study clinics taking part in this clinical trial.

Sites are located in the cities/states identified with the red pin:

Frequently Asked Questions (FAQs)