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

A clinical trial of an investigational COVID-19 vaccine for teens

Trial ID: NCT04649151 Part 2
The TeenCOVE Study is a Phase 2/3 clinical trial conducted by Moderna to determine whether an investigational bivalent vaccine, mRNA-1273.222, can protect teens ages 12–17 from COVID-19 and its variants.

Trial Details

The TeenCOVE Study is evaluating mRNA-1273.222, Moderna’s “bivalent” (addressing multiple viral strains at the same time) COVID-19 investigational vaccine to see if it will protect teens from getting sick if they come into contact with the virus that causes COVID-19 and multiple variants, including the Omicron variant. The mRNA-1273.222 investigational vaccine has been authorized for public use as a booster dose for adults in the U.S. under an Emergency Use Authorization (EUA). Moderna is continuing to evaluate this investigational vaccine in children and adults to learn more about how the investigational vaccine works in the body.

Estimated Enrollment

500 Participants

Phase

Phase 2/3

Eligibility Criteria

Participants must:

  • Be 12‒17 years old
  • Be unvaccinated against COVID-19
  • Be in good health
  • Be willing and able to comply with all study requirements

Participants must not:

  • Have not been exposed or tested positive for COVID-19 within 90 days prior to the first dose
  • Have traveled outside of the United States or home country 28 days prior to Screening Visit

Study Sites

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

What to Expect

The total duration of participation is approximately 12 months and includes phone calls and 10 visits to the clinical trial site.

Your child will have 2 injection visits, 180 days apart, where they will receive the investigational vaccine.

After each injection, your child will have a virtual visit during which the clinical trial team will call to check how your child is feeling. The clinical trial team will also have brief safety calls 2 weeks after your child’s injection visits and every 6 weeks following these, during the months your child does not have a clinical trial site visit.

You, or your child if they are capable and would like to do so, will also be asked to complete electronic diary (eDiary) entries reporting any of your child’s COVID-19 symptoms for the duration of the clinical trial.

Your child will be closely monitored by the clinical trial team if any symptoms of COVID-19 are reported at any time throughout their participation.

Insurance is not needed to participate, and qualified participants will receive compensation for their trial-related time and travel.

Frequently Asked Questions (FAQs)