An investigational COVID-19 vaccine study for adolescents

Trial ID: NCT04649151 Part 2
A research study to test an investigational vaccine that may protect adolescents between the ages of 12–17 from getting sick if they come in contact with the SARS-COV-2 virus, which causes COVID-19; also known as coronavirus. Moderna is committed to researching a safe and effective vaccine that protects people of all ages and from all backgrounds against COVID-19.

Trial Details

The mRNA-1273-P203 clinical trial is evaluating an investigational vaccine that may protect adolescents between the ages of 12–17 from getting COVID-19 if they come in contact with the SARS-COV-2 virus. Both the two-dose initial investigational vaccine series and the investigational third dose are being evaluated in this clinical trial.

A vaccine that prevents COVID-19 disease and SARS-CoV-2 transmission in adolescents would be a crucial public health tool to help curb the pandemic.

The purpose of this study is to seek an indication for use of the mRNA-1273 vaccine in adolescents of 12–17 years old. Volunteers will participate and be followed by medical staff for up to 25 months.

Estimated Enrollment

4,424 Participants

Phase

Phase 2/3

Eligibility Criteria

Participants must:

  • Be between 12 and 17 years old
  • Be in good health

Participants must not:

  • Have tested positive for COVID-19 or been in contact with anyone diagnosed with COVID-19 within 2 weeks prior to investigational vaccine administration
  • Be pregnant or breastfeeding
  • Have travelled outside of the United States in the past month
  • Have participated in another trial in the past month
  • Be a current smoker or have a history of smoking

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Study Sites

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

What to Expect

  • Participants who have not previously received a COVID-19 vaccine will receive the initial two-dose investigational vaccination series, followed by a 50µg third dose of the investigational trial vaccine, mRNA-1273.
    • The total length of trial participation is up to 17 months and includes up to 10 in-person visits to the clinical trial site and 3 virtual visits with the clinical trial doctor.
  • If the participant has previously completed an initial two-dose vaccination series, they will receive a 50µg investigational third dose of the investigational trial vaccine, mRNA-1273.
    • The total length of trial participation is up to 12 months and includes up to 5 in-person visits to the clinical trial site.
  • Participants’ onsite visits may include medical examinations like a physical exam, nasal swab, or blood draw.
  • Participants will have occasional phone calls with the clinical trial staff. During these phone calls, the clinical trial doctor and medical staff will check how the participant is feeling and ask for updates on their health.
  • Participants will be asked to use an eDiary app on their smartphone or trial-provided device to complete weekly entries about any COVID-19 symptoms for the duration of the clinical trial.

The clinical trial doctor and medical staff will talk to you and your child about additional medical support that your child 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 may be available.

Check Your Child's Eligibility

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

Share this Trial with a Family Member or Doctor

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Frequently Asked Questions (FAQs)