Moderna

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 adolescents

A research study conducted by Moderna is testing an investigational vaccine that may protect adolescents who are between the ages of 12 - 17 from getting sick if they come into contact with the SARS-COV-2 virus, which causes COVID-19; also known as coronavirus.

Trial ID: NCT04649151

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 vaccine is being investigated for prevention of COVID-19, the disease resulting from Severe Acute Respiratory Syndrome coronavirus (SARS-CoV-2) infection.

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. Study volunteers will participate and be followed by medical staff for a total of 13 months.

Estimated Enrollment

3,000 participants

Phase

2/3

Eligibility Criteria

Participants must:
  • Be between 12 and 17 years old
  • Have never tested positive for COVID-19
  • Be in good health
Participants must not:
  • 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

What to Expect

The total length of trial participation is a little over a year (13 months) and includes 6 study visits to the study clinic, and 2 visits by phone or video with the study doctor.

  • Study volunteers will be given two injections in the upper arm – one month apart. Each study volunteer has a chance of receiving either the mRNA-1273 study vaccine or the placebo. This random assignment will be a 2:1 ratio, meaning there is a 67% chance of receiving the study vaccine.

  • Study volunteers will have a nasal swab prior to each study injection to test for the presence of COVID-19.

  • Study volunteers will get a call from 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 each study volunteer is feeling and ask for updates on their health.

  • Study volunteers will be asked to use an eDiary app on their smartphone or a provided smartphone to complete weekly entries about any COVID-19 symptoms for the duration of the study.

  • Study volunteers will have their final visit to the research clinic about 12 months from the date of their second injection.

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 time will be available.

Frequently Asked Questions (FAQ)