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

Trial ID: mRNA-1273-P203 (TeenCOVE Part 3)

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

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

[#<OpenStruct header_icon="clipboard-check", heading="What to Expect", content="The total duration of participation is approximately 12 months and includes phone calls and 10 visits to the clinical trial site.\n\nYour child will have 2 injection visits, 180 days apart, where they will receive the investigational vaccine.\n\nAfter 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.\n\nYou, 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.\n\nYour child will be closely monitored by the clinical trial team if any symptoms of COVID-19 are reported at any time throughout their participation.\n\nInsurance is not needed to participate, and qualified participants will receive compensation for their trial-related time and travel.\n">]

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)

What is COVID-19?

COVID-19 is a respiratory illness caused by the SARS-CoV-2 virus. Common symptoms are similar to the flu and include fever, cough, and tiredness. More serious symptoms include difficulty breathing and, in rare cases, death. The World Health Organization declared COVID-19 a pandemic in March 2020. Since that time, there have been more than 500 million cases and 6.2 million deaths worldwide.

What is a clinical trial?

Clinical trials are carefully controlled scientific studies that evaluate how well investigational or modified medicines may treat or prevent diseases in people. Clinical trials are conducted to answer questions such as:

Is the investigational treatment or vaccine safe enough to outweigh the risks?
What is the best dose needed for the investigational treatment or vaccine to work?
How often should the investigational treatment or vaccine be given?
How effective is the investigational treatment or vaccine at treating or preventing symptoms or the condition?

A clinical trial follows a protocol that has been approved by regulatory agencies to ensure patients’ and trial participants’ safety. The protocol outlines the types of trial participants to include, the schedule of visits and procedures, safety precautions, and what and how data will be analyzed.

What are the phases of clinical trials and what is a phase 2/3 trial?

Clinical trials are conducted in phases. Each phase of the trial has a different purpose and helps scientists answer different questions:

In Phase 1 trials, researchers test a new vaccine, drug, or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 trials, the investigational vaccine, drug, or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
In Phase 3 trials, the investigational vaccine, drug, or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 trials, post marketing studies delineate additional information including the drug’s risks, benefits, and optimal use.

This clinical trial is a phase 2/3 trial. Phase 2/3 trials may provide more information about the safety and side effects of an investigational vaccine. Combining phases 2 and 3 may allow research questions to be answered more quickly or with fewer study volunteers. 

Reference: https://www.ciscrp.org/education-center/important-information/#faq

Why is diversity important in clinical trials?

Clinical trials and trial volunteers are vital to advancing research of an investigational vaccine that may potentially protect people of all ages and from all backgrounds.

Given that different populations and ages can respond differently to medical therapies, it is extremely important that this clinical trial include people of all ages, sexes, races, and ethnicities to ensure the investigational vaccine is safe and effective for everyone to use.

Will compensation for time be available as part of this clinical trial?

Compensation for your child’s trial-related time may be provided.

Does the mRNA-1273.222 investigational vaccine contain a live virus?

Often vaccines for viruses are made from a weakened or inactive (not live) virus, but the mRNA-1273.222 investigational 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 will hopefully help the body’s immune system protect itself if your child ever comes in contact with the SARS-CoV-2 virus. Your child cannot get COVID-19 from the mRNA-1273.222 investigational vaccine.

Can my child get COVID-19 from the investigational vaccine?

Your child cannot get infected with SARS-CoV-2 or get COVID-19 illness from the mRNA-1273 investigational vaccine.

What happens if my child is diagnosed with COVID-19 while in this trial? 

Each clinical trial participant will be closely monitored by the trial doctor and medical staff for symptoms of COVID-19 while in the TeenCOVE Study. If a participant is diagnosed with COVID-19 during the trial, the medical team will notify the child’s primary care physician and the medical team will continue to closely monitor the child’s well-being.

How can I check to see if my child is eligible for this trial?

You can check if your child is potentially eligible for this trial by completing a set of screening questions. You can find these on this web page by clicking the ‘Get Started’ button.

Can I remove my child from the trial at any time?

Participation is voluntary. You have the right to end your child’s participation in the clinical trial at any time for any reason, or no reason at all. The clinical trial doctor or sponsor also has the right to discontinue a participant at any time for that person’s safety or if the participant no longer meets the trial requirements.