An investigational COVID-19 vaccine study for adolescents

While COVID-19 has primarily impacted older people to date, evidence suggests that the burden of COVID-19 disease has begun to increase in younger age groups, particularly as schools in the US have reopened for in-person instruction. It is crucial to include children in vaccine trials to assure that all testing for safety and immune responses is representative of all ages.

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 in order 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.

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

Clinical trials and their participants are vital to creating a vaccine that will protect people of all ages and from all backgrounds against this devastating disease.

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

Yes, compensation for your family’s time will be available. We realize it takes a lot of time to come for site visits, so we want to make sure this is not too much of a burden for you and your child. The clinical trial site will review all these details with you. Also, you do not have to pay anything to be in the trial and you do not need to have medical insurance to participate. All trial-related services are provided at no cost to you.

Normally vaccines for viruses are made from a weakened or inactive (not live) virus, but the mRNA-1273 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 is thought to help the body’s immune system protect itself if you ever come in contact with the coronavirus.

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

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.

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.

Participants have the right to drop out of the clinical trial at any time for any reason, or no reason at all. The trial doctor or sponsor also has the right to discontinue a person’s participation at any time for the participant’s safety, or if the participant no longer meets the clinical trial requirements.