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

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.

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.

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

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.

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

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.

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.

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.