Clinical research studies include scientifically evaluated plans, or protocols, that outline how to test if a potential new medication or vaccine is safe and/or effective in people. All investigational medications and vaccines must be tested in clinical research studies before they can be submitted for approval by regulatory authorities. A clinical research study is conducted by doctors and researchers who follow strict guidelines to ensure the safety and wellbeing of the study volunteers who participate. Although side effects can occur in any clinical trial, the study is designed to minimize the risk and you will be monitored closely.

Clinical trials are conducted in phases. The trials at each phase have a different purpose and help 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 study 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 study 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 study is a phase 2/3 trial. Phase 2/3 trials may provide more information about the safety and side effects of the new 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 research studies and study volunteers are vital to creating a vaccine that will protect people of all ages and from all backgrounds against this devastating disease.

Given that certain populations and ages can respond differently to medical therapies, it is extremely important that this clinical research study include 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 time to come for study visits, so we want to make sure this is not too much of a burden for you and your child. The study site will review these details with you.

Normally vaccines for viruses are made from a weakened or inactive (not live) virus, but the mRNA-1273 study 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 study vaccine.

In order to understand if the study vaccine works, medical researchers are comparing the mRNA-1273 study vaccine to a saltwater placebo. A placebo looks like the study vaccine being tested but does not contain the study vaccine.

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

Study volunteers have the right to drop out of the study at any time for any reason, or no reason at all. The study doctor or sponsor also has the right to discontinue a study volunteer at any time for the volunteer’s safety, or if the study volunteer no longer meets the study requirements.