A COVID-19 VACCINE STUDY FOR CHILDREN
The primary purpose of the KidCOVE Study is to test the safety and effectiveness of the study vaccine, called mRNA-1273, that may protect children between the ages of 6 months and 11 years from getting sick if they come into contact with SARS-CoV-2, which causes COVID-19. The study vaccine is being compared to a placebo, which is a saltwater solution that looks just like the study vaccine but contains no active vaccine.
A vaccine that prevents COVID-19 disease and SARS-CoV-2 transmission in children would be a crucial public health tool to help curb the pandemic.
Moderna is committed to researching a safe and effective vaccine that protects people of all ages and from all backgrounds against COVID-19.
PARTICIPANTS MUST NOT
WHAT TO EXPECT
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 family’s time will be available.
The team at StarMed Healthcare are Pediatric Advanced Life Support (PALS) certified. PALS certification training is a program by the American Heart Association (AHA) that offers an advanced and systematic approach to pediatric assessment. This program is designed to equip health service providers with skills and knowledge for treating critically sick infants and children.
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:
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.
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.