KidCOVE Moderna COVID-19 Vaccination Trial
StarMed Healthcare is the only North Carolina clinic selected to help with Moderna’s vaccine trial for kids. The vaccine trial will research the shot’s effectiveness on kids aged 6 months to 5 years old. Interested in having your child participate? Please email us by clicking the button below:
A COVID-19 VACCINE STUDY FOR CHILDREN
A research study conducted by Moderna is testing an investigational vaccine that may protect children who are between the ages of 6 months and 5 years from getting sick if they come into contact with SARS-COV-2, which causes COVID-19; also known as coronavirus.
To participate in the trial, send an email to us by clicking the button below. Please be sure to include: Number of children with each child(s) age you would like to enroll, whether or not your child has had a previously confirmed COVID-19 diagnosis, child(s) ethnicity and the best phone number where we can reach you.
TRIAL DETAILS
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 5 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.
ELIGIBILITY CRITERIA
PARTICIPANTS MUST
- Be between 6 months and 5 years old
- Be in good health
PARTICIPANTS MUST NOT
- Have received an investigational or approved vaccine for COVID-19
- Be currently taking any investigational or approved treatments for COVID-19
- Have tested positive for COVID-19 or been in contact with anyone diagnosed with COVID-19 within 2 weeks prior to vaccine administration
- Have participated in another COVID-19 trial in the past month
WHAT TO EXPECT
- Your child will be given two injections in the upper arm – about 28 days apart. Your child has a chance of receiving either the mRNA-1273 study vaccine or the placebo. By using a placebo, medical researchers are able to understand if the study vaccine is effective in preventing COVID-19.
- You and your child will be asked to return to the study site up to six times depending on their enrollment assignment.
- You and your child will have two telemedicine visits with the study doctor after each injection, and then monthly after that to monitor for COVID-19 symptoms. During these phone calls, the study doctor and medical staff will check how your child is feeling and ask for updates on their health.
- You will be asked to use an eDiary app on your smartphone or a provided smartphone to report any COVID-19 symptoms your child experiences.
- Your child will be closely monitored by the study team if any symptoms of COVID-19 are reported at any time throughout their participation.
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.
COMMONLY ASKED QUESTIONS
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.
To participate in the trial, send an email to us by clicking the button below. Please be sure to include: Number of children with each child(s) age you would like to enroll, whether or not your child has had a previously confirmed COVID-19 diagnosis, child(s) ethnicity.