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Thank you for your interest in the Moderna vaccine trial for children. We are looking to enroll children in a vaccine study to assess the potential safety and immunogenicity of the Moderna COVID-19 vaccine.
Moderna is evaluating the effectiveness of their mRNA vaccine when given to children. In the United States, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for use of this vaccine in adults. Before such authorization can be extended to children, rigorous clinical trials must be performed. We feel fortunate to be administering these trials and we are appreciative of your interest in having your child partake in this clinical trial.
Benefits of Volunteering.
By volunteering for a clinical trial, you and your child may be helping in a worldwide effort to control the current pandemic. Our clinical trials and studies are open to the entire community. We appreciate you wanting to be part of the solution in helping us control this pandemic. Volunteers who are selected will be paid for participating in this research.
Risks Associated with Clinical Trials.
One of the most important parts of the consent process is for our team to discuss potential risks associated with one’s child participating in a clinical trial. Our team is here to clearly explain what the trial involves and to discuss any concerns you may have. Vaccine development is a highly regulated process. Clinical trials are one step in a rigorous development process. We value your trust in this process and we take seriously the safety and ethical responsibility entrusted upon us.
Will Participants Definitely Get the Vaccine?
The study is being conducted in two parts. The first part is “Open-Label” in which participants will definitely be given the vaccine, although the dosage will vary. The initial phase of the study will start with a small dose and escalate to a higher dose once safety and tolerability is established. Each step is evaluated by an internal safety review board and the study will move forward in a stepwise fashion based on the recommendation of this independent board. Once an optimal dose is established, the second part of the study will begin. This part is “Observer-Blind” where 1 in 4 of the participants will be receiving a placebo. The remaining participants will receive the vaccine. Participants and our study site will not be aware of whether a study vaccine or a placebo was given. This information will be made available to participants once the study has concluded.
What Study Volunteers Can Expect.
• Within a few days of reaching out to us, a member of our study team with contact you.
• A brief telephone screening interview will take place so we may ask some basic health questions to determine eligibility. These questions may include a brief medical history. If there is any informationpresented in this interview that prevents your child from partaking in the study, you will be informed atthat time.
• Basic information about the study will be provided by phone. If prescreening criteria are met and you wish to proceed, an appointment at our clinic will be arranged. At this visit, a more detailed discussionwill occur in person prior to the informed consent process. During the first visit, all questions will be answered and if all criteria are met and you agree to have your child proceed, informed consent will be signed.
During the study:
• The study requires coming into the study clinic (located in Ventura, California) for up to 6 clinic visits and approximately 2 telemedicine visits over 14 months. Expect 2-3 hours for the first visit, and about half that time for subsequent visits.
• A set schedule of follow up visits will be established at the initial visit and it will be important for this schedule to be followed.
• The current study involves receiving two injections at a set interval. Injections are not given at every visit. A few of the visits will also involve blood draws, lab tests and/or nasal swabs in order to assess the safety and effectiveness of the vaccine.
• You will be asked to keep track of how your child is feeling using an electronic diary for a period of time following each injection. In addition, a member of our team may be contacting you at various times between visits.
• If a participant becomes infected with the Covid-19 virus, the study staff will provide care or directparticipants
to an appropriate center for care.
• Study participants are compensated for time spent.
After the study:
We may ask if we can contact participants about future studies conducted by our facility.
What if I change my mind?
Clinical studies are always voluntary. Consent may be withdrawn at any time. If the vaccine has already been administered, we may ask that you bring your child back for a visit to perform a safety check.
Will I be paid for taking part in a research study?
You will be paid for your time and participation in the study. Compensation will be discussed during screening.
Who We Are?
Our study coordinators are independent of Moderna. The principal investigator is Dr. Carey Chronis, MD, FAAP, a board-certified pediatrician in Ventura, California. Dr. Chronis has been established in Ventura for over 20 years and is working with FOMAT Medical Research, an integrated research organization with a well-established history of conducting a wide variety of clinical research studies.