A research study carried out by Moderna is testing an investigational vaccine that may protect kids who are in between the eras of 6 months to A vaccine that prevents COVID-19 an illness and SARS-CoV-2 infection in kids would be a vital public wellness tool to aid curb the pandemic. Moderna is committed to researching a safe and effective vaccine the protects human being of all ages and also from every backgrounds versus COVID-19, consisting of those the are less than 12 year of age.
Estimated Enrollment6,975 entrants
Participants must not: have actually received an investigational or authorized vaccine for COVID-19 Be right now taking any kind of investigational or approved therapies for COVID-19 have tested hopeful for COVID-19 or been in contact through anyone diagnosed with COVID-19 within 2 weeks before vaccine administration Have participated in an additional COVID-19 psychological in the past month
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generally Asked questions (FAQs)What is a clinical research study study?
Clinical research study studies incorporate scientifically evaluate plans, or protocols, that outline just how to test if a potential brand-new medication or vaccine is for sure and/or reliable in people. Every investigational medications and also vaccines need to be experiment in clinical research study studies before they deserve to be submitted because that approval by regulatory authorities. A clinical research study study is conducted by doctors and also researchers that follow strict guidelines come ensure the safety and wellbeing the the research volunteers who participate. Back side effects can happen in any kind of clinical trial, the research is designed to minimize the risk and you will be monitored closely.
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Clinical trials are carried out in phases. The trials at each phase have a different purpose and aid scientists answer various questions:
In step 1 trials, researchers test a new vaccine, medicine or treatment in a little group of human being for the first time to evaluate its safety, recognize a safe dosage range, and also identify side effects.
In phase 2 trials, the examine vaccine, drug or treatment is offered to a larger group of world to see if the is effective and also to more evaluate the safety.
In phase 3 trials, the examine vaccine, medicine or therapy is offered to big groups of people to check its effectiveness, monitor side effects, to compare it to typically used treatments, and also collect information that will permit the medicine or treatment to be offered safely.
In step 4 trials, article marketing research studies delineate additional information including the drug’s risks, benefits, and also optimal use.
This study is a step 2/3 trial. Phase 2/3 trials may provide more information about the safety and side results of the brand-new vaccine. Combine phases 2 and 3 may permit research concerns to be answered much more quickly or through fewer research volunteers.
Reference: https://www.ciscrp.org/education-center/important-information/#faqWhy is diversity essential in clinical trials?
Clinical research studies and study volunteers are critical to creating a vaccine that will protect civilization of all ages and from all backgrounds versus this destructive disease.
Given that certain populations and ages have the right to respond differently to medical therapies, that is extremely necessary that this clinical research study study include youngsters of all ages, genders, races and ethnicities to ensure the vaccine is safe and also effective for anyone to use.will compensation because that time be accessible as component of this clinical trial?
Yes, compensation for your family’s time will certainly be available. Us realize it takes time to come for study visits, for this reason we desire to make certain this is not too much of a burden for you and your child. The study site will evaluation these details through you.does the mRNA-1273 study vaccine contain a live virus?
Normally vaccines for viruses are made from a weakened or inactive (not live) virus, but the mRNA-1273 study vaccine is different. The is do from an instructional molecule called mRNA the tells your cells how to do protein. In this case, the protein is a small part of the virus that is assumed to assist the body’s immune system safeguard itself if you ever come in call with the coronavirus.deserve to my child gain COVID-19 from the study vaccine gift researched?
Your son cannot gain infected with SARS-CoV-2 or get COVID-19 illness from the mRNA-1273 study vaccine.What is a placebo?
In bespeak to know if the study vaccine works, medical researchers room comparing the mRNA-1273 research vaccine come a saltwater placebo. A placebo looks like the study vaccine gift tested however does no contain the examine vaccine.What happens if my kid is diagnosed v COVID-19 if in this trial?
Each study volunteer will certainly be carefully monitored by the research doctor and also medical staff for symptoms of COVID-19 when in the KidCOVE Study. If a examine volunteer is diagnosed with COVID-19 during the trial, the research team will inform the child’s primary care physician and also the research team will proceed to screen the child’s well-being closely.How deserve to I inspect to see if my son is eligible because that this trial?
You can examine if your boy is perhaps eligible for this trial by completing a set of screening questions. You can discover these top top this net page by clicking the ‘Get Started’ button.
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Study volunteers have the right to drop out of the study at any kind of time for any reason, or no factor at all. The study doctor or sponsor likewise has the appropriate to discontinue a examine volunteer at any kind of time for the volunteer’s safety, or if the research volunteer no longer meets the examine requirements.
Check your Child's Eligibility
We’ll examine to check out if your child is eligible by questioning you some questions.