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Submitted URL: http://kidscovidshotstudy.com/
Effective URL: https://www.pfizerclinicaltrials.com/nct05543616-covid-19-vaccine-trial
Submission: On December 19 via api from US — Scanned from DE
Effective URL: https://www.pfizerclinicaltrials.com/nct05543616-covid-19-vaccine-trial
Submission: On December 19 via api from US — Scanned from DE
Form analysis
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POST /nct05543616-covid-19-vaccine-trial
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POST /nct05543616-covid-19-vaccine-trial
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POST /nct05543616-covid-19-vaccine-trial
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POST /nct05543616-covid-19-vaccine-trial
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<div class="study-locations-title other">
<div class="form-title">View locations for this study</div>
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Text Content
Skip to main content Menu Homepage * English About clinical trialsOur researchFor participants JOIN PFIZERLINK — A CLINICAL RESEARCH REGISTRY Get notified about Pfizer clinical trials that may be right for you — now and over time. Visit PfizerLink About clinical trials Visit About Clinical Trials page * CLINICAL TRIALS OVERVIEW * How clinical trials work * Diversity and inclusion in clinical trials * Protecting your safety & privacy * Pediatric clinical trials * Steps to join a clinical trial * FAQs * CLINICAL TRIAL RESOURCES FOR YOU * Hear from clinical trial participants * Information for caregivers * Educational tools and support resources * Community outreach event calendar Our research Visit Our Research page * AREAS OF FOCUS * Inflammation & Immunology * Rare Diseases * Internal Medicine * Vaccines * Oncology * OUR RESEARCH UNIT * Pfizer Clinical Research Unit (PCRU) * Referral program * Participant loyalty program * PCRU trial list For participants * For current clinical participants * For past clinical participants JOIN PFIZERLINK — A CLINICAL RESEARCH REGISTRY Get notified about Pfizer clinical trials that may be right for you — now and over time. Visit PfizerLink Homepage * English Find a trial * English REFINE YOUR SEARCH FIND A PFIZER CLINICAL TRIAL Search FILTER BY Location Age (years) Sex Male Female Find a trial Find a trial NOW ENROLLING KIDS 5-11 FOR A COVID-19 VACCINE STUDY Get started Get started Email Print As new COVID-19 variants continue to emerge, getting vaccinated can help protect your child from serious illness. If you are thinking about vaccinating your child against COVID-19 for the first time, consider joining our ongoing vaccine clinical trial. Though most children aren’t seriously harmed by COVID-19, some do become very sick. The CDC recommends that children receive an updated COVID-19 vaccine for better protection against newer variants. This study will help us learn how well one dose of Pfizer-BioNTech’s updated COVID-19 vaccine works in children who have not been previously vaccinated. The study vaccine has been authorized by the United States Food and Drug Administration for children at least 6 months of age. It is designed to protect against the newer COVID-19 variant called XBB.1.5. WHO MAY PARTICIPATE Joining a clinical trial is an important and personal decision. We thank you for considering participation as an option that may be right for your family. This study is enrolling children who: * Are 5 to 11 years old * Are generally healthy * Have not been vaccinated for COVID-19 Age 5 – 11 Years Current vaccination status No prior vaccines for COVID-19 Each clinical trial has its own guidelines for who can participate, called eligibility criteria. However, only the research study staff can determine if your child qualifies for the study. GET STARTED – SEE IF YOUR CHILD MAY BE ELIGIBLE Answer a 2-minute questionnaire. A first step as you consider this study is to answer a 2-minute online questionnaire about your child’s health and medical history. If your answers show the study might be a good fit for your child, you may choose to have your contact information shared with a Pfizer Clinical Trial Contact Center Navigator. Speak with a study representative. If you’re interested, a Pfizer Clinical Trial Contact Center Navigator will call you and do a more detailed review of the study and your child’s medical history to see if they may be able to participate and be referred to a study clinic that you select. Confirm your child’s eligibility. Your answers to these questions will only be linked to you if your responses indicate that your child may be eligible to participate in this study and you choose to share your contact information with the study team. Pfizer study team members and our partners will have access to reports containing aggregated data that will not be directly linked back to you or your child. Only the study staff can determine if your child meets the study’s eligibility criteria and is able to enroll in the study. WHAT TO EXPECT If your child enrolls in the study, they will receive a single dose of the study vaccine at their first study visit. Your child’s health will be carefully monitored by the study team for 6 months following their vaccination. They will have a follow-up visit at the study clinic about 1 month after they receive the study vaccine. The study team will also contact you by telephone 6 months after their vaccination. There is no cost to participate in this study. You will also be compensated for completing study-related activities. Number of vaccine doses 1 dose Study visit schedule At least 2 clinic visits and 1 telephone call over 6 months HELP MAKE A DIFFERENCE Children under the age of 10 account for 47% of pediatric COVID-19 deaths worldwide.1 Rates of severe disease and hospitalizations vary greatly by age, race and ethnicity, family income levels, and location.1,2,3 That is why it is important that children of all backgrounds participate in this study – to reflect the diversity of families around the world looking for better protection against COVID-19. REFERENCES: 1. CHILD MORTALITY AND COVID-19. UNICEF. UPDATED MARCH 2023. ACCESSED SEPTEMBER 28, 2023. HTTPS://DATA.UNICEF.ORG/TOPIC/CHILD-SURVIVAL/COVID-19/ 2. CHILDREN AND COVID-19: STATE-LEVEL DATA REPORT. AMERICAN ACADEMY OF PEDIATRICS. UPDATED MAY 15, 2023. ACCESSED SEPTEMBER 28, 2023. HTTPS://WWW.AAP.ORG/EN/PAGES/2019-NOVEL-CORONAVIRUS-COVID-19-INFECTIONS/CHILDREN-AND-COVID-19-STATE-LEVEL-DATA-REPORT/ 3. OBE A, ET AL. THE IMPACT OF THE COVID-19 PANDEMIC ON BLACK CHILDREN: A TWO-YEAR ASSESSMENT. BLACK COALITION AGAINST COVID. MARCH 2023. ACCESSED NOVEMBER 6, 2023. HTTPS://BLACKCOALITIONAGAINSTCOVID.ORG/WP-CONTENT/UPLOADS/2023/03/BCAC_REPORT.PDF HELP MAKE A DIFFERENCE FREQUENTLY ASKED QUESTIONS What are the possible side effects? As with any vaccine, local reactions at the injection site can be common – such as redness, swelling, or pain. There is also potential for other symptoms like a mild fever or fatigue. The known side effects will be further explained in the informed consent document and discussed with you by the study doctor before you consider having your child join the study. If there is any new information that we learn about the study vaccine during the clinical trial, the study doctor will share that with you as well. Is this helpful? Will my child receive a placebo? No, there is no placebo in this clinical trial. A placebo does not contain any active ingredients, but the study vaccine and placebo look alike. In this clinical trial, participants will receive one dose of the study vaccine. Is this helpful? What kinds of tests and procedures are you going to perform? At the beginning of the clinical trial, the study doctor will ask you about your child’s medical history, and any medications they are taking. Your child will have their blood drawn twice during the six months of the trial. The study team will give you more information about the tests and procedures during the review of the study’s informed consent document. Is this helpful? Learn more View locations for this study Find the closest location CONTINUE EXPLORING HOW CLINICAL TRIALS WORK PROTECTING YOUR SAFETY & PRIVACY STEPS TO JOIN A CLINICAL TRIAL FAQS * About Pfizer * For investigators * The Breakthrough newsletter * Site map * Terms of use * Privacy policy * Contact us Information on this website is directed toward U.S. residents only. © 2023 Pfizer Inc. All rights reserved. * * * We need your consent to proceed We use and store your consent for 13 months with 17 partners for Essential, Analytics, Personalisation, Marketing unless you change your preferences. We use cookies to enhance your website experience. We use necessary cookies to ensure our website functions properly and to keep it secure. These always need to be on. We use analytics cookies to measure website use, to learn what content is most useful to users and to help us improve it. We use marketing cookies to help us share content with you that you may find interesting and relevant. We use personalisation cookies to help manage your preferences and remember your settings. For more information see our Cookie Notice. You can change your settings or revoke your consent at any point in the future by clicking on the button which will appear in the bottom right of your screen. Manage SettingsReject AllAccept All Close ✖