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Submitted URL: http://kidscovidshotstudy.com/
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Submission: On December 19 via api from US — Scanned from DE

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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

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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


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