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CT05 -GSOP-
RF15 1 .0PHA SE 1/2/3/4 CLINICA L STUDY ASSENT
TEMPLA TE FOR YOUNGER CHILDREN 15-Feb-2021
Assent Version Date: 09Aug 2021 | Assent Version Number: 1
Assent Level: Study (Phase 1 Evaluation of Lower Dose Levels ) Younger children
Site #: N/A | Protocol No. C4591007 | Protocol Date: 0 6Aug 2021 Country: N/A | Derived From: N/A
The official version of this form is located in the electronic document management system.
This document was created based on QMS04 -GSOP -SD-GL06 5.0 CMCD Forms Template WORD 01 -Oct-2020.
TMF Doc ID: 173.16 (Study); 173.10 (Country/Central); 173.20 (Site)
PFIZER CONFIDENTIALPage 1of 9
090177e197c39a5f\Approved\Approved On: 09-Aug-2021 16:36 (GMT)
FDA-CBER-2021-5683-1076868
The official version of this form is located in the electronic document management system.
This document was created based on QMS04 -GSOP -SD-GL06 5.0 CMCD Forms Template WORD 01 -Oct-2020.
TMF Doc ID: 173.16 ( Study); 173.10 (Country/Central); 173.20 (Site)
PFIZER CONFIDENTIALPage 2 of 9
Hello there! I’m Doctor [NAME OF THE PI] and I want to
understand if COVID -19 vaccine can help prevent children and
young adults from getting a germ (called coronavirus) that can
make them sick with COVID -19 disease.
This is called a research study. A research study is when doctors
work together to try to see if the vaccine is safe and if it is can help
people from becoming sick and if the vaccine safe.
My nurses and I will describe the study to you and your mom or
dad or your guardian and we will answer any questions that you
have. You can ask to read the information given to your mom or
dad or your guardian about the study. After you learn more about
the study and if you want to be in this study, I will ask you to sign
this paper.
You can ask questions whenever you want to.
Doctor, I have a question for
you.
If I want to be in the study,
what will I need to do?
090177e197c39a5f\Approved\Approved On: 09-Aug-2021 16:36 (GMT)
FDA-CBER-2021-5683-1076869
The official version of this form is located in the electronic document management system.
This document was created based on QMS04 -GSOP -SD-GL06 5.0 CMCD Forms Template WORD 01 -Oct-2020.
TMF Doc ID: 173.16 ( Study); 173.10 (Country/Central); 173.20 (Site)
PFIZER CONFIDENTIALPage 3 of 9
Well, good question! We will start with
a visit where we will ask your mom or
dad or guardian some questions about
your health. Then I will do a physical
examination (like a checkup; measure
your height, weight, temperature , pulse,
blood pressure ).
If you are a girl, we may ask for your wee
(urine )to perform a pregnancy test, if my
nurse or I determine it is necessary.
My nurses or I will do a nose swab from
your nose with a swab (like Q -tip). This may
hurt a little .
090177e197c39a5f\Approved\Approved On: 09-Aug-2021 16:36 (GMT)
FDA-CBER-2021-5683-1076870
The official version of this form is located in the electronic document management system.
This document was created based on QMS04 -GSOP -SD-GL06 5.0 CMCD Forms Template WORD 01 -Oct-2020.
TMF Doc ID: 173.16 ( Study); 173.10 (Country/Central); 173.20 (Site)
PFIZER CONFIDENTIALPage 4of 9
My nurse or I will take a
little bit of your blood
with a needle from
your arm. This may hurt
a little.
You will need to get a total of 2 vaccine
injections (shots) during the study. You
may feel a little prick from the needle
when you get these shots. We will take
your temperature before you get the
shots to make sure you don’t have a
fever.
090177e197c39a5f\Approved\Approved On: 09-Aug-2021 16:36 (GMT)
FDA-CBER-2021-5683-1076871
The official version of this form is located in the electronic document management system.
This document was created based on QMS04 -GSOP -SD-GL06 5.0 CMCD Forms Template WORD 01 -Oct-2020.
TMF Doc ID: 173.16 ( Study); 173.10 (Country/Central); 173.20 (Site)
PFIZER CONFIDENTIALPage 5 of 9
In the next few days after your vaccine injections, your arms
may become red, puffy, or sore. You might also feel a bit
achy or tired, and you might get a fever.
If any of these things happen, you should tell your parents
and the doctor. Your mom or dad or guardian will complete
an electronic diary about how you are feeling for 7 days
after you receive each vaccine injection.
If you feel sickwhile you are in the study you must tell your
mom or dad or guardian who may need to contact your
doctor.
After your shots, you will
need to stay at the
clinic/hospital (doctor’s
office) for at least 30
minutes so that my
nurse or Ican make sure
you are okay.
090177e197c39a5f\Approved\Approved On: 09-Aug-2021 16:36 (GMT)
FDA-CBER-2021-5683-1076872
The official version of this form is located in the electronic document management system.
This document was created based on QMS04 -GSOP -SD-GL06 5.0 CMCD Forms Template WORD 01 -Oct-2020.
TMF Doc ID: 173.16 ( Study); 173.10 (Country/Central); 173.20 (Site)
PFIZER CONFIDENTIALPage 6 of 9
That is a great question!
You will come to my clinic/hospital for 4 visits.
We will collect a blood sample at 3 visits.
We will give you 1 injection at visit 1 and 1
injection at visit 2.
We will also collect a nose swab from your
nose at visit 1 and visit 2.
The whole study will last about 7months .
We will work with your mom or dad or your guardian
on scheduling these visits around your activities like
school.
You may have to come for extra visits and tests if your
doctor thinks they need to see you.
And how many times do I have
to come to see you, Doctor?
090177e197c39a5f\Approved\Approved On: 09-Aug-2021 16:36 (GMT)
FDA-CBER-2021-5683-1076873
The official version of this form is located in the electronic document management system.
This document was created based on QMS04 -GSOP -SD-GL06 5.0 CMCD Forms Template WORD 01 -Oct-2020.
TMF Doc ID: 173.16 ( Study); 173.10 (Country/Central); 173.20 (Site)
PFIZER CONFIDENTIALPage 7 of 9
While you are in the study, tell the doctor or your mom or dad
or your guardian if you feel sick. There is a chance that during
the study you could feel pain, feel bad or uncomfortable.
The injection could cause:
Redness, swelling, or pain at the injection site
Headache, tiredness, fever, chills, muscle pain, joint
pains, feeling sick (nausea).
It is possible that you might get chest pain, shortness of
breath, or feelings of having a fast -beating, fluttering or
pounding heart . You may need to come to the
clinic/hospital (doctor’s office) if you have these.
Other things that could happen:
If you become sick during the study, we may need your mom or
dad or guardian to bring you to the clinic/hospital .
This study will help us make better vaccines so that other
children like you could benefit from information we learn in this
study.
What might happen after
each of these visits to the
clinic/hospital?
090177e197c39a5f\Approved\Approved On: 09-Aug-2021 16:36 (GMT)
FDA-CBER-2021-5683-1076874
The official version of this form is located in the electronic document management system.
This document was created based on QMS04 -GSOP -SD-GL06 5.0 CMCD Forms Template WORD 01 -Oct-2020.
TMF Doc ID: 173.16 ( Study); 173.10 (Country/Central); 173.20 (Site)
PFIZER CONFIDENTIALPage 8 of 9PLEASE PUT A N“X” MARK IN THE BOX NEXT TO THE PICTURE THAT SHOWS
YOUR DECISION OF WHETHER OR NOT YOU WANT TO BE IN THIS STUDY
YES, I want to be in the study : NO, I do not want to be in this study:
Sign your name ( if age appropriate)
____________________________________________________
Printed First and Last Name of Child : __________________________
Now it’s up to you if you want to be in this
study. No one will be mad if you do not want
to be in the study or if you want to stop
being in the study at any time.
If you say okay now and you change your
mind about it later, just tell me or one of my
nurses or your mom or dad or your guardian.
If you have any questions you can have your
mom or dad or your guardian call me or one
of my nurses.
[provide the contact information for the PI]
090177e197c39a5f\Approved\Approved On: 09-Aug-2021 16:36 (GMT)
FDA-CBER-2021-5683-1076875
The official version of this form is located in the electronic document management system.
This document was created based on QMS04 -GSOP -SD-GL06 5.0 CMCD Forms Template WORD 01 -Oct-2020.
TMF Doc ID: 173.16 ( Study); 173.10 (Country/Central); 173.20 (Site)
PFIZER CONFIDENTIALPage 9of 9Statement of person conducting assent discussion:
1.I have explained the research study to the participant to the best of his or her ability to understand.
2.I have answered all the questions of the participant relating to this research study .
3.In my judgment , Ibelieve the participant ’s decision to enroll or not enroll is voluntary.
4.If the participant decides to enroll, the study doctor and study staff agree to respect the
participant ’s physical or emotional dissent at any time during this research when that dissent
pertains to anything being done solely for the purpose of this research.
Printed First and Last Name of Person Obtaining Assent :
_______________________________________________________________________
Signature of Person Obtaining Assent: ____ ________________ Date: __________ Time: _______
Phone number Of Person Obtaining Assent : _____________________ _____
Study Site Team Instructions: Only complete the section below if assent is required, and either only
verbal assent was obtained from the participant or assent was not obtained from the participant .
Please check appropriate box and sign below.
The undersigned, _____________________, hereby certifies that verbal assent was
obtained from the participant .
Assent was not obtained from the participant . (Please state the reason. Examples include :
participant lacks cognitive abilities to understand the information.)
Date: _____________
Time: ______________
Signature: _________________________________________
090177e197c39a5f\Approved\Approved On: 09-Aug-2021 16:36 (GMT)
FDA-CBER-2021-5683-1076876