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CT05 -GSOP-
RF15 1 .0PHA SE 2/3 CLINICA L STUDY ASSENT
TEMPLA TE FOR YOUNGER CHILDREN 15-Feb-2021
Assent Version Date: 06 Aug 2021 | Assent Version Number: 3Assent Level: Study (Phase 2/3 Placebo Controlled
Selected Dose)
Site #: N/A | Protocol No. C4591007 | Protocol Date: 06August 2021 Country: N/A | Derived From: 05 Mar 2021
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
090177e197c0f292\Approved\Approved On: 06-Aug-2021 21:07 (GMT)
FDA-CBER-2021-5683-1076755
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 the
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 .
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?
090177e197c0f292\Approved\Approved On: 06-Aug-2021 21:07 (GMT)
FDA-CBER-2021-5683-1076756
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,
pulse, blood pressure andtemperature).
Then my nurse or I w ill ask you to have
some tests done.
If you are a girl, we may ask for your urine to
perform a pregnancy test, if my nurse or I
determine it is necessary.
My nurse or I will put a swab (like a Q -tip) in
your nose. This may hurt a little .
090177e197c0f292\Approved\Approved On: 06-Aug-2021 21:07 (GMT)
FDA-CBER-2021-5683-1076757
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 a vein
in your arm. This may hurt
a little .
You will need to get 2 or4 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.
090177e197c0f292\Approved\Approved On: 06-Aug-2021 21:07 (GMT)
FDA-CBER-2021-5683-1076758
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 shots ,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 or your guardian 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 shot.
At any time while you are still taking part in the study, if you
get sick, your parent or guardian may need to contact your
doctor.
After your shots, you will
need to stay at the doctor’s
office for at least 30
minutes so that my nurse or
Ican make sure you are
okay.
090177e197c0f292\Approved\Approved On: 06-Aug-2021 21:07 (GMT)
FDA-CBER-2021-5683-1076759
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
And how many
times do I have to
come to see you,
Doctor?
That is a great question!
You will come to my clinic/hospital for 3 to 5visits.
We will take some blood sample from a vein in your
arm at least on 2 planned visits . You may have an
additional blood sample taken from a vein in your
arm at one more visit .
We will give you first shot at visit 1 and asecond shot
at visit 2. These shots will be given approximately
three weeks apart.
We will also take a nose swab at each visit where you
receive a shot.
We will tell you and your parents/guardian 6 months
after your second shot, if you were given the COVID -
19 vaccine at Visit 1 and Visit 2. If not you will be
offered 2 more shots approximately three weeks
apart.
The whole study will last about 2 years.
We will work with your mom or dad or your guardian on
scheduling these visits around your activities like school.
Your mom or dad or guardian will also be contacted up to 4
times by phone to ask about your health, 2 of these times, we
may ask them to bring you for a visit at my clinic/hospital.
You may have to come for extra visits and tests if your doctor
thinks they need to see you .
090177e197c0f292\Approved\Approved On: 06-Aug-2021 21:07 (GMT)
FDA-CBER-2021-5683-1076760
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 9While 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 shot could cause:
Redness, swelling, or pain where the needle goes in.
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 symptoms.
ther things that could happen:
If you become sick during the study, we may require your mom or
dad or guardian to bring you to the clinic/hospital or may ask them
to take a nose swab from your nose at home.
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?
090177e197c0f292\Approved\Approved On: 06-Aug-2021 21:07 (GMT)
FDA-CBER-2021-5683-1076761
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 (age appropriate)
____________________________________________________
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 nur ses or
your mom or dador your guardian .
If you have any questions you can have your mom
or dad or your guardian callme or one of my
nurses.
[provide the contact information for the PI ]
090177e197c0f292\Approved\Approved On: 06-Aug-2021 21:07 (GMT)
FDA-CBER-2021-5683-1076762
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 9Printed First and Last Name of Child :__________________________
Statement 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: _________________________________________
090177e197c0f292\Approved\Approved On: 06-Aug-2021 21:07 (GMT)
FDA-CBER-2021-5683-1076763