Document text
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)
Sponsor Consent Version Number (Study/ Country/Site) : [1/0/0] 09Aug 2021 Phase 2/3 Lower Dose Evaluation, Older Assent
PFIZER CONFIDENTIALPage 1 of 8We would like to tell you about a research study and see if you would like to take part.
You will need to read this information and then decide if you would like to be in this research
study .
This research study is to find out if a new COVID- 19 vaccine is safe and if it works in children
and young adults .
The study doctor and nurses will explain the study and answer any questions that you have.
You can circle or highlight things on this paper that you want to know more about. If you don’t
understand something, just ask us. It is okay to ask questions now and anytime later that you
think of them.
This document is called an assent form . If you have any doubts, concerns or worries please
tell your study team. You can discuss this information with your family and friends if you want
to.
If you are willing to be in this study, we will ask you to sign and date this assent form. If you
don’t want to take part that’s OK –no one will be mad at you.
WHY ARE WE DOING THIS STUDY?
In 20 19a new germ (coronavirus) started making adults and children ill with a disease called
COVID -19. Scientists and doctors have been working to make a vaccine that can help protect
adults and children against this coronavirus. Scientists and doctors have alre ady done some
research studies in healthy adults and children and the reare now a few vaccines that are
allowed to be given to healthy adults and some older children.
In this research study we are looking at how well one of these vaccines (called BNT162b2)
works in children like you and young adults . We want to find out if BNT162b2 can help protect
children and young adults against COVID- 19.
090177e197c39a5d\Approved\Approved On: 09-Aug-2021 16:30 (GMT)
FDA-CBER-2021-5683-1076773
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)
Sponsor Consent Version Number (Study/ Country/Site) : [1/0/0] 09Aug 2021 Phase 2/3 Lower Dose Evaluation , Older Assent
PFIZER CONFIDENTIALPage 2of 8WHA T HA PPEN S IN THE STUDY?
The Worl d Health Organization (WHO) has declared COVID -19 to be a pandemic (a disease
that has spread all over the world and is affecting lots of people); finding a vaccine to prevent
COVID -19 is an urgent need. To test this investigational vaccine as quickly as possible, this
study will be conducted in several steps. The study will only progress if the data collected
suggests it is safe to do so. The steps in the study are detailed below.
The steps in the study are detailed below. You are being asked to take part in the Phase
2/3Lower Dose Evaluation step of the study.
Phase 1 Lower Dose Evaluation will be carried out in 3 age groups. Every participant in
this Phase will receive tw o injections of the active study vaccine. The following age
groups will take part in this step of the study:
16 to less than 30 years of age,
12 to less th an 16 years of age , and
5 to less than 12 years of age.
The remaining step of the study will be the Phase 2/3 Lower Dose Evaluation . In this partwe
will use adose level selected from the Phase 1part of the study. This step of the study will
collect information from a large rnumber of children and young adults about the safety of the
vaccine and the amount of antibodies produced by the vaccine. In this part of the study all
participants will rece ive active vaccine. The age groups taking part in this step of the study will
be:
16 to less than 30 years of age,
12 to less th an 16 years of age , and
5 to less than 12 years of age.
Please note that this part of the original study called Phase 1 Dose Finding has been
completed . There were 3 age groups in this partand the study lookedat up to 3 dose levels
in each age group . The children in this part of the study were :
5 to less than 12 years of age,
2 to less than 5 years of age, and
6 months to less than 2 years of age .
Phase 2/3 Selected Dose is currently ongoing , andthedose level was selected from the
Phase 1 part of the study. This step of the study will collect information from a large rnumber
of children about the safety of the vaccine and the amount of antibodies produced by the
vaccine. In this Phase, all participants will receive either active vaccine or placebo. The children
in this step of the study will be:
5 to less than 12 years of age,
2 to less than 5 years of age, and
6 months to less than 2 years of age.
090177e197c39a5d\Approved\Approved On: 09-Aug-2021 16:30 (GMT)
FDA-CBER-2021-5683-1076774
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)
Sponsor Consent Version Number (Study/ Country/Site) : [1/0/0] 09Aug 2021 Phase 2/3 Lower Dose Evaluation , Older Assent
PFIZER CONFIDENTIALPage 3of 8This assent is for Phase 2/3Lower Dose Evaluation and there will be about approximately
96 children less than 16 years old, and about 64 participants 16 to less than 30 years of age
taking part in this Phase.
The total number of adults and children taking part in the study will depend on the results seen
during the study.
Everyone will be in this research study for about 7months.
Study Vaccines
Once the study doctor has confirmed that you meet the study requirements, you will be
assigned your study vaccine.
Phase 2/3Lower Dose Evaluation of the study is an “open -label phase”, which means in this
step all participants will receive active study vaccine.
All children/young adults in an given age group willreceive the same dose of vaccine. The dose
will be chosen based on the results from the earlier phases of the study. It is possible that the
different age groups may be given different dose levels. There will be 300 participants in each
age group that wil l be given their dose level. The age groups in this part of the study are:
16 to less than 30 years of age,
12 to less than 16 years of age , and
5 to less than 12 years of age.
The vaccine will be given to you through an injection into the muscle in your upper arm. Each
participant will receive two injections of vaccine, approximately three weeks apart. On the days
you receive your vaccine injection, you will be asked to wait with your child at the study site for
at least 30 minutes for observation.
During the study :
You will come to the research site for visits.
We will collect a blood sample at 3 visits. The amount of blood taken at each visit will
depend how old you are and will be either 10ml (2 teaspoons) or 20 mL (4 teaspoons).
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.
You may have to come for extra visits and tests if your doctor thinks they need to see
you.
The whole study will l ast about 7months.
You or y our Mom/Dad/guardian will have to answer some questions about you on a
smart phone/ APP (called an e -diary).
We will work with your mom or dad or your guardian on scheduling these visits around your
activities like school. W e will contact your mom or dad or guardian once or twice by phone to
ask about your health.
090177e197c39a5d\Approved\Approved On: 09-Aug-2021 16:30 (GMT)
FDA-CBER-2021-5683-1076775
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)
Sponsor Consent Version Number (Study/ Country/Site) : [1/0/0] 09Aug 2021 Phase 2/3 Lower Dose Evaluation , Older Assent
PFIZER CONFIDENTIALPage 4of 8There are 3 sorts of visits in the study. Vaccination visits, checkup visits and extra visits if you
get any have a reaction after your vaccination. The table below s hows you when these visits
will take place and what will happen .
090177e197c39a5d\Approved\Approved On: 09-Aug-2021 16:30 (GMT)
FDA-CBER-2021-5683-1076776
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)
Sponsor Consent Version Number (Study/ Country/Site) : [1/0/0] 09Aug 2021 Phase 2/3 Lower Dose Evaluation , Older Assent
PFIZER CONFIDENTIALPage 5of 8For the participants taking part in Phase 2/3Lower Dose Evaluation , the study doctor or
nurse will perform following assessment and procedures:
Visit Number 1 2 4 5
Visit Description and Visit TimingStudy
Vaccine 1
VisitStudy
Vaccine 2
Visit1-Month
Follow -up
Visit6-Month
Follow -up
Visit
Review and sign informed consent document X
Ask about medical histor y as well as date of
birth, sex, race and ethnicityX
Measure pulse rate, respiratory rate, blood
pressure, and body temperatureX X
Perform a physical exam, including
measurement of height and weight (height at
weight information will be collected at 1st visit
only).X X
If you are female and if needed, you will be
asked to provide a urine sample for a
pregnancy testX X
If needed, will discuss the use of appropriate
birth control with youX X X
Ask about medications you are currently takingX X X
Ask about any other vaccines you have been
givenX X X X
Check y ou meets all the study requirements X X
Take a nasal swab for the detection of virus
causing COVID -19X X
Collect blood sample (up to 20 mL) to test
antibody levelsX X X
Give vaccine injection in your arm and observe
for 30 -min following injectionX X
Thermometer & measuring device will be
provided. e -diary will be provided or app
downloadedX X
You will be asked to complete vaccination
e-diary for 7 days to record potential side
effects following each vaccinationX X
Ask how you are feeling X X X X
090177e197c39a5d\Approved\Approved On: 09-Aug-2021 16:30 (GMT)
FDA-CBER-2021-5683-1076777
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)
Sponsor Consent Version Number (Study/ Country/Site) : [1/0/0] 09Aug 2021 Phase 2/3 Lower Dose Evaluation , Older Assent
PFIZER CONFIDENTIALPage 6of 8WHAT ARE THE POSSIBLE UNCOMFORTABLE OR HARMFUL THINGS THAT COULD
HAPPEN WHILE I’M IN THIS RESEARCH STUDY?
You may feel tired or embarrassed by the questions the study doctor or nurse asks you.
If you are girl and have to give a wee (urine) sample you may feel embarrassed.
When you have your nose swab taken it might be painful or your nose might bleed a bit.
When you have a blood sample taken it may:
oHurt when the needle goes into your arm.
oCause a red spot or bruise on your arm or your arm might feel sore.
oMake you feel dizzy.
oCause an infection at the place where the needle went into your arm.
When you are given your vaccination it could hurt where the needles goes in your arm.
oIt could also make your arm red or swollen.
oYou might also feel sick or be sick.
oYou might get a headache, get pains in your muscles or joints or feel tired.
oYou might get chest pain, shortness of breath, or feelings of having a fast -
beating, fluttering or pounding heart . You may need to come in to see the study
doctor for further assessments if you have these symptoms.
oYou might also get a temperature, feel shivery or cold.
oYou could have an allergic reaction, which means you could have swelling of
the fac e, or lips. Other allergic reactions may include rash, hives or itching.
You might also feel unwell in other ways. Remember to tell your parent(s) or your guardian(s)
and the study doctor everything you are feeling while you are in the study including if y ou feel
sick.
DO I NEED TO USE BIRTH CONTROL?
If you are a girl , and have started to have periods, the study doctor or nurse may test your
urine to make sure you are not pregnant. The doctor or nurse will tell you if the test results
show you are pregnant . Depending on the laws of your area, the study doctor or nurse may
also tell your parent(s) or your guardian(s) about the results of the pregnancy test.
If you are a girl or boy who is sexually active, you must use birth control during the study and
for at least 28 days after you r last vaccination. If appropriate your study doctor will talk to you
about this and explain your options.
090177e197c39a5d\Approved\Approved On: 09-Aug-2021 16:30 (GMT)
FDA-CBER-2021-5683-1076778
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)
Sponsor Consent Version Number (Study/ Country/Site) : [1/0/0] 09Aug 2021 Phase 2/3 Lower Dose Evaluation , Older Assent
PFIZER CONFIDENTIALPage 7of 8If you are pregnant, planning to become pregnant or are breast feeding a baby, you cannot
be in the study as there may be r isks to the unborn baby or nursing baby. Nobody knows
what these risks are right now.
If you think you are pregnant during the study, you must tell the study doctor immediately. If
you become pregnant, you will have to leave the study. The study doctor ma y ask for
information about the pregnancy and the birth of the baby. The study doctor may share this
information with others who are working on this study.
If you are a boy ,and you think that you may have gotten a girl pregnant while you are in the
study , you must tell your study doctor immediately. The study doctor may ask for information
about the pregnancy and the birth of the baby. The study doctor may share this information
with others who are working on this study.
WHAT OTHER OPTIONS ARE THERE?
This study is for research purposes only. Your alternative is to not take part in this study.
Participation is voluntary and you do not have to be in the study if you don’t w ant to.
It is your choice if you want to to be in this study or not. No one will be mad if you choose not
to take part.
If you leave the study, you may be asked to come in for one last visit.
WHAT IF I HAVE QUESTIONS ?
You can ask questions about the study any time. You can call the study doctor any time. If
you want to ask questions about what it means to be in a research study, you or parent(s) or
your guardian(s) can call [insert IRB/IEC name] (a group of people who review the study to
protect your rights) at [insert IRB/IEC number].
For you to be in this study, you and your parent (s) or your guardian(s) must agree to you
being in it. But it is still up to you if you want to do it.
Please check one box below to show whether or not you want to be in this study.
Yes, I want to bein this study.
No, I do not want to be in this study.
______________________________________________________
Printed Name of Child/Young Person
_______________________________ ____________________ __________
Child/Young Person Signature Date Time
090177e197c39a5d\Approved\Approved On: 09-Aug-2021 16:30 (GMT)
FDA-CBER-2021-5683-1076779
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)
Sponsor Consent Version Number (Study/ Country/Site) : [1/0/0] 09Aug 2021 Phase 2/3 Lower Dose Evaluation , Older Assent
PFIZER CONFIDENTIALPage 8of 8Statement of person conducting assent discussion:
1.I have explained all aspects of the research to the participant to the best of his or her
ability to understand.
2.I have answered all questions of the participant relating to this research.
3.I believe 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 resea rch.
Printed Name of Person Obtaining Assent: ____________________________
Signature of Person Obtaining Assent: _________________ Date: ________ Time: ______
090177e197c39a5d\Approved\Approved On: 09-Aug-2021 16:30 (GMT)
FDA-CBER-2021-5683-1076780