Document text
CT05 -GSOP -RF05 7.0 Phase 1/2/3/4 Informed Consent
Pediatric Study Template (01 -Jul-2019)
TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version Number (Study /Country/Site) : [1/0/0]
Phase 2/3 Obtaining Serum Samples for Potential Troponin I Testing (allage groups) 13 Sep
2021
Protocol No. C4591007/PFIZER CONFIDENTIALPage:
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We 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
already 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.
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CT05 -GSOP -RF05 7.0 Phase 1/2/3/4 Informed Consent
Pediatric Study Template (01- Jul-2019)
TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version Number (Study /Country/Site) : [1/0/0]
Phase 2/3 Obtaining Serum Samples for Potential Troponin I Testing (allage groups) 13 Sep
2021
Protocol No. C4591007/PFIZER CONFIDENTIALPage:
2of 7
WHA T HA PPEN S IN THE STUDY?
The World 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 parts . The study will only
progress if the data collected suggests it is safe to do so.
Higher levels of a protein, called troponin I, found in the blood could be an early sign of
twocondition sthat affect the heart called myocarditis or pericarditis . If confirmed to be a
reliable sign of potential myocarditis or pericarditis, testing for this protein will be done to
help describe how often this may occur.
Phase 2/3 Obtaining Serum Samples for Pote ntial Troponin I Testing. This is the part
that you are being asked to participate in. This part will be carried out in 2 age groups in
order to collect blood samples for potential troponin I testing. The younger age group (5
to <12 years of age) will be p lacebo -controlled meaning you will receive either active
vaccine or placebo. The older age group (12 to <16 years of age) will be open -label
meaning everyone will receive active vaccine. The children and adolescents in this part
of the study will be:
12 to less than 16 years age, and
5 to less than 12 years of age.
Other parts of the study:
Phase 1 Dose Finding. Please note that this part of the study has been completed .
There were 3 age groups and the study look edat 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 1 Lower Dose Evaluation . This part will be carried out in 3 age groups and will
look at up to 2 do se levels. The age groups in this part of the study will be:
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.
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FDA-CBER-2021-5683-1077774
CT05 -GSOP -RF05 7.0 Phase 1/2/3/4 Informed Consent
Pediatric Study Template (01- Jul-2019)
TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version Number (Study /Country/Site) : [1/0/0]
Phase 2/3 Obtaining Serum Samples for Potential Troponin I Testing (allage groups) 13 Sep
2021
Protocol No. C4591007/PFIZER CONFIDENTIALPage:
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Phase 2/3 Selected Dose. In this partwe will use adose level selected from the Phase
1 Dose Finding 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, everyone will receive either active vaccine o r
placebo . The children in this part 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.
Phase 2/3 Lower Dose Evaluation. In this step of the study we will use a dose level
selected from the Phase 1 part of the study. This step of the study will collect
information from a larger number 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,
everyone will receive active vaccine. The age groups in this part of the study will be:
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.
Everyone will be in this research study for about 6months.
Study Vaccines
Once the study doctor has confirmed that you meet the study requirements, you will be
assigned your study vaccine.
If you areare between 5 and 11years old, once the study doctor has confirmed you
meet the study requirements, you will be randomly assigned (like flipping a coin) to
receive the active study vaccine or placebo (dummy) . For every 2 volunteers who
receive the study vaccine , 1 volunteer will receive placebo. No one (including you, your
Mom/Dad/guardian, or your doctor ) can choose which option you get. If you do not
receive the study vaccine you will have the opportunity to get it later in the study if you
and your parents want to.
This part of the study is a ‘placebo -controlled obs erver -blinded phase’ which means that
you, your parents and the study doctor will not know whether youwill be receiving the
study vaccine or placebo. The person who gives youthe injection will know because the
study vaccine and placebo do not look the sa me. The syringe will be covered with a
label so the contents are not visible and the person that gives you the injection will not
be able to talk about it. In case of urgent need, the study doctor can learn quickly
whether you received study vaccine or pla cebo.
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CT05 -GSOP -RF05 7.0 Phase 1/2/3/4 Informed Consent
Pediatric Study Template (01- Jul-2019)
TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version Number (Study /Country/Site) : [1/0/0]
Phase 2/3 Obtaining Serum Samples for Potential Troponin I Testing (allage groups) 13 Sep
2021
Protocol No. C4591007/PFIZER CONFIDENTIALPage:
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If you are between 12 and 15yearsold, once the study doctor has confirmed that they
meet the study requirements, you will receive active study vaccine.
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 2visits. The amount of blood taken at each visit
willbe about 5 mL (1 teaspoon).
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.
You or y our Mom/Dad/guardian will have to answer some questions about you on a
smart phone/ APP (ca lled 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.
There 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 shows you when
these visits will take place and what will happen .
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FDA-CBER-2021-5683-1077776
CT05 -GSOP -RF05 7.0 Phase 1/2/3/4 Informed Consent
Pediatric Study Template (01- Jul-2019)
TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version Number (Study /Country/Site) : [1/0/0]
Phase 2/3 Obtaining Serum Samples for Potential Troponin I Testing (allage groups) 13 Sep
2021
Protocol No. C4591007/PFIZER CONFIDENTIALPage:
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For the participants taking part in Phase 2/3 Obtainin g Serum Samples for Potential
Troponin I Testing , the study doctor or nurse will perform following assessment and
procedures:
Summary of Planned Study Visits and Procedures for ALL Participants up to 6-
Months After Vaccine 2:
Visit Number 301 302 303 304 305
Types of VisitClinic Clinic Clinic Telephone Telephone
Visit Description and
Visit TimingStudy
Vaccine 1Study
Vaccine 24-Day
Follow -
up Visit1-Month
Follow -up
Visit6-Month
Follow -up
Visit
Review and sign informed
consent documentX
Ask about medical histor y as
well as date of birth, sex,
race and ethnicityX
Measure pulse rate,
respirator y rate, blood
pressure ,and body
temperatureX X
Perform clinical assessment X X
If youareHIV positive, ask
for their latest CD4 counts
and HIV viral loadX X X
If youarefemale and able to
have children, youwill be
asked to provide a urine
sample for a pregnancy testX X
If needed, the study team
will discuss and confirm the
use of appropriate birth
control with youX X X X
Ask about medications you
are currently takingX X X X
Ask about any other
vaccines you have been
givenX X X X X
Check y ou meet all the
study requirementsXX
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CT05 -GSOP -RF05 7.0 Phase 1/2/3/4 Informed Consent
Pediatric Study Template (01- Jul-2019)
TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version Number (Study /Country/Site) : [1/0/0]
Phase 2/3 Obtaining Serum Samples for Potential Troponin I Testing (allage groups) 13 Sep
2021
Protocol No. C4591007/PFIZER CONFIDENTIALPage:
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Visit Number 301 302 303 304 305
Types of VisitClinic Clinic Clinic Telephone Telephone
Visit Description and
Visit TimingStudy
Vaccine 1Study
Vaccine 24-Day
Follow -
up Visit1-Month
Follow -up
Visit6-Month
Follow -up
Visit
Take a nasal swab for the
detection of virus causing
COVID -19XX
Collect blood sample
(approximately 5 mL at each
time)X X
Give vaccine injection in
your arm and observe for
30-min following injectionX X
You or your
Mom /Dad/guadian will be
shown how to use the e -
diary (or the study team will
assist you to download an
app), and at Visit 301 you
will be given a thermometer
and a caliper (measuring
device)X X
You or your
Mom /Dad/guadian will be
asked to complete a
vaccination e- diary for 7
days to record potential side
effects following each
vaccinationX X
Ask how you arefeeling X X X X X
Inform y ouand your
Mom /Dad/guadian about
which vaccine you were
given at Visit 301 and Visit
302X
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CT05 -GSOP -RF05 7.0 Phase 1/2/3/4 Informed Consent
Pediatric Study Template (01- Jul-2019)
TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version Number (Study /Country/Site) : [1/0/0]
Phase 2/3 Obtaining Serum Samples for Potential Troponin I Testing (allage groups) 13 Sep
2021
Protocol No. C4591007/PFIZER CONFIDENTIALPage:
7of 7
Summary of Planned Study Visits and Procedures for Participants 5 to <12 Years
Who Originally Received Placebo a t Visit 301 and Visit 302:
Visit Number A1 B1 C1 D1
Types of Visit Clinic Clinic Telephone Telephone
Visit Description and Visit TimingStudy
Vaccine
3Study
Vaccine
41-Month
Follow -up
Visit after
Vaccine 46-Month
Follow -up
Visit after
Vaccine 4
Inform y ou and your Mom /Dad/guadian that
you originally received placeboX
Measure pulse rate, respiratory rate, blood
pressure , and body temperatureX X
Perform clinical assessment X X
If youareHIV positive, ask for their latest
CD4 counts and HIV viral loadX X X
If youarefemale and able to have children,
youwill be asked to provide a urine sample
for a pregnancy testX X
If needed, the study team will discuss and
confirm the use of appropriate birth control
with youX X X
Ask about medications you are currently
takingX X X X
Take a nasal swab for the detection of virus
causing COVID -19X X
Collect blood sample (approximately 5 mL)
Blood draw is only for those who become
eligible for receipt of BNT162b2 (study
vaccine) or another COVID -19 vaccine
according to local or national
recommendations prior to Visit 303 .X
Give vaccine injection in your arm and
observe for 30 -min followi ng injectionX X
Ask how you arefeeling X X X X
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PFIZER CONFIDENTIALPage 8of 10WHAT 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.
Whenyou 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 face, or lips. Other allergic reactions may include rash, hives or itching.
You might also feel u nwell 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 you feel
sick.
DO I NEED TO USE BIRTH CONTROL?
If you are a girl , and have started to have per iods, 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) o r 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.
If you are pregnant, planning to become pregnant or are breast feeding a baby, you cannot
be in the study as there may be risks 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 may ask for
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PFIZER CONFIDENTIALPage 9of 10information about the pregnancy and the birth of the baby. The study doctor may sh are 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
abou t 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 fo r 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
Statement 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
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PFIZER CONFIDENTIALPage 10of 10participant’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 Name of Person Obtaining Assent: ____________________________
Signature of Per son Obtaining Assent: _________________ Date: ________ Time: ______
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