Document text
CT05 -GSOP -RF05
7.0PHA SE 1/2/3INFORMED CONSENT
PEDIA TRIC STUDY TEMPLA TE01-Jul-2019
Protocol Number: C4591007ICD Version Date : 10 Sep 2021
Phase 2/3 Obtaining Serum Samples for Potential
Troponin I Testing
Study
Country
SiteLanguage: English Center ID: N/A Country: N/A
ICD Derived From: N/A
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]
Ph2/3 Obtaining Serum Samples for Potential Troponin I Testing (all age groups) 13Sep2021
Protocol No. C4591007/PFIZER CONFIDENTIALIntro
Page:
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Dear Sir or Madam,
Thank you for taking the time to consider permitting your child to join this study. W e
understand that this may be a difficult decision. This consent document can help you
make your decision by explaining what youand your child can expect to happen
during this study , also known as a clinical trial or a research study.
Yourchild’s participation in this study is completely voluntary (yo ur choice) .You can
take as long as you need to make your decision. You can also choose to allow your
child to take part in the study now and have the option to change your mind later at any
time. Please keep in mind that even if you allow your child to participate, it is possible
thatyour child may not meet the study’s entry requirements.
Depending on your child’s age, mental status and local laws, the study tea m may need
to verify your child’s agreement ( called “assent”) to participate in this study .
We encourage you and your child to have conversations with family , caregivers,
doctors, and the study team about taking part in this study and whether it is the right
decision for your child . The study team will work with you and your child to answer a ll
questions that you or your child may have about the study. The study team includes the
study doctor, nurses, and other personnel who work with the study doctor.
If you choose to permit your child to participate in this study, you w ill be asked to sign
and date this consent document prior to the study to let the study team know your
decision.
You will receive a copy of this signed and dated consent document for your records.
Please keep this consent document for your reference.
We appreciate that you are thinking of permitting your child to takepart in this study.
Sincerely,
___________________
Study Doctor
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CONSENT TO TAKE PA RT IN STUDY
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) 13Sep
2021
Protocol No. C4591007/PFIZER CONFIDENTIALPage:
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Table of Contents
This Table of Contents describes the different sections of this consent document. Be
sure to read through all sections of this consent document before making your decision
about whether or not to participate in this study.
Section Page
1. Key study information and contact information 3
2. Brief summary of this study 4
3. What is the purpose of this study? 6
4. How long will my child participate in this study? 8
5. How many children will take part in this study? 8
6. What will happen during this study? 9
7. Are there any special instructions to follow for this study? 17
8. What are the possible risks and discomforts of this study? 17
9. What are the possible benefits of this study? 21
10.What other choices do I have if I do not want my child to join this
study?21
11. What happens if my child is injured during this study? 21
12. What if my child joinsthis study and then changes his/her m ind? 21
13. What will I have to pay for if my child takespart in this study? 22
14. Will my child be paid for taking part in this study? 22
15. What will happen to my child’s personal information? 22
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CONSENT TO TAKE PA RT IN STUDY
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) 13Sep
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16. Where can I find additional information about this study or the
study results?22
17. Signatures 23
Privacy Supplement
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CONSENT TO TAKE PA RT IN STUDY
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) 13Sep
2021
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1. Key Study Information and Contact Information
The study team will address anyquestions, concerns or complaints you or your child
may have before, during and after you rchild complete sthe study. The study team
includes the study doctor, nurses, and other personnel who work with the study doctor.
Phone numbers for the study team are listed below under “Study Site Contact
Information.” You willbe given a card with important emergency contact
information, including a 24 -hour number. Please s how this card to any doctor, nurse
or other health care provider if you seek emergency care for your child while they are
taking part in this study. This card includes information about the study that will help
them treat you r child .
If you have any general questions about your child’s rights as a study partici pant, or
would like to obtain information from, offer suggestions to, or speak with someone not
directly involved in the study, you may contact [For the site -level ICD , include as
appropriate: the Institutional Review Board orthe Independent Ethics Committee,
patient rights advocate, and/or bioethicist ]listed below.
Name of Study: A Phase 1, Open -Label Dose -Finding S tudy to Evaluate Safety ,
Tolerability , and Immunogen icity and A Phase 2/3 Placebo -Controlled, Observer -
Blinded Safety , Tolerability , and I mmunogen icity Study of a SARS -CoV-2 RNA
Vaccine Candidate Against COVID -19 in Healthy Children and Young A dults
Sponsor Consent Version Number (Study/Country/Site): 01/ 00 /00
[Institution] Study Number:
Sponsor Study Number: C4591007
Name of Company Sponsoring the Study: BioNTech. S tudy conducted by Pfizer
Name of Principal Investigator (Study Doctor):
Study Site Contact Information:
Contact Person:
Address:
Phone Number (Normal Business Hours):
Phone Number (Off -Hours or Emergency):
[Complete the following entries for the site- level ICD as appropriate. ]
[Institutional Review Board orIndependent Ethics Committee ]Contact
Information:
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CONSENT TO TAKE PA RT IN STUDY
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) 13Sep
2021
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Contact Person:
Address:
Phone Number:
Patient Rights A dvocate:
Contact Person:
Address:
Phone Number:
Bioethicist:
Contact Person:
Address:
Phone Number:
2. Brief Summary of this Study
This is a research study involving both Pfizer and BioNTech. Pfizer and BioNTech are
separate companies who are cooperating to perform this study. Pfizer is responsible for
conducting this study. BioNTech is the regulatory sponsor of this study. Funding for this
study is provided by BioN Tech and Pfizer and [study doctor/institution] will be paid to
conduct this study.
This study is different from your child’s regular medical care. The purpose of regular
medical care is to improve or otherwi se manage your child’s health, but the purpose of
research is to gather information to advance science and medicine and does not replace
your child’s regular medical care. If your child needs medical care during their time in the
study, you should contact your regular provider andinform the study team, as described
later in this document.
A new respiratory disease appeared in W uhan, China in December 2019, and has since
rapidly spread to many other countries around the world. In January 2020, the cause of
this disease was found to be a new Coronavirus; and the disease it causes was named
COVID -19 (Coronavirus disease 2019). Since then, many companies around the w orld
have quickly started to look for treatments and ways to prevent COVID -19. Children have
been affected by primary COVID -19 disease and develop fever and dry cough over half
the time. Symptoms also can include GI(Gastrointestinal) symptoms, including diarrhea
and vomiting, and in some cases can be the only presenting features . In addition, childr en
have also been affected by less common secondary inflammatory complications,
including MIS -C (Multi-Inflammatory Syndrome -Children). MIS -C is a condition with fever
and inflammation which can involve different organs of the body including heart, lungs,
kidneys, brain, skin, eyes or gastrointestinal organs. It is currently not know nwhat causes
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CONSENT TO TAKE PA RT IN STUDY
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) 13Sep
2021
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MIS-C, howe ver, many children with MIS-C had COVID- 19 or were exposed to COVID-
19.
Vaccines help thebody to produce antibodies to help fight off a disease. This research
study involves an investigational (not approved by health authorities in children of the age
being asked to volunteer for this study) vaccine to prevent COVID -19, that will be given
to volunteers. The vaccine is given by injection in 2 doses .
These vaccines do not contain the whole virus, or the part of the virus that can make your
child ill, inste ad the vaccines are made up of part of the virus’s genetic code, surrounded
by fatty particles called lipids. They use your child’s cells’ protein making machinery to
produce some, or all, of the spike protein seen on the outside of the virus. This spike
protein, made by your child’s body, may help your child’s body to produce antibodies to
fight against COVID -19. W e will check the level of antibodies you r child make sby taking
blood samples and testing them.
Up until June2021, the safety of BNT162b2 has been studied in clinical trials that have
included about 28,500 people who have received at least one dose of the vaccine. In
addition, since the vaccine has been approved for emergency use or received a
conditional marketing in many countries, by the end of April 2021 about 400million doses
have been distributed. BNT162b2 was approved by the FDA on 23 August 2021 to
prevent coronavirus disease 2019 (COVID -19) caused by severe acute respiratory
syndrome coronavirus 2 (SARS -CoV-2) in individuals 16 years of age and older .Based
on available data, the following risks have been determined to be caused by BNT162b2
vaccine: Injection site pain, injection site swelling, fatigue (tiredness), increased body
temperature (fever), chills, headache , diarrhea , joint aches, muscle aches, feeling sick
(nausea) , being sick (vomiting) , injection site redness, enlarged lymph glands, allergic
reaction (symptoms may include rash, itching, hives, and swelling of the face or lips),
decreased appetite , lethargy , sweating and night sweats , pain in arm, feeling weak or
unwell, and severe allergic reaction (anaphylaxis) .
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CONSENT TO TAKE PA RT IN STUDY
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) 13Sep
2021
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Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining
outside the heart) have occurred in some people who have received BNT162b2 . Cases
have mainly been reported in males under 30 years of age and following the second
vaccination. Symptoms include: Chest pain, shortness of breath, or feelings of having a
fast-beating, fluttering or pounding heart. As aprecaution, you should seek medical
attention right away if your child hasany of those symptoms after receiving the vaccine.
The chance of having this occur is very low.
Although not seen to date, it cannot yet be ruled out that the study vaccine could make a
later COVID -19 illness more severe .
Allowing your child to take part in this study is voluntary (your and your child’s choice).
There is no penalty or change to you/your child or your child’s regular medical care if you
decide not to allow your child to participate. You can choose to allow your child to take
part in the study now, and then change your mind later at any time without losing any
benefits or medical care to which you or your child are entitled. We encourage you and
your child to have conversations with your family, caregivers, doctors, and study team
about taking part in this study and whether it is right for your child. The study team will
work with you and your child to answer any questions that you and your child may have
about the study.
You will receive a copy of this signed and dated consent document for your records.
Please keep this consent document for your refe rence.
You are being asked to allow your child to take part in a research study that will evaluate
whether the investigational (study) vaccine to prevent COVID -19 is safe, tolerable and
produces immune response to the virus causing COVID -19. Th is vaccine is given by an
injection. You are being asked to allow your child to be in this research study because
your child is healthy and meets the age requirement for this study.
Depending on your child’s age, mental status and local laws, the study team may need
to verify your child’s agreement (called “assent”) to participate in this study . Your
child may give assent verbally, or they may be asked to print or sign their name on an
assent document similar to this consent document. They may have an opportunity to meet
privately with a member of the study team to ask confidential questions. Yourchild will
also be able to decide not to take part for confidential reasons, which, if they request,
would not be shared with you unless required by local law.
3. What is the p urpose of this 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 investiga tional vaccine as quickly as
possible, this study will be conducted in several parts , which are described below.
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CONSENT TO TAKE PA RT IN STUDY
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) 13Sep
2021
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Higher levels of a particular protein, called troponin I, found in the blood could be an early
sign of myocarditis or pericarditis. Additional work is being undertaken to understand if a
blood testfor troponin Ican beused as asign of potential myocarditis or pericarditis .
Blood samples will be drawn for possible troponin I testing in an additional group of
participants, and if confirmed to be a reliable sign of potential myocarditis or pericarditis,
testing for this heart enzyme will bedone to help describe how often this may occur.
Phase 2/3 Obtaining Serum Samples for Potential Troponin I Testing .This is the
part that you are being asked to allo w your child to participate in. This part will be
carried out in 2age groups in order to collect blood samples for potential troponin I
testing . The younger age group (5 to <12 years of age) will be placebo -controlled
meaning the children will receive either active vaccine or placebo . The dose level for
this age group is the same dose that is currently being tested in our ongoing Phase 2/3
study (10 mcg). The older age group ( 12 to <16 years of age) will be open -label meaning
every onewill receive active vaccine . The dose level for this age group is t he same dose
level currently EUA approved for this age group (30mcg) . 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.
If your child is 5 to <12 years of age, at approximately 6 months following the 2 nd
injection, you and your child will be informed by the study team whether y our child
was given the placebo injection or the active investigational COVID -19 vaccine at
Visit 301 and Visit 302. If your child originally received placebo, your child will be
offered the COVID -19 investigation al vaccine.
If your child becomes eligible for a COVID -19 vaccine according to local or
national recommendations before they are unblinded y our study doctor w ill
explain y our options.
If your child turns 12 years of age, before 6 months following the 2nd injection,
and was given placebo at Visit 301 and Visit 302, he or she has the following 2
options: receive a BNT162b2 10 -µg dose within the study (following provision of
informed consent) or receive a BNT162b2 30 -µg dose outside of the study .
Please note, in May 2021 the U.S. Food and Drug A dministration (FDA ) that
regulates vaccines issued an emergency use authorization (EUA) that allows
individuals 12 through 15 y ears of age to receive BNT162b2 at 30- µg. An EUA is
issued by the FDA to provide quick access to medical products, such as
vaccines, that can be used when there are no other adequate, approved or
available options during a public health emergency .
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CONSENT TO TAKE PA RT IN STUDY
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) 13Sep
2021
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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 andthe 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 1 Lower Dose Evaluation . This partwill be carried out in 3 age groups and will
look at up to 2 dose levels. The age groups in this part 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 .
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 or
placebo . The children in this partof 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 th an 16 years of age , and
5 to less than 12 years of age .
4. How long w ill my child participate in this study ?
Your child will be in this study for about 6 months.
5. How many children will take part in this study ?
The total number of children taking part in the whole study will depend on the results
seen during the study. It is expected thatapproximately 1250 children will take part in
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CONSENT TO TAKE PA RT IN STUDY
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) 13Sep
2021
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thePhase 2/3 Obtaining Serum Samples for Potential Troponin I Testing part of the
study.
This study will use competitive enrollment. This means that when a certain number of
people have enrolled in the study from all study sites combined, no one else will be
allowed to participate. So, it is possible that you may not be allowed to join the study.
6. What w ill happen during this study ?
Before any study procedures begin, or before you begin preparing your child for the study,
youwill be asked to read and sign this consent document. Depending on local law and
your child’s age, your child’s permission may be required for the study team to share
some of their test results w ith you.
After signing and dating this consent document, the study doctor will check if your child
meet sall the requirements to take part in this study. If your child does not meet the
requirements, they will not be able to take part in the study and the study doctor will
explain why this is the case. Similarly, i f your child qualif iesto take part in this study, the
study doctor will explain this as well.
Study Vaccines
If your child is 5 to <12 years of age, once the study doctor has confirmed that they meet
the study requirements, your child will be randomly assigned (like flipping a coin) to
receive the study vaccine or placebo. For every 2 volunteers who receive the
investigational COVID -19 vaccine, 1 volunteer will receive placebo. No one (including
you, your child, your child’s personal doctor or the study team) can choose this
assignment.
This partof the study is a ‘placebo -controlled observer -blind edphase’ which means that
you, your child and the study doctor will notknow whether your child will be receiving
the investigational COVID -19 vaccine or placebo. The person who gives your child the
injection will know because the investigational COVID -19 vaccine and placebo do not look
the same. The syringe will be covered with a label so the contents are not visible and the
person that gives your child the injection will not be able to talk about it. In case of urgent
need, the study doctor can learn quickly whether your child received study vaccine or
placebo.
If your child is 12 to <16 years of age, once the study doctor has confirmed that they meet
the study requirements, your child will receive active study vaccine.
The vaccine will be given to your child through an injection into the muscle in their upper
arm. Each participa nt will receive twoinjections, approximately three weeks apart. On the
days your child receive sthe injection, you will be asked to wait with your child at the study
site for at least 30 minutes for observation after they receiv einjection .
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CONSENT TO TAKE PA RT IN STUDY
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]
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Study Vaccines –after participating in the study for approximately 6 months after
receiving second injection
If your child is 5 to <12 years of age, when you and your child come for your child’s visit
at approximately 6-months after their second injection, you and your child will be told if
your child was given the investigational COVID -19 vaccine (BNT162b2) or placebo
injection .
If your child was given the investigational COVID -19 vaccine as their injection 1 and 2,
your child will not need any further injection sin the study.
If your child was given the placebo injection as their injection 1 and 2, they will be offered
two doses of active vaccine. Thefirst dose of investigational COVID -19 vaccine(active)
will be given as a third injection. Approximately 3 weeks later, your child will be given a
4thinjection which is the second dose of the investigational COVID -19 vaccine. For this
part, the study will be ‘unblinded’, meaning that you, your child and your doctor will know
that your child is getting the investigational COVID -19 vaccine.
Overview ofStudy Procedures and A ssessments
The table below lists the tests and procedures or assessments that your child will have
done at each of their visits during this phase of the study . You will have the following tests,
procedures or assessments during this study. In addition to the visits listed, your child’s
study doctor may ask you tobring your child in for extra visit(s)if necessary ,to protect
your child's well-being. It is important that your child and you attend each visit on the day
that your research study team arranges for your child .
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CONSENT TO TAKE PA RT IN STUDY
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]
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2021
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For the participants taking part in Phase 2/3Obtaining Serum Samples for Potential Troponin I Testing , the study
doctor or nurse will perform the 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 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 clinical assessment X X
If your child is HIV positive, ask for their latest
CD4 counts and HIV viral loadX X X
If your child is a female and if able to have
children, she will 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
your childX X X X
Ask about medications your child is currently
takingX X X X
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CONSENT TO TAKE PA RT IN STUDY
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]
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2021
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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
Ask about any other vaccines your child has
been givenX X X X X
Check y our child meets all the study
requirementsX
X
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 child’s arm and
observe for 30 -min following injectionX X
You will be shown/reminded 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 will be asked to complete a vaccination e-
diary for 7 days to record potential side effects
following each vaccinationX X
Ask how your child is feeling or if your child is
having any potential side effectsX X X X X
Inform y ou and your child about which vaccine
your child was given at Visit 301 and Visit 302X
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CONSENT TO TAKE PA RT IN STUDY
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]
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2021
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Summary of Planned study Visits and Procedures for Participants 5 to <12 y ears who originally received Placebo
at 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 child that your child originally received
placeboX
Measure pulse rate, respiratory rate, blood pressure , and body
temperatureX X
Perform clinical assessment X X
If your child is HIV positive, ask for their latest CD4 counts and
HIV viral loadX X X
If your child is a female and if able to have children, she will 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 your childX X X
Ask about medications your child is currently taking X X X X
Take a nasal swab for the detection of virus causing COVID -19 X X
Collect blood sample (approximately 5 mL)
Blood draw is only for participants who become eligible for receipt
of BNT162b2 or another COVID -19 vaccine according to local or
national recommendations prior to Visit 303 .X
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CONSENT TO TAKE PA RT IN STUDY
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]
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2021
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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
Give investigational COVID -19 vaccine injection in your child’s
arm and observe for 30 -min following injectionX X
Ask how your child is feeling or if your child is having any
potential side effectsX X X X
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CONSENT TO TAKE PA RT IN STUDY
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) 13Sep
2021
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6. Description of Study Procedures and Assessments
Biological Samples
The following blood and nasal biological samples will be taken in this study . Your child
must provide these samples in order to take part in this study. The samples may be stored
in a facility located in a different country from your study site.
Your child’s blood and nasal samples will be used only for scientific research. Each
sample will be labeled with a code so that the laboratory workers testing the samples will
not know who your child is. Some of the samples may be stored for future testing and
may be kept for up to 15 years after the study ends, at which time they will be destroyed.
In addition to testing for this study , any samples left over after the study is complete may
be used for additional research related to the development of product s. No testing of your
child’s DNA will be performed.
You may request that your child’s samples , if they can be identified, be destroyed at any
time. Any data already collected from those samples will still be used for the study. The
samples will remain the property of BioNTech/ Pfizer and may be shared with other
researchers as long as confidentiali ty is maintained . Notesting of your child’s DNA will
be performed. You and your child will not be told of additional tests, nor will youor your
child receive results of any of these tests except for nasal swab test results which will be
communicated to y our child’s study team doctor ad described later in this section .
Blood Samples for antibody testing :
All participants will have a blood sample taken at the following 2 planned visits : Visit 301
and V isit 303.
Each blood sample will be approximately 5 mLand will be collected using a needle.
Your child’s blood samples may be used to test for troponin I levels .
Nasal Swabs for detection of coronavirus causing COVID -19:
Your child will have nasal swab collected from his/her nose 2 times during the planned
study visits. A swab (which looks like a Q -tip) will be inserted into your child’s nose to
collect any fluid or mucus. These samples will be tested to detect the presence of
coronavirus causing COVID -19. Results of nasal swabs at Visit 301 and Vis it 302 (and
Visit A1 and Visit B1 if your child originally received placebo and goes on to receive
investigational COVID- 19 vaccine )will be provided to your study doctor, however, this
will take some time so you should not rely on this information for you r child’s medical
treatment.
Urine Samples:
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CONSENT TO TAKE PA RT IN STUDY
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) 13Sep
2021
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If yourchild is female who is able to have children in the opinion of study doctor, your
child will need to provide a urine sample for pregnancy testing to check she is not
pregnant before she is given the study vaccine injection. If your child has a positive urine
pregnancy test result , the study doctor will share the information with you and your child
will not be able to participa tein the study.
E-Diary :
At Visit 301,the study team will explain what you need to do and show you how to fill in
an electronic diary (or e-diary). As a parent(s)/legal guardian(s), as appropriate, you will
be required to complete the e -diary for your child. W e will either give you a device ( like a
mobile phone) or ask you to download an application (app) to your smart phone if you
have one. The device/app is secure, and your child’s confidentiality will be maintained.
You will also be given a thermometer and a measuring device (caliper).
The e-diary will prompt you to answer questions about how your child is feeling after
receiving the injection . At the Visit 301 and Visit 302, you will be instructed by the study
team to complete the e- diary every evening for 7 days after each injection isgiven to your
child. Day 1 of the e-diary completi onwill begin on the evening your child receives the
injection and thefollowing next 6 days (7 days in total). You will use the thermometer to
measure your child’s temperature .This temperature measuremen t will be oral (under
his/her tongue). You will then enter the temperature reading into the e-diary. The
measuring device will be used to measure the size of any redness or swelling on your
child’s arm where the injection was given. You will need to enter these measurements in
thee-diary. It is important that all of the requested information is entered in the e -diary.
Thee-diary will also ask other questions about potential side effects your child may have
after the injection. If your child has any seve re symptoms after vaccination, you should
contact your child’s study doctor and the study doctor or nurse may schedule an extra
unplanned visit to evaluate your child.
What happens if my child is participating and has a positive nose swab test result
after Visit 301 or Visit A1(if your child originally received placebo and goes on to
receive investigational COVID -19 vaccine at Visit A and B) but before the next
planned injection visit?
If your child has any potential COVID- 19/MIS-Csymptoms with a positive nose swab test
result after the Visit 301or Visit A1 (if your child received placebo) , your child’s study
team may need to delay the planned injection until your child becomes well.
If your child has a positive nose swab test result after Visit 301,without the presence of
anypotential COVID -19/MIS-Crelated symptoms, your child will be given theinjection as
planned in the study .
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CONSENT TO TAKE PA RT IN STUDY
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) 13Sep
2021
Protocol No. C4591007/PFIZER CONFIDENTIALPage:
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Leaving the Study Early
You or your child, may withdraw from the study at any time at your own request ,or your
child may be withdrawn at any time at the discretion of the investigator for safety,
behavioral, compliance, or administrative reasons. If you or your child decide to leave the
study, you/your child w illbe asked why you would like to withdraw.
After the study
The study vaccine is available only during this study and not after the study is over.
7. Are there any special instructions to follow for this study ?
It is important that you and your child follow all the instructions given to you by the study
nurse or study doctor and tell them if :
You or your child do notunderstand anything about the study
You or your child willnot be able to comply with the study requirements
There are changes in your child’s health
Your e- diary device or APP is not working properly
Your child takes any new medications or receive sany other vaccines
You or your child are going away for a long period
Your child wishes to take part in another research stud y
Your child previously took part in this study , have been in any other study in the
past 28 days, or iscurrently involved in any other study
Notify the study team if you /your child move sand provide your /your child’s new
contact information.
8. What are the possible risks and discomforts of this study ?
Any research has some risks, which may include negative effects that could make your
child unwell or uncomfortable and even potentially be serious or life-threatening. All
research participants taking part in the study will be watched carefully for any negative
effects; however, the study team does not know all the effects that the study vaccine may
have on your child.
If your child takes part in this study, the most likely risks or discomforts are discusse d
below.
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CONSENT TO TAKE PA RT IN STUDY
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]
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2021
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It is important that you/your child report to the study team all sy mptoms and side
effects as soon as they occur. Phone numbers for the study team are listed in
[Section 1] of this consent document.
Up until June 2021 , the safety of BNT162b2 has been studied in clinical trials that have
included about 28,500 people who have received at least one dose of the vaccine. In
addition, since the vaccine has been approved for emergency use or received a
conditional marketing a uthorization in many countries, by the end of April 2021 about 400
million doses have been distributed.
Based on the clinical study results, and information gathered during general use, the
following risks have been determined to be caused by BNT162b2 vaccine:
Very common (occurring in more than 1 in 10 people): injection site pain, injection site
swelling, fatigue (tiredness), increased body temperature (fever, more common after the
second dose), chills, headache , diarrhea , joint aches, and muscle ache s.
Common (between 1 in 10 and 1 in 100 people): feeling sick (nausea) , being sick
(vomiting) , and injection site redness.
Uncommon (between 1 in 100 and 1 in 1,000 people): enlarged lymph glands, allergic
reactions (symptoms may include rash, itching, hives), decreased appetite, lethargy,
sweating and night sweats, pain in arm, and feeling weak or unwell.
Rare (between 1 in 1,000 and 1 in 10,000 people): swelling of the face or lips.
Frequency that cannot be estimated from available data: severe allergic reaction
(anaphylaxis).
Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining
outside the heart) have occurred in some people who have received BNT162b2. Cases
have mainly been reported in males under 30 years of age and following the second
vaccination, however, there have been some cases reported in older males and females
as well as following the first vaccination. The chance of having this occur is very low and ,
inmost of these people, symptoms began within a few days to a week following
vaccination . As a precaution, you should seek medical attention right away if your child
has any of the following symptoms after receiving the vaccine:
Chest pain
Shortness of breat h
Feelings of having a fast -beating, fluttering, or pounding heart
Please also notify study staff, when appropriate, if your child has any of these
symptoms as your child may need to come in for an assessment .
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CONSENT TO TAKE PA RT IN STUDY
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) 13Sep
2021
Protocol No. C4591007/PFIZER CONFIDENTIALPage:
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Whilst some severe cases have been reported, most cases have been associated with
full resolution of symptoms in the short term, however, long -term follow -up is limited. It is
not known whether the risk of myocarditis or pericarditis is increased following additional
doses of the vaccine, e.g. follow ing a booster dose.
If your child has had myocarditis (inflammation of the heart muscle) or pericarditis
(inflammation of the lining outside the heart) previously, please tell your study
doctor.
As in all research studies, the COVID -19 vaccine may involve risks that might be expected
based on results from studies of similar vaccines, as well as risks that are currently
unknown.
Therefore, it is important that you report all symptoms and side effects that your child
experience sas soon as they occur, whether or not you think they are caused by the study
vaccine.
Due to the way in which the study vaccines are made, they cannot cause COVID -19
disease.
If my child catch esCOVID -19 disease, could the vaccine make it worse?
For some other vaccines tested in animals against similar viruses (but not the coronavirus
that causes COVID -19), there have been reports of the illness being more severe in the
animals that received the vaccine than in those that did not. So far this hasnot been seen
with BNT162b2. Itremains important for you/your child to contact your child’s study doctor
if you r child develop ssymptoms that might be caused by COVID -19 (for example, fever,
cough, shortness of breath).
Placebo Risks
As the placebo injection contains salt-water and no active ingredients, the chances of
having side effects mentioned above are less likely. In other studies, using the same
placebo injection, some people who received the placebo injection reported pain,
bruising, swelling and redness at the site of injection.
Risks from Study Procedures
Risks and possible discomforts you r child might have from the study procedures
include:
Blood Samples: The risks and possible discomforts involved in taking blood
include pain from inserting the needle, or less often, swelling, bruising, or
infection around the vein where the blood is collected. Your child may feel dizzy
or may faint. If your child has a previous history of feeling dizzy or fainting during
blood sample coll ection you should talk to the study doctor.
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CONSENT TO TAKE PA RT IN STUDY
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]
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2021
Protocol No. C4591007/PFIZER CONFIDENTIALPage:
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Nasal Swabs: The risks and possible discomfort involved in taking nasal swabs
may include pain or general discomfort. Sometimes it may cause the nose to
bleed.
Pregnancy -Related Risks; Use of Birth Control
If your child is currently pregnant, plan sto become pregnant, or isbreastfeeding a child,
sheshould not join this study. If yourchild is a male , heshould not father a baby while
taking part in this study.
Ifyour child is able to have children and is sexually active, they must use birth control
consistently and correctly for the duration of the study including and for at least 28 days
after they receive their last planned injection. This applies to male parti cipants as well as
female participants who take part in the research study. The study doctor will discuss
with your child the methods of birth control that they should use while in this research
study , if appropriate . The study doctor will help your child select the method that is
appropriate for them. The study doctor will also check that your child understands how to
use the birth control method and may review this with them at visits specified in the
Section 6in the tables describing study visits, if appropriate .
Birth control methods, even when used properly, are not perfect. If your child or their
partner becomes pregnant during the research study, or if they want to stop their required
birth control during the research study, they should tell the study doctor immediately . Your
child may be withdrawn from the research study if they stop using birth control or they
become pregnant.
If abstinence (not having sexual intercourse at all) is your child’s current lifestyle, and both
you/your child and the study doctor agree that it is your child’s selected method of
contraception, your child must continue not to have sexual intercourse forat least 28 days
after the last planned injection .
As permitted by local law, the study doctor may: (a) provide confidential contraceptive
counseling to your child (not discussed with you) and (b) help your child to assess
additional reproductive services, if needed. The study doctor will instruct you r child about
how to use their selected birth control method correctly and consistently and may review
this with you r child at visits specified in the Section 6in the tables describing study visits .
Pregnancy Follow -up
If your child or their partner become pregnant during the study , up until 28 days after your
child’s last study injection, please tell the 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. P lease also tell the
doctor who will be taking care of your child/their partner during the pregnancy that your
child took part in this study. The study doctor will ask if your child/their partner or their
pregnancy doctor is willing to provide updates on the progress of the pregnancy a nd its
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CONSENT TO TAKE PA RT IN STUDY
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) 13Sep
2021
Protocol No. C4591007/PFIZER CONFIDENTIALPage:
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outcome. If your child/their partner agree, this information will be provided to the
BioNTech /Pfizer for safety follow -up.
9. What are possible benefits of this study ?
Vaccination with BNT162b2 has been shown to be effective in preventing COVID -19 in
the people already studied who are 12 years and older .Continue to follow local
recommendations about how to avoid COVID -19 (for example, social distancing and
mask use). In addition, information learned from the research study may help other people
in the future.
10. What other choice s do I hav e if I do not want my child to join
this study ?
This study is for research purposes only. The only alternative is to not take part in this
study.
11. What happens if my child is injured during this study?
For mandatory research injury language, < click here > (retain this link in the study- level
ICD). The country -specific research injury language must be inc luded verbatim in the
country -level ICD .
12. What if my child joinsthis study and then changes his/her
mind?
You are free to withdraw your child from this research study at any time. Tell the study
doctor if you are thinking about this so that your child may end the research study in the
safest way. The research study team will also tell you if new information is learned that
could change your/your child’s mind about your child’s continu ation in this research study.
Your decision will not affect the medical care your child receives, and your child will not
lose any benefits to which he/she would otherwise be entitled .
While your child isparticipating, the study team will tell you in a timely manner if new
information is learned during the course of the study that could change your /your child’s
mind about continuing. If you decide to withdraw your child from receiving vaccine or if
your child decides to withdraw from receiving vaccine , your child may be asked to
continue to participate in the study procedures even though they would no longer take the
study vaccine .
If your child continues with the follow -up part of the study, information about your child’s
health will continue to be collected as described in [Section 6].
If you decide to stop your child participating in this study, you must notify the study doctor.
The study team will explain what other procedures or discussions should occur.
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CONSENT TO TAKE PA RT IN STUDY
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) 13Sep
2021
Protocol No. C4591007/PFIZER CONFIDENTIALPage:
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Sometimes the study doctor or BioNTech/Pfizer may decide to take you r child out of the
study (even if you do not agree) if:
•You/your child are unable or unwilling to follow the instructions of the study team;
•The study doctor decides that the study is not in your child’s best interest or that they
are no longer eligible to participate; or
• The study is stopped by the BioNTech/Pfizer , the Institutional R eview Board (IRB) or
Independent Ethics Committee (IEC) (a group of people who review the study to
protect your /your child’s rights), or by a government or regulatory agency .
The study team will give you a Privacy Supplement, which is considered part of this
consent document. It describes what happens to your/your child’s personal information
(including your child’s biological samples) and how it may be used if you withdraw your
child from the study or if your child withdraws from the study .
13. What w ill I have to pay forif my child takes part in this study ?
Youwill not ne ed to pay for thestudy vaccine, study -related procedures, or study visits.
14. Will my child be paid for taking part in this study ?
You will not receive any payment for your child taking part in this study. However, for
each visit you/your child completes, you/your child will be reimbursed by the study site to
cover reasonable expenses (for example, parking, meals, travel) that you have as a result
of your child taking part in this study. You/your child will be reimbursed by [enter, as
applicable, method of reimbursement; amounts; and reimbursement schedule; note
whether receipts are required] .]
BioNTech/Pfizer may use information resulting from the study to develop products or
processes from which it may make a profit. There are no plans to pay you/your childor
provide you with any products developed from this study. BioNTech/Pfizer will own all
products or processes that are developed using information from the study.
15. What w ill happen to my child’s personal information?
<Click here > for language to be inserted into this section. T his text must be inserted
verbatim . Any requested ch anges must be approved by Clinical Development Legal. Note
that t he Privacy Supplement follows this consent document, after the signature section.
16. Where can I find additional information about this study or the
study results?
A description of this clinical trial will be available onhttp://www.ClinicalTrials.gov , as
required by U.S. Law. This Web site will not include information that can identify your
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CONSENT TO TAKE PA RT IN STUDY
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) 13Sep
2021
Protocol No. C4591007/PFIZER CONFIDENTIALPage:
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child. At most, the Web site will include a summary of the results. You can search this
Web site at any time.
The study results, when available, may also be found onwww.pfizer.com and
https://www.clinicaltrialsregister.eu/ .
In addition, a plain summary of the study results will be made available in the EU database
at [insert link to the database] . This information will be provided no matter what the study’s
outcome. To the extent possib le, you will be able to access these summaries in the EU
database soon after they become available using the following EU trial number for the
study: [insert trial number] .
These websites arein English only. If you need assistance understanding these Web
sites, please ask a member of thestudy team .
BioNTech/Pfizer will provide the study doctor with information about the study results
when all participants have completed the study. At that time, certain of your child’s
individual study results may be given to you or your child’s doctor (if different from the
study doctor) in accordance with applicable law , but will notbe given to your/your child’s
family, your employer or any insurance company .
If any exploratory research is done, it may not be possible to link any results from that
exploratory research to specific individual, including your child. BioNTech/Pfizer does not
plan to return information from any exploratory research to you/your child, the study
doctor, or your child’s doctor (if different from the study doctor).
17. Signatures
The column for subject initials in the table below may be removed if not required by the
IRB/IEC, regulatory agencies, and/or other similar reviewers.
Agreement to Participate and to Process Data Initials
1. I confirm I have read (or, if I cannot read, a study team
member has read to me) and understand this consent
document for the study described above and have had the
opportunity to ask questions. I have had enough time to
review this consent document. I also have had an opportunity
to ask about the details of the study and to decide whether or
not I want my child to participate.
2. I have read and understand the Privacy Supplement. I
understand that taking part in the study will require the
processing (including collection, use, transfer, storage,
analysis and reporting) of my child’s personal information, as
explained in the Pri vacy Supplement. I understand and agree
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CONSENT TO TAKE PA RT IN STUDY
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]
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to the processing of my child’s personal information within
and outside my country of residence for health care, medical
research and/or regulatory purposes.
3. I understand that allowing my child to take part is voluntary
and that I am free to stop my child taking part in this study or
to withdraw my consent to the processing of my child’s
personal information at any time. I do not need to give any
reason and my child’s regular medical care and legal rights
will not be affected. However, even if I withdraw my consent
to processing, my child’s personal information held at that
time may be kept to comply with laws and regulations and to
maintain the integrity of the study. I also understand that my
child’s biological samples may not be able to be destroyed
because they may no longer be traceable to m y child , may
have already been used, or may have been given to a third
party.
4. I agree to the study team accessing my child’smedical
history, including information from medical records and test
results and any medical treatment my child receive s during
the course of the study, and if necessary, contacting my
child’s doctor or any other health care providers treating my
child for access to such information.
5. I understand that BioNTech/P fizer and/or others working with
or on behalf of the BioNTech/P fizer, Institutional R eview
Boards (IRBs) or I ndependent Ethics Committees (IECs) , and
regulatory agencies may need access to personal information
about my child generated at the study site or collected by the
study team for the study and any other research. I agree that
they may have access to my child’s personal information.
6. I do not give up any of my child’s legal rights by signing and
dating this consent document. I have been told that I will
receive a copy of this signed and dated document.
7. I agree for my child to take part in the study described in this
document.
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CONSENT TO TAKE PA RT IN STUDY
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]
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2021
Protocol No. C4591007/PFIZER CONFIDENTIALPage:
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In the section below, the term “legally acceptable representative” should be replaced
with the term required per local regulation (country -level).
Signature Lines to be Included:
_________________________________________ _______
Printe d name of participant
As the consenting adult providing permission for this child to participate in the study, I
acknowledge that ( Please check oneof the following):
□ I am the biological or adoptive parent of the child.
□ I am the legal guardian or legally acceptable representative of the child.
[If neither option below is checked, then the consent of the second
parent/guardian/legally acceptable representative must be obtained . If there are two
parents/guardians/legally acceptable representatives available to give permission, and
they disagree about allowing the child to participate in the study, the child should not be
enrolled unless that disagreement can be resolved. ] Page 25of 28
I also acknowledge that ( Please check oneof the following):
□ I have sole legal responsibility for the care and custody of the child.
□ The other adult(s) with whom I share legal responsibility for the care and
custody of the child (for exa mple, biological parent, adoptive parent, or legal
guardian or representative) is (1) aware of and agrees with my granting
permission for this child to participate in the study OR(2)deceased, unknown,
incompetent, or not reasonably available (someone is “not r easonably available”
when he/she cannot be reached by phone/mail/email because, for example,
he/she is on active military duty or is incarcerated).
____________________________ ____________________
Printed name of parent/guardian/legally acceptable representative
________________________________________________ ______________
Signature of parent/ guardian/ legally acceptable representative Date of signature§
[Include the statements and signature lines below for a second parent/guardian/legally
acceptable representative if (1) required by the IRB/IEC; (2) required by local law (e.g. ,
parents are divorced and have shared custody of the child); or (3) the second
parent/guardian/legally acceptable representative is (or would like to be) involved in the
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FDA-CBER-2021-5683-1077873
CONSENT TO TAKE PA RT IN STUDY
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]
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2021
Protocol No. C4591007/PFIZER CONFIDENTIALPage:
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consent process and there is reason to believe that he/she may disagree with the
decision of the first parent/guardian/legally acceptable representative.
Consent of Second Parent/Guardian/Legally Acceptable Representative:
As the consenting adult providing permission for this child to participate in the study, I
acknowledge that ( Please check oneof the following):
□ I am the biological or adoptive parent of the chi ld.
□ I am the legal guardian or legally acceptable representative of the child.
_______________________________________________
Printed name of parent/guardian/legally acceptable representative
________________________________________________ ______________
Signature of parent/guardian/legally acceptable representative Date of signature§]
[If local IRB /IEC permits assent of older children to be obtained by co -signature, include
the following :
Participant’s A ssent:
_______________________________ ______________ _____________
Signature of participant Date of signature§]
Person Obtaining Consent:
_______________________________ ______________
Printed n ame of person conducting the consent d iscussion
_______________________________ ______________ ______________
Signature of person c onducting the consent d iscussion† Date of signature
§Parent /guardian/ legally acceptable representative must personally date their
respective signature s.
†The investigator, or an appropriately qualified and trained person designated by the
investigator to conduct the informed consent process, must sign and date the consent
document during the same discussion when the participant’s parent/guardian/legally
acceptable representative signs the consent document.
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FDA-CBER-2021-5683-1077874
PRIVA CY SUPPLEMENT
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]
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2021
Protocol No. C4591007/PFIZER CONFIDENTIALPage:
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For mandatory country -specific data privacy language to be inserted in this Privacy
Supplement, < click here > (retain this link in the study -level ICD). The country -specific
data privacy language must be includ ed verbatim in the country -level ICD. Any
requested changes must be approved by Clinical Development Legal.
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