Document text
CT05 -GSOP -RF05
7.0PHA SE [1/2/3] INFORMED CONSENT
PEDIA TRIC STUDY TEMPLA TE01-Jul-2019
Protocol Number: C4591007ICD Version Date :09Aug2021
Phase 2 /3 Lower Dose Evaluation , Parental Consent
Study
Country
SiteLanguage: 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] 09Aug 2021 Phase 2/3 Lower Dose Evaluation , Parental Consent
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. We
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 (your choice ). You can
take as long as you need to make your decision. You can also choose to allow your child
totake 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 that your
child may not meet the study’s entry requirements.
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 .]
We encourage youand your child to have conversations with family , caregivers,
doctors, and 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 all
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 youchoose to permit your child to participate in this study, you will be asked to sign
this consent document prior to the study to let the study team know your decision.
You will receive a signed copy of this 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] 09 Aug 2021 Phase 2/3 Lower Dose Evaluation, Parent al Consent
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 4
2.Brief summary of this study 5
3.What is the purpose of this study? 7
4.How long will my child participate in this study? 8
5.How many children will take part in this study? 9
6.What will happen during this study? 9
7.Are there any special instructions to follow for this study? 14
8.What are the possible risks and discomforts of this study? 14
9.What are the possible benefits of this study? 17
10.What other choices do I have if I do not want my child to join this
study?17
11. What happens if my child is injured during this study? 17
12. What if my child joinsthis study and then changes his/her m ind? 18
13. What will I have to pay for if my child takespart in this study? 18
14. Will my child be paid for taking part in this study? 18
15. What will happen to my child’s personal information? 19
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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] 09 Aug 2021 Phase 2/3 Lower Dose Evaluation, Parent al Consent
Protocol No. C4591007/PFIZER CONFIDENTIALPage:
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16. Where can I find additional information about this study or the
study results?19
17. Signatures 19
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] 09Aug 2021 Phase 2/3 Lower Dose Evaluation , Parent al Consent
Protocol No. C4591007/PFIZER CONFIDENTIALPage:
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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 yourchild complete s the 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 show 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 gene ral questions about your child’s rights as a study participant, or would
like to obtain information from, offer suggestions to, or speak with someone notdirectly
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 study to Evaluate Safety ,
Tolerability , and Immunogen icity and 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): 0 1/ 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:
Contact Person:
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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] 09Aug 2021 Phase 2/3 Lower Dose Evaluation , Parent al Consent
Protocol No. C4591007/PFIZER CONFIDENTIALPage:
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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.
A new respiratory disease appeared in W uhan, China in December 2019, and has since
rapidly spread to many other countries aroun d 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 both the primary COVID -19 disease and the 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 MIS-C, however, many children with MIS-C had COVID -
19 or were exposed to COVID- 19.
Vaccines help your body to produce antibodies to help you to fight off a disease. This
research study involves an investigational vaccine to prevent COVID -19, that will be given
to volunteers. The vaccine is given by injection. The study will also test the study va ccine
at different dose levels (amount of vaccine).
These vaccines do not contain the whole virus, or the part of the virus that can make you
ill, instead the vaccines are made up of part of the virus’s genetic code, surrounded by
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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] 09 Aug 2021 Phase 2/3 Lower Dose Evaluation, Parent al Consent
Protocol No. C4591007/PFIZER CONFIDENTIALPage:
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fatty particles called lipids. They use person’s own 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 the person’s own body, may help thebody to produce antibodies to fight
against COVID- 19. We will check the level ofantibodies your child make sby taking blood
samples and testing them.
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 authorization in many countries, by the end of April about 400
million doses have been distributed. 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 nig ht sweats, pain in arm, feeling weak or unwell, and 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. Symptoms include: Chest pain, shortness of breath, or feelings of having a
fast-beating, fluttering or pounding heart. As a precaution, 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.
You are being asked to allow your child to take part in a research study that will investigate
whether the investigational (study) vaccine to prevent COVID -19 is safe, tolerable and
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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] 09Aug 2021 Phase 2/3 Lower Dose Evaluation , Parent al Consent
Protocol No. C4591007/PFIZER CONFIDENTIALPage:
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causes immune response to the virus causing COVID -19. The vaccine is given by an
injection.
Overall, the study has twoPhases;
In Phase 1 we will study how safe the vaccine is and the immune response it
produces at different doses. We will then choose a dose level for Phase 2/3.
In Phase 2/3 we will study how safe the vaccine is and the immune response it
produces inlarger number of children and young adults.
This consent is for Phase 2/3 Lower Dose Evaluation. More details of you and your
child’s part of the study are written later in this document.
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.
You are be ing asked to allow your child to be in this research study because your child is
healthy and meets the age requirement for this study.
This study is different from your child’s regular medical care. The purpose of regular
medical care is to improve or otherwise 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. Ifyour child needs medical care during their time in the
study, you should contact your regular provider and inform the study team, as described
later in this document.
Allowing your child taking part in this study is voluntary (your and your child’s choic e).
There is no penalty or change to youor your regular medical care if youdecide not to
allow your child to participate. Youcan choose toallow your child totake part in the study
now, and then change your mind later at any time without losing any ben efits or medical
care to which you or your child are entitled. We encourage youto 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 to answer any questions
that you may have about the study.
You will receive a signed copy of this consent document for your records. Please keep
this consent document for your reference.
3. What is the purpose 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 investigational vaccine as quic kly as
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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] 09Aug 2021 Phase 2/3 Lower Dose Evaluation , Parent al Consent
Protocol No. C4591007/PFIZER CONFIDENTIALPage:
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possible, this study will be conducted in several steps, which are described below.
Currently, the authorized dose of the vaccine in adolescents and young adults 12 years
and older is 30 µg. To reduce the reactions that can occur soon after vaccinat ion and to
determine whether similar immune responses are produced, additional lower dose levels
of the vaccine (3 µg and 10 µg) will be evaluated in ages 5 to 30 years.
Phase 1 Lower Dose Evaluation will be carried out in 3 age groups. Every participant
in this Phase will receive two 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.
This is the part that you are being asked to allow y our child to take part in .
Phase 2/3 Lower Dose Evaluation .Every participant in this Phase will receive two
injections of the active study vaccine. In this part we 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
receive 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 r
number 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
4. How long w ill my child participate in this study ?
Your child will be in this study for about 7months.
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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] 09Aug 2021 Phase 2/3 Lower Dose Evaluation , Parent al Consent
Protocol No. C4591007/PFIZER CONFIDENTIALPage:
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5. How many children will take part in this study ?
This consent is for Phase 2/3Lower Dose Evaluation and there will be about
approximately 600children less than 16 years old, and about 300 participants 16 to less
than 30 years of age taking part in this P hase.
The total number of children taking part in the whole study will depend on the results seen
during 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 comb ined, no one else will be
allowed to participate. So, it is possible that your child 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 and date 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 with you .
After si gning this consent document, the st udy doctor will check if you r 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, if your child does qualify to take partin this study, the study doctor will
explain this as well.
Study Vaccines
Once the study doctor has confirmed that your child meets the study requirements, your
child will be assigned to a dose -level group for the study vaccine.
Phase 2/3Lower Dose Evaluation of the study is an “open -label phase ”, which means
in this phase all participants will receive active study vaccine.
In this phase, all children /young adults in an given age group will receive the same dose
level. The dose level 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 300participants in e achage group that will 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.
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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] 09Aug 2021 Phase 2/3 Lower Dose Evaluation , Parent al Consent
Protocol No. C4591007/PFIZER CONFIDENTIALPage:
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The vaccine will be given to you r child through an injection into the muscle in their upper
arm. Each participant will receive twoinjections of vaccine , approximately three weeks
apart. On the days your child receive sthe vaccine injection, you will be asked to wait with
your child at the study site for at least 30 minutes for observation after they receiv e
vaccine.
Overview of Study Procedures and A ssessments
The table below lists the tests and procedures or assessments that you r child will have
done at each of their visit. It is important that your child and you attend each visit on the
day that your research study team arranges for your child. You will have the following
tests, procedures or assessments during this study. In addition to the visits listed, your
study doctor may ask you to bring your child in for extra visits if necessary ,to protect
your child's well-being.
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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] 09Aug 2021 Phase 2/3 Lower Dose Evaluation , Parent al Consent
Protocol No. C4591007/PFIZER CONFIDENTIALPage:
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For the participants taking part in Phase 2/3Lower Dose Evaluation , the study
doctor or nurse will perform following assessment and procedures:
Visit Number1 2 3 4
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 your child is a female and if needed, she
will be asked to provide a urine sample for a
pregnancy testX X
If needed, will discuss the use of appropriate
birth control with your childX X X
Ask about medications your child is currently
takingX X X
Ask about any other vaccines your child has
been givenX X X X
Check y our child meets all the study
requirementsX X
Take a nasal swab for the detection of virus
causing COVID -19X X
Collect blood sample to test antibody levels X X X
Give vaccine injection in child’s arm and
observe for 30 -min following injectionX X
You will be shown/reminded how to use the
e-diary or assist you to download an app,
thermometer and caliper (measuring device)X X
You will be asked to complete vaccination
e-diary for 7 days to record potential side
effects following each vaccinationX X
Ask how your child is feeling X 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] 09Aug 2021 Phase 2/3 Lower Dose Evaluation , Parent al Consent
Protocol No. C4591007/PFIZER CONFIDENTIALPage:
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Description of Study Procedures and Assessments
Biological Samples
The following 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 s ite.
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 additional 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. 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 confidentiality is maintained . Notesting of your child’s DNA will
be performed. You will not be told of additional tests, nor will you receive results of any of
these tests.
Blood Samples for antibody testing :
Your child will have blood taken three times during the planned study visits.
Each blood sample will be collected using a needle.
The volume of blood collected will depend on the age of your child ;
20 mL is to be collected from participants 16 years of age or older;
10 mL is to be collected from participants 12 to less than 16 years of age;
5 mL to be collected from participants 5 to less than 12 years of age .
Your child’s blood samples will be used to test if he/she already had antibodies against
the coronavirus that causes COVID -19 when you enrolled in the study and may be used
to test antibody levels after vaccination .
Nasal Swabs for detection of coronavirus causing COVID -19:
Your child will have nasal swab collected from his/her nose 2times during the planned
study visits. A swab (which looks likea 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 1 and Visit 2 will be
provided to your study doctor, however, this will take some time so you should not rely on
this information for your child’s medical treatment.
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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] 09Aug 2021 Phase 2/3 Lower Dose Evaluation , Parent al Consent
Protocol No. C4591007/PFIZER CONFIDENTIALPage:
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Urine Samples:
If yourchild is a female who is able to have children in the opinion of study doctor, your
child will need to provide urine sample for pregnancy testing to check she is not pregnant
before she gets 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 participant in the study.
E-Diary :
At Visit 1, the study team will explain what you or your child need to do and show you
how to fill in an electronic diary (or e -diary). W e will either give you or your child 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
maintain ed. You will also be given a thermometer and a measuring device (caliper).
The e-diary will prompt you or your child to answer questions about how your child is
feeling after receiving the study vaccination. 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 be ginon the evening your child receives theinjection
and the following next 6 days (7 days in total). You will use the thermomet er to measure
your child’s oral temperature (under his/her tongue). You or your child 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. These
measurements will need to be entered intothee-diary.
The e -diary will also ask other questions about potential side effects your child may have
after the injection. If your child has any severe symptoms after vaccination, you should
contact your study doctor and the study doctor or nurse may schedule an extra unplanned
visit to evaluate your child.
It is very important that you complete the e- diary regularly as instructed . If this is
not completed, the study doctor or nurse may contact y ou to check how y our child
is doing.
Watch for following symptoms:
What happens if my child is participating and has a positive nose swab test result
after Visit 1 but before Visit 2 ?
If your child has any potential COVID -19 symptoms with a positive nose swab test result
after visit 1 and before visit 2, your child may still be given the second study injection.
Leaving the Study Early
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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] 09Aug 2021 Phase 2/3 Lower Dose Evaluation , Parent al Consent
Protocol No. C4591007/PFIZER CONFIDENTIALPage:
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You or your child, may withdraw from the study at any time at your own request ,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 would be 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 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 any other vaccines
You or your child are going away for a long period
Your child wishes to take part in another research study
Your child previously took part in this study , have been in any other study in the
past 28 days, or are currently involved in any other study
Notify the study team if you move and provide your new contact information.
8. What are the possible risks and discomforts of this study ?
Any research has some 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 watch ed 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 discussed
below.
It is important that you report to the study team all symptoms and side effects as
soon as they occur to your child . Phone numbers for the study team are listed in
[Section 1] of this consent 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] 09Aug 2021 Phase 2/3 Lower Dose Evaluation , Parent al Consent
Protocol No. C4591007/PFIZER CONFIDENTIALPage:
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Up until June 2021 , the safety of BNT162b2 has been studied in clinic al 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 authorization in many countries, by the end of April 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 aches.
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,
sweati ng 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 breath
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.
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. following a booster dose.
If your child has had myocarditis (inflammation of t he heart muscle) or pericarditis
(inflammation of the lining outside the heart) previously, please tell your 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] 09Aug 2021 Phase 2/3 Lower Dose Evaluation , Parent al Consent
Protocol No. C4591007/PFIZER CONFIDENTIALPage:
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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 you r child
experience s as 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 has
not been seen with BNT162b2. Itremains important for you 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).
Risks from Study Procedures
Risks and possible discomforts you 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
collection you should talk to the study doctor.
Nasal Swabs: The risks and possible discomforts 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 iscurrently pregnant, plan to become pregnant, or isbreastfeeding a child,
theyshould 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 at least 28 days after they
receive their last injection. This applies to male participants 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. 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 each of their research study visits.
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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] 09Aug 2021 Phase 2/3 Lower Dose Evaluation , Parent al Consent
Protocol No. C4591007/PFIZER CONFIDENTIALPage:
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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 and the study doctor agree that it is your child’s selected method of contraception,
your child must continue not to have sexual intercourse for the duration of his/her
participation in this study.
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 visit 1, visit 2 ,visit 3 .
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 . Please also tell the
doctor who will be taking care of your child/their partner during the pregnancy that you
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 and its
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 groups of people already studied, but not yet at this dose level in theage group of
your child .Because of this, t hey still need 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 choices do I hav e if I do no t 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 included verbatim in the
country -level ICD .
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FDA-CBER-2021-5683-1076797
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] 09Aug 2021 Phase 2/3 Lower Dose Evaluation , Parent al Consent
Protocol No. C4591007/PFIZER CONFIDENTIALPage:
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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 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 mind about
continuing. If you decide to withdraw your child from the study, you r child may be asked
to cont inue 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 would occur.
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 review board (IRB) or
independent ethics committee (IEC) (a group of people who review the study to protect
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 biological samples) and how it may be used if you withdraw your child
from the study.
13. What w ill I have to pay forif my child takes part in this study ?
You will not need to pay for study 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 will be reimbursed by the study site to cover
reasonable expenses (for example , parking, meals, travel) that you have as a result of
taking part in this study. You will be reimbursed by [enter, as applicable, method of
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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] 09Aug 2021 Phase 2/3 Lower Dose Evaluation , Parent al Consent
Protocol No. C4591007/PFIZER CONFIDENTIALPage:
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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 child or
provide you with any products developed from this study. BioNTech/Pfizer will own all
products or pr ocesses 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. This text must be inserted
verbatim . Any requested changes must be approved by Clinical Development Legal. Note
that the Privacy Supplement follows this consent document, after the signature s ection.
16. Where can I find additional information about this study or the
study results?
A description of this clinical trial will be available on http://www.ClinicalTrials.gov , as
required by U.S. Law. This Web site will not include information that can identify you r
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 on www.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 possible, 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 w ebsites are in 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 doctor (if different from the study
doctor) i n accordance with applicable law, but will notbe given to your 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, includin g your child. BioNTech/Pfizer does
not plan to return information from any exploratory research to you/your child, the study
doctor, or your doctor (if different from the study doctor).
17. Signatures
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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] 09Aug 2021 Phase 2/3 Lower Dose Evaluation , Parent al Consent
Protocol No. C4591007/PFIZER CONFIDENTIALPage:
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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 whe ther or
not I want my child to participate.
2. I h ave 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 Privacy Supplement. I understand and agree
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 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
mychild’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 tocomply 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 my child, may
have already been used, or may have been given to a third
party.
4. I agree to the study team accessin g my child’s medical history,
including information from medical records and test results and
any medical treatment my child receive during the course of
the study, and if necessary, contacting my doctor or any other
health care providers treating my child for access to such
information.
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FDA-CBER-2021-5683-1076800
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] 09Aug 2021 Phase 2/3 Lower Dose Evaluation , Parent al Consent
Protocol No. C4591007/PFIZER CONFIDENTIALPage:
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5. I understand that the BioNTech/P fizer and/or others working
with or on behalf of the BioNTech/P fizer, institutional review
boards (IRBs) or independent 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 this
consent document. I have been told that I will receive a signed
and dated copy of this document.
7. I agree for my child to take part in the study described in this
document.
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:
_________________________________________ _______
Printed 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, andthey disagree about allowing
the child to participate in the study, the child should not be enrolled unless that
disagreement can be resolved. ]
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 example, biological parent, adoptive parent, or legal guardian or
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FDA-CBER-2021-5683-1076801
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) :
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Protocol No. C4591007/PFIZER CONFIDENTIALPage:
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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 reasonably 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
consent process and there is reason to believe that he/she may disagree with the decision
of the first parent/guardian/legal ly 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 child.
□ 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:
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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) :
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Protocol No. C4591007/PFIZER CONFIDENTIALPage:
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_______________________________ ______________
Printed n ame of person conducting the consent d iscussion
_______________________________ ______________ ______________
Signature of person c onducting the consent d iscussion† Date of signature
§Participant /parent /guardian/ legally acceptable representative/impartial witness 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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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] 09Aug 2021 Phase 2/3 Lower Dose Evaluation , Parental Consent
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 included verbatim in the country -level ICD. Any requested
changes must be approved by Clinical Develo pment Legal.
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