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 1 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 Cons ent 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]
09Aug2021 Phase 1 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. 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 ).Youcan
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 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
this consent document prior to the study to let the study team know your decision.
You will receive a signed copy of this consent d ocument 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 Cons ent 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]
09Aug2021 Phase 1 Lower Dose Evaluation , Parental 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? 8
4. How long will my child participate in this study? 9
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 jointhis
study?17
11. What happens if my child is injured during this study? 18
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? 19
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 Cons ent 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]
09Aug2021 Phase 1 Lower Dose Evaluation , Parental 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 20
Privacy Supplement
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CONSENT TO TAKE PA RT IN STUDY
CT05 -GSOP -RF05 7.0 Phase 1/2/3/4 Informed Cons ent 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]
09Aug2021 Phase 1 Lower Dose Evaluation , Parental 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 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 participant, 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 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 Cons ent 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]
09Aug2021 Phase 1 Lower Dose Evaluation , Parental 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 BioNT ech and Pfizer and [study doctor/institution] will be paid to
conduct this study.
A new respiratory disease appeared in Wuhan, 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 world
have quickl y 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 (M ulti-Inflammatory Syndrome -
Children). MIS -C is a con dition 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
vaccine 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
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CONSENT TO TAKE PA RT IN STUDY
CT05 -GSOP -RF05 7.0 Phase 1/2/3/4 Informed Cons ent 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]
09Aug2021 Phase 1 Lower Dose Evaluation , Parental Consent Protocol No. C4591007
PFIZER CONFIDENTIALPage:
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by 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 produ ce 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 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 distri buted. 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, musc le 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 sweat s,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 you r child has any 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 mor e severe.
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CONSENT TO TAKE PA RT IN STUDY
CT05 -GSOP -RF05 7.0 Phase 1/2/3/4 Informed Cons ent 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]
09Aug2021 Phase 1 Lower Dose Evaluation , Parental Consent Protocol No. C4591007
PFIZER CONFIDENTIALPage:
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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 causes immune response to the virus causing COVID -19. The vaccin e is
given by aninjection.
Overall, t his 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 1 Lower Dose Evaluation participants and you are being
asked to allow your child to take part in this phase. In Phase 1 of the stu dy, all
participants will receive the active study vaccine. In this Phase 1, up to two different
dose levels (amount of vaccine) will be studied. Your child will be assigned to one of the
twodose level group s.
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 a n
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. You rchild
will also be able to decide not to take part for confidential reasons, which, if th ey
request, would not be shared with you unless required by local law.
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.
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. If your 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 t aking part in this study is voluntary (your and your child’s choice) .
There is no penalty or cha nge to you or you r regular medical care if y oudecide not to
allow your child to participate. Youcan choose to allow you r child totake part in the
study now, and then change your mind later at any time without losing an y benefits or
medical care to which you or your child are entitled. W e encourage you to have
conversations with your family, caregivers, doctors, and study team about taking part in
this study and whether it is right for you r child . The study team will wor k with you to
answer any questions that you may have about the study.
Youwill receive a signed copy of this consent document for your records. Please keep
this consent document for your reference.
090177e197c39a5a\Approved\Approved On: 09-Aug-2021 16:23 (GMT)
FDA-CBER-2021-5683-1076706
CONSENT TO TAKE PA RT IN STUDY
CT05 -GSOP -RF05 7.0 Phase 1/2/3/4 Informed Cons ent 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]
09Aug2021 Phase 1 Lower Dose Evaluation , Parental Consent Protocol No. C4591007
PFIZER CONFIDENTIALPage:
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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
quickly as 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 vaccination
and to determ ine 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.
The steps in the study are detailed below. You are being asked to allow your child to
take part in the Phase 1 Lower Dose Evaluation step .
Phase 1 Lower Dose Evaluation will be carried out in 3 age groups. Every participant
in this Phase will receive tw o injections of the active study vaccine. The following
age groups will take part in this step of the study:
16 to less than 30 years of age,
12 to less th an 16 years of age , and
5 to less than 12 years of age.
The remaining step of the study will be the Phase 2/3 Lower Dose Evaluation . In this
partwe will use adose level selected from the Phase 1 part 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 recei ve 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, and thedose 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 theamount 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:
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CONSENT TO TAKE PA RT IN STUDY
CT05 -GSOP -RF05 7.0 Phase 1/2/3/4 Informed Cons ent 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]
09Aug2021 Phase 1 Lower Dose Evaluation , Parental Consent Protocol No. C4591007
PFIZER CONFIDENTIALPage:
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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.
5. How many children will take part in this study ?
This consent is for Phase 1 Lower Dose Evaluation and there will be about
approximately 96 children less than 16 years old, and about 64 participants 16 to less
than 30 years of age taking part in this P hase.
The total number of children taking part in the 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 combined, no one else will be
allowed to participate. So, it is possible that you r child may not be allowed to join the
study.
6. What w ill happen during this study ?
Before any study procedures begin, or b efore you begin preparing your child for the
study, you will 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 study 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, i f you r child does qualify to take part in 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 1 Lower Dose Evaluation of the study is an “open -label dose -finding phase ”,
which means in this phase all participants will receive active study vaccine.
In this phase, either 1 or two dose levels of the study vaccine will be studied depending
on the age of the participant . The re will be 32participants in each age group that will be
given each dose level.
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CONSENT TO TAKE PA RT IN STUDY
CT05 -GSOP -RF05 7.0 Phase 1/2/3/4 Informed Cons ent 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]
09Aug2021 Phase 1 Lower Dose Evaluation , Parental Consent Protocol No. C4591007
PFIZER CONFIDENTIALPage:
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Age of child/adult taking part 3µg Dose level 10µg Dose level
5 to less than 12 years of age
12 to less than 16 years of age
16 to less than 30 years of age,
represents 32 participants
If your child is 5 to less than 12 years of age they will be given the 3 µgdose.
If your child is 12 years or older they will be given either the 3 µgdose or the 10 µg
dose. They will have a 50:50 chance of getting either dose. The dose level will be
chosen by chance by a computer and neither you nor the study team has any influence
over this.
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 th e days you r child receive sthe vaccine injection, you will be asked to wait
with your child at the stud y 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 Cons ent 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]
09Aug2021 Phase 1 Lower Dose Evaluation , Parental Consent Protocol No. C4591007
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For the participants taking part in Phase 1 Lower Dose Evaluation , the study doctor or
nurse will perform following assessment and procedures :
Visit Number1 2 3 4 5
Visit Description and Visit Timing Study
Vaccine 1Study
Vaccine 27-Day
Follow -up
Visit1-Month
Follow -up
Visit or
phone call6-Month
Follow -
up Phone
Call
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 yourchild 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 X
Ask about medications your child is currently
takingX X X X
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 -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 or your child 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 X
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CONSENT TO TAKE PA RT IN STUDY
CT05 -GSOP -RF05 7.0 Phase 1/2/3/4 Informed Cons ent 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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Description of Study Procedures and Assessments
Biological Samples
The following biological samples will be taken in this study. You r 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 labo ratory 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 destro yed 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 . No testing of your c hild’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 lessthan 16years of age ;
5 mL to be collected from participants 5 to lessthan 12years 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 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 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 Cons ent 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]
09Aug2021 Phase 1 Lower Dose Evaluation , Parental Consent Protocol No. C4591007
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Urine Samples:
If your child 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 or
your child how to fill in an electronic diary (or e- diary ). We will either give you a device
(like a mobile phone) or ask you to download an application (app) to your or your child’s
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 or your child to answer questions about how your child is
feeling after receiving the study vaccination. You will be instructed by the st udy 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 the
injection and the following 6 days (7 days in total). You will use the thermometer 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 w here the injection was
given. These measurements will need to be entered into thee-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 the e -diary is completed as instructed . If this is not
completed, the study doctor or n urse may contact y ou to check how your 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 will not be given the second study injection.
Your child will however be asked to stay in the study so we can collect safet y
information 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 Cons ent 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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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 ,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 watched carefully
for any negative effect s; 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.
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CONSENT TO TAKE PA RT IN STUDY
CT05 -GSOP -RF05 7.0 Phase 1/2/3/4 Informed Cons ent 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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It is important that y ou report to the study team a ll 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.
Up until June 2021 , the safety of BNT162b2 has been studied in clinical trials that have
included about 2 8,500 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,
sweating and night sweats, pain in arm, and feeling weak o r unwell.
Rare (between 1 in 1,000 and 1 in 10,000 people): swelling of the face or lips.
Frequency thatcannot 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, y ou should seek medical attention right away if
your child hasany 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, w hen appropriate, if y our 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 sho rt term, however, long -term follow -up is limited. It
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CONSENT TO TAKE PA RT IN STUDY
CT05 -GSOP -RF05 7.0 Phase 1/2/3/4 Informed Cons ent 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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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 you r 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 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 t he
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 Samp les: 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 cau se the nose to
bleed.
Pregnancy -Related Risks; Use of Birth Control
If your child is currently pregnant, plan to become pregnant, or isbreastfeeding a child,
theyshould not join this study. If you r child 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
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CONSENT TO TAKE PA RT IN STUDY
CT05 -GSOP -RF05 7.0 Phase 1/2/3/4 Informed Cons ent 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]
09Aug2021 Phase 1 Lower Dose Evaluation , Parental Consent Protocol No. C4591007
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they receive th eir 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.
Birth co ntrol 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, you r 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 you r 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 and visit 4 .
Pregnancy Follow -up
If you r 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 you r child /their partner during the pregnancy
that you took part in this study. The study doctor will ask if you r child/their partner or
their pregnancy doctor is willing to provide updates on the progress of the pregnancy
and its outcome. If you r 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 the age group of
your child . Because of this, they 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 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.
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CONSENT TO TAKE PA RT IN STUDY
CT05 -GSOP -RF05 7.0 Phase 1/2/3/4 Informed Cons ent 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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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 mind about your child’s continu ation in this research study. Your
decision will not affect the medical care your chil d rec eives and your child will not lose
any benefits to which he/she would otherwise be entitled .
While you r child is participating, the study team will tell you in a timely manner if new
information is learned during the course of the study that could ch ange your mind about
continuing. If you decide to withdraw your child from the study, you r child may be asked
to continue to participate in the study procedures even though they would no longer
take the study vaccine .
If you r child continues with the foll ow-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 chi ld’spersonal 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 ?
Youwill not need to pay for study vaccine, study- related procedures, or study visits.
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CONSENT TO TAKE PA RT IN STUDY
CT05 -GSOP -RF05 7.0 Phase 1/2/3/4 Informed Cons ent 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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PFIZER CONFIDENTIALPage:
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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 com pletes, 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
reimbursement; amounts; a nd 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 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 changes 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 descriptio n 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 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 comp leted 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) in 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, including your child. BioNTech/Pfizer does
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CONSENT TO TAKE PA RT IN STUDY
CT05 -GSOP -RF05 7.0 Phase 1/2/3/4 Informed Cons ent 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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PFIZER CONFIDENTIALPage:
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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
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 u nderstand 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 righ ts 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’s medical
history, including info rmation from medical records and test
results and any medical treatment my child receive during the
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CONSENT TO TAKE PA RT IN STUDY
CT05 -GSOP -RF05 7.0 Phase 1/2/3/4 Informed Cons ent 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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PFIZER CONFIDENTIALPage:
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course of the study, and if necessary, contacting my doctor or
any other health care providers treating my child for access to
such information.
5. I und erstand that the BioNTech/PFizer 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 gene rated 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:
_________________________________________ _______
Printe d name of partici pant
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. ]
I also acknowledge that ( Please check oneof the following):
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CONSENT TO TAKE PA RT IN STUDY
CT05 -GSOP -RF05 7.0 Phase 1/2/3/4 Informed Cons ent 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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□ 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
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 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:
_______________________________ ______________ _____________
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FDA-CBER-2021-5683-1076721
CONSENT TO TAKE PA RT IN STUDY
CT05 -GSOP -RF05 7.0 Phase 1/2/3/4 Informed Cons ent 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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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
§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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FDA-CBER-2021-5683-1076722
CONSENT TO TAKE PA RT IN STUDY
CT05 -GSOP -RF05 7.0 Phase 1/2/3/4 Informed Cons ent 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 1 Lower Dose Evaluation , Parental Consent Protocol No. C4591007
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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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