Document text
CT05 -GSOP -RF05
7.0PHA SE 1/2/3INFORMED CONSENT
PEDIA TRIC STUDY TEMPLA TE01-Jul-2019
Protocol Number: C4591007ICD Version Date : 06Aug 2021
Phase 2/3 Placebo -Controlled Selected Dose
Study
Country
SiteLanguage: English Center ID: N/A Country: N/A
ICD Derived From: 02 Jul 2021
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) : [5/0/0]
Phase 2/ 3 Placebo- Controlled Selected Dose (all age groups) 06Aug 2021
Protocol No. C4591007/PFIZER CONFIDENTIALIntro
Page:
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Dear Sir or Madam,
Thank you for taking the time to consider permitting your child to join this study. W e
understand that this may be a difficult decision. This consent document can help you
make your decision by explaining what youand your child can expect to happen
during this study , also known as a clinical trial or a research study.
Yourchild’s participation in this study is completely voluntary (yo ur choice) .You can
take as long as you need to make your decision. You can also choose to allow your
child to take part in the study now and have the option to change your mind later at any
time. Please keep in mind that even if you allow your child to participate, it is possible
thatyour child may not meet the study’s entry requirements.
Depending on your child’s age, mental status and local laws, the study tea m may need
to verify your child’s agreement ( called “assent”) to participate in this study .
We encourage you and your child to have conversations with family , caregivers,
doctors, and the study team about taking part in this study and whether it is the right
decision for your child . The study team will work with you and your child to answer a ll
questions that you or your child may have about the study. The study team includes the
study doctor, nurses, and other personnel who work with the study doctor.
If you choose to permit your child to participate in this study, you w ill be asked to sign
and date this consent document prior to the study to let the study team know your
decision.
You will receive a copy of signed and dated consent document for your re cords. 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) : [5/0/0]
Phase 2/3 Placebo -Controlled Selected Dose (all age groups) 06Aug 2021
Protocol No. C4591007/PFIZER CONFIDENTIALPage:
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Table of Contents
This Table of Contents describes the different sections of this consent document. Be
sure to read through all sections of this consent document before making your decision
about whether or not to participate in this study.
Section Page
1. Key study information and contact information 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? 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? 20
8. What are the possible risks and discomforts of this study? 20
9. What are the possible benefits of this study? 24
10.What other choices do I have if I do not want my child to join this
study?24
11. What happens if my child is injured during this study? 24
12. What if my child joinsthis study and then changes his/her m ind? 24
13. What will I have to pay for if my child takespart in this study? 25
14. Will my child be paid for taking part in this study? 25
15. What will happen to my child’s personal information? 25
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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) : [5/0/0]
Phase 2/3 Placebo -Controlled Selected Dose (all age groups) 06Aug 2021
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16. Where can I find additional information about this study or the
study results?25
17. Signatures 26
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) : [5/0/0]
Phase 2/3 Placebo -Controlled Selected Dose (all age groups) 06Aug 2021
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): 05/ 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) : [5/0/0]
Phase 2/3 Placebo -Controlled Selected Dose (all age groups) 06Aug 2021
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.
This study is different from your child’s regular medical care. The purpose of regular
medical care is to improve or otherwi se manage your child’s health, but the purpose of
research is to gather information to advance science and medicine and does not replace
your child’s regular medical care. If your child needs medical care during their time in the
study, you should contact your regular provider andinform the study team, as described
later in this document.
A new respiratory disease appeared in W uhan, China in December 2019, and has since
rapidly spread to many other countries around the world. In January 2020, the cause of
this disease was found to be a new Coronavirus; and the disease it causes was named
COVID -19 (Coronavirus disease 2019). Since then, many companies around the w orld
have quickly started to look for treatments and ways to prevent COVID -19. Children have
been affected by primary COVID -19 disease and develop fever and dry cough over half
the time. Symptoms also can include GI(Gastrointestinal) symptoms, including diarrhea
and vomiting, and in some cases can be the only presenting features . In addition, childr en
have also been affected by aless 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, howe ver, many children with MIS-C had COVID -19 or were exposed to COVID -
19.
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FDA-CBER-2021-5683-1076809
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) : [5/0/0]
Phase 2/3 Placebo -Controlled Selected Dose (all age groups) 06Aug 2021
Protocol No. C4591007/PFIZER CONFIDENTIALPage:
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Vaccines help thebody to produce antibodies to help fight off a disease. This research
study involves an investigational (not approved by health authorities in children of the age
being asked to volunteer for this study) vaccine to prevent COVID -19, that will be given
to volunteers. The vaccine is given by injection in 2 doses .
These vaccines do not contain the whole virus, or the part of the virus that can make your
child ill, inste ad the vaccines are made up of part of the virus’s genetic code, surrounded
by fatty particles called lipids. They use your child’s cells’ protein making machinery to
produce some, or all, of the spike protein seen on the outside of the virus. This spike
protein, made by your child’s body, may help your child’s body to produce antibodies to
fight against COVID -19. W e will check the level of antibodies you r child make sby taking
blood samples and testing them.
Up until June2021, the safety of BNT162b2 has been studied in clinical trials that have
included about 28,500 people who have received at least one dose of the vaccine. In
addition, since the vaccine has been approved for emergency use or received a
conditional marketing in many countries, by the end of April 2021 about 400million doses
have been distributed. 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
swell ing of the face or lips), decreased appetite, lethargy , sweating and night 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
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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) : [5/0/0]
Phase 2/3 Placebo -Controlled Selected Dose (all age groups) 06Aug 2021
Protocol No. C4591007/PFIZER CONFIDENTIALPage:
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attention right away if your child hasany of those symptoms after receiving the vaccine.
The chance of having this occur is very low.
Although not seen to date, it cannot yet be ruled out that the study vaccine could make a
later COVID -19 illness more severe .
Allowing your child taking part in this study is voluntary (your and your child’s choice) .
There is no penalty or cha nge to you /your child or you rchild’s regular medical care if y ou
decide not to allow your child to participate. You can choose to allow your child to take
part in the study now, and then change your mind later at any time without losing any
benefits or medical care to which you or your child are entitled. We encourage youand
your child to have conversations with your family, caregivers, doctors, and study team
about taking part in this study and whether it is right for your child. The study team will
work with youand your childto answer any questions that you and your child may have
about the study.
You will receive a copy of this signed and dated consent document for your records.
Please keep this consent document for your reference.
You are being asked to allow your child to take part in a research study that will evaluate
whether the investigational (study) vaccine to prevent COVID -19 is safe, tolerable and
produces immune response to the virus causing COVID -19. Th is vaccine is given by an
injection. You are being asked toallow your child to be in this research study because
your child is healthy and meets the age requirement for this study.
Depending on your child’s age, mental status and local laws, the study team may need
to verify your child’s agreement (called “assent ”) to participate in this study . Your
child may give assent verbally, or they may be asked to print or sign their name on an
assent document similar to this consent document. They may have an opportunity to meet
privately with a member of the study team toask confidential questions. Yourchild will
also be able to decide not to take part for confidential reasons, which, if they request,
would not be shared with you unless required by local law.
3. What is the purpose of this study ?
The World Health Organizat ion (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 urge nt need.
To test this investigational vaccine as quickly as possible, this study will be conducted in
several steps . You are being asked to allow your child to take part in the Phase 2/3
Selected Dose step. The steps in the study are detailed below.
The Study has already started and all the children that are needed have already joined
the first part of the study. The first part of the study was called Phase 1 Dose Finding .
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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) : [5/0/0]
Phase 2/3 Placebo -Controlled Selected Dose (all age groups) 06Aug 2021
Protocol No. C4591007/PFIZER CONFIDENTIALPage:
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There were 3 age groups in the Phase 1 Dose Finding part and the study look edat up to
3 dose levels in each age group . The children in this part of the study were :
5 to less than 12 years of age,
2 to less than 5 years of age, and
6 months to less than 2 years of age .
Enrollment into this step has been completed.
Phase 1 Lower Dose Evaluation will be carried out in 3 age groups. In this step, the
study will look at up to 2 dose levels. 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 le ss than 12 years of age.
Phase 2/3 Selected Dose . In this step we will use adose level selected from the Phase
1 Dose Finding part of the study. This is the part that you are being asked to allow
your child to take part in, as an additional 2,250 participants will be included to enlarge
the size of the pediatric safety database .This step of the study will collect information
from a large rnumber of children about the safety of the vaccine and the amount of
antibodies produced by the vaccine. In this Phase, everyone will receive either active
vaccine or placebo. The children in this 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 .
The remaining step of the study will be the Phase 2/3 Lower Dose Evaluation.
In this part of the study we 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 , everyone 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 .
You are being asked to allow y our child to take part inPhase 2/3 Selected Dose .
At approximate ly6 months follow ingthe2ndinjection , you and your child will be
informed by the study team whether y our child was given the placebo injection or
the active investigational COVID -19 vaccine at Visit 1 and Visit 2. If your child
originally received placebo, your child will be offered the COVID- 19 investigation al
vaccine .
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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) : [5/0/0]
Phase 2/3 Placebo -Controlled Selected Dose (all age groups) 06Aug 2021
Protocol No. C4591007/PFIZER CONFIDENTIALPage:
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If your child become seligible for aCOVID -19 vaccine according to local or
national recommendations before they are unblinded y our study doctor w ill
explain y our options.
4. How long w ill my child participate in this study ?
Your child will be in this study for about 2 6 months.
5. How many children will take part in this study ?
The total number of children taking part in the whole study will depend on the results
seen during the study. It is expected that approximately 6750 children will take part in
thePhase 2/3 Selected Dose part of the study.
This study will use competitive enrollment. This means that when a certain number of
people have enrolled in the study from all study sites combined, no one else will be
allowed to participate. So, it is possible that you may not be allowed to join the study.
6. What w ill happen during this study ?
Before any study procedures begin, or before you begin preparing your child for the study,
youwill be asked to read and sign this consent document. Depending on local law and
your child’s age, your child’s permission may be required for the study team to share
some of their test results with you .
After signing and dating this consent document, the study doctor will check if your child
meet sall the requirements to take part in this study. If your child does not meet the
requirements, they will not be able to take part in the study and the study doctor will
explain why this is the case. Similarly, i f your child qualif iesto take part in this study, the
study doctor will explain this as well.
Study Vaccines
Once the study doctor has confirmed that your child meets the study requirements, your
child will be randomly assigned (like flipping a coin) to receive the study vaccine or
placebo. For every 2 volunteers who receive the investigational COVID -19 vaccine, 1
volunteer will receive placebo. No one (including you, your child, your child’s personal
doctor or the study team) can choose this assignment.
This phase of the study is a‘placebo -controlled observer -blind edphase’ which means
that you, your child and the study doctor will notknow whether your child will be receiving
the investigational COVID -19 vaccine or placebo. The person who gives your child the
injection will know because the investigational COVID -19 vaccine and placebo do not look
the same. The syringe will be covered with a label so the contents are not visible and the
person that gives your child the injection will not be able to talk about it. In case of urgent
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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) : [5/0/0]
Phase 2/3 Placebo -Controlled Selected Dose (all age groups) 06Aug 2021
Protocol No. C4591007/PFIZER CONFIDENTIALPage:
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need, the study doctor can learn quickly whether your child received study vaccine or
placebo.
If your child is 2 years of age or older , the investigation alCOVID -19 vaccine or placebo
will be given to you r child through an injection into the muscle in their upper arm. If your
child is less than 2 years of age, the COVID -19 vaccine or placebo will be given to your
child through an injection into the muscle in their thigh.
Each participant will receive twoinjections, approximately three weeks apart. On the days
your child receive sthe injection, you will be asked to wait with your child at the study site
for at least 30 minutes for observation after they receiv einjection .
Study Vaccines –after participating in the study for approximately 6 months after
receiving second injection
When you and your child come for your child’s visit at approximately 6-months after their
second injection, you and your child will be told if your child was given the investigational
COVID -19 vaccine (BNT162b2) or placebo injection .
If your child was given the investigational COVID -19 vaccine as their injection 1 and 2,
your child will not need any further injection sin the study.
If your child was given the placebo injection as their injection 1 and 2, they will be offered
two doses of active vaccine. Thefirst dose of investigational COVID -19 vaccine(active)
will be given as a third injection. Approximately 3 weeks later, your child will be given a
4thinjection which is the second dose of the investigational COVID -19 vaccine. For this
part, the study will be ‘unblinded’, meaning that you, your child and your doctor will know
that your child is getting the investigational COVID -19 vaccine.
Overview ofStudy Procedures and A ssessments
The table below lists the tests and procedures or assessments that your child will have
done at each of their visits during this phase of the study . You will have the following tests,
procedures or assessments during this study. In addition to the visits listed, yourchild’s
study doctor may ask you tobring your child in for extra visit(s)if necessary ,to protect
your child's well-being. It is important that your child and you attend each visit on the day
that your research study team arranges for your child .
Please note that Visit 3 is not shown in the table below a s it is optional and, if your child
is invited to attend that visit, you will be provided with a separate consent document
explaining the optional procedures that will be conducted at that visit.
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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) : [5/0/0]
Phase 2/3 Placebo -Controlled Selected Dose (all age groups) 06 Aug 2021
Protocol No. C4591007/PFIZER CONFIDENTIALPage:
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For the participants taking part in Phase 2/3Selected Dose , the study doctor or nurse will perform following
assessment and procedures :
Summary of Planned Study Visits and Procedures for ALL Participants up to 6 -months after Vaccine 2:
Visit Number 1 2 4 5
Types of Visit
Clinic ClinicClinic or
TelephoneClinic
Visit Description and Visit TimingStudy Vaccine
1Study Vaccine
21-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 (for
children 5 years of age or older) , and body temperatureX X
Perform a targeted physical exam, including measurement
of height and weight (height and weight information will be
collected at Visit 1 only ).X X
If your child is HIV positive, ask for their latest CD4 counts
and HIV viral loadX X X
If yourchild is a female and if able to have children, she
will be asked to provide a urine sample for a pregnancy
testX X
If needed, the study team will discuss and confirm the use
of appropriate birth control with your childX X X
Ask about medications your child is currently taking X X X
Ask about any other vaccines your child has been given XXX X
Check y our child meets all the study requirements XX
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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) : [5/0/0]
Phase 2/3 Placebo -Controlled Selected Dose (all age groups) 06 Aug 2021
Protocol No. C4591007/PFIZER CONFIDENTIALPage:
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Visit Number 1 2 4 5
Types of Visit
Clinic ClinicClinic or
TelephoneClinic
Visit Description and Visit TimingStudy Vaccine
1Study Vaccine
21-Month
Follow -up Visit6-Month
Follow -up Visit
Take a nasal swab for the detection of virus causing
COVID -19XX
Collect blood sample (approximately 5 mL at each time) to
test antibody levels
XX
(Only if your child
is par t of the group
participating in the
immunogenicity
assessment at this
visit)X
(Not required if
your child is
included in the
group added to
enlarge the size of
the pediatric
safety database )
Give vaccine injection in your child’s arm or thigh and
observe for 30 -min following injectionX X
You will be shown/reminded how to use the e -diary (or the
study team will assist you to download an app), and at
Visit 1 you will be given a thermometer and a caliper
(measuring device)X X
You will be asked to complete a vaccination e- diary for 7
days to record potential side effects following each
vaccinationX X
Ask how your child is feeling or if your child is having any
potential side effectsX X X X
Inform y ou and your child about which vaccine your child
was given at Visit 1 and Visit 2X
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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) : [5/0/0]
Phase 2/3 Placebo -Controlled Selected Dose (all age groups) 06 Aug 2021
Protocol No. C4591007/PFIZER CONFIDENTIALPage:
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Summary of Planned Study Visits and Procedures for Participants who originally received Investigational
COVID -19 Vaccine at Visit 1 and Visit 2; or who originally received Placebo at these visits and prefer not to
receive the COVID -19 Vaccine :
Visit Number X Y
Types of VisitClinic or Telephone Clinic or Telephone
Visit Description and Visit Timing12-M onth follow up 24-M onth follow up
If your child is HIV positive, ask for their latest CD4
counts and HIV viral loadX X
Ask about medications your child is currently taking X X
Collect blood sample (approximately 5 mL at each time)
to test antibody levels XX
If your child had a blood sample collected, a sk if y our
child is having any potential side effects after blood
collection X X
You will be asked to return the e -diary or you will be
assisted in deleting the app from y our own deviceX
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FDA-CBER-2021-5683-1076817
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) : [5/0/0]
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Protocol No. C4591007/PFIZER CONFIDENTIALPage:
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Summary of Planned study Visits and Procedures for Participants who originally received Placebo at Visit 1 and
Visit 2:
Visit Number A B C D E F
Types of Visit Clinic Clinic Telephone Telephone TelephoneClinic or
Telephone
Visit Description and Visit TimingStudy
Vaccine 3Study
Vaccine 41-Month
Follow -up
Visit after
vaccine 46-Month
Follow -up
Visit after
vaccine 412-Month
Follow -up
Visit after
vaccine 418-Month
Follow -up
Visit after
vaccine 4
Inform y ou and y our child that your child originally
received placeboX
Measure pulse rate, respiratory rate, blood
pressure (for children 5 years of age or older) , and
body temperatureX X
Perform a targeted physical exam X X
If your child is HIV positive, ask for their latest CD4
counts and HIV viral loadX X X X X
If yourchild is a female and if able to have children,
she will be asked to provide a urine sample for a
pregnancy testX X
If needed, the study team will discuss and confirm
the use of appropriate birth control with your childX X X
Ask about medications your child is currently taking X X X X X X
Take a nasal swab for the detection of virus
causing COVID -19X X
Check y our child meets all the study requirements X X
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FDA-CBER-2021-5683-1076818
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) : [5/0/0]
Phase 2/3 Placebo -Controlled Selected Dose (all age groups) 06 Aug 2021
Protocol No. C4591007/PFIZER CONFIDENTIALPage:
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Visit Number A B C D E F
Types of Visit Clinic Clinic Telephone Telephone TelephoneClinic or
Telephone
Visit Description and Visit TimingStudy
Vaccine 3Study
Vaccine 41-Month
Follow -up
Visit after
vaccine 46-Month
Follow -up
Visit after
vaccine 412-Month
Follow -up
Visit after
vaccine 418-Month
Follow -up
Visit after
vaccine 4
Give investigational COVID -19 vaccine injection in
your child’s arm and observe for 30 -min following
injectionX X
Ask how your child is feeling or if your child is
having any potential side effectsX X X X
You will be asked to return the e -diaryor you will
be assisted in deleting the app from y our own
deviceX
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FDA-CBER-2021-5683-1076819
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) : [5/0/0]
Phase 2/3 Placebo -Controlled Selected Dose (all age groups) 06 Aug 2021
Protocol No. C4591007/PFIZER CONFIDENTIALPage:
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Description of Study Procedures and A ssessments
Biological Samples
The following blood and nasal biological samples will be taken in this study . Your child
must provide these samples in order totake part in this study. The samples may be stored
in a facility located in a different country from your study site.
Your child’s blood and nasal samples will be used only for scientific research. Each
sample will be labeled with a code so that the laboratory workers testing the samples will
not know who your child is. Some of the samples may be stored for future testing and
may be kept for up to 1 5 years after the study ends, at which time they will be destroyed.
In addition to testing for this study , any samples left over after the study is complete may
be used for additional research related to the development of product s. No testing of your
child’sDNA 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 and your child will not be told of additional tests, nor will youor your
child receive results of any of these tes tsexcept for nasal swab test results which will be
communicated to your child’s study team doctor ad described later in this section .
Blood Samples for antibody testing :
All participants will have a blood sample taken at the following 2 planned visits : Visit 1
and V isit 5.
Your child may be selected to give more blood samples:
At Visit 2 , the study team will inform you whether your child is part of a group
selected to provide a blood sample at 1 month after the second injection.
At Visit 2 ora later visit, the study team will inform you whether your child is part
of a group selected to provide a blood sample at12 months and/or 24 months
after second injection .
Each blood sample will be approximately 5 mLand will be collected using a needle.
Your child’s blood samples will be used to test if he/she already had antibodies against
the coronavirus that causes COVID -19 when your child wasenrolled in the study and may
be used to test antibody levels after vaccination.
Nasal Swabs for detection o f coronavirus causing COVID -19:
Your child will have a nasal swab collected from his/her nose at 2 planned visits at Visit
1 and Visit 2 .
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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) : [5/0/0]
Phase 2/3 Placebo -Controlled Selected Dose (all age groups) 06 Aug 2021
Protocol No. C4591007/PFIZER CONFIDENTIALPage:
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At Visit 5,you and your child will beinformed whether your child originally received
placebo or COVID -19 investigation alvaccine at Visit 1 and Visit 2. If your child originally
received placebo and goes on to receive theinvestigation alvaccine as injection s3 and
4, your child will have a nasal swab collected from his/her nose visits A and B .
An additional nasal swab will be collected each time your child becomes ill with potential
COVID -19/MIS -C like illness. If your child becomes ill, you will be expected to contact
the study site and thestudy staff may ask you to collect your child’s nasal swab or ask
you to bring your child to the study site. A swab (which looks like a Q-tip)will be inserted
into your child’s nostril and rotated at least four times for a total of at least 15 seconds.
The same swab will then be inserted with the same steps as noted above for theother
nostril to collect any fluid or mucus. These samples will be tested to detect the presenc e
of coronavirus causing COVID -19. Results of nasal swabs collected at each
vaccination visit as well as from ev ery illness v isit will be prov ided to your child’s
study doctor, however, this will take some time so you should not rely on this
information for your child’s medical treatment . This is why, it is important that you
contact your child’s usual health care provider if your child has symptoms listed above
and you think that your child needs medical care.
Urine Samples:
If yourchild is female who is able to have children in the opinion of study doctor, your
child will need to provide urine s ample for pregnancy testing to check she is not pregnant
before she is given the study vaccine injection. If your child has a positive urine pregnancy
test result , the study doctor will share the information with you and your child will not be
able to participant in the study.
E-Diary :
The e -diary includes a vaccination part and COVID- 19/MIS -C illness part.
At Visit 1, the study team will explain what you need to do and show you how to fill in an
electronic diary (or e-diary). As a parent(s)/legal guardian(s), as appropriate, you will be
required to complete the e- diary for your child. We will either give you a device (like a
mobile phone) or ask you to download an application (app) to your smart phone if you
have one. The device/app is secure, and your child’s confidentiality will be maintained.
You will also be given a thermometer and a measuring device (caliper).
Vaccination part of the e -diary
The e-diary will prompt you to answer questions about how your child is feeling after
receiving the injection . At the Visit 1 and Visit 2, y ou 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
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FDA-CBER-2021-5683-1076821
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) : [5/0/0]
Phase 2/3 Placebo -Controlled Selected Dose (all age groups) 06 Aug 2021
Protocol No. C4591007/PFIZER CONFIDENTIALPage:
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and the following next 6 days (7 days in total). You will use the thermometer to measure
your child’s temperature .This temperature measurement will be oral (under his/her
tongue) for children 2 years of age and older, and axillary (under the arm) for children
less than 2 years of age. You will then enter the temperature reading into the e- diary.
The measuring device will be used to measure the size of any redness or swelling on
your child’s arm where the injection was given. You will need to enter these
measurements inthee-diary. It is important that all of the requested information is entered
in the e -diary.
The vaccination part of 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 child’s study doctor and the study doctor or
nurse may schedule an extra unplanned visit to evaluate your child.
COVID -19/MIS -C illness part of the e -diary
You will need to complete the COVID -19/MIS -C illness e-diary once a week which is
separate from the e-diary completed after each vaccination mentioned above. This will
continue for the entire duration of the time that yourchild is in the study . The
purpose isto report whether your child experiences any COVID -19/MIS -C illness like
symptoms (listed in section below )or is diagnosed with COVID -19. In addition to
completing this e-diary weekly, you willalso need to complete this e-diary if your child
experienc es any of the below listed symptoms at any time during participation in this
study .
You may receive text messages to the device or your own smartphone, or emails (if you
provide your email address) to remind you to complete the COVID- 19/MIS -Cillness par t
of the e -diary.
It is very important that you complete the e- diary regularly as instructed . If this is
not completed, the study doctor or nurse will contact y ou to check how y our child
is doing.
Watch for following symptoms:
Children develop fever and dry cough over half the time and GI (Gastrointestinal)
symptoms, including diarrhea and vomiting, and in some cases can be the only
presenting features. If your child develops any of the symptoms below during their study
participation ,contact your child’sstudy doctor immediately.
A diagnosis of COVID -19
Fever
New or increased cough
Diarrhea
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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) : [5/0/0]
Phase 2/3 Placebo -Controlled Selected Dose (all age groups) 06 Aug 2021
Protocol No. C4591007/PFIZER CONFIDENTIALPage:
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Vomiting
New or increased shortness of breath
Chills
New or increased muscle pain
New loss of taste/smell
Sore throat
Inability to eat/poor feeding;
Abdominal pain;
A serious medical condition associated with COVID -19 in children is known as MIS-C.
The cause forMIS-C is unknown. If your child has a hospitalization for COVID -19 or
a severe illness without a known cause , contact the study doctor immediately .
Note contacting the study doctor is not in place of y our child’s routine care. If your
child feels unwell enough that you would normally see a healthcare professional,
please contact y our child’s usual provider as well as the study doctor.
The study doctor may ask you to have a telephone conversation, video call or to visit the
site with your child to talk about how they are feeling and if they have needed any other
medical care. The study team will also ask you to help your child to take a nasal swab, or
the study team may take a swab to check for the coronavirus. Wewill give you separate
instructions about how to take a nasal swab and how to ship the swab to the clinical site ,
if needed. The res ults from this swab will be provided to the study doctor once it is
available, but this will take some time, and cannot be used to diagnose COVID -19.
Thisis why ,it is important that you contact your child’s usual health care provider if your
child has symptoms listed above and you think thatyour child needs medical care.
If your child is diagnosed with COVID -19/MIS -C, for the purposes of the study, the study
doctor will contact your child’s usual provider, and any facility where your child is treated,
to obtain details and collect medical records : by signing this informed consent document,
you agree to this.
What happens if my child is participating and has a positive nose swab test result
after Visit 1 or Visit A(if your child originally received placebo and goes on to
receive investigational COVID -19 vaccine at Visit A and B) but before the next
planned injection visit?
If your child has any potential COVID- 19/MIS-Csymptoms with a positive nose swab test
result after the Visit 1or Visit A (if your child received placebo) , your child’s study team
may need to delay the planned injection until your child becomes well .
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FDA-CBER-2021-5683-1076823
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) : [5/0/0]
Phase 2/3 Placebo -Controlled Selected Dose (all age groups) 06 Aug 2021
Protocol No. C4591007/PFIZER CONFIDENTIALPage:
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If your child has a positive nose swab test result after Visit 1, without the presence of any
potential COVID -19/MIS -Crelated symptom s, your child will be given theinjection as
planned in the study .
Leaving the Study Early
You or your child, may withdraw from the study at any time at your own request ,or your
child may be withdrawn at any time at the discretion of the investigator forsafety,
behavioral, compliance, or administrative reasons. If you or your child decide to leave the
study, you/your child w illbe asked why you would like to withdraw.
After the study
The study vaccine is available only during this study and not after the study is over.
7. Are there any special instructions to follow for this study ?
It is important that you and your child follow all the instructions given to you by the study
nurse or study doctor and tell them if :
You or your child do notunderstand anything about the study
You or your child willnot be able to comply with the study requirements
There are changes in your child’s health
Your e- diary device or APP is not working properly
Your child takes any new medications or receive s any o ther 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 iscurrently involved in any other study
Notify the study team if you /your child move sand provide your /your child’s new
contact information.
8. What are the possible risks and discomforts of this study ?
Any research has some risks, which may include negative effects that could make your
child unwell or uncomfortable and even potentially be serious or life-threatening. All
research participants taking part in the study will be watched carefully for any negative
effects; howeve r, the study team does not know all the effects that the study vaccine may
have on your child.
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FDA-CBER-2021-5683-1076824
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) : [5/0/0]
Phase 2/3 Placebo -Controlled Selected Dose (all age groups) 06 Aug 2021
Protocol No. C4591007/PFIZER CONFIDENTIALPage:
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If your child takes part in this study, the most likely risks or discomforts are discussed
below.
It is important that you/your child report to the study team all sy mptoms and side
effects as soon as they occur. Phone numbers for the study team are listed in
[Section 1] of this consent document.
Up until June 2021 , the safety of BNT162b2 has been studied in clinical trials that have
included about 28,500 people who have received at least one dose of the vaccine. In
addition, since the vaccine has been approved for emergency use or received a
conditional marketing authorization in many countries, by the end of April 2021 about 400
million doses have been distributed.
Based on the clinical study results, and information gathered during general use, the
following risks have been determined to be caused by BNT162b2 vaccine:
Very common (occurring in more than 1 in 10 people): injection site pain, injection site
swelling, fatigue (tiredness), increased body temperature (fever, more common after the
second dose), chills, headache , diarrhea , joint aches, and muscle 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 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 re ported 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 medic al 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 .
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FDA-CBER-2021-5683-1076825
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) : [5/0/0]
Phase 2/3 Placebo -Controlled Selected Dose (all age groups) 06 Aug 2021
Protocol No. C4591007/PFIZER CONFIDENTIALPage:
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Whilst some severe cases have been reported, most cases have been associated with
full resolution of symptoms in the short term, however, long -term follow -up is limited. I t 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 hashad 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 onresults from studies of similar vaccines, as well as risks that are currently
unknown.
Therefore, it is important that you report all symptoms and side effects that your child
experience sas soon as they occur, whether or not you think they are caused bythe study
vaccine.
Due to the way in which the study vaccines are made, they cannot cause COVID -19
disease.
If my child catch esCOVID -19 disease, could the vaccine make it worse?
For some other vaccines tested in animals against similar viruses (but not the coronavirus
that causes COVID -19), there have been reports of the illness being more severe in the
animals that received the vaccine than in those that did not. So far this hasnot been seen
with BNT162b2. Itremains important for you/your child to contact your child’s study doctor
if you r child develop ssymptoms that might be caused by COVID -19 (for example, fever,
cough, shortness of breath).
Placebo Risks
As the placebo injection contains salt-water and no active ingredients, the chances of
having side effects mentioned above are less likely. In other studies, using the same
placebo injection, some people who received the placebo injection reported pain,
bruising, swelling and redness at the site of injection.
Risks from Study Procedures
Risks and possible discomforts you r child might have from the study procedures
include:
Blood Samples: The risks and possible discomforts involved in taking blood
include pain from inserting the needle, or less often, swelling, bruising, or
infection around the vein where the blood is collected. Your child may feel dizzy
or may faint. If your child has a previous history of feeling dizzy or fainting during
blood sample collection you should talk to the study doctor.
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CONSENT TO TAKE PA RT IN STUDY
CT05 -GSOP -RF05 7.0 Phase 1/2/3/4 Informed Consent Pediatric Study Template (01 -Jul-2019)
TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version Number (Study/Country/Site) : [5/0/0]
Phase 2/3 Placebo -Controlled Selected Dose (all age groups) 06 Aug 2021
Protocol No. C4591007/PFIZER CONFIDENTIALPage:
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Nasal Swabs: The risks and possible discomfort involved in taking nasal swabs
may include pain or general discomfort. Sometimes it may cause the nose to
bleed.
Pregnancy -Related Risks; Use of Birth Control
If your child is currently pregnant, plan sto become pregnant, or isbreastfeeding a child,
sheshould not join this study. If yourchild is a male , heshould not father a baby while
taking part in this study.
Ifyour child is able to have children and is sexually active, they must use birth control
consistently and correctly for the duration of the study including and for at least 28 days
after they receive their last planned injection. This applies to male participants as well as
female participants who take part in the resea rch study. The study doctor will discuss
with your child the methods of birth control that they should use while in this research
study , if appropriate . The study doctor will help your child select the method that is
appropriate for them. The study docto r will also check that your child understands how to
use the birth control method and may review this with them at visits specified in the
Section 6in the tables describing study visits, if appropriate .
Birth control methods, even when used properly, are not perfect. If your child or their
partner becomes pregnant during the research study, or if they want to stop their required
birth control during the research study, they should tell the study doctor immediately . Your
child may be withdrawn from the research study if they stop using birth control or they
become pregnant.
If abstinence (not having sexual intercourse at all) is your child’s current lifestyle, and both
you/your child and the study doctor agree that it is your child’s selected method of
contraception, your child must continue not to have sexual intercourse forat least 28 days
after the last planned injection .
As permitted by local law, the study doctor may: (a) provide confidential contraceptive
counseling to your child (not discussed with you) and (b) help your child to assess
additional reproductive services, if needed. The study doctor will instruct you r child about
how to use their selected birth control method correctly and consistently and may review
this with you r child at visits specified in the Section 6in the tables describing study visits .
Pregnancy Follow -up
If your child or their partner become pregnant during the study , up until 28 days after your
child’s last study injection, please tell the study doctor immediately . The study doctor
may ask for information about the pregnancy and the birth of the baby. The study doctor
may share this information with others who are working on this study. P lease also tell the
doctor who will be taking care of your child/their partner during the pregnancy that your
child took part in this study. The study doctor will ask if your child/their partner or their
pregnancy doctor is willing to provide updates on the progress of the pregnancy a nd its
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FDA-CBER-2021-5683-1076827
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) : [5/0/0]
Phase 2/3 Placebo -Controlled Selected Dose (all age groups) 06 Aug 2021
Protocol No. C4591007/PFIZER CONFIDENTIALPage:
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outcome. If your child/their partner agree, this information will be provided to the
BioNTech /Pfizer for safety follow -up.
9. What are possible benefits of this study ?
Vaccination with BNT162b2 has been shown to be effective in preventing COVID -19 in
the groups of people already studied, but not yet 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.
11. What happens if my child is injured during this study?
For mandatory research injury language, < click here > (retain this link in the study- level
ICD). The country -specific research injury language must be inc luded verbatim in the
country -level ICD .
12. What if my child joinsthis study and then changes his/her
mind?
You are free to withdraw your child from this research study at any time. Tell the study
doctor if you are thinking about this so that your child may end the research study in the
safest way. The research study team will also tell you if new information is learned that
could change your/your child’s mind about your child’s continu ation in this research study.
Your decision will not affect the medical care your child receives, and your child will not
lose any benefits to which he/she would otherwise be entitled .
While your child isparticipating, the study team will tell you in a timely manner if new
information is learned during the course of the study that could change your /your child’s
mind about continuing. If you decide to withdraw your child from receiving vaccine or if
your child decides to withdraw from receiving vaccine , your child may be asked to
continue to participate in the study procedures even though they would no longer take the
study vaccine .
If your child continues with the follow -up part of the study, information about your child’s
health will continue to be collected as described in [Section 6].
If you decide to stop your child participating in this study, you must notify the study doctor.
The study team will explain what other procedures or discussions should occur.
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FDA-CBER-2021-5683-1076828
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) : [5/0/0]
Phase 2/3 Placebo -Controlled Selected Dose (all age groups) 06 Aug 2021
Protocol No. C4591007/PFIZER CONFIDENTIALPage:
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Sometimes the study doctor or BioNTech/Pfizer may decide to take you r child out of the
study (even if you do not agree) if:
•You/your child are unable or unwilling to follow the instructions of the study team;
•The study doctor decides that the study is not in your child’s best interest or that they
are no longer eligible to participate; or
• The study is stopped by the BioNTech/Pfizer , the Institutional R eview Board (IRB) or
Independent Ethics Committee (IEC) (a group of people who review the study to
protect your /your child’s rights), or by a government or regulatory agency .
The study team will give you a Privacy Supplement, which is considered part of this
consent document. It describes what happens to your/your child’s personal information
(including your child’s biological samples) and how it may be used if you withdraw your
child from the study or if your child withdraws from the s tudy.
13. What w ill I have to pay forif my child takes part in this study ?
Youwill not need to pay for thestudy vaccine, study -related procedures, or study visits.
14. Will my child be paid for taking part in this study ?
You will not receive any payment for your child taking part in this study. However, for
each visit you/your child completes, you /your child will be reimbursed by the study site to
cover reasonable expenses (for example, parking, meals, travel) that you have as a result
of your child taking part in this study. You/your child will be reimbursed by [enter, as
applicable, method of reimbursement; amounts; and reimbursement schedule; note
whether receipts are required] .]
BioNTech/Pfizer may use information resulting from the study to develop produ cts 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 t his study or the
study results?
A description of this clinical trial will be available onhttp://www.ClinicalTrials.gov , as
required by U.S. Law. This Web site will not include information that can identify your
child. At most, the Web site will include a summary of the results. You can search this
Web site at any time.
090177e197c3bf91\Approved\Approved On: 09-Aug-2021 16:42 (GMT)
FDA-CBER-2021-5683-1076829
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) : [5/0/0]
Phase 2/3 Placebo -Controlled Selected Dose (all age groups) 06 Aug 2021
Protocol No. C4591007/PFIZER CONFIDENTIALPage:
26of 14
The study results, when available, may also be found onwww.pfizer.com and
https://www.clinicaltrialsregister.eu/ .
In addition, a plain summary of the study results will be made available in the EU database
at [insert link to the database] . This information will be provided no matter what the study’s
outcome. To the extent 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 completed the study. At that time, certain of your child’s
individual study results may be given to you or your child’s doctor (if different from the
study doctor) in accordance with applicable law , but will notbe given to your/your child’s
family, your e mployer or any insurance company .
If any exploratory research is done, it may not be possible to link any results from that
exploratory research to specific individual, including your child. BioNTech/Pfizer does not
plan to return information from any exploratory research to you/your child, the study
doctor, or your child’s doctor (if different from the study doctor).
17. Signatures
The column for subject initials in the table below may be removed if not required by the
IRB/IEC, regulatory agencies, and/or other similar reviewers.
Agreement to Participate and to Process Data Initials
1. I confirm I have read (or, if I cannot read, a study team
member has read to me) and understand this consent
document for the study described above and have had the
opportunity to ask questions. I have had enough time to
review this consent document. I also have had an opportunity
to ask about the details of the study and to decide whether or
not I want my child to participate.
2. I have read and 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.
090177e197c3bf91\Approved\Approved On: 09-Aug-2021 16:42 (GMT)
FDA-CBER-2021-5683-1076830
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) : [5/0/0]
Phase 2/3 Placebo -Controlled Selected Dose (all age groups) 06 Aug 2021
Protocol No. C4591007/PFIZER CONFIDENTIALPage:
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3. I understand that allowing my child to take part is voluntary
and that I am free to stop my child taking part in this study or
to withdraw my consent to the processing of my child’s
personal information at any time. I do not need to give any
reason and my child’s regular medical care and legal 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 s during
the course of the study, and if necessary, contacting my
child’s doctor or any other health care providers treating my
child for access to such information.
5. I understand that BioNTech/P fizer and/or others working with
or on behalf of the BioNTech/P fizer, Institutional R eview
Boards (IRBs) or I ndependent Ethics Committees (IECs) , and
regulatory agencies may need access to personal information
about my child generated at the study site or collected by the
study team for the study and any other research. I agree that
they may have access to my child’s personal information.
6. I do not give up any of my child’s legal rights by signing and
dating this consent document. I have been told that I will
receive a copy of this signed and dated document.
7. I agree for my child to take part in the study described in this
document.
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:
090177e197c3bf91\Approved\Approved On: 09-Aug-2021 16:42 (GMT)
FDA-CBER-2021-5683-1076831
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) : [5/0/0]
Phase 2/3 Placebo -Controlled Selected Dose (all age groups) 06 Aug 2021
Protocol No. C4591007/PFIZER CONFIDENTIALPage:
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_________________________________________ _______
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):
□ 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):
090177e197c3bf91\Approved\Approved On: 09-Aug-2021 16:42 (GMT)
FDA-CBER-2021-5683-1076832
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) : [5/0/0]
Phase 2/3 Placebo -Controlled Selected Dose (all age groups) 06 Aug 2021
Protocol No. C4591007/PFIZER CONFIDENTIALPage:
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□ 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:
_______________________________ ______________
Printed n ame of person conducting the consent d iscussion
_______________________________ ______________ ______________
Signature of person c onducting the consent d iscussion† Date of signature
§Parent /guardian/ legally acceptable representative must personally date their
respective signature s.
†The investigator, or an appropriately qualified and trained person designated by the
investigator to conduct the informed consent process, must sign and date the consent
document during the same discussion when the participant’s parent/guardian/legally
acceptable representa tive signs the consent document.
090177e197c3bf91\Approved\Approved On: 09-Aug-2021 16:42 (GMT)
FDA-CBER-2021-5683-1076833
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) : [5/0/0]
Phase 2/3 Placebo -Controlled Selected Dose (all age groups) 06 Aug 2021
Protocol No. C4591007/PFIZER CONFIDENTIALPage:
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For mandatory country -specific data privacy language to be inserted in this Privacy
Supplement, < click here > (retain this link in the study -level ICD). The country -specific
data privacy language must be included verbatim in the country -level ICD. Any
requested changes must be approved by Clinical Development Legal.
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FDA-CBER-2021-5683-1076834