125742 45 S211 M5 c4591001 interim ado mth6 iec irb consent form

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C4591001 Page 1of 5
CONFIDENTIAL 15-Nov-2021 11:55:00 GMT16.1.3.1 LIST OF INDEPENDENT ETHICS COMMITTEE (IEC) OR INSTITUTIONAL REVIEW BOARD (IRB)
UNITED STATES
Study Site Number Independent Ethics Committee or Institutional Review Board Address(es)
1005 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1006 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1007 Cincinnati Children’ s Hospital Medical Center IRB
3333 Burnet Ave, MLC 5020
Cincinnati, OH 45229
UNITED STATES
1008 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1009 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
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Page 1
FDA-CBER-2022-5812-0224557
C4591001 Page 2of 5
CONFIDENTIAL 15-Nov-2021 11:55:00 GMTStudy Site Number Independent Ethics Committee or Institutional Review Board Address(es)
1013 Copernicus Group IRB
5000 Centregreen Way, Ste 200
Cary, NORTH CAROLINA 27513
UNITED STATES
1016 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1039 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1044 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1057 Copernicus Group Institutional Revie w Board
5000 Centregreen Way, Ste 200
Cary, NORTH CAROLINA 27513
UNITED STATES
1066 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
090177e1989ac43f\Approved\Approved On: 22-Nov-2021 06:02 (GMT)
Page 2
FDA-CBER-2022-5812-0224558
C4591001 Page 3of 5
CONFIDENTIAL 15-Nov-2021 11:55:00 GMTStudy Site Number Independent Ethics Committee or Institutional Review Board Address(es)
1077 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1084 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1091 Copernicus Group Institutional Revie w Board
5000 Centregreen Way, Ste 200
Cary, NORTH CAROLINA 27513
UNITED STATES
1123 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1124 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1125 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1126 Kaiser Permanente Northern California Institutional Review Board
1800 Harrison St, 10th Fl
Oakland, CA 94612
UNITED STATES
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FDA-CBER-2022-5812-0224559
C4591001 Page 4of 5
CONFIDENTIAL 15-Nov-2021 11:55:00 GMTStudy Site Number Independent Ethics Committee or Institutional Review Board Address(es)
1131 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1139 WESTERN INSTI TUTIONAL REVIEW BOARD
1019 39th Ave SE, Ste 120
Puyallup, WASHINGTON 98374 -2115
UNITED STATES
1140 WESTERN INSTITUTIONAL REVIEW BOARD
1019 39th Ave S.E, Ste 120
Puyallup, WA 98374
UNITED STATES
1142 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NORTH CAROLINA 27513
UNITED STATES
1147 Western Institutional Review Board
1019 39th Ave Se, Ste 120
Puyallup, WASHINGTON 98374
UNITED STATES
1150 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1152 Copernicus Group IRB
5000 Centregreen Way, Ste 200
Cary, NORTH CAROLINA 27513
UNITED STATES
090177e1989ac43f\Approved\Approved On: 22-Nov-2021 06:02 (GMT)
Page 4
FDA-CBER-2022-5812-0224560
C4591001 Page 5of 5
CONFIDENTIAL 15-Nov-2021 11:55:00 GMTStudy Site Number Independent Ethics Committee or Institutional Review Board Address(es)
1156 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1223 Yale University Human Research Protection Program (Human Investigation Committee)
25 Science Park, 3rd Fl, 150 Munson St
New Haven, CT 06520
UNITED STATES
1235 Western Institutional Review Board
1019 39th Ave. SE, Ste 120
Puyallup, WA 98374
UNITED STATES
1270 Kaiser Permanente Northern California Institutional Review Board
1800 Harrison St, 10th Fl
Oakland, CA 94612
UNITED STATES
090177e1989ac43f\Approved\Approved On: 22-Nov-2021 06:02 (GMT)
Page 5
FDA-CBER-2022-5812-0224561
CLINICAL STUDY INF ORMED CONSENT
ADDENDUM Page:
1 of 7
Protocol Number:
C4591001 Associated ICD Ver sion Date :
Parent ICD (03Feb2021) ICD Addendum Version Date :
07Jul2021
Study
Country SiteLanguage: Englis h Center ID: Not Applicable Country: Not Applicable
CT05 -GSOP -RF07 3.0Addendum ICD Template ( 01-Jun- 2016)
CONFIDENTIAL
TMF Doc ID:
173.15 (Study); 173.09 (Country/Central); 173.2 4 (Site) INFORMED CONSENT AND /OR ASSENT ADDENDUM FOR
A PHASE 1/2/3, PLACEBO -CONTROLLED, RANDOMIZED, OBSERVER-BLIND,
DOSE-FINDING STUDY TO EVALUATE THE SAFETY, TOLERABILITY,
IMMUNOGENICITY, AND EFFICACY OF SARS -COV -2 RNA VACCINE
CANDIDATES AGAINST COVID-19 IN HEALT HY INDIVIDUALS
P
rotocol Number: C4591001
Y
ou have already si gned a consent form to allow your child to participate in the
research study mentioned above. This addendum is part of the consent procedure. It
has been written to provide you with additional information on your child’s new s chedule
of study visits, tests, and procedures and reimbursement to cover any reasonable
expenses (for example, parking, meals, travel) associated with these new visits. It also
provides the latest information on BNT162b2 v accine risks that you will want to know .
All other information in the main consent form not addressed in this addendum still
applies.
A
dministration of BNT 162b2 to Participants Originally Assigned to Placebo
Y
ou were asked by the study s ite whether you w ould consider your child receiving
BNT162b2 vaccine (active study vaccine) if they received placebo during the earl ier part
of the study. Since it is confir med that they received placebo, and have expressed
willingness to receive the BNT162b2 vaccine, you are now being asked to read, sign
and date this consent document before c ommencing any new set of study -related
procedures.
A
fter signing this consent addendum , the study doctor will check if y our child meets all
the requirements to receive BNT162b2 vacci ne. If they do not meet the requirements,
they will not be able to receive the vaccine and the study doctor will explain why this is
the case.
O
nce the study doc tor has confirmed your child meet the study requi rements to receiv e
BNT1 62b2 vaccine , they will receive 2 injections, appr oximately 3 weeks apart . The
injection will be given into the muscle in their upper arm and will be asked to wait at the
study site for at least 30 minutes for observation after receivi ng the vaccine .
090177e197c431c1\Approved\Approved On: 09-Aug-2021 22:09 (GMT)
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CLINICAL STUDY I NFORMED CONSENT
ADDENDUM Page:
3 of 7
Protocol Number:
C4591001 Associ ated ICD Ve rsion Date :
Parent ICD (03Feb2021) ICD Addendum Version D ate:
07Jul2021
Study
Country SiteLanguage: Englis h Center ID: Not Appli cable Country: Not Applica ble
CT05 -GSOP -RF07 3.0 Addendum ICD Template ( 01-Jun- 2016)
CONFIDENTIAL
TMF Doc ID : 173.1
5 (Study); 173.09 (Country/Central); 173.2 4 (Site) In addition to the above :
•you will remember that your child has been asked to attend an extra visit (i.e.
convalescent visit) to the study site about a month after their potential COVID -19
illness visit. Now, that the study team has obtained enough clinical data in the
study from these convalescent vi sits, it is no longer a requirement for your child
to attend this extra visit after their potential COVID -19 illness.
•You will also rem ember that you and/or your child have been asked to tell the
study doctor immediately if your child or their partner become pregnant during
the study, up until 6 months after their last study injection. However, the reporting
duration has now been revised to 28days after their last study injection.
Study Vaccine Risks
Up until the June 2021 , the s afety 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 marketi ng authorization in many countries, by the end of April 2021 about
400 million doses have been distributed.
B
ased on the clinical study results , and information gathered during general use, the
following risks have been determined to be caused by BNT162b2 vaccine:
V
ery common (occurring in more than 1 in 10 people): i njection site pain, injectio n site
swelling, fatigue (tiredness), increased body temperature ( fever , more common after the
second dose), chills, headache, diarrhea, joint aches , and muscle aches.
C
ommon ( between 1 in 10 and 1 in 100 people): feeling sick (nausea) , being sick
(vomiting), and injection site redness.
U
ncommon ( between 1 in 100 and 1 in 1, 000 people): enlarged lymph glands , allergic
reactions (symptoms may include rash, itchi ng, hives ), decreased appetite, lethargy ,
sweating and night sweats, pain in arm, and feeling weak or unwell .
R
are (between 1 in 1,000 and 1 in 10,000 people): swelling of the face or lips.
F
requency that cannot be estim ated from available data: severe allergic reaction
(anaphylaxis) .
M
yocarditis (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
090177e197c431c1\Approved\Approved On: 09-Aug-2021 22:09 (GMT)
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CLINICAL STUDY I NFORMED CONSENT
ADDENDUM Page:
4 of 7
Protocol Number:
C4591001 Associ ated ICD Ve rsion Date :
Parent ICD (03Feb2021) ICD Addendum Version D ate:
07Jul2021
Study
Country SiteLanguage: Englis h Center ID: Not Appli cable Country: Not Applica ble
CT05 -GSOP -RF07 3.0 Addendum ICD Template ( 01-Jun- 2016)
CONFIDENTIAL
TMF Doc ID : 173.1
5 (Study); 173.09 (Country/Central); 173.2 4 (Site) 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, i n most of these people, symptoms began within a few days to a week
following vaccina tion. As a precaution, y our child should seek medical attention right
away if they have any of the following symptoms after receiving the v accine:
•Chest pain
•Shortness of breath
•Feelings of having a fast -beating, fluttering, or pounding heart
P
lease also notify study staff, when appropriate, if your child has any of these
symptoms.
W
hilst some severe cases have been reported, most cases have been associated with
full resolution of symptoms in the short term, however, long-term follow -up is limited. It
is not known whether the risk of myocarditis or pericarditis is increased following
additional doses of the vaccine, e.g. following a booster dose.
I
f your child has had myocarditis (inflammation of the heart muscle) or pericarditis
(inflammation of the lining outside the heart) previously, please tell your child’s study
doctor.
T
he part of this study that included 2,260 12-15 year olds ( 1131 of whom received
BNT162b2) demonstrated similar risks in this age group. There were no confi rmed
cases o f myocarditis or pericarditis in the data from this part of the study, however as
mentioned above there is a very low chance that this may occur after vaccination.
A
s in all research studi es, the COVID -19 vaccine may involve risks that might be
expect ed based on results from studies of similar vaccines , as well as risks that are
currently unknown.
T
herefore, it is important that you/your child report al l symptoms and side effects that
your child experiences as soon as they occur, whether or not you think they are caused
by the study vaccine.
D
ue to the way in which the study vaccines are made, they cannot cause COVID -19
disease.
If my child catch es COVID-19 disease, could the vaccine make it worse?
For some other vaccines tested in animals against similar viruses (b ut not the
coronavirus that causes COVID -19), there have been reports of the illness being more
severe in the animals that received the vac cine than in those that did not. So far this has
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CLINICAL STUDY I NFORMED CONSENT
ADDENDUM Page:
5 of 7
Protocol Number:
C4591001 Associ ated ICD Ve rsion Date :
Parent ICD (03Feb2021) ICD Addendum Version D ate:
07Jul2021
Study
Country SiteLanguage: Englis h Center ID: Not Appli cable Country: Not Applica ble
CT05 -GSOP -RF07 3.0Addendum ICD Template ( 01-Jun- 2016)
CONFIDENTIAL
TMF Doc ID : 173.15
(Study); 173.09 (Country/Central); 173.2 4 (Site) not been seen with BNT162b2. It remains important for you/your child to contact your
child’s study doctor if your child develop symptoms that might be caused by COVID -19
(for example, fever, cough, s hortness of breath).
Key Remind ers
Vaccinati on with BNT162b2 has been shown to be ef fective in preventing
COVID -19 but your child still needs to follow local recommendat ions about how
to avoid COVID -19 (for example, social distancing and mask use).
It is also very important that you continue to complete the COVID -19 Illnes s e-
Diary regul arly on your child’ s behal f as ins tructe d. If you do not, your study
doctor or nurse will contact you or your child to check how they are.
Will
my child be paid for receiving the active study vaccine and for the additional
visits to the study site? ?
Your child will not receive any payment fo r receiving the active study vaccine . However,
you will be reimbursed $XX.XX by the study site for the onsite visit(s) yo u/your child
complete as part of th eir new study schedule to cover out -of-pocket expenses, such as
travel and parking.
P
lease take as much time as you need to ask questions from the research study team
before you agree for your child t o receive the ac tive vaccine . If after receiving this
information you agree f or your child to receive the active st udy vaccine, please sign
below.
SIGN ATURES:
•I have read the information in this addendum to the informed consent document .
•I have had an oppo rtunit y to ask questions and all of my questi ons have been
answered to my sat isfaction.
•I have been given enough t ime to decide whether or not I want my ch ild to
receive the active vaccine.
•I voluntarily agree for my child to receive the active vacci ne.
•I do not give up any of my or my child’s legal rights by signing this addendum to
the informed consent document .
•I have been told that I will recei ve a signed and dat ed copy of this addendum .
SIGNATURE LINE (S) TO BE COMPLETED FOR A CHILD PARTICIPA NT:
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CLINICAL STUDY I NFORMED CONSENT
ADDENDUM Page:
6 of 7
Protocol Number:
C4591001 Associ ated ICD Ve rsion Date :
Parent ICD (03Feb2021) ICD Addendum Version D ate:
07Jul2021
Study
Country SiteLanguage: Englis h Center ID: Not Appli cable Country: Not Applica ble
CT05 -GSOP -RF07 3.0 Addendum ICD Template ( 01-Jun- 2016)
CONFIDENTIAL
TMF Doc ID : 173.1
5 (Study); 173.09 (Country/Central); 173.2 4 (Site) As the consenting adult providing permission for this child to participate in the study, I
acknowledge that ( Please check one of the following):
□ I am the biological or adoptive parent of the child.
□ I am the legal guardian or legally acceptable represent ative of the child.
I al
so acknowledge that ( Please check one of the foll owing):
□I have sole legal respons ibility for the care and custody of the child.
□The other adult(s) with whom I share legal responsibility for the care and
custody of the child (for example, biological parent, adoptive parent, or legal
guardian or repr esentat ive) is (1) aware of and agr ees with my granting
permission for this child to participate in the study OR (2) deceased, unknown,
incompetent, or not reasonably available (someone is “not reasonably available”when he/she cannot be reached by phone/m ail/emai l because, for example,
he/she is on active military duty or is incarcerated).
________________
___________________________________________
Printed Name of Parent / Guar dian / Legally Acceptable Representative
________________
___________________ __________________ ______ ____
Signature of Parent / Guardian / Legally Ac ceptable Representative Date of signature§
C
onsent of Second Par ent/Guardian/Legally Acceptable R epresentative:
As the consenting adult providing per missi on for this child to partici pate in the study, I
acknowledge that (Please check one of 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 / Relationship to study participant
Legally Acceptable Representative
________________
_________________________ ______________
Signature of Parent / Guardian / Date of signature§
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CLINICAL STUDY I NFORMED CONSENT
ADDENDUM Page:
7 of 7
Protocol Number:
C4591001 Associ ated ICD Ve rsion Date :
Parent ICD (03Feb2021) ICD Addendum Version D ate:
07Jul2021
Study
Country SiteLanguage: Englis h Center ID: Not Appli cable Country: Not Applica ble
CT05 -GSOP -RF07 3.0 Addendum ICD Template ( 01-Jun- 2016)
CONFIDENTIAL
TMF Doc ID : 173.1
5 (Study); 173.09 (Country/Central); 173.2 4 (Site) Legally Acceptable Representative
P
ERSON OBTAINING CONSENT
________________
____________________
Printed Name of the Person Conducting the
Consent Discussion
________________
_____________________ ______________
Signature of the Person Conducting th e Date of signature
Consent Discussion †
§Participant /parent/guardian/legally acceptable representative must personally date their
signature
†The investigator, or an appropriately qualified and trained person designated by the
investigator to conduc t the informed consent process, must sign and date the consent
document during the same interview when the participant/parent/guardian/legally
acceptable representative signs the addendum .
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CLINICAL STUDY
OLDER CHILDREN ASSENT ADDENDUM Page:
1 of 5
Protocol Number:
C4591001 Associ ated ICD Version Date :
Older Children Assent (03Feb2021) ICD Addendum Version Date :
07Jul2021
Study
Country SiteLanguage: Englis h Center ID: Not Applicable Country: Not Applicable
CT05 -GSOP -RF07 3.0 Addendum ICD Template ( 01-Jun- 2016)
CONFIDENTIAL
TMF Doc ID:
173.15 (Study); 173.09 (Country/Central); 173.2 4 (Site) OLDER CHILDREN ASSENT ADDENDUM FOR
A PHASE 1/2/3, PLACEBO -CONTROLLED, RANDOMIZED, OBSERVER-BLIND,
DOSE-FINDING STUDY TO EVALUATE THE SAFETY, TOLERABILITY,
IMMUNOGENICITY, AND EFFICACY OF SARS -COV -2 RNA VACCINE
CANDIDATES AGAINST COVID-19 IN HEALTHY INDIVID UALS
P
rotocol Number: C4591001
Y
ou have already signed the assent form to participate in the research study mentioned
above. This addendum is part of the assent procedure. It has been written to provide
you with additional information on your new s chedu le of study visits, tests, and
procedures . It also provides the latest information on study vaccine risks that you will
want to know . All other information in the main assent form not addressed in this
addendum still applies.
A
dministration of BNT 162b2 to Par ticipants Originally Assigned to Placebo
Y
ou were asked by the study s ite whether you would consider receiving BNT162b2
vaccine (will be referred as ‘active vaccine ’ or ‘active study vaccine’) if you received
placebo during the earl ier part of the study. Since it is confir med that you received
placebo, and e xpressed your willingness to receive the active vaccine, you ar e now
being asked to read and sign this assent form before conducting any new set of study -
related procedures. Your parent(s) or your guardian(s) will be asked to sign another
form.
A
fter signing this assent document, the study doctor will check if y ou meet all the
requirements to receive the active vaccin e. If you do not meet the requirements, you will
not be able to receive the vacci ne and the study doctor will explain why this is the case.
O
nce the study doc tor has confirmed you meet the study requi rements to receiv e active
vaccine , you will rec eive 2 injections, appr oximately 3 weeks apart . The injection will be
given into the musc le in your upper arm, just like how y ou received previous study
injections. After that , you, along with your parent (s) or guardian (s) will be asked to wait
at the study site for at least 30 minutes for observation after receivi ng the vaccine .
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CLINICAL STUDY
OLDER CHILDREN ASSENT ADDENDUM Page:
3 of 5
Protoco l Number:
C4591001 Associ ated ICD Ve rsion Date :
Older Children Assen t (03Feb2021) ICD Addendum Version D ate:
07Jul2021
Study
Country SiteLanguage: Englis h Center ID: Not Appli cable Country: Not Applica ble
CT05 -GSOP -RF07 3.0 Addendum ICD Template ( 01-Jun- 2016 )
CONFIDENTIAL
TMF Doc I
D: 173.15 (S tudy); 173.09 (Country/Central); 173.2 4 (Site) In addition to the above :
•you will remember that you have been asked to attend an extra visit to the study
site about a month after your potential COVID -19 illness visit. Now, that the study
team has obtained enough clinical data in the study from these visits, it is no
longer a requirement for you to attend this ext ra visi t after the potential COVID -19
illness.
•You will also rem ember that you hav e been asked to tell the study doctor
immediately if you or your partner become pregnant during the study, up until 6
months after your last study injection. However, the reporting duration has now
been revised to 28days after your last study injection.
Study Vaccine Risks
The injection could cause pain, swelling, and redness where it is given.
Other side effects could include: fatigue (tiredness) , increased body temperature (fever ),
chills , headache, diarrhea, joint aches , muscle aches , feeling sick (nausea) , being sick
(vomiting) , enlarged lymph glands , allergic reaction (symptoms may include rash,
itching, hives, and swelling of the face or lips) , decreased appetite, lethargy, sw eating
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, 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 in most of these people, symptoms began within a few days to a week
following vaccin ation. As a prec aution, y ou should seek medical attention right away if
you have any of the following symptoms after receiving the vaccine:
•Ches t pain
•Shortness of breath
•Feelings of having a fast -beating, fluttering, or pounding heart
P
lease also notify study staff, when appropriate, if you have any of these symptoms.
W
hilst some severe cases have been reported, most cases have been associated with
full resolution of symptoms in the short term, however, long-term follow -up is limited. It
is not known whether the risk of myocarditis or pericarditis is increased following
additional doses of the vaccine, e.g. following a booster dose.
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CLINICAL STUDY
OLDER CHILDREN ASSENT ADDENDUM Page:
4 of 5
Protoco l Number:
C4591001 Associ ated ICD Ve rsion Date :
Older Children Assen t (03Feb2021) ICD Addendum Version D ate:
07Jul2021
Study
Country SiteLanguage: Englis h Center ID: Not Appli cable Country: Not Applica ble
CT05 -GSOP -RF07 3.0 Addendum ICD Template ( 01-Jun- 2016 )
CONFIDENTIAL
TMF Doc I
D: 173.15 (S tudy); 173.09 (Country/Central); 173.2 4 (Site) If you have had myocarditis (inflammation of the heart muscle) or pericarditis
(inflammation of the lining outside the heart) previously, please tell your study doctor.
T
he study team will monitor you for risks or discomforts during the study. However, the
study team does not know all the effects that the vac cine, or your participation in this
study, may have on you.
Therefore, it is important that you report all symptoms and side effects that you
experience as soon as they occur, whether or not you thi nk they are c aused by the
study vaccine. Due to the way in which the study vaccines are made, they cannot caus e
COVID -19 disease.
P
lease take as much time as you need to ask questions from the research study team
before agreeing to receive the active vacc ine. You can circle or highlight things on this
paper you want to know more about. If you don’t understand something, just ask us. It is
okay to ask questions now and anytime later that you think of them.
Please check one box below to show whether or not you want to receive the
active study vaccine.
Yes, I want to receive the active study vaccine .
No, I do not want to receive the active study vaccine .
______________________________________________________ Printed Name of Child/Young Person
________________
_______________ ____________________ __________
Child/Young Person Signature Date Time
Statement of person conducting assent discussion:
1.I have explained all aspects of transition from placebo to active vaccine to the
partic ipant to the best of his or her abi lity to understand.
2.I have answered all ques tions of the partic ipant relating to this transition from
placebo to active vaccine .
3.I believe the partic ipant’s decision to receive or not receive active vaccine is
voluntary.
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OLDER CHILDREN ASSENT ADDENDUM Page:
5 of 5
Protoco l Number:
C4591001 Associ ated ICD Ve rsion Date :
Older Children Assen t (03Feb2021) ICD Addendum Version D ate:
07Jul2021
Study
Country SiteLanguage: Englis h Center ID: Not Appli cable Country: Not Applica ble
CT05 -GSOP -RF07 3.0 Addendum ICD Template ( 01-Jun- 2016 )
CONFIDENTIAL
TMF Doc I
D: 173.15 (S tudy); 173.09 (Country/Central); 173.2 4 (Site) 4.If the partic ipant decides to recei ve active vaccine , the study doctor and study staff
agree to respect the partic ipant’s physical or emotional dissent at any time during
this research when that dissent pertains to anything being done solely for the
purpose of this research.
P
rinted Name of Person Obtaining Assent: ____________________________
Signature of Person Obtaining Assent: ___________ Date: ________ Time: ______
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7.0 PHASE 1/2/3 CLINICAL STUDY
INFORMED CONSENT TEMPLATE 01-Jul-2019
Protocol Number: C4591001 ICD Version Date : Parent ICD, P hase 2/3, 02Jul2021
Study
Country
SiteLanguage: English Center ID: Not Applicable Country: Not
Applicable
ICD Derived From: Parent ICD, Phase 2/3 , 25Jun2021
CT05 -GSOP -RF04 7.0 Phase 1/2/3/4 Clinical Study Informed Consent Template (01-Jul-2019)
TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version (Study) Parent, Phase 2/3 , 02Jul2021
Protocol No: C4591001
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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 informat ion and contact information 4
2. Brief summary of this study 5
3. What is the purpose of this study? 6
4. How long will my child participate in this study? 7
5. How many adults and children will take part in this study? 7
6. What will happen during this study? 7
7. Are there any special instructions to follow for this study? 13
8. What are the possible risks and discomforts of this study? 13
9. What are the possible benefits of this study? 16
10. What will happen to my child’s blood and nasal swab samples? 17
11. What other choices do I have if I do not want my child join this
study?17
12.What happens if my child is injured during this study? 17
13.What if I join this study and then change my mind? 17
14.What will I have to pay for if I let my child take part in this study? 18
15.Will my child be paid for taking part in this study? 18
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16.What will happen to my child’s personal information? 19
17.Where can I find additional information about this study or the
study results?19
18.Signatures 19
Privacy Supplement
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1. Key Study Information and Contact Information
The study team will address any questions, concerns or complaints you or your child
may have before, during and after you r child complete the study. The study team
includes the study doctor, nurses, and others who work with the study doctor.
Phone numbers for the study team are listed below under “Study S ite Contact
Information.” You also will be given a card with important emergency contact
information, including a 24 -hour number. Show this card to any doctor, nurse or
other health care provider if your child seeks emergency care while 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 or the Independent Ethics Committee,
patient rights advocate, and/or bioethicist ] listed below.
Name of Study: A PHASE 1/2/3, PLACEBO -CONTROLLED, RANDOMIZED,
OBSERVER -BLIND, DOSE -FINDING STUDY TO EVALUATE THE SAFETY,
TOLERABILITY, IMMUNOGENICITY, AND EFFICACY OF SARS -COV -2 RNA
VACCINE CANDIDATES AGAINST COVID -19 IN HEALTHY INDIVIDUALS
[Institution] Study Number:
Sponsor Study Number: C4591001
Name of Company Sponsoring the Study: BioNTech. Pfizer is conducting the study
for BioNTech
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 or Independent Ethics Committee ] Contact
Information:
Contact Person:
Address:
Phone Number:
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Sponsor Consent Version (Study) Parent, Phase 2/3 , 02Jul2021
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Patient Rights Advocate:
Contact Person:
Address:
Phone Number:
Bioethicist:
Contact Person:
Address:
Phone Number:
2. Brief Summary of this Study
You are being asked to allow your child to take part in a research study that involves
comparing an investigational (study) vaccine against a placebo (injection with no active
ingredient) to see if the vaccine can prevent COVID -19. The vaccine is given by
injection.
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 take part 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 a n opportunity to
meet privately with a member of the study team to ask confidential questions. Your child
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 l aw. Also, if your child
reach es the legally recognized age of majority (adulthood) during the study, they must
separately provide their consent to continue taking part in the study.
You are being asked to allow your child to be in this research study becau se your child
is healthy and over the age of 12.
This is a research study involving both Pfizer and B ioNTech . Pfizer and BioNTech are
separate companies who are cooperating to perform this study. Pfizer is responsible for
conducting this study. B ioNTech is the regulatory sponsor of this study. Funding for this
study is provided by BioNTech and Pfizer and [the study doctor/institution] will be paid
to conduct this study.
A new respiratory disease appeared in Wuhan, China in December 2019 and has si nce
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 quickly started to look for treatments and ways to prevent COVID -19.
Vaccines help your body to produce antibodies to help you to fight off a disease . This
research study involves 2 investigational vaccines to prevent COVID -19, that will be
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given to volunteers . The vaccines are given by injection. The vaccines are slightly
different but work in the same way. The study will also test each of these vaccines at
different dose levels (amounts of vaccine).
These vaccines do not cont ain the whole virus, or the parts of the virus that can make
your child ill, instead the vaccines are made up of part of the virus’s genetic code,
surrounded by fatty particles called lipids. They use a persons 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. We will check how many antibodies you r child
make s by taking blood samples and testing them .
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 you r child need s 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 to t aking part in this study is voluntary (your choice). There is n o
penalty or change to you or your child’s regular medical care if y ou decide not to allow
your child to participate. You can choose to let your child take part in the study now, and
then change your mind later at any time without losing any benefits or medical care to
which you or your child are entitled. We encourage you to have conversations with your
family, friends , doctors, and study team about this study and whether it is right for your
child. The study team will wor k with you to answer any questions that you may have
about the study.
You will receive a signed copy of this consent document for your records. Please keep
this consent document for your reference.
3. What is the purpose of this study?
The World Health Organ ization (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
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quickly as possible, this study has been separated into 2 phase s. In both the phase s we
will try to see if the vaccine works to prevent COVID -19, as well as :
•Phase 1 where we choose which vaccines at which dose levels are safest and
make the most antibodie s.
•Phase 2/3 where we look at one vaccine at one dose level in lots of people to
collect even more information about the safety of the vaccines and the amounts
of antibodies they produce .
Your child is being asked to take part in Phase 2/3.
The study will compare the results of the people who receive the study vaccine
(BNT162b2 ) with those who receive a placebo (a placebo does not contain any active
ingredients). In this study the placebo will be salt-water, also known as normal saline.
Everyone in Phase 2/3 of the study will receive 2 injections of either:
•Study vaccine followed by study vaccine
•Placebo followed by placebo
In Phase 2/3 everyone who receives the study vaccine will receive the same vaccine at
the same dose, that was chosen based on the results from Phase 1.
The study doctor will determine whether you r child is eligible for the study. This study
will require y our child to visit the study doctor to undergo study procedures and to
provide information about their health. You/your child will also be required to contact
the study doctor if your child experience any of the COVID -19 symptoms (explained
later in this document).
4. How long will my child participate in this study?
Your child could be in this study for up to about 26 months and will need to visit the
study site 6 or 7 planned times during the study . Your child will also need to visit the
study site if they experience COVID -19 symptoms .
5. How many adults and children will take part in this study?
Approximately 44,193 volunteers could take part in the 2 phase s of this study.
In Phase 2/3 of the study up to 43,998 volunteers will take part , in which approximately
2000 will be of 12 to 15 years of age and the remaining will be above the age of 16
years .
6. What will happen during this study?
Before any study procedures begin, or before you r child begin s preparing for the study,
you will be asked to read and sign this consent document. We may also ask your child
to read and sign a similar document.
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Sponsor Consent Version (Study) Parent, Phase 2/3 , 02Jul2021
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After signing this consent document, the study doctor will check if you r child meet s all of
the requirements to take part in this study. If you r 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.
Study Vaccine s
Once the study doctor has confirmed you r child meet s the study requirements , you r
child will be randomly assigned (like flipping a coin) to receive the study vaccine or
placebo. For every 1 volunteer who receive s the study vaccine, 1 volunteer will receive
the placebo. No one (including you, your child, your child’s personal doctor or the study
team) can choose th is assignment .
This is a n ‘observer -blind study’ , which means that you , your child and the study doctor
will not know whether you r child will receiv e the study vaccine or placebo . The person
who gives you r child the vaccine will know because the vaccine and placebo do not look
the same . The syringe will be covered with a label so the co ntents are not visible and
the person that gives you r child the vaccine will not be able to talk about it. In case of
urgent need, the study doctor can learn quickly whether you r child received study
vaccine or placebo .
The study vaccine or placebo will b e given to you r child through an injection into the
muscle of the upper arm. All volunteers will receive 2 injections, approximately 3 weeks
apart. On the days you r child receive s the study vaccine or placebo, you and your child
will be asked to wait at the study site for at least 30 minutes for observation .
Overview of Study Procedures and Assessments
The table below lists the tests and procedures or assessments that will be done in this
research study. In addition to the visits listed, the study doctor may ask you r child to
come in for extra visit(s) if necessary, to protect their well-being.
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Blood samples for antibody testing
Your child will have blood taken 5 times during the planned visits of the study. This will
be used to test if they already had antibodies against the coronavirus that causes
COVID -19 when they enrolled in the study and may be used to test their antibody levels
after vaccination . If you r child is 16 years of age or above , about 20 mL of blood (about
4 teaspoons) will be collected f rom their arm using a needle at these visits. Alternatively,
if your child is between 12 to 15 years of age , about 10 mL of blood (about 2 teaspoons)
will be collected from their arm using a needle at the above specified visits.
E-Diary
At Visit 1, the study team will show you or your child how to fill in an electronic diary (or
e-Diary). Parent(s)/ legal guardian (s), as appropriate, will be required to complete the e -
diary on behalf of y ounger age group children , whilst children in older age group might
not require similar level of support from their parent(s)/ legal guardian (s). Therefore,
older age group children (e.g. 16 years or above ) are expected to complete the e -diary
themselves.
We will either give you/ your child a device (a bit like a mobile phone) or ask to
download an application (‘app’) to smart phone if you or your child has one. The
device/app is secure, and your child’s confidentiality will be maintained.
There are 2 parts to the e -Diary. Everyone will nee d to complete the COVID -19 illness
part of the e -Diary on the device or app on their smartphone. The COVID -19 illness e -
Diary will prompt you/ your child to record any COVID -19 symptoms (see below) every 7
days or at any time you r child has COVID -19 symptoms. You or your child may also
receive text messages to the device or your /your child’s own smartphone, or emails (if
you/they provide your /their email address) to remind you /your child to complete the
COVID -19 illness part of the e -Diary.
If you r child is part of a subset of participants, you/ your child will also be instructed by
the study team to complete the vaccination part of the e-Diary for 7 days after each
vaccination, once a day in the evening with the first day being the day of the
vaccination.
You/ your child will be given a thermometer and a measuring device to take home. You/
your child will use the thermometer to measure temperature under the tongue and will
use the measuring device to measure any redness or swelling where the injection was
given. You/ your child will need to record these measurements in the vaccination part of
the e-Diary.
The vaccination part of the e-Diary will also ask other questions ab out potential side
effects you r child may have after the injection. If you r child has any severe symptoms
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after vaccination, you/ your child should contact your study doctor and the study doctor
or nurse may schedule an extra visit.
It is very important that you / your child, as appropriate, complete the e -Diary regularly
as instructed. If this was not completed , your study doctor or nurse will contact you / your
child to check how your child is doing .
Urine pregnancy test
If your child is female and has started her periods, she will be asked to provide a urine
sample to check she is not pregnant before given the study injection .
What happens if my child has positive nasal swab test result?
Nasal swabs obtained during the study (at Visits 1 and 2, and at the time of a potential
COVID -19 illness – see below) will be tested in a research laboratory. P ositive results
from the Visit 1 and 2 swabs, and all results from the illness visit swabs, will be provided
to your study doctor, but this will take some time so you should not rely on these for
your child’s medical treatment .
If You r Child Gets COVID -19 Symptoms
If you r child gets any of the following you must contact the study doctor straight
away . Note that this is not instead of routine medical care. If you r child feels
unwell enough that you would normally see a healthcare professional, please
contact your usual provider , as we ll as the study doctor .
•A diagnosis of COVID -19;
•Fever;
•New or increased cough;
•New or increased shortness of breath;
•Chills ;
•New or increased muscle pain ;
•New l oss of taste/smell ;
•Sore throat ;
•Diarrhea;
•Vomiting .
The study doctor may ask you /your child to have a telephone conversation , video call or
to visit the site 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 nose swab ,
or the study team may take a swab to check for the coronavirus. We will give you /your
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child separate instructions about how to take a nose swab and how to ship the swab to
the laboratory if needed . The result from this swab will be provided to the study docto r
once it is available, but this will take some time, and cannot be used to diagnose
COVID -19. This is why it is important that you contact your usual provider if you r child
has COVID -19 symptoms and think you r child need s medical care.
If your child is diagnosed with COVID -19, for the purposes of the study, the study doctor
will contact your child’s usual provider , and any facility where you child is treated , to
obtain details and collect medical records : by signing this informed consent document,
you agree to this .
After the study
The study vaccine is available only during this study and not after the study is over. If
you leave the study before receiving the study vaccine, it may be available to you
through an authorized healthcare professional.
7. Are there any special instructions to follow for this study?
It is important you and your child follow all the instructions given by the study nurse or
doctor and tell them if:
•You don’t understand anything about the study
•You /your child are not able to comply with the study requirements
•There are changes in your child’s health
•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
8. What are the possible risks and discomforts of this study?
Any research has some risks, which may include negative effects that could make you r
child unwell or uncomfortable and even potentially be serious or life -threatening. All
research participants taking part in the study will be watched carefully for any negative
effects; however, the study team does not know all the effects that the study vacci ne
may have on you r child .
If you r child takes part in this study, the most likely risks or discomforts are discussed
below.
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It is important that you / your child report to the study team all symptoms and side
effects as soon as they occur. Phone numbers for the study team are listed in
[Section 1 ] of this consent document.
Study Vaccine Risks
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 rece ived 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 (sym ptoms 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 BN T162b2.
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 , in most of these people, symptoms began within a few days to a week
following vaccination . As a precaution, your child should seek medical attention right
away if you r child has any of the following symptoms after receiving the vaccine:
•Chest pain
•Shortness of breath
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•Feelings of having a fast -beating, fluttering, or pounding heart
Please also notify study staff, when appropriate, if you r child has any of these symptoms.
Whilst some severe cases have been reported, most cases have been associated with
full resolution of symptoms in the short term, however, long -term follow -up is limited. It is
not known whether the risk of myocarditis or pericarditis is increased following additional
doses of the vaccine, e.g. following a booster dose.
If you r child has had myocarditis (inflammation of the heart muscle) or pericarditis
(inflammation of the lining outside the heart) p reviously, please tell their 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 / your child report all symptoms and side effects that
your 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 es COVID -19 disease, could the vaccine make it worse?
For some other vaccines tested in animals against similar viruses (but not the coronavirus
that causes COVID -19), there have been reports of the illness being more severe in the
animals that received the vaccine than in those that did not. So far this has not been seen
with BNT162b2. It remains i mportant for you / your child to contact your child’s study
doctor if you r child develop symptoms that might be caused by COVID -19 (for example,
fever, cough, shortness of breath).
Placebo Risks
As the placebo injection contain s salt -water and no active ing redients, the chances of
having the side effects mentioned above are less likely. In other studies, using the same
placebo , some volunteers who received the placebo injection reported pain, bruising,
swelling and redness at the site of injection.
Risks from Study Procedures
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TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version (Study) Parent, Phase 2/3 , 02Jul2021
Protocol No: C4591001
CONFIDENTIAL Page:
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Risks and possible discomforts 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. You r child may feel dizzy
or may faint. If you r child has a previous history of feeling dizzy or fainting during
blood sample collection, you should talk to the study doctor.
• Nasal S wabs : The risks and possible discomforts invo lved in takin g 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, plans to become pregnant, or is breast feeding a child,
they should not join this study.
If you r child is able to have children and is sexually active, they must use birth control
consistently and correctly for at least 28 days after they receive their last injection . This
applies to males as well as females who take part in the research study. The study
doctor will discuss with you r child the methods of birth control that they should use while
in this research study . The study doctor will help you r child select the method that is
appropriate for them . The study doctor will also check that you r child understand s how
to use the birth control method and may review this with them at each of their research
study visits.

Birth control methods, even wh en used properly are not perfect. If you r 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 . You r child may b e withdrawn from the research study if they stop using
birth control or they become pregnant.

Pregnancy Follow -up
If you r child or their your partner become pregnant during the study, up until 28 days
after their last study injection , please tell the study doctor immediately . Please also tell
the doctor who will be taking care of your child/their partner during the pregnancy that
your child 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
BioNTech/ Pfizer for safety follow -up.

9. What are possible benefits of this study?
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Sponsor Consent Version (Study) Parent, Phase 2/3 , 02Jul2021
Protocol No: C4591001
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Vacci nation with BNT162b2 has been shown to be effective in preventing COVID -19.
You child should still follow local recommendations about how to avoid COVID -19 (for
example, social distancing and mask use).
10. What will happen to my child’s blood and nasal swab
samples?
Your child’s blood and nasal swab 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 you r child is. Some of the samples may be stored for future
testing and may be kept for up to 15 years after the study ends, at which time they will
be destroyed. In addition to testing for this study, any samples left over after the study
is complete may be used for additional research related to the development of products.
No testing of your child’s DNA will be performed.
You may request that your child’s samples, if they can be identified, be destroyed at any
time. Any data already collected from those samples will still be used for the study. The
samples will remain the property of BioNTech/ Pfizer and may be shared with other
researchers as long as confidentiality is maintained, and no testing of your child’s DNA
will be performed. You and your child will not be told of additional tests, nor will you or
your child receive results of any of the se tests.
11. What other choices do I have 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 .
12. 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 -specif ic research injury language must be included verbatim in the
country -level ICD .
13. Can I withdraw my child from the study?
Yes. You are free to withdraw your consent for your child and discontinue their
participation in the research study at any time . Your decision will not affect your or your
child’s regular medical care or any benefits to which you /your child is are entitled. Tell
the study doctor if you are thinking about stopping or decide to stop so that you r child
can end participation in the study in the safest way.
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 change your mind about
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TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version (Study) Parent, Phase 2/3 , 02Jul2021
Protocol No: C4591001
CONFIDENTIALPage:
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your child continuing in this study. If you decide to withdraw your child from the study,
your child may be asked to continue to participate in the study procedures even though
they would no longer receive the study vaccine.
If your child continue s with the study, information about their 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 i s not in your child’s best interest or that they
are no longer eligible to participate; or
•The study is stopped by BioNTech/Pfizer , the institutional review board (IRB) or
independent ethics committee (IEC) (a group of people who review the study to
protect your 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 child’s personal information
(including biological samples) and how it may be used if you withdraw your child from
the study.
14. What will I have to pay for if my child takes part in this study?
You will not need to pay for any of the study vaccines (COVID -19 Vaccine or placebo),
study -related procedures, or study visits.
15. 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 complete s, you will be reimb ursed 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; and reimbursement schedule ; note whether receipts are
required].
BioNTech/Pfizer may use information resulting from the study to develop products or
processes from which they may make a profit. There are no plans to pay you /your child
or provide you /your child with any products developed from this research.
BioNTech/Pfizer will own all products or processes that are developed using information
from the study.
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CT05 -GSOP -RF04 7.0 Phase 1/2/3/4 Clinical Study Informed Consent Template (01-Jul-2019)
TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version (Study) Parent, Phase 2/3 , 02Jul2021
Protocol No: C4591001
CONFIDENTIALPage:
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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 to participate.
2. I have read and understand the Privacy Supplement. I understand that taking part
in the study will require the processing (including colle ction, 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 he alth care,
medical research and/or regulatory purposes.
3. I understand that taking 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 tim e. I do not need to give any reason and my child’s
regular medical care and legal rights will not be affected. However, even if I
withdraw my consent to processing, my child’s personal information held at that
time may be kept to comply with laws and regul ations and to maintain the integrity
of the study. I also understand that my child’s biological samples may not be able
to be destroyed because they may no longer be traceable to my child , may have
already been used, or may have been given to a third part y.
4. I agree to the study team accessing my child’s medical history, including
information from medical records and test results and any medical treatment my
child receive during the course of the study, and if necessary, contacting my
child’s doctor or any other health care providers treating my child for access to
such information.
5. I understand that BioNTech/Pfizer and/or others working with or on behalf of
BioNTech/Pfizer , institutional review boards (IRBs) or independent ethics
committees (IECs) , and regulatory agencies may need access to personal
information about my child generated at the study site or collected by the study
team for the study and any other research. I agree that they may have access to
my child’s personal information.
6.I do not give up any of my child’s legal rights by signing this consent document. I
have been told that I will receive a signed and dated copy of this document.
7. I agree for my child to take part in the study described in this document.
In the section below, the term “legally acceptable representative” should be replaced with the
term required per local regulation (country -level).
As the consenting adult providing permission for this child to participate in the study, I
acknowledge that ( Please check one of the following):
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Sponsor Consent Version (Study) Parent, Phase 2/3 , 02Jul2021
Protocol No: C4591001
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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.
[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 one of the following):
□I have sole legal responsibility for the care and custody of the child.
□The other adult(s) with whom I share legal responsibility for the care and custody of the
child (for example, biological parent, adoptive parent, or legal guardian or representative)
is (1) aware of and agrees with my granting permission for this child to participate in the
study OR (2) deceased, unknown, incompetent, or not reasonably available (someone is
“not reasonably available” when he/she cannot be reached by phone/mail/email because,
for example, he/she is on active military duty or is incarcerated) .
_____________________________________
Printed name of parent/guardian/legally acceptable representative
________________________________________________ ______________
Signature of parent/guardian/legally acceptable representative Date of signature§
[Include the statements and signature lines below for a second parent/guardian/legally
acceptable representative if (1) required by the IRB/IEC; (2) required by local law ( e.g.,
parents are divorced and have shared custody of the child); or (3) the second
parent/guardian/legally acceptable representative is (or would like to be) involved in
the consent process and there is reason to believe that he/she may disagree with the
decision of the first parent/guardian/legally acceptable represen tative.
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 one of the following):
□I am the biological or adoptive parent of the child.
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CT05 -GSOP -RF04 7.0 Phase 1/2/3/4 Clinical Study Informed Consent Template (01-Jul-2019)
TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version (Study) Parent, Phase 2/3 , 02Jul2021
Protocol No: C4591001
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□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§]
Person Obtaining Consent:
_____________________________________________
Printed name of person conducting the consent discussion
_____________________________________________ ______________
Signature of person conducting the consent discussion† Date of signature
§ Participant /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 th e consent document during the
same discussion when the participant’s parent/guardian/legally acceptable representative signs
the consent document .
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CT05 -GSOP -RF04 7.0 Phase 1/2/3/4 Clinical Study Informed Consent Template (01-Jul-2019)
TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version (Study) Parent, Phase 2/3 , 02Jul2021
Protocol No: C4591001
CONFIDENTIALPage:
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PRIVACY SUPPLEMENT
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.
Who will use my child’s personal information, how will they use it, and where will
it be stored?
[Mandatory study language – retain the below paragraph and delete this green text before
finalis ation]
Any personal information collected about you /your child during this study will be entered
into records, including health records, maintained by the study team at your study site.
You/your child’s records that include information that directly identifies you/your child may
be uploaded to secure systems maintain ed by a third party engaged by BioNTech/ Pfizer
so that BioNTech/ Pfizer and/or BioNTech/ Pfizer representatives can review and verify
study data. Some of the uploaded records will be kept for XX years. The remaining
records that are uploaded will be tempor ary and removed from the secure system after
the study is over.
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SD-GL11 1.0 PHASE 1/2/3 CLINICAL STUDY ASSENT
TEMPLATE FOR OLDER CHILDREN 30-Apr-2020
Protocol Number: C4591001 Assent Version Date : Phase 2/3, 02Jul2021
Study
Country
SiteLanguage: English Center ID: Not Applicable Country: Not Applicable
Assent Derived From: Older Children Assent, Phase 2/3, 25Jun2021
CT05 -GSOP -SD-GL11 Phase 1/2/3/4 Clinical Study Assent Template for Older Children 30 -Apr-2020
TMF Doc ID: 173.16 (Study); 173.10 (Country/Central); 173.20 (Site)
Sponsor Assent Version Number (Study/Country/Site) : Phase 2/3 , 02Jul2021
Protocol No. C4591001 / CONFIDENTIALPage 1
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•This template is used by informed consent document authors to develop the assent document for
11-year-olds through legal age of adulthood .
•Do not delete the header at the top of this page until the assent is customized at the country/site -
level.
•Before sending the assent to the institutional review board (IRB) /independent ethics committee
(IEC) , remove the header at the top of this page, rem ove all inapplicable text, remove all
instructional green text, and replace all blue text with appropriate language.
•The assent must be filed in the Pfizer Trial Master File .
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SD-GL11 1.0 PHASE 1/2/3 CLINICAL STUDY ASSENT
TEMPLATE FOR OLDER CHILDREN 30-Apr-2020
Protocol Number: C4591001 Assent Version Date : Phase 2/3, 02Jul2021
Study
Country
SiteLanguage: English Center ID: Not Applicable Country: Not Applicable
Assent Derived From: Older Children Assent, Phase 2/3, 25Jun2021
CT05 -GSOP -SD-GL11 Phase 1/2/3/4 Clinical Study Assent Template for Older Children 30 -Apr-2020
TMF Doc ID: 173.16 (Study); 173.10 (Country/Central); 173.20 (Site)
Sponsor Assent Version Number (Study/Country/Site) : Phase 2/3 , 02Jul2021
Protocol No. C4591001 / CONFIDENTIALPage 2
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We are asking if you would like to be in a research study to see if a vaccine to prevent
COVID -19 is safe and if it can help prevent children and adults from getting COVID -19.
Research studies are the way we find out if test medicines or vaccines are safe and if they
work.
The study is being done with healthy children and adults and that is why the study doctor
wants to know if you want to take part in the research study .
WHY ARE WE DOING THIS STUDY ?
We are doing this study to collect information in children and adults to see if the vaccine is
safe and if it can help prevent people from getting COVID -19.
The study doctor and nurses will explain the study and answer any questions that you have.
You can circle or highlight things on this paper you want to know more about. If you don’t
understand something, just ask us. It is okay to ask questions now and anytime later that you
think of them.
If you decide to be in this study, you will be asked to sign this form. Your parent(s) or your
guardian(s ) will sign another form. You can talk to your parent(s) or your guardian(s) and ask
to read the information the study doctor gives them .
WHAT WILL HAPPEN TO ME IF I GO INTO THE STUDY ?
The study starts with a n appointment with the study doctor and some tests to see if you can
be in the study. If you decide to take part in the study you will be given an injection in your
arm at your first and second visit and will need to give at least 5 blood samples. There will be
at least 6 visits to the study clinic over roughly the next 2 years.
If you get ill with COVID -19 like symp toms, the study doctor may ask you to have a telephone
conversation, video call or to visit the site to talk about how you are feeling and if you have
needed any other medical care.
A RESEARCH STUDY TO SEE IF A VACCINE AGAINST COVID -19
IS SAFE AND WORKS
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SD-GL11 1.0 PHASE 1/2/3 CLINICAL STUDY ASSENT
TEMPLATE FOR OLDER CHILDREN 30-Apr-2020
Protocol Number: C4591001 Assent Version Date : Phase 2/3, 02Jul2021
Study
Country
SiteLanguage: English Center ID: Not Applicable Country: Not Applicable
Assent Derived From: Older Children Assent, Phase 2/3, 25Jun2021
CT05 -GSOP -SD-GL11 Phase 1/2/3/4 Clinical Study Assent Template for Older Children 30 -Apr-2020
TMF Doc ID: 173.16 (Study); 173.10 (Country/Central); 173.20 (Site)
Sponsor Assent Version Number (Study/Country/Site) : Phase 2/3 , 02Jul2021
Protocol No. C4591001 / CONFIDENTIALPage 3
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At your first visit, the study doctor or nurse will give you or your parent(s) / guardian (s) a
device (a bit like a mobile phone) or ask to download an applicati on (‘app’) to smart phone if
you or your parent(s)/ guardian (s) have one. The device/app is secure and your information
will be maintained in con fidence. The study doctor will show you or your parent(s)/
guardian(s) on how to fill in the electronic diary (also called e -Diary).
There are 2 parts to the electronic diary . Everyone will need to complete the COVID -19
illness part of the e -Diary on the device or app on their smartphone. The COVID -19 illness e -
Diary will prompt you or your p arent(s)/ guardian(s) to record any COVID -19 symptoms every
7 days or at any time you have COVID -19 symptoms. You or your parent(s)/ guardian(s) may
also receive text messages to your / their device or your / their own smartphone, or emails (if
you or your parent(s)/ guardian(s) provide an email address) to remind you or your parent(s)/
guardian(s) to complete the COVID -19 illness part of the e -Diary.
If you are part of a selected group of participants , you or your parent(s)/ guardian (s) will also
be asked to fill in an e-Diary about how you are feeling for 7 days afer your vaccine injections .
If you decide the take part t he following will happen:
At your first visit:
•Before you are given your injection , the study doctor or nurse will take your
temperature , measure your height and weight, do a physical exam and ask you some
questions about your health.
•The study doctor or nurse will take a blood sample from your arm using a needle (this
will be either 20mL or 10 mL depending on your age gr oup) and take a sample from
your nose using a swab (like a Q -tip).
•You will then be given an injection into the muscle at the top of your arm.
•If you are part of the selected group of participants, y ou or your parent(s)/ guardian (s)
will be asked to complete an electronic diary about how you are feeling for 7 days after
the visit.
At your second visit:
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TEMPLATE FOR OLDER CHILDREN 30-Apr-2020
Protocol Number: C4591001 Assent Version Date : Phase 2/3, 02Jul2021
Study
Country
SiteLanguage: English Center ID: Not Applicable Country: Not Applicable
Assent Derived From: Older Children Assent, Phase 2/3, 25Jun2021
CT05 -GSOP -SD-GL11 Phase 1/2/3/4 Clinical Study Assent Template for Older Children 30 -Apr-2020
TMF Doc ID: 173.16 (Study); 173.10 (Country/Central); 173.20 (Site)
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Protocol No. C4591001 / CONFIDENTIALPage 4
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•You will be given your second injection , the study doctor or nurse will take your
temperature and ask you some questions about your healt h before they give your
inject ion in your arm.
•If you are part of the selected group of participants, y ou or your parent(s)/ guardian (s)
will be asked to complete an electronic diary about how you are feeling for 7 days after
the visit.
It is very important that you or your parent(s)/ guardian(s) , as appropriate, complete the
e-Diary regularly as instructed. If this was not completed , your study doctor or nurse will
contact you or your parent(s)/ guardian(s) to check how you are doing.
At the other 4 visits the study doctor or nurse will ask you some questions about your health
and will take a blood sample from your arm using a needle. Each blood sample will be either
about 2 0mL (4 teaspoons) or 10 mL (2 teaspoons) depending on your age group.
When you visit the study doctor, the study doctor will write down information about you. Only
people who are working on this study will see your information. They are required to keep
your information private.
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SD-GL11 1.0 PHASE 1/2/3 CLINICAL STUDY ASSENT
TEMPLATE FOR OLDER CHILDREN 30-Apr-2020
Protocol Number: C4591001 Assent Version Date : Phase 2/3, 02Jul2021
Study
Country
SiteLanguage: English Center ID: Not Applicable Country: Not Applicable
Assent Derived From: Older Children Assent, Phase 2/3, 25Jun2021
CT05 -GSOP -SD-GL11 Phase 1/2/3/4 Clinical Study Assent Template for Older Children 30 -Apr-2020
TMF Doc ID: 173.16 (Study); 173.10 (Country/Central); 173.20 (Site)
Sponsor Assent Version Number (Study/Country/Site) : Phase 2/3 , 02Jul2021
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What are the Study Injections ?
There are 2 types of injections in the study. The active study injection and a dummy placebo
injection. A dummy placebo is a pretend vaccine that looks just like the test vaccine but has
no active ingredients in it.
Once the study doctor has checked that it is OK for you to be in the study a computer will
decide if you will get the active study injection or the dummy placebo. You and your
parent(s)/guardian(s) will not be told which injection you will get.
For every 1 child/ young person who receive s the study vaccine, 1 child/ young person will
receive the placebo. No one (including you, your parents, your personal doctor or the study
team) can choose which injection you will get .
WHAT ARE THE POSSIBLE BENEFITS TO ME IF I AGREE TO BE IN THIS
STUDY?
Vaccination with BNT162b2 (which is active study injection) has been shown to be effective
in preventing COVID -19. You should still follow local recommendations about how to avoid
COVID -19 (for example, social distancing and mask use).
WHAT ARE THE POSSIBLE UNCOMFORTABLE OR HARMFUL THINGS
THAT COULD HAPPEN TO ME IF I AGREE TO BE IN THIS STUDY?
There is a chance that during the study you could feel pain or feel bad or uncomfortable.
Please let the study doctor know if you experience any of these things. The study team will
monitor you for risks or discomforts during the study. However, the study team does not
know all the effects that the vaccine, or your participation in this study, may have on you.
The inje ction could cause pain, swelling, and redness where it is given .
Other side effects could include fatigue (tiredness), increased body temperature (fever),
chills, headache, diarrhea, joint aches, muscle aches, feeling sick (nausea), being sick
(vomiting), enlarged lymph glands, allergic reaction (symptoms may include rash, itching,
hives, and swelling of the face or lips), decreased appetite, lethargy, sweating and night
sweats, pain i n arm, feeling weak or unwell, and severe allergic reaction (anaphylaxis).
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TEMPLATE FOR OLDER CHILDREN 30-Apr-2020
Protocol Number: C4591001 Assent Version Date : Phase 2/3, 02Jul2021
 Study
 Country
 Site Language: English Center ID: Not Applicable
Country: Not Applicable

Assent Derived From: Older Children Assent, Phase 2/3, 25Jun2021

CT05 -GSOP -SD-GL11 Phase 1/2/3/4 Clinical Study Assent Template for Older Children 30 -Apr-2020
TMF Doc ID: 173.16 (Study); 173.10 (Country/Central); 173.20 (Site)
Sponsor Assent Version Number (Study/Country/Site) : Phase 2/3 , 02Jul2021
Protocol No. C4591001 / CONFIDENTIAL Page 6
of 9

Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining
outside the heart) have occurred in some people who have received the active study vaccine .
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 occu r is very low and , in most
of these people, symptoms began within a few days to a week following vaccination . As a
precaution, y ou should seek medical a ttention right away if you have 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 you have any of these symptoms.

Whilst some severe cases have been reported, most cases have been associated with full
resolution of symptoms in the short term, however, long -term follow -up is limited. It is not
known whether the risk of myocarditis or pericarditis is increased following additional doses of
the vaccine, e.g. following a booster dose.

If you have had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of
the lining outside the heart) previously, please tell your study doctor.

In addition,
• Taking a blood sample may:
o hurt when the needle goes into your arm.
o cause a red spot or bruise on your arm or your arm might feel sore.
o make you feel dizzy.
o cause an infection at the place where the needle went into your arm.
• Taking a swab from your nose may:
o hurt when the sample i s taken.
o Cause your nose to bleed .
• You may feel embarrassed by the questions the study doctor or nurse asks you.
090177e19778175a\Approved\Approved On: 02-Jul-2021 17:37 (GMT)
Page 46
FDA-CBER-2022-5812-0224602
CT05 -GSOP -
SD-GL11 1.0 PHASE 1/2/3 CLINICAL STUDY ASSENT
TEMPLATE FOR OLDER CHILDREN 30-Apr-2020
Protocol Number: C4591001 Assent Version Date : Phase 2/3, 02Jul2021
Study
Country
SiteLanguage: English Center ID: Not Applicable Country: Not Applicable
Assent Derived From: Older Children Assent, Phase 2/3, 25Jun2021
CT05 -GSOP -SD-GL11 Phase 1/2/3/4 Clinical Study Assent Template for Older Children 30 -Apr-2020
TMF Doc ID: 173.16 (Study); 173.10 (Country/Central); 173.20 (Site)
Sponsor Assent Version Number (Study/Country/Site) : Phase 2/3 , 02Jul2021
Protocol No. C4591001 / CONFIDENTIALPage 7
of 9
You might also feel other things. Remember to tell your parent(s) or your guardia n(s) and the
study doctor everything you are feeling while you are in the study including if you feel unwell .
Pregnancy, Contraceptives and Babies (do I need to use birth control?)
If you are a girl :
If you are pregnant, planning to become pregnant or breast feeding a baby, you cannot be in
the study.
If you think you are pregnant during the study, you must tell the study doctor immediately.
The study doctor may ask for information about the pregnan cy and the birth of the baby. The
study doctor may share this information with others who are working on this study.
If you have started to have periods, the study doctor or nurse will test your urine to make sure
you are not pregnant before you are give n your injections . The doctor or nurse will tell you if
the test results show you are pregnant. Depending on the laws of your area, the study doctor
or nurse may also tell your parent(s) or your guardian(s) about the results of the pregnancy
test.
If you are sexually active, you must use birth control consistently and correctly during the
study and for at least 28 days after your second injection . Your study doctor or nurse will
discuss this wit h you if it is appropriate to do so.
If you are a boy :
If you are sexually active, you must use birth control (eg a condom) consistently and correctly
during the study and for at least 28 days after your second injection. Your study doctor or
nurse will di scuss this with you if it is appropriate to do so.
If you think that you may have gotten a girl pregnant, you must tell your 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.
WHAT OTHER OPTIONS ARE THERE?
090177e19778175a\Approved\Approved On: 02-Jul-2021 17:37 (GMT)
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FDA-CBER-2022-5812-0224603
CT05 -GSOP -
SD-GL11 1.0 PHASE 1/2/3 CLINICAL STUDY ASSENT
TEMPLATE FOR OLDER CHILDREN 30-Apr-2020
Protocol Number: C4591001 Assent Version Date : Phase 2/3, 02Jul2021
Study
Country
SiteLanguage: English Center ID: Not Applicable Country: Not Applicable
Assent Derived From: Older Children Assent, Phase 2/3, 25Jun2021
CT05 -GSOP -SD-GL11 Phase 1/2/3/4 Clinical Study Assent Template for Older Children 30 -Apr-2020
TMF Doc ID: 173.16 (Study); 173.10 (Country/Central); 173.20 (Site)
Sponsor Assent Version Number (Study/Country/Site) : Phase 2/3 , 02Jul2021
Protocol No. C4591001 / CONFIDENTIALPage 8
of 9
This study is for research purposes only. Your alternative is to not take part in this study.
Taking part is voluntary and you do not have to be in the study if you don’t want to.
It is your choice if you want to be in this study or not. No one will be mad if you choose not to
take part.
Your doctors or your parent(s) or your guardian(s) cannot make you be in the study if you
don't want to be in it. If you say okay now to being in the study and you change your mind
about it later, you can stop being in the study. Just tell the study doct or or your parent(s) or
your guardian(s) if you want to stop at any time . If you quit the study, you will be asked to
come in for one last visit.
WHAT IF I HAVE QUESTIONS?
You can ask questions about the study at any time.
You can call the study docto r any time.
If you want to ask questions about what it means to be in a research study, you or your
parent(s) or your guardian(s) can call [insert IRB /IEC name ] (a group of people who review
the study to protect your rights) at [insert IRB /IEC number ].
For you to be in this study , you and your parent(s) or your guardian(s) must agree to you
being in it. But it is still up to you if you want to do it.
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FDA-CBER-2022-5812-0224604
CT05 -GSOP -
SD-GL11 1.0 PHASE 1/2/3 CLINICAL STUDY ASSENT
TEMPLATE FOR OLDER CHILDREN 30-Apr-2020
Protocol Number: C4591001 Assent Version Date : Phase 2/3, 02Jul2021
Study
Country
SiteLanguage: English Center ID: Not Applicable Country: Not Applicable
Assent Derived From: Older Children Assent, Phase 2/3, 25Jun2021
CT05 -GSOP -SD-GL11 Phase 1/2/3/4 Clinical Study Assent Template for Older Children 30 -Apr-2020
TMF Doc ID: 173.16 (Study); 173.10 (Country/Central); 173.20 (Site)
Sponsor Assent Version Number (Study/Country/Site) : Phase 2/3 , 02Jul2021
Protocol No. C4591001 / CONFIDENTIALPage 9
of 9
Please check one box below to show whether or not you want to be in this study .
 Yes, I want to be in this study .
 No, I do not want to be in this study .
______________________________________________________
Printed Name of Child/Young Person
_____________________________ __ ____________________ __________
Child/Young Person Signature Date Time
Statement of person conducting assent discussion:
1.I have explained all aspects of the research to the partic ipant to the best of his or her
ability to understand.
2.I have answered all questions of the partic ipant relating to this research.
3.I believe the partic ipant’s decision to enroll or not enroll is voluntary.
4.If the partic ipant decides to enroll, the study doctor and study staff agree to respect the
partic ipant’s physical or emotional dissent at any time during this research when that
dissent pertains to anything being done solely for the purpose of this research.
Printed Name of Person Obtaining Assent: ____________________________
Signature of Person Obtaining Assent: ________ _________ Date: ________ Time: ______
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Page 49
FDA-CBER-2022-5812-0224605
Helpdesk
Phone: 866 40
2 1154 Date: 19JUN2020
A-1426 -0086-5151 Q
RG English (United Sta tes) Version
: 2
Template
Version : 11
Page 1 of 28Participa
nt Guide
to Using the
TrialMa
x App for Vacc
ination
and CO
VID-19 Illnes
s Diary
Pfizer
C45910
01-Post -12-July-2020
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Page 50FDA-CBER-2022-5812-022460 6
Page 2 of 28TrialMa
x App
Thank
you for participating in the C45910
01-Post -12-July-2020 study.

This c
linical study uses the TrialMax App to record important information
during
the study. The TrialMax App will be used on your personal device or
on a p
rovisioned device supplied by the site. This booklet explains how to
use the
TrialMax App on either device t
ype.
Please n
ote that pictures within this guide will not always appear exactly
the sam
e way on your personal device, as every device has different display
setting
s.
Importa
nt: The Tri
alMax App whet
her on your personal or provisioned
device i
s to gather information to advance science and medicine during this
research
study and does not replace your regular medical care. For urgent
issues,
please contact your study clinic staff on the contact number
provid
ed.
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Page 3 of 28App Gu
idelines
Please f
ollow these points when using the TrialMax App for this clinical
study.
1.Always
keep your device charged .
2.Always
download any updates to the TrialMax App.
3.Do not share y
our PIN code.
4.After en
tering your d iary r
esponses, please ensure they are sent
by tap
ping the ‘Save’ button.
5.Your d
evice will need a mobile network or Wi -Fi con
nection to
send da
ta. If your device is not connected to a mobile network or
Wi-Fi con
nection, your data will automatically send o nce you
r
device i
s connected again.
6.After en
tering your diary r
esponses, please ensure they are sent
by tap
ping the ‘Save’ button.
If you
have installed the TrialMax App on
your personal device, additional
guideli
nes.
7.If pro
mpted when installing or using the TrialMax App, always
accept
permissions for the TrialMax App to sync with your device’s
calenda
r. This will allow the reminder notifications for your diary
to di splay.
8.Do not
delete the TrialMax App unless instructed by the study
clinic
staff.
➢If you
accidentally delete the TrialMax App or
are planning
to cha
nge your device, please call the helpdesk (866 402
1154)
as soon as possible.
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Page 8 of 28Multip
le Choice Questions:
•Select t
he response that best describes your answer to each question,
a blac
k dot will appear in the circular button.
•When yo
u are ready to move to the next set of questions, press ‘Next’.
•To go
to the previous page, press ‘Back’ to review or modify you r
answer
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Page 9 of 28Inform
ation Pop -ups
These po
p-ups di
splay important information, such as confirming the
severity
of a symptom, confirming a temperature you have entered or, to
contac
t your study doctor.
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Page 11 of 28Travel
ing and Changing Time Zones with TrialMax App
Always
take your personal or provisioned device with you when traveling
in ord
er to complete the TrialMax App away from home.
If tra
veling via airplane, turn off your device during the flight to avoid any
interfer
ence.
If you
are using a device provided by the
site:
•The dat
e and time will update automatically to the new time zone
when you
turn the device on.
If you
are using your own device:
•Make sur
e your settings allow for automatic update of date and
time.
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FDA-CBER-2022-5812-0224616
Page 12 of 28Sendin
g Data
The TrialMa
x App sends data automatically each time you login or save a
diary
entry, provided the device is connected to a mobile network or Wi -Fi
network.

The Tri
alMax App can be used offline temporarily; however, remember to
log in
to the TrialMax App when the devi
ce is connected to a mobile network
or Wi -Fi netwo
rk as soon as possible to allow data sending to occur.
REMINDER
- Keep you
r device charged
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Page 14 of 28It’s i
mportant that you complete the “Vaccination Diary” as requested,
because
you can’t go back after midnight to fill in any missed entries.
Notific
ations are set up to help you r emember t
o complete your diary. Site
staff
will set the notification alert time when they set -up you
r TrialMax
App ac
tivation code. You can change the alert time as needed in the
‘Settin
gs’ button.
Once yo
u’ve selected the ‘Vaccination Diary’ button you wi ll be a
ble to
record
symptoms, their severity and if those symptoms resulted in a
hospit
alization/emergency room visit.
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Page 15 of 28General
instructions
The stu
dy clinic staff will give you a digital thermometer and show you how
to use
it to measure your temperature under y
our tongue. Follow these
instru
ctions for all temperature measurements you record in the TrialMax
App.
NOTE : The provis
ioned thermometer measures temperature in degrees
Fahrenh
eit (F). Al
l entries made into the diary should be recorded in
degrees Fahrenh
eit.
•You ca
n record the temperature displayed on the thermometer into
the Tri
alMax App.
•You ca
n keep this thermom eter at
the end of the study.
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Page 16 of 28Thermo
meter use
How to
take care of the thermometer:
•The ther
mometer is waterproof.
•To dis
infect, you can put it completely in water or wipe it with a tissue
dipped
in a mild disinfectant.
•Do not
put the thermom
eter in hot water or household bleach
produc
ts.
•Do not
leave the thermometer in direct sunlight or let it fall or be hit,
as thi
s could damage it.
•Do not
try to open the thermometer.
•Please r
efer to the instructions in the thermometer box if you nee d
further
instructions for use, care, and maintenance instructions.
If you
have any problems with measuring your temperature, if
thermom
eter stops working, or if you lose or break the thermometer,
please
call the study doctor or study clinic staff.
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Page 17 of 28Instru
ctions for taking and entering your temperature after
study
vaccination
•On the
day you had your vaccination and for 6 more days (7 days in
total)
, you will measure your temperature (under your tongue) every
evening,
and at any time you feel feverish
.
•Enter y
our measured temperature in the TrialMax App between
6:00PM
and 11:59PM.
•If you
r temperature is 102 °F or h
igher, please call the study doctor or
nurse t
o schedule an extra appointment so that they can assess the
temperat
ure.
•If you
have a fever or
a temperature of 102°F or higher on the last day
you co
mplete the TrialMax App (day 7), keep measuring your
temperat
ure daily until the temperature is below 102°F for at least
one day
. Make a note of the date and temperature as you will need to
give this
information to the study doctor or nurse.
•It is
also important to let your study doctor or nurse know whether
you ha
ve been hospitalised/or went to the ER for any of the ongoing
sympto
ms.
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Page 20 of 28•The meas
uring device can be adjusted by sliding the two measuring
pointer
s so that t
hey are closer or further away from each other.
•Once th
e measuring device is the correct size to measure the biggest
part o
f the redness/swelling, the size is displayed as a number. The
number
the arrow is pointing to in the window is the number tha t
should
be recorded in the TrialMax App.
•If the
size is between two numbers, record the larger number in the
TrialMa
x App.
▪For exa
mple, if the measurement is between 4 and 5, then 5
should
be recorded in the TrialMax App.
•If the
size of the redness or swelling
is bigger than 21, then 21 should
be recor
ded in the TrialMax App. Please c
all the study doctor or study
clinic
staff to discuss or schedule an extra appointment so that they
can ta
ke a look at the redness/swelling.
▪Note: A
pop-up in
the TrialMax App wil
l remind you to contact the
study
doctor if you have reported a value of 21.
•If the
redness or swelling at the injection site is ongoing on the last
day yo
u complete the TrialMax App (Day 7), you will need to make a
note of
the date that this resolved. Give this information to the study
doctor
or study clinic staff.
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Page 21 of 28Instru
ctions
for assessing any pain at the injection site:
•On the
day you had your vaccination and for 6 more days (7 days in
total)
, you will need to examine the arm where you
were given the
injecti
on (injection site) to see if there is any pain at the injection site.
•Inform
ation must be recorded in the TrialMax App eac
h day between
6:00PM
and 11:59PM.
•If you
have pain at the injection site, you will need to assess if the pain
was mil
d, moderate or severe, and record this information in the
TrialMa
x App.
•Definit
ions of mild, moderate and severe pain will be dis played
to you
before t
his symptom is recorded.
•If the
pain at the injection site is severe, please notify the study doctor
or stu
dy clinic staff to discuss or schedule an extra appointment so
that t
hey can assess the pain at the injection site.
▪Note: A
pop-up in
the TrialMax App will remind you to contact the
study
doctor if you have reported a severe symptom.
•If the
pain at the injection site is ongoing on the last day you
complet
e the TrialMax App (Day 7), you will need to make a note of
the dat
e that thi s resol
ved. Give this information to the study doctor
or stu
dy clinic staff.
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Page 22 of 28Instru
ctions for assessing any fatigue (tiredn
ess), head
ache,
vomiti
ng, diarrh
ea, chills, new and worsened muscle
pain, new
or wor
sened joint
pain:
•On the
day you had your study vaccination and for 6 more days (7
days i
n total), you will be asked whether you had experienced fatigue
(tirednes
s), heada
che, vomiting, diarrh
ea, chills, new or worsened
muscle
pain and new
or worsened joint
pain since vacci nation
. This
inform
ation must be recorded in the TrialMax App each day between
6:00PM
and 11:59PM.
•If you
experience any of these symptoms you will need to assess if
they were
mild, moderate or severe, and record this information in
the Tri
alMax App.
•Definit
ions of mild, moderate and severe symptoms will be displayed
to you
before this is recorded.
•If a symp
tom you are experiencing is severe, please call the study
doctor
or study clinic staff to schedule an extra appointment so that
they ca
n investigate.
▪Note: A
pop-up in
the TrialMax App will remind you to contact the
study
doctor if you have reported a severe
symptom.
•If you
have symptom(s) that continue past the last day you completed
the Tri
alMax App (Day 7), you will need to tell the study doctor or
study
clinic staff the date that the symptom(s) stopped. Please make a
note of
the date your symptom s stop
ped.
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Page 24 of 28Notific
ations are set up to help you remember
to complete your diary. Site
staff
will set the notification alert time when they set -up you
r TrialMax
App ac
tivation code. You wil
l get a reminder to complete the Illness Diary
only week
ly, if the Illness Diary is not completed before the schedul ed
notifi
cation alert time. You ca
n change the alert time as needed in the
‘Settin
gs’ button.
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Page 25 of 28Instru
ctions for assessing sympto
ms in the COIVID -19 Ill
ness
Diary
•Starti
ng on the day your diary is activated you will be asked to note if
you ex
perience any of
the following symptoms or events: A diagnosis
of COV
ID-19, fever, new or in
crease d cough, new or in
crease d
shortn
ess of breath, chills,
new or in
crease d muscle p
ain, new loss
of
taste o
r smell, sore thr
oat, diarrhea
, or vomitin
g. This information
can be
recorded in the TrialMax App at any
time.
•The Ill
ness Diary must be completed a minimum of once every 7 days,
even when
there are no symptoms or events to report.
Careful
ly review the symptoms
listed
in the diary an d select “
yes”
or “no
” depending how you
are
feeling
when completing the
diary.
If you
selected “Yes” to
experienc
ing any of the listed
sympto
ms a pop -up mess
age will
appear
prompting you to con
tact
your s
tudy clinic to schedule an
illness
check with the study team.
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Page 26 of 28Visits
to the Study Clinic
IMPORT
ANT: Remember
to take your personal or provisioned device to
every st
udy clinic visit (scheduled or unscheduled).
Speak t
o study clinic staff if:
•You ha
ve any questions about the App or the study
•Your d
evice is lost, stolen or damaged
•You ha
ve questions about your health or participation in the study
If you
are using your own device, please do not uninstall the Trial Max App
during
the duration of the study.
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Page 27 of 28
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Page 28 of 28Helpde
sk
Telephon
e: 866 40
2 1154
Helpdesk
Priority PIN: 19
Availa
ble hours: 24 hours per day, 7 days per week.
For when
you:
•Forget
your PIN code or cannot log into TrialMax App
•Need help
with a technical issue
•Have an
y other questions about using the TrialMax App
When ca
lling the Helpdesk, you will be asked to enter a PIN. Enter the PIN
code ab
ove to enter the priority queue. The Help
desk will ask for the
followi
ng information. This information can be found in t his gu
ide or on the
sticker
supplied by the clinic staff: Study
protocol, Study code, Site number
and yo
ur Participant number.
It is
important not to provide any information about your health to the
Helpdesk.
Please c
ontact your study doctor or study clin ic sta
ff for health
concern
s.
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FDA-CBER-2022-5812-0224633

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Exhibit C EFTA00090144 CURRICULUM VITAE Ryan C. W. Hall, M.D., DFAPA Updated 10/11/21 EXHIBIT D EFTA00090145 TABLE OF CONTENTS PRESENT POSITION 2 EDUCATION 2 MEDICAL LICENSE 3 CERTIFICATION 3 ADDITIONAL TRAINING 3 SOCIET…
EFTA00156682 — Lisa M. Rocchio Ph.D
Lisa M. Rocchio Ph.D Phone: EDUCATION 1995 Ph.D. Clinical Psychology University of Rhode Island, Kingston. RI 1992 MA Clinical Psychology University of Rhode Island. Kingston, RI 1989 BA Psychology and English Emory Univ…

Federal Writers' Project

[Folkways, and Social Customs]
Accession no. W UNIT Form -3 0eAf-,7_4_ Collection (or Type) Date received /0/r.o/re. Consignment no. Shipped from Label Amount Title ..7‘;-erf-1-0,-07.-0.-• Place of origin Date./0,/-17 Project worker Project editor Rem…
[Mamie Brown, Librarian]
Approximately 2100 wird. SOUTH CAhINA 'OJECT Life History TITLE MI E 1.3i.i.ON Date of First ,iriting January lIth,1939 Name of Person Interviewed Madeline iillen(colored) ?ictitious Name Mamie Brown Street Addreds 4 Nor…
[Robbins, Ill.--A folklore in the making]
Accession no. WPA L. C. PROJECT _ Form -3 UNIT s645 Date received 10/1U/40 Consignment no. 1 Shipped from *ash. Office Label Amount 21p Eakil:tril__Collection (or Type) Title Robbins I11, A folklore In zakta& Place of or…

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