Document text
CT05 -GSOP -RF04
7.0PHA SE 1CLINICA L STUDY
INFORMED CONSENT TEMPLA TE01-Jul-2019
Protocol Number: C4591007ICD Version Date :
(Study): Phase 1 Lower Dose Evaluation (Adult) V1 09Aug2021
Study
Country
SiteLanguage: English Center ID: N/A Country: N/A
ICD Derived From: N/A
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 Date (Study): Phase 1 Lower Dose Evaluation (Adult) V1 09Aug 2021
2021
Protocol No. C45910 07PFIZER CONFIDENTIALIntro
Page:
1of 1
Dear Sir/Madam,
Thank you for taking the time to consider if you would like tojoin this study. We
understand that this may be a difficult decision. This consent document can help you
make your decision by explaining what you can expect to happen during this study ,
also known as a clinical trial or a research study.
Taking part in this study is completely voluntary (your choice) . Take as long as you
need to make your decision. You also can choose to take part in the study now, and then
change your mind later at any time. Please keep in mind that even if you choose to take
part, it ma y turn out that you do not meet the study’s entry requirements.
We encourage you to have conversations with your family, caregivers, doctors, and
study team about taking part in this study and whether it is right for you. The study team
will work with you to answer any questions that you may have about the study. The study
team includes the study doctor, nurses, and others who work with the study doctor.
If you choose to take partin this study, you will be asked to sign and date this consent
document before you start the study to let the study team know your decision.
You will receive a signed and dated copy of thisconsent document for your records.
Please keep thisconsent document for your reference.
We appreciate that you are thinking of taking part in this study.
Sincerely,
___________________
Study Doctor
090177e197c39a58\Approved\Approved On: 09-Aug-2021 16:14 (GMT)
FDA-CBER-2021-5683-1076670
CONSENT TO TAKE PA RT IN STUDY
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 Date (Study): Phase 1 Lower Dose Evaluation (Adult) V1 09Aug2021
Protocol No. C45910 07PFIZER CONFIDENTIALPage:
2of 22
Table of Contents
This Table of Contents describes the different sections of this consent document. Be sure
to read through all sections of this consent document before making your decision about
whether or not to participate in this study.
Section Page
1.Key study information and contact information 4
2.Brief summary of this study 5
3.What is the purpose of this study? 7
4.How long will Iparticipate in this study? 8
5.How many adults and children will take part in this study? 8
6.What will happen during this study? 9
7.Are there any special instructions to follow for this study? 14
8.What are the possible risks and discomforts of this study? 14
9.What are the possible benefits of this study? 17
10. What other choices do I have if I do not want to join this study? 17
11. What happens if I am injured during this study? 17
12. What if I join this study and then changes mymind? 17
13. What will I have to pay for if Itake part in this study? 18
14. Will Ibe paid for taking part in this study? 18
15. What will happen to my personal information? 18
16. Where can I find additional information about this study or the
study results?18
090177e197c39a58\Approved\Approved On: 09-Aug-2021 16:14 (GMT)
FDA-CBER-2021-5683-1076671
CONSENT TO TAKE PA RT IN STUDY
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 Date (Study): Phase 1 Lower Dose Evaluation (Adult) V1 09Aug2021
Protocol No. C45910 07PFIZER CONFIDENTIALPage:
3of 22
17. Signatures 19
Privacy Supplement
090177e197c39a58\Approved\Approved On: 09-Aug-2021 16:14 (GMT)
FDA-CBER-2021-5683-1076672
CONSENT TO TAKE PA RT IN STUDY
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 Date (Study): Phase 1 Lower Dose Evaluation (Adult) V1 09Aug2021
Protocol No. C45910 07PFIZER CONFIDENTIALPage:
4of 22
1. Key Study Information and Contact Information
The study team will address anyquestions, concerns or complaints you may have before,
during and after youcomplete the study. The study team includes the study doctor,
nurses, and other personnel who work with the study doctor.
Phone numbers for the study team are listed below under “Study Site Contact
Information.” You willbe given a card with important emergency contact
information, including a 24- hour number. Please show this card to any doctor, nurse
or other health care provider if you seek emergency care while they are taking part in this
study. This card includes information about the study that will help them treat you.
If you have any general questions about your rights as a study participant, or would like
to obtain information from, offer suggestions to, or speak with someone notdirectly
involved in the study, you may contact [For the site -level ICD , include as appropriate: the
Institutional Review Board orthe Independent Ethics Committee, patient rights advocate,
and/or bioethicist ]listed below.
Name of Study: A Phase 1, Open -Label Dose -Finding study to Evaluate Safety ,
Tolerability , and Immunogen icity and Phase 2/3 Placebo -Controlled, Observer -
Blinded Safety , Tolerability , and I mmunogen icity Study of a SARS -CoV-2 RNA
Vaccine Candidate against COVID -19 in Healthy Children and Young A dults
Sponsor Consent Version Number (Study/Country/Site): 0 1/ 00 / 00
[Institution] Study Number:
Sponsor Study Number: C4591007
Name of Company Sponsoring the Study: BioNTech. S tudy conducted by Pfizer
Name of Principal Investigator (Study Doctor):
Study Site Contact Information:
Contact Person:
Address:
Phone Number (Normal Business Hours):
Phone Number (Off -Hours or Emergency):
[Complete the following entries for the site- level ICD as appropriate. ]
[Institutional Review Board orIndependent Ethics Committee ]Contact
Information:
Contact Person:
Address:
090177e197c39a58\Approved\Approved On: 09-Aug-2021 16:14 (GMT)
FDA-CBER-2021-5683-1076673
CONSENT TO TAKE PA RT IN STUDY
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 Date (Study): Phase 1 Lower Dose Evaluation (Adult) V1 09Aug2021
Protocol No. C45910 07PFIZER CONFIDENTIALPage:
5of 22
Phone Number:
Patient Rights A dvocate:
Contact Person:
Address:
Phone Number:
Bioethicist:
Contact Person:
Address:
Phone Number:
2. Brief Summary of this Study
This is a research study involving both Pfizer and BioNTech. Pfizer and BioNTech are
separate companies who are cooperating to perform this study. Pfizer is responsible for
conducting this study. BioNTech is the regulatory sponsor of this study. Funding for this
study is provided by BioNT ech and Pfizer and [study doctor/institution] will be paid to
conduct this study.
A new respiratory disease appeared in Wuhan, China in December 2019, and has since
rapidly spread to many other countries ar ound 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 a nd ways to prevent COVID -19.
Vaccines help your body to produce antibodies to help you to fight off a disease. This
research study involves an investigational vaccine to prevent COVID -19, that will be
given to volunteers. The vaccine is given by injection . The study will also test the study
vaccine at different dose levels (amount of vaccine).
These vaccines do not contain the whole virus, or the part of the virus that can make
you ill, instead the vaccines are made up of part of the virus’s genetic code, surrounded
by fatty particles called lipids. They use person’s own cells’ protein making ma chinery to
produce some, or all, of the spike protein seen on the outside of the virus. This spike
protein, made by the person’s own body, may help thebody to produce antibodies to
fight against COVID -19. W e will check the level of antibodies youmake by taking blood
samples and testing them.
090177e197c39a58\Approved\Approved On: 09-Aug-2021 16:14 (GMT)
FDA-CBER-2021-5683-1076674
CONSENT TO TAKE PA RT IN STUDY
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 Date (Study): Phase 1 Lower Dose Evaluation (Adult) V1 09Aug2021
Protocol No. C45910 07PFIZER CONFIDENTIALPage:
6of 22
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 app roved for emergency use or received a
conditional marketing authorization in many countries, by the end of April about 400
million doses have been distributed. Based on available data, the following risks have
been determined to be caused by BNT162b2 vaccine: Injection site pain, injection site
swelling, fatigue (tiredness), increased body temperature (fever), chills, headache ,
diarrhea , joint aches, muscle aches, feeling sick (nausea) , being sick (vomiting),
injection site redness, enlarged lymph glands, allergic reaction (symptoms may include
rash, itching, hives, and swelling of the face or lips) , decreased appetite , lethargy,
sweating and night sweat s, pain in arm, feeling weak or unwell, and severe allergic
reaction (anaphylaxis).
Myocarditis (infl ammation of the heart muscle) and pericarditis (inflammation of the
lining outside the heart) have occurred in some people who have received BNT162b2.
Cases have mainly been reported in males under 30 years of age and following the
second vaccination .Symptoms include: Chest pain, shortness of breath, or feelings of
having a fast -beating, fluttering or pounding heart. As a precaution, you should seek
medical attention right away if you have any of those symptoms after receiving the
vaccine . The chance of having this occur is very low.
Although not seen to date, it cannot yet be ruled out that the study vaccine could make
a later COVID -19 illness more severe.
You are being asked to take part in a research study that will investigate whether the
investigational (study) vaccine to prevent COVID- 19 is safe, tolerable and causes immune
response to the virus causing COVID -19. The vaccine is given by aninjection.
Overall, the study has twoPhases;
In Phase 1 we will study how safe the vaccine is and the immune response it
produces at different doses. We will then choose a dose level for Phase 2/3.
090177e197c39a58\Approved\Approved On: 09-Aug-2021 16:14 (GMT)
FDA-CBER-2021-5683-1076675
CONSENT TO TAKE PA RT IN STUDY
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 Date (Study): Phase 1 Lower Dose Evaluation (Adult) V1 09Aug2021
Protocol No. C45910 07PFIZER CONFIDENTIALPage:
7of 22
In Phase 2/3 we will study how safe the vaccine is and the immune response it
produces in a larger num ber of children and young adults.
For this part of the study, this consent is for Phase 1 Lower Dose Evaluation participants
and you are being asked to see if you would like to take part in this phase.
In the P hase 1 of the study, all participants will receive the active study vaccine. In
this Phase 1, upto two different dose levels (amount of vaccine) will be studied.
Youwill be assigned to one of the twodose level group s.
From the Phase 1, we will choose a dose for the Phase 2/3. In this part of the
study , we will study how safe the vaccine is and the immune response it produces
in a larger number of children and young adults.
You are being asked to be in this research study because youarehealthy and meet th e
age requirement for this study.
This study is different from your regular medical care. The purpose of regular medical
care is to improve or otherwise manage your health, but the purpose of research is to
gather information to advance science and medicine and does not replace your regular
medical care. If you need medical care during your time in the study, you should contact
your regular provider and inform the study team, as described later in this document.
Taking part in this study is voluntary (your choice) . There is no penalty or change to you
or you r regular medical care if y oudecide not to participate. Youcan choose totake part
in the study now, and then change your mind later at any time without losing any benefits
or medical care to which you are entitled. We encourage you to have conversations with
your family, caregivers, doctors, and study team about taking part in this study and
whether it is right for you. The study team will work with you to answer any questions that
you may have about the study.
You will receive a signed and dated copy of this consent document for your records.
Please keep this consent document for your reference.
3. What is the purpose of this study ?
The World Health Organization ( WHO) has declared COVID -19 to be a pandemic (a
disease that has spread all over the world and is affecting lots of people); finding a
vaccine to prevent COVID -19 is an urgent need. To test this investigational vaccine as
quickly as possible, this study will be cond ucted in several steps, which are described
below. Currently, the authorized dose of the vaccine in adolescents and young adults 12
years and older is 30 µg. To reduce the reactions that can occur soon after vaccination
and to determine whether similar immune responses are produced, additional lower
dose levels of the vaccine (3 µg and 10 µg) will be evaluated in ages 5 to 30 years.
The steps in the study are detailed below.
090177e197c39a58\Approved\Approved On: 09-Aug-2021 16:14 (GMT)
FDA-CBER-2021-5683-1076676
CONSENT TO TAKE PA RT IN STUDY
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 Date (Study): Phase 1 Lower Dose Evaluation (Adult) V1 09Aug2021
Protocol No. C45910 07PFIZER CONFIDENTIALPage:
8of 22
You are being asked to take part in the Phase 1 Lower Dose Evaluation step of the
study.
Phase 1 Lower Dose Evaluation will be carried out in 3 age groups. Every participant
in this Phase will receive tw o injections of the active study vaccine. The following
age groups will take part in this step of the study:
16 to less than 30 years of age,
12 to less th an 16 years of age , and
5 to less than 12 years of age.
The remaining step of the study will be the Phase 2/3 Lower Dose Evaluation . In this
partwe will use adose level selected from the Phase 1 part of the study. This step of the
study will collect information from a large rnumber of children and young adults about the
safety of the vaccine and the amount of antibodies produced by the vaccine. In this part
of the study all participants will receive active vaccine. The age groups taking part in this
step of the study will be:
16 to less than 30 years of age,
12 to less th an 16 years of age , and
5 to less than 12 years of age.
Please note that this part of the original study called Phase 1 Dose Finding has been
completed . There were 3 age groups in this partand the study lookedat up to 3 dose
levels in each age group . The children in this part of the study were :
5 to less than 12 years of age,
2 to less than 5 years of age, and
6 months to less than 2 years of age .
Phase 2/3 Selected Dose is currently ongoing ,andthedose level was selected from
the Phase 1 part of the study. This step of the study will collect information from a large r
number of children about the safety of the vaccine and the amount of antibodies produced
by the vaccine. In this Phase, all participants will receive either active vaccine or placebo.
The children in this step of the study will be:
5 to less than 12 years of age,
2 to less than 5 years of age, and
6 months to less than 2 years of age .
4. How long w ill Iparticipate in this study ?
Youwill be in this study for about 7 months.
5. How many adults and children will take part in this study ?
090177e197c39a58\Approved\Approved On: 09-Aug-2021 16:14 (GMT)
FDA-CBER-2021-5683-1076677
CONSENT TO TAKE PA RT IN STUDY
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 Date (Study): Phase 1 Lower Dose Evaluation (Adult) V1 09Aug2021
Protocol No. C45910 07PFIZER CONFIDENTIALPage:
9of 22
This consent is for Phase 1Lower Dose Evaluation and there will be about
approximately 96 children less than 16 years old, and about 64 participants 16 to less
than 30 years of age taking part in this P hase.
The total number of adults and children taking part in the study will depend on the results
seen during the study.
This study will use competitive enrollment. This means that when a certain number of
people have enrolled in the study from all study sites combined, no one else will be
allowed to participate. So, it is possible that you may not be allowed to join the study.
6. What w ill happen during this study ?
Before any study procedures begin, or b efore you begin preparing for the study, you will
be asked to read and sign and date this consent document .
After signing this consent document, the study doctor will check if youmeet all the
requirements to take part in this study. If you do not meet the requirements, youwill not
be able to take part in the study and the study doctor will explain why this is the case.
Similarly, i f you qualify to take part in this study ,the study doctor will explain this as well.
Study Vaccines
Once the study doctor has confirmed that youmeet the study requirements, you will be
assigned to a dose -level group for the study vaccine.
Phase 1Lower Dose Evaluation of the study is an “open -label dose -finding phase ”,
which means in this phase all participants will receive active study vaccine.
In this phase, either 1 or twodose levels of the study vaccine will be studied depending
on the age of the participant . There will be 32participants in each age group that will be
given each dose level.
Age of child/adult taking part 3µg Dose level 10µg Dose level
5 to less tha n 12 years of age
12 to less than 16 years of age
16 to less than 30 years of age,
represents 32 participants
090177e197c39a58\Approved\Approved On: 09-Aug-2021 16:14 (GMT)
FDA-CBER-2021-5683-1076678
CONSENT TO TAKE PA RT IN STUDY
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 Date (Study): Phase 1 Lower Dose Evaluation (Adult) V1 09Aug2021
Protocol No. C45910 07PFIZER CONFIDENTIALPage:
10of 22
You will be given either the 3 µ g dose or the 10 µg dose. You will have a 50:50 chance
of getting either dose. The dose level will be chosen by chance by a computer and neither
you nor the study team has any influence over this.
The vaccine will be given to youthrough an injection into the muscle in their upper arm.
Each participant will receive twoinjections of vaccine , approximately three weeks apart.
On th e days you receive the vaccine injection, you will be asked to wait at the study site
for at least 30 minutes for observation after they receiv evaccine.
Overview of Study Procedures and A ssessments
The table below lists the tests and procedures or assessments that you will have done at
each visit. It is important that you attend each visit on the day that your research study
team arrange sfor you. You willhave the following tests, procedures or assessments
during this study. In addition to the visits listed, your study doctor may ask you to come in
for extra visits if necessary, to protect your well- being.
090177e197c39a58\Approved\Approved On: 09-Aug-2021 16:14 (GMT)
FDA-CBER-2021-5683-1076679
CONSENT TO TAKE PA RT IN STUDY
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 Date (Study): Phase 1 Lower Dose Evaluation (Adult) V1 09Aug2021
Protocol No. C45910 07PFIZER CONFIDENTIALPage:
11of 22
For the participants taking part in Phase 1 Lower Dose Evaluation , the study doctor or
nurse will perform following assessment and procedures :
Visit Number1 2 3 4 5
Visit Description and Visit TimingStudy
Vaccine 1
VisitStudy
Vaccine 2
Visit7-Day
Follow -up
Visit1-Month
Follow -up
Visit or
phone call6-Month
Follow -up
Phone Call
Review and sign informed consent document X
Ask about medical histor y as well as date of
birth, sex, race and ethnicityX
Measure pulse rate, respiratory rate, blood
pressure, and body temperatureX X
Perform a physical exam, including
measurement of height and weight (height at
weight information will be collected at 1st visit
only).X X
If you arefemale and if needed, youwill be
asked to provide a urine sample for a
pregnancy testX X
Ifneeded, will discuss the use of appropriate
birth control with youX X X X
Ask about medications you arecurrently taking X X X X
Ask about any other vaccines you have been
givenX X X X X
Check y oumeets all the study requirements X X
Take a nasal swab for the detection of virus
causing COVID -19X X
Collect blood sample (~20mL) to test antibody
levelsX X X
Give vaccine injection in yourarm and observe
for 30 -min following injectionX X
You will be shown/reminded how to use the
e-diary or assist you to download an app,
thermometer and caliper (measuring device)X X
You will be asked to complete vaccination
e-diary for 7 days to record potential side
effects following each vaccinationX X
Ask how you are feeling X X X X X
090177e197c39a58\Approved\Approved On: 09-Aug-2021 16:14 (GMT)
FDA-CBER-2021-5683-1076680
CONSENT TO TAKE PA RT IN STUDY
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 Date (Study): Phase 1 Lower Dose Evaluation (Adult) V1 09Aug2021
Protocol No. C45910 07PFIZER CONFIDENTIALPage:
12of 22
Description of Study Procedures and A ssessments
Biological Samples
The following biological samples will be taken in this study. You must provide these
samples in order to take part in this study. The samples may be stored in a facility located
in a different country from your study site.
Your blood and nasal samples will be used only for scientific research. Each sample will
be labele d with a code so that the laboratory workers testing the samples will not know
who youare. Some of the samples may be stored for future testing and may be kept for
up to 15 years after the study ends, at which time they will be destroyed. In additional to
testing for this study , any samples left over after the study is complete may be used for
additional research related to the development of product. No testing of your DNA will be
performed.
You may request that your 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 confid entiality is maintained . Notesting of your DNA will be performed. You will
not be told of additional tests, nor will you receive results of any of these tests.
Blood Samples for antibody testing :
You will have blood taken three times during the planned study visits.
Each blood sample will be approximately 20mLand will be collected using a needle.
Your blood samples will be used to test if you already had antibodies against the
coronavirus that causes COVID -19 when you enrolled in the study and may be used to
test antibody levels after vaccination .
Nasal Swabs for detection of coronavirus causing COVID -19:
You will have nasal swab collected from your nose twotimes during the planned study
visits. A swab (which looks like a Q-tip)will be inserted into your nose to collect any fluid
or mucus. These samples will be tested to detect the presence of coronavirus causing
COVID -19. Results of nasal swabs at Visit 1 and Visit 2 will be provided to your study
doctor, however, this will take some time so you should not rely on this information for
your medical treatment.
Urine Samples:
If youare female and able to have children in the opinion of study doctor, youwill need
to provide urine sample for pregnancy testing before you get the study vaccine injection.
If youhavea positive urine pregnancy test result , the study doctor will tell you and you
will not be able to participant in the study.
090177e197c39a58\Approved\Approved On: 09-Aug-2021 16:14 (GMT)
FDA-CBER-2021-5683-1076681
CONSENT TO TAKE PA RT IN STUDY
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 Date (Study): Phase 1 Lower Dose Evaluation (Adult) V1 09Aug2021
Protocol No. C45910 07PFIZER CONFIDENTIALPage:
13of 22
E-Diary :
At Visit 1, the study team will explain what you need to do and show you how to fill in an
electronic diary (or e -diary). W e will either give you a device (like a mobile phone) or ask
you to download an application (app) to your smart phone if you have one. The device/app
is secure, and your confidentiality will be maintained. You will also be given a thermometer
and a measuring device (caliper).
The e-diary will prompt you to answer questions about how you are feeling after receiving
the study vaccination. You will be instructed by the study team to complete the e- diary
every evening for 7 days after each injection. Day 1 of the e- diary completi onwill begin
on the evening youreceive theinjection and thefollowing 6 days (7 days in total). You
will use the thermometer to measure your oral temperature (under your tongue). You will
then enter the temperature reading into the e- diary. The measuring device will be used
to measure the size of any redness or swellin g on your arm where the injection was given.
You will need to enter these measurements in thee-diary.
The e -diary will also ask other questions about potential side effects you may have after
the injection. If youhave any severe symptoms after vaccinati on, you should contact your
study doctor and the study doctor or nurse may schedule an extra unplanned visit to
evaluate you .
It is very important that you complete the e- diary regularly as instructed . If this is
not completed, the study doctor or nurse will contact y ou to check how y ouare.
What happens if Ihavea positive nose swab test result after Visit 1 but before
Visit 2 ?
If you have any potential COVID -19 symptoms with a positive nose swab test result
after visit 1 and before visit 2, youwill not be given the second study injection. You will
however be asked to stay in the study so we can collect safety information .
Leaving the Study Early
You may withdraw from the study at any time at your own request . You could also be
withdrawn at any time at the discretion of the investigator for safety, behavioral,
compliance, or administrative reasons. If you decide to leave the study, you would be
asked why you would like to withdraw.
After the study
The study vaccine is available only during this study and not after the study is over.
090177e197c39a58\Approved\Approved On: 09-Aug-2021 16:14 (GMT)
FDA-CBER-2021-5683-1076682
CONSENT TO TAKE PA RT IN STUDY
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 Date (Study): Phase 1 Lower Dose Evaluation (Adult) V1 09Aug2021
Protocol No. C45910 07PFIZER CONFIDENTIALPage:
14of 22
7. Are there any special instructions to follow for this study ?
It is important that you follow all the instructions given to you by the study nurse or doctor
and tell them if :
You do notunderstand anything about the study
You willnot be able to comply with the study requirements
There are changes in your health
Your e- diary device or APP is not working properly
Youtake any new medications or receive any other vaccines
You are going awa y for a long period
Youwish to take part in another research study
Youpreviously took part in this study , have been in any other study in the past 28
days, or are currently involved in any other study
Notify the study team if you move and provide your new contact information.
8. What are the possible risks and discomforts of this study ?
Any research has some has some risks, which may include negative effects that could
make you unwell or uncomfortable and even potentially be serious or life -threatening. All
research participants taking part in the study will be watched carefully for any negative
effects; however, the study team does not know all the effects that the study vaccine may
have on you.
If you take part in this study, the most likely risks or discomforts are discussed below.
It is important that you report to the study team all symptoms and side effects as
soon as they occur. Phone numbers for the study team are listed in [Section 1]of
this consent document.
Up until June 2021 , the safety of BNT162b2 has been studied in clinical trials that have
included about 28,500 people who have received at least one dose of the vaccine. In
addition, since the vaccine has been approved for emergency use or received a
conditional marketing authorization in many countries, by the end of April 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), c hills, headache , diarrhea , joint aches, and muscle aches.
090177e197c39a58\Approved\Approved On: 09-Aug-2021 16:14 (GMT)
FDA-CBER-2021-5683-1076683
CONSENT TO TAKE PA RT IN STUDY
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 Date (Study): Phase 1 Lower Dose Evaluation (Adult) V1 09Aug2021
Protocol No. C45910 07PFIZER CONFIDENTIALPage:
15of 22
Common (between 1 in 10 and 1 in 100 people): feeling sick (nausea) , being sick
(vomiting) , and injection site redness.
Uncommon (between 1 in 100 and 1 in 1,000 people): enlarged lymph glands, allergic
reactions (symptoms may include rash, itching, hives), decreased appetite, lethargy,
sweating and night sweats, pain in arm, and feeling weak or unwell.
Rare (between 1 in 1,000 and 1 in 10,000 people): swelling of the face or lips.
Frequency that cannot be estimated from available data: severe allergic reaction
(anaphylaxis).
Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining
outside the heart) have occurred in some people who have received BNT162b2. Cases
have mainly been reported in males under 30 years of age and following the second
vaccination, however, there have been some cases reported in older males and females
as well as following the first vaccination. The chance of having this occur is very low a nd,
inmost of these people, symptoms began within a few days to a week following
vaccination . As a precaution, you should seek medical attention right away if 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 youhaveany of these symptoms
as youmay need to come in for an assessment.
Whilst some severe cases have been reported, most cases have been associated with
full resolution of symptoms in the short term, however, long -term follow -up is limited. It is
not known whether the risk of myocarditis or pericarditis is increased following additional
doses of the vaccine, e.g. following a booster dose.
If you havehad myocarditis (inflammation of the heart muscle) or pericarditis
(inflammation of the lining outside the heart) previously, please tell your study doctor.
As in all research studies, the COVID -19 vaccine may involve risks that might be expected
based on results from studies of similar vaccines, as well as risks that are currently
unknown.
Therefore, it is important that you report all symptoms and side effects that youexperience
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.
090177e197c39a58\Approved\Approved On: 09-Aug-2021 16:14 (GMT)
FDA-CBER-2021-5683-1076684
CONSENT TO TAKE PA RT IN STUDY
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 Date (Study): Phase 1 Lower Dose Evaluation (Adult) V1 09Aug2021
Protocol No. C45910 07PFIZER CONFIDENTIALPage:
16of 22
If you catch 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. Itremains important for you to contact your study doctor
if you develop symptoms that might be caused by COVID- 19 (for example, fever, cough,
shortness of breath).
Risks from Study Procedures
Risks and possible discomforts you might have from the study procedures include:
Blood Sampl es: 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 may feel dizzy or may faint. If you have
a previous history of feeling dizzy or fainting during blood sample collection you
should talk to the study doctor.
Nasal Swabs: The risks and possible discomforts involved in taking nasal swabs
may include pain or general discomfort. Sometimes it may cause the nose tobleed.
Pregnancy -Related Risks; Use of Birth Control
If youarecurrently pregnant, plan to become pregnant, or arebreastfeeding a child, you
should not join this study. If you aremale , you should not father a baby while taking part
in this study.
Ifyou areable to have children and are sexually active, youmust use birth control
consistently and correctly for the duration of the study including at least 28 days after you
receive your last injection. This applies to male participants as well as female participants
who take part in the research study.
The study doctor will discuss with you the methods of birth control that youshould use
while in this research study. The study doctor will help youselect the method that is
appropriate for you. The st udy doctor will also check that you understand how to use the
birth control method and may review this with you at each research study visits.
Birth control methods, even when used properly are not perfect. If you or your partner
becomes pregnant during the research study, or if youwant to stop birth control during
the research study, youshould tell the study doctor immediately . You may be withdrawn
from the research study if youstop using birth control or become pregnant.
If abstinence (not having sexu al intercourse at all) is your current lifestyle, and both you
and the study doctor agree that it is your selected method of contraception, you must
continue not to have sexual intercourse for the duration of your participation in this study .
090177e197c39a58\Approved\Approved On: 09-Aug-2021 16:14 (GMT)
FDA-CBER-2021-5683-1076685
CONSENT TO TAKE PA RT IN STUDY
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 Date (Study): Phase 1 Lower Dose Evaluation (Adult) V1 09Aug2021
Protocol No. C45910 07PFIZER CONFIDENTIALPage:
17of 22
Pregnancy Follow -up
If youor your partner become pregnant during the study , up until 28 days after your last
study injection, please tell the study doctor immediately . Please also tell the doctor who
will be taking care of you/your partner during the pregnancy that you took part in this
study. The study doctor will ask if you/your partner or their pregnancy doctor is willing to
provide updates on the progress of the pregnancy a nd its outcome. If you/your partner
agree, this information will be provided to the BioNTech /Pfizer for safety follow -up.
9. What are possible benefits of this study ?
Vaccination with BNT162b2 has been shown to be effective in preventing COVID -19 in
the groups of people already studied , but not yet at this dose level .Because of this, you
still need to follow local recommendations about how to avoid COVID -19 (for example,
social distancing and mask use). In addition, information learned from the research study
may help other people in t he future.
10. What other choice s do I hav e if I do not want to join this
study ?
This study is for research purposes only. The only alternative is to not take part in this
study.
11. What happens if I am injured during this study ?
For mandatory research injury language, <click here> (retain this link in the study- level
ICD). The country -specific research injury langua ge must be included verbatim in the
country -level ICD .
12. What if I join this study and then change my mind?
You are free to withdraw from this research study at any time. Tell the study doctor if you
are thinking about this so youmay end the research study in the safest way. The research
study team will also tell you if new information is learned that could change your mind
about continu ation in this research study. Your decision will not affect the medical care
youreceive, and y ouwill not lose any benefits to which youwould otherwise be entitled .
While you are 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
continuing. If you decide to withdraw from the study, youmay be asked to continue to
participate in the study procedures even though youwould no longer be given the study
vaccine .
If you continue with the follow -up part of the study, information about your health will
continue to be collected as described in [Section 6].
If you decide to stop participating in this study, you must notify the study doctor. The study
team will explain what other procedures or discussions would occur.
090177e197c39a58\Approved\Approved On: 09-Aug-2021 16:14 (GMT)
FDA-CBER-2021-5683-1076686
CONSENT TO TAKE PA RT IN STUDY
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 Date (Study): Phase 1 Lower Dose Evaluation (Adult) V1 09Aug2021
Protocol No. C45910 07PFIZER CONFIDENTIALPage:
18of 22
Sometimes the study docto r or BioNTech/Pfizer may decide to take you out of the study
(even if you do not agree) if:
•Youare unable or unwilling to follow the instructions of the study team;
•The study doctor decides that the study is not in your best interest or that you areno
longer eligible to participate; or
•The study is stopped by the BioNTech/Pfizer , the institutional review board (IRB) or
independent ethics committee (IEC) (a group of people who review the study to protect
your rights), or by a government or regulato ry agency .
The study team will give you a Privacy Supplement , which is considered part of this
consent document. It describes what happens to your personal information (including
your biological samples) and how it may be used if you withdraw from the stud y.
13. What w ill I have to pay forifI take part in this study ?
Youwill not need to pay for study vaccine, study- related procedures, or study visits.
14. Will I be paid for taking part in this study ?
You will not receive any payment for taking part in this study. However, for each visit you
complete , you will be reimbursed by the study site to cover reasonable expenses (for
example, parking, meals, travel) that you have as a result of taking part in this study. You
will be reimbursed by [enter, as applicabl e, method of reimbursement; amounts; and
reimbursement schedule; note whether receipts are required] .]
BioNTech/Pfizer may use information resulting from the study to develop products or
processes from which it may make a profit. There are no plans to pay you or provide you
with any products developed from this study. BioNTech/Pfizer will own all products or
processes that are developed using information from the study.
15. What w ill happen to my personal information?
<Click here > for language to be inserted into this section. This text must be inserted
verbatim . Any requested changes must be approved by Clinical Development Legal. Note
that t he Privacy Supplement follows this consent document, after the signature section.
16. Where can I find additional information about this study or the
study results?
A description of this clinical trial will be available onhttp://www.ClinicalTrials.gov , as
required by U.S. Law. This W eb site will not include information that can identify you . At
most, the Web site will include a summary of the results. You can search this Web site at
any time. ]
The study results, when available, may also be found onwww.pfizer.com and
https://www.clinicaltrialsregister.eu/ .
090177e197c39a58\Approved\Approved On: 09-Aug-2021 16:14 (GMT)
FDA-CBER-2021-5683-1076687
CONSENT TO TAKE PA RT IN STUDY
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 Date (Study): Phase 1 Lower Dose Evaluation (Adult) V1 09Aug2021
Protocol No. C45910 07PFIZER CONFIDENTIALPage:
19of 22
In addition, a plain summary of the study results will be made available in the EU database
at [insert link to the database] . This information will be provided no matter what the study’s
outcome. To the extent possible, you will be able to access these summaries in the EU
database soon after they become available using the following EU trial number for the
study: [insert trial number].
These websites arein English only. If you need assistance understanding these Web
sites, please ask a member of the study team.
BioNTech/Pfizer will provide the study doctor with information about the study results
when all participants have completed the study. At that time, certain of your individual
study results may be given to you or your doctor (if different from the study doctor) in
accordance with applicable law , but will notbe given to your family, your employer or any
insurance company .
If any exploratory research is done, it may not be possible to link any results from that
exploratory research to specific individual, including you. BioNTech/Pfizer does not plan
to return information from any exploratory research to you, the study doctor, or your doctor
(if different from the study doctor).
17. Signatures
The column for subject initials in the table below may beremoved if not required by the
IRB/IEC, regulatory agencies, and/or other similar reviewers.
Agreement to Participate and to Process Data Initials
1. I confirm I have read (or, if I cannot read, a study team
member has read to me) and understand this consent
document for the study described above and have had the
opportunity to ask questions. I have had enough time to
review this consent document. I also have had an opportunity
to ask about the details of the study and to decide whether or
not I want to participate.
2. I h ave read and understand the Privacy Supplement. I
understand that taking part in the study will require the
processing (including collection, use, transfer, storage,
analysis and reporting) of my personal information, as
explained in the Privacy Supplement. I understand and agree
to the processing of my personal information within and
outside my country of residence for health care, medical
research and/or regulatory purposes.
3. I unders tand thattakingpart is voluntary and that I am free to
stop taking part in this study or to withdraw my consent to the
processing of my personal information at any time. I do not
090177e197c39a58\Approved\Approved On: 09-Aug-2021 16:14 (GMT)
FDA-CBER-2021-5683-1076688
CONSENT TO TAKE PA RT IN STUDY
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 Date (Study): Phase 1 Lower Dose Evaluation (Adult) V1 09Aug2021
Protocol No. C45910 07PFIZER CONFIDENTIALPage:
20of 22
need to give any reason and myregular medical care and legal
rights will not be affected. However, even if I withdraw my
consent to processing, my personal information held at that
time may be kept tocomply with laws and regulations and to
maintain the integrity of the study. I also understand that my
biological samples may not be able to be destroyed because
they may no longer be traceable to me, may have already been
used, or may have been given to a third party.
4. I agree to the study team accessing mymedical history,
including information from medical records and test results and
any medical treatment Ireceive during the course of the study,
and if necessary, contacting my doctor or any other health care
providers treating mefor access to such information.
5. I understand that the BioNTech/PFizer and/or others working
with or on behalf of the BioNTech/P fizer, institutional review
boards (IRBs) or independent ethics committees (IECs) , and
regulatory agencies may need access to personal information
about megenerated 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 personal information.
6. I do not give up any of my 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 to take part in the study described in this document.
In the section below, the term “legally acceptable representative” should be replaced
with the term required per local regulation (country -level).
Signature Lines to be Included:
_________________________________________
Printed name of participant
________________________________________________ ______________
Signature of participant Date of signature§
(If no legally acceptable representative is used)
§Participant must personally date their signature.
090177e197c39a58\Approved\Approved On: 09-Aug-2021 16:14 (GMT)
FDA-CBER-2021-5683-1076689
CONSENT TO TAKE PA RT IN STUDY
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 Date (Study): Phase 1 Lower Dose Evaluation (Adult) V1 09Aug2021
Protocol No. C45910 07PFIZER CONFIDENTIALPage:
21of 22
Person Obtaining Consent:
____________________________________
Printed Name of the Person Conducting the
Consent Discussion
________________________________________ _______________
Signature of the Person Conducting the Date of signature
Consent Discussion†
†The investigator, or an appropriately qualified and trained person designated by the
investigator to conduct the informed consent process, must sign and date the consent
document during the same discussion when the participant signs the consent document .
090177e197c39a58\Approved\Approved On: 09-Aug-2021 16:14 (GMT)
FDA-CBER-2021-5683-1076690
CONSENT TO TAKE PA RT IN STUDY
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 Date (Study): Phase 1 Lower Dose Evaluation (Adult) V1 09Aug2021
Protocol No. C45910 07PFIZER CONFIDENTIALPage:
22of 22
For mandatory country -specific data privacy language to be inserted in this Privacy
Supplement, <click here > (retain this link in the study- level ICD). The country -specific
data privacy language must be includ ed verbatim in the country -level ICD. Any requested
changes must be approved by Clinical Development Legal.
090177e197c39a58\Approved\Approved On: 09-Aug-2021 16:14 (GMT)
FDA-CBER-2021-5683-1076691