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CT05 -GSOP -RF07
3.0CLINICA L STUDY INFORMED
CONSENT ADDENDUM TEMPLA TE01-JUN-2016
CT05-GSOP -RF07 3.0Addendum ICD Template ( 01-Jun-2016)
PFIZER CONFIDENTIALINFORMED CONSENT ADDENDUM FOR : A PHA SE 1, OPEN -LABEL DOSE -
FINDING STUDY TO EVA LUATE S AFETY, TOLERA BILITY, AND
IMMUNOGENICITY AND PHA SE 2/3 PLA CEBO CONTROLLED, OBSERVER -
BLINDED SA FETY, TOLERA BILITY, A ND IMMUNOGENICITY STUDY OF A SARS-
COV- 2 RNA VACCINE CA NDIDATE AGAI NST COVID -19 IN HEA LTHY CHILDREN
AND YOUNG ADULTS
Protocol Number: C4591007
A change has been made to the research study you are currently taking part in. This
informed consent addendum provides that additional information . All other information i n
the main consent form not addressed in this addendum still applies.
The following section describes the change(s) . Please take as much time as you need
to ask questions before agreeing to continue. If you want to drop out, you sh ould tell
your research study team who will make sure you end the research study in the safest
way and inform you about follow -up care, if needed.
Change to the research study you are currently taking part in :
If your child turns 12 years of age, before 6 months following the 2nd injection,
and was given placebo at Visit 1 and Visit 2, he or she has the following 2
options: receive a BNT162b2 10 -µg dose within the study (following provision of
informed conse nt) or receive a BNT162b2 30 -µg dose outside of t he study.
Please note, inMay 2021 the U.S. Food and Drug Administration (FDA) that
regulates vaccines issued an emergency use authorization (EUA) that allows
individuals 12 through 15 y ears of age to rec eive BNT162b2 at 30 -µg. An
EUA is issued by the F DA to provide quick access to medical products, such as
vaccines, that can be used when there are no other adequate, approved or
available options during a public health emergency.
As the EUA approval is age based as noted a bove but you opt for your 12-ye ar-
old child to receive the 10-µgwithin this study, please complete th is inform ed
consent .
You have the right to withdraw from this rese arch study at any time. If a fter receiving
this information you agree to continue taking part in this research s tudy, please sign
below.
SIGNA TURES:
I have read the information in this addendum to the informed consent document.
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CLINICA L STUDY INFORMED CONSENT
ADDENDUMPage:
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Protocol Number: Associ ated ICD Version Date :
06/Aug/2021ICD A ddendum Version Date :
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Study
CountrySiteLanguage: Center ID: <if applicable> Country: <if applicable>
CT05 -GSOP -RF07 3.0 Addendum ICD Template ( 01-Jun-2016)
PFIZER CONFIDENTIALI have had an opportunit y to ask questions and all of m y questions have been
answered to my satisfaction.
I have been given enough time t o decide whether or not I want to continue in the
study.
I voluntarily agree to continue takingpart in this study.
I do not give up any ofmy legal rights by signing t his consent document.
I have been told that I will receive a signed and dated copy o f this document.
OPTION 2: SIGNA TURE LINES TO BE INCLUDED FOR A CHILD PARTI CIPANT:
________________________________________________________________
Printed name of mole cular prescreening participant
_________________________________________
PrintedName of Parent / Legally Acceptable Representative
_________________________________________________ ______________
Signature of Parent / Legally Accept able Representative Date of signature§
As the consent ing adult providing permission for this minor to participate in a research stu dyI
acknowledge that:
_ I am a biological parent of this minor child and m y spouse, the ch ild’s other biological parent, is aware
of and in agreement with study participation or is deceased, unknown, incompetent, or not reasonably
available
_ I am th e adoptive parent or legal guardian of this minor child and any other adult with whom I share
legal responsibility for the care and custody of this child is aware of and in agree ment with study
participation or is incompetent or not reasonably available
Ihave sole legal responsibility for the care and custody of this minor child (if legal custo dy is shared
between divorced parents both parent signatures are required)
Signature lines iflocal regulations require signatures from both parents.
_____________________________________ ___________________________
Printed Name of Parent / Relationship to study participant
Legal lyAcceptable Representative
_________________________________________ ______________
Signature of Parent / Date of signature§
Legally Acceptable Repr esentative
If local IRB permits assent of older children to be obtained by the co -signature, include
appropriate signature line.
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FDA-CBER-2021-5683-1077784
CLINICA L STUDY INFORMED CONSENT
ADDENDUMPage:
3of 3
Protocol Number: Associ ated ICD Version Date :
06/Aug/2021ICD A ddendum Version Date :
13/Sep/202 1
Study
CountrySiteLanguage: Center ID: <if applicable> Country: <if applicable>
CT05 -GSOP -RF07 3.0 Addendum ICD Template ( 01-Jun-2016)
PFIZER CONFIDENTIAL_______________________________ ______________ _____________
Signature of Child Date of signature§
Additional Signature Lines to be included:
PERSON OBTA INING CONSENT
____________________________________
Printed Name of the Person Conducting the
Consent Discuss ion
_____________________________________ ______________
Signature of the Person Conducting the Date of signature
Consent Discussion†
†The in vestigator, 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
interview when the subject signs the consent document .
CONSENT FOR STUDY PA RTICIPA NT WHO CA NNOT REA D
The study participant has indicated that he/she is unable to read . One or more members of the
study team read the consent document to the study participant, discussed it with the study
participant, and gave the study p articipant an opportunity to ask questions.
_________________________________________
Printed name of impartial witness‡
_________________________________________ __ ____________
Signature of impartial witness Date of signature§
Not applicable ( Check this box if the Signature of an impar tial witness is not required . Signature of an
impartial witness is required if the subject or subject’ s legal representative cannot read.)
§Subject/legally acceptable represent ative/impartial witness must personally date their signature.
‡Impartial W itness: A person, who is independent of the study, who cannot be unfairly influenced by
peopl e involved with the study, who attends the informed consent process if the subject o r the subject’s
legal representative cannot read, and who reads the informed c onsent and any other written information
supplied to the subject. Guidance for Industr y E6 Go od Clinical Practice: Consolidated Guidance.
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