Document text
ETMF Copy of: 270.01|C4591001|17-Jul-2020 | Active | 15-Feb-2021 10:23:13 AM|UNITED STATES|1098090177e1968ea843\Final\Final On: 18-Mar-2021 14:01 (GMT )
FDA-CBER-2021-5683-0000218
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FDA-CBER-2021-5683-0000219
This page is a manifestation of an electronic record that was signed electronically.
Document Name: Pfizer CV Wolf
Document ID: 4748
No. Pages: 1
Statement of Testament: I have reviewed and approve the document
Electronic Signature for: Thomas Wolf
Electronically Signed by: TWolf
Date & Time: 15/JUL/2020 4:30 PM CDT
IP Address: 173.20.218.78ETMF Copy of: 270.01|C4591001|15-Jul-2020 | Active | 15-Feb-2021 10:23:13 AM|UNITED STATES|1101090177e1968ea843\Final\Final On: 18-Mar-2021 14:01 (GMT )
FDA-CBER-2021-5683-0000220
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FDA-CBER-2021-5683-0000221
Rankin One Page CV
Unique ID: 5eced176e3fe120042917213 v.2eBinder Document ID: 5eced176e3fe120042917213 v.2 page: 1 of 2ETMF Copy of: 270.01|C4591001|28-May-2020 | Active | 15-Feb-2021 10:20:59 AM|UNITED STATES|1109090177e1968ea843\Final\Final On: 18-Mar-2021 14:01 (GMT )
FDA-CBER-2021-5683-0000222
eSignature Addendum
All eSignatures below were executed using Florence eBinders
21 CFR Part 11 compliant software for eSignatures
Rankin One Page CV
Unique ID: 5eced176e3fe120042917213 v.2eBinder Document ID: 5eced176e3fe120042917213 v.2 page: 2 of 2Current Electronic Signatures (v.2):
Signed electronically by: Bruce Rankin ([email protected])
Date: 28-May-2020 @ 07:47 AM EDT
Reason: Approval
Previous Electronic Signatures:
There are no signatures for any previous versions.ETMF Copy of: 270.01|C4591001|28-May-2020 | Active | 15-Feb-2021 10:20:59 AM|UNITED STATES|1109090177e1968ea843\Final\Final On: 18-Mar-2021 14:01 (GMT )
FDA-CBER-2021-5683-0000223
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FDA-CBER-2021-5683-0000224
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FDA-CBER-2021-5683-0000225
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FDA-CBER-2021-5683-0000226
ABBREVIATED CURRICULUM VITAE
TMF Doc ID
270.01, 272.01PFIZER CONFIDENTIAL
Page 1 of 1INV02-INV04-WI-GL02-SD01
Version 1.0, 01-Apr-2019 Last Name First Name Middle Name
Full Legal
Name: GloverRichard M.
Professional Mailing Address:
Street Address 1: Alliance for Multispecialty Research, LLC Street Address 2: 700 Medical Center Drive, Suite 110
City:
NewtonState/Province:KSCountry:USAZip/Postal Code:67114
Email Address: [email protected]
Academic Qualifications:
Degree and/or Certification Date (yyyy) Institution and/or Country
Medical Doctorate 1988 University of Kansas School of Medicine
Bachelor of Science 1980 University of Kansas School of Medicine
Medical License Number State/Province Country
04-22805 KS USA
Current Position at Study Site:
Start Date Title Institution or Company State/Province & Country
02/2017 Sub-I Alliance for Multispecialty Research, LLC KS/USA
Previous Relevant Positions Including Academic Appointments:
Start and End Dates Title Institution or Company Country
2003- 02/2017 Sub-I Heartland Research Associates, LLC USA
2005- Present Physician Axtell Clinic, PA USA
1991- 2005 Physician Axtell Clinic- Broadway USA
Brief Summary of Relevant Clinical Research Experience:
Sub-I conducting clinical research Phase II- V in areas including Gastroenterology, Anti-Infective, Auditory, Cardiovascular,
Dermatology, Device, Endocrine/Metabolism, Female Health, Hyperlipidemia, Hypertension, Male Health, Musculoskeletal, Neurological, Ophthalmology, Psychiatric, Respiratory, Smoking Cessation, Urogenital, Weight Control, Vaccines.
Signature:
Signature Date: (dd-Mmm-yyyy)
I will update and resubmit my abbreviated CV if there are changes and particularly if there is any change in status which would
adversely affect the assessment of my suitability to conduct/participate in clinical studies.
NOTE: THIS CV MUST BE LIMITED TO THE INFORMATION IN THIS TEMPLATE FOR INCLUSION IN THE ICH-E3
COMPLIANT CLINICAL STUDY REPORT. ABBREVIATED CV’S CAN BE NO MORE THAN 3 PAGES, DO NOT INCLUDE
ATTACHMENTS OR TEXT ON REVERSE PAGES.
1030432 Richard M. Glover, II, MD Current Sponsor-Specific CVs "Expires:" 28 May 2022ETMF Copy of: 270.01|C4591001|28-May-2020 | Active | 15-Feb-2021 10:20:59 AM|UNITED STATES|1114090177e1968ea843\Final\Final On: 18-Mar-2021 14:01 (GMT )
FDA-CBER-2021-5683-0000227
This is a representation of an electronic record that was signe d
electronically.
This page is the manifestation of the electronic signature(s).
Document Name: Richard M. Glover, II, MD Current Sponsor-Specific CVs
"Expires:" 28 May 2022
Document ID: 1030432
Statement of Testament: I reviewed the contents of this document
Electronic Signature for: Richard M. Glover, II, MD
Electronically Signed by: [email protected]
Date and Time of Signature: 28 May 2020 18:24 EDT
1030432 Richard M. Glover, II, MD Current Sponsor-Specific CVs "Expires:" 28 May 2022ETMF Copy of: 270.01|C4591001|28-May-2020 | Active | 15-Feb-2021 10:20:59 AM|UNITED STATES|1114090177e1968ea843\Final\Final On: 18-Mar-2021 14:01 (GMT )
FDA-CBER-2021-5683-0000228
ETMF Copy of: 270.01|C4591001|13-Jul-2020 | Active | 15-Feb-2021 10:22:11 AM|UNITED STATES|1116090177e1968ea843\Final\Final On: 18-Mar-2021 14:01 (GMT )
FDA-CBER-2021-5683-0000229
ETMF Copy of: 270.01|C4591001|21-May-2020 | Active | 15-Feb-2021 10:20:59 AM|UNITED STATES|1117090177e1968ea843\Final\Final On: 18-Mar-2021 14:01 (GMT )
FDA-CBER-2021-5683-0000230
ABBREVIATED CURRICULUM VITAE TEMPLATE
TMF Doc ID
270.01, 272.01PFIZER CONFIDENTIAL
Page 1 of 1INV02-INV04-WI-GL02-SD01
Version 2.0, 16-Mar-2020 Last Name First Name Middle Name
Full LN aml
em:Nr EderFrank Steven
Pof sN iinfgml Mm nlnga AddoN iir
Street Address 1:
Meridian Clinical Research, LLCStreet Address 2:1290 Upper Front Street
City: BinghamtonState/Province:NYCountry:USAZip/Postal Code:13901
E: m n l AddoN iir sNdNoy : . o: N [email protected]:
A. m dN :n. c u m lnsn.mQ nfgir
DNaoN N m gdtfo CN oQnsn.mQ nfg DmQ N /(((() IgiQn QuQnfg mgdtfo CfugQ o(
Doctor of Medicine 1993 State University of New York – Health and Science Center at
Brooklyn, USA
Bachelor of Science 1989 Long Island University, USA
MNdn.ml Ln.NgiN eu : b N o SQm Q NtPof vn g. N Cf ugQ o(
197948-1 New York USA
CuooN gQ Pf in Q nfg mQ SQud( Sn Q N r
SQmoQ DmQ N Tn QlN IgiQn QuQnfg fo C f: p m g( SQm Q NtPof vn g. N & Cf ugQ o(
7/2019 Investigator Meridian Clinical Research, LLC NY, USA
PoNvnfu i R N lNvmgQ Pf in Q nf gi Ig. ludn ga A. m dN:n. Appf n gQ:NgQir
SQmoQ mgd Egd Dm Q N i Tn QlN IgiQn QuQnfg fo C f: p m g( Cf ugQ o(
1996 to Present Attending Physician UHS Primary Care USA
9/2002 – 7/2019 Investigator Regional Clinical Research,
Inc.USA
1995 to 1996 Chief Resident Wilson Memorial Hospital USA
1993 to 1995 Resident Wilson Memorial Hospital USA
Bon Ns S u ::m o( f s RN lNvmgQ Clngn.ml RNiNmo. h ExpN onNg. Nr
Conducting Pharmaceutical Clinical Research in the area of out-patient studies for 18 + years with numerous pharmaceutical companies. Has been an Investigator for numerous clinical studies in the areas of migraine, diabetes, stress incontinence, osteoarthritis, hypertension, hyperlipidemia, osteoporosis, GERD, COPD, Flu Vaccines, RSV, meningitis, depression and erectile dysfunction
Snagm Q uoNr Snagm Q uoN DmQ Nr /d d - M : : - (((()
I wn ll updm Q N m gd oN iub: n Q : ( m bboN vn m Q N d CV n s QhNoN moN .h mgaNi mgd pm oQn.u l mol( ns QhNoN ni mg( . hm gaN ng iQm Qui whn . h wf uld
mdvNoi Nl( mssN.Q QhN miiNii: N gQ f s : ( iun Q m bnlnQ( Qf . f gdu. Q tpmoQn.npmQ N ng . lngn.ml iQudnNi@
NOTE: THIS CV MUST BE LIMITED TO THE INFORMATION IN THIS TEMPLATE FOR INCLUSION IN THE ICH-E3
COMPLIANT CLINICAL STUDY REPORT. ABBREVIATED CV’S CAN BE NO MORE THAN 3 PAGES, DO NOT INCLUDE
ATTACHMENTS OR TEXT ON REVERSE PAGES.
.
100008 3 Frank Steven Eder, MD Sponsor CV 19 May 2020 C4591001 United Medical AssociatesETMF Copy of: 270.01|C4591001|20-May-2020 | Active | 15-Feb-2021 10:20:59 AM|UNITED STATES|1118090177e1968ea843\Final\Final On: 18-Mar-2021 14:01 (GMT )
FDA-CBER-2021-5683-0000231
This is a representation of an electronic record that was signe d
electronically.
This page is the manifestation of the electronic signature(s).
Document Name: Frank Steven Eder, MD Sponsor CV 19 May 2020 C4591001
United Medical Associates
Document ID: 1000083
Statement of Testament: I reviewed the contents of this document
Electronic Signature for: Frank Steven Eder, MD
Electronically Signed by: [email protected]
Date and Time of Signature: 20 May 2020 08:50 EDT
100008 3 Frank Steven Eder, MD Sponsor CV 19 May 2020 C4591001 United Medical AssociatesETMF Copy of: 270.01|C4591001|20-May-2020 | Active | 15-Feb-2021 10:20:59 AM|UNITED STATES|1118090177e1968ea843\Final\Final On: 18-Mar-2021 14:01 (GMT )
FDA-CBER-2021-5683-0000232
FDA-CBER-2021-5683-0000233
This is a representation of an electronic record that was signe d
electronically.
This page is the manifestation of the electronic signature(s).
Document Name: Paul Simon Bradley, Md Pfizer One Page Current CV 31 Jan
2019 Expires 01 Jan 2021 Archived
Document ID: 201638
Statement of Testament: I approved the contents of this document
Electronic Signature for: Paul Bradley, MD
Electronically Signed by: [email protected]
Date and Time of Signature: 01 Feb 2019 09:19 CST
201638Paul Simon Bradley, Md Pfizer One Pa ge Current CV 31 Jan 2019 Expires 01 Jan 2021 Ar
chivedETMF Copy of: 270.01|C4591001|01-Feb-2019 | Active | 15-Feb-2021 10:20:59 AM|UNITED STATES|1120090177e1968ea843\Final\Final On: 18-Mar-2021 14:01 (GMT )
FDA-CBER-2021-5683-0000234
FDA-CBER-2021-5683-0000235
FDA-CBER-2021-5683-0000236
ABBREVIATED CURRICULUM VITAE TEMPLATE
TMF Doc ID
270.01, 272.01PFIZER CONFIDENTIAL
Page 1 of 1INV02-INV04-WI-GL02-SD01
Version 2.0, 16-Mar-2020 Last Name First Name Middle Name
Full Legal
Name: EssinkBrandon James
Professional Mailing Address:
Street Address 1:
3319 North 107th StreetStreet Address 2:
City: OmahaState/Province:NebraskaCountry:USAZip/Postal Code:68134
Email Address: [email protected]
Academic Qualifications:
Degree and/or Certification Date (yyyy) Institution and/or Country
Family Practice Procedural Fellowship2004 University of Nebraska Medical Center, USA
Family Practice Residency 2003 University of Nebraska Medical Center, USA
Doctor of Medicine 2001 University of Nebraska Medical Center, USABachelor of Science 1997 University of Nebraska – Lincoln, USA
Medical License Number State/Province Country
22302 Nebraska USA
74013 Georgia USA
7971 South Dakota USA
04-41270 Kansas USA
Current Position at Study Site: Principal Investigator
Start Date Title Institution or Company State/Province & Country
2003-Present Principal Investigator Meridian Clinical Research, LLC NE/USA
Previous Relevant Positions Including Academic Appointments:
Start and End Dates Title Institution or Company Country
2002-Present Sub-Investigator Meridian Clinical Research,
LLCUSA
2015-Present Physician Bryan Telemedicine USA
Brief Summary of Relevant Clinical Research Experience:
Cardiovascular (HTN) Hyperlipidemia – 15 OTC - 10Respiratory (COPD) – 12 Restless Legs - 4Gastrointestinal (GERD, Constipation, Heartburn) – 15 Osteoporosis - 4Vaccine (Adult and Pediatric) – 86 Contraception - 3Musculoskeletal (OA, chronic pain, fibromyalgia, IBS) – 17 Genitourinary (OAB, BPH, sexual dysfunction, UTI) - 12Dermatologic (herpes labials, psoriasis) – 15 Endocrinology (diabetes, thyroid) - 8Migraine - 8
Signature:
Signature Date: (dd-Mmm-yyyy)
I will update and resubmit my abbreviated CV if there are changes and particularly if there is any change in status which would
adversely affect the assessment of my suitability to conduct/participate in clinical studies.
NOTE: THIS CV MUST BE LIMITED TO THE INFORMATION CONTAINED IN THIS TEMPLATE FOR INCLUSION IN THE
ICH-E3 COMPLIANT CLINICAL STUDY REPORT. MULTI-PAGE CVS ARE NOT ACCEPTABLE. DO NOT INCLUDE
ATTACHMENTS, AND TEXT ON THE REVERSE SIDE.
908335Brandon Ja mes Essink, MD Version 2.0 16 MAR 2020 Pfizer One Pa ge Current CV 24 Apr 20
20 Expires 24 Apr 2022 ArchivedETMF Copy of: 270.01|C4591001|24-Apr-2020 | Active | 03-Mar-2021 6:39:59 AM|UNITED STATES|1123090177e1968ea843\Final\Final On: 18-Mar-2021 14:01 (GMT )
FDA-CBER-2021-5683-0000237
This is a representation of an electronic record that was signe d
electronically.
This page is the manifestation of the electronic signature(s).
Document Name: Brandon James Essink, MD Version 2.0 16 MAR 2020 Pfizer
One Page Current CV 24 Apr 2020 Expires 24 Apr 2022 Archived
Document ID: 908335
Statement of Testament: I reviewed the contents of this document
Electronic Signature for: Brandon Essink
Electronically Signed by: [email protected]
Date and Time of Signature: 24 Apr 2020 15:55 CDT
908335Brandon Ja mes Essink, MD Version 2.0 16 MAR 2020 Pfizer One Pa ge Current CV 24 Apr 20
20 Expires 24 Apr 2022 ArchivedETMF Copy of: 270.01|C4591001|24-Apr-2020 | Active | 03-Mar-2021 6:39:59 AM|UNITED STATES|1123090177e1968ea843\Final\Final On: 18-Mar-2021 14:01 (GMT )
FDA-CBER-2021-5683-0000238
ETMF Copy of: 270.01|C4591001|19-May-2020 | Active | 03-Mar-2021 6:40:03 AM|UNITED STATES|1124090177e1968ea843\Final\Final On: 18-Mar-2021 14:01 (GMT )
FDA-CBER-2021-5683-0000239
FDA-CBER-2021-5683-0000240
This is a representation of an electronic record that was signe d
electronically.
This page is the manifestation of the electronic signature(s).
Document Name: Charles Harold Harper, MD Pfizer One Page Current CV 22
Jan 2019 Expires 01 Jan 2021 Archived 01 Jan 2021
Document ID: 196341
Statement of Testament: I approved the contents of this document
Electronic Signature for: Charles Harper
Electronically Signed by: [email protected]
Date and Time of Signature: 23 Jan 2019 10:27 CST
196341Charles Harold Harper ,MD Pfi zer One Pa geCurrent CV 22Jan 2019Expires 01Jan 2021
Archi ved01Jan 2021ETMF Copy of: 270.01|C4591001|23-Jan-2019 | Active | 03-Mar-2021 6:40:05 AM|UNITED STATES|1125090177e1968ea843\Final\Final On: 18-Mar-2021 14:01 (GMT )
FDA-CBER-2021-5683-0000241
ETMF Copy of: 270.01|C4591001|13-Feb-2020 | Active | 16-Mar-2021 6:14:56 AM|UNITED STATES|1126090177e1968ea843\Final\Final On: 18-Mar-2021 14:01 (GMT )
FDA-CBER-2021-5683-0000242
ABBREVIATED CURRICULUM VITAE TEMPLATE
TMF Doc ID
270.01, 272.01PFIZER CONFIDENTIAL
Page 1 of 1INV02-INV04-WI-GL02-RF10
Version 1.0, 15-Feb-2016 Last Name First Name Middle Name
Full Legal
Name: KleinTracy R.
Professional Mailing Address:
Street Address 1:
Alliance for Multispecialty Research, LLCStreet Address 2: 1709 S. Rock Rd.
City: WichitaState/Province:KSCountry:USAZip/Postal Code:67207
Email Address: b rak@ c. leinQ amrllkckom
Akademik t ualifikab ions:
Degree and/or Cerb ifikab ion Dab e (@ @ @ @ y Insb ib ub ion and/or Counb r@
Residency 2002 Wichita State University
Medical Doctorate 1999 University of Kansas School of Medicine
BA / Chemistry 1995 Tabor College
Medikal Likense Num) er Sb ab e/Provinke Counb r@
04-28967/ MD KS USA
Currenb Posib ion ab Sb ud@ Sib e:
Sb arb Dab e Tib le Insb ib ub ion or Compan@ Sb ab e/Provinke & Counb r@
2017 PI Alliance for Multispecialty Research, LLC (east)KS/ USA
Previous Relevanb Posib ions Inkluding Akademik Appoinb menb s:
Sb arb and End Dab es Tib le Insb ib ub ion or Compan@ Counb r@
2002- 2017 PI/ Sub- I Heartland Research Associates, LLC (East) USA
2003- 2005 Medical Director Heartland Diabetes Associates,
LLCUSA
2001- Present Family Practice Family Medicine East,
CharteredUSA
Brief Summar@ of Relevanb Clinikal Researkh Experienke:
PI conducting clinical research Phase II –V in areas including Gastroenterology, Anti- Infective, Auditory, Cardiovascular, De rmatology,
Device, Endocrine/ Metabolism, Female Health, Hyperlipidemia, Hypertension, Male Health, Musculoskeletal, Neurological, Ophthalmology, Psychiatric, Respiratory, Smoking Cessation, Urogenital, Weight Control, Vaccines.
Signab ure:
Signab ure Dab e: (dd-Mmm-@ @ @ @ y
I will updab e and resu) mib m@ a) ) reviab ed CV if b here are khanges and parb ikularl@ if b here is an@ khange in sb ab us whikh would
adversel@ affekb b he assessmenb of m@ suib a) ilib @ b o kondukb /parb ikipab e in klinikal sb udiesc
NOTE: THIS CV MUST BE LIMITED TO THE INFORMATION CONTAINED IN THIS TEMPLATE FOR INCLUSION IN THE
ICH-E3 COMPLIANT CLINICAL STUDY REPORT. MULTI-PAGE CVS ARE NOT ACCEPTABLE. DO NOT INCLUDE
ATTACHMENTS, AND TEXT ON THE REVERSE SIDE.
1111433Tracy R. Klein, MD Current Sponsor-Specific CVs re moved additional USA "Expires:" 30
Jun 2022ETMF Copy of: 270.01|C4591001|30-Jun-2020 | Active | 16-Mar-2021 6:12:48 AM|UNITED STATES|1127090177e1968ea843\Final\Final On: 18-Mar-2021 14:01 (GMT )
FDA-CBER-2021-5683-0000243
This is a representation of an electronic record that was signe d
electronically.
This page is the manifestation of the electronic signature(s).
Document Name: Tracy R. Klein, MD Current Sponsor-Specific CVs removed
additional USA "Expires:" 30 Jun 2022
Document ID: 1111433
Statement of Testament: I reviewed the contents of this document
Electronic Signature for: Tracy R. Klein, MD
Electronically Signed by: [email protected]
Date and Time of Signature: 30 Jun 2020 14:18 EDT
1111433Tracy R. Klein, MD Current Sponsor-Specific CVs re moved additional USA "Expires:" 30
Jun 2022ETMF Copy of: 270.01|C4591001|30-Jun-2020 | Active | 16-Mar-2021 6:12:48 AM|UNITED STATES|1127090177e1968ea843\Final\Final On: 18-Mar-2021 14:01 (GMT )
FDA-CBER-2021-5683-0000244
ABBREVIATED CURRICULUM VITAE TEMPLATE
TMF Doc ID
270.01, 272.01PFIZER CONFIDENTIAL
Page 1 of 1INV02-INV04-WI-GL02-SD01
Version 2.0, 16-Mar-2020 Last Name First Name Middle Name
Full e ga N m KochMark
P:ro N ffs ri gl Mgs ls i n Add:N ff
Street Address:
1307 8th AvenueOther Street Address:Suite 202
City: Fort WorthState/Province:TXCountry:USAZip/Postal Code:76104
Ea gsl Add:N ffm a g:bbrk@ c. NiQg. sg:N fNg:k@ tkr a
AkgdN a sk / uglsoskgQ sr i f m
DNn: NN gi d(r: CN :QsoskgQ sr i DgQN y ))))S Ii fQsQuQsri gi d(r: Crui Q :)
Doctor of Medicine 1992 University of Texas Health Science Center at San Antonio
Bachelor of Science in Biochemistry 1988 University of Dallas
MNdskgl LskN if N eu av N : pQgQ N(P: r. si kN Crui Q :)
J4274 Texas USA
Cu::N iQ PrfsQ sr i gQ pQud) psQ N m
pQg:Q DgQN TsQlN Ii fQsQuQsr i r : Cr a & gi ) pQgQ N(P: r. si kN h C r u iQ :)
May 2016 Principal Investigator Ventavia Research Group, LLC TX, USA
P:N.s r u f R N lN.g iQ PrfsQ sri f Ii kludsi n AkgdN as k A & &rs i QaNiQfm
pQg:Q gi d Ei d DgQ N f TsQlN Ii fQsQuQsr i r : Cr a & gi ) Crui Q :)
Oct 2015 – Present Sub-Investigator Ventavia Research Group, LLCUSA
Oct 2000 – Present Physician JPS Residency Program USA
Sep 2005 – Present Physician/Member JPS Physicians Group USA
2000 – 2005 Physician North Texas Affiliated MedicalUSA
B:sNo pua a g:) ro RN lN.g iQ Clsi skgl RN fNg:k@ Ex& N :s Nik Nm
Trial for Efficacy, Immunogenicity, And Safety Study of Clostridium Difficile Vaccine in Subjects at Risk of C. Difficile Infec tion;
RSV Vaccine with Aluminum in Healthy Third-Trimester Pregnant Women and Safety and Efficacy of Maternally Transferred Antibodie s
in Preventing RSV Disease in Their Infants;Study to Describe the Safety, Tolerability, And Immunogenicity of a Respiratory Syncytial Virus (RSV) Vaccine in Healthy Adults;Study to Assess the Efficacy, Safety, And Immunogenicity of a Plant-Derived Quadrivalent VLP Influenza Vaccine in Adults 65 Years of Age and Older;A Phase 3, Randomized, Double-Blind Trial to Evaluate the Safety and Immunogenicity of A 20-Valent Pneumococcal Conjugate Vacci ne
in Pneumococcal Vaccine-Naïve Adults 18 Years of Age and Older;A Phase 3, Randomized, Observer-Blind, Multicenter Study to Evaluate the Efficacy, Immunogenicity and Safety of Seqirus' Cell-Based Quadrivalent Subunit Influenza Virus Vaccine (Qivc) Compared to A Non-Influenza Vaccine When Administrated in Healthy Subjects Aged 6 Months Through 47 Months;A Phase 2b, Placebo-Controlled, Randomized, Observer-Blind Study to Evaluate the Safety, Tolerability, and Immunogenicity of A Respiratory Syncytial Virus (Rsv) Vaccine When Administered Concomitantly with Tetanus, Diphtheria, and Acellular Pertussis Vac cine
(Tdap) in Healthy Nonpregnant Women 18 to 40 Years of Age;
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I wsll u& dgQN gi d :N fuva s Q a ) gvv:N .s g QN d CV so Q @ N :N g:N k@gi nN f gi d & g:Qskulg:l) so Q @ N:N sf gi ) k@ gi nN si f Q gQuf w@ sk@ wruld
gd. N :fNl ) g ooN kQ Q @ N gffN ffa N iQ ro a ) fusQ gv slsQ ) Qr kri dukQ (&g:Qsks&gQ N si klsi skgl f Q udsNft
NOTE: THIS CV MUST BE LIMITED TO THE INFORMATION IN THIS TEMPLATE FOR INCLUSION IN THE ICH-E3
COMPLIANT CLINICAL STUDY REPORT. ABBREVIATED CV’S CAN BE NO MORE THAN 3 PAGES, DO NOT INCLUDE
ATTACHMENTS OR TEXT ON REVERSE PAGES.
1006732 Mark Koch Pfizer CV Current CV 20 May 2020 Expired 19 May 2021ETMF Copy of: 270.01|C4591001|22-May-2020 | Active | 16-Mar-2021 6:13:24 AM|UNITED STATES|1128090177e1968ea843\Final\Final On: 18-Mar-2021 14:01 (GMT )
FDA-CBER-2021-5683-0000245
This is a representation of an electronic record that was signe d
electronically.
This page is the manifestation of the electronic signature(s).
Document Name: Mark Koch Pfizer CV Current CV 20 May 2020 Expired 19
May 2021
Document ID: 1006732
Statement of Testament: I approved the contents of this document
Electronic Signature for: Mark Koch
Electronically Signed by: [email protected]
Date and Time of Signature: 22 May 2020 15:04 CDT
1006732 Mark Koch Pfizer CV Current CV 20 May 2020 Expired 19 May 2021ETMF Copy of: 270.01|C4591001|22-May-2020 | Active | 16-Mar-2021 6:13:24 AM|UNITED STATES|1128090177e1968ea843\Final\Final On: 18-Mar-2021 14:01 (GMT )
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eSignature Addendum
All eSignatures below were executed using Florence eBinders
21 CFR Part 11 compliant software for eSignatures
Y ozviak_CV
Unique ID: 5f11a96658e6f7003acc7bf2 v.3eBinder Document ID: 5f11a96658e6f7003acc7bf2 v.3 page: 2 of 2Current Electronic Signatures (v.3):
Signed electronically by:
Date: 27-Aug-2020 @ 10:34 AM EST
Reason: Approval
Previous Electronic Signatures:
There are no signatures for any previous versions.ETMF Copy of: 270.01|C4591001|27-Aug-2020 | Active | 15-Feb-2021 10:22:12 AM|UNITED STATES|1169090177e1968ea843\Final\Final On: 18-Mar-2021 14:01 (GMT )
FDA-CBER-2021-5683-0000281
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FDA-CBER-2021-5683-0000282
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FDA-CBER-2021-5683-0000284
ETMF Copy of: 270.01|C4591001|24-Jun-2020 | Active | 15-Feb-2021 10:22:10 AM|UNITED STATES|1177090177e1968ea843\Final\Final On: 18-Mar-2021 14:01 (GMT )
FDA-CBER-2021-5683-0000285
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FDA-CBER-2021-5683-0000289
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(b) (6)
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eSignature Addendum
All eSignatures below were executed using Florence eBinders
21 CFR Part 11 compliant software for eSignatures
One Page CV Williams
Unique ID: 5f1591a23561f0310c7a7dd1 v.2eBinder Document ID: 5f1591a23561f0310c7a7dd1 v.2 page: 2 of 2Current Electronic Signatures (v.2):
Signed electronically by:
Date: 20-Jul-2020 @ 01:32 PM CDT
Reason: Approval
Previous Electronic Signatures:
There are no signatures for any previous versions.ETMF Copy of: 270.01|C4591001|20-Jul-2020 | Active | 15-Feb-2021 10:23:29 AM|UNITED STATES|1251090177e1968ea843\Final\Final On: 18-Mar-2021 14:01 (GMT )
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ETMF Copy of: 270.01|C4591001|18-May-2020 | Active | 15-Feb-2021 10:24:24 AM|UNITED STATES|1264090177e1968ea843\Final\Final On: 18-Mar-2021 14:01 (GMT )
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ETMF Copy of: 270.01|C4591001|31-Jul-2020 | Active | 15-Feb-2021 10:24:24 AM|UNITED STATES|1269090177e1968ea843\Final\Final On: 18-Mar-2021 14:01 (GMT )
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ETMF Copy of: 270.01|C4591001|13-Feb-2020 | Active | 15-Feb-2021 10:24:24 AM|UNITED STATES|1270090177e1968ea843\Final\Final On: 18-Mar-2021 14:01 (GMT )
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