Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 12 15 Documents
· 4 pages
C4591001: R oadmap for Event Selection and SDTM Dataset Updates for Reactogenicity Background: As discussed with the Agency on 08 April 2021, any events reported in the general adverse event data (AE domain ) which meet criteria for reactogenicity have been added to the FACE and VS domains and used to update the summary records in the CE domain , as described below. Add a flag in SUPPDM : QNAM=REACTOFL, QLABEL=Reactogenicity Population Fl ag For vaccinated subjects…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 12 15 Documents
· 60 pages
E-Diary Transmission – Subjects 12 Through 15 and 16 Through 25 Years of Age (Reactogenicity Subset) – Safety Population .................................................... 2 Local Reactions, by Maximum Severity, Within 7 Days After Each Dose – Subjects 12 Through 15 and 16 Through 25 Years of Age (Reactogenicity Subset) – Safety Pop ulation …
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 12 15 Documents
· 77 pages
E-Diary Transmission – Subjects 12 Through 15 and 16 Through 25 Years of Age (Reactogenicity Subset) – Safety Population .................................................... 2 Local Reactions, by Maximum Severity, Within 7 Days After Each Dose – Subjects 12 Through 15 and 16 Through 25 Years of Age (Reactogenicity Subset) – Safety Pop ulation …
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 12 15 Documents
· 3 pages
Supplemental Analysis Reviewer Guide sBLA for 12-15 Years of Age BioNTech SE and PFIZER INC. Study C4591001 090177e19939f708\Final\Final On: 31-Jan-2022 15:29 (GMT) FDA-CBER-2022-5812-0492642 Study C4591001 2 Table of Contents Contents 1. Introduction ................................ ................................ ................................ ................................ . 3 090177e19939f708\Final\Final On: 31-Jan-2022 15:29…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 12 15 Documents
· 60 pages
Clinical Study Data Reviewer’s Guide sBLA Analysis for Participants, 12-15 Years of Age BioNTech SE and PFIZER INC. Study C4591001 090177e198d52630\Final\Final On: 10-Dec-2021 03:01 (GMT) FDA-CBER-2022-5812-0492582 Study C4591001 Clinical Study Data Reviewer’s Guide This document is confidential Page 2 of 60 Clinical Data Reviewer’s Guide Revision history Version Summary of Major Change(s) and Impact Version Date 1.0 First approved version of…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 12 15 Documents
· 131 pages
Annotated Stud y Book for Stud y Desi gn: C4591001 Stud y Desi gn Version: 14.0 Sponsor: Pfizer Protocol: C4591001 Sponsor Dru g Name: BLINDED THERAPY C4591001 - COVID19 Generated by Central Designer TM January 14, 2021 12:00PMAnnotated Study Book - C4591001 Page 1 of 131 090177e198d5262f\Final\Final On: 10-Dec-2021 03:01 (GMT) FDA-CBER-2022-5812-0492451 Visits SCR MAIN INFORMED CONSENT DEMOGRAPHY DATE OF VISIT INCLUSION/EXCLUSION CRITERIA (INC EXC S) INCLUSION/EXCLUSION CRITERIA…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 12 15 Documents
· 86 pages
Clinical Study Data Reviewer’s Guide sBLA (12-1 5 Years of Age) BioNTech SE and PFIZER INC. Study C4591001 090177e198dd640c\Final\Final On: 14-Dec-2021 04:49 (GMT) FDA-CBER-2022-5812-0492365 Study C4591001 Clinical Study Data Reviewer’s Guide This document is confidential Page 2 of 86 Clinical Data Reviewer’s Guide Revision history Version Summary of Major Change(s) and Impact Version Date 1.0 First approved version of Clinical Data…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 12 15 Documents
· 131 pages
Annotated Stud y Book for Stud y Desi gn: C4591001 Stud y Desi gn Version: 14.0 Sponsor: Pfizer Protocol: C4591001 Sponsor Dru g Name: BLINDED THERAPY C4591001 - COVID19 Generated by Central Designer TM January 14, 2021 12:00PMAnnotated Study Book - C4591001 Page 1 of 131 090177e196b6fd5d\Final\Final On: 06-Apr-2021 21:26 (GMT) FDA-CBER-2022-5812-0492234 Visits SCR MAIN INFORMED CONSENT DEMOGRAPHY DATE OF VISIT INCLUSION/EXCLUSION CRITE RIA (INC EXC S) INCLUSION/EXCLUSION CRITERIA…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 12 15 Documents
· 89 pages
Compound: PF -07302048; Protocol: C4591001 Page 1of 16 ========================================================================================================================== PFIZER CONFIDENTIAL SDTM Creation: . (.) Source Data: adsl Output File: ./nda2/C4591001_Narratives_Abbr/profile Date of Generation: 15FEB2021 (21:40)Table of Abbreviations Category Abbreviation Text Action -Subject N No action O Other P Drug withdrawn (study intervention discontinued) TC Concomitant drug…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 12 15 Documents
· 76 pages
Compound: PF -07302048; Protocol: C4591001 Page 1of 65 ========================================================================================================================== PFIZER CONFIDENTIAL SDTM Creation: . (.) Source Data: adsl Output File: ./nda2/C4591001 Narratives Abbr/profile D ate o f Generation: 15SEP2021 (12:45)Table of Abbreviations Category Abbreviation Text Action -Subject N No action O Other P Drug withdrawn (study intervention discontinued) TC Concomitant drug…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 12 15 Documents
· 19 pages
C4591001 Page 1of 17 CONFIDENTIAL 15-Nov-2021 11:54:10 GMT 16.1.4.1 LIST OF INVESTIGATORS AND NUMBER OF SITES AND PARTICIPANTS BY COUNTRY Total Number of Sites (Per Study ):29 Total Number of Subjects Screened (Per Study ): 2268 Total Number of Subjects Randomized/Entered (Per Study ):2268 UNITED STATES Number of Sites (Per Country ): 29 Number of Subjects Screened (Per Country ): 6713 Number of Subjects Randomized/Entered (Per Country ): 6500 Coordinating Investigator: Stephen…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 12 15 Documents
· 278 pages
16.2.5.1 Listing of Subjects Who Received Vaccine Not as Random ized – All Subjects 12 Through 15 Years of Age Vaccine Group (as Randomized) Subject Randomization Date Vaccination Date Dose No. Vaccine Received No subject meets the reporting criteria. PFIZER CONFIDENTIAL SDTM Creation: 30SEP2021 (11:35) Source Dat a: adsl Table Generation: 03NOV2021 (13:12) (Data Cutoff Date: 02SEP2021, Database Snapshot Date: 27SEP2021 ) Output File: ./nda2 unblinded/C4591001 SPeds/adsl…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 12 15 Documents
· 5 pages
Template Version: January 2021 Confidential Page 1of 2Pfizer Regulatory Quality Assurance Audit Certificate I, the undersigned, confirm and certify that the following inves tigator site audit activities were performed. Study C4591001 Two (2) investigator site audits we re performed between 17-Jun-2021 a nd 02-Sep-2021 for Study C4591001. Investigator NameCenter NumberCountry Dates of AuditType of AuditName of Auditor Rupp, Richard Earl 1142 United States 21 Jun 2021 to 24 Jun 2021 Routine…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 12 15 Documents
· 91 pages
C4591001 Page 1of 89 CONFIDENTIAL 19-Mar-2021 16:13:09 GMT 16.1.4.1 LIST OF INVESTIGATORS AND NUMBER OF SITES AND SUBJECTS BY THE COUNTRY Total Number of Sites (Per Study ):153 Total Number of Subjects Screened (Per Study ): 48092 Total Number of Subjects Randomized/Entered (Per Study ):45121 ARGENTINA Number of Sites (Per Country ): 1 Number of Subjects Screened (Per Country ): 5896 Number of Subjects Randomized/Entered (Per Country ): 5615 Coordinating Investigator: <None Entered>…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 12 15 Documents
· 583 pages
16.2.5.2.1 Listing of Medication Errors – Subjects 12 Through 25 Years of Age Age Group (Years) Subject Dose No.a Start Date Type of Medication Error Action Taken Was a Concomitant Medication Given (Yes/No) Was the Nondrug Treatment Given (Yes/No) Stop Date Discontinued From Study (Yes/No) Medication Error– Associated AE (Yes/No) 16-25 C4591001 1011 10111215 1 19OCT2020 Product administration error DOSE NOT CHANGED N N 19OCT2020 N N C4591001 1024 10241091 1…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 12 15 Documents
· 72 pages
Analysis Data Reviewer’s Guide sBLA Analysis for Participants 12-15 Years of Age BioNTech SE and PFIZER INC. Study C4591001 ADRG Template Version 2019-07- 23 090177e198d550b8\Final\Final On: 10-Dec-2021 03:00 (GMT) FDA-CBER-2022-5812-0492162 Study C4591001 Analysis Data Reviewer’s Guide Page 2 of 72 ANA LYSIS DATA REVI EWER GUIDE REVISION HISTORY Version Summary of Major Change(s) and Impact Version Date 1.0 First approved version of Analysis Data…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 12 15 Documents
· 234 pages
Level Term Code SOC PT Acute HIV infection 10000807 INFECTIONS AND INFESTATIONS PT Asymptomatic HIV infection 10003581 INFECTIONS AND INFESTATIONS PT Blood HIV RNA 10049826 INVESTIGATIONS PT Blood HIV RNA below assay limit 10049829 INVESTIGATIONS PT Blood HIV RNA decreased 10049828 INVESTIGATIONS PT Blood HIV RNA fluctuation 10076287 INVESTIGATIONS PT Blood HIV RNA increased 10049827 INVESTIGATIONS PT Congenital HIV infection 10010504 CO NGENITAL, FAMILIAL AND GENE TIC DISORDERS PT CSF HIV…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 12 15 Documents
· 61 pages
Clinical Reviewer: Susan K. Wollersheim, MD STN:125742/45 i sBLA Clinical Review Memorandum Application Type Supplemental Biologics License Application (sBLA ) STN 125742/45 CBER Received Date December 16, 2021 PDUFA Goal Date June 17, 2022 Division / Office DVRPA / OVRR Priorit y Review (Yes/No ) Yes Reviewer Name Susan K. Wollersheim, MD Review Completion Date / Stamped Date July 8, 2022 Supervisory Concurrence Lucia Lee, M.D.; Team Leader …
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 12 15 Documents
· 520 pages
Page 1 of 520 ***Confidential*** Header Text: c4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1223 Site Name: (1223) Yale New Haven Medical Center Subject No: 12231273 Subject Initials: --- Generated By: Generated Time (GMT): 10-Nov-2021 20:44 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE 3…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 12 15 Documents
· 295 pages
Page 1 of 295 ***Confidential*** Header Text: c4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates Subject No: 11561357 Subject Initials: --- Generated By: Generated Time (GMT): 10-Nov-2021 20:44 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5,…