Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 12 15 Documents
· 402 pages
Interim Clinical Study Report Protocol C4591001 CONFIDENTIAL 1.TITLE PAGE Vaccine Name and Compound Number:BNT162 RNA -Based COVID -19 Vaccines, Compound Number: PF -07302048 Report Title: Interim Report –Adolescents : A Phase 1/2/3, Placebo- Controlled, Randomized, Observer -Blind, Dose - Finding Stud y to Evaluate the Safet y, Tolerability, Immunogenicit y, and Efficacy of SARS -COV -2 RNA Vaccine Candidates Against COVI D-19 in Healthy Individuals Protocol Number: Protocol…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 12 15 Documents
· 96 pages
Protocol C4591001 (PF-07302048 ) Statistical Analysis Plan CONFIDENTIAL Page 1 TMF Doc ID: 98.03Protocol C4591001 A PHASE 1/2/3, PLACEBO -CONTROLLED, RANDOMIZED, OBSERVER -BLIND , DOSE -FINDING STUDY T O EVALUATE THE SAFETY, TOLERAB ILITY, IMMUNOGENICITY, AND EFFICACY OF SARS -COV -2RNA VACCINE CANDIDATES AGAINST C OVID -19 IN HEALTHY INDIVIDUALS Statistical Analysis Plan (SAP) Version: 5 Date: 17Mar 2021 090177e196897024\Approved\Approved On: 17-Mar-2021 16:05 (GMT) …
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 12 15 Documents
· 3 pages
InterimClinical Study Report Protocol C4591001 PFIZER CONFIDENTIAL Template date: 01-July-2020 Page 116.1.5.1 S PONSOR CLINICAL STUDY REPORT APPROVAL FORM PROTOCOL NUMBER: C4591001 REPORTTITLE: Interim Report – Adolescents: 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 COVI D-19 in Healthy …
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 12 15 Documents
· 33 pages
Interim Clinical Study Report Protocol C4591001 CLINICAL STUDY REPORT SYNOPSIS CONFIDENTIAL Page 1Vaccine Name and Compound Number: BNT162 RNA -Based COVID -19 Vaccines, Compound Number: PF-07302048 Report Title: Interim Report –Adolescents : A Phase 1/2/3, Placebo -Controlled, Randomized, Observer -Blind, Dose -Finding Study to Evaluate the Safety , Tolerability , Immunogenicit y, and Efficacy of SARS -COV -2 RNA Vaccine Candidates Against COVID -19 in Healthy Individuals Protocol…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 12 15 Documents
· 45 pages
C4591001 COMPREHENSIVE LIST OF ALL CLINICAL SITES Page 1 of 9 PFIZER CONFIDENTIAL 04-Oct-2021 14:03:58 GMT Site Identifier Investigator Name (Prior Clinical Investigator(s)) Site Address at Time of Clinical Study Site Contact Information at Time of Clinical Study 1005 Matthew Davis Rochester Clinical Research, Inc. 500 Helendale Rd, Ste 265 Rochester, NEW YORK 14609 UNITED STATES Phone: (585) -288-0890 Email: [email protected] …
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 12 15 Documents
· 10 pages
COVID-19 Vaccine (BNT162, PF -07302048) BLA STN 125742/45 Module 1.11.3 Response to FDA Request for Information PFIZER CONFIDENTIAL Page 1 COVID-19 Vaccine (BNT162, PF -07302048; COMIRNATY) BLA STN 125742/45 Response to CBER Information Request of 14 March Regarding Additional Reactogenicity Data for Adolescents 12 Through 15 Years of Age 18March 2022 090177e199a7b0df\Approved\Approved On: 18-Mar-2022 11:04 (GMT) FDA-CBER-2022-5812-0235613 COVID-19 Vaccine (BNT162, PF -07302048) BLA STN…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 12 15 Documents
· 8 pages
BNT162b2 5.2 Tabular Listing of Clinical Studies PFIZER CONFIDENTIAL Page 11.TABULAR LISTING OF C LINICAL STUDIES INCL UDED IN THE SUBMISSION Information is provided for the clinical study included in the present supplemental submission data for COMI RNATY (BNT162b2 ). Details provided in the table include study objectives, brief description of the design of the study , dose regimens, number of participants vaccinated, a brief description of the study population, and the ty pe of…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 12 15 Documents
· 2 pages
090177e199313780\Approved\Approved On: 27-Jan-2022 01:37 (GMT) (b) (6) (b) (6) (b) (6) FDA-CBER-2022-5812-0235483 COMIRNATY® (COVID- 19 mRNA Vaccine) sBLA 125742/45 1.12.14. Environmental Assessment 26 January 2022 PFIZER CONFIDEN TIAL Page 2 Curriculum Vita e of the Expert Pfizer Worldwide R&D Groton, CT 06340 EDUCATION M.B.A. Masters in Business Administration, Profess ional Certificate in Industrial Hygiene B.S. Chemistry, EMPLOYMENT HISTORY …
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 12 15 Documents
· 4 pages
COVID-19 Vaccine (BNT162, PF -07302048) BLA STN 125742/45 Module 1.11.3 Response to FDA Request for Information PFIZER CONFIDENTIAL Page 1BNT162b2 (COMIRNATY) BLA STN 125742/45 Response to CBER Comments Received on 1 9January 2022Regarding Datasets for Adolescents 12 Through 15 Years of Age 02February 2022 090177e199402cef\Approved\Approved On: 02-Feb-2022 14:19 (GMT) FDA-CBER-2022-5812-0235485 COVID-19 Vaccine (BNT162, PF -07302048) BLA STN 125742/45 Module 1.11.3 Response to FDA Request for…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 12 15 Documents
· 218 pages
16.2.7.1 Adverse Events Legend Page Category Abbreviation Text Action - Stud y Vaccine Dose NA Not applicable P Investi gational product withdrawn Action - Sub ject TC Concomitant dru g treatment given TCN Concomitant non-dru g treatment given Cause of AE CD Concomitant dru g treatmen t CND Concomitant non-dru g treatmen t O Othe r Outcome N Not recovered/not resolve d R Recovered/resolve d RS Recovered/resolved with sequelae RG Recoverin g/resolvin g Toxicit y Grade 1…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 12 15 Documents
· 3283 pages
PF-07302048 (BNT162 RNA- Based COVID- 19 Vaccines) Protocol C4591001 Final Protocol Amendment 18, 07September 2021 CONFIDENTIAL CT02- GSOP Clinical Protocol Template Phase 1 2 3 4 (05 December 2019) Page 1A PHASE 1/2 /3, PLACEBO -CONTROLLED , RANDOMIZED, OBSERV ER-BLIND, DOSE -FINDING STUDY T O EVALUATE THE SAFETY, TOLERABI LITY, IMMUNOGENICITY, AND EFFICACY OF SARS -COV -2RNA VACCINE CANDIDATES AGAINST C OVID -19 IN HEALTHY INDIVIDUALS Study Sponsor: BioNTech Study Conducted By: Pfizer…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 12 15 Documents
· 176 pages
Annotated Stud y Book for Stud y Desi gn: C4591001 Stud y Desi gn Version: 19.0 Sponsor: Pfizer Protocol: C4591001 Sponsor Dru g Name: BLINDED THERAPY C4591001 - COVID19 Generated by Central Designer TM March 30, 2021 10:56AM3DJH RI $QQRWDWHG 6WXG\%RRN & ILOH & 8VHUV]KDQ JG$SS'DWD/RFDO$ SSV4'1'.;<1=&354RUDF BFEH IG G B BEIFFI E090177e196cd54aa\A pproved\A pproved On: 16-A pr-2021 13:33 (GMT ) Page 1…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 12 15 Documents
· 172 pages
Annotated Stud y Book for Stud y Desi gn: C4591001 Study Design Version: 16.0 Sponsor: Pfizer Protocol: C4591001 Sponsor Dru g Name: BLINDED THERAPY C4591001 - COVID1 9 Generated by Central Designer TM Februar y 22, 2021 8:10AMPage 1 of 11 5 Annotated Study Book - C4591001 2/22/2021 file:///C:/Users/zhan gd70/A ppData/Local/A pps/2.0/7 QDN0DKX.747/1YNZC0P6.4R Q/orac..03.0 _182cbe9101fd197d _0006.0003 _951f9bb66f2d394e/HtmlResources/AnnotatedStud ybook.htm l 090177e19657e614\Approved\Approved…