Pfizer Documents (PHMPT/FDA)
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· 125 pages
Page 1 of 125 ***Confidential*** Header Text: C4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty Subject No: 12051075 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 13:11 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)
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· 183 pages
Page 1 of 183 ***Confidential*** Header Text: C4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified Site No: 1205 Site Name: (1205) Hacettepe University Medical Faculty Subject No: 12051077 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 13:11 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)
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· 128 pages
Page 1 of 128 ***Confidential*** Header Text: C4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1232 Site Name: (1232) Columbus Regional Research Institute Subject No: 12321159 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 17:24 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,…
Pfizer Documents (PHMPT/FDA)
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· 161 pages
Page 1 of 161 ***Confidential*** Header Text: C4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1232 Site Name: (1232) Columbus Regional Research Institute Subject No: 12321175 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 17:24 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,…
Pfizer Documents (PHMPT/FDA)
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· 201 pages
Page 1 of 201 ***Confidential*** Header Text: C4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1232 Site Name: (1232) Columbus Regional Research Institute Subject No: 12321213 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 17:24 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,…
Pfizer Documents (PHMPT/FDA)
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· 172 pages
Page 1 of 172 ***Confidential*** Header Text: C4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1232 Site Name: (1232) Columbus Regional Research Institute Subject No: 12321293 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 17:24 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,…
Pfizer Documents (PHMPT/FDA)
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· 141 pages
Page 1 of 141 ***Confidential*** Header Text: C4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1232 Site Name: (1232) Columbus Regional Research Institute Subject No: 12321299 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 17:24 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,…
Pfizer Documents (PHMPT/FDA)
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· 623 pages
Page 1 of 623 ***Confidential*** Header Text: c4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1235 Site Name: (1235) LSU Health Shreveport Subject No: 12351071 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 19:09 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 option is…
Pfizer Documents (PHMPT/FDA)
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· 160 pages
Page 1 of 160 ***Confidential*** Header Text: c4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1235 Site Name: (1235) LSU Health Shreveport Subject No: 12351130 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 19:09 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 option is…
Pfizer Documents (PHMPT/FDA)
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· 175 pages
Page 1 of 175 ***Confidential*** Header Text: c4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified Site No: 1235 Site Name: (1235) LSU Health Shreveport Subject No: 12351205 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 19:09 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 option is…
Pfizer Documents (PHMPT/FDA)
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· 301 pages
Page 1 of 301 ***Confidential*** Header Text: c4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1241 Site Name: (1241) Hospital Irma Dulce Subject No: 12411051 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 19:09 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 option is…
Pfizer Documents (PHMPT/FDA)
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· 236 pages
Page 1 of 236 ***Confidential*** Header Text: c4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1241 Site Name: (1241) Hospital Irma Dulce Subject No: 12411053 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 19:09 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 option is…
Pfizer Documents (PHMPT/FDA)
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· 263 pages
Page 1 of 263 ***Confidential*** Header Text: c4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1241 Site Name: (1241) Hospital Irma Dulce Subject No: 12411067 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 19:09 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 option is…
Pfizer Documents (PHMPT/FDA)
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· 1917 pages
PF-07302048 (BNT162b2) Reporting Period Summary Monthly Safety Report (SMSR) 2 01 January 2021 through 31 January 2021 CONFIDENTIAL Page 1SUMMARY MONTHLY SAFETY REPORT 2 for ACTIVE SUBSTANCE: PF-07302048 (BNT162b2) ATC CODE: J07BX031 AUTHORISATION PROCEDURE in the EU: Centralised INTERNATIONAL BIRTH DATE (IBD):219 December 2020 EUROPEAN UNION REFERENCE DATE (EURD): 21 December 2020 INTERVAL COVERED BY THIS REPORT: 01 JANUARY 2021through 31 JANUARY 2021 DATE OF THIS REPORT: 12FEBRUARY 2021…
Pfizer Documents (PHMPT/FDA)
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· 578 pages
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Pfizer Documents (PHMPT/FDA)
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· 207 pages
PF-07302048 (BNT162 b2 RNA- Based COVID -19 Vaccine) Protocol C4591007 Final Protocol Amendment 21, 05 March 06Aug 2021 PFIZER CONFIDENTIAL CT02- GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) Page 1A PHASE 1 ,OPEN-LABEL DOSE -FINDING STUDY TO EVALUATE S AFETY, TOLERABILITY , AND IMMUNOGENICITY AND PHASE 2/3 PLACEBO -CONTROLLED, OBSERVER- BLINDED SAFETY, TOLERABILIT Y, AND IMMUNOGENICITY STUDY OF A SARS -COV -2 RNA VACCI NE CANDIDATE AGAINST CO VID-19 IN HEALTHY CHILDREN …
Pfizer Documents (PHMPT/FDA)
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· 186 pages
PF-07302048 (BNT162 b2 RNA- Based COVID -19 Vaccine) Protocol C4591007 Final Protocol Amendment 2 , 06 Aug 2021 PFIZER CONFIDENTIAL CT02- GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) Page 1A PHASE 1 ,OPEN-LABEL DOSE -FINDING STUDY TO EVALUATE S AFETY, TOLERABILITY , AND IMMUNOGENICITY AND PHASE 2/3 PLACEBO -CONTROLLED, OBSERVER- BLINDED SAFETY, TOLERABILIT Y, AND IMMUNOGENICITY STUDY OF A SARS -COV -2 RNA VACCI NE CANDIDATE AGAINST CO VID-19 IN HEALTHY CHILDREN AND YOUNG…
Pfizer Documents (PHMPT/FDA)
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· 3409 pages
PF-07302048 (BNT162b2) Reporting Period Summary Monthly Safety Report ( SMSR) 3 01 February 2021 through 28 February 2021 CONFIDENTIAL Page 1SUMMARY MONTHLY SAFETY REPORT 3 for ACTIVE SUBSTANCE: PF-07302048 (BNT162b2) ATC CODE: J07BX 031 AUTHORISATION PROCEDURE in the EU: Centralised INTERNATIONAL BIRTH DATE (IBD):219 December 2020 EUROPEAN UNION REFERENCE DATE (EURD): 21 December 2020 INTERVAL COVERED BY THIS REPORT: 01 FEBRUARY 2021 through 28 FEBRUARY 2021 DATE OF THIS REPORT: 12MARCH 2021…
Pfizer Documents (PHMPT/FDA)
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· 4823 pages
PF-07302048 (BNT162b2) Reporting Period Summary Monthly Safety Report (SMSR) 4 01 March 2021 through 31 March 2021 CONFIDENTIAL Page 1SUMMARY MONTHLY SAFETY REPORT 4 for ACTIVE SUBSTANCE: PF-07302048 (BNT162b2) ATC CODE: J07BX 031 AUTHORISATION PROCEDURE in the EU: Centralised INTERNATIONAL BIRTH DATE (IBD):219 December 2020 EUROPEAN UNION REFERENCE DATE (EURD): 21 December 2020 INTERVAL COVERED BY THIS REPORT: 01 MARCH 2021through 31 MARCH 2021 DATE OF THIS REPORT: 14APRIL2021 Report Prepared…
Pfizer Documents (PHMPT/FDA)
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· 636 pages
BNT162b2 Module 1.6.3 Correspondence Regarding Meetings CONFIDENTIAL Page 1 of 6 1.6.3 CORRESPONDENCE REGARDING MEETINGS The following is a brief summary of the significant meetings and communications between Pfizer and FDA regarding IND 19736. Copies of these correspondences are also provided. Key US Regulatory Interactions Date Regulatory Communication Additional Information 26 June 2020 FDA Type C Meeting CRMTS #12645 The purpose of this Type C Meeting was to…