Pfizer Documents (PHMPT/FDA)
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· 625 pages
Page 1 of 625 ***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: 1091 Site Name: (1091) Aventiv Research Inc. Subject No: 10911197 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 10:31 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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· 142 pages
FDA-CBER-2021-5683-0788848 FDA-CBER-2021-5683-0788849 FDA-CBER-2021-5683-0788850 FDA-CBER-2021-5683-0788851 FDA-CBER-2021-5683-0788852 FDA-CBER-2021-5683-0788853 FDA-CBER-2021-5683-0788854 FDA-CBER-2021-5683-0788855 FDA-CBER-2021-5683-0788856 FDA-CBER-2021-5683-0788857 FDA-CBER-2021-5683-0788858 FDA-CBER-2021-5683-0788859 FDA-CBER-2021-5683-0788860 FDA-CBER-2021-5683-0788861 FDA-CBER-2021-5683-0788862 FDA-CBER-2021-5683-0788863 FDA-CBER-2021-5683-0788864 FDA-CBER-2021-5683-0788865…
Pfizer Documents (PHMPT/FDA)
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· 204 pages
FDA-CBER-2021-5683-0788644 FDA-CBER-2021-5683-0788645 FDA-CBER-2021-5683-0788646 FDA-CBER-2021-5683-0788647 FDA-CBER-2021-5683-0788648 FDA-CBER-2021-5683-0788649 FDA-CBER-2021-5683-0788650 FDA-CBER-2021-5683-0788651 FDA-CBER-2021-5683-0788652 FDA-CBER-2021-5683-0788653 FDA-CBER-2021-5683-0788654 FDA-CBER-2021-5683-0788655 FDA-CBER-2021-5683-0788656 FDA-CBER-2021-5683-0788657 FDA-CBER-2021-5683-0788658 FDA-CBER-2021-5683-0788659 FDA-CBER-2021-5683-0788660 FDA-CBER-2021-5683-0788661…
Pfizer Documents (PHMPT/FDA)
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· 137 pages
Page 1 of 137 ***Confidential*** Header Text: c4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1066 Site Name: (1066) Solaris Clinical Research Subject No: 10661350 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 10:05 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…
Pfizer Documents (PHMPT/FDA)
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· 206 pages
Page 1 of 206 ***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: 1066 Site Name: (1066) Solaris Clinical Research Subject No: 10661242 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 10:05 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…
Pfizer Documents (PHMPT/FDA)
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· 162 pages
Page 1 of 162 ***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: 1066 Site Name: (1066) Solaris Clinical Research Subject No: 10661202 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 10:05 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…
Pfizer Documents (PHMPT/FDA)
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· 150 pages
Page 1 of 150 ***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: 1036 Site Name: (1036) Trinity Clinical Research Subject No: 10361140 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 04:44 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 option is…
Pfizer Documents (PHMPT/FDA)
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· 191 pages
Page 1 of 191 ***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc. Subject No: 10181159 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 04:44 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,…
Pfizer Documents (PHMPT/FDA)
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· 228 pages
Page 1 of 228 ***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc. Subject No: 10181132 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 04:44 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,…
Pfizer Documents (PHMPT/FDA)
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· 156 pages
Page 1 of 156 ***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc. Subject No: 10181111 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 04:44 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,…
Pfizer Documents (PHMPT/FDA)
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· 315 pages
Page 1 of 315 ***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc. Subject No: 10181090 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 04:44 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,…
Pfizer Documents (PHMPT/FDA)
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· 213 pages
Page 1 of 213 ***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc. Subject No: 10181031 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 04:44 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,…
Pfizer Documents (PHMPT/FDA)
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· 379 pages
Page 1 of 379 ***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research Subject No: 10161289 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 04:44 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)
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· 157 pages
Page 1 of 157 ***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research Subject No: 10161277 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 04:44 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)
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· 158 pages
Page 1 of 158 ***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research Subject No: 10161265 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 04:44 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)
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· 219 pages
Page 1 of 219 ***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research Subject No: 10161199 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 04:44 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)
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· 197 pages
Page 1 of 197 ***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research Subject No: 10161128 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 04:44 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)
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· 193 pages
Page 1 of 193 ***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research Subject No: 10161120 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 04:44 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)
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· 3 pages
BNT162b2 BLA STN 125742/0 M 1.11.3Response to FDA Information Request 1BNT162b2 BLASTN 125742/0 Response to CBER 18 May 2021 Information Request Regardin gDatasets May2021 090177e19712a0c4\Approved\Approved On: 19-May-2021 18:00 (GMT) FDA-CBER-2021-5683-0780567 BNT162b2 BLA STN 125742/0 M 1.11.3Response to FDA Information Request 21.INTRODUCTION Reference is made to Amendment 132 (dated 09 April 2021) to EUA 27034 to extend emergency use authorization of the Pfizer -BioNTech COVID- 19…
Pfizer Documents (PHMPT/FDA)
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· 2 pages
Pfizer Global Regulatory Affairs Pfizer Inc. 400 Arcola Road Collegeville, PA 19426 Global Product Developm ent 19May2021 Marion Gruber, Ph.D. Director Office of Vaccines Research and Review Food and Drug Administration Center for Bi ologicsEvaluation and Research DocumentControl Center 10903 New Hampshire Avenue WO71, G112 Silver Spring, MD 20993 -0002THIS DOCUMENT CONTAINS CONFIDENTIAL AND/OR TRADE SECRET INFORMATION THAT IS DISCLOSED ONLY IN CONNECTION WITH THE LICENSING AND/OR …