Pfizer Documents (PHMPT/FDA)
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· 341 pages
Page 1 of 341 ***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: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center Subject No: 10071117 Subject Initials: --- Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per…
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: 06-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center Subject No: 10071101 Subject Initials: --- Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per…
Pfizer Documents (PHMPT/FDA)
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· 249 pages
Page 1 of 249 ***Confidential*** Header Text: c4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center Subject No: 10071097 Subject Initials: --- Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per…
Pfizer Documents (PHMPT/FDA)
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· 614 pages
Page 1 of 614 ***Confidential*** Header Text: c4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 06-Jun-2020 00:47 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center Subject No: 10071050 Subject Initials: --- Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per…
Pfizer Documents (PHMPT/FDA)
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· 182 pages
Page 1 of 182 ***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: 1008 Site Name: (1008) Clinical Research Professionals Inc. Subject No: 10081337 Subject Initials: --- Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol…
Pfizer Documents (PHMPT/FDA)
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· 146 pages
Page 1 of 146 ***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: 1008 Site Name: (1008) Clinical Research Professionals Inc. Subject No: 10081184 Subject Initials: --- Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol…
Pfizer Documents (PHMPT/FDA)
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· 158 pages
C4591001 1231 ARGENTINA Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072442/P220395-0042L 0.5 mg/ml SOLUTION BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072765/P220395-0042L 0.5 mg/ml SOLUTION BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813…
Pfizer Documents (PHMPT/FDA)
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· 46 pages
16.2.2.2 Listing of Important Protocol Deviations – Phase 2 Protocol Deviation Category Protocol Deviation Subcategory Number of Subjects Subject (Number of Deviations if >1) Concomitant Medications Subject rec eived systemic corticosteroids (>=20mg/day of prednisone or equivalent) for >=14 days is prohibited from 28 days prior to enrollment to specified visits/cohorts per protocol. 1 C4591001 1003 10031101 PFIZER CONFIDENTIAL SDTM Creation: 17NOV2020 (10:49) Source…
Pfizer Documents (PHMPT/FDA)
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· 112 pages
16.2.1.1 Listing of Subjects Withdrawn From the Study – Phase 1, 2 Doses, 21 Days Apar t Vaccine Candidate Age Group (Years) Vaccine Group (as Randomized) Subject Dose No. Rel Daya Withdrawal Date Study Phase Withdrawal Reason Commentb No subject meets the reporting criteria. a. Relative Day (Rel Day) = date of withdrawal - date of last vaccination + 1. For a withdrawal that occurred before the date of the first study vaccination,…
Pfizer Documents (PHMPT/FDA)
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· 139 pages
C4591001 1231 ARGENTINA Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072442/P220395-0042L 0.5 mg/ml SOLUTION BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072765/P220395-0042L 0.5 mg/ml SOLUTION BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A E220395-0035L002/P220395-0048L 0.5 mg/ml SOLUTION BNT162b2 0.5 mg/ml 0.3 ml Vial…
Pfizer Documents (PHMPT/FDA)
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UTMB -Shi Lab SOP TITLE: Manual 96 -well Neutralization Assay for the Detection of Functional Antibodies to SARS -CoV-2 in Test Serum using Cytation 7 Image Reader Doc. Number: SHI -SOP -10011 Version: 2.0 UTMB -Shi Lab CONFIDENTIAL Page 1 TABLE OF CONTENTS 1.HISTORICAL REVISION SUMMARY ............................................................................... 2 Table 1. Chronological Summary of Previous Versions ........................................................ 2 2.PURPOSE…
Pfizer Documents (PHMPT/FDA)
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· 3 pages
BNT162b2 2.7.1 Summary of Biopharmaceutic Studies and Associated Analytical Methods CONFIDENTIAL Page 12.7.1 SUMMARY OF BIO PHARMACEUTIC STUDIES AND ASSOCIATED ANALYTICAL METHODS 090177e19671a370\Approved\Approved On: 17-Mar-2021 14:08 (GMT) FDA-CBER-2021-5683-0142288 BNT162b2 2.7.1 Summary of Biopharmaceutic Studies and Associated Analytical Methods CONFIDENTIAL Page 2SUMMARY OF BIOPHARMACEUTIC STUDIES AND ASSOCIATED ANALYTICAL METHODS COVID -19 diagnostic and severe acute respiratory …
Pfizer Documents (PHMPT/FDA)
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16.1.7.2 Listing of Subjects Who Transferred to a Different Site – All Subjects ≥16 Years of Ag e Age Group (Years) Subject Transferred to Site Reason for Transfer 16-55 C4591001 1013 10131005 1117 Subject movin g to another site 16-55 C4591001 1013 10131498 1015 Subject is moving 16-55 C4591001 1013 10131518 1044 CTM request 16-55 C4591001 1022 10221179 1015 Subject change of address 16-55 C4591001 1055 10551061 1261 Subject moving to new site. 16-55 C4591001…
Pfizer Documents (PHMPT/FDA)
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· 226 pages
Page 1 of 226 ***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic Subject No: 10061098 Subject Initials: --- Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per…
Pfizer Documents (PHMPT/FDA)
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· 288 pages
Page 1 of 288 ***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic Subject No: 10061176 Subject Initials: --- Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol…
Pfizer Documents (PHMPT/FDA)
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· 249 pages
Page 1 of 249 ***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic Subject No: 10061094 Subject Initials: --- Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per…
Pfizer Documents (PHMPT/FDA)
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· 507 pages
Page 1 of 507 ***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic Subject No: 10061040 Subject Initials: --- Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per…
Pfizer Documents (PHMPT/FDA)
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· 259 pages
Page 1 of 259 ***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic Subject No: 10061052 Subject Initials: --- Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per…
Pfizer Documents (PHMPT/FDA)
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· 187 pages
Page 1 of 187 ***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: 1006 Site Name: (1006) J. Lewis Research, Inc. Foothill Family Clinic Subject No: 10061020 Subject Initials: --- Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per…
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: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc. Subject No: 10051411 Subject Initials: --- Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04 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,…