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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: 3 Date: 02Nov2020 090177e19568e83f\Approved\Approved On: 02-Nov-2020 21:20 (GMT) FDA-CBER-2021-5683-0216667…
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16.2.5.1 Listing of Subjects Who Received Vacc ine Not as Randomized – All Subjects ≥16 Years of Age Vaccine Group (as Randomized) Age Group (Years) Subject Randomization Date Vaccination Date Dose No. Vaccine Received BNT162b2 (30 μg) 16-55 C4591001 1012 10121103 01SEP2020 22SEP2020 2 Placebo 16-55 C4591001 1088 10881077 21AUG2020 11SEP2020 2 Placebo 16-55 C4591001 1116 11161226 11SEP2020 11SEP2020 1 Placebo 16-55 C4591001 1116 11161226 11SEP2020 02OCT2020 2 Placebo …
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BNT162b2 1.4.2. Statement of Right to Reference PFIZER CONFIDENTIAL Page 11.4.2. STATEMENT OF RIGHT T O REFERENCE The following Drug Master File (DMF) / Master File (MF) Letters of Authorization are provided herein as presented in Table 1.4.2-1. Table 1.4.2-1.DMF Letters of Authorization DMF/ MF Holder DMF/ MF NumberDMF /MF Subject Reference Inform ation Gerresheimer Buende GmbHDMF 9543 Type I Tubular Containers 2 mL T ype I borosilicate glass vial, 13 mm finish Gerresheimer Buende …
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090177e196fde963\Approved\Approved On: 10-May-2021 08:45 (GMT) FDA-CBER-2021-5683-0225038
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090177e196a1387a\Approved\Approved On: 26-Mar-2021 06:28 (GMT) FDA-CBER-2021-5683-0225037
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Date: September 22, 2020 DMF#: 011820 Holder: SCHOTT AG Subject: GLASS VIALS MANUFACTURED IN MULLHEIM, GERMANY. Letter of Authorization for: Entire DMF 011820 SCHOTT AG hereby authorizes the following company to incorporate by reference information regarding packag- ing material in DMF 011820 into any application filed by this company for their product. We also authorize the FDA to review all informati on in DMF 011820 when considering any…
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090177e196a0ee17\Approved\Approved On: 26-Mar-2021 06:12 (GMT) FDA-CBER-2021-5683-0225035
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To: Food and Drug Administration Center for Biologics Evaluation and Research Document Control Center 10903 New Hampshire Ave. Building 71, Room G112 Silver Spring, MD 20993-0002 Copy to Pfizer Inc. as US Agent for BioNTech RNA Pharmaceuticals GmbH 500 Arcola Road Collegeville, PA 19436 USA Piombino Dese (Italy), August 25, 2020 DMF Type III no. #011321 Submission date: Submitted on January 15, 1995 revised on May 22, 2015 DMF Holder: Stevanato Group S.p.A. Letter of…
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Diluent For Use with [COVID-19 mRNA Vaccine (nucleoside modified)] COMIRNATYTM COMDILRMComirnaty Diluent Label 2P May 10, 2021 am Black 1.25” x 2.75”Comirnaty Diluent Label_2.pdf 1 5/10/21 4:41 PM 090177e197028df4\Approved\Approved On: 11-May-2021 20:52 (GMT) FDA-CBER-2021-5683-0225031
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September 17, 2020 Drug Master File # 10953 - Letter of Authorization Our internal reference: B4013 update 1 Page 1 of 2 September 17, 2020 Our internal reference : B4013 update 1 DMF#: 10953 Holder: Datwyler Pharma Packaging Belgium NV Subject : Rubber Compounds Letter of Authorization for: compound FM457/0 , located in record # 026, Update 3, pages 1-7, dated April 21, 2020. Dear DMF Staff: Datwyler Pharma Packaging Belgium NV hereby authorizes Pfizer Inc. as US…
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Page 1 of 326 ***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: 1150 Site Name: (1150) Senders Pediatrics Subject No: 11501294 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 option is…
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Page 1 of 337 ***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: 1150 Site Name: (1150) Senders Pediatrics Subject No: 11501210 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 option is…
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Page 1 of 223 ***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: 1147 Site Name: (1147) Ochsner Health System Subject No: 11471327 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 option is…
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Page 1 of 216 ***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: 1147 Site Name: (1147) Ochsner Health System Subject No: 11471281 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 option is…
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Page 1 of 269 ***Confidential*** Header Text: c4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 14-Jan-2021 02:25 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1139 Site Name: (1139) Duke University Medical Center Subject No: 11391246 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…
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Page 1 of 278 ***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: 1131 Site Name: (1131) PriMED Clinical Research Subject No: 11311301 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 option…
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Page 1 of 250 ***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: 1091 Site Name: (1091) Aventiv Research Inc. Subject No: 10911447 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 option is…
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Page 1 of 316 ***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: 1039 Site Name: (1039) ARC Clinical Research at Wilson Parke Subject No: 10391285 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,…
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Page 1 of 380 ***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research Subject No: 10161327 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…
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Page 1 of 456 ***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic South Subject No: 10091382 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…