Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic South Subject No: 10091123 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…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 186 pages
Page 1 of 186 ***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: 1008 Site Name: (1008) Clinical Research Professionals Inc. Subject No: 10081667 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 amendment 5,…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 167 pages
Page 1 of 167 ***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: 1008 Site Name: (1008) Clinical Research Professionals Inc. Subject No: 10081628 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)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 207 pages
Page 1 of 207 ***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC Subject No: 10111029 Subject Initials: --- Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21 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)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 173 pages
Page 1 of 173 ***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: 1008 Site Name: (1008) Clinical Research Professionals Inc. Subject No: 10081603 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)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 205 pages
Page 1 of 205 ***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic South Subject No: 10091149 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…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 272 pages
Page 1 of 272 ***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic South Subject No: 10091135 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…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family Clinic South Subject No: 10091128 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…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 124 pages
Page 1 of 124 ***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: 10081152 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)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 157 pages
Page 1 of 157 ***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: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center Subject No: 10071443 Subject Initials: --- Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04 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)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 173 pages
Page 1 of 173 ***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: 10081056 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)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 169 pages
Page 1 of 169 ***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: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center Subject No: 10071441 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)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 181 pages
Page 1 of 181 ***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: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center Subject No: 10071347 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)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 172 pages
Page 1 of 172 ***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: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center Subject No: 10071315 Subject Initials: --- Generated By: pfe.levissc Generated Time (GMT): 19-Apr-2021 21:04 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)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 459 pages
Page 1 of 459 ***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: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical Center Subject No: 10071306 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)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 217 pages
16.2.8.1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and Symptoms – Dose 1 All -Available Efficacy Populatio n Subject (Country/Age in Years/Sex) Vaccine Group (as Randomized) Dose/Rel Daya Start Date of First Symptom Stop Date of Last Symptom Visit 1 N-Binding Assay/ Visit 1 NAAT/ Visit 2 NAAT Signs and Symptoms SARS -CoV -2 NAAT Result (Central Lab/Local Labb) C4591001 1003 10031122 (USA/48/M)* …
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 15 pages
USUBJID SUBJID C4591001 1005 10051328 10051328 C4591001 1005 10051400 10051400 C4591001 1005 10051412 10051412 C4591001 1005 10051416 10051416C4591001 1005 10051419 10051419C4591001 1006 10061136 10061136C4591001 1006 10061137 10061137C4591001 1006 10061159 10061159C4591001 1006 10061162 10061162C4591001 1006 10061170 10061170C4591001 1006 10061184 10061184C4591001 1006 10061192 10061192C4591001 1006 10061194 10061194C4591001 1006 10061202 10061202C4591001 1006 10061209 10061209C4591001 1006…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 8 pages
SUBJECTN UMBERST RInformed consent date Cohort selection 10071038 6/10/2020 STAGE 1 SENTINEL COHORTS 10021069 6/10/2020 STAGE 1 SENTINEL COHORTS 10031054 6/10/2020 STAGE 1 SENTINEL COHORTS 10071052 6/11/2020 STAGE 1 SENTINEL COHORTS 10031038 6/5/2020 STAGE 1 SENTINEL COHORTS 10071049 6/11/2020 STAGE 1 SENTINEL COHORTS 10011064 6/16/2020 STAGE 1 SENTINEL COHORTS 10011063 6/16/2020 STAGE 1 SENTINEL COHORTS 10031069 6/15/2020 STAGE 1 SENTINEL COHORTS 10071051 6/11/2020 STAGE 1 SENTINEL COHORTS…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 84 pages
Analysis Data Reviewer Guide BLA Analysis for Participants ≥16 Years of Age BioNTech SE and PFIZER INC. Study C4591001 090177e196f38d37\Final\Final On: 04-May-2021 20:03 (GMT) FDA-CBER-2021-5683-0023066 Study C4591001 Analysis Data Reviewer’s Guide 2 ANALYSIS DATA REVIEWER GUIDE REVISION HISTORY Version Summary of Major Change(s) and Impact Version Date 1.0 First approved version of Analysis Data Reviewer Guide 3-May-2021 090177e196f38d37\Final\Final On: 04-May-2021 20:03 (GMT)…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 3 pages
GenderAge (in months)95th Percentile BMI Value Male 143.5 24.1475 Male 144.5 24.22985 Male 145.5 24.31172 Male 146.5 24.3931 Male 147.5 24.47397 Male 148.5 24.55434 Male 149.5 24.6342 Male 150.5 24.71352 Male 151.5 24.79232 Male 152.5 24.87058 Male 153.5 24.94829 Male 154.5 25.02545 Male 155.5 25.10206 Male 156.5 25.17811 Male 157.5 25.2536 Male 158.5 25.32853 Male 159.5 25.40289 Male 160.5 25.47668 Male 161.5 25.5499 Male 162.5 25.62256 Male 163.5 25.69464 Male 164.5 25.76616 Male 165.5…