125742 45 S211 M5 c4591001 interim ado mth6 protocol deviations
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16.2.2 Listing of Important Proto col Deviations – All Subjects 12 Through 15 Years of Age Unique Subject Identifier/ Vaccine Group (as Randomized) Deviation Occurrence Site Identifier Protocol Deviation Category Protocol Deviation Subcategory Protocol Deviation Start Date Visit Designator C4591001 1006 10061272/ BNT162b2 (30 μg) 1006 Inclusion/exclusion Participant met exclusion criterion #01 (participant having other medical or psychiatric condition) 16DEC2020 V1_DAY1_VAX1_L C4591001 1006 10061287/ Placebo 1006 Concomitant medications Receipt of any other nonstudy coronavirus vaccine at any time prior to or durin g the stud y.11JUN2021 V2_VAX2_L C4591001 1006 10061287/ Placebo 1006 Concomitant medications Receipt of any other nonstudy coronavirus vaccine at any time prior to or durin g the stud y.14MAY2021 V2_VAX2_L C4591001 1007 10071415/ Placebo 1007 Concomitant medications Receipt of any other nonstudy coronavirus vaccine at any time prior to or durin g the stud y.03JUN2020 V2_VAX2_L C4591001 1007 10071415/ Placebo 1007 Concomitant medications Receipt of any other nonstudy coronavirus vaccine at any time prior to or durin g the stud y.13MAY2021 V2_VAX2_L C4591001 1007 10071428/ Placebo 1007 Concomitant medications Receipt of any other nonstudy coronavirus vaccine at any time prior to or durin g the stud y.05JUN2021 V2_VAX2_L C4591001 1007 10071428/ Placebo 1007 Concomitant medications Receipt of any other nonstudy coronavirus vaccine at any time prior to or durin g the stud y.05MAY2021 V2_VAX2_L C4591001 1007 10071429/ Placebo 1007 Concomitant medications Receipt of any other nonstudy coronavirus vaccine at any time prior to or durin g the stud y.03JUN2021 V2_VAX2_L C4591001 1007 10071429/ Placebo 1007 Concomitant medications Receipt of any other nonstudy coronavirus vaccine at any time prior to or durin g the stud y.13MAY2021 V2_VAX2_L C4591001 1007 10071492/ Placebo 1007 Concomitant medications Receipt of any other nonstudy coronavirus vaccine at any time prior to or durin g the stud y.03JUN2021 V2_VAX2_L 090177e1988b770e\Final\Final On: 09-Nov-2021 04:12 (GMT) Page 1 FDA-CBER-2022-5812-0228119 16.2.2 Listing of Important Proto col Deviations – All Subjects 12 Through 15 Years of Age Unique Subject Identifier/ Vaccine Group (as Randomized) Deviation Occurrence Site Identifier Protocol Deviation Category Protocol Deviation Subcategory Protocol Deviation Start Date Visit Designator C4591001 1007 10071492/ Placebo 1007 Concomitant medications Receipt of any other nonstudy coronavirus vaccine at any time prior to or durin g the stud y.13MAY2021 V2_VAX2_L C4591001 1007 10071499/ Placebo 1007 Concomitant medications Receipt of any other nonstudy coronavirus vaccine at any time prior to or durin g the stud y.04JUN2021 V2_VAX2_L C4591001 1007 10071499/ Placebo 1007 Concomitant medications Receipt of any other nonstudy coronavirus vaccine at any time prior to or durin g the stud y.13MAY2021 V2_VAX2_L C4591001 1007 10071515/ Placebo 1007 Concomitant medications Receipt of any other nonstudy coronavirus vaccine at any time prior to or durin g the stud y.05JUN2021 V2_VAX2_L C4591001 1007 10071515/ Placebo 1007 Concomitant medications Receipt of any other nonstudy coronavirus vaccine at any time prior to or durin g the stud y.14MAY2021 V2_VAX2_L C4591001 1007 10071528/ Placebo 1007 Concomitant medications Receipt of any other nonstudy coronavirus vaccine at any time prior to or durin g the stud y.03JUN2021 V2_VAX2_L C4591001 1007 10071528/ Placebo 1007 Concomitant medications Receipt of any other nonstudy coronavirus vaccine at any time prior to or durin g the stud y.13MAY2021 V2_VAX2_L C4591001 1007 10071543/ Placebo 1007 Concomitant medications Receipt of any other nonstudy coronavirus vaccine at any time prior to or durin g the stud y.03JUN2021 V2_VAX2_L C4591001 1007 10071543/ Placebo 1007 Concomitant medications Receipt of any other nonstudy coronavirus vaccine at any time prior to or durin g the stud y.13MAY2021 V2_VAX2_L C4591001 1007 10071554/ Placebo 1007 Concomitant medications Receipt of any other nonstudy coronavirus vaccine at any time prior to or durin g the stud y.17JUN2021 V2_VAX2_L 090177e1988b770e\Final\Final On: 09-Nov-2021 04:12 (GMT) Page 2 FDA-CBER-2022-5812-0228120 16.2.2 Listing of Important Proto col Deviations – All Subjects 12 Through 15 Years of Age Unique Subject Identifier/ Vaccine Group (as Randomized) Deviation Occurrence Site Identifier Protocol Deviation Category Protocol Deviation Subcategory Protocol Deviation Start Date Visit Designator C4591001 1007 10071554/ Placebo 1007 Concomitant medications Receipt of any other nonstudy coronavirus vaccine at any time prior to or durin g the stud y.22MAY2021 V2_VAX2_L C4591001 1007 10071573/ Placebo 1007 Concomitant medications Receipt of any other nonstudy coronavirus vaccine at any time prior to or durin g the stud y.03JUN2021 V2_VAX2_L C4591001 1007 10071593/ Placebo 1007 Concomitant medications Receipt of any other nonstudy coronavirus vaccine at any time prior to or durin g the stud y.21JAN2021 V1_DAY1_VAX1_L C4591001 1007 10071601/ Placebo 1007 Concomitant medications Receipt of any other nonstudy coronavirus vaccine at any time prior to or durin g the stud y.13MAY2021 V2_VAX2_L C4591001 1007 10071603/ Placebo 1007 Concomitant medications Receipt of any other nonstudy coronavirus vaccine at any time prior to or durin g the stud y.05JUN2021 V2_VAX2_L C4591001 1007 10071604/ Placebo 1007 Concomitant medications Receipt of any other nonstudy coronavirus vaccine at any time prior to or durin g the stud y.12JUN2021 V2_VAX2_L C4591001 1007 10071604/ Placebo 1007 Concomitant medications Receipt of any other nonstudy coronavirus vaccine at any time prior to or durin g the stud y.13MAY2021 V2_VAX2_L C4591001 1007 10071618/ Placebo 1007 Concomitant medications Receipt of any other nonstudy coronavirus vaccine at any time prior to or durin g the stud y.03JUN2021 V2_VAX2_L C4591001 1007 10071618/ Placebo 1007 Concomitant medications Receipt of any other nonstudy coronavirus vaccine at any time prior to or durin g the stud y.13MAY2021 V2_VAX2_L C4591001 1007 10071635/ Placebo 1007 Concomitant medications Receipt of any other nonstudy coronavirus vaccine at any time prior to or durin g the stud y.14MAY2021 V2_VAX2_L 090177e1988b770e\Final\Final On: 09-Nov-2021 04:12 (GMT) Page 3 FDA-CBER-2022-5812-0228121 16.2.2 Listing of Important Proto col Deviations – All Subjects 12 Through 15 Years of Age Unique Subject Identifier/ Vaccine Group (as Randomized) Deviation Occurrence Site Identifier Protocol Deviation Category Protocol Deviation Subcategory Protocol Deviation Start Date Visit Designator C4591001 1007 10071654/ Placebo 1007 Concomitant medications Receipt of any other nonstudy coronavirus vaccine at any time prior to or durin g the stud y.17MAY2021 V2_VAX2_L C4591001 1007 10071662/ Placebo 1007 Concomitant medications Receipt of any other nonstudy coronavirus vaccine at any time prior to or durin g the stud y.05JUN2021 V2_VAX2_L C4591001 1008 10081879/ Placebo 1008 Concomitant medications Receipt of any other nonstudy coronavirus vaccine at any time prior to or durin g the stud y.12JUN2021 V2_VAX2_L C4591001 1008 10081879/ Placebo 1008 Concomitant medications Receipt of any other nonstudy coronavirus vaccine at any time prior to or durin g the stud y.21MAY2021 V202_SURVEIL_SWAB|643544415756058 C4591001 1009 10091229/ Placebo 1009 Investigational product Subject was vaccinated despite the site being instructed to discontinue further vaccination18MAR2021 Unplanned Vaccination C4591001 1009 10091320/ Placebo 1009 Inclusion/exclusion Participant met exclusion criterion #01 (participant having other medical or ps ychiatric condition)10DEC2020 V1_DAY1_VAX1_L C4591001 1009 10091366/ Placebo 1009 Investigational product Subject was vaccinated despite the site being instructed to discontinue further vaccination26FEB2021 Unplanned Vaccination C4591001 1013 10131839/ Placebo 1013 Concomitant medications Receipt of any other nonstudy coronavirus vaccine at any time prior to or durin g the stud y.02JUL2021 V2_VAX2_L C4591001 1039 10391320/ Placebo 1039 Concomitant medications Receipt of any other nonstudy coronavirus vaccine at any time prior to or durin g the stud y.13JUN2021 V2_VAX2_L C4591001 1039 10391320/ Placebo 1039 Concomitant medications Receipt of any other nonstudy coronavirus vaccine at any time prior to or durin g the stud y.17MAY2021 V2_VAX2_L 090177e1988b770e\Final\Final On: 09-Nov-2021 04:12 (GMT) Page 4 FDA-CBER-2022-5812-0228122 16.2.2 Listing of Important Proto col Deviations – All Subjects 12 Through 15 Years of Age Unique Subject Identifier/ Vaccine Group (as Randomized) Deviation Occurrence Site Identifier Protocol Deviation Category Protocol Deviation Subcategory Protocol Deviation Start Date Visit Designator C4591001 1039 10391327/ Placebo 1039 Concomitant medications Receipt of any other nonstudy coronavirus vaccine at any time prior to or durin g the stud y.05JUN2021 V2_VAX2_L C4591001 1039 10391327/ Placebo 1039 Concomitant medications Receipt of any other nonstudy coronavirus vaccine at any time prior to or durin g the stud y.15MAY2021 V2_VAX2_L C4591001 1044 10441271/ Placebo 1044 Concomitant medications Receipt of any other nonstudy coronavirus vaccine at any time prior to or durin g the stud y.14JUN2021 V2_VAX2_L C4591001 1044 10441271/ Placebo 1044 Concomitant medications Receipt of any other nonstudy coronavirus vaccine at any time prior to or durin g the stud y.24MAY2021 V2_VAX2_L C4591001 1044 10441293/ Placebo 1044 Concomitant medications Receipt of any other nonstudy coronavirus vaccine at any time prior to or durin g the stud y.04JUN2021 V101_VAX3 C4591001 1044 10441294/ Placebo 1044 Concomitant medications Receipt of any other nonstudy coronavirus vaccine at any time prior to or durin g the stud y.04JUN2021 V101_VAX3 C4591001 1044 10441356/ Placebo 1044 Concomitant medications Receipt of any other nonstudy coronavirus vaccine at any time prior to or durin g the stud y.04JUN2021 V2_VAX2_L C4591001 1044 10441356/ Placebo 1044 Concomitant medications Receipt of any other nonstudy coronavirus vaccine at any time prior to or durin g the stud y.14MAY2021 V2_VAX2_L C4591001 1057 10571389/ Placebo 1057 Concomitant medications Receipt of any other nonstudy coronavirus vaccine at any time prior to or durin g the stud y.12JUN2021 V2_VAX2_L C4591001 1057 10571389/ Placebo 1057 Concomitant medications Receipt of any other nonstudy coronavirus vaccine at any time prior to or durin g the stud y.23MAY2021 V2_VAX2_L 090177e1988b770e\Final\Final On: 09-Nov-2021 04:12 (GMT) Page 5 FDA-CBER-2022-5812-0228123 16.2.2 Listing of Important Proto col Deviations – All Subjects 12 Through 15 Years of Age Unique Subject Identifier/ Vaccine Group (as Randomized) Deviation Occurrence Site Identifier Protocol Deviation Category Protocol Deviation Subcategory Protocol Deviation Start Date Visit Designator C4591001 1077 10771282/ Placebo 1077 Concomitant medications Receipt of any other nonstudy coronavirus vaccine at any time prior to or durin g the stud y.15MAY2021 V2_VAX2_L C4591001 1077 10771289/ Placebo 1077 Concomitant medications Receipt of any other nonstudy coronavirus vaccine at any time prior to or durin g the stud y.14MAY2021 V2_VAX2_L C4591001 1077 10771290/ Placebo 1077 Concomitant medications Receipt of any other nonstudy coronavirus vaccine at any time prior to or durin g the stud y.14MAY2021 V2_VAX2_L C4591001 1084 10841543/ Placebo 1084 Investigational product Other IP deviation 07JUN2021 Vax 4 C4591001 1084 10841579/ Placebo 1084 Concomitant medications Receipt of any other nonstudy coronavirus vaccine at any time prior to or durin g the stud y.14MAY2021 V2_VAX2_L C4591001 1091 10911455/ Placebo 1091 Concomitant medications Receipt of any other nonstudy coronavirus vaccine at any time prior to or durin g the stud y.03JUN2021 V2_VAX2_L C4591001 1091 10911455/ Placebo 1091 Concomitant medications Receipt of any other nonstudy coronavirus vaccine at any time prior to or durin g the stud y.13MAY2021 V2_VAX2_L C4591001 1091 10911456/ Placebo 1091 Concomitant medications Receipt of any other nonstudy coronavirus vaccine at any time prior to or durin g the stud y.03JUN2021 V2_VAX2_L C4591001 1091 10911456/ Placebo 1091 Concomitant medications Receipt of any other nonstudy coronavirus vaccine at any time prior to or durin g the stud y.13MAY2021 V2_VAX2_L C4591001 1091 10911461/ Placebo 1091 Concomitant medications Receipt of any other nonstudy coronavirus vaccine at any time prior to or durin g the stud y.09JUN2021 V2_VAX2_L 090177e1988b770e\Final\Final On: 09-Nov-2021 04:12 (GMT) Page 6 FDA-CBER-2022-5812-0228124 16.2.2 Listing of Important Proto col Deviations – All Subjects 12 Through 15 Years of Age Unique Subject Identifier/ Vaccine Group (as Randomized) Deviation Occurrence Site Identifier Protocol Deviation Category Protocol Deviation Subcategory Protocol Deviation Start Date Visit Designator C4591001 1091 10911461/ Placebo 1091 Concomitant medications Receipt of any other nonstudy coronavirus vaccine at any time prior to or durin g the stud y.19MAY2021 V2_VAX2_L C4591001 1139 11391169/ Placebo 1139 Concomitant medications Receipt of any other nonstudy coronavirus vaccine at any time prior to or durin g the stud y.01JUN2021 V2_VAX2_L C4591001 1139 11391169/ Placebo 1139 Concomitant medications Receipt of any other nonstudy coronavirus vaccine at any time prior to or durin g the stud y.11MAY2021 V2_VAX2_L C4591001 1139 11391171/ Placebo 1139 Concomitant medications Receipt of any other nonstudy coronavirus vaccine at any time prior to or durin g the stud y.09JUN2021 V2_VAX2_L C4591001 1139 11391171/ Placebo 1139 Concomitant medications Receipt of any other nonstudy coronavirus vaccine at any time prior to or durin g the stud y.19MAY2021 V2_VAX2_L C4591001 1140 11401357/ Placebo 1140 Concomitant medications Receipt of any other nonstudy coronavirus vaccine at any time prior to or durin g the stud y.03JUN2021 V2_VAX2_L C4591001 1140 11401357/ Placebo 1140 Concomitant medications Receipt of any other nonstudy coronavirus vaccine at any time prior to or durin g the stud y.13MAY2021 V2_VAX2_L C4591001 1147 11471284/ Placebo 1147 Concomitant medications Receipt of any other nonstudy coronavirus vaccine at any time prior to or durin g the stud y.23JUN2021 V4_MONTH6_L C4591001 1147 11471284/ Placebo 1147 Concomitant medications Receipt of any other nonstudy coronavirus vaccine at any time prior to or durin g the stud y.30MAY2021 V4_MONTH6_L C4591001 1147 11471322/ Placebo 1147 Concomitant medications Receipt of any other nonstudy coronavirus vaccine at any time prior to or durin gthe stud y.04JUN2021 V2_VAX2_L 090177e1988b770e\Final\Final On: 09-Nov-2021 04:12 (GMT) Page 7 FDA-CBER-2022-5812-0228125 16.2.2 Listing of Important Proto col Deviations – All Subjects 12 Through 15 Years of Age Unique Subject Identifier/ Vaccine Group (as Randomized) Deviation Occurrence Site Identifier Protocol Deviation Category Protocol Deviation Subcategory Protocol Deviation Start Date Visit Designator C4591001 1147 11471322/ Placebo 1147 Concomitant medications Receipt of any other nonstudy coronavirus vaccine at any time prior to or durin g the stud y.14MAY2021 V2_VAX2_L C4591001 1147 11471323/ Placebo 1147 Concomitant medications Receipt of any other nonstudy coronavirus vaccine at any time prior to or durin g the stud y.04JUN2021 V2_VAX2_L C4591001 1147 11471323/ Placebo 1147 Concomitant medications Receipt of any other nonstudy coronavirus vaccine at any time prior to or durin g the stud y.14MAY2021 V2_VAX2_L C4591001 1147 11471327/ BNT162b2 (30 μg) 1147 Concomitant medications Receipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. 04JUN2021 V2_VAX2_L C4591001 1147 11471327/ BNT162b2 (30 μg) 1147 Concomitant medications Receipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. 07MAY2021 V2_VAX2_L C4591001 1147 11471335/ Placebo 1147 Concomitant medications Receipt of any other nonstudy coronavirus vaccine at any time prior to or durin g the stud y.10JUN2021 V2_VAX2_L C4591001 1147 11471335/ Placebo 1147 Concomitant medications Receipt of any other nonstudy coronavirus vaccine at any time prior to or durin g the stud y.20MAY2021 V2_VAX2_L C4591001 1147 11471336/ Placebo 1147 Concomitant medications Receipt of any other nonstudy coronavirus vaccine at any time prior to or durin g the stud y.12AUG2021 V2_VAX2_L C4591001 1147 11471336/ Placebo 1147 Concomitant medications Receipt of any other nonstudy coronavirus vaccine at any time prior to or durin g the stud y.22JUL2021 V2_VAX2_L 090177e1988b770e\Final\Final On: 09-Nov-2021 04:12 (GMT) Page 8 FDA-CBER-2022-5812-0228126 16.2.2 Listing of Important Proto col Deviations – All Subjects 12 Through 15 Years of Age Unique Subject Identifier/ Vaccine Group (as Randomized) Deviation Occurrence Site Identifier Protocol Deviation Category Protocol Deviation Subcategory Protocol Deviation Start Date Visit Designator C4591001 1150 11501171/ BNT162b2 (30 μg) 1150 Concomitant medications Receipt of any other nonstudy coronavirus vaccine at any time prior to or during the study. 01SEP2021 V2_VAX2_L C4591001 1152 11521698/ Placebo 1152 Concomitant medications Receipt of any other nonstudy coronavirus vaccine at any time prior to or durin g the stud y.15MAY2021 V2_VAX2_L C4591001 1152 11521726/ Placebo 1152 Concomitant medications Receipt of any other nonstudy coronavirus vaccine at any time prior to or durin g the stud y.12JUN2021 V2_VAX2_L C4591001 1152 11521747/ Placebo 1152 Concomitant medications Receipt of any other nonstudy coronavirus vaccine at any time prior to or durin g the stud y.20JUL2021 V101_VAX3 C4591001 1152 11521751/ Placebo 1152 Concomitant medications Receipt of any other nonstudy coronavirus vaccine at any time prior to or durin g the stud y.17MAY2021 V2_VAX2_L C4591001 1152 11521754/ Placebo 1152 Concomitant medications Receipt of any other nonstudy coronavirus vaccine at any time prior to or durin g the stud y.20MAY2021 V2_VAX2_L C4591001 1156 11561336/ Placebo 1156 Concomitant medications Receipt of any other nonstudy coronavirus vaccine at any time prior to or durin g the stud y.03JUN2021 V2_VAX2_L C4591001 1156 11561336/ Placebo 1156 Concomitant medications Receipt of any other nonstudy coronavirus vaccine at any time prior to or durin g the stud y.13MAY2021 V2_VAX2_L C4591001 1156 11561353/ Placebo 1156 Concomitant medications Receipt of any other nonstudy coronavirus vaccine at any time prior to or durin g the stud y.10JUN2021 V101_VAX3 C4591001 1156 11561359/ Placebo 1156 Concomitant medications Receipt of any other nonstudy coronavirus vaccine at any time prior to or durin g the stud y.08JAN2021 V1_DAY1_VAX1_L 090177e1988b770e\Final\Final On: 09-Nov-2021 04:12 (GMT) Page 9 FDA-CBER-2022-5812-0228127 16.2.2 Listing of Important Proto col Deviations – All Subjects 12 Through 15 Years of Age Unique Subject Identifier/ Vaccine Group (as Randomized) Deviation Occurrence Site Identifier Protocol Deviation Category Protocol Deviation Subcategory Protocol Deviation Start Date Visit Designator PFIZER CONFIDENTIAL SDTM Creation: 30SEP2021 (10:35) Source Dat a: addv Table Generation: 08NOV2021 (14:40) (Data Cutoff Date: 02SEP2021, Database Snapshot Date: 27SEP2021 ) Output File: ./nda2 unblinded/C4591001 SPeds/addv l001 1ped6 090177e1988b770e\Final\Final On: 09-Nov-2021 04:12 (GMT) Page 10 FDA-CBER-2022-5812-0228128