Document text
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 Data: addv Table Generation: 24NOV2020 (13:02)
(Cutoff Date: 14NOV2020, Snapshot Date: 16NOV2020) Output File: ./nda2_unblinded/C4591001_EUA_FAEF_RR/addv_l001_pd2
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16.2.2.3 Listing of Important Protocol Deviations – Phase 2/3 Analysis (All Subjects )
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject (Number
of
Deviations if >1)
Concomita nt
Medications Subject received 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. 7 C4591001 1003
10031101
C4591001 1007
10071276
C4591001 1007
10071315
C4591001 1028
10281026
C4591001 1039
10391019
C4591001 1130
11301039
C4591001 1261
12611054
Receipt of blood/plasma products or immunoglobulins within 60 days before enrollment through
conclusion of the study. 1 C4591001 1231
12313895
Inclusion/Exclusion Participant failed to meet inclusion criterion #03 (Healthy participants who are determined by
medical history, physical examination and clinical judgement of the investigator to be eligible for
inclusion in the study) 13 C4591001 1037
10371333
C4591001 1094
10941191
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16.2.2.3 Listing of Important Protocol Deviations – Phase 2/3 Analysis (All Subjects )
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject (Number
of
Deviations if >1)
C4591001 1095
10951107
C4591001 1122
11221034
C4591001 1170
11701334
C4591001 1170
11701344
C4591001 1174
11741066
C4591001 1205
12051028
C4591001 1217
12171005
C4591001 1229
12291165
C4591001 1231
12311088
C4591001 1231
12315608
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16.2.2.3 Listing of Important Protocol Deviations – Phase 2/3 Analysis (All Subjects )
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject (Number
of
Deviations if >1)
C4591001 1265
12651164
Participant met exclusion criterion #02 (participant having known infection with HIV, HCV or
HBV) 9 C4591001 1098
10981155
C4591001 1098
10981162
C4591001 1098
10981168
C4591001 1098
10981169
C4591001 1170
11701457
C4591001 1224
12241158
C4591001 1226
12262255
C4591001 1251
12511050
C4591001 1265
12651186
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16.2.2.3 Listing of Important Protocol Deviations – Phase 2/3 Analysis (All Subjects )
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject (Number
of
Deviations if >1)
Participant met exclusion criterion #11 (women who are pregnant or breastfeeding) 6 C4591001 1087
10871557
C4591001 1093
10931058
C4591001 1096
10961031
C4591001 1156
11561015
C4591001 1232
12321213
C4591001 1241
12411279
Participant met exclusion criterion #22 (investigator site staff or Pfizer employees directly involved
in the conduct of the study, site staff otherwise supervised by the investigator, and their respective
family members) 6 C4591001 1112
11121058
C4591001 1161
11611002
C4591001 1161
11611008
C4591001 1161
11611011
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16.2.2.3 Listing of Important Protocol Deviations – Phase 2/3 Analysis (All Subjects )
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject (Number
of
Deviations if >1)
C4591001 1161
11611014
C4591001 1161
11611018
Participant met exclusion criterion #13 (participant receiving treatment with immunosuppressive
therapy as specified in protocol) 5 C4591001 1038
10381061
C4591001 1047
10471122
C4591001 1047
10471228
C4591001 1097
10971107
C4591001 1101
11011077
Participant met exclusion criterion #05 (previous clinical or microbiological diagnosis of COVID -
19) 2 C4591001 1054
10541033
C4591001 1235
12351167
Participant met exclusion criterion #16 (Participation in other studies involving study intervention
within 28 days prior to study entry and/or during study participation) 2 C4591001 1006
10061099
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16.2.2.3 Listing of Important Protocol Deviations – Phase 2/3 Analysis (All Subjects )
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject (Number
of
Deviations if >1)
C4591001 1134
11341067
Participant failed to meet inclusion criterion #01 (Male or female participants between the ages of
18 and 55 years, inclusive, 65 and 85 years, inclusive, or 18 and 85 years, inclusive, at
randomization (dependent upon study phase). 1 C4591001 1142
114210 84
Participant failed to meet inclusion criterion #04 (Participants who, in the judgment of the
investigator, are at risk for acquiring COVID -19) 1 C4591001 1129
11291117
Informed Consent Subject/LAR did not sign ICD & did not give verbal consent 1 C4591001 1120
11201299
Investigational Product Dosing/administration error, subject did not receive correct dose of vaccine 151 C4591001 1003
10031120
C4591001 1068
10681001
C4591001 1068
10681002
C4591001 1068
10681003
C4591001 1068
10681004
C4591001 1068
10681005
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16.2.2.3 Listing of Important Protocol Deviations – Phase 2/3 Analysis (All Subjects )
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject (Number
of
Deviations if >1)
C4591001 1068
10681006
C4591001 1068
10681007
C4591001 1068
10681008
C4591001 1068
10681009
C4591001 1068
10681010
C4591001 1068
10681011
C4591001 1068
10681012
C4591001 1068
10681013
C4591001 1068
10681014
C4591001 1068
10681015
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16.2.2.3 Listing of Important Protocol Deviations – Phase 2/3 Analysis (All Subjects )
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject (Number
of
Deviations if >1)
C4591001 1068
10681016
C4591001 1068
10681017
C4591001 1068
10681018
C4591001 1068
10681019
C4591001 1068
10681020
C4591001 1068
10681021
C4591001 1068
10681022
C4591001 1068
10681023
C4591001 1068
10681024
C4591001 1068
10681025
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16.2.2.3 Listing of Important Protocol Deviations – Phase 2/3 Analysis (All Subjects )
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject (Number
of
Deviations if >1)
C4591001 1068
10681026
C4591001 1068
10681027
C4591001 1068
10681028
C4591001 1068
10681029
C4591001 1068
10681030
C4591001 1068
10681031
C4591001 1068
10681032
C4591001 1068
10681033
C4591001 1068
10681034
C4591001 1068
10681035
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16.2.2.3 Listing of Important Protocol Deviations – Phase 2/3 Analysis (All Subjects )
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject (Number
of
Deviations if >1)
C4591001 1068
10681036
C4591001 1068
10681037
C4591001 1068
10681038
C4591001 1068
10681039
C4591001 1068
10681040
C4591001 1068
10681041
C4591001 1068
10681042
C4591001 1068
10681043
C4591001 1068
10681044
C4591001 1068
10681045
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16.2.2.3 Listing of Important Protocol Deviations – Phase 2/3 Analysis (All Subjects )
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject (Number
of
Deviations if >1)
C4591001 1068
10681046
C4591001 1068
10681047
C4591001 1068
10681050
C4591001 1068
10681051
C4591001 1068
10681052
C4591001 1068
10681053
C4591001 1068
10681054
C4591001 1068
10681055
C4591001 1068
10681056
C4591001 1068
10681057
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16.2.2.3 Listing of Important Protocol Deviations – Phase 2/3 Analysis (All Subjects )
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject (Number
of
Deviations if >1)
C4591001 1068
10681058
C4591001 1068
10681059
C4591001 1068
10681060
C4591001 1068
10681061
C4591001 1068
10681062
C4591001 1068
10681063
C4591001 1068
10681064
C4591001 1068
10681065
C4591001 1068
10681066
C4591001 1068
10681068
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16.2.2.3 Listing of Important Protocol Deviations – Phase 2/3 Analysis (All Subjects )
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject (Number
of
Deviations if >1)
C4591001 1068
10681069
C4591001 1068
10681071
C4591001 1068
10681072
C4591001 1068
10681073
C4591001 1068
10681074
C4591001 1068
10681075
C4591001 1068
10681076
C4591001 1068
10681077
C4591001 1068
10681078
C4591001 1068
10681079
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16.2.2.3 Listing of Important Protocol Deviations – Phase 2/3 Analysis (All Subjects )
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject (Number
of
Deviations if >1)
C4591001 1068
10681080
C4591001 1068
10681081
C4591001 1068
10681082
C4591001 1068
10681083
C4591001 1068
10681084
C4591001 1091
10911001
C4591001 1091
10911004
C4591001 1091
10911005
C4591001 1091
10911008
C4591001 1091
10911010
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16.2.2.3 Listing of Important Protocol Deviations – Phase 2/3 Analysis (All Subjects )
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject (Number
of
Deviations if >1)
C4591001 1091
10911012
C4591001 1091
10911014
C4591001 1091
10911015
C4591001 1129
11291091
C4591001 1141
11411011
C4591001 1141
11411014
C4591001 1141
11411023
C4591001 1141
11411065
C4591001 1141
11411066
C4591001 1141
11411068
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16.2.2.3 Listing of Important Protocol Deviations – Phase 2/3 Analysis (All Subjects )
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject (Number
of
Deviations if >1)
C4591001 1141
11411080
C4591001 1141
11411093
C4591001 1141
11411139
C4591001 1231
12313428
C4591001 1231
12313429
C4591001 1231
12313446
C4591001 1231
12313449
C4591001 1231
12313456
C4591001 1231
12313459
C4591001 1231
12313461
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16.2.2.3 Listing of Important Protocol Deviations – Phase 2/3 Analysis (All Subjects )
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject (Number
of
Deviations if >1)
C4591001 1231
12313467
C4591001 1231
12313468
C4591001 1231
12313469
C4591001 1231
12313478
C4591001 1231
12313479
C4591001 1231
12313480
C4591001 1231
12313483
C4591001 1231
12313486
C4591001 1231
12313487
C4591001 1231
12313492
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16.2.2.3 Listing of Important Protocol Deviations – Phase 2/3 Analysis (All Subjects )
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject (Number
of
Deviations if >1)
C4591001 1231
12313496
C4591001 1231
12313497
C4591001 1231
12313498
C4591001 1231
12313501
C4591001 1231
12313503
C4591001 1231
12313505
C4591001 1231
12313506
C4591001 1231
12313508
C4591001 1231
12313509
C4591001 1231
12313511
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16.2.2.3 Listing of Important Protocol Deviations – Phase 2/3 Analysis (All Subjects )
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject (Number
of
Deviations if >1)
C4591001 1231
12313512
C4591001 1231
12313514
C4591001 1231
12313515
C4591001 1231
12313517
C4591001 1231
12313518
C4591001 1231
12313519
C4591001 1231
12313524
C4591001 1231
12313528
C4591001 1231
12313530
C4591001 1231
12313533
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16.2.2.3 Listing of Important Protocol Deviations – Phase 2/3 Analysis (All Subjects )
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject (Number
of
Deviations if >1)
C4591001 1231
12313534
C4591001 1231
12313536
C4591001 1231
12313537
C4591001 1231
12313538
C4591001 1231
12313541
C4591001 1231
12313542
C4591001 1231
12313546
C4591001 1231
12313549
C4591001 1231
12313551
C4591001 1231
12313553
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16.2.2.3 Listing of Important Protocol Deviations – Phase 2/3 Analysis (All Subjects )
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject (Number
of
Deviations if >1)
C4591001 1231
12313554
C4591001 1231
12313556
C4591001 1231
12313562
C4591001 1231
12313564
C4591001 1231
12313567
IP administered that was deemed not suitable for use by Almac 144 C4591001 1024
10241002 (2)
C4591001 1024
10241003 (2)
C4591001 1024
10241004 (2)
C4591001 1024
10241006 (2)
C4591001 1024
10241009
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16.2.2.3 Listing of Important Protocol Deviations – Phase 2/3 Analysis (All Subjects )
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject (Number
of
Deviations if >1)
C4591001 1024
10241010
C4591001 1024
10241014 (2)
C4591001 1024
10241015
C4591001 1024
10241018
C4591001 1024
10241019
C4591001 1024
10241021
C4591001 1024
10241023 (2)
C4591001 1024
10241031
C4591001 1024
10241032
C4591001 1024
10241033
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16.2.2.3 Listing of Important Protocol Deviations – Phase 2/3 Analysis (All Subjects )
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject (Number
of
Deviations if >1)
C4591001 1024
10241037
C4591001 1024
10241039
C4591001 1024
10241040
C4591001 1024
10241041
C4591001 1024
10241042
C4591001 1024
10241044
C4591001 1024
10241046
C4591001 1024
10241049
C4591001 1024
10241054
C4591001 1024
10241055
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16.2.2.3 Listing of Important Protocol Deviations – Phase 2/3 Analysis (All Subjects )
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject (Number
of
Deviations if >1)
C4591001 1024
10241057
C4591001 1024
10241059
C4591001 1024
10241061
C4591001 1024
10241065
C4591001 1024
10241066
C4591001 1024
10241067
C4591001 1024
10241068
C4591001 1024
10241071
C4591001 1024
10241072
C4591001 1024
10241074
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16.2.2.3 Listing of Important Protocol Deviations – Phase 2/3 Analysis (All Subjects )
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject (Number
of
Deviations if >1)
C4591001 1024
10241077
C4591001 1024
10241078
C4591001 1024
10241081
C4591001 1024
10241083
C4591001 1024
10241084
C4591001 1024
10241085
C4591001 1024
10241087
C4591001 1024
10241091
C4591001 1024
10241094
C4591001 1024
10241096
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16.2.2.3 Listing of Important Protocol Deviations – Phase 2/3 Analysis (All Subjects )
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject (Number
of
Deviations if >1)
C4591001 1024
10241097
C4591001 1024
10241100
C4591001 1024
10241102
C4591001 1024
10241104
C4591001 1024
10241108
C4591001 1044
10441001
C4591001 1044
10441002
C4591001 1044
10441004
C4591001 1044
10441007
C4591001 1044
10441010
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16.2.2.3 Listing of Important Protocol Deviations – Phase 2/3 Analysis (All Subjects )
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject (Number
of
Deviations if >1)
C4591001 1044
10441015
C4591001 1044
10441016
C4591001 1044
10441018
C4591001 1044
10441028
C4591001 1044
10441029
C4591001 1044
10441031
C4591001 1044
10441032
C4591001 1044
10441034
C4591001 1044
10441036
C4591001 1044
10441037
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16.2.2.3 Listing of Important Protocol Deviations – Phase 2/3 Analysis (All Subjects )
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject (Number
of
Deviations if >1)
C4591001 1044
10441041
C4591001 1044
10441045
C4591001 1044
10441047
C4591001 1044
10441048
C4591001 1044
10441049
C4591001 1044
10441050
C4591001 1044
10441052
C4591001 1044
10441054
C4591001 1044
10441055
C4591001 1044
10441060
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16.2.2.3 Listing of Important Protocol Deviations – Phase 2/3 Analysis (All Subjects )
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject (Number
of
Deviations if >1)
C4591001 1044
10441062
C4591001 1044
10441063
C4591001 1044
10441067
C4591001 1044
10441068
C4591001 1044
10441071
C4591001 1044
10441073
C4591001 1044
10441075
C4591001 1044
10441076
C4591001 1044
10441079
C4591001 1044
10441080
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16.2.2.3 Listing of Important Protocol Deviations – Phase 2/3 Analysis (All Subjects )
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject (Number
of
Deviations if >1)
C4591001 1044
10441083
C4591001 1044
10441085
C4591001 1044
10441088
C4591001 1044
10441089
C4591001 1044
10441090
C4591001 1044
10441092
C4591001 1044
10441093
C4591001 1044
10441094
C4591001 1163
11631117
C4591001 1163
11631121
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16.2.2.3 Listing of Important Protocol Deviations – Phase 2/3 Analysis (All Subjects )
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject (Number
of
Deviations if >1)
C4591001 1163
11631124
C4591001 1163
11631126
C4591001 1163
11631127
C4591001 1163
11631131
C4591001 1163
11631132
C4591001 1163
11631133
C4591001 1163
11631136
C4591001 1163
11631142
C4591001 1163
11631144
C4591001 1163
11631145
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16.2.2.3 Listing of Important Protocol Deviations – Phase 2/3 Analysis (All Subjects )
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject (Number
of
Deviations if >1)
C4591001 1163
11631149
C4591001 1254
12541002
C4591001 1254
12541004
C4591001 1254
12541005
C4591001 1254
12541008
C4591001 1254
12541010
C4591001 1254
12541011
C4591001 1254
12541014
C4591001 1254
12541016
C4591001 1254
12541018
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16.2.2.3 Listing of Important Protocol Deviations – Phase 2/3 Analysis (All Subjects )
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject (Number
of
Deviations if >1)
C4591001 1254
12541019
C4591001 1254
12541023
C4591001 1254
12541025
C4591001 1254
12541026
C4591001 1254
12541027
C4591001 1254
12541029
C4591001 1254
12541030
C4591001 1254
12541033
C4591001 1254
12541035
C4591001 1254
12541037
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16.2.2.3 Listing of Important Protocol Deviations – Phase 2/3 Analysis (All Subjects )
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject (Number
of
Deviations if >1)
C4591001 1254
12541038
C4591001 1254
12541040
C4591001 1260
12601002
C4591001 1260
12601003
C4591001 1260
12601005
C4591001 1260
12601006
C4591001 1260
12601008
C4591001 1260
12601009
C4591001 1260
12601013
C4591001 1260
12601014
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16.2.2.3 Listing of Important Protocol Deviations – Phase 2/3 Analysis (All Subjects )
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject (Number
of
Deviations if >1)
C4591001 1260
12601016
C4591001 1260
12601017
C4591001 1260
12601025
C4591001 1260
12601026
C4591001 1260
12601027
C4591001 1260
12601029
C4591001 1260
12601032
C4591001 1260
12601033
C4591001 1260
12601036
Incorrect vaccine allocation/assigned to subject 10 C4591001 1012
10121103
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16.2.2.3 Listing of Important Protocol Deviations – Phase 2/3 Analysis (All Subjects )
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject (Number
of
Deviations if >1)
C4591001 1054
10541024
C4591001 1079
10791130
C4591001 1081
10811053
C4591001 1088
10881077
C4591001 1090
10901334
C4591001 1116
11161226
C4591001 1177
11771089
C4591001 1231
12311057
C4591001 1265
12651026
Other IP deviation 9 C4591001 1037
10371356
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16.2.2.3 Listing of Important Protocol Deviations – Phase 2/3 Analysis (All Subjects )
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject (Number
of
Deviations if >1)
C4591001 1126
11261053
C4591001 1161
11611015
C4591001 1163
11631003
C4591001 1163
11631007
C4591001 1163
11631008
C4591001 1163
11631010
C4591001 1163
11631011
C4591001 1163
11631096
Subject was vaccinated despite meeting temporary delay criterion #4 (receiving short -term (<14
days) systemic corticosteroids, IP administration should be delayed untill systemic corticosteroid
use has been discontinued for at least 28 days. 4 C4591001 100 7
10071105
C4591001 1028
10281241
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16.2.2.3 Listing of Important Protocol Deviations – Phase 2/3 Analysis (All Subjects )
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject (Number
of
Deviations if >1)
C4591001 1097
10971060
C4591001 1231
12311499
IP documentation error – IP preparation form errors 3 C4591001 1163
11631008 (2)
C4591001 1163
11631013
C4591001 1163
11631039
Incorrect IP assigned to subject due to IRT not being utilized 3 C4591001 1121
11211071
C4591001 1163
11631005
C4591001 1163
11631006
Subject was vaccinated despite being ineligible 2 C4591001 1092
10921158
C4591001 1112
11121270
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16.2.2.3 Listing of Important Protocol Deviations – Phase 2/3 Analysis (All Subjects )
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject (Number
of
Deviations if >1)
Administration error, incorrect container, but correct IP administered 1 C4591001 1056
10561445
Blind compromised 1 C4591001 1068
10681001
Laboratory Nasal swab can't be analyzed due to incorrect shipping procedure 3 C4591001 1068
10681043
C4591001 1068
10681068
C4591001 1128
11281313
Other All data considered unreliable due to lack of PI oversight ident ified as significant quality event 43 C4591001 1161
11611001
C4591001 1161
11611002
C4591001 1161
11611003
C4591001 1161
11611004
C4591001 1161
11611005
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16.2.2.3 Listing of Important Protocol Deviations – Phase 2/3 Analysis (All Subjects )
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject (Number
of
Deviations if >1)
C4591001 1161
11611006
C4591001 1161
11611007
C4591001 1161
11611008
C4591001 1161
11611009
C4591001 1161
11611010
C4591001 1161
11611011
C4591001 1161
11611012
C4591001 1161
11611013
C4591001 1161
11611014
C4591001 1161
11611015
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16.2.2.3 Listing of Important Protocol Deviations – Phase 2/3 Analysis (All Subjects )
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject (Number
of
Deviations if >1)
C4591001 1161
11611016
C4591001 1161
11611017
C4591001 1161
11611018
C4591001 1161
11611019
C4591001 1161
11611020
C4591001 1161
11611021
C4591001 1161
11611022
C4591001 1161
11611023
C4591001 1161
11611024
C4591001 1161
11611025
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16.2.2.3 Listing of Important Protocol Deviations – Phase 2/3 Analysis (All Subjects )
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject (Number
of
Deviations if >1)
C4591001 1161
11611026
C4591001 1161
11611027
C4591001 1161
11611028
C4591001 1161
11611029
C4591001 1161
11611030
C4591001 1161
11611031
C4591001 1161
11611032
C4591001 1161
11611033
C4591001 1161
11611034
C4591001 1161
11611035
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16.2.2.3 Listing of Important Protocol Deviations – Phase 2/3 Analysis (All Subjects )
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject (Number
of
Deviations if >1)
C4591001 1161
11611036
C4591001 1161
11611037
C4591001 1161
11611038
C4591001 1161
11611040
C4591001 1161
11611041
C4591001 1161
11611042
C4591001 1161
11611043
C4591001 1161
11611044
Procedures/Tests Procedure/Test not done 1 C4591001 1146
11461010
Note: Data for subjects randomized on or after 10OCT2020 are included to comprehensively show all data reported but are subje ct to change with
additional follow -up.
Note: HIV -positive subjects are included in this summary but not included in the analyses o f the overall study objectives
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16.2.2.3 Listing of Important Protocol Deviations – Phase 2/3 Analysis (All Subjects )
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject (Number
of
Deviations if >1)
PFIZER CONFIDENTIAL SDTM Creation: 17NOV2020 (10:49) Source Data: addv Table Generation: 24NOV2020 (13:02)
(Cutoff Date: 14NOV2020, Snapshot Date: 16NOV2020) Output File: ./nda2_unblinded/C4591001_EUA_FAEF_RR/addv_l001_pd_al l
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16.2.2.4 Listing of Important Protocol Deviations – Subjects Enrolled in Multiple Site s
Protocol Deviation
Category Protocol Deviation Subcategory Number
of
Subjects Subject (Number of
Deviations if >1)
Inclusi on/Exclusion Participant met exclusion criterion #04 (receipt of medications intended to prevent
COVID -19) 1 C4591001 1133 11331382
Investigational Product Subject was enrolled more than once in the study, at different sites 2 C4591001 1056 10561101
C4591001 1133 11331382
PFIZER CONFIDENTIAL SDTM Creation: 17NOV2020 (10:49) Source Data: addv Table Generation: 24NOV2020 (15:23)
(Cutoff Date: 14NOV20 20, Snapshot Date: 16NOV2020) Output File: ./nda2 unblinded/C4591001 EUA FAEF RR/addv l001 pd menrl
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