125742 45 S211 M5 c4591001 interim ado excluded patients
Document text
16.2.3.1.1 Listing of Subjects Excluded From Immunogenicity Populations –
Subjects 12 Through 25 Years of Age (Immunogenicity Subset )
Age
Group
(Years) Subject Population Reason for Exclusion
12-15 C4591001 100 6
10061212 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1006
10061220 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1006
10061227 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1006
10061248 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1006
10061261 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1006
10061280 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1006
10061282 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1007
10071467 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1007
10071471 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1007
10071523 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
090177e196ae8aa9\Final\Final On: 01-Apr-2021 06:51 (GMT)
Page 1
FDA-CBER-2022-5812-0223848
16.2.3.1.1 Listing of Subjects Excluded From Immunogenicity Populations –
Subjects 12 Through 25 Years of Age (Immunogenicity Subset )
Age
Group
(Years) Subject Population Reason for Exclusion
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1007
10071574 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1008
10081764 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2; did not have blood
collection within 28 -42 days after Dose 2.
C4591001 1008
10081800 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1009
10091221 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1009
10091265 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1009
10091280 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and de terminate immunogenicity result after Dose 2.
C4591001 1009
10091281 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1009
10091288 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1009
10091354 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
090177e196ae8aa9\Final\Final On: 01-Apr-2021 06:51 (GMT)
Page 2
FDA-CBER-2022-5812-0223849
16.2.3.1.1 Listing of Subjects Excluded From Immunogenicity Populations –
Subjects 12 Through 25 Years of Age (Immunogenicity Subset )
Age
Group
(Years) Subject Population Reason for Exclusion
C4591001 1013
10131822 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1013
10131828 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1013
10131841 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1013
10131850 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1013
10131855 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1016
10161334 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1016
10161338 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2; did not have blood
collection within 28 -42 days after Dose 2.
C4591001 1016
10161356 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1039
10391269 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
090177e196ae8aa9\Final\Final On: 01-Apr-2021 06:51 (GMT)
Page 3
FDA-CBER-2022-5812-0223850
16.2.3.1.1 Listing of Subjects Excluded From Immunogenicity Populations –
Subjects 12 Through 25 Years of Age (Immunogenicity Subset )
Age
Group
(Years) Subject Population Reason for Exclusion
C4591001 1044
10441276 Dose 2 evaluable Did not have blood collection within 28 -42 days after Dose 2.
C4591001 1044
10441295 Dose 2 all-
available Did not have at least 1 valid and d eterminate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1057
10571378 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1057
10571396 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not receive Dose 2 within 19 -42 days after Dose 1; did not have at least 1 valid and determinate
immunogenicity result after Dose 2.
C4591001 1057
10571399 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1057
10571400 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1057
10571409 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1057
10571412 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1066
10661408 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1066
10661417 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
090177e196ae8aa9\Final\Final On: 01-Apr-2021 06:51 (GMT)
Page 4
FDA-CBER-2022-5812-0223851
16.2.3.1.1 Listing of Subjects Excluded From Immunogenicity Populations –
Subjects 12 Through 25 Years of Age (Immunogenicity Subset )
Age
Group
(Years) Subject Population Reason for Exclusion
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1077
10771274 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1077
10771288 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1091
10911413 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1123
11231431 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1123
11231432 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1123
11231438 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1123
11231439 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1123
11231440 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1123
11231441 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
090177e196ae8aa9\Final\Final On: 01-Apr-2021 06:51 (GMT)
Page 5
FDA-CBER-2022-5812-0223852
16.2.3.1.1 Listing of Subjects Excluded From Immunogenicity Populations –
Subjects 12 Through 25 Years of Age (Immunogenicity Subset )
Age
Group
(Years) Subject Population Reason for Exclusion
C4591001 1123
11231448 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1124
11241249 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1126
11261269 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1126
11261277 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1131
11311275 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1139
11391151 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1139
11391156 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1139
11391170 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1140
11401336 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1140
11401337 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
090177e196ae8aa9\Final\Final On: 01-Apr-2021 06:51 (GMT)
Page 6
FDA-CBER-2022-5812-0223853
16.2.3.1.1 Listing of Subjects Excluded From Immunogenicity Populations –
Subjects 12 Through 25 Years of Age (Immunogenicity Subset )
Age
Group
(Years) Subject Population Reason for Exclusion
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1142
11421319 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1142
11421330 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1142
11421343 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1147
11471274 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1150
11501119 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1150
11501129 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1152
11521625 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1152
11521640 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1152
11521641 Dose 2 all-
available Did not receive Dose 2.
Dose 2 evaluable Did not receive 2 doses of the vaccine to which they were randomly assigned.
090177e196ae8aa9\Final\Final On: 01-Apr-2021 06:51 (GMT)
Page 7
FDA-CBER-2022-5812-0223854
16.2.3.1.1 Listing of Subjects Excluded From Immunogenicity Populations –
Subjects 12 Through 25 Years of Age (Immunogenicity Subset )
Age
Group
(Years) Subject Population Reason for Exclusion
C4591001 1152
11521645 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1152
11521656 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1152
11521657 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1152
11521661 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1152
11521667 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1152
11521679 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1152
11521683 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1152
11521684 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1152
11521686 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1152
11521689 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
090177e196ae8aa9\Final\Final On: 01-Apr-2021 06:51 (GMT)
Page 8
FDA-CBER-2022-5812-0223855
16.2.3.1.1 Listing of Subjects Excluded From Immunogenicity Populations –
Subjects 12 Through 25 Years of Age (Immunogenicity Subset )
Age
Group
(Years) Subject Population Reason for Exclusion
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1152
11521697 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1156
11561257 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1156
11561304 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1156
11561311 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1156
11561321 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1156
11561324 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1235
12351246 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1270
12701177 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1270
12701187 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
090177e196ae8aa9\Final\Final On: 01-Apr-2021 06:51 (GMT)
Page 9
FDA-CBER-2022-5812-0223856
16.2.3.1.1 Listing of Subjects Excluded From Immunogenicity Populations –
Subjects 12 Through 25 Years of Age (Immunogenicity Subset )
Age
Group
(Years) Subject Population Reason for Exclusion
16-25 C4591001 1006
10061137 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at lea st 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1006
10061159 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1007
10071434 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1007
10071447 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1007
10071454 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1007
10071473 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1008
10081743 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1009
10091210 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1009
10091235 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1011
10111213 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
090177e196ae8aa9\Final\Final On: 01-Apr-2021 06:51 (GMT)
Page 10
FDA-CBER-2022-5812-0223857
16.2.3.1.1 Listing of Subjects Excluded From Immunogenicity Populations –
Subjects 12 Through 25 Years of Age (Immunogenicity Subset )
Age
Group
(Years) Subject Population Reason for Exclusion
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1013
10131059 Dose 2 evaluable Did not have blood collection within 28 -42 days after Dose 2.
C4591001 1013
10131276 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determina te immunogenicity result after Dose 2.
C4591001 1013
10131653 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1013
10131763 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1013
10131817 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1013
10131829 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2; did not have blood
collection within 28 -42 days after Dose 2.
C4591001 1013
10131834 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity resu lt after Dose 2.
Dose 2 evaluable Did not receive Dose 2 within 19 -42 days after Dose 1; did not have at least 1 valid and determinate
immunogenicity result after Dose 2; did not have blood collection within 28 -42 days after Dose 2.
C4591001 1015
10151150 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1018
10181032 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
090177e196ae8aa9\Final\Final On: 01-Apr-2021 06:51 (GMT)
Page 11
FDA-CBER-2022-5812-0223858
16.2.3.1.1 Listing of Subjects Excluded From Immunogenicity Populations –
Subjects 12 Through 25 Years of Age (Immunogenicity Subset )
Age
Group
(Years) Subject Population Reason for Exclusion
C4591001 1046
10461346 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1047
10471275 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1047
10471306 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1056
10561171 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1056
10561392 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2; did not have blood
collection within 28 -42 days after Dose 2.
C4591001 1057
10571217 Dose 2 evaluable Did not have blood collection within 28 -42 days after Dose 2.
C459 1001 1057
10571366 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1057
10571368 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1068
10681119 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2; did not have blood
collection within 28 -42 days after Dose 2.
090177e196ae8aa9\Final\Final On: 01-Apr-2021 06:51 (GMT)
Page 12
FDA-CBER-2022-5812-0223859
16.2.3.1.1 Listing of Subjects Excluded From Immunogenicity Populations –
Subjects 12 Through 25 Years of Age (Immunogenicity Subset )
Age
Group
(Years) Subject Population Reason for Exclusion
C4591001 1079
10791162 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not receive Dose 2 within 19 -42 days after Dose 1; did not have at least 1 valid and determinate
immunogenicity result after Dose 2; did not have blood collection within 28 -42 days after Dose 2.
C4591001 1080
10801055 Dose 2 evaluab le Had important protocol deviation(s) as determined by the clinician.
C4591001 1080
10801179 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1082
10821036 Dose 2 evaluable Did not have blood collection within 28 -42 days after Dose 2.
C4591001 1084
10841423 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1085
10851373 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1087
10871565 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1088
10881200 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1090
10901328 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2; did not have blood
collection within 28 -42 days after Dose 2.
C4591001 1091
10911389 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
090177e196ae8aa9\Final\Final On: 01-Apr-2021 06:51 (GMT)
Page 13
FDA-CBER-2022-5812-0223860
16.2.3.1.1 Listing of Subjects Excluded From Immunogenicity Populations –
Subjects 12 Through 25 Years of Age (Immunogenicity Subset )
Age
Group
(Years) Subject Population Reason for Exclusion
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1091
10911391 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1092
10921146 Dose 2 evaluable Did not have blood collection within 28 -42 days after Dose 2.
C4591001 1093
10931174 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1093
10931203 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1095
10951271 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2; did not have blood
collection within 28 -42 days after Dose 2.
C4591001 1095
10951310 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2; did not have blood
collection within 28 -42 days a fter Dose 2.
C4591001 1096
10961032 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C459100 1 1096
10961196 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1096
10961392 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
090177e196ae8aa9\Final\Final On: 01-Apr-2021 06:51 (GMT)
Page 14
FDA-CBER-2022-5812-0223861
16.2.3.1.1 Listing of Subjects Excluded From Immunogenicity Populations –
Subjects 12 Through 25 Years of Age (Immunogenicity Subset )
Age
Group
(Years) Subject Population Reason for Exclusion
C4591001 1098
10981177 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1109
11091391 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not receive Dose 2 within 19 -42 days after Dose 1; did not have at least 1 valid and determinate
immunogenicity result after Dose 2.
C4591001 1109
11091532 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result afte r Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1111
11111183 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1112
11121260 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1114
11141021 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1116
11161320 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1116
11161322 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2; did not have blood
collection within 28 -42 days after Dose 2.
C4591001 1120
11201337 Dose 2 evaluable Did not have blood collection within 28 -42 days after Dose 2.
090177e196ae8aa9\Final\Final On: 01-Apr-2021 06:51 (GMT)
Page 15
FDA-CBER-2022-5812-0223862
16.2.3.1.1 Listing of Subjects Excluded From Immunogenicity Populations –
Subjects 12 Through 25 Years of Age (Immunogenicity Subset )
Age
Group
(Years) Subject Population Reason for Exclusion
C4591001 1123
11231416 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1123
11231417 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1123
11231429 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1123
11231430 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1125
11251240 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1126
11261231 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1126
11261234 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1131
11311064 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1131
11311268 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1133
11331609 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
090177e196ae8aa9\Final\Final On: 01-Apr-2021 06:51 (GMT)
Page 16
FDA-CBER-2022-5812-0223863
16.2.3.1.1 Listing of Subjects Excluded From Immunogenicity Populations –
Subjects 12 Through 25 Years of Age (Immunogenicity Subset )
Age
Group
(Years) Subject Population Reason for Exclusion
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1135
11351239 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1135
11351323 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1135
11351461 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1135
11351492 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1135
11351497 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1135
11351556 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1139
11391132 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2; did not have blood
collection within 28 -42 days after Dose 2.
C4591001 1140
11401316 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity resu lt after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1141
11411006 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
090177e196ae8aa9\Final\Final On: 01-Apr-2021 06:51 (GMT)
Page 17
FDA-CBER-2022-5812-0223864
16.2.3.1.1 Listing of Subjects Excluded From Immunogenicity Populations –
Subjects 12 Through 25 Years of Age (Immunogenicity Subset )
Age
Group
(Years) Subject Population Reason for Exclusion
C4591001 1141
11411269 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1142
11421338 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1147
11471260 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1149
11491079 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1149
11491302 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1150
11501016 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1150
11501188 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1152
11521115 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1152
11521451 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1152
11521464 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
090177e196ae8aa9\Final\Final On: 01-Apr-2021 06:51 (GMT)
Page 18
FDA-CBER-2022-5812-0223865
16.2.3.1.1 Listing of Subjects Excluded From Immunogenicity Populations –
Subjects 12 Through 25 Years of Age (Immunogenicity Subset )
Age
Group
(Years) Subject Population Reason for Exclusion
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1152
11521632 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1156
11561203 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1156
11561288 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1156
11561329 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1162
11621479 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1168
11681069 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1170
11701089 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2; did not have blood
collection within 28 -42 days after Dose 2.
C4591001 1170
11701392 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2; did not have blood
collection within 28 -42 days after Dose 2.
C4591001 1170
11701419 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
090177e196ae8aa9\Final\Final On: 01-Apr-2021 06:51 (GMT)
Page 19
FDA-CBER-2022-5812-0223866
16.2.3.1.1 Listing of Subjects Excluded From Immunogenicity Populations –
Subjects 12 Through 25 Years of Age (Immunogenicity Subset )
Age
Group
(Years) Subject Population Reason for Exclusion
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1171
11711211 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1171
11711221 Dose 2 evaluable Did not receive Dose 2 within 19 -42 days after Dos e 1.
C4591001 1177
11771540 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1204
12041144 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1204
12041275 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1218
12181047 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1220
12201015 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1221
12211036 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1224
12241183 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1224
12241187 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
090177e196ae8aa9\Final\Final On: 01-Apr-2021 06:51 (GMT)
Page 20
FDA-CBER-2022-5812-0223867
16.2.3.1.1 Listing of Subjects Excluded From Immunogenicity Populations –
Subjects 12 Through 25 Years of Age (Immunogenicity Subset )
Age
Group
(Years) Subject Population Reason for Exclusion
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1232
12321302 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1235
12351014 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1235
12351230 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1254
12541121 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1254
12541178 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2; did not have blood
collection within 28 -42 days after Dose 2.
C4591001 1258
12581069 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2; did not have blood
collection within 28 -42 days after Dose 2.
C4591 001 1264
12641095 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
C4591001 1270
12701195 Dose 2 all-
available Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
Dose 2 evaluable Did not have at least 1 valid and determinate immunogenicity result after Dose 2.
090177e196ae8aa9\Final\Final On: 01-Apr-2021 06:51 (GMT)
Page 21
FDA-CBER-2022-5812-0223868
16.2.3.1.1 Listing of Subjects Excluded From Immunogenicity Populations –
Subjects 12 Through 25 Years of Age (Immunogenicity Subset )
Age
Group
(Years) Subject Population Reason for Exclusion
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:24) Source Data: adsl Table Generation: 28MAR2021 (12:59)
(Cutoff Date: 13MAR2021, Snapshot Date: 25MAR2021) Output File: ./nda2 unblinded/C4591001 BLA/adsl l001 excl ped eval
090177e196ae8aa9\Final\Final On: 01-Apr-2021 06:51 (GMT)
Page 22
FDA-CBER-2022-5812-0223869
16.2.3.2.1 Listing of Subjects Excluded From Safety Po pulation – Subjects 12 Through 25 Years of Age
Age Group
(Years) Subject Reason for Exclusion
12-15 C4591001 1057 10571413 Subject did not receive stud y vaccine.
C4591001 1077 10771293 Subject did not receive stud y vaccine.
C4591001 1091 10911451 Subject did not receive stud y vaccine.
C4591001 1140 11401346 Subject did not receive stud y vaccine.
16-25 C4591001 1013 10131740 Subject did not receive stud y vaccine.
C4591001 1057 10571211 Subject did not receive stud y vaccine.
C4591001 1092 10921128 Subject did not receive stud y vaccine.
C4591001 1093 10931055 Subject did not receive stud y vaccine.
C4591001 1112 11121229 Subject did not receive stud y vaccine.
C4591001 1120 11201038 Subject did not receive stud y vaccine.
C4591001 1122 11221026 Subject did not receive stud y vaccine.
C4591001 1123 11231027 Subject did not receive stud y vaccine.
C4591001 1129 11291048 Subject did not receive stud y vaccine.
C4591001 1161 11611006 Unreliable data due to lack of PI oversi ght.
C4591001 1161 11611015 Unreliable data due to lack of PI oversi ght.
C4591001 1161 11611016 Unreliable data due to lack of PI oversi ght.
C4591001 1161 11611018 Unreliable data due to lack of PI oversi ght.
C4591001 1161 11611019 Unreliable data due to lack of PI oversi ght.
C4591001 1224 12241170 Subject did not receive stud y vaccine.
C4591001 1231 12313443 Subject did not receive stud y vaccine.
C4591001 1231 12313527 Subject did not receive stud y vaccine.
C4591001 1248 12481025 Subject did not receive study vaccine.
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:24) Source Data: adsl Table Generation: 27MAR2021 (01:37)
(Cutoff Date: 13MAR2021, Snapshot Date: 25MAR2021) Output File: ./nda2 _unblinded/C4591001 _BLA/adsl _l001_excl_ped_saf_all
090177e196ac9159\Final\Final On: 31-Mar-2021 13:05 (GMT)
Page 23
FDA-CBER-2022-5812-0223870
16.2.3.2.2 Listing of Subjects Excluded From Safety Population – Phase 2/3 Subjects 16-55 Years of Age
Age Group (Years) Subject Reason for Exclusion
16-55 C4591001 1003 10031140 Subject did not receive stud y vaccine.
C4591001 1003 10031143 Subject did not receive stud y vaccine.
C4591001 1005 10051381 Subject did not receive stud y vaccine.
C4591001 1013 10131017 Subject did not receive stud y vaccine.
C4591001 1013 10131740 Subject did not receive stud y vaccine.
C4591001 1036 10361050 Subject did not receive stud y vaccine.
C4591001 1057 10571031 Subject did not receive stud y vaccine.
C4591001 1057 10571211 Subject did not receive stud y vaccine.
C4591001 1057 10571212 Subject did not receive stud y vaccine.
C4591001 1057 10571215 Subject did not receive stud y vaccine.
C4591001 1057 10571268 Subject did not receive stud y vaccine.
C4591001 1066 10661335 Subject did not receive stud y vaccine.
C4591001 1071 10711162 Subject did not receive stud y vaccine.
C4591001 1081 10811105 Subject did not receive stud y vaccine.
C4591001 1082 10821013 Subject did not receive stud y vaccine.
C4591001 1089 10891346 Subject did not receive stud y vaccine.
C4591001 1089 10891351 Subject did not receive stud y vaccine.
C4591001 1092 10921128 Subject did not receive stud y vaccine.
C4591001 1093 10931055 Subject did not receive stud y vaccine.
C4591001 1109 11091349 Subject did not receive stud y vaccine.
C4591001 1112 11121229 Subject did not receive stud y vaccine.
C4591001 1116 11161015 Subject did not receive stud y vaccine.
C4591001 1120 11201038 Subject did not receive stud y vaccine.
C4591001 1120 11201252 Subject did not receive stud y vaccine.
C4591001 1122 11221006 Subject did not receive stud y vaccine.
C4591001 1122 11221026 Subject did not receive stud y vaccine.
C4591001 1123 11231027 Subject did not receive stud y vaccine.
C4591001 1123 11231301 Subject did not receive stud y vaccine.
C4591001 1126 11261074 Subject did not receive stud y vaccine.
C4591001 1129 11291048 Subject did not receive stud y vaccine.
090177e196ac9178\Final\Final On: 31-Mar-2021 13:07 (GMT)
Page 24
FDA-CBER-2022-5812-0223871
16.2.3.2.2 Listing of Subjects Excluded From Safety Population – Phase 2/3 Subjects 16-55 Years of Age
Age Group (Years) Subject Reason for Exclusion
C4591001 1133 11331162 Subject did not receive stud y vaccine.
C4591001 1135 11351389 Subject did not receive stud y vaccine.
C4591001 1149 11491108 Subject did not receive stud y vaccine.
C4591001 1161 11611002 Unreliable data due to lack of PI oversi ght.
C4591001 1161 11611005 Unreliable data due to lack of PI oversi ght.
C4591001 1161 11611006 Unreliable data due to lack of PI oversi ght.
C4591001 1161 11611011 Unreliable data due to lack of PI oversi ght.
C4591001 1161 11611015 Unreliable data due to lack of PI oversi ght.
C4591001 1161 11611016 Unreliable data due to lack of PI oversi ght.
C4591001 1161 11611018 Unreliable data due to lack of PI oversi ght.
C4591001 1161 11611019 Unreliable data due to lack of PI oversi ght.
C4591001 1162 11621024 Subject did not receive stud y vaccine.
C4591001 1162 11621477 Subject did not receive stud y vaccine.
C4591001 1167 11671003 Subject did not receive stud y vaccine.
C4591001 1168 11681030 Subject did not receive stud y vaccine.
C4591001 1205 12051028 Subject did not receive stud y vaccine.
C4591001 1212 12121023 Subject did not receive stud y vaccine.
C4591001 1223 12231200 Subject did not receive stud y vaccine.
C4591001 1223 12231234 Subject did not receive stud y vaccine.
C4591001 1224 12241170 Subject did not receive stud y vaccine.
C4591001 1231 12311409 Subject did not receive stud y vaccine.
C4591001 1231 12311516 Subject did not receive stud y vaccine.
C4591001 1231 12311926 Subject did not receive stud y vaccine.
C4591001 1231 12312176 Subject did not receive stud y vaccine.
C4591001 1231 12312483 Subject did not receive stud y vaccine.
C4591001 1231 12313443 Subject did not receive stud y vaccine.
C4591001 1231 12313527 Subject did not receive stud y vaccine.
C4591001 1231 12313869 Subject did not receive stud y vaccine.
C4591001 1231 12314738 Subject did not receive stud y vaccine.
C4591001 1231 12315308 Subject did not receive stud y vaccine.
090177e196ac9178\Final\Final On: 31-Mar-2021 13:07 (GMT)
Page 25
FDA-CBER-2022-5812-0223872
16.2.3.2.2 Listing of Subjects Excluded From Safety Population – Phase 2/3 Subjects 16-55 Years of Age
Age Group (Years) Subject Reason for Exclusion
C4591001 1232 12321037 Subject did not receive stud y vaccine.
C4591001 1235 12351167 Subject did not receive stud y vaccine.
C4591001 1248 12481018 Subject did not receive stud y vaccine.
C4591001 1248 12481025 Subject did not receive stud y vaccine.
C4591001 1248 12481060 Subject did not receive stud y vaccine.
C4591001 1248 12481218 Subject did not receive stud y vaccine.
C4591001 1251 12511204 Subject did not receive stud y vaccine.
C4591001 1260 12601049 Subject did not receive stud y vaccine.
C4591001 1260 12601070 Subject did not receive stud y vaccine.
C4591001 1264 12641018 Subject did not receive stud y vaccine.
C4591001 4444 44441135 Subject did not recei ve study vaccine.
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:24) Source Data: adsl Table Generation: 30MAR2021 (13:27)
(Cutoff Date: 13MAR2021, Snapshot Date: 25MAR2021) Output File: ./nda2 unblinded/C4591001 EUA 1655/adsl l001 excl saf1655
090177e196ac9178\Final\Final On: 31-Mar-2021 13:07 (GMT)
Page 26
FDA-CBER-2022-5812-0223873