125742 S1 M5 5351 c4591001 fa interim excluded patients sensitive
Document text
16.2.3.1 Listing of Subjects Excluded From All -Available and Evaluable Efficacy Population s
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
BNT162b2 (30
μg) 12-15 C4591001 1007 10071409 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predef ined window (19 -42 days after Dose 1).
16-55 C4591001 1001 10011125 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predef ined window (19 -42 days after Dose 1).
C4591001 1003 10031143 Dose 1 all -available
efficacy Did not receive at least 1 vaccination.
Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Randomized but did not meet all eligibility criteria; did not
receive all vaccinations as randomized or did not receive Dose 2
within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Randomized but did not meet all eligibility criteria; did not
receive all vaccinations as randomized or did not receive Dose 2
within the predefined window (19 -42 days after Dose 1).
C4591001 1005 10051369 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as ra ndomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1005 10051371 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
090177e1959af310\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 1
FDA-CBER-2021-5683-0017934
16.2.3.1 Listing of Subjects Excluded From All -Available and Evaluable Efficacy Population s
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predef ined window (19 -42 days after Dose 1).
C4591001 1005 10051378 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predef ined window (19 -42 days after Dose 1).
C4591001 1005 10051381 Dose 1 all -available
efficacy Did not receive at least 1 vaccination.
Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1005 10051385 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefin ed window (19 -42 days after Dose 1).
C4591001 1005 10051393 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predef ined window (19 -42 days after Dose 1).
090177e1959af310\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 2
FDA-CBER-2021-5683-0017935
16.2.3.1 Listing of Subjects Excluded From All -Available and Evaluable Efficacy Population s
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
C4591001 1005 10051396 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predef ined window (19 -42 days after Dose 1).
C4591001 1005 10051400 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predef ined window (19 -42 days after Dose 1).
C4591001 1005 10051408 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predef ined window (19 -42 days after Dose 1).
C4591001 1006 10061180 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predef ined window (19 -42 days after Dose 1).
C4591001 1007 10071431 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefin ed window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
090177e1959af310\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 3
FDA-CBER-2021-5683-0017936
16.2.3.1 Listing of Subjects Excluded From All -Available and Evaluable Efficacy Population s
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
C4591001 1007 10071434 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefin ed window (19 -42 days after Dose 1).
C4591001 1007 10071438 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predef ined window (19 -42 days after Dose 1).
C4591001 1007 10071439 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefin ed window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1007 10071440 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefin ed window (19 -42 days after Dose 1).
C4591001 1007 10071445 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predef ined window (19 -42 days after Dose 1).
090177e1959af310\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 4
FDA-CBER-2021-5683-0017937
16.2.3.1 Listing of Subjects Excluded From All -Available and Evaluable Efficacy Population s
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
C4591001 1007 10071447 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefin ed window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1007 10071450 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefin ed window (19 -42 days after Dose 1).
C4591001 1007 10071451 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predef ined window (19 -42 days after Dose 1).
C4591001 1007 10071452 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predef ined window (19 -42 days after Dose 1).
C4591001 1007 10071454 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefin ed window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
090177e1959af310\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 5
FDA-CBER-2021-5683-0017938
16.2.3.1 Listing of Subjects Excluded From All -Available and Evaluable Efficacy Population s
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
C4591001 1008 10081492 Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not rece ive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1008 10081529 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receiv e
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1008 10081629 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not rece ive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1008 10081688 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predef ined window (19 -42 days after Dose 1).
C4591001 1008 10081693 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefin ed window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1008 10081695 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
090177e1959af310\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 6
FDA-CBER-2021-5683-0017939
16.2.3.1 Listing of Subjects Excluded From All -Available and Evaluable Efficacy Population s
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefin ed window (19 -42 days after Dose 1).
C4591001 1008 10081703 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predef ined window (19 -42 days after Dose 1).
C4591001 1008 10081704 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predef ined window (19 -42 days after Dose 1).
C4591001 1008 10081710 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefin ed window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1008 10081715 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1008 10081717 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
090177e1959af310\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 7
FDA-CBER-2021-5683-0017940
16.2.3.1 Listing of Subjects Excluded From All -Available and Evaluable Efficacy Population s
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not rece ive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1008 10081719 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receiv e
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1008 10081722 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefin ed window (19 -42 days after Dose 1).
C4591001 1008 10081727 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predef ined window (19 -42 days after Dose 1).
C4591001 1008 10081731 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefin ed window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1008 10081736 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
090177e1959af310\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 8
FDA-CBER-2021-5683-0017941
16.2.3.1 Listing of Subjects Excluded From All -Available and Evaluable Efficacy Population s
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefin ed window (19 -42 days after Dose 1).
C4591001 1008 10081737 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predef ined window (19 -42 days after Dose 1).
C4591001 1008 10081741 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefin ed window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1008 10081743 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefin ed window (19 -42 days after Dose 1).
C4591001 1008 10081745 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predef ined window (19 -42 days after Dose 1).
C4591001 1009 10091210 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
090177e1959af310\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 9
FDA-CBER-2021-5683-0017942
16.2.3.1 Listing of Subjects Excluded From All -Available and Evaluable Efficacy Population s
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predef ined window (19 -42 days after Dose 1).
C4591001 1009 10091230 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefin ed window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1009 10091244 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1009 10091254 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not rece ive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1009 10091256 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receiv e
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1009 10091258 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
090177e1959af310\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 10
FDA-CBER-2021-5683-0017943
16.2.3.1 Listing of Subjects Excluded From All -Available and Evaluable Efficacy Population s
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefin ed window (19 -42 days after Dose 1).
C4591001 1009 10091260 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predef ined window (19 -42 days after Dose 1).
C4591001 1011 10111039 Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1011 10111232 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not rece ive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1011 10111235 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predef ined window (19 -42 days after Dose 1).
C4591001 1011 10111236 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefin ed window (19 -42 days after Dose 1).
090177e1959af310\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 11
FDA-CBER-2021-5683-0017944
16.2.3.1 Listing of Subjects Excluded From All -Available and Evaluable Efficacy Population s
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1011 10111237 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1012 10121001 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not rece ive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1012 10121103 Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1);
had other important protocol deviations on or prior to 7 days after
Dose 2.
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1);
had other importan t protocol deviations on or prior to 14 days
after Dose 2.
C4591001 1012 10121163 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predef ined window (19 -42 days after Dose 1).
C4591001 1013 10131138 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
090177e1959af310\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 12
FDA-CBER-2021-5683-0017945
16.2.3.1 Listing of Subjects Excluded From All -Available and Evaluable Efficacy Population s
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefin ed window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1013 10131544 Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1013 10131670† Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predef ined window (19 -42 days after Dose 1).
C4591001 1013 10131809 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefin ed window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1015 10151199 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefin ed window (19 -42 days after Dose 1).
C4591001 1015 10151259 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
090177e1959af310\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 13
FDA-CBER-2021-5683-0017946
16.2.3.1 Listing of Subjects Excluded From All -Available and Evaluable Efficacy Population s
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predef ined window (19 -42 days after Dose 1).
C4591001 1015 10151261 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefin ed window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1015 10151262 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefin ed window (19 -42 days after Dose 1).
C4591001 1015 10151265 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predef ined window (19 -42 days after Dose 1).
C4591001 1015 10151266 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefin ed window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1016 10161047 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
090177e1959af310\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 14
FDA-CBER-2021-5683-0017947
16.2.3.1 Listing of Subjects Excluded From All -Available and Evaluable Efficacy Population s
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefin ed window (19 -42 days after Dose 1).
C4591001 1016 10161087 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predef ined window (19 -42 days after Dose 1).
C4591001 1016 10161341 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predef ined window (19 -42 days after Dose 1).
C4591001 1016 10161345 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefin ed window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1016 10161347 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1016 10161349 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
090177e1959af310\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 15
FDA-CBER-2021-5683-0017948
16.2.3.1 Listing of Subjects Excluded From All -Available and Evaluable Efficacy Population s
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not rece ive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1018 10181025 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receiv e
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1018 10181028 Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1018 10181054 Dose 2 all-available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1018 10181142 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not rece ive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1018 10181165 Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predef ined window (19 -42 days after Dose 1).
C4591001 1018 10181186 Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
090177e1959af310\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 16
FDA-CBER-2021-5683-0017949
16.2.3.1 Listing of Subjects Excluded From All -Available and Evaluable Efficacy Population s
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1018 10181266 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not rece ive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1018 10181310 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receiv e
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1018 10181311 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefin ed window (19 -42 days after Dose 1).
C4591001 1018 10181353 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predef ined window (19 -42 days after Dose 1).
C4591001 1019 10191166 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
090177e1959af310\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 17
FDA-CBER-2021-5683-0017950
16.2.3.1 Listing of Subjects Excluded From All -Available and Evaluable Efficacy Population s
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predef ined window (19 -42 days after Dose 1).
C4591001 1019 10191254 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefin ed window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1019 10191318 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1019 10191321 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not rece ive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1024 10241002 Evaluable efficacy (7
days) Had other important protocol deviations on or prior to 7 days
after Dose 2.
Evaluable efficacy (14
days) Had other important protocol deviations on or prior to 14 days
after Dose 2.
C4591001 1024 10241004 Evaluable efficacy (7
days) Had other important protocol deviations on or prior to 7 days
after Dose 2.
Evaluable efficacy (14
days) Had other important protocol deviations on or prior to 14 days
after Dose 2.
C4591001 1024 10241006 Evaluable efficacy (7
days) Had other important protocol deviations on or prior to 7 days
after Dose 2.
090177e1959af310\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 18
FDA-CBER-2021-5683-0017951
16.2.3.1 Listing of Subjects Excluded From All -Available and Evaluable Efficacy Population s
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
Evaluable efficacy (14
days) Had other important protocol deviations on or prior to 14 days
after Dose 2.
C4591001 1024 10241009 Evaluable efficacy (7
days) Had other important protocol deviations on or prior to 7 days
after Dose 2.
Evaluable efficacy (14
days) Had other important protocol deviations on or prior to 14 days
after Dose 2.
C4591001 1024 10241014 Evaluable efficacy (7
days) Had other important protocol deviations on or prior to 7 days
after Dose 2.
Evaluable efficacy (14
days) Had other important protocol deviations on or prior to 14 days
after Dose 2.
C4591001 1024 10241015 Evaluable efficacy (7
days) Had other important protocol deviations on or prior to 7 days
after Dose 2.
Evaluable efficacy (14
days) Had other important protocol deviations on or prior to 14 days
after Dose 2.
C4591001 1024 10241021 Evaluable efficacy (7
days) Had other important protocol deviations on or prior to 7 days
after Dose 2.
Evaluable efficacy (14
days) Had other important protocol deviations on or prior to 14 days
after Dose 2.
C4591001 1024 10241023 Evaluable efficacy (7
days) Had other important protocol deviations on or prior to 7 days
after Dose 2.
Evaluable efficacy (14
days) Had other important protocol deviations on or prior to 14 days
after Dose 2.
C4591001 1024 10241032 Evaluable efficacy (7
days) Had other important protocol deviations on or prior to 7 days
after Dose 2.
Evaluable efficacy (14
days) Had other important protocol deviations on or prior to 14 days
after Dose 2.
C4591001 1024 10241033 Evaluable efficacy (7
days) Had other important protocol deviations on or prior to 7 days
after Dose 2.
Evaluable efficacy ( 14
days) Had other important protocol deviations on or prior to 14 days
after Dose 2.
090177e1959af310\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 19
FDA-CBER-2021-5683-0017952
16.2.3.1 Listing of Subjects Excluded From All -Available and Evaluable Efficacy Population s
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
C4591001 1024 10241039 Evaluable efficacy (7
days) Had other important protocol deviations on or prior to 7 days
after Dose 2.
Evaluable efficacy (14
days) Had other important protocol deviations on or prior to 14 days
after Dose 2.
C4591001 1024 10241040 Evaluable efficacy (7
days) Had other important protocol deviations on or prior to 7 days
after Dose 2.
Evaluable efficacy (14
days) Had other important protocol deviations on or prior to 14 days
after Dose 2.
C4591001 1024 10241042 Evaluable efficacy (7
days) Had other important protocol deviations on or prior to 7 days
after Dose 2.
Evaluable efficacy (14
days) Had other important protocol deviations on or prior to 14 days
after Dose 2.
C4591001 1024 10241044 Evaluable efficacy (7
days) Had other important protocol deviations on or prior to 7 days
after Dose 2.
Evaluable efficacy (14
days) Had other important protocol deviations on or prior to 14 days
after Dose 2.
C4591001 1024 10241046 Evaluable efficacy (7
days) Had other important protocol deviations on or prior to 7 days
after Dose 2.
Evaluable efficacy (14
days) Had other important protocol deviations on or prior to 14 days
after Dose 2.
C4591001 1024 10241054 Evaluable efficacy (7
days) Had other important protocol deviations on or prior to 7 days
after Dose 2.
Evaluable efficacy (14
days) Had other important protocol deviations on or prior to 14 days
after Dose 2.
C4591001 1024 10241055 Evaluable efficacy ( 7
days) Had other important protocol deviations on or prior to 7 days
after Dose 2.
Evaluable efficacy (14
days) Had other important protocol deviations on or prior to 14 days
after Dose 2.
C4591001 1024 10241061 Evaluable efficacy (7
days) Had other important protocol deviations on or prior to 7 days
after Dose 2.
090177e1959af310\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 20
FDA-CBER-2021-5683-0017953
16.2.3.1 Listing of Subjects Excluded From All -Available and Evaluable Efficacy Population s
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
Evaluable efficacy (14
days) Had other important protocol deviations on or prior to 14 days
after Dose 2.
C4591001 1024 10241066 Evaluable efficacy (7
days) Had other important protocol deviations on or prior to 7 days
after Dose 2.
Evaluable efficacy (14
days) Had other important protocol deviations on or prior to 14 days
after Dose 2.
C4591001 1024 10241067 Evaluable efficacy (7
days) Had other important protocol deviations on or prior to 7 days
after Dose 2.
Evaluable efficacy (14
days) Had other important protocol deviations on or prior to 14 days
after Dose 2.
C4591001 1024 10241071 Evaluable efficacy (7
days) Had other important protocol deviations on or prior to 7 days
after Dose 2.
Evaluable efficacy (14
days) Had other important protocol deviations on or prior to 14 days
after Dose 2.
C4591001 1024 10241072 Evaluable efficacy (7
days) Had other important protocol deviations on or prior to 7 days
after Dose 2.
Evaluable efficacy (14
days) Had other important protocol deviations on or prior to 14 days
after Dose 2.
C4591001 1024 10241074 Evaluable efficacy (7
days) Had other important protocol deviations on or prior to 7 days
after Dose 2.
Evaluable efficacy ( 14
days) Had other important protocol deviations on or prior to 14 days
after Dose 2.
C4591001 1024 10241078 Evaluable efficacy (7
days) Had other important protocol deviations on or prior to 7 days
after Dose 2.
Evaluable efficacy (14
days) Had other important protocol deviations on or prior to 14 days
after Dose 2.
C4591001 1024 10241084 Evaluable efficacy (7
days) Had other important protocol deviations on or prior to 7 days
after Dose 2.
Evaluable efficacy (14
days) Had other important protocol deviations on or prior to 14 days
after Dose 2.
090177e1959af310\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 21
FDA-CBER-2021-5683-0017954
16.2.3.1 Listing of Subjects Excluded From All -Available and Evaluable Efficacy Population s
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
C4591001 1024 10241085 Evaluable efficacy (7
days) Had other important protocol deviations on or prior to 7 days
after Dose 2.
Evaluable efficacy (14
days) Had other important protocol deviations on or prior to 14 days
after Dose 2.
C4591001 1024 10241091 Evaluable efficacy (7
days) Had other important protocol deviations on or prior to 7 days
after Dose 2.
Evaluable efficacy (14
days) Had other important protocol deviations on or prior to 14 days
after Dose 2.
C4591001 1 024 10241094 Evaluable efficacy (7
days) Had other important protocol deviations on or prior to 7 days
after Dose 2.
Evaluable efficacy (14
days) Had other important protocol deviations on or prior to 14 days
after Dose 2.
C4591001 1024 10241100 Evaluable efficacy (7
days) Had other important protocol deviations on or prior to 7 days
after Dose 2.
Evaluable efficacy (14
days) Had other important protocol deviations on or prior to 14 days
after Dose 2.
C4591001 1024 10241102 Evaluable efficacy (7
days) Had other important protocol deviations on or prior to 7 days
after Dose 2.
Evaluable efficacy (14
days) Had other important protocol deviations on or prior to 14 days
after Dose 2.
C4591001 1024 10241104 Evaluable efficacy (7
days) Had other important protocol deviations on or prior to 7 days
after Dose 2.
Evaluable efficacy (14
days) Had other important protocol deviations on or prior to 14 days
after Dose 2.
C4591001 1024 10241108 Evaluable efficacy (7
days) Had other important protocol deviations on or prior to 7 days
after Dose 2.
Evaluable efficacy (14
days) Had other important protocol deviations on or prior to 14 days
after Dose 2.
C4591001 1028 10281072 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
090177e1959af310\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 22
FDA-CBER-2021-5683-0017955
16.2.3.1 Listing of Subjects Excluded From All -Available and Evaluable Efficacy Population s
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
Evaluable efficacy (7
days) Did not receive all vacc inations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1028 10281267 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predef ined window (19 -42 days after Dose 1).
C4591001 1028 10281282 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefin ed window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1028 10281286 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefin ed window (19 -42 days after Dose 1).
C4591001 1028 10281287 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predef ined window (19 -42 days after Dose 1).
C4591001 1028 10281291 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
090177e1959af310\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 23
FDA-CBER-2021-5683-0017956
16.2.3.1 Listing of Subjects Excluded From All -Available and Evaluable Efficacy Population s
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predef ined window (19 -42 days after Dose 1).
C4591001 1036 10361011 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefin ed window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1036 10361050 Dose 1 all -available
efficacy Did not receive at least 1 vaccination.
Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Randomized but did not meet all eligibility criteria; did not
receive all vaccinat ions as randomized or did not receive Dose 2
within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Randomized but did not meet all eligibility criteria; did not
receive all vaccinations as randomized or did not receiv e Dose 2
within the predefined window (19 -42 days after Dose 1).
C4591001 1036 10361127 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predef ined window (19 -42 days after Dose 1).
C4591001 1036 10361135 Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
090177e1959af310\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 24
FDA-CBER-2021-5683-0017957
16.2.3.1 Listing of Subjects Excluded From All -Available and Evaluable Efficacy Population s
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
C4591001 1036 10361144 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not rece ive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1036 10361145 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1037 10371068 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1037 10371078 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefin ed window (19 -42 days after Dose 1).
C4591001 1037 10371337 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predef ined window (19 -42 days after Dose 1).
090177e1959af310\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 25
FDA-CBER-2021-5683-0017958
16.2.3.1 Listing of Subjects Excluded From All -Available and Evaluable Efficacy Population s
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
C4591001 1037 10371349 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefin ed window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1038 10381061 Evaluable efficacy (7
days) Had other important protocol deviations on or prior to 7 days
after Dos e 2.
Evaluable efficacy (14
days) Had other important protocol deviations on or prior to 14 days
after Dose 2.
C4591001 1039 10391224 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not rece ive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1039 10391226 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receiv e
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1039 10391233 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefin ed window (19 -42 days after Dose 1).
C4591001 1039 10391234† Dose 2 all -available
efficacy Did not receive 2 vaccinations.
090177e1959af310\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 26
FDA-CBER-2021-5683-0017959
16.2.3.1 Listing of Subjects Excluded From All -Available and Evaluable Efficacy Population s
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predef ined window (19 -42 days after Dose 1).
C4591001 1039 10391240 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefin ed window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1039 10391241 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefin ed window (19 -42 days after Dose 1).
C4591001 1042 10421069 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predef ined window (19 -42 days after Dose 1).
C4591001 1042 10421251 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefin ed window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1044 10441001 Evaluable efficacy (7
days) Had other important protocol deviations on or prior to 7 days
after Dos e 2.
090177e1959af310\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 27
FDA-CBER-2021-5683-0017960
16.2.3.1 Listing of Subjects Excluded From All -Available and Evaluable Efficacy Population s
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
Evaluable efficacy (14
days) Had other important protocol deviations on or prior to 14 days
after Dose 2.
C4591001 1044 10441015 Evaluable efficacy (7
days) Had other important protocol deviations on or prior to 7 days
after Dose 2.
Evaluable efficacy (14
days) Had other important protocol deviations on or prior to 14 days
after Dose 2.
C4591001 1044 10441028 Evaluable efficacy (7
days) Had other important protocol deviations on or prior to 7 days
after Dose 2.
Evaluab le efficacy (14
days) Had other important protocol deviations on or prior to 14 days
after Dose 2.
C4591001 1044 10441029 Evaluable efficacy (7
days) Had other important protocol deviations on or prior to 7 days
after Dose 2.
Evaluable efficacy (14
days) Had other important protocol deviations on or prior to 14 days
after Dose 2.
C4591001 1044 10441031 Evaluable efficacy (7
days) Had other important protocol deviations on or prior to 7 days
after Dose 2.
Evaluable efficacy (14
days) Had other important protocol deviations on or prior to 14 days
after Dose 2.
C4591001 1044 10441034 Evaluable efficacy (7
days) Had other important protocol deviations on or prior to 7 days
after Dose 2.
Evaluable efficacy (14
days) Had other important protocol deviations on or prior to 14 days
after Dose 2.
C4591001 1044 10441037 Evaluable efficacy (7
days) Had other important protocol deviations on or prior to 7 days
after Dose 2.
Evaluable efficacy (14
days) Had other important protocol deviations on or prior to 14 days
after Dose 2.
C4591001 1044 10441045 Evaluable efficacy (7
days) Had other important protocol deviations on or prior to 7 days
after Dose 2.
Evaluable efficacy (14
days) Had other important protocol deviations on or prior to 14 days
after Dose 2.
090177e1959af310\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 28
FDA-CBER-2021-5683-0017961
16.2.3.1 Listing of Subjects Excluded From All -Available and Evaluable Efficacy Population s
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
C4591001 1044 10441048 Evaluable efficacy (7
days) Had other important protocol deviations on or prior to 7 days
after Dose 2.
Evaluable efficacy (14
days) Had other important protocol deviations on or prior to 14 days
after Dose 2.
C4591001 1 044 10441050 Evaluable efficacy (7
days) Had other important protocol deviations on or prior to 7 days
after Dose 2.
Evaluable efficacy (14
days) Had other important protocol deviations on or prior to 14 days
after Dose 2.
C4591001 1044 104410 52 Evaluable efficacy (7
days) Had other important protocol deviations on or prior to 7 days
after Dose 2.
Evaluable efficacy (14
days) Had other important protocol deviations on or prior to 14 days
after Dose 2.
C4591001 1044 10441054 Evaluable efficacy (7
days) Had other important protocol deviations on or prior to 7 days
after Dose 2.
Evaluable efficacy (14
days) Had other important protocol deviations on or prior to 14 days
after Dose 2.
C4591001 1044 10441060 Evaluable efficacy (7
days) Had other important protocol deviations on or prior to 7 days
after Dose 2.
Evaluable efficacy (14
days) Had other important protocol deviations on or prior to 14 days
after Dose 2.
C4591001 1044 10441063 Evaluable efficacy (7
days) Had other important protocol deviations on or prior to 7 days
after Dose 2.
Evaluable efficacy (14
days) Had other important protocol deviations on or prior to 14 days
after Dose 2.
C4591001 1044 10441068 Evaluable efficacy (7
days) Had other important protocol deviations on or prior to 7 days
after Dose 2.
Evaluable efficacy (14
days) Had other important protocol deviations on or prior to 14 days
after Dose 2.
C4591001 1044 10441071 Evaluable efficacy (7
days) Had other important protocol deviations on or prior to 7 days
after Dose 2.
090177e1959af310\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 29
FDA-CBER-2021-5683-0017962
16.2.3.1 Listing of Subjects Excluded From All -Available and Evaluable Efficacy Population s
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
Evaluable efficacy (14
days) Had other important protocol deviations on or prior to 14 days
after Dose 2.
C4591001 1044 10441076 Evaluable efficacy (7
days) Had other important protocol deviations on or prior to 7 days
after Dose 2.
Evaluable efficacy (14
days) Had other important protocol deviations on or prior to 14 days
after Dose 2.
C4591001 1044 10441079 Evaluable efficacy (7
days) Had other important protocol deviations on or prior to 7 days
after Dose 2.
Evaluable efficacy (14
days) Had other important protocol deviations on or prior to 14 days
after Dose 2.
C4591001 1044 10441088 Evaluable efficacy (7
days) Had other important protocol deviations on or prior to 7 days
after Dose 2.
Evaluable efficacy ( 14
days) Had other important protocol deviations on or prior to 14 days
after Dose 2.
C4591001 1044 10441089 Evaluable efficacy (7
days) Had other important protocol deviations on or prior to 7 days
after Dose 2.
Evaluable efficacy (14
days) Had other important protocol deviations on or prior to 14 days
after Dose 2.
C4591001 1046 10461285 Evaluable efficacy (7
days) Did not re ceive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined windo w (19 -42 days after Dose 1).
C4591001 1046 10461319 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predef ined window (19 -42 days after Dose 1).
C4591001 1046 10461324 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
090177e1959af310\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 30
FDA-CBER-2021-5683-0017963
16.2.3.1 Listing of Subjects Excluded From All -Available and Evaluable Efficacy Population s
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predef ined window (19 -42 days after Dose 1).
C4591001 1046 10461327 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefin ed window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1046 10461329 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1046 10461331 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not rece ive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1046 10461333 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receiv e
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1046 10461337 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
090177e1959af310\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 31
FDA-CBER-2021-5683-0017964
16.2.3.1 Listing of Subjects Excluded From All -Available and Evaluable Efficacy Population s
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefin ed window (19 -42 days after Dose 1).
C4591001 1046 10461338 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predef ined window (19 -42 days after Dose 1).
C4591001 1052 10521064 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefin ed window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1052 10521080 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefin ed window (19 -42 days after Dose 1).
C4591001 1052 10521139 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predef ined window (19 -42 days after Dose 1).
C4591001 1052 10521143 Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
090177e1959af310\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 32
FDA-CBER-2021-5683-0017965
16.2.3.1 Listing of Subjects Excluded From All -Available and Evaluable Efficacy Population s
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1054 10541022 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not rece ive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1054 10541033 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Randomized but did not meet all eligibility criteria; did not
receive all vaccinations as randomized or did not receive Dose 2
within the predefined window (19 -42 days after Dose 1); had
other important protocol deviations on or prior to 7 days after
Dose 2.
Evaluable efficacy (14
days) Randomized but did not meet all eligibility criteria; did not
receive all vaccinations as randomized or did not receive Dose 2
within the predefined window (19 -42 days after Dose 1); had
other important protocol devi ations on or prior to 14 days after
Dose 2.
C4591001 1054 10541055 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the pre defined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1054 10541064 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
090177e1959af310\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 33
FDA-CBER-2021-5683-0017966
16.2.3.1 Listing of Subjects Excluded From All -Available and Evaluable Efficacy Population s
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefin ed window (19 -42 days after Dose 1).
C4591001 1054 10541138 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predef ined window (19 -42 days after Dose 1).
C4591001 1054 10541204† Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefi ned window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1054 10541206 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefin ed window (19 -42 days after Dose 1).
C4591001 1054 10541207 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predef ined window (19 -42 days after Dose 1).
C4591001 1056 10561013 Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
090177e1959af310\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 34
FDA-CBER-2021-5683-0017967
16.2.3.1 Listing of Subjects Excluded From All -Available and Evaluable Efficacy Population s
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
C4591001 1056 10561027 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vac cinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1056 10561097 Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1056 10561146 Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1056 10561193 Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1056 10561195 Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1056 10561271 Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1056 10561293 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
090177e1959af310\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 35
FDA-CBER-2021-5683-0017968
16.2.3.1 Listing of Subjects Excluded From All -Available and Evaluable Efficacy Population s
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predef ined window (19 -42 days after Dose 1).
C4591001 1056 10561300 Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1056 10561316 Evaluable efficacy (7
days) Did not receive all vaccinations as rando mized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1056 10561317 Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1056 10561352 Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1056 10561361 Dose 2 all-available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1056 10561402 Evaluable efficacy (7
days) Did not receive all vaccinations as rando mized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1056 10561452 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
090177e1959af310\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 36
FDA-CBER-2021-5683-0017969
16.2.3.1 Listing of Subjects Excluded From All -Available and Evaluable Efficacy Population s
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predef ined window (19 -42 days after Dose 1).
C4591001 1056 10561516 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefin ed window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1056 10561550 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefin ed window (19 -42 days after Dose 1).
C4591001 1056 10561569 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predef ined window (19 -42 days after Dose 1).
C4591001 1056 10561576 Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1056 10561579 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
090177e1959af310\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 37
FDA-CBER-2021-5683-0017970
16.2.3.1 Listing of Subjects Excluded From All -Available and Evaluable Efficacy Population s
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not rece ive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1056 10561587 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predef ined window (19 -42 days after Dose 1).
C4591001 1056 10561588 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefin ed window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1056 10561590 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1056 10561593 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not rece ive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1056 10561594 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receiv e
Dose 2 within the predefined window (19 -42 days after Dose 1).
090177e1959af310\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 38
FDA-CBER-2021-5683-0017971
16.2.3.1 Listing of Subjects Excluded From All -Available and Evaluable Efficacy Population s
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1056 10561599 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefin ed window (19 -42 days after Dose 1).
C4591001 1056 10561600 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predef ined window (19 -42 days after Dose 1).
C4591001 1056 10561606 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefin ed window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1056 10561608 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefin ed window (19 -42 days after Dose 1).
C4591001 1056 10561612 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
090177e1959af310\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 39
FDA-CBER-2021-5683-0017972
16.2.3.1 Listing of Subjects Excluded From All -Available and Evaluable Efficacy Population s
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predef ined window (19 -42 days after Dose 1).
C4591001 1056 10561613 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefin ed window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1056 10561614 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefin ed window (19 -42 days after Dose 1).
C4591001 1056 10561618 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predef ined window (19 -42 days after Dose 1).
C4591001 1056 10561622 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predef ined window (19 -42 days after Dose 1).
C4591001 1056 10561626 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefin ed window (19 -42 days after Dose 1).
090177e1959af310\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 40
FDA-CBER-2021-5683-0017973
16.2.3.1 Listing of Subjects Excluded From All -Available and Evaluable Efficacy Population s
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1056 10561633 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1056 10561634 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not rec eive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1056 10561635 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not recei ve
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or d id not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1056 10561639 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1056 10561643 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
090177e1959af310\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 41
FDA-CBER-2021-5683-0017974
16.2.3.1 Listing of Subjects Excluded From All -Available and Evaluable Efficacy Population s
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predef ined window (19 -42 days after Dose 1).
C4591001 1057 10571129 Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1057 10571212 Dose 1 all -available
efficacy Did not receive at least 1 vaccination.
Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 day s after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1057 10571279 Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not rece ive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1057 10571331 Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1057 10571357 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1066 10661198 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
090177e1959af310\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 42
FDA-CBER-2021-5683-0017975
16.2.3.1 Listing of Subjects Excluded From All -Available and Evaluable Efficacy Population s
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not re ceive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1066 10661203 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefin ed window (19 -42 days after Dose 1).
C4591001 1066 10661321 Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predef ined window (19 -42 days after Dose 1).
C4591001 1066 10661332 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefin ed window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1066 10661335 Dose 1 all -available
efficacy Did not receive at least 1 vaccination.
Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within th e predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1066 10661358 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
090177e1959af310\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 43
FDA-CBER-2021-5683-0017976
16.2.3.1 Listing of Subjects Excluded From All -Available and Evaluable Efficacy Population s
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1066 10661386 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not rece ive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1066 10661388 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predef ined window (19 -42 days after Dose 1).
C4591001 1066 10661391 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predef ined window (19 -42 days after Dose 1).
C4591001 1068 10681002 Evaluable efficacy (7
days) Had other important protocol deviations on or prior to 7 days
after Dose 2.
Evaluable efficacy (14
days) Had other important protocol deviations on or prior to 14 days
after Dose 2.
C4591001 1068 10681006 Evaluable efficacy (7
days) Had other important protocol deviations on or prior to 7 days
after Dose 2.
Evaluable efficacy (14
days) Had other important protocol deviations on or prior to 14 days
after Dose 2.
090177e1959af310\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 44
FDA-CBER-2021-5683-0017977
16.2.3.1 Listing of Subjects Excluded From All -Available and Evaluable Efficacy Population s
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
C4591001 1068 10681011 Evaluable efficacy (7
days) Had other important protocol deviations on or prior to 7 days
after Dose 2.
Evaluable efficacy (14
days) Had other important protocol deviations on or prior to 14 days
after Dose 2.
C4591001 1068 10681016 Evaluable efficacy (7
days) Had other important protocol deviations on or prior to 7 days
after Dose 2.
Evaluable efficacy (14
days) Had other important protocol deviations on or prior to 14 days
after Dose 2.
C4591001 1068 10681021 Evaluable efficacy (7
days) Had other important protocol deviations on or prior to 7 days
after Dose 2.
Evaluable efficacy ( 14
days) Had other important protocol deviations on or prior to 14 days
after Dose 2.
C4591001 1068 10681024 Evaluable efficacy (7
days) Had other important protocol deviations on or prior to 7 days
after Dose 2.
Evaluable efficacy (14
days) Had other important protocol deviations on or prior to 14 days
after Dose 2.
C4591001 1068 10681027 Evaluable efficacy (7
days) Had other important protocol deviations on or prior to 7 days
after Dose 2.
Evaluable efficacy (14
days) Had other important protocol deviations on or prior to 14 days
after Dose 2.
C4591001 1068 10681034 Evaluable efficacy (7
days) Had other important protocol deviations on or prior to 7 days
after Dose 2.
Evaluable efficacy (14
days) Had other important protocol deviations on or prior to 14 days
after Dose 2.
C4591001 1068 10681035 Evaluable efficacy (7
days) Had other important protocol deviations on or prior to 7 days
after Dose 2.
Evaluable efficacy (14
days) Had other important protocol deviations on or prior to 14 days
after Dose 2.
C4591001 1068 10681042 Evaluable efficacy (7
days) Had other important protocol deviations on or prior to 7 days
after Dose 2.
090177e1959af310\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 45
FDA-CBER-2021-5683-0017978
16.2.3.1 Listing of Subjects Excluded From All -Available and Evaluable Efficacy Population s
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
Evaluable efficacy (14
days) Had other important protocol deviations on or prior to 14 days
after Dose 2.
C4591001 1068 10681046 Evaluable efficacy (7
days) Had other important protocol deviations on or prior to 7 days
after Dose 2.
Evaluable efficacy (14
days) Had other important protocol deviations on or prior to 14 days
after Dose 2.
C4591001 1068 10681053 Evaluable efficacy ( 7
days) Had other important protocol deviations on or prior to 7 days
after Dose 2.
Evaluable efficacy (14
days) Had other important protocol deviations on or prior to 14 days
after Dose 2.
C4591001 1068 10681058 Evaluable efficacy (7
days) Had other important protocol deviations on or prior to 7 days
after Dose 2.
Evaluable efficacy (14
days) Had other important protocol deviations on or prior to 14 days
after Dose 2.
C4591001 1068 10681060 Evaluable efficacy (7
days) Had other important protocol deviations on or prior to 7 days
after Dose 2.
Evaluable efficacy (14
days) Had other important protocol deviations on or prior to 14 days
after Dose 2.
C4591001 1068 10681061 Evaluable efficacy (7
days) Had other important protocol deviations on or prior to 7 days
after Dose 2.
Evaluable efficacy (14
days) Had other important protocol deviations on or prior to 14 days
after Dose 2.
C4591001 1068 10681072 Evaluable efficacy (7
days) Had other important protocol deviations on or prior to 7 days
after Dose 2.
Evaluable efficacy (14
days) Had other important protocol deviations on or prior to 14 days
after Dose 2.
C4591001 1068 10681073 Evaluable efficacy (7
days) Had other important protocol deviations on or prior to 7 days
after Dose 2.
Evaluable efficacy (14
days) Had other important protocol deviations on or prior to 14 days
after Dose 2.
090177e1959af310\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 46
FDA-CBER-2021-5683-0017979
16.2.3.1 Listing of Subjects Excluded From All -Available and Evaluable Efficacy Population s
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
C4591001 1068 10681077 Evaluable efficacy (7
days) Had other important protocol deviations on or prior to 7 days
after Dose 2.
Evaluable efficacy ( 14
days) Had other important protocol deviations on or prior to 14 days
after Dose 2.
C4591001 1068 10681081 Evaluable efficacy (7
days) Had other important protocol deviations on or prior to 7 days
after Dose 2.
Evaluable efficacy (14
days) Had other important protocol deviations on or prior to 14 days
after Dose 2.
C4591001 1071 10711008 Evaluable efficacy (7
days) Did not re ceive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined windo w (19 -42 days after Dose 1).
C4591001 1071 10711095 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predef ined window (19 -42 days after Dose 1).
C4591001 1071 10711235 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predef ined window (19 -42 days after Dose 1).
C4591001 1071 10711244 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefin ed window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
090177e1959af310\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 47
FDA-CBER-2021-5683-0017980
16.2.3.1 Listing of Subjects Excluded From All -Available and Evaluable Efficacy Population s
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
C4591001 1071 10711250 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1073 10731038 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not rece ive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1079 10791004 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receiv e
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1079 10791058 Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1079 10791079 Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1079 10791135 Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predef ined window (19 -42 days after Dose 1).
090177e1959af310\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 48
FDA-CBER-2021-5683-0017981
16.2.3.1 Listing of Subjects Excluded From All -Available and Evaluable Efficacy Population s
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
C4591001 1079 10791252 Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1079 10791315 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not rece ive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1081 10811071 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predef ined window (19 -42 days after Dose 1).
C4591001 1081 10811105 Dose 1 all -available
efficacy Did not receive at least 1 vaccination.
Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1082 10821078 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefin ed window (19 -42 days after Dose 1).
090177e1959af310\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 49
FDA-CBER-2021-5683-0017982
16.2.3.1 Listing of Subjects Excluded From All -Available and Evaluable Efficacy Population s
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
C4591001 1082 10821211 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predef ined window (19 -42 days after Dose 1).
C4591001 1082 10821215 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predef ined window (19 -42 days after Dose 1).
C4591001 1082 10821216 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefin ed window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1082 10821218 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1082 10821220 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not rece ive
Dose 2 within the predefined window (19 -42 days after Dose 1).
090177e1959af310\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 50
FDA-CBER-2021-5683-0017983
16.2.3.1 Listing of Subjects Excluded From All -Available and Evaluable Efficacy Population s
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
C4591001 1083 10831141 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receiv e
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1083 10831152 Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1083 10831197 Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1084 10841035 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predef ined window (19 -42 days after Dose 1).
C4591001 1084 10841118 Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1084 10841272 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not rece ive
Dose 2 within the predefined window (19 -42 days after Dose 1).
090177e1959af310\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 51
FDA-CBER-2021-5683-0017984
16.2.3.1 Listing of Subjects Excluded From All -Available and Evaluable Efficacy Population s
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
C4591001 1084 10841533 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predef ined window (19 -42 days after Dose 1).
C4591001 1084 10841537 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefin ed window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1084 10841538 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefin ed window (19 -42 days after Dose 1).
C4591001 1085 10851245 Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predef ined window (19 -42 days after Dose 1).
C4591001 1085 10851332 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefin ed window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1085 10851373 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
090177e1959af310\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 52
FDA-CBER-2021-5683-0017985
16.2.3.1 Listing of Subjects Excluded From All -Available and Evaluable Efficacy Population s
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefin ed window (19 -42 days after Dose 1).
C4591001 1087 10871209 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predef ined window (19 -42 days after Dose 1).
C4591001 1087 10871336 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefin ed window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1087 10871557 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1);
had other important protocol deviations on or prior to 7 days after
Dose 2.
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1);
had other important protocol deviations on or prior to 14 days
after Dose 2.
C4591001 1087 10871562 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
090177e1959af310\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 53
FDA-CBER-2021-5683-0017986
16.2.3.1 Listing of Subjects Excluded From All -Available and Evaluable Efficacy Population s
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1087 10871582 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1087 10871586 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefin ed window (19 -42 days after Dose 1).
C4591001 1087 10871594 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predef ined window (19 -42 days after Dose 1).
C4591001 1087 10871595 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predef ined window (19 -42 days after Dose 1).
C4591001 1087 10871596 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefin ed window (19 -42 days after Dose 1).
090177e1959af310\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 54
FDA-CBER-2021-5683-0017987
16.2.3.1 Listing of Subjects Excluded From All -Available and Evaluable Efficacy Population s
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1087 10871597 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1088 10881045 Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receiv e
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1088 10881077 Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1);
had other important protocol deviations on or prior to 7 days after
Dose 2.
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the p redefined window (19 -42 days after Dose 1);
had other important protocol deviations on or prior to 14 days
after Dose 2.
C4591001 1089 10891158 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not rece ive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1089 10891182 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receiv e
Dose 2 within the predefined window (19 -42 days after Dose 1).
090177e1959af310\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 55
FDA-CBER-2021-5683-0017988
16.2.3.1 Listing of Subjects Excluded From All -Available and Evaluable Efficacy Population s
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1089 10891311 Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as ran domized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1089 10891346 Dose 1 all -available
efficacy Did not receive at least 1 vaccination.
Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predef ined window (19 -42 days after Dose 1).
C4591001 1089 10891351 Dose 1 all -available
efficacy Did not receive at least 1 vaccination.
Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not rece ive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1090 10901136 Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1090 10901510 Evaluable efficacy (7
days) Did not receive all vaccinations as ra ndomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
090177e1959af310\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 56
FDA-CBER-2021-5683-0017989
16.2.3.1 Listing of Subjects Excluded From All -Available and Evaluable Efficacy Population s
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
C4591001 1090 10901547 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1090 10901548 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not rece ive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1090 10901557 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predef ined window (19 -42 days after Dose 1).
C4591001 1090 10901558 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefin ed window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1090 10901559 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
090177e1959af310\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 57
FDA-CBER-2021-5683-0017990
16.2.3.1 Listing of Subjects Excluded From All -Available and Evaluable Efficacy Population s
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
C4591001 1091 10911005 Evaluable efficacy (7
days) Had other important protocol deviations on or prior to 7 days
after Dose 2.
Evaluable efficacy (14
days) Had other important protocol deviations on or prior to 14 days
after Dose 2.
C4591001 1091 10911008 Evaluable efficacy (7
days) Had other important protocol deviations on or prior to 7 days
after Dose 2.
Evaluable efficacy (14
days) Had other important protocol deviations on or prior to 14 days
after Dose 2.
C4591001 1091 10911015 Evaluable efficacy (7
days) Had other important protocol deviations on or prior to 7 days
after Dose 2.
Evaluable efficacy (14
days) Had other important protocol deviations on or prior to 14 days
after Dose 2.
C4591001 1091 10911039 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1091 10911077 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not rece ive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1091 10911130 Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1091 10911232 Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
090177e1959af310\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 58
FDA-CBER-2021-5683-0017991
16.2.3.1 Listing of Subjects Excluded From All -Available and Evaluable Efficacy Population s
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predef ined window (19 -42 days after Dose 1).
C4591001 1091 10911358 Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1091 10911380 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not rece ive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1091 10911382 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receiv e
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1091 10911384 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefin ed window (19 -42 days after Dose 1).
C4591001 1091 10911386 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predef ined window (19 -42 days after Dose 1).
090177e1959af310\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 59
FDA-CBER-2021-5683-0017992
16.2.3.1 Listing of Subjects Excluded From All -Available and Evaluable Efficacy Population s
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
C4591001 1091 10911387 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predef ined window (19 -42 days after Dose 1).
C4591001 1092 10921128 Dose 1 all -available
efficacy Did not receive at least 1 vaccination.
Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1092 10921249 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefin ed window (19 -42 days after Dose 1).
C4591001 1092 10921271 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predef ined window (19 -42 days after Dose 1).
C4591001 1092 10921272 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
090177e1959af310\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 60
FDA-CBER-2021-5683-0017993
16.2.3.1 Listing of Subjects Excluded From All -Available and Evaluable Efficacy Population s
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predef ined window (19 -42 days after Dose 1).
C4591001 1093 10931055 Dose 1 all -available
efficacy Did not receive at least 1 vaccination.
Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Randomized but did not meet all eligibility criteria; did not
receive all vaccinations as randomized or did not receive Dose 2
within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Randomized but did not meet all eligibility criteria; did not
receive all vaccinations as randomized or did not receive Dose 2
within the predefined window (19 -42 days after Dose 1).
C4591001 1093 10931058 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1);
had other important protocol deviations on or prior to 7 days after
Dose 2.
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1);
had other important protocol deviations on or prior to 14 days
after Dose 2.
C4591001 1093 10931065 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1093 10931209 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
090177e1959af310\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 61
FDA-CBER-2021-5683-0017994
16.2.3.1 Listing of Subjects Excluded From All -Available and Evaluable Efficacy Population s
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not rece ive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1093 10931211 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receiv e
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1093 10931214 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1093 10931218 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not rec eive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1093 10931219 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not recei ve
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1093 10931223 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
090177e1959af310\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 62
FDA-CBER-2021-5683-0017995
16.2.3.1 Listing of Subjects Excluded From All -Available and Evaluable Efficacy Population s
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefin ed window (19 -42 days after Dose 1).
C4591001 1093 10931224 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predef ined window (19 -42 days after Dose 1).
C4591001 1094 10941186 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefin ed window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1094 10941188 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not rece ive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1094 10941192 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predef ined window (19 -42 days after Dose 1).
C4591001 1095 10951110 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
090177e1959af310\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 63
FDA-CBER-2021-5683-0017996
16.2.3.1 Listing of Subjects Excluded From All -Available and Evaluable Efficacy Population s
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefin ed window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1095 10951124 Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1095 10951141 Dose 2 all-available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predef ined window (19 -42 days after Dose 1).
C4591001 1095 10951168 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefin ed window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1095 10951173 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefin ed window (19 -42 days after Dose 1).
C4591001 1095 10951208 Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
090177e1959af310\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 64
FDA-CBER-2021-5683-0017997
16.2.3.1 Listing of Subjects Excluded From All -Available and Evaluable Efficacy Population s
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
C4591001 1095 10951307 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not rece ive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1096 10961141 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predef ined window (19 -42 days after Dose 1).
C4591001 1096 10961287 Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1096 10961288 Evaluable efficacy (7
days) Did not receive all vaccinations as rando mized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1096 10961344 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1098 10981029 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
090177e1959af310\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 65
FDA-CBER-2021-5683-0017998
16.2.3.1 Listing of Subjects Excluded From All -Available and Evaluable Efficacy Population s
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1098 10981169† Evaluable efficacy (7
days) Randomized but did not meet all eligibility criteria; had other
important protocol deviations on or prior to 7 days after Dose 2.
Evaluable efficacy (14
days) Randomized but did not meet all eligibility criteria; had other
important protocol deviat ions on or prior to 14 days after Dose 2.
C4591001 1098 10981189 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the prede fined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1098 10981200 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefin ed window (19 -42 days after Dose 1).
C4591001 1101 11011021 Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1107 11071018 Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predef ined window (19 -42 days after Dose 1).
C4591001 1107 11071162 Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
090177e1959af310\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 66
FDA-CBER-2021-5683-0017999
16.2.3.1 Listing of Subjects Excluded From All -Available and Evaluable Efficacy Population s
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
C4591001 1109 11091059 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not rece ive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1109 11091234 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predef ined window (19 -42 days after Dose 1).
C4591001 1109 11091349 Dose 1 all -available
efficacy Did not receive at least 1 vaccination.
Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Randomized but did not meet all eligibility criteria; did not
receive all vaccinations as randomized or did not receive Dose 2
within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Randomiz ed but did not meet all eligibility criteria; did not
receive all vaccinations as randomized or did not receive Dose 2
within the predefined window (19 -42 days after Dose 1).
C4591001 1109 11091391 Evaluable efficacy (7
days) Did not receive all vacci nations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days a fter Dose 1).
C4591001 1109 11091406 Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
090177e1959af310\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 67
FDA-CBER-2021-5683-0018000
16.2.3.1 Listing of Subjects Excluded From All -Available and Evaluable Efficacy Population s
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
C4591001 1109 11091414 Evaluable efficacy (7
days) Did not receive all vaccinations as rando mized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1109 11091417 Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predef ined window (19 -42 days after Dose 1).
C4591001 1109 11091422 Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1109 11091522 Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1110 11101006 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefin ed window (19 -42 days after Dose 1).
C4591001 1110 11101039 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predef ined window (19 -42 days after Dose 1).
C4591001 1110 11101069 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
090177e1959af310\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 68
FDA-CBER-2021-5683-0018001
16.2.3.1 Listing of Subjects Excluded From All -Available and Evaluable Efficacy Population s
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predef ined window (19 -42 days after Dose 1).
C4591001 1110 11101154 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefin ed window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1110 11101333 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1110 11101374 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not rece ive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1110 11101379 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receiv e
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1111 11111064 Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
090177e1959af310\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 69
FDA-CBER-2021-5683-0018002
16.2.3.1 Listing of Subjects Excluded From All -Available and Evaluable Efficacy Population s
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predef ined window (19 -42 days after Dose 1).
C4591001 1111 11111099 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefin ed window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1111 11111105 Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1112 11121058 Dose 2 all-available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Randomized but did not meet all eligibility criteria; did not
receive all vaccinations as randomized or did not receive Dose 2
within the predefined window (19 -42 days after Dose 1); had
other important protocol deviations on or prior to 7 days after
Dose 2.
Evaluable efficacy (14
days) Randomized but did not meet all eligibility criteria; did not
receive all vaccinations as randomized or did not receive Dose 2
within the predefined window (19 -42 days after Dose 1); had
other important protocol devi ations on or prior to 14 days after
Dose 2.
C4591001 1112 11121101 Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy ( 14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1112 11121192 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
090177e1959af310\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 70
FDA-CBER-2021-5683-0018003
16.2.3.1 Listing of Subjects Excluded From All -Available and Evaluable Efficacy Population s
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vac cinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1112 11121229 Dose 1 all -available
efficacy Did not receive at least 1 vaccination.
Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predef ined window (19 -42 days after Dose 1).
C4591001 1112 11121270† Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Randomized but did not meet all eligibility criteria; did not
receive all vaccinations as r andomized or did not receive Dose 2
within the predefined window (19 -42 days after Dose 1); had
other important protocol deviations on or prior to 7 days after
Dose 2.
Evaluable efficacy (14
days) Randomized but did not meet all eligibility criteria; did not
receive all vaccinations as randomized or did not receive Dose 2
within the predefined window (19 -42 days after Dose 1); had
other important protocol deviations on or prior to 14 days after
Dose 2.
C4591001 1112 11121331 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1) .
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
090177e1959af310\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 71
FDA-CBER-2021-5683-0018004
16.2.3.1 Listing of Subjects Excluded From All -Available and Evaluable Efficacy Population s
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
C4591001 1114 11141037 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vac cinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1116 11161015 Dose 1 all -available
efficacy Did not receive at least 1 vaccination.
Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Randomized but did not meet all eligibility criteria; did not
receive all vaccinations as randomized or did not receive Dose 2
within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Randomized but did not meet all elig ibility criteria; did not
receive all vaccinations as randomized or did not receive Dose 2
within the predefined window (19 -42 days after Dose 1).
C4591001 1116 11161143 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable ef ficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1116 11161172 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefin ed window (19 -42 days after Dose 1).
C4591001 1116 11161226 Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1);
090177e1959af310\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 72
FDA-CBER-2021-5683-0018005
16.2.3.1 Listing of Subjects Excluded From All -Available and Evaluable Efficacy Population s
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
had other important protocol deviations on or prior to 7 days after
Dose 2.
Evaluable efficacy (14
days) Did not receiv e all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1);
had other important protocol deviations on or prior to 14 days
after Dose 2.
C4591001 1117 11171070 Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined win dow (19 -42 days after Dose 1).
C4591001 1120 11201299 Dose 1 all -available
efficacy Did not provide informed consent.
Dose 2 all -available
efficacy Did not provide informed consent.
Evaluable efficacy (7
days) Did not provide informed consent; had other important protocol
deviations on or prior to 7 days after Dose 2.
Evaluable efficacy (14
days) Did not provide informed consent; had other important protocol
deviations on or prior to 14 days after Dose 2 .
C4591001 1120 11201320 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predef ined window (19 -42 days after Dose 1).
C4591001 1120 11201363 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefin ed window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
090177e1959af310\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 73
FDA-CBER-2021-5683-0018006
16.2.3.1 Listing of Subjects Excluded From All -Available and Evaluable Efficacy Population s
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
C4591001 1120 11201388 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefin ed window (19 -42 days after Dose 1).
C4591001 1120 11201398 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predef ined window (19 -42 days after Dose 1).
C4591001 1120 11201404 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefin ed window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1120 11201407 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefin ed window (19 -42 days after Dose 1).
C4591001 1120 11201409 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predef ined window (19 -42 days after Dose 1).
090177e1959af310\Final\Final On: 24-Nov-2020 13:48 (GMT)
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FDA-CBER-2021-5683-0018007
16.2.3.1 Listing of Subjects Excluded From All -Available and Evaluable Efficacy Population s
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
C4591001 1120 11201417 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefin ed window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1120 11201418 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefin ed window (19 -42 days after Dose 1).
C4591001 1120 11201430 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predef ined window (19 -42 days after Dose 1).
C4591001 1120 11201431 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predef ined window (19 -42 days after Dose 1).
C4591001 1121 11211025 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefin ed window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
090177e1959af310\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 75
FDA-CBER-2021-5683-0018008
16.2.3.1 Listing of Subjects Excluded From All -Available and Evaluable Efficacy Population s
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
C4591001 1122 11221026 Dose 1 all -available
efficacy Did not receive at least 1 vaccination.
Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within th e predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1123 11231027 Dose 1 all -available
efficacy Did not receive at least 1 vaccination.
Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not r eceive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1123 1 1231144 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predef ined window (19 -42 days after Dose 1).
C4591001 1123 11231154 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1123 11231168 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
090177e1959af310\Final\Final On: 24-Nov-2020 13:48 (GMT)
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FDA-CBER-2021-5683-0018009
16.2.3.1 Listing of Subjects Excluded From All -Available and Evaluable Efficacy Population s
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefin ed window (19 -42 days after Dose 1).
C4591001 1123 11231208 Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predef ined window (19 -42 days after Dose 1).
C4591001 1123 11231263 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefin ed window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1123 11231301 Dose 1 all -available
efficacy Did not receive at least 1 vaccination.
Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Randomized but did not meet all eligibility criteria; did not
receive all vaccinations as randomized or did not receive Dose 2
within the predefined window (19 -42 days after Dose 1) .
Evaluable efficacy (14
days) Randomized but did not meet all eligibility criteria; did not
receive all vaccinations as randomized or did not receive Dose 2
within the predefined window (19 -42 days after Dose 1).
C4591001 1123 11231386 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
090177e1959af310\Final\Final On: 24-Nov-2020 13:48 (GMT)
Page 77
FDA-CBER-2021-5683-0018010
16.2.3.1 Listing of Subjects Excluded From All -Available and Evaluable Efficacy Population s
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
C4591001 1123 11231403 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not rec eive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1123 11231405 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not recei ve
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1123 11231408 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefin ed window (19 -42 days after Dose 1).
C4591001 1123 11231410 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predef ined window (19 -42 days after Dose 1).
C4591001 1123 11231411 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefin ed window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
090177e1959af310\Final\Final On: 24-Nov-2020 13:48 (GMT)
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FDA-CBER-2021-5683-0018011
16.2.3.1 Listing of Subjects Excluded From All -Available and Evaluable Efficacy Population s
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
C4591001 1124 11241049 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefin ed window (19 -42 days after Dose 1).
C4591001 1124 11241100 Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predef ined window (19 -42 days after Dose 1).
C4591001 1125 11251148 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefin ed window (19 -42 days after Dose 1).
Evaluable efficacy (14
days) Did not receive all vaccinations as randomized or did not receive
Dose 2 within the predefined window (19 -42 days after Dose 1).
C4591001 1125 11251159 Dose 2 all -available
efficacy Did not receive 2 vaccinations.
Evaluable efficacy (7
days) Did not receive all vaccinations as randomized or did not rece
…[truncated]