125742 S1 M5 5351 c4591001 interim mth6 excluded patients sensitive
Document text
16.2.3.1 Listing of Subjects Excluded From All-Available and Evaluable Efficacy Population
– Blinded Placebo-Controlled Follow-up Period
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
BNT162b2 (30
μg) 12-15 C4591001 1006 10061272 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days) Randomized but did not meet all eligibility criteria; did not
receive all vaccinations as rand omized or did not receive Dose 2
within the predefined window (19-42 da ys after Dose 1).
C4591001 1007 10071409 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1007 10071622 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1007 10071642 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1044 10441359 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1057 10571396 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1057 10571413 Dose 1 all-available
efficac yDid not receive at least 1 vaccination.
Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1066 10661407 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
090177e196af7326\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 1
FDA-CBER-2021-5683-0220386
16.2.3.1 Listing of Subjects Excluded From All-Available and Evaluable Efficacy Population
– Blinded Placebo-Controlled Follow-up Period
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
C4591001 1091 10911414 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1091 10911451 Dose 1 all-available
efficac yDid not receive at least 1 vaccination.
Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1139 11391261 Dose 2 all-available
efficac yUnblinded prior to 7 days post Dose 2.
Evaluable efficacy (7
days)Unblinded prior to 7 days post Dose 2.
C4591001 1140 11401346 Dose 1 all-available
efficac yDid not receive at least 1 vaccination.
Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1142 11421363 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1147 11471327 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1152 11521641 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
090177e196af7326\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 2
FDA-CBER-2021-5683-0220387
16.2.3.1 Listing of Subjects Excluded From All-Available and Evaluable Efficacy Population
– Blinded Placebo-Controlled Follow-up Period
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
16-55 C4591001 1001 10011125 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1003 10031143 Dose 1 all-available
efficac yDid not receive at least 1 vaccination.
Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days) Randomized but did not meet all eligibility criteria; did not
receive all vaccinations as rand omized or did not receive Dose 2
within the predefined window (19-42 da ys after Dose 1).
C4591001 1005 10051381 Dose 1 all-available
efficac yDid not receive at least 1 vaccination.
Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1005 10051411 Dose 2 all-available
efficac yUnblinded prior to 7 days post Dose 2.
Evaluable efficacy (7
days)Unblinded prior to 7 days post Dose 2.
C4591001 1008 10081492 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1008 10081529 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1011 10111039 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
090177e196af7326\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 3
FDA-CBER-2021-5683-0220388
16.2.3.1 Listing of Subjects Excluded From All-Available and Evaluable Efficacy Population
– Blinded Placebo-Controlled Follow-up Period
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
C4591001 1012 10121001 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1012 10121103 Evaluable efficacy (7
days) Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 days after Dose 1);
had other important protocol deviations on or prior to 7 days a fter
Dose 2.
C4591001 1012 10121163 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1013 10131138 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1013 10131544 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1013 10131670† Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1013 10131834 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1015 10151199 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1016 10161047 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
090177e196af7326\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 4
FDA-CBER-2021-5683-0220389
16.2.3.1 Listing of Subjects Excluded From All-Available and Evaluable Efficacy Population
– Blinded Placebo-Controlled Follow-up Period
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1016 10161087 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1016 10161341 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1018 10181025 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1018 10181028 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1018 10181054 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1018 10181142 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1018 10181165 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1018 10181186 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1018 10181266 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
090177e196af7326\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 5
FDA-CBER-2021-5683-0220390
16.2.3.1 Listing of Subjects Excluded From All-Available and Evaluable Efficacy Population
– Blinded Placebo-Controlled Follow-up Period
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1018 10181310 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1018 10181311 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1019 10191166 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1019 10191254 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1024 10241002 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 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.
C4591001 1024 10241006 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 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.
C4591001 1024 10241023 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 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.
C4591001 1024 10241033 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 days
after Dose 2.
090177e196af7326\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 6
FDA-CBER-2021-5683-0220391
16.2.3.1 Listing of Subjects Excluded From All-Available and Evaluable Efficacy Population
– Blinded Placebo-Controlled Follow-up Period
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.
C4591001 1024 10241040 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 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.
C4591001 1024 10241044 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 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.
C4591001 1024 10241054 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 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.
C4591001 1024 10241061 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 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.
C4591001 1024 10241067 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 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.
C4591001 1024 10241072 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 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.
C4591001 1024 10241078 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 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.
090177e196af7326\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 7
FDA-CBER-2021-5683-0220392
16.2.3.1 Listing of Subjects Excluded From All-Available and Evaluable Efficacy Population
– Blinded Placebo-Controlled Follow-up Period
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.
C4591001 1024 10241091 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 days
after Dose 2.
C4591001 1024 10241094 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 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.
C4591001 1024 10241102 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 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.
C4591001 1024 10241108 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 days
after Dose 2.
C4591001 1028 10281072 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1028 10281267 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1036 10361011 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1036 10361050 Dose 1 all-available
efficac yDid not receive at least 1 vaccination.
Dose 2 all-available
efficac yDid not receive 2 vaccinations.
090177e196af7326\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 8
FDA-CBER-2021-5683-0220393
16.2.3.1 Listing of Subjects Excluded From All-Available and Evaluable Efficacy Population
– Blinded Placebo-Controlled Follow-up Period
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
Evaluable efficacy (7
days) Randomized but did not meet all eligibility criteria; did not
receive all vaccinations as rand omized or did not receive Dose 2
within the predefined window (19-42 da ys after Dose 1).
C4591001 1036 10361127 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1036 10361135 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1037 10371068 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1037 10371078 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1038 10381061 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 days
after Dose 2.
C4591001 1042 10421069 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1042 10421251 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1044 10441001 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 days
after Dose 2.
090177e196af7326\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 9
FDA-CBER-2021-5683-0220394
16.2.3.1 Listing of Subjects Excluded From All-Available and Evaluable Efficacy Population
– Blinded Placebo-Controlled Follow-up Period
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
C4591001 1044 10441015 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 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.
C4591001 1044 10441029 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 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.
C4591001 1044 10441034 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 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.
C4591001 1044 10441045 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 days
after Dose 2.
C4591001 1044 10441048 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 days
after Dose 2.
C4591001 1044 10441050 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 days
after Dose 2.
C4591001 1044 10441052 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 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.
C4591001 1044 10441060 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 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.
C4591001 1044 10441068 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 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.
090177e196af7326\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 10
FDA-CBER-2021-5683-0220395
16.2.3.1 Listing of Subjects Excluded From All-Available and Evaluable Efficacy Population
– Blinded Placebo-Controlled Follow-up Period
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
C4591001 1044 10441076 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 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.
C4591001 1044 10441088 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 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.
C4591001 1044 10441272 Dose 2 all-available
efficac yUnblinded prior to 7 days post Dose 2.
Evaluable efficacy (7
days)Unblinded prior to 7 days post Dose 2.
C4591001 1046 10461285 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1046 10461348 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1052 10521064 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1052 10521080 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1052 10521139 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1052 10521143 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
090177e196af7326\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 11
FDA-CBER-2021-5683-0220396
16.2.3.1 Listing of Subjects Excluded From All-Available and Evaluable Efficacy Population
– Blinded Placebo-Controlled Follow-up Period
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
C4591001 1054 10541022 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1054 10541033 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days) Randomized but did not meet all eligibility criteria; did not
receive all vaccinations as rand omized or did not receive Dose 2
within the predefined window (19-42 da ys after Dose 1).
C4591001 1054 10541055 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1054 10541064 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1054 10541138 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1056 10561013 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1056 10561027 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1056 10561097 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
090177e196af7326\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 12
FDA-CBER-2021-5683-0220397
16.2.3.1 Listing of Subjects Excluded From All-Available and Evaluable Efficacy Population
– Blinded Placebo-Controlled Follow-up Period
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
C4591001 1056 10561146 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1056 10561193 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1056 10561195 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1056 10561271 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1056 10561293 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1056 10561300 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1056 10561316 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1056 10561317 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1056 10561352 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1056 10561361 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1056 10561402 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1056 10561452 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
090177e196af7326\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 13
FDA-CBER-2021-5683-0220398
16.2.3.1 Listing of Subjects Excluded From All-Available and Evaluable Efficacy Population
– Blinded Placebo-Controlled Follow-up Period
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
C4591001 1056 10561516 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1056 10561550 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1056 10561569 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1056 10561576 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1056 10561579 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1056 10561643 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1057 10571129 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1057 10571212 Dose 1 all-available
efficac yDid not receive at least 1 vaccination.
Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1057 10571279 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1057 10571331 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
090177e196af7326\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 14
FDA-CBER-2021-5683-0220399
16.2.3.1 Listing of Subjects Excluded From All-Available and Evaluable Efficacy Population
– Blinded Placebo-Controlled Follow-up Period
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
C4591001 1066 10661198 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1066 10661203 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1066 10661321 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1066 10661332 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1066 10661335 Dose 1 all-available
efficac yDid not receive at least 1 vaccination.
Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1066 10661406 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1068 10681002 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 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.
C4591001 1068 10681011 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 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.
C4591001 1068 10681021 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 days
after Dose 2.
090177e196af7326\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 15
FDA-CBER-2021-5683-0220400
16.2.3.1 Listing of Subjects Excluded From All-Available and Evaluable Efficacy Population
– Blinded Placebo-Controlled Follow-up Period
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
C4591001 1068 10681024 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 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.
C4591001 1068 10681034 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 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.
C4591001 1068 10681042 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 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.
C4591001 1068 10681053 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 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.
C4591001 1068 10681060 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 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.
C4591001 1068 10681072 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 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.
C4591001 1068 10681077 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 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.
C4591001 1071 10711008 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
090177e196af7326\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 16
FDA-CBER-2021-5683-0220401
16.2.3.1 Listing of Subjects Excluded From All-Available and Evaluable Efficacy Population
– Blinded Placebo-Controlled Follow-up Period
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
C4591001 1071 10711095 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1071 10711235 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1073 10731038 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1079 10791004 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1079 10791058 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1079 10791079 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1079 10791135 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1079 10791252 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1081 10811071 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1081 10811105 Dose 1 all-available
efficac yDid not receive at least 1 vaccination.
090177e196af7326\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 17
FDA-CBER-2021-5683-0220402
16.2.3.1 Listing of Subjects Excluded From All-Available and Evaluable Efficacy Population
– Blinded Placebo-Controlled Follow-up Period
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1082 10821078 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1083 10831141 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1083 10831152 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1083 10831197 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1084 10841035 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1084 10841118 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1084 10841272 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1085 10851245 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1085 10851332 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
090177e196af7326\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 18
FDA-CBER-2021-5683-0220403
16.2.3.1 Listing of Subjects Excluded From All-Available and Evaluable Efficacy Population
– Blinded Placebo-Controlled Follow-up Period
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1087 10871209 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1087 10871336 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1087 10871557 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1087 10871562 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1088 10881045 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1088 10881077 Evaluable efficacy (7
days) Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 days after Dose 1);
had other important protocol deviations on or prior to 7 days a fter
Dose 2.
C4591001 1089 10891158 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1089 10891182 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
090177e196af7326\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 19
FDA-CBER-2021-5683-0220404
16.2.3.1 Listing of Subjects Excluded From All-Available and Evaluable Efficacy Population
– Blinded Placebo-Controlled Follow-up Period
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1089 10891311 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1089 10891346 Dose 1 all-available
efficac yDid not receive at least 1 vaccination.
Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1089 10891351 Dose 1 all-available
efficac yDid not receive at least 1 vaccination.
Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1090 10901136 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1090 10901510 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1091 10911005 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 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.
C4591001 1091 10911015 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 days
after Dose 2.
C4591001 1091 10911039 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
090177e196af7326\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 20
FDA-CBER-2021-5683-0220405
16.2.3.1 Listing of Subjects Excluded From All-Available and Evaluable Efficacy Population
– Blinded Placebo-Controlled Follow-up Period
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
C4591001 1091 10911077 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1091 10911130 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1091 10911232 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1091 10911358 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1091 10911387 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1092 10921128 Dose 1 all-available
efficac yDid not receive at least 1 vaccination.
Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1092 10921249 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1093 10931055 Dose 1 all-available
efficac yDid not receive at least 1 vaccination.
Dose 2 all-available
efficac yDid not receive 2 vaccinations.
090177e196af7326\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 21
FDA-CBER-2021-5683-0220406
16.2.3.1 Listing of Subjects Excluded From All-Available and Evaluable Efficacy Population
– Blinded Placebo-Controlled Follow-up Period
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
Evaluable efficacy (7
days) Randomized but did not meet all eligibility criteria; did not
receive all vaccinations as rand omized or did not receive Dose 2
within the predefined window (19-42 da ys after Dose 1).
C4591001 1093 10931058 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1093 10931065 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1093 10931211 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1095 10951110 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1095 10951124 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1095 10951141 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1095 10951168 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
090177e196af7326\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 22
FDA-CBER-2021-5683-0220407
16.2.3.1 Listing of Subjects Excluded From All-Available and Evaluable Efficacy Population
– Blinded Placebo-Controlled Follow-up Period
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
C4591001 1095 10951173 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1095 10951208 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1096 10961141 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1096 10961197 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 days
after Dose 2.
C4591001 1096 10961287 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1096 10961288 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1096 10961344 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1098 10981029 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys 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 da ys after Dose 2.
C4591001 1098 10981189 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1098 10981200 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
090177e196af7326\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 23
FDA-CBER-2021-5683-0220408
16.2.3.1 Listing of Subjects Excluded From All-Available and Evaluable Efficacy Population
– Blinded Placebo-Controlled Follow-up Period
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1101 11011021 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1107 11071018 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1107 11071162 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1109 11091059 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1109 11091234 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1109 11091349 Dose 1 all-available
efficac yDid not receive at least 1 vaccination.
Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days) Randomized but did not meet all eligibility criteria; did not
receive all vaccinations as rand omized or did not receive Dose 2
within the predefined window (19-42 da ys after Dose 1).
C4591001 1109 11091391 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1109 11091406 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1109 11091414 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
090177e196af7326\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 24
FDA-CBER-2021-5683-0220409
16.2.3.1 Listing of Subjects Excluded From All-Available and Evaluable Efficacy Population
– Blinded Placebo-Controlled Follow-up Period
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
C4591001 1109 11091417 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1109 11091422 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1109 11091522 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1110 11101006 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1110 11101039 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1110 11101069 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1110 11101154 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1110 11101333 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1111 11111064 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1111 11111099 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
090177e196af7326\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 25
FDA-CBER-2021-5683-0220410
16.2.3.1 Listing of Subjects Excluded From All-Available and Evaluable Efficacy Population
– Blinded Placebo-Controlled Follow-up Period
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1111 11111105 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1112 11121058 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1112 11121101 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1112 11121192 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1112 11121229 Dose 1 all-available
efficac yDid not receive at least 1 vaccination.
Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1112 11121270† Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1114 11141037 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1116 11161015 Dose 1 all-available
efficac yDid not receive at least 1 vaccination.
090177e196af7326\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 26
FDA-CBER-2021-5683-0220411
16.2.3.1 Listing of Subjects Excluded From All-Available and Evaluable Efficacy Population
– Blinded Placebo-Controlled Follow-up Period
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days) Randomized but did not meet all eligibility criteria; did not
receive all vaccinations as rand omized or did not receive Dose 2
within the predefined window (19-42 da ys after Dose 1).
C4591001 1116 11161143 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1116 11161172 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1116 11161226 Evaluable efficacy (7
days) Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 days after Dose 1);
had other important protocol deviations on or prior to 7 days a fter
Dose 2.
C4591001 1117 11171070 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1121 11211025 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1122 11221026 Dose 1 all-available
efficac yDid not receive at least 1 vaccination.
Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
090177e196af7326\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 27
FDA-CBER-2021-5683-0220412
16.2.3.1 Listing of Subjects Excluded From All-Available and Evaluable Efficacy Population
– Blinded Placebo-Controlled Follow-up Period
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
C4591001 1123 11231027 Dose 1 all-available
efficac yDid not receive at least 1 vaccination.
Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1123 11231144 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1123 11231154 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1123 11231168 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1123 11231208 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1123 11231263 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1123 11231301 Dose 1 all-available
efficac yDid not receive at least 1 vaccination.
Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days) Randomized but did not meet all eligibility criteria; did not
receive all vaccinations as rand omized or did not receive Dose 2
within the predefined window (19-42 da ys after Dose 1).
090177e196af7326\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 28
FDA-CBER-2021-5683-0220413
16.2.3.1 Listing of Subjects Excluded From All-Available and Evaluable Efficacy Population
– Blinded Placebo-Controlled Follow-up Period
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
C4591001 1123 11231386 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1124 11241049 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1124 11241100 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1125 11251148 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1125 11251159 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1125 11251243 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1126 11261053 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 days
after Dose 2.
C4591001 1127 11271022 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1128 11281126 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
090177e196af7326\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 29
FDA-CBER-2021-5683-0220414
16.2.3.1 Listing of Subjects Excluded From All-Available and Evaluable Efficacy Population
– Blinded Placebo-Controlled Follow-up Period
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
C4591001 1129 11291061 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1129 11291238 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1129 11291249 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1131 11311024 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1133 11331052 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1133 11331122 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1133 11331295 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1133 11331316 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1133 11331341 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
090177e196af7326\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 30
FDA-CBER-2021-5683-0220415
16.2.3.1 Listing of Subjects Excluded From All-Available and Evaluable Efficacy Population
– Blinded Placebo-Controlled Follow-up Period
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
C4591001 1133 11331346 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1133 11331509 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1134 11341033 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1134 11341153 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1134 11341174 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1134 11341177 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1134 11341228 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1135 11351061 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1135 11351199 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
090177e196af7326\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 31
FDA-CBER-2021-5683-0220416
16.2.3.1 Listing of Subjects Excluded From All-Available and Evaluable Efficacy Population
– Blinded Placebo-Controlled Follow-up Period
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
C4591001 1135 11351389 Dose 1 all-available
efficac yDid not receive at least 1 vaccination.
Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1135 11351428 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1135 11351430 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1135 11351523 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1136 11361043 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1136 11361108 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1136 11361111 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1140 11401301 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
090177e196af7326\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 32
FDA-CBER-2021-5683-0220417
16.2.3.1 Listing of Subjects Excluded From All-Available and Evaluable Efficacy Population
– Blinded Placebo-Controlled Follow-up Period
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1141 11411011 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 days
after Dose 2.
C4591001 1141 11411014 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 days
after Dose 2.
C4591001 1141 11411023 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 days
after Dose 2.
C4591001 1141 11411065 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 days
after Dose 2.
C4591001 1141 11411096 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1141 11411127 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1141 11411164 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1141 11411166 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1141 11411179 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1141 11411249 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1146 11461010 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1147 11471212 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
090177e196af7326\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 33
FDA-CBER-2021-5683-0220418
16.2.3.1 Listing of Subjects Excluded From All-Available and Evaluable Efficacy Population
– Blinded Placebo-Controlled Follow-up Period
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
C4591001 1149 11491005 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1149 11491031 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1149 11491067 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1149 11491088 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1149 11491209 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1152 11521034 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1152 11521477 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1156 11561006 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1157 11571070 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
090177e196af7326\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 34
FDA-CBER-2021-5683-0220419
16.2.3.1 Listing of Subjects Excluded From All-Available and Evaluable Efficacy Population
– Blinded Placebo-Controlled Follow-up Period
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
C4591001 1157 11571169 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1161 11611001 Dose 1 all-available
efficac yData considered potentially unre liable due to lack of PI oversi ght
identified as si gnificant qualit y event.
Dose 2 all-available
efficac yData considered potentially unre liable due to lack of PI oversi ght
identified as si gnificant qualit y event.
Evaluable efficacy (7
days) Data considered potentially unre liable due to lack of PI oversi ght
identified as significant qua lity event; did not receive all
vaccinations as randomized or di d not receive Dose 2 within the
predefined window (19-42 days after Dose 1); had other
important protocol devia tions on or prior to 7 da ys after Dose 2.
C4591001 1161 11611002 Dose 1 all-available
efficac yData considered potentially unre liable due to lack of PI oversi ght
identified as si gnificant qualit y event.
Dose 2 all-available
efficacy Did not receive 2 v accinations; data considered potentially
unreliable due to lack of PI oversight identified as significan t
qualit y event.
Evaluable efficacy (7
days) Randomized but did not meet all eligibility criteria; data
considered potentially unreliable due to lack of PI oversight
identified as significant qua lity event; did not receive all
vaccinations as randomized or di d not receive Dose 2 within the
predefined window (19-42 da ys after Dose 1).
C4591001 1161 11611006 Dose 1 all-available
efficac yData considered potentially unre liable due to lack of PI oversi ght
identified as si gnificant qualit y event.
Dose 2 all-available
efficacy Did not receive 2 v accinations; data considered potentially
unreliable due to lack of PI oversight identified as significan t
qualit y event.
Evaluable efficacy (7
days) Data considered potentially unre liable due to lack of PI oversi ght
identified as significant qua lity event; did not receive all
vaccinations as randomized or di d not receive Dose 2 within the
predefined window (19-42 da ys after Dose 1).
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16.2.3.1 Listing of Subjects Excluded From All-Available and Evaluable Efficacy Population
– Blinded Placebo-Controlled Follow-up Period
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
C4591001 1161 11611009 Dose 1 all-available
efficac yData considered potentially unre liable due to lack of PI oversi ght
identified as si gnificant qualit y event.
Dose 2 all-available
efficac yData considered potentially unre liable due to lack of PI oversi ght
identified as si gnificant qualit y event.
Evaluable efficacy (7
days) Data considered potentially unre liable due to lack of PI oversi ght
identified as significant qua lity event; did not receive all
vaccinations as randomized or di d not receive Dose 2 within the
predefined window (19-42 days after Dose 1); had other
important protocol deviations on or prior to 7 da ys after Dose 2.
C4591001 1161 11611011 Dose 1 all-available
efficac yData considered potentially unre liable due to lack of PI oversi ght
identified as si gnificant qualit y event.
Dose 2 all-available
efficac yData considered potentially unre liable due to lack of PI oversi ght
identified as si gnificant qualit y event.
Evaluable efficacy (7
days) Randomized but did not meet all eligibility criteria; data
considered potentially unreliable due to lack of PI oversight
identified as significant qua lity event; did not receive all
vaccinations as randomized or di d not receive Dose 2 within the
predefined window (19-42 days after Dose 1); had other
important protocol deviations on or prior to 7 da ys after Dose 2.
C4591001 1161 11611014 Dose 1 all-available
efficac yData considered potentially unre liable due to lack of PI oversi ght
identified as si gnificant qualit y event.
Dose 2 all-available
efficac yData considered potentially unre liable due to lack of PI oversi ght
identified as si gnificant qualit y event.
Evaluable efficacy (7
days) Randomized but did not meet all eligibility criteria; data
considered potentially unreliable due to lack of PI oversight
identified as significant qua lity event; did not receive all
vaccinations as randomized or di d not receive Dose 2 within the
predefined window (19-42 days after Dose 1); had other
important protocol deviations on or prior to 7 da ys after Dose 2.
C4591001 1161 11611017 Dose 1 all-available
efficac yData considered potentially unre liable due to lack of PI oversi ght
identified as si gnificant qualit y event.
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16.2.3.1 Listing of Subjects Excluded From All-Available and Evaluable Efficacy Population
– Blinded Placebo-Controlled Follow-up Period
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
Dose 2 all-available
efficac yData considered potentially unre liable due to lack of PI oversi ght
identified as si gnificant qualit y event.
Evaluable efficacy (7
days) Data considered potentially unre liable due to lack of PI oversi ght
identified as significant qua lity event; did not receive all
vaccinations as randomized or di d not receive Dose 2 within the
predefined window (19-42 days after Dose 1); had other
important protocol devia tions on or prior to 7 da ys after Dose 2.
C4591001 1161 11611019 Dose 1 all-available
efficac yData considered potentially unre liable due to lack of PI oversi ght
identified as si gnificant qualit y event.
Dose 2 all-available
efficac yData considered potentially unre liable due to lack of PI oversi ght
identified as si gnificant qualit y event.
Evaluable efficacy (7
days) Data considered potentially unre liable due to lack of PI oversi ght
identified as significant qua lity event; did not receive all
vaccinations as randomized or di d not receive Dose 2 within the
predefined window (19-42 days after Dose 1); had other
important protocol deviations on or prior to 7 da ys after Dose 2.
C4591001 1161 11611020 Dose 1 all-available
efficac yData considered potentially unre liable due to lack of PI oversi ght
identified as si gnificant qualit y event.
Dose 2 all-available
efficac yData considered potentially unre liable due to lack of PI oversi ght
identified as si gnificant qualit y event.
Evaluable efficacy (7
days) Data considered potentially unre liable due to lack of PI oversi ght
identified as significant qua lity event; did not receive all
vaccinations as randomized or di d not receive Dose 2 within the
predefined window (19-42 days after Dose 1); had other
important protocol deviations on or prior to 7 da ys after Dose 2.
C4591001 1161 11611026 Dose 1 all-available
efficac yData considered potentially unre liable due to lack of PI oversi ght
identified as si gnificant qualit y event.
Dose 2 all-available
efficac yData considered potentially unre liable due to lack of PI oversi ght
identified as si gnificant qualit y event.
Evaluable efficacy (7
days)Data considered potentially unre liable due to lack of PI oversi ght
identified as si gnificant qualit y event; did not receive all
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FDA-CBER-2021-5683-0220422
16.2.3.1 Listing of Subjects Excluded From All-Available and Evaluable Efficacy Population
– Blinded Placebo-Controlled Follow-up Period
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
vaccinations as randomized or di d not receive Dose 2 within the
predefined window (19-42 days after Dose 1); had other
important protocol deviations on or prior to 7 da ys after Dose 2.
C4591001 1161 11611032 Dose 1 all-available
efficac yData considered potentially unre liable due to lack of PI oversi ght
identified as si gnificant qualit y event.
Dose 2 all-available
efficac yData considered potentially unre liable due to lack of PI oversi ght
identified as si gnificant qualit y event.
Evaluable efficacy (7
days) Data considered potentially unre liable due to lack of PI oversi ght
identified as significant qua lity event; did not receive all
vaccinations as randomized or di d not receive Dose 2 within the
predefined window (19-42 days after Dose 1); had other
important protocol deviations on or prior to 7 da ys after Dose 2.
C4591001 1161 11611034 Dose 1 all-available
efficac yData considered potentially unre liable due to lack of PI oversi ght
identified as si gnificant qualit y event.
Dose 2 all-available
efficac yData considered potentially unre liable due to lack of PI oversi ght
identified as si gnificant qualit y event.
Evaluable efficacy (7
days) Data considered potentially unre liable due to lack of PI oversi ght
identified as significant qua lity event; did not receive all
vaccinations as randomized or di d not receive Dose 2 within the
predefined window (19-42 days after Dose 1); had other
important protocol deviations on or prior to 7 da ys after Dose 2.
C4591001 1161 11611041 Dose 1 all-available
efficac yData considered potentially unre liable due to lack of PI oversi ght
identified as si gnificant qualit y event.
Dose 2 all-available
efficac yData considered potentially unre liable due to lack of PI oversi ght
identified as si gnificant qualit y event.
Evaluable efficacy (7
days) Data considered potentially unre liable due to lack of PI oversi ght
identified as significant qua lity event; did not receive all
vaccinations as randomized or di d not receive Dose 2 within the
predefined window (19-42 days after Dose 1); had other
important protocol deviations on or prior to 7 da ys after Dose 2.
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FDA-CBER-2021-5683-0220423
16.2.3.1 Listing of Subjects Excluded From All-Available and Evaluable Efficacy Population
– Blinded Placebo-Controlled Follow-up Period
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
C4591001 1162 11621005 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1162 11621118 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1162 11621128 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 days
after Dose 2.
C4591001 1162 11621374 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1162 11621381 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1162 11621391 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1162 11621477 Dose 1 all-available
efficac yDid not receive at least 1 vaccination.
Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days) Randomized but did not meet all eligibility criteria; did not
receive all vaccinations as rand omized or did not receive Dose 2
within the predefined window (19-42 da ys after Dose 1).
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16.2.3.1 Listing of Subjects Excluded From All-Available and Evaluable Efficacy Population
– Blinded Placebo-Controlled Follow-up Period
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
C4591001 1162 11621524 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1162 11621566 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1163 11631006 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1163 11631069 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1163 11631117 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 days
after Dose 2.
C4591001 1163 11631121 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 days
after Dose 2.
C4591001 1163 11631124 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 days
after Dose 2.
C4591001 1163 11631127 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 days
after Dose 2.
C4591001 1163 11631136 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 days
after Dose 2.
C4591001 1163 11631142 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 days
after Dose 2.
C4591001 1163 11631145 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 days
after Dose 2.
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FDA-CBER-2021-5683-0220425
16.2.3.1 Listing of Subjects Excluded From All-Available and Evaluable Efficacy Population
– Blinded Placebo-Controlled Follow-up Period
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
C4591001 1167 11671111 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1168 11681030 Dose 1 all-available
efficac yDid not receive at least 1 vaccination.
Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1169 11691049 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 days
after Dose 2.
C4591001 1170 11701023 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1170 11701112 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1170 11701205 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1170 11701300 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1170 11701316 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1170 11701365 Evaluable efficacy (7
days)Randomized but did not meet all eligibility criteria; had other
important protocol deviations on or prior to 7 da ys after Dose 2.
C4591001 1170 11701422† Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1170 11701435 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1170 11701441 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
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FDA-CBER-2021-5683-0220426
16.2.3.1 Listing of Subjects Excluded From All-Available and Evaluable Efficacy Population
– Blinded Placebo-Controlled Follow-up Period
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
C4591001 1170 11701450 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1170 11701451 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1170 11701452 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1170 11701457† Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 days
after Dose 2.
C4591001 1171 11711042 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1171 11711072 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1171 11711151 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1171 11711153 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1171 11711214 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1171 11711219 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1171 11711225 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1171 11711229 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1171 11711236 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
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FDA-CBER-2021-5683-0220427
16.2.3.1 Listing of Subjects Excluded From All-Available and Evaluable Efficacy Population
– Blinded Placebo-Controlled Follow-up Period
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
C4591001 1171 11711242 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1171 11711249 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1177 11771491 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1178 11781061 Evaluable efficacy (7
days) Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 days after Dose 1);
had other important protocol deviations on or prior to 7 days a fter
Dose 2.
C4591001 1178 11781107 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1179 11791138 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1194 11941061 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1195 11951055 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1195 11951061 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1197 11971042 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
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FDA-CBER-2021-5683-0220428
16.2.3.1 Listing of Subjects Excluded From All-Available and Evaluable Efficacy Population
– Blinded Placebo-Controlled Follow-up Period
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
C4591001 1197 11971045 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1203 12031037 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1205 12051028 Dose 1 all-available
efficac yDid not receive at least 1 vaccination.
Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1207 12071024 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1208 12081018 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1209 12091013 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1212 12121023 Dose 1 all-available
efficac yDid not receive at least 1 vaccination.
Dose 2 all-available
efficac yDid not receive 2 vaccinations.
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FDA-CBER-2021-5683-0220429
16.2.3.1 Listing of Subjects Excluded From All-Available and Evaluable Efficacy Population
– Blinded Placebo-Controlled Follow-up Period
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
Evaluable efficacy (7
days) Randomized but did not meet all eligibility criteria; did not
receive all vaccinations as rand omized or did not receive Dose 2
within the predefined window (19-42 da ys after Dose 1).
C4591001 1213 12131012 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 days
after Dose 2.
C4591001 1214 12141016 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1214 12141036 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1218 12181045 Dose 2 all-available
efficac yUnblinded prior to 7 days post Dose 2.
Evaluable efficacy (7
days)Unblinded prior to 7 days post Dose 2.
C4591001 1218 12181046 Dose 2 all-available
efficac yUnblinded prior to 7 days post Dose 2.
Evaluable efficacy (7
days)Unblinded prior to 7 days post Dose 2.
C4591001 1218 12181051 Dose 2 all-available
efficac yUnblinded prior to 7 days post Dose 2.
Evaluable efficacy (7
days)Unblinded prior to 7 days post Dose 2.
C4591001 1218 12181055 Dose 2 all-available
efficac yUnblinded prior to 7 days post Dose 2.
Evaluable efficacy (7
days)Unblinded prior to 7 days post Dose 2.
C4591001 1218 12181059 Dose 2 all-available
efficac yUnblinded prior to 7 days post Dose 2.
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FDA-CBER-2021-5683-0220430
16.2.3.1 Listing of Subjects Excluded From All-Available and Evaluable Efficacy Population
– Blinded Placebo-Controlled Follow-up Period
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
Evaluable efficacy (7
days)Unblinded prior to 7 days post Dose 2.
C4591001 1219 12191047 Dose 2 all-available
efficac yUnblinded prior to 7 days post Dose 2.
Evaluable efficacy (7
days)Unblinded prior to 7 days post Dose 2.
C4591001 1219 12191054 Dose 2 all-available
efficac yUnblinded prior to 7 days post Dose 2.
Evaluable efficacy (7
days)Unblinded prior to 7 days post Dose 2.
C4591001 1220 12201020 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 days
after Dose 2.
C4591001 1220 12201036 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1220 12201059 Dose 2 all-available
efficac yUnblinded prior to 7 days post Dose 2.
Evaluable efficacy (7
days)Unblinded prior to 7 days post Dose 2.
C4591001 1220 12201063 Dose 2 all-available
efficac yUnblinded prior to 7 days post Dose 2.
Evaluable efficacy (7
days) Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 days after Dose 1);
unblinded prior to 7 da ys post Dose 2.
C4591001 1221 12211024 Dose 2 all-available
efficac yUnblinded prior to 7 days post Dose 2.
Evaluable efficacy (7
days)Unblinded prior to 7 days post Dose 2.
090177e196af7326\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 46
FDA-CBER-2021-5683-0220431
16.2.3.1 Listing of Subjects Excluded From All-Available and Evaluable Efficacy Population
– Blinded Placebo-Controlled Follow-up Period
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
C4591001 1221 12211079 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 days
after Dose 2.
C4591001 1223 12231200 Dose 1 all-available
efficac yDid not receive at least 1 vaccination.
Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days) Randomized but did not meet all eligibility criteria; did not
receive all vaccinations as rand omized or did not receive Dose 2
within the predefined window (19-42 da ys after Dose 1).
C4591001 1223 12231234 Dose 1 all-available
efficac yDid not receive at least 1 vaccination.
Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1224 12241176 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1226 12261072 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1226 12261114 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1226 12261409 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
090177e196af7326\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 47
FDA-CBER-2021-5683-0220432
16.2.3.1 Listing of Subjects Excluded From All-Available and Evaluable Efficacy Population
– Blinded Placebo-Controlled Follow-up Period
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
C4591001 1226 12261797 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1226 12262136 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1226 12262229 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1226 12262255† Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 days
after Dose 2.
C4591001 1226 12262262 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1226 12262313 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1229 12291204 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1230 12301045† Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1230 12301099 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1230 12301113 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1230 12301148 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
090177e196af7326\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 48
FDA-CBER-2021-5683-0220433
16.2.3.1 Listing of Subjects Excluded From All-Available and Evaluable Efficacy Population
– Blinded Placebo-Controlled Follow-up Period
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1231 12311027 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1231 12311125 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1231 12311189 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1231 12311200 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1231 12311409 Dose 1 all-available
efficac yDid not receive at least 1 vaccination.
Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1231 12311443 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1231 12311499 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 days
after Dose 2.
C4591001 1231 12311532 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
090177e196af7326\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 49
FDA-CBER-2021-5683-0220434
16.2.3.1 Listing of Subjects Excluded From All-Available and Evaluable Efficacy Population
– Blinded Placebo-Controlled Follow-up Period
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1231 12311641 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1231 12311801 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1231 12311825 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1231 12311894 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1231 12311911 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1231 12311991 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1231 12312052 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1231 12312077 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1231 12312284 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
090177e196af7326\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 50
FDA-CBER-2021-5683-0220435
16.2.3.1 Listing of Subjects Excluded From All-Available and Evaluable Efficacy Population
– Blinded Placebo-Controlled Follow-up Period
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
C4591001 1231 12312339 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1231 12312361 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1231 12312365 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1231 12312372 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1231 12312375 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1231 12312403 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1231 12312435 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1231 12312451 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1231 12312559 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
090177e196af7326\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 51
FDA-CBER-2021-5683-0220436
16.2.3.1 Listing of Subjects Excluded From All-Available and Evaluable Efficacy Population
– Blinded Placebo-Controlled Follow-up Period
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1231 12312577 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1231 12313006 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1231 12313175 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1231 12313207 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1231 12313225 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1231 12313289 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1231 12313357 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1231 12313428 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
090177e196af7326\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 52
FDA-CBER-2021-5683-0220437
16.2.3.1 Listing of Subjects Excluded From All-Available and Evaluable Efficacy Population
– Blinded Placebo-Controlled Follow-up Period
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1231 12313429 Dose 2 all-available
efficac yUnblinded prior to 7 days post Dose 2.
Evaluable efficacy (7
days)Unblinded prior to 7 days post Dose 2; had other important
protocol deviations on or prior to 7 da ys after Dose 2.
C4591001 1231 12313449 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1231 12313456 Dose 2 all-available
efficac yUnblinded prior to 7 days post Dose 2.
Evaluable efficacy (7
days)Unblinded prior to 7 days post Dose 2; had other important
protocol deviations on or prior to 7 da ys after Dose 2.
C4591001 1231 12313459 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1231 12313467 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1231 12313469 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1231 12313479 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
090177e196af7326\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 53
FDA-CBER-2021-5683-0220438
16.2.3.1 Listing of Subjects Excluded From All-Available and Evaluable Efficacy Population
– Blinded Placebo-Controlled Follow-up Period
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
C4591001 1231 12313483 Dose 2 all-available
efficac yUnblinded prior to 7 days post Dose 2.
Evaluable efficacy (7
days)Unblinded prior to 7 days post Dose 2; had other important
protocol deviations on or prior to 7 da ys after Dose 2.
C4591001 1231 12313486 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1231 12313487 Dose 2 all-available
efficac yUnblinded prior to 7 days post Dose 2.
Evaluable efficacy (7
days)Unblinded prior to 7 days post Dose 2; had other important
protocol deviations on or prior to 7 da ys after Dose 2.
C4591001 1231 12313492 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1231 12313497 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1231 12313498 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1231 12313501 Dose 2 all-available
efficac yUnblinded prior to 7 days post Dose 2.
Evaluable efficacy (7
days)Unblinded prior to 7 days post Dose 2; had other important
protocol deviations on or prior to 7 da ys after Dose 2.
C4591001 1231 12313505 Dose 2 all-available
efficac yUnblinded prior to 7 days post Dose 2.
090177e196af7326\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 54
FDA-CBER-2021-5683-0220439
16.2.3.1 Listing of Subjects Excluded From All-Available and Evaluable Efficacy Population
– Blinded Placebo-Controlled Follow-up Period
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
Evaluable efficacy (7
days)Unblinded prior to 7 days post Dose 2; had other important
protocol deviations on or prior to 7 da ys after Dose 2.
C4591001 1231 12313506 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1231 12313508 Dose 2 all-available
efficac yUnblinded prior to 7 days post Dose 2.
Evaluable efficacy (7
days)Unblinded prior to 7 days post Dose 2; had other important
protocol deviations on or prior to 7 da ys after Dose 2.
C4591001 1231 12313509 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1231 12313512 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1231 12313514 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1231 12313515 Dose 2 all-available
efficac yUnblinded prior to 7 days post Dose 2.
Evaluable efficacy (7
days)Unblinded prior to 7 days post Dose 2; had other important
protocol deviations on or prior to 7 da ys after Dose 2.
C4591001 1231 12313517 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
090177e196af7326\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 55
FDA-CBER-2021-5683-0220440
16.2.3.1 Listing of Subjects Excluded From All-Available and Evaluable Efficacy Population
– Blinded Placebo-Controlled Follow-up Period
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
C4591001 1231 12313518 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1231 12313519 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1231 12313528 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1231 12313533 Dose 2 all-available
efficac yUnblinded prior to 7 days post Dose 2.
Evaluable efficacy (7
days)Unblinded prior to 7 days post Dose 2; had other important
protocol deviations on or prior to 7 da ys after Dose 2.
C4591001 1231 12313534 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1231 12313537 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1231 12313541 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1231 12313542 Dose 2 all-available
efficac yUnblinded prior to 7 days post Dose 2.
090177e196af7326\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 56
FDA-CBER-2021-5683-0220441
16.2.3.1 Listing of Subjects Excluded From All-Available and Evaluable Efficacy Population
– Blinded Placebo-Controlled Follow-up Period
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
Evaluable efficacy (7
days)Unblinded prior to 7 days post Dose 2; had other important
protocol deviations on or prior to 7 da ys after Dose 2.
C4591001 1231 12313546 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1231 12313551 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1231 12313553 Dose 2 all-available
efficac yUnblinded prior to 7 days post Dose 2.
Evaluable efficacy (7
days)Unblinded prior to 7 days post Dose 2; had other important
protocol deviations on or prior to 7 da ys after Dose 2.
C4591001 1231 12313554 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1231 12313556 Dose 2 all-available
efficac yUnblinded prior to 7 days post Dose 2.
Evaluable efficacy (7
days)Unblinded prior to 7 days post Dose 2; had other important
protocol deviations on or prior to 7 da ys after Dose 2.
C4591001 1231 12313564 Dose 2 all-available
efficac yUnblinded prior to 7 days post Dose 2.
Evaluable efficacy (7
days)Unblinded prior to 7 days post Dose 2; had other important
protocol deviations on or prior to 7 da ys after Dose 2.
C4591001 1231 12313567 Dose 2 all-available
efficac yUnblinded prior to 7 days post Dose 2.
Evaluable efficacy (7
days)Unblinded prior to 7 days post Dose 2; had other important
protocol deviations on or prior to 7 da ys after Dose 2.
090177e196af7326\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 57
FDA-CBER-2021-5683-0220442
16.2.3.1 Listing of Subjects Excluded From All-Available and Evaluable Efficacy Population
– Blinded Placebo-Controlled Follow-up Period
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
C4591001 1231 12313592 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1231 12313622 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1231 12313662 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1231 12313709 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1231 12313869 Dose 1 all-available
efficac yDid not receive at least 1 vaccination.
Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1231 12313892 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1231 12313967 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1231 12314179 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
090177e196af7326\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 58
FDA-CBER-2021-5683-0220443
16.2.3.1 Listing of Subjects Excluded From All-Available and Evaluable Efficacy Population
– Blinded Placebo-Controlled Follow-up Period
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
C4591001 1231 12314205 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1231 12314290 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1231 12314314 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1231 12314385 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1231 12314416 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1231 12314502 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1231 12314525 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1231 12314580 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1231 12314590 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1231 12314700 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
090177e196af7326\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 59
FDA-CBER-2021-5683-0220444
16.2.3.1 Listing of Subjects Excluded From All-Available and Evaluable Efficacy Population
– Blinded Placebo-Controlled Follow-up Period
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1231 12314713 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1231 12315189 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1231 12315204 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1231 12315223 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1231 12315269 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1231 12315308 Dose 1 all-available
efficac yDid not receive at least 1 vaccination.
Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1231 12315429 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1231 12315441 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
090177e196af7326\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 60
FDA-CBER-2021-5683-0220445
16.2.3.1 Listing of Subjects Excluded From All-Available and Evaluable Efficacy Population
– Blinded Placebo-Controlled Follow-up Period
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
C4591001 1231 12315518 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1231 12315600 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1232 12321033 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1232 12321037 Dose 1 all-available
efficac yDid not receive at least 1 vaccination.
Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days) Randomized but did not meet all eligibility criteria; did not
receive all vaccinations as rand omized or did not receive Dose 2
within the predefined window (19-42 da ys after Dose 1).
C4591001 1232 12321101 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1232 12321175 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1232 12321219 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1232 12321233 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
090177e196af7326\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 61
FDA-CBER-2021-5683-0220446
16.2.3.1 Listing of Subjects Excluded From All-Available and Evaluable Efficacy Population
– Blinded Placebo-Controlled Follow-up Period
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
C4591001 1232 12321250 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1232 12321293 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1232 12321299 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1232 12321305 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1232 12321354 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 days
after Dose 2.
C4591001 1232 12321361 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1232 12321373 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 days
after Dose 2.
C4591001 1232 12321382 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 days
after Dose 2.
C4591001 1232 12321385 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 days
after Dose 2.
C4591001 1232 12321394 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 days
after Dose 2.
C4591001 1232 12321395 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 days
after Dose 2.
C4591001 1232 12321396 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
090177e196af7326\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 62
FDA-CBER-2021-5683-0220447
16.2.3.1 Listing of Subjects Excluded From All-Available and Evaluable Efficacy Population
– Blinded Placebo-Controlled Follow-up Period
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1232 12321412 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1232 12321419 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1232 12321425 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1235 12351188 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1241 12411132 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1241 12411144 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1241 12411482 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1241 12411766 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
090177e196af7326\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 63
FDA-CBER-2021-5683-0220448
16.2.3.1 Listing of Subjects Excluded From All-Available and Evaluable Efficacy Population
– Blinded Placebo-Controlled Follow-up Period
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
C4591001 1241 12411993 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1241 12412382 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1246 12461025 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1247 12471054 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1247 12471149 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1247 12471151 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1248 12481025 Dose 1 all-available
efficac yDid not receive at least 1 vaccination.
Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1248 12481048 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1248 12481169 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
090177e196af7326\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 64
FDA-CBER-2021-5683-0220449
16.2.3.1 Listing of Subjects Excluded From All-Available and Evaluable Efficacy Population
– Blinded Placebo-Controlled Follow-up Period
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
C4591001 1248 12481175 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1251 12511095 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1251 12511204 Dose 1 all-available
efficac yDid not receive at least 1 vaccination.
Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1254 12541023 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1254 12541142 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1254 12541154 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1260 12601049 Dose 1 all-available
efficac yDid not receive at least 1 vaccination.
Dose 2 all-available
efficac yDid not receive 2 vaccinations.
090177e196af7326\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 65
FDA-CBER-2021-5683-0220450
16.2.3.1 Listing of Subjects Excluded From All-Available and Evaluable Efficacy Population
– Blinded Placebo-Controlled Follow-up Period
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
Evaluable efficacy (7
days) Randomized but did not meet all eligibility criteria; did not
receive all vaccinations as rand omized or did not receive Dose 2
within the predefined window (19-42 da ys after Dose 1).
C4591001 1260 12601126 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1261 12611054 Evaluable efficacy (7
days) Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 days after Dose 1);
had other important protocol deviations on or prior to 7 days a fter
Dose 2.
C4591001 1265 12651164† Evaluable efficacy (7
days)Randomized but did not meet all eligibility criteria; had other
important protocol deviations on or prior to 7 da ys after Dose 2.
C4591001 4444 44441043 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 4444 44441134 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 4444 44441135 Dose 1 all-available
efficac yDid not receive at least 1 vaccination.
Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 4444 44441273 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 4444 44441569 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
090177e196af7326\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 66
FDA-CBER-2021-5683-0220451
16.2.3.1 Listing of Subjects Excluded From All-Available and Evaluable Efficacy Population
– Blinded Placebo-Controlled Follow-up Period
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 4444 44441572 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 4444 44441818 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 4444 44441951 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 4444 44442058 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 4444 44442062 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 4444 44442065 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 4444 44442070 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 4444 44442080 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 4444 44442084 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 4444 44442085 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 4444 44442087 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
090177e196af7326\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 67
FDA-CBER-2021-5683-0220452
16.2.3.1 Listing of Subjects Excluded From All-Available and Evaluable Efficacy Population
– Blinded Placebo-Controlled Follow-up Period
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
C4591001 4444 44442088 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 4444 44442093 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 4444 44442113 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 4444 44442114 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 4444 44442131 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 4444 44442135 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 4444 44442157 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 4444 44442159 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 4444 44442174 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 4444 44442188 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 4444 44442190 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 4444 44442194 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 4444 44442197 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 4444 44442199 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
090177e196af7326\Final\Final On: 01-Apr-2021 13:56 (GMT)
Page 68
FDA-CBER-2021-5683-0220453
16.2.3.1 Listing of Subjects Excluded From All-Available and Evaluable Efficacy Population
– Blinded Placebo-Controlled Follow-up Period
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
C4591001 4444 44442216 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 4444 44442217 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 4444 44442219 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 4444 44442226 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 4444 44442236 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 4444 44442241 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 4444 44442245 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 4444 44442250 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 4444 44442255 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 4444 44442262 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 4444 44442268 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 4444 44442269 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 4444 44442270 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 4444 44442277 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 4444 44442278 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
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16.2.3.1 Listing of Subjects Excluded From All-Available and Evaluable Efficacy Population
– Blinded Placebo-Controlled Follow-up Period
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
C4591001 4444 44442283 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 4444 44442287 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 4444 44442288 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 4444 44442298 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 4444 44442306 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 4444 44442313 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 4444 44442314 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 4444 44442319 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
>55 C4591001 1003 10031120 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 days
after Dose 2.
C4591001 1005 10051214 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1005 10051293 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1005 10051403 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
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FDA-CBER-2021-5683-0220455
16.2.3.1 Listing of Subjects Excluded From All-Available and Evaluable Efficacy Population
– Blinded Placebo-Controlled Follow-up Period
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1007 10071105 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 days
after Dose 2.
C4591001 1007 10071213 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1011 10111028 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1011 10111181 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1011 10111201 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1012 10121139 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1012 10121149 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1013 10131176 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1013 10131186 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1013 10131714 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1016 10161026 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
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16.2.3.1 Listing of Subjects Excluded From All-Available and Evaluable Efficacy Population
– Blinded Placebo-Controlled Follow-up Period
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
C4591001 1016 10161162 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1019 10191201 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1019 10191299 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1019 10191308 Dose 2 all-available
efficac yUnblinded prior to 7 days post Dose 2.
Evaluable efficacy (7
days)Unblinded prior to 7 days post Dose 2.
C4591001 1019 10191314 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1021 10211221 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1022 10221150 Dose 1 all-available
efficac yDid not receive at least 1 vaccination.
Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1024 10241003 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 days
after Dose 2.
C4591001 1024 10241031 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 days
after Dose 2.
C4591001 1024 10241037 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 days
after Dose 2.
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16.2.3.1 Listing of Subjects Excluded From All-Available and Evaluable Efficacy Population
– Blinded Placebo-Controlled Follow-up Period
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
C4591001 1024 10241041 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 days
after Dose 2.
C4591001 1024 10241049 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 days
after Dose 2.
C4591001 1024 10241057 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 days
after Dose 2.
C4591001 1024 10241059 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 days
after Dose 2.
C4591001 1024 10241065 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 days
after Dose 2.
C4591001 1024 10241068 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 days
after Dose 2.
C4591001 1024 10241077 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1024 10241081 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 days
after Dose 2.
C4591001 1024 10241083 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 days
after Dose 2.
C4591001 1024 10241087 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 days
after Dose 2.
C4591001 1024 10241096 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 days
after Dose 2.
C4591001 1024 10241097 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 days
after Dose 2.
C4591001 1027 10271206† Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
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FDA-CBER-2021-5683-0220458
16.2.3.1 Listing of Subjects Excluded From All-Available and Evaluable Efficacy Population
– Blinded Placebo-Controlled Follow-up Period
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
C4591001 1037 10371057 Dose 1 all-available
efficac yDid not receive at least 1 vaccination.
Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days) Randomized but did not meet all eligibility criteria; did not
receive all vaccinations as rand omized or did not receive Dose 2
within the predefined window (19-42 da ys after Dose 1).
C4591001 1037 10371275 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1037 10371356 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 days
after Dose 2.
C4591001 1039 10391019 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1044 10441002 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 days
after Dose 2.
C4591001 1044 10441004 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 days
after Dose 2.
C4591001 1044 10441007 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 days
after Dose 2.
C4591001 1044 10441010 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 days
after Dose 2.
C4591001 1044 10441016 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 days
after Dose 2.
C4591001 1044 10441018 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 days
after Dose 2.
C4591001 1044 10441032 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 days
after Dose 2.
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FDA-CBER-2021-5683-0220459
16.2.3.1 Listing of Subjects Excluded From All-Available and Evaluable Efficacy Population
– Blinded Placebo-Controlled Follow-up Period
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
C4591001 1044 10441036 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 days
after Dose 2.
C4591001 1044 10441041 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 days
after Dose 2.
C4591001 1044 10441047 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 days
after Dose 2.
C4591001 1044 10441049 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 days
after Dose 2.
C4591001 1044 10441055 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 days
after Dose 2.
C4591001 1044 10441062 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 days
after Dose 2.
C4591001 1044 10441067 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 days
after Dose 2.
C4591001 1044 10441073 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 days
after Dose 2.
C4591001 1044 10441075 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 days
after Dose 2.
C4591001 1044 10441080 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 days
after Dose 2.
C4591001 1044 10441083 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 days
after Dose 2.
C4591001 1044 10441085 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 days
after Dose 2.
C4591001 1044 10441090 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 days
after Dose 2.
C4591001 1044 10441092 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 days
after Dose 2.
C4591001 1044 10441093 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 days
after Dose 2.
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FDA-CBER-2021-5683-0220460
16.2.3.1 Listing of Subjects Excluded From All-Available and Evaluable Efficacy Population
– Blinded Placebo-Controlled Follow-up Period
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
C4591001 1044 10441094 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 days
after Dose 2.
C4591001 1044 10441113 Dose 1 all-available
efficac yDid not receive at least 1 vaccination.
Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1046 10461084 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1046 10461245 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1047 10471122 Evaluable efficacy (7
days)Randomized but did not meet all eligibility criteria; had other
important protocol deviations on or prior to 7 da ys after Dose 2.
C4591001 1047 10471228 Evaluable efficacy (7
days)Randomized but did not meet all eligibility criteria; had other
important protocol deviations on or prior to 7 da ys after Dose 2.
C4591001 1047 10471300 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1052 10521062 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1052 10521142 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1054 10541071 Dose 1 all-available
efficac yDid not receive at least 1 vaccination.
Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
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16.2.3.1 Listing of Subjects Excluded From All-Available and Evaluable Efficacy Population
– Blinded Placebo-Controlled Follow-up Period
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
C4591001 1054 10541175 Dose 1 all-available
efficac yDid not receive at least 1 vaccination.
Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1056 10561034 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1056 10561078 Dose 1 all-available
efficac yDid not receive at least 1 vaccination.
Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1056 10561095 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1056 10561120 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1056 10561123 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1056 10561229 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1056 10561298 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
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16.2.3.1 Listing of Subjects Excluded From All-Available and Evaluable Efficacy Population
– Blinded Placebo-Controlled Follow-up Period
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
C4591001 1056 10561301 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1056 10561303 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1056 10561306 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1056 10561353 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1056 10561399 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1056 10561404 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1056 10561409 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1056 10561625 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1066 10661128 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1068 10681004 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 days
after Dose 2.
C4591001 1068 10681005 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 days
after Dose 2.
C4591001 1068 10681008 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 days
after Dose 2.
C4591001 1068 10681009 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 days
after Dose 2.
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16.2.3.1 Listing of Subjects Excluded From All-Available and Evaluable Efficacy Population
– Blinded Placebo-Controlled Follow-up Period
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
C4591001 1068 10681019 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 days
after Dose 2.
C4591001 1068 10681023 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 days
after Dose 2.
C4591001 1068 10681029 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 days
after Dose 2.
C4591001 1068 10681030 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 days
after Dose 2.
C4591001 1068 10681039 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 days
after Dose 2.
C4591001 1068 10681041 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 days
after Dose 2.
C4591001 1068 10681044 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 days
after Dose 2.
C4591001 1068 10681050 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 days
after Dose 2.
C4591001 1068 10681056 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 days
after Dose 2.
C4591001 1068 10681057 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 days
after Dose 2.
C4591001 1068 10681059 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 days
after Dose 2.
C4591001 1068 10681062 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 days
after Dose 2.
C4591001 1068 10681068 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 days
after Dose 2.
C4591001 1068 10681078 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 days
after Dose 2.
C4591001 1068 10681079 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 days
after Dose 2.
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16.2.3.1 Listing of Subjects Excluded From All-Available and Evaluable Efficacy Population
– Blinded Placebo-Controlled Follow-up Period
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
C4591001 1068 10681084 Evaluable efficacy (7
days)Had other important protocol deviations on or prior to 7 days
after Dose 2.
C4591001 1071 10711023 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1071 10711169 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1071 10711178 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1072 10721065 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1079 10791234 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1079 10791264 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1079 10791271 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1079 10791283 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1080 10801064 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1080 10801217 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
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16.2.3.1 Listing of Subjects Excluded From All-Available and Evaluable Efficacy Population
– Blinded Placebo-Controlled Follow-up Period
Vaccine Group
(as
Randomized) Age
Group
(Years) Subject Population Reason for Exclusion
C4591001 1081 10811053 Evaluable efficacy (7
days) Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 days after Dose 1);
had other important protocol deviations on or prior to 7 days a fter
Dose 2.
C4591001 1081 10811061 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1081 10811139 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1081 10811150 Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1082 10821062 Dose 1 all-available
efficac yDid not receive at least 1 vaccination.
Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1082 10821126 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a s randomized or did not recei ve
Dose 2 within the predefined window (19-42 da ys after Dose 1).
C4591001 1083 10831173 Dose 2 all-available
efficac yDid not receive 2 vaccinations.
Evaluable efficacy (7
days)Did not receive all vaccinations a
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