125742 S1 M5 5351 c4591001 fa interim compliance sensitive

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16.2.5.1.2 Listing of Subjects Who Received Vaccine Not as Randomized – Phase 2 
Vaccine Group  
(as Randomized)  Age Group  
(Years)  Subject  Randomization  
Date  Vaccination  
Date  Dose  
No. Vaccine Received  
  
No subject meets the reporting criteria.              
  
PFIZER CONFIDENTIAL SDTM Creation: 05SEP2020 (14:18) Source Data: adsl Table Generation: 10SEP2020 (21:41)  
(Cutoff Date: 02SEP2020, Snapshot Date: 04SEP2020) Output File: ./nda2_unblinded/C4591001_IA _P2/adsl_l001_p2_rand_notvax   
 
 
090177e194e7a45f\Final\Final On: 14-Sep-2020 01:45 (GMT) 
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FDA-CBER-2021-5683-0019395
16.2.5.1.4 Listing of Subjects Who Received Vaccine Not as Randomized – All Subject s 
Vaccine Group  
(as Randomized)  Age Group  
(Years)  Subject  Randomization  
Date  Vaccination  
Date  Dose  
No. Vaccine Received  
  
BNT162b1 (100 μg)  18-55 C4591001 1001 10011026  18MAY2020  13AUG2020  2 BNT162b1 (10 μg)  
  18-55 C4591001 1001 10011028  20MAY2020  17AUG2020  2 BNT162b1 (10 μg)  
  18-55 C4591001 1001 10011030  20MAY2020  17AUG2020  2 BNT162b1 (10 μg)  
  18-55 C4591001 1001 10011032  20MAY2020  13AUG2020  2 BNT162b1 (10 μg)  
  18-55 C4591001 1001 10011034  20MAY2020  17AUG2020  2 BNT162b1 (10 μg)  
  18-55 C4591001 1002 10021023  18MAY2020  17AUG2020  2 BNT162b1 (10 μg)  
  18-55 C4591001 1002 10021024  18MAY2020  31AUG2020  2 BNT162b1 (10 μg)  
  18-55 C4591001 1002 10021027  18MAY2020  17AUG2020  2 BNT162b1 (10 μg)  
  18-55 C4591001 1002 10021034  21MAY2020  17AUG2020  2 BNT162b1 (10 μg)  
  18-55 C4591001 1002 10021035  21MAY2020  18AUG2020  2 BNT162b1 (10 μg)  
  18-55 C4591001 1002 10021036  21MAY2020  18AUG2020  2 BNT162b1 (10 μg)  
  18-55 C4591001 1002 10021038  21MAY2020  17AUG2020  2 BNT162b1 (10 μg)  
BNT162b2 (30 μg)  16-55 C4591001 1012 10121103  01SEP2020  22SEP2020  2 Placebo  
  16-55 C4591001 1088 10881077  21AUG2020  11SEP2020  2 Placebo  
  16-55 C4591001 1116 11161226  11SEP2020  11SEP2020  1 Placebo  
  16-55 C4591001 1116 11161226  11SEP2020  02OCT2020  2 Placebo  
  16-55 C4591001 1135 11351480  22OCT2020  22OCT2020  1   
  16-55 C4591001 1163 11631006  31JUL2020  31JUL2020  1   
  16-55 C4591001 1204 12041111  16SEP2020  16SEP2020  1   
  16-55 C4591001 1208 12081004  23OCT2020  13NOV2020  2   
  >55 C4591001 1081 10811053  17AUG2020  09SEP2020  2 Placebo  
  >55 C4591001 1121 11211071  22SEP2020  03SEP2020  1 Placebo  
  >55 C4591001 1121 11211071  22SEP2020  22SEP2020  2 Placebo  
  >55 C4591001 1163 11631005  31JUL2020  31JUL2020  1   
  >55 C4591001 1170 11701160  01SEP2020  22SEP2020  2   
Placebo  16-55 C4591001 1042 10421266  20OCT2020  11NOV2020  2   
090177e1959b0965\Final\Final On: 24-Nov-2020 13:48 (GMT) 
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16.2.5.1.4 Listing of Subjects Who Received Vaccine Not as Randomized – All Subject s 
Vaccine Group  
(as Randomized)  Age Group  
(Years)  Subject  Randomization  
Date  Vaccination  
Date  Dose  
No. Vaccine Received  
  
  16-55 C4591001 1090 10901334  03SEP2020  03SEP2020  1 BNT162b2 (30 μg)  
  16-55 C4591001 1090 10901334  03SEP2020  24SEP2020  2 BNT162b2 (30 μg)  
  16-55 C4591001 1146 11461328  23OCT2020  13NOV2020  2   
  >55 C4591001 1054 10541024  21AUG2020  10OCT2020  2 BNT162b2 (30 μg)  
  >55 C4591001 1163 11631008  31JUL2020  31JUL2020  1   
  >55 C4591001 1177 11771089  19AUG2020  09SEP2020  2 BNT162b2 (30 μg)  
  >55 C4591001 1231 12311057  11AUG2020  11AUG2020  1 BNT162b2 (30 μg)  
  >55 C4591001 1265 12651026  31AUG2020  31AUG2020  1 BNT162b2 (30 μg)  
  >55 C4591001 1265 12651026  31AUG2020  21SEP2020  2 BNT162b2 (30 μg)  
  
Note: Data for subjects randomized on or after 10OCT2020 are included to comprehensively show all data reported but are subje ct to change with 
additional follow -up. 
PFIZER CONFIDENTIAL SDTM Creation: 17NOV2020 (10:49) Source Data: adsl Table Generation: 17 NOV2020 (22:37)  
(Cutoff Date: 14NOV2020, Snapshot Date: 16NOV2020) Output File: ./nda2 unblinded/C4591001 IA P3 2MPD2/adsl l001 p3 rand notva x  
 
 
090177e1959b0965\Final\Final On: 24-Nov-2020 13:48 (GMT) 
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FDA-CBER-2021-5683-0019397