125742 45 S211 M5 c4591001 interim ado mth6 excluded patients

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16.2.3 Listing of Subjects Excluded From the Safety Population – All Subjects 12 Through 15 Years of Age 
Vaccine Group  
(as Randomized) Subject Reason for Exclusion 
  
BNT162b2 (30 μg) C4591001 1057 10571413 Subjectdid not receive stud y vaccine.
  C4591001 1091 10911451 Subject did not receive stud y vaccine.
  C4591001 1140 11401346 Subject did not receive stud y vaccine.
Placebo C4591001 1077 10771293 Subject did not recei ve study vaccine. 
PFIZER CONFIDENTIAL SDTM Creation: 30SEP2021 (11:35) Source Dat a: adsl Table Generation: 03NOV2021 (13:12)  
(Data Cutoff Date: 02SEP2021, Database Snapshot Date: 27SEP2021 ) Output File: ./nda2 _unblinded/C4591001 _S_Peds/adsl _l001_exc_saf1_ped6
 
090177e1988b7712\Final\Final On: 09-Nov-2021 04:11 (GMT) 
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FDA-CBER-2022-5812-0224550
16.2.3.1 Listing of Subjects Excluded From All-Available and Evaluable Efficacy Population – Subjects 12 Through 15 
Years of Age – 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  as randomized or did not 
receive Dose 2 within the predefined window (19-42 days 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  as randomized or did not 
receive Dose 2 within the predefined window (19-42 days 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  as randomized or did not 
receive Dose 2 within the predefined window (19-42 days after 
Dose 1). 
    C4591001 1044 10441359 Evaluable efficacy (7 
days) Did not receive all vaccinations  as randomized or did not 
receive Dose 2 within the predefined window (19-42 days after 
Dose 1). 
    C4591001 1057 10571396 Evaluable efficacy (7 
days) Did not receive all vaccinations  as randomized or did not 
receive Dose 2 within the predefined window (19-42 days after 
Dose 1). 
    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. 
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FDA-CBER-2022-5812-0224551
16.2.3.1 Listing of Subjects Excluded From All-Available and Evaluable Efficacy Population – Subjects 12 Through 15 
Years of Age – 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  as randomized or did not 
receive Dose 2 within the predefined window (19-42 days after 
Dose 1). 
    C4591001 1066 10661407 Evaluable efficacy (7 
days) Did not receive all vaccinations  as randomized or did not 
receive Dose 2 within the predefined window (19-42 days after 
Dose 1). 
    C4591001 1091 10911414 Dose 2 all-available 
efficac yDid not receive 2 vaccinations. 
      Evaluable efficacy (7 
days) Did not receive all vaccinations  as randomized or did not 
receive Dose 2 within the predefined window (19-42 days after 
Dose 1). 
    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  as randomized or did not 
receive Dose 2 within the predefined window (19-42 days 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  as randomized or did not 
receive Dose 2 within the predefined window (19-42 days after 
Dose 1). 
090177e1988b7713\Final\Final On: 09-Nov-2021 04:12 (GMT) 
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FDA-CBER-2022-5812-0224552
16.2.3.1 Listing of Subjects Excluded From All-Available and Evaluable Efficacy Population – Subjects 12 Through 15 
Years of Age – Blinded Placebo-Controlled Follow-up Period 
Vaccine Group 
(as 
Randomized)       Age 
Group  
(Years)                     Subject                               Population                 Reason for Exclusion       
  
    C4591001 1142 11421363 Evaluable efficacy (7 
days) Did not receive all vaccinations  as randomized or did not 
receive Dose 2 within the predefined window (19-42 days after 
Dose 1). 
    C4591001 1147 11471327 Dose 2 all-available 
efficac yDid not receive 2 vaccinations. 
      Evaluable efficacy (7 
days) Did not receive all vaccinations  as randomized or did not 
receive Dose 2 within the predefined window (19-42 days after 
Dose 1). 
    C4591001 1152 11521641 Dose 2 all-available 
efficac yDid not receive 2 vaccinations. 
      Evaluable efficacy (7 
days) Did not receive all vaccinations  as randomized or did not 
receive Dose 2 within the predefined window (19-42 days after 
Dose 1). 
Placebo 12-15 C4591001 1006 10061219 Evaluable efficacy (7 
days) Did not receive all vaccinations  as randomized or did not 
receive Dose 2 within the predefined window (19-42 days after 
Dose 1). 
    C4591001 1007 10071415 Evaluable efficacy (7 
days) Did not receive all vaccinations  as randomized or did not 
receive Dose 2 within the predefined window (19-42 days after 
Dose 1); had other important protocol deviations on or prior to  7 
days after Dose 2.
    C4591001 1007 10071593 Dose 2 all-available 
efficac yDid not receive 2 vaccinations. 
      Evaluable efficacy (7 
days) Did not receive all vaccinations  as randomized or did not 
receive Dose 2 within the predefined window (19-42 days after 
Dose 1). 
    C4591001 1008 10081871 Dose 2 all-available 
efficac yDid not receive 2 vaccinations. 
      Evaluable efficacy (7 
days) Did not receive all vaccinations  as randomized or did not 
receive Dose 2 within the predefined window (19-42 days after 
Dose 1). 
090177e1988b7713\Final\Final On: 09-Nov-2021 04:12 (GMT) 
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FDA-CBER-2022-5812-0224553
16.2.3.1 Listing of Subjects Excluded From All-Available and Evaluable Efficacy Population – Subjects 12 Through 15 
Years of Age – Blinded Placebo-Controlled Follow-up Period 
Vaccine Group 
(as 
Randomized)       Age 
Group  
(Years)                     Subject                               Population                 Reason for Exclusion       
  
    C4591001 1008 10081884 Dose 2 all-available 
efficac yDid not receive 2 vaccinations. 
      Evaluable efficacy (7 
days) Did not receive all vaccinations  as randomized or did not 
receive Dose 2 within the predefined window (19-42 days after 
Dose 1). 
    C4591001 1009 10091229 Dose 2 all-available 
efficac yDid not receive 2 vaccinations. 
      Evaluable efficacy (7 
days) Did not receive all vaccinations  as randomized or did not 
receive Dose 2 within the predefined window (19-42 days after 
Dose 1). 
    C4591001 1009 10091320 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 1009 10091338 Dose 2 all-available 
efficac yDid not receive 2 vaccinations. 
      Evaluable efficacy (7 
days) Did not receive all vaccinations  as randomized or did not 
receive Dose 2 within the predefined window (19-42 days after 
Dose 1). 
    C4591001 1009 10091363 Dose 2 all-available 
efficac yDid not receive 2 vaccinations. 
      Evaluable efficacy (7 
days) Did not receive all vaccinations  as randomized or did not 
receive Dose 2 within the predefined window (19-42 days after 
Dose 1). 
    C4591001 1009 10091366 Dose 2 all-available 
efficac yDid not receive 2 vaccinations. 
      Evaluable efficacy (7 
days) Did not receive all vaccinations  as randomized or did not 
receive Dose 2 within the predefined window (19-42 days after 
Dose 1). 
    C4591001 1016 10161316 Dose 2 all-available 
efficac yDid not receive 2 vaccinations. 
090177e1988b7713\Final\Final On: 09-Nov-2021 04:12 (GMT) 
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FDA-CBER-2022-5812-0224554
16.2.3.1 Listing of Subjects Excluded From All-Available and Evaluable Efficacy Population – Subjects 12 Through 15 
Years of Age – 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  as randomized or did not 
receive Dose 2 within the predefined window (19-42 days after 
Dose 1). 
    C4591001 1016 10161379 Dose 2 all-available 
efficac yDid not receive 2 vaccinations. 
      Evaluable efficacy (7 
days) Did not receive all vaccinations  as randomized or did not 
receive Dose 2 within the predefined window (19-42 days after 
Dose 1). 
    C4591001 1044 10441360 Evaluable efficacy (7 
days) Did not receive all vaccinations  as randomized or did not 
receive Dose 2 within the predefined window (19-42 days after 
Dose 1). 
    C4591001 1077 10771293 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  as randomized or did not 
receive Dose 2 within the predefined window (19-42 days after 
Dose 1). 
    C4591001 1123 11231501 Evaluable efficacy (7 
days) Did not receive all vaccinations  as randomized or did not 
receive Dose 2 within the predefined window (19-42 days after 
Dose 1). 
    C4591001 1126 11261254 Evaluable efficacy (7 
days) Did not receive all vaccinations  as randomized or did not 
receive Dose 2 within the predefined window (19-42 days after 
Dose 1). 
    C4591001 1126 11261287 Dose 2 all-available 
efficac yDid not receive 2 vaccinations. 
      Evaluable efficacy (7 
days) Did not receive all vaccinations  as randomized or did not 
receive Dose 2 within the predefined window (19-42 days after 
Dose 1). 
090177e1988b7713\Final\Final On: 09-Nov-2021 04:12 (GMT) 
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FDA-CBER-2022-5812-0224555
16.2.3.1 Listing of Subjects Excluded From All-Available and Evaluable Efficacy Population – Subjects 12 Through 15 
Years of Age – Blinded Placebo-Controlled Follow-up Period 
Vaccine Group 
(as 
Randomized)       Age 
Group  
(Years)                     Subject                               Population                 Reason for Exclusion       
  
    C4591001 1131 11311292 Evaluable efficacy (7 
days) Did not receive all vaccinations  as randomized or did not 
receive Dose 2 within the predefined window (19-42 days after 
Dose 1). 
    C4591001 1147 11471280 Dose 2 all-available 
efficac yDid not receive 2 vaccinations. 
      Evaluable efficacy (7 
days) Did not receive all vaccinations  as randomized or did not 
receive Dose 2 within the predefined window (19-42 days after 
Dose 1). 
    C4591001 1156 11561359 Evaluable efficacy (7 
days)Had other important protocol deviations on or prior to 7 days 
after Dose 2.
    C4591001 1270 12701237 Dose 2 all-available 
efficac yDid not receive 2 vaccinations. 
      Evaluable efficacy (7 
days) Did not receive all vaccinations  as randomized or did not 
receive Dose 2 within the predefined window (19-42 days after 
Dose 1). 
PFIZER CONFIDENTIAL SDTM Creation: 30SEP2021 (11:35) Source Dat a: adsl Table Generation: 03NOV2021 (11:35)  
(Data Cutoff Date: 02SEP2021, Database Snapshot Date: 27SEP2021 ) Outpu tFile: ./nda2 unblinded/C4591001 SPeds/adsl l001 excl peds effpop
 
090177e1988b7713\Final\Final On: 09-Nov-2021 04:12 (GMT) 
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FDA-CBER-2022-5812-0224556