125742 45 S211 M5 c4591001 interim ado compliance sensitive

Pfizer Documents (PHMPT/FDA)

Pfizer Bla Submission

Pfizer 12 15 Documents

1

Document text

16.2.5.1.1 Listing of Subjects Who Received Vaccine Not as Randomized – Subjects 12 Through 25 Years of Age 
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: 25MAR2021 (23:24) Source Data: adsl Table Generation: 27MAR2021 (01:45)  
(Cutoff Date: 13MAR2021, Snapshot Date: 25MAR2021) Output File: ./nda2 _unblinded/C4591001 _BLA/adsl _l001_ped_rand_notvax  
 
090177e196ac9127\Final\Final On: 31-Mar-2021 13:00 (GMT) 
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FDA-CBER-2022-5812-0223373