125742 45 S211 M5 c4591001 interim ado interlab standard

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Protocol C4591001
16.1. 10List of Laboratories Under Vaccine Research & De velopment Over sight
Page 1
 CONFIDENTIALList of La boratories–Interim – Adolescents
Organization Address Service (s)Provided
Pfizer Vaccine Research & 
Development401 N orthMiddletown Road
Pearl River, NY 1 0965
USARBD -binding IgG level assay ;
N-binding antibo dyassay; and
RT-PCR on nasal s wabs for
SAR S-CoV-2
Pfizer Vaccine Research & 
Developmen t111 Ideation Way
Nutley, NJ 07110
USASARS -CoV- 2 neutralizati on 
assay -NT50
Abbre viations : IgG = i mmuno globul in G; N= SARS -CoV -2nucleoprotein ;NT50= 50% neutraliz ing
titer; RBD = receptor-binding domain ;RT-PCR =reverse transcription –polymerase chain reaction ;
SAR S-CoV-2 = severe a cute r espiratory syndrome corona virus 2 .
Note:  The laboratories listed are those unde r Pfizer Vaccine Research & Developme ntoversight.  See 
Appen dix 16.1.4 .2.List o f Contract Research Organizations ,Vendors ,and Service Providers ,for all 
other ex ternal l aborator ies.
Protocol C4591001 List of Lab oratories –Inter im –Adolescents , Final , Version 1.0,07Apr2021 .  
090177e196ba720b\Final\Final On: 07-Apr-2021 20:26 (GMT) 
FDA-CBER-2022-5812-0224076