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Vaccines

UNSOL_AE Dataset Narratives - Cervarix, July 18, 2007

To: Mr. Matt Whitman
File: STN 125259/0 - Cervarix®
RE: UNSOL_AE Dataset Narratives
Date: July 18, 2007

We have the following comments:

In review of the UNSOL_AE datasets, subjects with potentially autoimmune diseases were identified (as per GSK AID designation and by CBER reviewer*). A list of the subject identification numbers is noted below.
Please submit narratives for these subjects to the BLA. If narratives have already been submitted to the BLA for some of these subjects, please indicate their location within the BLA.

PID numbers:

13143135187190316584
852363931269215900
677215058416*11150
8561914118866767706
7736*2371*7141*5225
*4101*27751441*5471
766911937*37169
683840834718876
1433916130701679301
73824169556297254
160575018*1063
*731*237195182241
82811681371902108
1745055202187510842
1009108762030517284
30644660312718
129081702