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