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Vaccines, Blood & Biologics

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Vaccines

Source Documents and Narratives - Cervarix, October 15, 2007

To: Mr. Matthew Whitman
File: STN 125259/0 CERVARIX
RE: Source Documents and Narratives
Date: October 15, 2007
CBER requests the source documentation for the following subjects participating in the HSV trials. (Narratives were provided within the 8/27/07 Level 1 and 2 meta-analysis document.)
Subject ID: 01605
Study: 208141/016 (HSV-016)
Vaccine: Blinded (gD2t AS04 or Al(OH)3)
Encephalitis, Myasthenia gravis, cellulitis

Subject ID: 03869
Study: 208141/017 (HSV-017)
Vaccine: Blinded (gD2t AS04 or Al(OH)3)
Multiple Sclerosis

Subject ID: 01435
Study: 208141/007 (HSV-007)
Vaccine: MPL-containing vaccine (gD2t AS04 or AS04)
Multiple Sclerosis


In addition, within the 27-Aug-20007 Level 1 and 2 meta-analysis, the following three subjects were identified as having developed neuroinflammatory events in the HPV-008 trial: Subjects PID 2475, 14411, and 1020. Full narratives were not provided for subjects PID 2475 and 14411, and source documentation was not provided for any of the subjects. Please provide the narratives and source documentation for subjects PID 2475 and 14411, and the source documentation for subject PID 1020.