Request for Clinical Narratives - Cervarix, September 6, 2007

To: Mr. Matthew Whitman
 File: STN 125259/0 CERVARIX
 RE: Request for Clinical Narratives
 Date: September 6, 2007


 Please provide clinical narratives for the following subjects identified in the safety datasets for Protocols 001, 007, 008, 013, and 015. If any of these narratives are already included within BLA 125259, please indicate their location in the BLA.


 Study 001:
 PID 6556 (US) - urinary retention


 Study 007:
 PID 7217 (BRAZ) - nephritis


 Study 008:
 PID 97 (US) - multiple psychiatric disorders
 PID 2433 (US) - urinary retention
 PID 3602 (US) - facial numbness
 PID 1363 (US) - facial numbness
 PID 71564 (BRAZ) - hypotension, outcome 4 (causal)
 PID 10152 (GER) - shock (not serious, not causal)


 Study 013:
 PID 2753 (GER) - vasculitis (not serious, not causal, not in AID)


 Study 015:
 PID 7991 (CAN) - psoriasis
 PID 7705 (CAN) - bipolar disorder, psychoses
