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Vaccines, Blood & Biologics

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Vaccines

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