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Vaccines, Blood & Biologics

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Vaccines

Clinical Narrative Request - Cervarix, August 3, 2007

To: Mr. Matthew Whitman
File: STN 125259/0 CERVARIX
RE: Clinical Narrative Request
Date: August 3, 2007


Please respond to the following comment:


1. In review of the unsolicited adverse event dataset for Protocol 015, subject #9490 (Center 22810, US) was described as having denervation atrophy of the right leg at Day 93 post-dose 2. Please provide a clinical narrative to the BLA for this subject