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CBER’s July 18 Clinical Request RE: AE Variables - Cervarix, July 19, 2007
RE: Cervarix STN 125259/0
Date: July 19, 2007 12:33 PM
Subject: Cervarix – CBER’s July 18 Clinical Request RE: AE Variables
In addition to the Cervarix-specific material indicated within the email from 7/18/07, please also conduct requested analyses in all studies in which Cervarix is a study vaccine. These would include the Phase I/II studies (HPV-002, HPV-003, HPV-004, HPV-005), as well as ongoing IND and non-IND studies (including but not limited to HPV-010, HPV-018, HPV-011, HPV-031, HPV-032, HPV-033, HPV-035, and HPV-036). We are also requesting these analyses for IND and non-IND studies for non-Cervarix related products in which MPL is a component (from GSK and Corixa).