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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

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Record of Conversation - Cervarix, February 26, 2008

Record of Communication

STN Number: 125259/0
Manufacturer: GlaxoSmithKline Biologicals
Product: Human Papillomavirus Vaccine, ASO4 Adjuvant-Adsorbed

To: Matt Whitman
From: Helen S. Gemignani, Regulatory Project Manager
Subject: Request for Clarification RE: Thrombocytopenia
Date: 26-Feb-2008
Time: 12:28 pm
Contact Phone: 610 787-3726

Signature:

We have requests for clarification in regard to the document entitled "24 Oct 2007 IR request_table_14 Dec 2007.doc", and in particular, to the -b(4)- BB-IND ------b(4)---- treatment arm entries on page 2 of the document.

  1. Please clarify that there was only one patient who had thromboctyopenia and one patient who had diabetes mellitus.
  2. Please clarify whether there are source documents available for either of these cases and submit them for our review.
  3. Please confirm that there are no other cases of thrombocytopenia reported to BBIND -b(4)- in a --b(4)-- treatment arm.

Please submit your responses as an amendment to the BLA.

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