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
Time: 12:28 pm
Contact Phone: 610 787-3726
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.
- Please clarify that there was only one patient who had thromboctyopenia and one patient who had diabetes mellitus.
- Please clarify whether there are source documents available for either of these cases and submit them for our review.
- 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.