Record of Telephone Conversation-Cervarix, August 9, 2007

Record of Telephone Conversation

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

To: File
 From: Helen S. Gemignani, Regulatory Project Manager
 Subject: MPL Safety Analysis Plan Statistical Discussion
 Telecon Date: August 9, 2007 Telecon Time: 11:30 am – 12:00 pm
 Telecon Initiated by: GSK
 Contact Phone: 610 787-3726 Mr. Whitman
  Signature:


Summary of Telecon

As a follow up to this morning's telecon (9-10 AM), this 11:30 am telecon discussed the details of the statistical analysis plan and how to analyze the combined data from all studies for products that have MPL. Dr. Lee clarified the issues of a weighted, fixed effect, true meta-analysis. GSK's statisticians were in agreement. GSK and CBER were in agreement and this issue of analysis has been resolved.

GSK indicated that the CBER recommendation for a true meta-analysis will not impact on the timelines that they proposed for submission of data from their clinical studies for products that include MPL.

End of Teleconference

Action Items
•GSK will perform a true meta-analysis and submit to CBER by August 27, 2007.   

FDA Participants
•Gopa Raychaudhuri
•Nancy Miller
•Martha Lee
•Amelia Dale Horne
•Helen Gemignani

GSK Participants
•Amy Scott
•Vince Ahonkai
•Matt Whitman
•Gary Dubin
•Brigitte Cheuvart
•Fabian Tibaldi
•Marie-Pierre David
