Record of Telephone Conversation - Cervarix, July 18, 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: Discussion of July 10, 2007, Request for Information for MPL Adverse Events
Telecon Date: July 18, 2007 Telecon Time: 10:00 – 11:00 am
Telecon Initiated by: GSK
Contact Phone: 610 787-3726 Mr. Whitman

Signature:


Summary of Telecon

CBER and GSK held a telecon to clarify some items in CBER’s July 10, 2007, request for adverse event data in regard to all of GSK’s INDs and BLA that use MPL adjuvant.

CBER stated that they would like to review and agree to the analysis plan before GSK does their analysis. It was requested that GSK submit data files as well as the analysis. The analysis will include events from study HPV-009. The meta-analysis will be done across all INDs.

GSK is waiting for an anti-phospholipid antibody study from NIH and expect a Final Clinical Study Report any day. Data from this study will be included in the analysis.

End of Teleconference

Action Items
•CBER will provide to GSK a list of AE variables that will be captured by GSK.

 

FDA Participants
•Gopa Raychaudhuri
•Nancy Miller
•Martha Lee
•Helen Gemignani
•Joseph Toerner
•Douglas Pratt
•Amelia Dale Horne
•Loris McVittie
•Sara Gagneten
•Jennifer Ross
•Dale Slavin
•Ronald Rabin


 GSK Participants
•Matt Whitman
•Clare Kahn
•Gary Dubin
•Tom Verstraten
•Patrizia Izurieta
