System Info - 105687 SHONE, DEANNA 23-Sep-2009 15:50:53 SHONEDE
RECORD OF TELEPHONE CONVERSATION
Submission Type: Original Application Submission ID: 125259/0 Office: OVRR
Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant
Telecon Date/Time: 18-SEP-2009 12:00 AM Initiated by FDA? Yes
Author: LORI AUSTIN-HANSBERRY
Telecon with OBE/GSK
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
Subject: Notes from GSK Meeting (Telecon) on September 18, 2009
Dr. Rickey Wilson
Dr. Hector Izurieta
Dr. Michael Nguyen
Dr. Clare Kahn (GSK
GSK contacted FDA on September 18 to clarify the terms of the postmarketing study requirement. GSK was concerned about committing to absolute study metrics that might later turn out not to be feasible once the study is initiated.
In particular, they were concerned that in their preliminary sample size calculations, GSK estimated that approximately 500,000 women would need to be monitored to achieve sufficient power to detect a relative risk of 2.0 for spontaneous abortions. Hence, GSK asked that the vaccine approval letter only include a broad outline of the study protocol, with the understanding that (a) GSK was fully committed to a post licensure study to assess the risk of spontaneous abortions after Cervarix vaccination and (b) FDA must approve the final study design.
The terms agreed upon were that the approval letter would state the following:
(1) Full commitment to a postmarketing analytic epidemiologic study
(2) Study population would be women whose estimated date of conception occurred -30 to +90 days of nearest vaccination.
(3) The study would include karyotype analysis in a subset of women.
(4) The draft protocol would be submitted 2 months after product licensure and the final protocol 6 months after product licensure.
(5) The study would commence preferably within 6 months but no longer than 12 months after study protocol finalization.
Michael D. Nguyen, MD
LCDR, U.S. Public Health Service
Medical Officer | Vaccine Safety Branch
FDA | Center for Biologics Evaluation and Research
Woodmont Office Complex 1, Rm 473S, HFM-222
1401 Rockville Pike, Suite 400S
Rockville, MD 20852