System Info - 105034 SHONE, DEANNA 16-Sep-2009 16:10:11 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: 22-JUN-2009 06:14 PM Initiated by FDA? Yes
Author: HELEN GEMIGNANI
Request for NCI Analysis of spontaneous abortions seen in 008 and 009.
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
From: Gemignani, Helen S
Sent: Monday, June 22, 2009 6:14 PM
Cc: 'Cynthia.A.D'Ambrosio@gsk.com'; 'email@example.com'
Subject: Cervarix BLA - Request for Statistical Information
Please refer to your March 27, 2009 submission to the BLA. A summary report of the
NCI analysis of spontaneous abortions in the peri-vaccination period was included in
the Supplement to the Cumulative Safety Update of the BLA on pp. 128-131. CBER
requests that you submit the full analysis report and methodology used to
demonstrate that the difference noted between treatment groups was not
statistically significant. Please submit data used to conduct this analysis.
You also indicate that the data regarding spontaneous abortions were presented to
the IDMC for study HPV-008. CBER requests meeting reports from the IDMC
meeting(s) at which this issue was discussed.
Please submit your response as an amendment to the BLA.
Helen Sullivan Gemignani
Regulatory Project Manager
Division of Vaccines and Related Products Applications/Viral Vaccine Branch