System Info - 105022 SHONE, DEANNA 16-Sep-2009 14:55:27 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: 16-SEP-2009 01:06 PM Initiated by FDA? Yes
Author: HELEN GEMIGNANI
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
From: Gemignani, Helen S
Sent: Wednesday, September 16, 2009 1:06 PM
Cc: 'firstname.lastname@example.org'; 'Cynthia.A.D'Ambrosio@gsk.com'
Subject: Cervarix - Postmarketing Comments
Please refer to your US Managed Care Safety Study (MCO) protocol concept submitted to the BLA on August 13, 2009:
1) Please include “reactive arthritis” among pre-specified endpoints.
2) Section 7, related to adverse events and serious adverse events, will require further clarification.
3) As an exploratory analysis, please conduct SaTScan (spatial and temporal scan statistics) or similar statistical analysis to identify onset interval clusters of all primary and secondary endpoints specified above within the 12 month follow-up period.
4) Please define time windows, after vaccination, specific to each adverse event.
5) Please perform primary analyses of serious adverse events occurring with onset times which are specific to the adverse event, in addition to the proposed 12 month follow-up.
6) Please implement additional self-control design methods in the MCO-base study for all primary and secondary endpoints specified above.
Helen Sullivan Gemignani
Regulatory Project Manager
Division of Vaccines and Related Products Applications/Viral Vaccine Branch