System Info - 105353 SHONE, DEANNA 18-Sep-2009 15:01:42 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 01:30 PM Initiated by FDA? Yes
Author: HELEN GEMIGNANI
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
From: Gemignani, Helen S
Sent: Friday, September 18, 2009 1:30 PM
To: 'Matt.Whitman@gsk.com'; 'email@example.com'
Cc: 'Cynthia.A.D'Ambrosio@gsk.com'; Nguyen, Michael D.
Subject: Cervarix - Postmarketing Comments
In light of GSK’s concerns regarding feasibility, patient recruitment, and time required to complete the study, we suggest increasing the time period for analysis.
We suggest analyzing pregnancies whose:
- estimated date of conception lies between day -30 until day +90 days from nearest vaccination; and
- the spontaneous abortion occurred on or after the day of vaccination; and
- the estimated gestational age is less than 3 months at the time of pregnancy loss. (unless there are data to suggest that we should include SAB’s greater than 3 months EGA)
Please contact Michael Nguyen, M.D., at 301 827-2952, if you have any additional questions or need for clarification.
Helen Sullivan Gemignani
Regulatory Project Manager
Division of Vaccines and Related Products Applications/Viral Vaccine Branch