System Info - 100608 SHONE, DEANNA 27-Jul-2009 17:50:07 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: 26-JUL-2009 02:53 PM Initiated by FDA? Yes
Author: HELEN GEMIGNANI
Information Request RE: HPV-009
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
From: Gemignani, Helen S
Sent: Sunday, July 26, 2009 2:53 PM
Cc: 'email@example.com'; 'Cynthia.A.D'Ambrosio@gsk.com'
Subject: Cervarix BLA - Information Request RE: HPV-009
In the safety report for subject PID 389954 (study HPV-009), the case report states the following:
"Follow-up received on 11 December 2007 : On 10 December 2007 a copy of the biopsy report from the National Cancer Institute of the United States was obtained : Diagnosis : colon, total colectomy : severe mucosal injury with penetrating ulcers, fibrinopurulent pseudomembranous exudate, inflammatory polyps and inflammatory pseudopolyps, bacterial and fungal elements are present on surface and luminal area. The differential diagnosis is broad and includes idiopathic inflammatory bowel disease (IBD), infections, ischemic or drug induced injury. This case was seen in consultation with the GI pathology section of the Armed Forces Institute of Pathology and they agree with out interpretation. They do not favor IBD as the most possible etiology. A copy of their report is in our files."
1) CBER requests submission of this report to the Cervarix BLA.
Helen Sullivan Gemignani
Regulatory Project Manager
Division of Vaccines and Related Products Applications/Viral Vaccine Branch