Record of Telephone Conversation - Cervarix, Sept. 2, 2009

System Info - 104120  SHONE, DEANNA   02-Sep-2009 15:50:52  SHONEDE

RECORD OF TELEPHONE CONVERSATION

Submission Type: Original Application   Submission ID:  125259/0    Office: OVRR  

Product:

Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant

Applicant:                                                                       

GlaxoSmithKline Biologicals          

Telecon Date/Time:  02-SEP-2009 02:08 PM     Initiated by FDA?  Yes

Telephone Number:    

Communication Categorie(s):

Other

Author:  HELEN GEMIGNANI

Telecon Summary:

HPV-008 TVC numbers Response to IR

FDA Participants:  

Non-FDA Participants:   

Trans-BLA Group: No

Related STNs:  None

Related PMCs:  None

Telecon Body:

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From: Matt.Whitman@gsk.com [mailto:Matt.Whitman@gsk.com]
Sent: Wednesday, September 02, 2009 2:08 PM
To: Gemignani, Helen S
Subject: Cervarix FDA Question HPV-008 TVC numbers
This discrepancy between N's in Table 13 and the N's in supplement 192 is due to the following reasons:
Table 13 presents the description of all efficacy cohorts.  Actually the N's of each cohort are considered as the number maximum of subjects that could be included in any analysis depending on the eligibility of the subjects for this specific analysis. Eligibility criteria are dependent of the nature of the endpoint as well as the cohort used.
Supplement 192 shows the incidence rates and vaccine efficacy against CIN2+ associated with HPV-16/18 in all subjects, irrespective of their baseline HPV DNA and serostatus in the TVC cohort. For this analysis, the eligibility criteria used was:

Follow up time for cytology or biopsy visits (difference between last biopsy or cytology visit and first  biopsy or cytology visit) is at least one day (as follow up started after day 1).