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Vaccines

Record of Telephone Conversation - Cervarix, Sept. 1, 2009

System Info - 104046  SHONE, DEANNA   02-Sep-2009 11:05:54  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:  01-SEP-2009 05:57 PM     Initiated by FDA?  Yes

Telephone Number:    

Communication Categorie(s):

Information Request

Author:  HELEN GEMIGNANI

Telecon Summary:

TVC Numbers Information Request

FDA Participants:  

Non-FDA Participants:   

Trans-BLA Group: No

     

Related STNs:  None

Related PMCs:  None

Telecon Body:


From: Gemignani, Helen S
Sent: Tuesday, September 01, 2009 5:57 PM
To: Miller, Nancy; Lee, Martha (CBER)
Cc: Levis, Robin
Subject: Cervarix 09.01.2009 Telecon RE: TVC Numbers

Martha Lee, Nancy Miller and I called Matt Whitman, GSK, to inquire about two tables in the HPV-008 study report.  Table 13 shows the number of recipients for TVC for HPV as 9319 and TVC for HAV as 9325.  Supplement 192, of the same report, shows the number of recipients for TVC for HPV as 8667 and TVC for HAV as 8682.  We asked GSK to resolve and provide CBER with an explanation for this discrepancy and for the correct values.

Mr. Whitman will get back to us.

Helen Sullivan Gemignani
Regulatory Project Manager
FDA/CBER/OVRR
Division of Vaccines and Related Products Applications/Viral Vaccine Branch
(301) 827-3070