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Vaccines

Record of Telephone Conversation - Cervarix, June 22, 2009

System Info - 105034  SHONE, DEANNA   16-Sep-2009 16:10:11  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:  22-JUN-2009 06:14 PM                Initiated by FDA?  Yes

Telephone Number:    

Communication Categorie(s):

Information Request

Author:  HELEN GEMIGNANI

Telecon Summary:

Request for NCI Analysis of spontaneous abortions seen in 008 and 009.

FDA Participants:  

Non-FDA Participants:   

Trans-BLA Group: No    

Related STNs:  None

Related PMCs:  None

Telecon Body:


From: Gemignani, Helen S

Sent: Monday, June 22, 2009 6:14 PM

To: 'Matt.Whitman@gsk.com'

Cc: 'Cynthia.A.D'Ambrosio@gsk.com'; 'nicholas.perombelon@gsk.com'

Subject: Cervarix BLA - Request for Statistical Information

Please refer to your March 27, 2009 submission to the BLA. A summary report of the

NCI analysis of spontaneous abortions in the peri-vaccination period was included in

the Supplement to the Cumulative Safety Update of the BLA on pp. 128-131. CBER

requests that you submit the full analysis report and methodology used to

demonstrate that the difference noted between treatment groups was not

statistically significant. Please submit data used to conduct this analysis.

You also indicate that the data regarding spontaneous abortions were presented to

the IDMC for study HPV-008. CBER requests meeting reports from the IDMC

meeting(s) at which this issue was discussed.

Please submit your response as an amendment to the BLA.

Thank you,

Helen Sullivan Gemignani

Regulatory Project Manager

FDA/CBER/OVRR

Division of Vaccines and Related Products Applications/Viral Vaccine Branch

(301) 827-3070