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Vaccines

Record of Telephone Conversation - Cervarix, September 22, 2009

System Info - 105725  SHONE, DEANNA   24-Sep-2009 11:05:26  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-SEP-2009 06:47 PM     Initiated by FDA?  Yes

Telephone Number:    

Communication Categorie(s):

Advice

Author:  HELEN GEMIGNANI

Telecon Summary:

Commitment

FDA Participants:  

Non-FDA Participants:   

Trans-BLA Group: No

Related STNs:  None

Related PMCs:  None

Telecon Body:


 

From: Gemignani, Helen S
Sent: Tuesday, September 22, 2009 6:47 PM
To: 'Matt.Whitman@gsk.com'; 'nicholas.perombelon@gskbio.com'
Cc: 'Cynthia.A.D'Ambrosio@gsk.com'
Subject: Cervarix - Commitment

In regard to your commitment to a post-licensure analytic epidemiologic study to assess the risk of spontaneous abortion following Cervarix vaccination, please acknowledge agreement to the following timetable which states that you will conduct this trial according to the following schedule:

Final Protocol Submission: No later than 6 months after vaccine licensure

Study Start Date: No later than 12 months after protocol finalization

Final Report Submission: No later than 6 months after study completion

 

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