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Record of Telephone Conversation - Cervarix, October 6, 2009

System Info - 107041  SHONE, DEANNA   06-Oct-2009 17:16:23  SHONEDE


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


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


GlaxoSmithKline Biologicals          

Telecon Date/Time:  06-OCT-2009 11:08 AM               Initiated by FDA?  Yes

Telephone Number:    

Communication Categorie(s):

Information Request


Telecon Summary:

PMC Request for Clarification

FDA Participants:  

Non-FDA Participants:   

Trans-BLA Group: No

Related STNs:  None

Related PMCs:  None

Telecon Body:

From:                     Gemignani, Helen S 

Sent:                      Tuesday, October 06, 2009 11:08 AM

To:                          'Matt.Whitman@gsk.com'; nicholas.perombelon@gsk.com

Cc:                          Cynthia.A.D'Ambrosio@gsk.com

Subject:                Cervarix - PMC Request for Clarification

We accept your submitted PMC protocol and pregnancy registry commitments; However, please clarify that the 50,000 subject cohort, who will be vaccinated with Cervarix, will contain, at minimum, a cumulative total of 135,000 doses administered.


Helen Sullivan Gemignani

Regulatory Project Manager

Division of Vaccines and Related Products Applications

Office of Vaccines Research and Review

Center for Biologics Evaluation and Research

Food and Drug Administration

phone: (301) 827-3070



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