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Record of Telephone Conversation - Cervarix, August 5, 2009

Record of Telephone Conversation 

STN Number: 125259/0 

Manufacturer: GlaxoSmithKline Biologicals 

Product: Human Papillomavirus Vaccine, ASO4 Adjuvant-Adsorbed 

To: File 

From: Helen S. Gemignani, Regulatory Project Manager Subject: Information Request Clarification 

Telecon Date: August 5, 2009 

Telecon Time: 3:32pm 

Telecon Initiated: Laura Montague 

Contact Phone: 610 787-3726 


Summary of Telecon 

We acknowledge receipt of your July 31, 2009, response to our July 26, 2009 Information Request, in which you provided four tables of information in regard to persistent infection. We request that you provide these analyses for the Total Vaccinated Cohort, as in Table 97, p. 355, of the clinical study for HPV-008. 

End of Teleconference 

Action Items 

• GSK to revise response and resubmit as advised. 

FDA Participants 

• Laura Montague 

GSK Participants 

• Matt Whitman