Record of Telephone Conversation
STN Number: 125259/0
Manufacturer: GlaxoSmithKline Biologicals
Product: Human Papillomavirus Vaccine, ASO4 Adjuvant-Adsorbed
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
• GSK to revise response and resubmit as advised.
• Laura Montague
• Matt Whitman