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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

Record of Telephone Conversation, March 27, 2012 - MenHibrix

Date:               March 27, 2012

Subject:           Teleconference to Discuss Potential Alternative Plans to Replace the (b)(4) Diluent

Participants:

CBER:
Jennifer Bridgewater (Consumer Safety Officer)
David Staten (Project Manager)
Joseph Temenak (Project Manager)

GSK:
Jody Gould, Director, Vaccines, North American Regulatory Affairs
Norris Pyle, Assistant Director, Vaccines, North American Regulatory Affairs

Product:
Hiberix STN 125347/152

Discussion:
Reference is made to the March 22, 2012, CR letter issued for this supplement because the manufacture of the diluent has been issued OAI status. Since the same diluent will be used for the MenHibrix presentation, FDA wanted to discuss possible ---(b)(4)--- for the diluent presentation. MenHibrix is due for approval June 1, 2012.

GSK stated that they are looking into a ---(b)(4)--- for the (b)(4) diluent. GSK stated they might be able to ------(b)(4)------- themselves or re-new the contract the had with --(b)(4)--.

FDA asked what are the planned number of doses for launch. GSK will have to get back to us regarding this. GSK did state that the number of vaccine doses will be limiting because of product and it is not related to the diluent.

Post-note: GSK is planning to -------------(b)(4)--------------.