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Vaccines, Blood & Biologics

Minutes of Telephone Conference, October 12, 2010 - MenHibrix

Date: 12 October 2010
To:STN 125363 FDA Regulatory File
From: David C. Staten, Jr., MPH, CDR, USPHS
BLA Regulatory Project Manager

Joseph Temenak, Ph.D., CDR, USPHS
BLA Chairman

Subject:Record of FDA and GlaxoSmithKline October 6, 2010 Telephone Conference
Reference: Item 67 (c, d, and e) Complete Response Letter

Jennifer Bridgewater
Daron Freedberg
Rajesh Gupta
Tina Roecklein
David Staten
Liz Sutkowski
Joseph Temenak
Willie Vann


Nancy Cauwenberghs, Director, Technical Regulatory Unit
Jean-Francois Dierick, Manager, QC Biochemistry
Jody Gould, Director, Vaccines, North American Regulatory Affairs
Kalliopi Grigoriadou, Scientist, Technical Regulatory Unit
Dominique Labbe, Expert Scientist, Analytical R&D
Olivier Laloux, Director, Analytical R&D
Christophe Lenfant, Senior Project Manager, Analytical R&D
Norris Pyle, Assistant Director, Vaccines, North American Regulatory Affairs
Catherine Vigano-Wolff, Scientist, Technical Regulatory Unit
Xavier Raquet, Senior Scientist, Technical Regulatory Unit

This telephone conference was requested by GSK to discuss their response to Item 67 from the June 11, 2010 FDA Complete Response letter. GSK specifically wanted to discuss the request for the addition of free HIB, MenC, and MenY free polysaccharide content on the MenHibrix final container vaccine. GSK proposed to replace the requested –b(4)-- assay with a (b)(4) by --------(b)(4)----------. As presented in their PowerPoint presentation, GSK would like to use this assay for the following reason;

  1. The free-PS content test by (b)(4) is not accurate for polysaccharides of -(b)(4)-.
  2. Free-PS content by ---------(b)(4)--------- has been developed to replace free-PS content test by (b)(4) on the three monovalent (b)(4) conjugates, Hib-TT, PSC-TT, and PSY-TT.
  3. The presence of sucrose --(b)(4)-- in the final container interferes with the PS quantification by --------(b)(4)----------.
  4. Free-PS content tests are not enough specific/sensitive/accurate/robust to be implemented on MenHibrix final container.

GSK showed data that --------(b)(4)---------- in final product was able to detect degraded conjugates. GSK confirmed that degraded conjugates were not tested in clinical trails.

FDA stated that there are two approved products that currently have a free PS content assay on the final container. GSK explained that MenHibrix is different from these products because MenHibrix is lyophilized and the conjugates are –b(4)---- polysaccharides. FDA suggested more exploration of techniques, for example, --------------(b)(4)---------------- .

Restating the points above, GSK stated that a valid free-PS content assay can not be used. Instead, GSK wants to implement a --------------(b)(4)---------- ---- for the final container. GSK asked if FDA concurs with this proposal. FDA stated that the agency has insufficient data to make any decision regarding this change in ---(b)(4)--- for the final container. GSK stated that additional justifications as to why they prefer the --------(b)(4)---------- method will be submitted. These data will be submitted in the CR

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