Results Memo, April 25, 2012 - MenHibrix

To             STN# 125363; MENHIBRIX File

From         Dr. James L. Kenney, HFM-682
Team Lead, Laboratory of Microbiology, In-vivo Testing and Standards

Through:  Dr. William McCormick, HFM-680
                  Director, Division of Biological Standards and Quality Control

CC:           Joseph Temenak, HFM-481 Chair, BLA Review Committee

Subject:    Endotoxin and Sterility Test results on Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine, Product Lot Numbers:  ---------------------------(b)(4)---------------------------.

 

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GlaxoSimithKline Biologicals submitted three lots of Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine (MENHIBRIX).  These lots were tested for sterility and endotoxin in the Division of Biological Standards and Quality Control’s Laboratory of Microbiology, In-vivo Testing and Standards at CBER and the results are as follows:

Product	Lot Number	Endotoxin Test Results*	Sterility Test Results
MENHIBRIX	----(b)(4)------	-------(b)(4)--------------	Passed
MENHIBRIX	----(b)(4)------	-------(b)(4)--------------	Passed
MENHIBRIX	----(b)(4)------	-------(b)(4)--------------	Passed

      * Endotoxin Lot-release specifications are ---(b)(4)--- one dose is -(b)(4)-- mL after reconstitution.