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Serology Review Memo, March 27, 2012 - MenHibrix


March 27, 2012

ToFile for 125363/0

Freyja Lynn, Consumer Safety Officer, DBPAP/OVRR

ThroughJay E. Slater, M.D., Director, DBPAP/OVRR
SubjectSerology Review Memo for BLA Supplement 125363/0/23 (MenHibrix)
Response to CBER CR letter of September 21, 2011, data submitted in support of 125363/21
SponsorGlaxoSmithKline (GSK)
Documents Reviewed:

BLA supplement 125363/0/23, file name: “raw_data_precision_profil.”


Due to ongoing concerns regarding the quality of the meningococcal serum bactericidal assays (SBA) used to assess the efficacy of the Group Y component of the vaccine, CBER issued a second CR letter on 21 September 2011, with three questions related to the serology.  GSK submitted a partial response (125363/0/19) on 26 October, 2011 and this partial submission was discussed in a telecon between GSK and CBER on 8 November, 2011.  Based on the questions posed in the CR letter and the additional feedback from the telecon, GSK submitted a full response to the CR letter on 1 December, 2011.  During review of the 1 December, 2011 I identified the need for additional data in order to complete my review.  Those data were received December 19, 2011 as 125363/23.  I have reviewed those data and have no further questions regarding them.