3/10/2008 Telecon - Rotarix

MEMORANDUM

DATE:	March 10, 2008, 11:00 AM
FROM:	Laraine S. Henchal, Microbiologist Reveiwer, DVRPA, CBER, Review Committee Chair, STN 125265/0
SUBJECT:	Telecon in regard to inclusion/exclusion of Neisseria meningitidis assay data from review for BLA for Rotarix®

I received a call from Milan Blake and Chris Lynch in regard to the necessity for inclusion of Chris's review of the Neisseria meningitidis assay data in the BLA. Since the co-administration of other vaccines study 060 is considered by CBER to be the pivotal co-administration study, and no Neisseria vaccine was administered in that study, we all agreed that it was not necessary to include the assay review in the file.

CBER participants:

Laraine Henchal
Christian Lynch
Milan Blake