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Vaccines, Blood & Biologics

3/10/2008 Telecon - Rotarix


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

Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

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Silver Spring, MD 20993-0002

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