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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

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

 

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