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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

Record of Email Communication, October 30, 2009 - MenHibrix

Submission Type: BLA     Submission ID: 125363/0    Office: OVRR

Product:
Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate
Vaccine

Applicant:
GlaxoSmithKline Biologicals

Telecon Date/Time: 30-Oct-2009 12:00 PM         Initiated by FDA? No
Telephone Number:

Communication Category(s):
1. Information Request

Author: JASON HUMBERT

Telecon Summary:
Information provided by GSK that was requested in the Oct. 21, 2009 telecon.

FDA Participants: Jason Humbert

Non-FDA Participants: Dr. Jody Gould, GSK

Telecon Body:
The following information was provided by GSK via e-mail as a preliminary response to the Oct. 21 information request. If the information provided is acceptable, GSK will submit this formally to the BLA.

(b)(4)

17 pages determined to be not releasable (b)(4)