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Vaccines

Record of Email Communication, October 21, 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:  21-Oct-2009 12:00 PM             Initiated by FDA? Yes

Communication Category: Information Request

Author:                     JASON HUMBERT

Brief Description: Request for information regarding immunogenicity analyses and analyses of AEs for Hib-MenCY lots B and C combined separately from Hib-MenCY lot A

FDA Participants:                   Jason Humbert
Non-FDA Participant(s):        Jody Gould, PhD (GSK)

Telecon Body:          The following e-mail was provided to GSK:

Good morning Jody,

We have the following request for information regarding STN 125363/0:

* Please provide immunogenicity analyses and analyses of solicited and unsolicited adverse events (with corresponding comparisons to the control group) for Hib-MenCY- TT lots B and C combined separately from Hib-MenCY-TT lot A.

Please let me know if you have any questions pertaining to this request.

Thank you.


V/r, Jason

Jason Humbert
LCDR, USPHS
Regulatory Project Manager
Division of Vaccines and Related Product Applications
Office of Vaccines Research and Review Center for Biologics Evaluation and Research Food and Drug Administration
Tel: (301) 827-6019
Fax: (301) 827-3532