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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
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