Record of Email Communication, February 4, 2010 - 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: 04-Feb-2010 01:48 PM Initiated by FDA? Yes
Telephone Number: Communication Categorie(s):
1. Information Request

Author: JASON HUMBERT Telecon Summary:
IR for clarification of calculated senstivity for anti-HBs assay

FDA Participants: Jason Humbert

Non-FDA Participants: Jody Gould, Ph.D., GSK

Telecon Body: The following was provided to Dr. Gould via e-mail: Dear Jody,
We have the following information request related to BLA 125363/0:

• In m5.3.5.4.3 "Performance Characteristics and Validation - For –b(4)--------------------------- on page 30, Table 12, you have reported a sensitivity of –b(4)--- although the numerical values in the equation provided in the footnote would yield -b(4)- We request that you: 1) clarify the values used for this calculation, e.g., whether it is the case that the correct denominator for calculating sensitivity was used to generate the value of –b(4)-- but the incorrect number was listed in the denominator provided in the footnote; and, 2) submit a copy of the corrected table with footnotes to the BLA.

If you have any questions regarding this request, please do not hesitate to contact me.
 

V/r,
Jason Humbert