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Vaccines, Blood & Biologics

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Vaccines

Record of Email Communication, February 3, 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: 03-Feb-2010 12:51 PM           Initiated by FDA? No
Telephone Number: Communication Categorie(s):
1. Information Request
 
Author: JASON HUMBERT Telecon Summary:
Response to 2-2-10 IR regarding the polio assays
 
FDA Participants: Jason Humbert
 
Non-FDA Participants: Jody Gould, PhD
 
 
Telecon Body:
Hi Jason -
 
Following up on this query. I also just left a voicemail message for you at your office.
I had asked the lab to check on this and they confirmed the -----(b)(4)-------------------- was used in study 009. (Note: the -----(b)(4)-------------------- was also used in study 005.)
The -----(b)(4)------------- is specified in Table 6 of the 009 study report (p 109) and in the text discussion of the assays (p 110). The SOP and validation for this assay is provided in module 5. Table 2 of the synopsis is in error - apologies for the confusion this caused.
Please advise if you would like me to send an official clarification to the BLA or if this email will suffice.
 
Regards, Jody
Jody Ann Gould, PhD Head, Neisseria Vaccines
North American Regulatory Affairs
jody.a.gould@gsk.com
610-787-3765 (phone)
610-787-7063 (fax)