
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)