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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

Record of Email Communication, February 2, 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: 02-Feb-2010 10:57 AM           Initiated by FDA? Yes
Telephone Number: Communication Categorie(s):
1. Information Request
 
Author: JASON HUMBERT Telecon Summary:
IR for SOP/Validation of --(b)(4)-- used to measure anti-polivirus types 1, 2 and 3
 
FDA Participants: Jason Humbert
 
Non-FDA Participants: Jody Gould, Ph.D., GSK
 
Telecon Body: The following was provided to Dr. Gould via e-mail: Good morning Jody,
We have the following information request related to BLA 125363/0:
 
1. In testing of sera, an --(b)(4)-- was used to measure anti-poliovirus types 1, 2, and 3 antibodies. Please provide the SOPs and validation documentation for these assays. If these have been previously submitted to another file, please reference the submission number.
 
If you have any questions regarding this request, please do not hesitate to contact me. V/r,
Jason Humbert