• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

  • Print
  • Share
  • E-mail

Section Contents Menu

Vaccines

Record of Email Communication, February 2, 2010 AM - 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 12:00 AM           Initiated by FDA? Yes
Telephone Number: Communication Categorie(s):
1. Other - Request for column for testing
 
Author: CAMPBELL, KAREN Telecon Summary:
Request for qualified --------------------(b)(4)------------------------------------------------------------- for MenC-TT and MenY-TT conjugates in the final container vaccine
 
FDA Participants: Karen Campbell
 
Non-FDA Participants: Norris Pyle, GSK
 
Telecon Body: The following was provided to GSK via e-mail:
 
Dear Norris,
 
 
In the testing lab we are interested in receiving a qualified --------(b)(4)---------- supplied by                       ---(b)(4)----- used in performing the test for ------------(b)(4)------------------------------------ for MenC- TT and MenY-TT conjugates in the final container vaccine.
 
Please contact me if you have any questions. The column can be sent to:
Al Del Grosso
 
Center for Biologics Evaluation and Research
Nicholson Lane Research Center, Lab B209
5516 Nicholson Lane
Kensington, MD 20895
Telephone 301 435 4988
 
 
Karen Campbell