Record of Telephone Conversation - Cervarix, June 19, 2009

System Info - 97529  SHONE, DEANNA   24-Jun-2009 16:27:17  SHONEDE

RECORD OF TELEPHONE CONVERSATION

 

Submission Type: Original Application   Submission ID:  125259/0    Office: OVRR  

Product:

Human Papillomavirus Vaccine, AS04 Adjuvant-Adsorbed

Applicant:                                                                       

GlaxoSmithKline Biologicals          

Telecon Date/Time:  19-JUN-2009 03:16 PM                Initiated by FDA?  Yes

Telephone Number:   

Communication Categorie(s):

Information Request

Author:  HELEN GEMIGNANI

Telecon Summary:

Dataset Variable Clarification

FDA Participants:  

Non-FDA Participants:   

Trans-BLA Group: No

Related STNs:  None

Related PMCs:  None

Telecon Body:

From: Gemignani, Helen S
Sent: Friday, June 19, 2009 3:16 PM
To: 'Matt.Whitman@gsk.com'
Subject: Information Request - Dataset Variable Clarification

Please refer to the Cervarix BLA.  In the dataset "epcconc", there are 19 PIDs with a code of "241" for the variable "ACTIVITY".  Please explain what "241" stands for.