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Vaccines

Record of Telephone Conversation - Cervarix, June 22, 2009 AM

System Info - 103096  SHONE, DEANNA   24-Aug-2009 17:42:27  SHONEDE

RECORD OF TELEPHONE CONVERSATION

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

Product:

Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant

Applicant:                                                                       

GlaxoSmithKline Biologicals          

Telecon Date/Time:  22-JUN-2009 09:07 AM               Initiated by FDA?  Yes

Telephone Number:    

Communication Categorie(s):

Other

Author:  HELEN GEMIGNANI

Telecon Summary:

Response to 6/19/09 CBER Stats Information Request

FDA Participants:  

Non-FDA Participants:   

Trans-BLA Group: No

Related STNs:  None

Related PMCs:  None

Telecon Body:


From: Matt.Whitman@gsk.com [mailto:Matt.Whitman@gsk.com]
Sent: Monday, June 22, 2009 9:07 AM
To: Gemignani, Helen S
Cc: Cynthia.A.D'Ambrosio@gsk.com; nicholas.perombelon@gskbio.com
Subject: Re: Information Request - Dataset Variable Clarification


Hi Helen,
Here is the response:
The Code  '241'  stands for  the Visit 10 Month 48  'Exit colposcopy'.  
For your information, please find a complete description of all activities in the EPCCONC dataset:

10 = VISIT1  (Day 0)
20 = VISIT2  (Month 1)
30 = VISIT3  (Month 6)
40 = VISIT4  (Month 7)
50 = VISIT5  (Month 12)
60 = VISIT6  (Month 18)
70 = VISIT7  (Month 24)
80 = VISIT8  (Month 30)
90 = VISIT9  (Month 36)
95 = VISIT9 Optional   (Month 42)
241 = Visit 10 Exit Colposcopy   (Month 48)
Let me know if you need further clarification.
Matt
 

"Gemignani, Helen S" <Helen.Gemignani@fda.hhs.gov>

19-Jun-2009 15:15

To  Matt.Whitman@gsk.com
 

cc

 

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.