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Vaccines

Record of Telephone Conversation - Cervarix, August 26, 2009

System Info - 103686  SHONE, DEANNA   28-Aug-2009 17:13:57  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:  26-AUG-2009 12:34 PM               Initiated by FDA?  Yes

Telephone Number:    

Communication Categorie(s):

Information Request

Author:  HELEN GEMIGNANI

Telecon Summary:

Information Request for Results in TVC cohort

FDA Participants:  

Non-FDA Participants:   

Trans-BLA Group: No

Related STNs:  None

Related PMCs:  None

Telecon Body:


From:                     Gemignani, Helen S 

Sent:                      Wednesday, August 26, 2009 12:34 PM

To:                          'Matt.Whitman@gsk.com'

Cc:                          'nicholas.perombelon@gsk.com'; 'Cynthia.A.D'Ambrosio@gsk.com'

Subject:                Cervarix - Request for Results in TVC cohort

To assist Dr. Miller with her VRBPAC slides, could you please fill in the table below for the TVC cohort (irrespective of baseline PCR and serostatus) or indicate location in BLA or study HPV-008.

HPV-008:  Efficacy against incident infection, and persistent infection (6- and 12- months) related to

HPV 16 and/or 18 irrespective of baseline PCR and serostatus (TVC cohort)

 

Cervarix

Havrix

Efficacy

(96.1% CI)

Endpoint

N

Number of cases

N

Number of cases

 

Incident infection

 

 

 

 

 

6-month persistent infection

 

 

 

 

 

12-month persistent infection