Record of Telephone Conversation - Cervarix, March 18, 2008

System Info - 99602  SHONE, DEANNA   15-Jul-2009 16:32:25  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:  18-MAR-2008 02:46 PM              Initiated by FDA?  Yes

Telephone Number:    

Communication Categorie(s):

Other

Author:  HELEN GEMIGNANI

Telecon Summary:

Response to CBER's 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: Tuesday, March 18, 2008 2:46 PM
 To: Sullivan, Helen M
 Cc: Sharon.W.Shapowal@gsk.com
 Subject: Question regarding Excel files in Safety Output

Dear Helen,
 With respect to the safety data output to be provided in GSK's response to the CR letter, we wish to advise that the data will be available as Excel spreadsheet output, not as SAS transport files, since these data are being extracted from our OCEANS database which is the "living" safety database, not our clinical trials database.  We are planning to submit the native Excel files along with PDF published versions of the Excel worksheets.  If this is acceptable to the Division, we will negotiate with CBER IT the acceptable way to include these files in the eCTD application. The tables in view will include:

Appendix Table 1        Overview of deaths reported for all clinical studies that include vaccination with Cervarix (OCEANS output, data lock-point of December 31, 2007)  (XL sheet)

Appendix Table 2        Serious adverse events for all clinical studies that include vaccination with Cervarix (OCEANS output, data lock-point of September 30, 2007)    (XL sheet)

Appendix Table 3        Percentage of subjects reporting the occurrence of serious adverse events classified by MedDRA Primary System Organ Class and Preferred Term, for all clinical studies that include vaccination with Cervarix (OCEANS output, data lock-point of September 30, 2007)  (Analysis Table)

Appendix Table 4        Pregnancy outcomes overall for Studies HPV-001, 003, 004, 005, 007, 008, 009, 012, 012 Ext, 013, 013 Ext, 014, 014 Ext, 015, 016 (Total vaccinated cohort, data lock-point of September 30, 2007)        (Analysis table)

Appendix Table 5        Pregnancy outcomes around vaccination for Studies HPV-001, 003, 004, 005, 007, 008, 009, 012, 012 Ext, 013, 013 Ext, 014, 014 Ext, 015, 016 (Total vaccinated cohort, data lock-point of September 30, 2007)        (Analysis Table)

Appendix Table 6        Description of spontaneous abortions for Studies HPV-001, 003, 004, 005, 007, 008, 009, 012, 012 Ext, 013, 013 Ext, 014, 014 Ext, 015, 016 (Total vaccinated cohort, data lock-point of September 30, 2007)         (XL sheet)

Appendix Table 7        Description of stillbirths for Studies HPV-001, 003, 004, 005, 007, 008, 009, 012, 012 Ext, 013, 013 Ext, 014, 014 Ext, 015, 016 (Total vaccinated cohort, data lock-point of September 30, 2007)           (XL sheet)

Appendix Table 8        Description of congenital anomalies in infants in all clinical studies in which Cervarix has been administered (OCEANS output, data lock-point of September 30, 2007)         (XL sheet)

Appendix Table 9        Description of abnormal infant outcomes other than congenital anomalies in infants in Studies HPV-001, 003, 004, 005, 007, 008, 012, 012 Ext, 013, 013 Ext, 014, 014 Ext, 015, 016 (Total vaccinated cohort, data lock-point of September 30, 2007)         (XL sheet)

Appendix Table 10        Description of abnormal infant outcomes other than congenital anomalies in infants in Study HPV-009 (Total vaccinated cohort, data lock-point of September 30, 2007)         (XL sheet)

Appendix Table 11        Study discontinuations due to adverse events for studies included in BLA (Studies HPV-001, 003, 004, 005, 007, 008, 009, 012, 012 Ext, 013, 013 Ext, 014, 014 Ext, 015, 016) classified by MedDRA Primary System Organ Class and Preferred Term (Total vaccinated cohort, data lock-point of September 30, 2007)         (XL sheet)

Appendix Table 12        Medically significant adverse events during the entire follow-up period for Studies HPV-008, 012, 012 Ext, 013, 013 Ext, 014, 014 Ext, 015 and 016 (Total vaccinated cohort, data lock-point of September 30, 2007)         (XL sheet)

Appendix Table 13        Percentage of subjects reporting the occurrence of medically significant adverse events, classified by MedDRA Primary System Organ Class and Preferred Term, during the entire follow-up period for Studies HPV-008, 012, 012 Ext, 013, 013 Ext, 014, 014 Ext, 015 and 016 (Total vaccinated cohort, data lock-point of December 31, 2007)         (Analysis Table)
 Can you please check to see if the CBER review team (medical officer and/or statistician), wish to have the Excel data in a form that can be manipulated?  If so, we will need an exemption to submit them to the e-CTD.  If not, we can simply scan the data tables and there will be no problems (with CBER compliance check) upon submission.  
 Thanks
 Matt

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