Record of Telephone Conversation - Cervarix, Sept. 16, 2009

System Info - 105022  SHONE, DEANNA   16-Sep-2009 14:55:27  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:  16-SEP-2009 01:06 PM     Initiated by FDA?  Yes

Telephone Number:    

Communication Categorie(s):

Advice

Author:  HELEN GEMIGNANI

Telecon Summary:

Postmarketing Comments

FDA Participants:  

Non-FDA Participants:   

Trans-BLA Group: No

Related STNs:  None

Related PMCs:  None

Telecon Body:


From: Gemignani, Helen S
Sent: Wednesday, September 16, 2009 1:06 PM
To: 'Matt.Whitman@gsk.com'
Cc: 'nicholas.perombelon@gskbio.com'; 'Cynthia.A.D'Ambrosio@gsk.com'
Subject: Cervarix - Postmarketing Comments

Please refer to your US Managed Care Safety Study (MCO) protocol concept submitted to the BLA on August 13, 2009:

1) Please include “reactive arthritis” among pre-specified endpoints.

2) Section 7, related to adverse events and serious adverse events, will require further clarification.

3) As an exploratory analysis, please conduct SaTScan (spatial and temporal scan statistics) or similar statistical analysis to identify onset interval clusters of all primary and secondary endpoints specified above within the 12 month follow-up period.

4) Please define time windows, after vaccination, specific to each adverse event.

5) Please perform primary analyses of serious adverse events occurring with onset times which are specific to the adverse event, in addition to the proposed 12 month follow-up.

6) Please implement additional self-control design methods in the MCO-base study for all primary and secondary endpoints specified above.

 

Helen Sullivan Gemignani
 Regulatory Project Manager
 FDA/CBER/OVRR
 Division of Vaccines and Related Products Applications/Viral Vaccine Branch
 (301) 827-3070
