Record of Telephone Conversation - Cervarix, October 8, 2009

System Info - 107649  SHONE, DEANNA   14-Oct-2009 13:21:09  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:  08-OCT-2009 03:01 PM                Initiated by FDA?  Yes

Telephone Number:    

Communication Categorie(s):

Advice

Author:  LORI AUSTIN-HANSBERRY

Telecon Summary:

PMC Sample Size

FDA Participants:  

Non-FDA Participants:   

Trans-BLA Group: No

Related STNs:  None

Related PMCs:  None

Telecon Body: 

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Dear Mr. Perombelon:

Thank you for this quick clarification.  FDA recommends that GSK’s PMC study on autoimmune diseases achieve a cohort size sufficient to analyze 135,000 total doses or 45,000 individuals with the complete 3-dose vaccination series.  These 2 sample sizes have been developed and approved by internal FDA vaccine safety working groups and have been implemented in recent postmarketing safety studies for both Gardasil and Menactra.  To provide more meaningful safety data on these rare events, FDA recommends configuring the PMC to achieve the stated sample size targets.  In the event that GSK is unable to respond by tomorrow afternoon regarding this last suggestion, CBER will likely state in the approval letter that “FDA has recommended these sample size targets, however the final protocol is still under negotiation with the sponsor.”  

Best regards,

Lori Austin-Hansberry, MSA, BSN
CDR, U. S. Public Health Service
Sr. Regulatory Project Manager, FDA/CBER/OBE/DE
1401 Rockville Pike, Rm 434S, HFM-220
Rockville, MD 20852-1448
LJA@fda.hhs.gov
Office: 301-827-6048
Fax: 301-827-5218