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Vaccines

Record of Telephone Conversation - Cervarix, September 18, 2009

System Info - 105353  SHONE, DEANNA   18-Sep-2009 15:01:42  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-SEP-2009 01:30 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: Friday, September 18, 2009 1:30 PM
To: 'Matt.Whitman@gsk.com'; 'nicholas.perombelon@gskbio.com'
Cc: 'Cynthia.A.D'Ambrosio@gsk.com'; Nguyen, Michael D.
Subject: Cervarix - Postmarketing Comments

In light of GSK’s concerns regarding feasibility, patient recruitment, and time required to complete the study, we suggest increasing the time period for analysis.

We suggest analyzing pregnancies whose:

  1. estimated date of conception lies between day -30 until day +90 days from nearest vaccination; and
  2. the spontaneous abortion occurred on or after the day of vaccination; and
  3. the estimated gestational age is less than 3 months at the time of pregnancy loss. (unless there are data to suggest that we should include SAB’s greater than 3 months EGA)

Please contact Michael Nguyen, M.D., at 301 827-2952, if you have any additional questions or need for clarification.

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