Archived Content

The content on this page is provided for reference purposes only. This content has not been altered or updated since it was archived.

Vaccines, Blood & Biologics

Record of Telephone Conversation - Cervarix, September 22, 2009

System Info - 105725  SHONE, DEANNA   24-Sep-2009 11:05:26  SHONEDE


Submission Type: Original Application   Submission ID:  125259/0    Office: OVRR  


Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant


GlaxoSmithKline Biologicals          

Telecon Date/Time:  22-SEP-2009 06:47 PM     Initiated by FDA?  Yes

Telephone Number:    

Communication Categorie(s):



Telecon Summary:


FDA Participants:  

Non-FDA Participants:   

Trans-BLA Group: No

Related STNs:  None

Related PMCs:  None

Telecon Body:


From: Gemignani, Helen S
Sent: Tuesday, September 22, 2009 6:47 PM
To: ''; ''
Cc: 'Cynthia.A.D''
Subject: Cervarix - Commitment

In regard to your commitment to a post-licensure analytic epidemiologic study to assess the risk of spontaneous abortion following Cervarix vaccination, please acknowledge agreement to the following timetable which states that you will conduct this trial according to the following schedule:

Final Protocol Submission: No later than 6 months after vaccine licensure

Study Start Date: No later than 12 months after protocol finalization

Final Report Submission: No later than 6 months after study completion


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

Page Last Updated: 04/13/2015
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English