• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

  • Print
  • Share
  • E-mail

Section Contents Menu

Vaccines

August 29 Clinical Request - Cervarix, September 20, 2007

Gemignani, Helen S


From: Matt.Whitman@gsk.com
Sent: Thursday, September 20, 2007 2:04 PM
To: Sullivan, Helen M
Subject: RE: Cervarix - August 29 Clinical Request

Hi Helen - thanks for clarifying.
If you could forward this e-mail on to Dr. Miller and/or the reviewers, we can point her/them to some of the clinical narratives in the
Aug 29 request:
Here's the list and location in Module 5.3.5.3, Oceans Safety Output to Data Lock Point of September 30, 2006, with page
numbers.
From your Aug 29 request:
Study 008
PID 15532 - p. 652
PID 15218 - p. 648
PID 15465 - p. 366 (epilepsy/convulsion in request - abdominal pain in narrative)
PID 85968 - p. 568
PID 15553 - p. 367
PID 86051 - p. 721
Study 013
PID 1369 - p. 254
Study 015
PID 2371 - p. 125
PID 1520 - p. 280


"EMF <fda.hhs.gov>" made the following annotations.
------------------------------------------------------------------------------
This message was sent by GlaxoSmith Kline across the Internet in encrypted format and was succes
============================================