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Vaccines, Blood & Biologics

Partial Response to Email of Oct 15, 2007 - Cervarix, October 23, 2007

From: Edward.M.Yuhas@gsk.com
To: Sullivan, Helen M;
Subject: Cervarix: Partial Response to Email of Oct 15, 2007
Date: Tuesday, October 23, 2007 11:22:02 AM

Helen, At Sharon Shapowal's request, I am sending you information regarding the treatment regimens that the 6 patients (identified in your Oct 15, 2007 email) received. The information is as follows: PID: 01605 (HSV-016). Received HSV vaccine using an adjuvant containing MPL (gD2t AS04). PID: 03869 (HSV-017). Received HSV vaccine using an adjuvant containing MPL (gD2t AS04). PID: 01435 (HSV-007). Received HSV vaccine using an adjuvant containing MPL (gD2t AS04). PID 2475 (HPV-008). Received Cervarix (with AS04 adjuvant containing MPL). PID 14411 (HPV-008). Received Havarix (contains MPL but without AS04). PID: 1020 (HPV-008). Received Cervarix (with AS04 adjuvant containing MPL). Please note that information (unblinded) regarding pids 01605, 03869 and 01435 was contained in our submission of Sep 28, 2007 to the BLA (sequence #0016) (Module 5.3.5.3, the study report body, Appendix A-III.) If you have any additional questions on this information, please let me know. A formal submission of this information to the BLA will be made shortly. The "source documentation" also requested by FDA in the aforementioned email is being acquired and will also be sent to you shortly. Regards

"EMF <fda.hhs.gov>" made the following annotations.
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