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Vaccines

Record of Telephone Conversation - Cervarix, October 24, 2007

System Info - 94751 GEMIGNANI, HELEN 20-May-2009 18:16:52 GEMIGNANI

RECORD OF TELEPHONE CONVERSATION

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

Product:
Human Papillomavirus Vaccine, AS04 Adjuvant-Adsorbed

Applicant:
GlaxoSmithKline Biologicals

Telecon Date/Time: 24-OCT-2007 12:00 AM Initiated by FDA? Yes
Telephone Number: 610 787-3726

Communication Categorie(s):
Information Request

Author: HELEN GEMIGNANI

Telecon Summary:
Clinical: Source document request

FDA Participants:

Non-FDA Participants:

Trans-BLA Group: No


Related STNs: None

Related PMCs: None

Telecon Body:
To: Mr. Matthew Whitman
File: STN 125259/0 CERVARIX
RE: Source Document Request
Date: October 24, 2007

Please refer to your September 28, 2007, submission to the BLA and the Final Integrated Analysis Report (Analysis Levels 1, 2, 3, and 4). There were cases of neuroinflammatory events in both the vaccine (2) and control (2) arms. Please provide the source documents for the following neuro-inflammatory disease cases:

1) Study: ----------b(4)----------
Subject #16003 - MS at 376 days Post Dose (PD) #1
(vaccine arm)
2) Study: ----------b(4)----------
Subject #03332 - encephalitis at 5 months PD #1 (vaccine arm)
3) Study: ----------b(4)----------
Subject # unknown - encephalitis (non-MPL arm)
4) Study: ----------b(4)----------
Subject #03332 - encephalitis 168 days PD #1 (non-MPL arm)

In addition please provide source documentation for the following cases:
5.) Study: ----------b(4)----------
Subject #148 - cutaneous vasculitis at 182 days PD #2
6) Study ----------b(4)----------
Subject #120 - ulcerative colitis
7) Study: ----------b(4)----------
Subject #50 - Crohn's disease at 149 days PD #4
8) Study: ----------b(4)----------
Subject #19 - sarcoidosis at 61 days PD #7
9) Study: ----------b(4)----------
Subject #103 - sarcoidosis at 130 days PD #3
10) Study: ----------b(4)----------
Subject #111 - rheumatoid arthritis day 3 PD #2
11) Study: ----------b(4)----------
Subject 1060 - thrombocytopenia day 0 PD #2
12) Study: ----------b(4)----------
Subject #5541 - arthritis with knee replacement at 79 days PD #1
13) Study: ---b(4)-- Study -----b(4)----(BB-IND ---b(4)--)
Subject # "unknown" enrolled in ---b(4)-- group – thrombocytopenia
14) Study: -----b(4)---- Studies-01,03,06,08,09,10 and 11 (BB-IND ---b(4)--)
Subject #37 enrolled in ---b(4)-- group – thrombocytopenia
15) Study: -----b(4)---- Study ---b(4)-- (BB-IND ---b(4)--)
Subject #35 - thrombocytopenia
16) Study: -----b(4)---- Study ---b(4)-- (BB-IND ---b(4)--)
Subject # “unknown", enrolled in Group 4 – thrombocytopenia