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Vaccines, Blood & Biologics

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Vaccines

Unblinded Tables - Cervarix, August 1, 2007

To: Mr. Matt Whitman
File: STN 125259/0 - CERVARIX
RE: Unblinded Tables
Date: August 1, 2007


We have the following comments pertaining to unblinded tables.
1. Thank you for your submission of July 26, 2007 (125259.7). In Section 2.7.4 - Summary of Clinical Safety, we are requesting that you submit unblinded versions of the following additional tables to the BLA:


Table 38 p. 114
Table 39 p. 116
Table 44 p. 148
Table 46 p. 151
Table 47 pp. 153-154
Table 57 pp. 171-172
Table 58 p. 174
Table 59 p. 175 (Within this table, please indicate the treatment the mother received, the time from the dose of the last vaccine to conception, and the time from last vaccination to diagnosis of event).
Table 60 p. 176
Table 61 p. 177