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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

HPV-010 Subject Treatment Allocation - Cervarix, September 26, 2007

To: Mr. Matthew Whitman
File: STN 125259/0 CERVARIX
RE: HPV-010 Subject Treatment Allocation
Date: September 26, 2007


Please refer to study HPV-010. Within the meta-analysis for potentially autoimmune events, subject PID #1658, who received either Gardasil or Cervarix, developed possible MS at 33 days after dose 2 of blinded study material. We acknowledge that the study is ongoing, but please provide the treatment allocation for this subject by the unblinded statistician as soon as possible.