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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

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Meta-Analysis of Adverse Events- Cervarix, September 4, 2007

To: Mr. Matthew Whitman
File: STN 125259/0 CERVARIX
RE: Meta-Analysis of Adverse Events
Date: September 4, 2007


Regarding your submission to the BLA dated Aug. 27, 2007, we request that you provide an analysis for testing the homogeneity of relative risks among the studies in the Level 2 analyses. In your response, please include the statistical analysis plan and the results.

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