Published in Medical Letter on the CDC and FDA, July 10th, 2005
"Part 2 of this series investigates the statistical considerations of vaccine evaluation in an active-control trial. In particular, the strengths and weaknesses of the noninferiority methodology will be explored and contrasted for T-cell independent (does not elicit a memory response) and T-cell dependent (elicits a memory response) vaccines. At present, the noninferiority model is widely accepted as the primary tool for comparing the immunogenicity of a new or reformulated vaccine to an already existing licensed product," scientists writing in...
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