JSM 2004 - Toronto

Abstract #301116

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Activity Number: 339
Type: Contributed
Date/Time: Wednesday, August 11, 2004 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #301116
Title: Proportion of Similar Response to Evaluate Similarity of Immune Response in Vaccines Clinical Trials
Author(s): Katherine E.D. Giacoletti*+ and Joseph F. Heyse
Companies: Merck & Co., Inc. and Merck & Co., Inc.
Address: UNA-102, Blue Bell, PA, 19422,
Keywords: similarity ; equivalence
Abstract:

Studies to demonstrate the similarity of immune responses are important parts of vaccine clinical development programs. In such studies there is particular interest in demonstrating that the distributions of antibody responses are equivalent for multiple vaccine lots drawn from the manufacturing process and for different formulations of a vaccine. Traditionally, a comparison on the basis of Geometric Mean Titer is used for this analysis of equivalence. Proportion of Similar Response (PSR) has been proposed as an alternative method. We will investigate the properties of PSR analysis in the settings of (a) three or more distributions, (b) unequal variances, and (c) baseline covariate adjustments. The properties will be investigated using simulation methods. An example from a vaccine development program will be provided to illustrate the methods.

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Revised March 2004