This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.

Abstract Details

Activity Number: 513
Type: Contributed
Date/Time: Wednesday, August 4, 2010 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #306906
Title: Considerations in Vaccine Lot Consistency Trials
Author(s): Xiao Sun*+ and Joshua Chen
Companies: Merck Research Laboratories and Merck Research Laboratories
Address: 351 N. Sumneytown Pike, North Wales, PA, 19454,
Keywords: vaccine trial ; lot consistency ; power

Demonstration of lot consistency in randomized clinical trials using three consecutively manufactured lots is generally required prior to licensure of an experimental vaccine. Lot consistency is declared if the 95% CI of the ratios of geometric mean of titers for each of the three pairs of lots is contained within a prespecified margin. In many cases, lot consistency study is designed as a substudy embedded in a larger clinical trial with objectives other than lot consistency, for example, to show noninferior immune response between two age groups, with one age group within the lot consistency substudy and the other outside the substudy. In this presentation, we will discuss some statistical considerations for such a trial. In particular, we will discuss the impact of between-lot variability on the power of showing lot consistency and the appropriate strategy for the noninferiority test.

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