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Activity Number:
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324
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Type:
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Contributed
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Date/Time:
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Tuesday, August 4, 2009 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #305107 |
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Title:
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Application of Subsampling Methods for the Correlation of Immunogenicity and Efficacy in Vaccine Trials
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Author(s):
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Yanli Zhao*+ and William Wang and Ivan S.F. Chan
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Companies:
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Merck & Co., Inc. and Merck & Co., Inc. and Merck & Co., Inc.
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Address:
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, , 19454,
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Keywords:
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biomarker ; case cohort ; vaccine ; correlation
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Abstract:
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In many large vaccine efficacy trials where time to event survival design is applied, validating a vaccine immunogenicity biomarker is an important task for future bridging purposes, yet sometimes it is often difficult or even infeasible to obtain immunogenicity measurements from the full cohort. The case-cohort and nested case-control designs have the potential to overcome this limitation due to their flexibility in subsampling. In this talk, we will review and discuss how to apply these case-control and case-cohort methods in vaccine studies. In addition, via simulation under various vaccine efficacy trial scenarios, we will compare the performance of these two subsampling methods and a "hybrid" method, with that from the method utilizing the full cohort.
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- The address information is for the authors that have a + after their name.
- Authors who are presenting talks have a * after their name.
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