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Activity Number:
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145
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Type:
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Contributed
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Date/Time:
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Monday, July 30, 2007 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #309684 |
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Title:
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Estimation of Long-Term Vaccine Efficacy and Waning Effects Using Surveillance Interval Data
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Author(s):
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Martha Lee*+ and Tsai-Lien Lin
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Companies:
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Food and Drug Administration and Food and Drug Administration
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Address:
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1401 Rockville Pike, Rockville, MD, 20852,
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Keywords:
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vaccine efficacy ; waning effects ; surveillance ; interval data ; breakthrough case
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Abstract:
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Introduction: In light of logistical and financial limitations of clinical trials for long periods of follow-up, epidemiologic data are often used in estimating long-term vaccine efficacy and waning effects. Many mathematical models have been proposed to investigate waning vaccine efficacy. In this study, we focus on the analytic methods for interval data collected through surveillance system. Methods: Breakthrough cases can be identified in surveillance system. We adapt the basic concept of non-inferiority to test effect preservation between two adjunct surveillance intervals. Waning effects can be detected as effect preservation fails. Results: We apply the proposed methods to both real-world and simulated datasets. Conclusion: This study is of importance in evaluating long-term vaccine efficacy.
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