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Activity Number: 422
Type: Roundtables
Date/Time: Wednesday, August 6, 2014 : 7:00 AM to 8:15 AM
Sponsor: Biopharmaceutical Section
Abstract #312981
Title: Vaccine Effectiveness Studies: Designs and Challenges
Author(s): Lihan Yan*+
Companies: FDA
Keywords: Vaccine Effectiveness ; Vaccine Efficacy
Abstract:

Studies for evaluating vaccine effectiveness have become increasingly difficult and costly for various reasons, including the rare disease rate, stringent effectiveness threshold required by the regulatory agency, and sometimes inability of using a placebo group for ethical reasons. While vaccine efficacy studies are typically performed pre-marketing, post-marketing effectiveness may be required when the vaccine is approved under the accelerated approval mechanism based on immune response data with reasonable predictability. This roundtable will focus discussion on various strategies of designing a vaccine efficacy/effectiveness study, either pre-licensure or post-licensure, and challenges in interpreting the analysis results. The participants are encouraged to share experiences in planning and analyzing data from the designed studies. The discussions will cover topics such as the test-negative effectiveness study design, cluster-randomization designs, and other more conventional designs.


Authors who are presenting talks have a * after their name.

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