Bridging Studies for Assays used in Vaccine Clinical Trials
*Tsai-Lien Lin, FDA Keywords: As efficacy trials for many vaccines have become or are becoming unfeasible, demonstration of vaccine efficacy relies heavily on the immunogenicity endpoints. Bridging studies are often needed for assays used to measure antibody levels before and after vaccination. This presentation will provide an overview of various situations where bridging studies are conducted and appropriate questions that should be addressed under different situations. The challenge of linking a new assay to a previously established correlate of protection will be discussed. Real examples will be used to illustrate the issues, with a special focus on the assays for pneumococcal vaccines.
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Key Dates
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November 1 - December 17, 2013
Online proposal submission for a session, short course and Town Hall Open -
January 6 - March 11, 2014
Online proposal submission for Roundtables Open -
April 30 - May 28, 2014
Abstract Submission Open -
June 4, 2014
Online Registration Opens -
August 8 - August 22, 2014
Invited Abstract Editing -
August 11, 2014
Short Course materials due from Instructors -
September 1, 2014
Housing Deadline -
September 15, 2014
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 22 - September 24, 2014
Marriott Wardman Park, Washington, DC