Bridging Studies for WHO Pn ELISA
Peter C. Giardina, Pfizer Inc. *Charles Tan, Pfizer Keywords: The measurement of serotype-specific anti-capsular polysaccharide antibodies has been and remains the mainstay of pneumococcal (Pn) vaccine evaluation. New method formats that allow the simultaneous measurement of antibodies to several antigens in small volumes of serum are urgently required to support the development of extended-valency Pn vaccines, especially for infant populations. Bridging studies are required to evaluate how well the new method formats agree in terms of technical measurement characteristics. Potential implications for clinical use of the new method format also have to be assessed. Goldblatt et al (2011) described a study that compared a new multiplexed method for measuring anti-Pn antibodies with the existing WHO consensus enzyme-linked immunosorbent assay (ELISA). In this presentation, we’ll review the experimental and statistical methodology used to compare an additional multiplexed assay format to the WHO ELISA format. Potential enhancements to be considered for design and analysis of future bridging studies are discussed.
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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