Topics in the Design of Multivalent Vaccine Studies
Ivan Chan, Merck Research Labs *Meihua Wang, Merck Research Labs Keywords: Multivalent vaccines, superiority, non-inferiority, overall type 1 error Multivalent vaccines, containing multiple antigens, pose specific issues in design and analysis. We present several topics that have been motivated by a real immunogenicity study assessing the value of sequential administration of two vaccines. These issues are: (i) criteria for defining a superiority margin, in the absence of a correlate of protection; (ii) the relationship between non-inferiority and superiority hypotheses, for different endpoints; (iii) considerations of the overall type 1 error for the study in the presence of multiple endpoints. We address each of these issues for the study in question, and describe broader applicability of our findings.
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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
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April 30 - May 28, 2014
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June 4, 2014
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August 8 - August 22, 2014
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August 11, 2014
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September 1, 2014
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September 15, 2014
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September 22 - September 24, 2014
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