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.