Analysis of Studies to Evaluate Immune Response to Combination Vaccines | Zendy

Amelia Dale Horne | Zendy; Peter A. Lachenbruch | Zendy; Pamela R. Getson | Zendy; Henry Hsu | Zendy

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Analysis of Studies to Evaluate Immune Response to Combination Vaccines

Author(s) -

Amelia Dale Horne,

Peter A. Lachenbruch,

Pamela R. Getson,

Henry Hsu

Publication year - 2001

Publication title -

clinical infectious diseases

Language(s) - English

Resource type - Journals

SCImago Journal Rank - 3.44

H-Index - 336

eISSN - 1537-6591

pISSN - 1058-4838

DOI - 10.1086/322566

Subject(s) - medicine , covariate , sample size determination , clinical trial , immunology , intensive care medicine , econometrics , statistics , mathematics

The development and evaluation of new combination vaccines is an important public health endeavor. Trials to evaluate these vaccines are customarily designed and analyzed as noninferiority studies. We explain the concept of noninferiority and highlight important issues that can be challenging in the statistical evaluation of these vaccines. Topics covered include end points, hypotheses, and analyses for comparing geometric mean concentrations (or titers) of antibody and proportion of vaccine recipients responding; covariate adjustment; the problem of multiplicity and its impact on sample size; and choice of a meaningful difference to rule out.

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