Prediction of pertussis vaccine efficacy using a correlates of protection model.

A previously developed statistical model relates vaccine immune responses to protection against pertussis disease in a household contact setting. Before this model can be used to predict the risk of disease based on immune responses, it must be validated to demonstrate reliable predictions. The model is shown here to be validated in terms of statistical criteria (Prentice surrogacy measures) as well as predictive capability in an independent efficacy trial (meta-analysis).

Type I error and power in noninferiority/equivalence trials with correlated multiple endpoints: an example from vaccine development trials.

Clinical trials necessary for the development of new treatment often require testing of multiple endpoints for equivalence or noninferiority relative to an existing effective standard therapy. An example is a vaccine study with multiple antibody measurements in sera of subjects receiving a combination vaccine such as a pneumococcal vaccine, which contains many different serotypes of the pneumococcal organism. This article describes testing methods for the demonstration of simultaneous marginal equivalence or noninferiority of two treatments on each component of the response vector that follows a multivariate normal distribution.