Abstract
The best method of evaluating the efficacy of a vaccine is to compare the incidence of the disease against which it is prepared in randomized, placebo-controlled clinical trials involving vaccinated and unvaccinated subjects. In the case of Streptococcus pneumoniae, the proposed alternatives are evaluations of the so-called "correlates of protection" (i.e. markers of the vaccine-induced immune response that predict protection from infection and disease) and nasopharyngeal carriage. The aim of this paper is to discuss the most important limitations of the immunological criteria suggested for licensing new pneumococcal vaccines, and comment on the use of carriage as an endpoint for evaluating efficacy. Data showed why the use of a single serological correlate of protection cannot be considered the best means of evaluating pneumococcal vaccines and highlighted the importance of using carriage for efficacy evaluation but in the meantime the need to develop new sensitive and specific methods.