SPf66 vaccine trial in Brazil: conceptual framework study design and analytical approach

This paper describes the study population and the study design of the phase III field trial of the SPf66 vaccine in Brazil. Assessment of validity and precision principles necessary for the appropriate evaluation of the protective effect of the vaccine are discussed, as well as the results of the pr...

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Bibliographic Details
Published in:Revista da Sociedade Brasileira de Medicina Tropical
Main Authors: M. Urdaneta, A. Prata, C.J. Struchiner, C.E. Tosta, P. Tauil, M. Boulos
Format: Article in Journal/Newspaper
Language:English
Published: Sociedade Brasileira de Medicina Tropical (SBMT) 1996
Subjects:
Online Access:https://doi.org/10.1590/S0037-86821996000300007
https://doaj.org/article/34f7c37043b54ad5895d5e9d382a2f2f
Description
Summary:This paper describes the study population and the study design of the phase III field trial of the SPf66 vaccine in Brazil. Assessment of validity and precision principles necessary for the appropriate evaluation of the protective effect of the vaccine are discussed, as well as the results of the preliminary analyses of the gathered data. The analytical approach for the estimation of the protective effect of the vaccine is presented. This paper provides the conceptual framework for future publications.