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

• 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: Vacina antimalárica; Ensaio de campo SPf66; Eficácia vacinal; Arctic medicine. Tropical medicine; RC955-962; Arctic
• Online Access: https://doi.org/10.1590/S0037-86821996000300007; https://doaj.org/article/34f7c37043b54ad5895d5e9d382a2f2f

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.