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 trail 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.
Urdaneta
M
M
Escola Nacional de Saúde Pública, Fundação Oswaldo Cruz, Faculdade de Medicina do Triângulo Mineiro, Uberaba, Minas Gerais.
Prata
A
A
Struchiner
C J
CJ
Tosta
C E
CE
Tauil
P
P
Boulos
M
M
D000293:Adolescent; D000328:Adult; D000818:Animals; D001938:Brazil / Q000453:epidemiology; D002648:Child; D004197:Disease Reservoirs; D005260:Female; D006801:Humans; D017780:Malaria Vaccines / Q000276:immunology*; D016778:Malaria, Falciparum / Q000401:mortality / Q000517:prevention & control; D008297:Male; D008875:Middle Aged; D010963:Plasmodium falciparum / Q000276:immunology*; D015800:Protozoan Proteins / Q000276:immunology*; D011994:Recombinant Proteins; D015203:Reproducibility of Results; D012107:Research Design; D012424:Rural Population / Q000706:statistics & numerical data; D017741:Survivors; D014614:Vaccines, Synthetic / Q000276:immunology*
D017780:Malaria Vaccines; D015800:Protozoan Proteins; D011994:Recombinant Proteins; C066269:SPf66 protein, Plasmodium; D014614:Vaccines, Synthetic