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BACKGROUND: There has been much debate about the appropriate statistical methodology for the evaluation of malaria field studies and the challenges in interpreting data arising from these trials. METHODS: The present paper describes, for a pivotal phase III efficacy of the RTS, S/AS01 malaria vaccine, the methods of the statistical analysis and the rationale for their selection. The methods used to estimate efficacy of the primary course of vaccination, and of a booster dose, in preventing clinical episodes of uncomplicated and severe malaria, and to determine the duration of protection, are described. The interpretation of various measures of efficacy in terms of the potential public health impact of the vaccine is discussed. CONCLUSIONS: The methodology selected to analyse the clinical trial must be scientifically sound, acceptable to regulatory authorities and meaningful to those responsible for malaria control and public health policy.

Original publication

DOI

10.1186/1475-2875-10-222

Type

Journal article

Journal

Malar J

Publication Date

04/08/2011

Volume

10

Keywords

Africa, Biostatistics, Child, Child, Preschool, Double-Blind Method, Humans, Immunization, Secondary, Infant, Malaria, Malaria Vaccines, Treatment Outcome, Vaccination