title: Statistical methodology for the evaluation of vaccine efficacy in a phase III multi-centre trial of the RTS, S/AS01 malaria vaccine in African children.
abstract: 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.
authors.affiliation: GlaxoSmithKline Biologicals, Wavre, Belgium. marc.lievens@gskbio.com
authors.forename: Marc
authors.initials: M
authors.lastname: Lievens
authors.forename: John J
authors.initials: JJ
authors.lastname: Aponte
authors.forename: John
authors.initials: J
authors.lastname: Williamson
authors.forename: Bruno
authors.initials: B
authors.lastname: Mmbando
authors.forename: Ali
authors.initials: A
authors.lastname: Mohamed
authors.forename: Philip
authors.initials: P
authors.lastname: Bejon
authors.forename: Amanda
authors.initials: A
authors.lastname: Leach
mesh_terms: D000349:Africa; D056808:Biostatistics / Q000379:methods*; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D006801:Humans; D007117:Immunization, Secondary / Q000379:methods; D007223:Infant; D008288:Malaria / Q000276:immunology* / Q000517:prevention & control*; D017780:Malaria Vaccines / Q000008:administration & dosage / Q000276:immunology*; D016896:Treatment Outcome; D014611:Vaccination / Q000379:methods
chemical_list: D017780:Malaria Vaccines