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

Malaria Journal

Methodology

John J Aponte¹  Marc Lievens²  Amanda Leach²  Ali Mohamed³  Philip Bejon⁴  John Williamson⁵  Bruno Mmbando⁶ 

[1] Centre de Recerca en Salut Internacional de Barcelona (CRESIB), Hospital Clínic, Universitat de Barcelona, Spain;GlaxoSmithKline Biologicals, Wavre, Belgium;Ifakara Health Institute, Ifakara, Tanzania;KEMRI-Wellcome Trust Research Program, Kilifi, Kenya;KEMRI/CDC Research and Public Health Collaboration, Kisumu, Kenya;National Institute for Medical Research, Dar es salaam, Tanzania;

关键词: Malaria;    Severe Malaria;    Vaccine Efficacy;    Booster Dose;    Clinical Malaria;   

DOI  :  10.1186/1475-2875-10-222

 received in 2011-03-03, accepted in 2011-08-04,  发布年份 2011

来源: Springer

【 摘 要 】

BackgroundThere 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.MethodsThe 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.ConclusionsThe 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.Trial registrationClinicaltrials.gov NCT00866619

【 授权许可】

CC BY   
© Lievens et al; licensee BioMed Central Ltd. 2011