Methodology
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
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* Corresponding author: Marc Lievens marc.lievens@gskbio.com
1 GlaxoSmithKline Biologicals, Wavre, Belgium
2 Centre de Recerca en Salut Internacional de Barcelona (CRESIB), Hospital Clínic, Universitat de Barcelona, Spain
3 KEMRI/CDC Research and Public Health Collaboration, Kisumu, Kenya
4 National Institute for Medical Research, Dar es salaam, Tanzania
5 Ifakara Health Institute, Ifakara, Tanzania
6 KEMRI-Wellcome Trust Research Program, Kilifi, Kenya
Malaria Journal 2011, 10:222 doi:10.1186/1475-2875-10-222
Published: 4 August 2011Abstract
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.
Trial registration
Clinicaltrials.gov NCT00866619