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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.

Lievens, M., Aponte, J. J., Williamson, J., Mmbando, B., Mohamed, A., Bejon, P. and Leach, A. (2011) 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, 10 (222). pp. 1-7. ISSN 1475-2875

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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.

Item Type: Article
Keywords: Malaria, Vaccine, African, Tanzania, statistical method, evaluation of vaccine, vaccine efficacy
Subjects: Malaria > Vaccines
Divisions: Ifakara Health Institute > Biomedical
Depositing User: Mr Joseph Madata
Date Deposited: 18 Jul 2012 06:42
Last Modified: 16 Aug 2012 15:57
URI: http://ihi.eprints.org/id/eprint/24

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