Charles Darwin University

CDU eSpace
Institutional Repository

 
CDU Staff and Student only
 

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, Marc, Aponte, John J., Williamson, John, Mmbando, Bruno, Mohamed, Ali, Bejon, Philip and Leach, Amanda J. (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,10:1-7.

Document type: Journal Article
Attached Files (Some files may be inaccessible until you login with your CDU eSpace credentials)
Name Description MIMEType Size Downloads
Download this reading Leach_44331.pdf Published version application/pdf 1.13MB 49
Reading the attached file works best in Firefox, Chrome and IE 9 or later.

IRMA ID 75039815xPUB485
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
Author Lievens, Marc
Aponte, John J.
Williamson, John
Mmbando, Bruno
Mohamed, Ali
Bejon, Philip
Leach, Amanda J.
Journal Name Malaria Journal
Publication Date 2011
Volume Number 10
eISSN 1475-2875
Scopus ID 2-s2.0-79961108687
Start Page 1
End Page 7
Total Pages 7
Place of Publication United Kingdom
Publisher BioMed Central
HERDC Category C1 - Journal Article (DIISR)
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.

Trial registration
Clinicaltrials.gov NCT00866619
DOI http://dx.doi.org/10.1186/1475-2875-10-222   (check subscription with CDU E-Gateway service for CDU Staff and Students  check subscription with CDU E-Gateway in new window)
Additional Notes This is an Open Access article distributed under the terms of the Creative Commons Attribution License 2.0, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Description for Link Link to CC Attribution 2.0 License
URL https://creativecommons.org/licenses/by/2.0/


© copyright

Every reasonable effort has been made to ensure that permission has been obtained for items included in CDU eSpace. If you believe that your rights have been infringed by this repository, please contact digitisation@cdu.edu.au.

 
Versions
Version Filter Type
Access Statistics: 25 Abstract Views, 49 File Downloads  -  Detailed Statistics
Created: Tue, 24 Feb 2015, 12:37:03 CST