[Design of field studies on vaccines which involves capturing indirect effect].

Zhonghua Liu Xing Bing Xue Za Zhi

Department of Epidemiology and Health Statistics, School of Medicine, Zhejiang University, Hangzhou, China.

Published: February 2011

For most variety of vaccines, two types of effects-direct and indirect, can result from immunization programs. Unimmunized individuals in the population that receive immunization program can benefit from the vaccines in addition to the protection from immunization. The classical vaccine trails allocate individuals into study and control arms with individual randomization, so the programs' cost-benefit is underestimated due to the impossible measurement on indirect effect. The objectives of the present work are to introduce the conceptual framework, developed by Halloran et al, for four types of study designs that differentiate and account for direct, indirect, total and overall effects of intervention programs, and to explain the relationships of these effects as well. With the examples of field trails of oral cholera vaccines in Bangladesh and Vi typhoid vaccine in India, further issues refer to the identification of indirect effect. The application in practice is also discussed.

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