Premium
A multi‐country cluster randomized controlled effectiveness evaluation to accelerate the introduction of Vi polysaccharide typhoid vaccine in developing countries in Asia: rationale and design
Author(s) -
Acosta Camilo J.,
Galindo Claudia M.,
Ali Mohammad,
Elyazeed Remon Abu,
Leon Ochiai R.,
Carolina DanovaroHolliday M.,
Page AnneLaure,
Thiem Vu Dinh,
Jin Yang,
Park Jin Kyung,
Lee Hyejon,
Puri Mahesh K.,
Ivanoff Bernard,
Agtini Magdarina D,
Soeharno Rooswanti,
Simanjuntak Cyrus H.,
Punjabi Narain H.,
Canh Do Gia,
Sur Dipika,
Nizami Qamaruddin,
Manna Byomkesh,
Baiqing Dong,
Anh Dang Duc,
Honghui Yang,
Bhattacharya Sujit Kumar,
Bhutta Zulfikar,
Trach Dang Duc,
Xu ZhiYi,
Pang Tikki,
Donner Allan,
Clemens John D.
Publication year - 2005
Publication title -
tropical medicine and international health
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.056
H-Index - 114
eISSN - 1365-3156
pISSN - 1360-2276
DOI - 10.1111/j.1365-3156.2005.01517.x
Subject(s) - typhoid fever , randomized controlled trial , cluster (spacecraft) , typhoid vaccine , medicine , public health , vaccine trial , environmental health , vaccination , vaccine efficacy , cluster randomised controlled trial , virology , computer science , nursing , surgery , programming language
Summary Phase‐III vaccine efficacy trials typically employ individually randomized designs intended to ensure that measurements of vaccine protective efficacy reflect only direct vaccine effects. As a result, decisions about introducing newly licensed vaccines into public health programmes often fail to consider the substantially greater protection that may occur when a vaccine is deployed in public health programmes, due to the combination of direct plus indirect vaccine protective effects. Vaccine total protection can be better evaluated with cluster randomized trials. Such a design was considered to generate policy relevant data to accelerate the rationale introduction of the licensed typhoid fever Vi polysaccharide (PS) vaccine in Asia by the Diseases of the Most Impoverished (DOMI) typhoid fever programme. The DOMI's programme multi‐country study is one of the largest cluster randomized vaccine trials ever mounted in Asia, which includes approximately 200 000 individuals. Its main objective is to determine the effectiveness of a licensed Vi PS vaccine. The rationale and design of this study are discussed. Preliminary results are presented that determined the final planning of the trial before immunization. Important methodological and practical issues regarding vaccine cluster randomized designs are illustrated.