title: 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.
abstract: 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.
authors.affiliation: International Vaccine Institute, Seoul, South Korea. camilo_acosta2003@yahoo.com
authors.forename: Camilo J
authors.initials: CJ
authors.lastname: Acosta
authors.forename: Claudia M
authors.initials: CM
authors.lastname: Galindo
authors.forename: Mohammad
authors.initials: M
authors.lastname: Ali
authors.forename: Remon Abu
authors.initials: RA
authors.lastname: Elyazeed
authors.forename: R Leon
authors.initials: RL
authors.lastname: Ochiai
authors.forename: M Carolina
authors.initials: MC
authors.lastname: Danovaro-Holliday
authors.forename: Anne-Laure
authors.initials: AL
authors.lastname: Page
authors.forename: Vu Dinh
authors.initials: VD
authors.lastname: Thiem
authors.forename: Yang
authors.initials: Y
authors.lastname: Jin
authors.forename: Jin Kyung
authors.initials: JK
authors.lastname: Park
authors.forename: Hyejon
authors.initials: H
authors.lastname: Lee
authors.forename: Mahesh K
authors.initials: MK
authors.lastname: Puri
authors.forename: Bernard
authors.initials: B
authors.lastname: Ivanoff
authors.forename: Magdarina D
authors.initials: MD
authors.lastname: Agtini
authors.forename: Rooswanti
authors.initials: R
authors.lastname: Soeharno
authors.forename: Cyrus H
authors.initials: CH
authors.lastname: Simanjuntak
authors.forename: Narain H
authors.initials: NH
authors.lastname: Punjabi
authors.forename: Do Gia
authors.initials: DG
authors.lastname: Canh
authors.forename: Dipika
authors.initials: D
authors.lastname: Sur
authors.forename: Qamaruddin
authors.initials: Q
authors.lastname: Nizami
authors.forename: Byomkesh
authors.initials: B
authors.lastname: Manna
authors.forename: Dong
authors.initials: D
authors.lastname: Bai-qing
authors.forename: Dang Duc
authors.initials: DD
authors.lastname: Anh
authors.forename: Yang
authors.initials: Y
authors.lastname: Honghui
authors.forename: Sujit Kumar
authors.initials: SK
authors.lastname: Bhattacharya
authors.forename: Zulfikar
authors.initials: Z
authors.lastname: Bhutta
authors.forename: Dang Duc
authors.initials: DD
authors.lastname: Trach
authors.forename: Zhi-Yi
authors.initials: ZY
authors.lastname: Xu
authors.forename: Tikki
authors.initials: T
authors.lastname: Pang
authors.forename: Allan
authors.initials: A
authors.lastname: Donner
authors.forename: John D
authors.initials: JD
authors.lastname: Clemens
mesh_terms: D000293:Adolescent; D000328:Adult; D002648:Child; D002675:Child, Preschool; D002681:China / Q000453:epidemiology; D016000:Cluster Analysis; D003906:Developing Countries; D006801:Humans; D007214:Indonesia / Q000453:epidemiology; D007223:Infant; D008875:Middle Aged; D010154:Pakistan / Q000453:epidemiology; D010342:Patient Acceptance of Health Care; D011135:Polysaccharides, Bacterial / Q000009:adverse effects / Q000627:therapeutic use*; D011159:Population Surveillance / Q000379:methods; D015995:Prevalence; D012485:Salmonella typhi / Q000302:isolation & purification; D014435:Typhoid Fever / Q000453:epidemiology / Q000382:microbiology / Q000517:prevention & control*; D014436:Typhoid-Paratyphoid Vaccines / Q000009:adverse effects / Q000627:therapeutic use*; D014744:Vietnam / Q000453:epidemiology
chemical_list: D011135:Polysaccharides, Bacterial; D014436:Typhoid-Paratyphoid Vaccines; C057664:Vi polysaccharide vaccine, typhoid