In Asia, approximately 45% of children younger than 5 years of age are hospitalized due to rotavirus [20]. Because of the history of previous rotavirus vaccine candidates, which have shown low efficacy in developing world countries [2], efficacy studies with PRV were recently conducted in developing countries in these regions [21] and [22] because differences in host populations,

associated health conditions, and the epidemiology of PFI-2 nmr rotavirus disease among children in the developing world could affect efficacy and immunogenicity of the vaccine. Given the history of rotavirus vaccine performance in the developing world, WHO expert Committee on Biological Standardization recommended that the efficacy of ‘new’ rotavirus vaccine

should be demonstrated in diverse geographical regions including developing countries before widespread implementation [23]. A double-blind, placebo-controlled, clinical trial was conducted to evaluate the efficacy of PRV against severe rotavirus gastroenteritis (RVGE) in rural Matlab, Bangladesh [21]. The study was conducted in multiple vaccination centres in a rural community following good clinical practice (GCP) guidelines, maintaining cold chain requirements and successful follow up of the study participants. Given that this was the first trial with clinical outcomes for any rotavirus vaccine conducted in MAPK Inhibitor Library chemical structure Bangladesh, the methodology, including operation, logistics, and lessons-learned are described in this report. The study was conducted in rural Bangladesh at Matlab, where the International Centre for Diarrhoeal Disease Research, Bangladesh (ICDDR,B) has been maintaining a field research site since 1963 (Fig. 1).

Matlab is a low-lying riverine area which lies 55 km south-east about of Dhaka, the capital of Bangladesh. The principal occupations in the Matlab area are farming and fishing. Since 1966 a Health and Demographic Surveillance System (HDSS), which consists of regular cross-sectional censuses and longitudinal registration of vital events, has been maintained in the area [24]. A central treatment facility, Matlab hospital, staffed by physicians and paramedics provides free therapy for 12,000–15,000 diarrhoea patients a year. The study was conducted in the “intervention area” where the ICDDR,B provides maternal, child health and family planning services (MCH-FP) [25]. The health service infrastructure in the ICDDR,B intervention area includes (i) Fixed Site Clinics (FSC) housed in the community health research worker’s (CHRW’s) home, which is run by a team of 41 well trained CHRWs, and (ii) four Sub-Centre Clinics, each covering about 28,000 people (called a block), run by paramedical staff. The total population covered in the ICDDR,B HDSS intervention area is about 112,000.