They are also responsible for recording vital events, referral of severely sick children and mothers, and collecting health information about diarrhoea, acute respiratory infections and breast feeding and for family planning counseling and services, etc. Our study was conducted in the MCH-FP

intervention area and the study vaccines were distributed through the FSCs. Diarrhoea cases in the MCH-FP area are treated at home by a trained mother in each ‘bari’ (cluster of houses) called ‘bari mother’ through use of oral rehydration solution (ORS). CHRWs supervise the bari mothers and provide ORS. More severe cases SAHA HDAC are referred to the hospital by the bari mothers. Patients with diarrhoea are provided free treatment by the ICDDR,B hospital in Matlab or at the Community Treatment Centre at Nayergaon where there are an inpatient facilities. The other three sub-centres do not have inpatient facilities. The Matlab hospital treats about 12,000 to 15,000 diarrhoea patients each year and the Nayergaon Centre treats about 800–1000 diarrhoea patients each year. Because of the long standing relationship of the ICDDR,B with the community, and because these centres are known to provide high quality care to patients with diarrhoea, nearly all patients with severe diarrhoea living in the HDSS area (as well as the surrounding areas) come to an ICDDR,B

facility when they have severe diarrhoea. The clinical trial was part of an Asian study (Bangladesh and Vietnam) and was conducted from March 2007 to March 2009. Eligible children were identified through second Matlab HDSS database LGK-974 in vivo [21].

A few days after birth field workers hired for this study from the community briefed all mothers about this rotavirus vaccine study. They used a brief information sheet containing the basic information regarding the study vaccine. The information provided to the mothers earlier helped them in understanding the contents of the long consent form in giving consent during enrollment. Healthy infants between 4 and 12 weeks of age were eligible for enrollment and were randomly assigned 1:1 ratio to receive either three oral doses of PRV or placebo at approximately 6 weeks, 10 weeks and 14 weeks of age along with other routine vaccines (oral poliovirus vaccine [OPV], Bacillus Calmette-Guérin [BCG], diphtheria-tetanus-whole cell pertussis [DTPw] and hepatitis B [HepB]) of the Expanded Program on Immunization (EPI) schedule. Vaccination was organized at 41 fixed-site clinics twice/month. Twelve field-workers routinely visited study participants at their homes for nearly two years as part of the safety and efficacy follow-up. Telephone contact was made in case the mothers along with the participants were not available at home due to visit to relatives home for social visit. Field-workers visited all children at 7 days and 14 days after each dose and, subsequently once a month, until the end of the follow-up period.