For a given subject, the total duration of the study was 12–24 months depending on when they were enrolled. For the evaluation of safety, all subjects were followed for serious adverse events (SAEs), including intussusception for 14 days following any vaccination and for vaccine-related SAEs and deaths until the end of the study. The vaccines for the study were preserved initially in the cold room of ICDDR,B Dhaka Virology laboratory. The temperature was always maintained at 2–8 °C. Thereafter the vaccines were transported to Matlab
(3 h drive from Dhaka) in multiple foam boxes. At Matlab the vaccines were kept in the three refrigerators supported by a 24-h Panobinostat supplier stand by generator. One attendant remained on duty during the night at Matlab for the cold room in case of any emergencies (power failure, alarm etc.). Vaccines were transported daily morning from Matlab to multiple FSCs in the foam boxes with cold packs. These were supported by a back-up box which contain only ice packs to be used in case of increase in temperature of the vaccine boxes. The INCB024360 molecular weight temperature was monitored during transportation and storage at field site by using a thermometer (Fisher Scientific) which allowed to observe temperature from outside. For the evaluation of immunogenicity a sub-set of study subjects participated in the immunogenicity cohort
of the study. Blood samples were collected during the period between July 15, 2007 and November 26, 2007. Two ml of venous blood were collected at the FSC consecutively from 150 participants prior to Dose 1 and 147 participants 14 days (±3 days) after Dose 3 of PRV/placebo. Blood samples were transferred to Matlab hospital and laboratory and serum was separated and stored within 2 h of collection of samples. Blood samples were evaluated for antibody responses, serum rotavirus-specific total IgA by enzyme-linked immunoassay (EIA) as well as serum neutralizing antibodies (neutralization-based EIA), to PRV as described [21], [26] and [27]. A catchment design was employed including surveillance for acute gastroenteritis
at Matlab hospital and Nayergaon community diarrhoea treatment centre in the study areas [21]. Stool samples were obtained from participants with gastroenteritis who reported to a medical facility as soon as possible [21]. Clinical and laboratory data were collected on standardized forms for all participants attending to Matlab and Nayergaon with symptoms of AGE. Study nurse collected all parameters (temperature, numbers and consistency of stool passed, vomiting episodes, behaviour) every two hourly to assess the severity of GE. All cases of acute gastroenteritis episodes (AGE) among participants in the study presenting to these facilities were evaluated for the presence of rotavirus antigen in the stool samples.
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