Participating sites were located in rural Kassena-Nankana district, Ghana; rural Karemo division, Siaya district, Nyanza province, Western Kenya; urban Bamako, Mali; rural Matlab, Bangladesh; and urban and periurban Nha Trang, Vietnam. The design and efficacy results of these trials have been previously reported [7] and [8]. In summary, participants were randomly assigned to receive three doses of PRV or placebo in a 1:1 ratio at approximately 6, 10 and 14 weeks of age. Following the first dose of study Selleck GSK1349572 vaccine, participants were visited at home at least monthly by field workers through up to 24

months of age to remind parents to present to a study medical facility if their child experienced an episode of acute gastroenteritis (AGE; defined as 3 or more looser-than-normal stools and/or forceful vomiting within a 24-h period). A common study protocol, symptom collection standard operating procedure (SOP), and data collection forms were used across all study sites. At the medical facility, Everolimus datasheet signs and symptoms (i.e. those items contained within the VSS and CSS) from the start of the episode

through discharge were collected by a trained study clinical staff (Table 1). Because the scoring systems require capture of signs and symptoms since the beginning of an episode, the information collected by study clinical staff was based on a combination of parental recall of symptoms before presentation and clinical staff examination and parental recall while at the medical facility. In previous trials [6] and [24], diary cards were provided to parents at enrollment so that they could record AGE symptoms of enrolled children if an episode occurred after vaccination. However, in these

trials, parental diary cards were not utilized mafosfamide due concerns that limited literacy in certain trial sites would prevent accurate data collection. In these trials, the VSS was modified in three ways. First, the score for “treatment” was modified from responses of “Hospitalization (score = 2)” and “Rehydration (score = 1)” in the original VSS to the revised “hospitalized or received IV rehydration (score = 2)” and “received oral rehydration medication (score = 1)”, respectively. Secondly, dehydration was measured using the WHO IMCI dehydration criteria, rather than based on measuring acute weight loss. The guidelines include clinical signs that are used to evaluate the level of dehydration in children: appearance, sunken eyes, thirst, skin pinch and respiration. Although guidelines no longer advocate use of respiration, this parameter was included in this study since it was of historical importance in previously reported WHO assessments of dehydration. Finally, an axillary temperature was measured and this was converted to rectal during analysis.