4%, 95% CI: 25.5,98.2), but not during the second year (−54.7%, 95% CI: −1752.7,82.3); only 5 RVGE occurred during the second year. For every 100 person-years of follow-up for the entire study period, 1.8 cases of severe RVGE were prevented by PRV; during the first year of life, 3.3 cases of severe RVGE were prevented for 100 person-years.

For this analysis of clinic based-data, PRV did not have significant efficacy against all or severe gastroenteritis of any cause (Table 2). Although there was a slight increase in severe non-rotavirus gastroenteritis among the PRV group, this difference was not significant during the entire follow-up period (VE −15.1%, 95% CI: −55.0,59.2). In the intention-to-treat analysis of the entire study period, there were 6 cases of severe RVGE in PRV recipients and 15 cases in placebo recipients, check details yielding an efficacy of 59.1% (95% CI: 11.5,87.0). In the first year of life in the intention-to-treat analysis, there were 3 RVGE cases among PRV recipients and 13 among placebo recipients, yielding an efficacy against severe RVGE of 76.4% (95% CI: 14.1,95.7). Among HIV-infected children identified at enrollment who were evaluable during the follow-up period, there was one case of severe RVGE among PRV recipients and no cases among placebo recipients (IRR undefined,

Table 3). PS-341 mw There were more cases of severe gastroenteritis due to any cause among HIV-infected PRV recipients than among HIV-infected placebo recipients,

but this did not meet statistical significance (5/21 vs. 1/17 respectively, IRR 7.6, 95% CI: 0.85,361). None of the 8 infants who developed HIV-infection after enrollment during the HIV-testing at 6, 9 and 12 weeks, presumably though breast-feeding, experienced RVGE after they tested HIV-positive. One child, a PRV recipient, developed severe RVGE at 8 months of age, before having a newly positive PCR test for HIV at 12 months. Montelukast Sodium Among almost 15,000 home visits, a total of 3143 episodes of gastroenteritis in the prior 2 weeks were reported, of which 199 (6.3%) were classified with severe dehydration and 488 (15.5%) with moderate dehydration (Table 4). The vaccine efficacy against gastroenteritis with severe dehydration during the entire study period was 29.7% (95% CI: 2.5,49.3); efficacy during the first year was 34.4% (95% CI: 5.3,54.6) and during the second year was 18.3% (95% CI: −44.9,54.0). During the entire follow-up period, 12 cases of gastroenteritis with severe dehydration per 100 person-years were prevented by PRV (95% CI: 3,22), and 19 cases per 100 person-years in the first year (95% CI: 4,34). Using the modified Clark scoring system, although fewer gastroenteritis cases were classified as severe than when using IMCI criteria, PRV showed a similar point estimate for protective efficacy against severe gastroenteritis in the first year, although not statistically significant (34.8%, 95% CI: −19.6,64.4).