Compliance
to Selleck DAPT vaccine intake was high for subsequent doses; only 3.5% of infants did not receive all the three intended doses. Vaccine efficacy in children up to 2 years of age was 55.1% (95% CI 39.9 to 66.4; p < 0.0001); the vaccine efficacy in the second year of life of 48.9 (95% CI 17.4 to 68.4; p = 0.0056) was only marginally less than that in the first year of life [56.3% (95% CI 36.7 to 69.9; p < 0.0001)]. The results were similar in the intent-to-treat (ITT) population where up to 2 years efficacy of 55.8% (95% CI 41.3 to 66.7; p < 0.0001) did not differ substantially from that in the first [57.2% (95% CI 38.9 to 70.1; p < 0.0001)] or the second year of life at 49% (95% CI 17.5 to 58.4; p = 0.0055). There was no significant interaction of treatment group and site with vaccine efficacy (p = 0.4802). The secondary endpoint analyses strongly supported the primary analysis (Table 1). In the second year of life, the vaccine efficacy
against RVGE of any severity requiring hospitalization or supervised rehydration therapy, RVGE requiring hospitalization ≥6 h and severe GE of any etiology were 34.3% (95% CI 17.2 to 47.8), 35.9% (95% CI −9.1 to 62) and 10.9 (95% CI −17 to 31.8) respectively. For the genotype specific analysis, there were a total of 199 episodes of severe RVGE that occurred in 195 subjects up to 2 years of age. For this particular analysis, a subject could contribute more than one primary event if associated with a different genotype. Four subjects had more than one episode of severe RVGE with different genotypes; three in the vaccine group and one in the placebo. The most prevalent Screening Library supplier (85%) rotavirus genotypes identified in the 199 episodes were G1P[8]
(37%; n = 74), G2P[4] (31%; n = 61), G12P[6] (11%; n = 21) and G12P[8] (7%; n = 13). A post hoc analyses on 17-DMAG (Alvespimycin) HCl the genotype specific efficacy is consistent with the overall protective efficacy. The G9P[4] genotype had an imbalance of cases with nine in the vaccine group and one in the placebo group ( Table 2). Survival curves in the vaccine group compared with the placebo group showed a significantly increased cumulative proportion of infants without severe RVGE (Fig. 2). We calculated that 40 infants would need to be immunized to prevent one episode of severe RVGE in the first 2 years of life (95% CI 28.0 to 63.0) and 21 had to be immunized to prevent RVGE of any severity in the same period (95% CI 16.0 to 32.0). Fig. 3 displays the incidence rate ratios for the primary outcome and several secondary outcomes as a forest plot. In children up to 2 years of age, the incidence of severe RVGE per 100 person years was 1.3 in the vaccine group and 2.9 in the placebo group for an incidence rate ratio of 0.45 (95% CI 0.34 to 0.60) and an absolute rate reduction of 1.6 (95% CI 0.9 to 2.2).