Between groups, the percentages of children with adverse events were compared using Fisher’s Exact Test. The analysis for reactogenicity was performed on the intention-to-treat population (including all children who received at least 1 dose of vaccine). The number of children with general symptoms was determined for each group after administration of each vaccine dose and compared between groups. The analysis of immunogenicity was also performed for both

the per protocol and intention-to-treat populations (at least 2 doses of vaccine were required). The IgA seroconversion rate (with 95%CI) was calculated for each group to evaluate the immune TGF-beta inhibitor responses induced by the vaccines and geometric mean antibody titers (GMT) were calculated for those individuals who seroconverted. selleck inhibitor Viral shedding was calculated as the percentage of children shedding virus each day post-vaccination when stool samples were available. In addition, the percent of children who shed at least once during the 7-day observation period after each dose was also calculated. We first tested the safety of 2 doses of the higher titer vaccine (106.3 FFU/dose) in 29 adult volunteers aged 18–40 years. During the 30 days post-vaccination of each dose, no diarrhea or severe adverse reaction was reported by any of the volunteers. One month

after each dose, neither blood cell counts nor BUN concentration increased. Serum transaminase levels stayed below 40 IU/ml for >85% of volunteers or slightly elevated (42–56 IU/ml) in 10% of volunteers after 2 doses of vaccination. One individual had elevated levels of both SGOT and SGPT (71 and

48 IU/ml, respectively) before vaccination and the levels remained in this range after 2 doses of vaccine. No shedding of the vaccine virus occurred in these adults following vaccination. Thus the Ethical Review Committees allowed the vaccine to be tested further in healthy infants. A total of 200 subjects (119 boys and 81 girls) were enrolled in the infant study. Their mean age (±SD) was 8.7 ± 1.6 Oxymatrine weeks at the time they received the first dose and 17.2 (±1.6) weeks at the time of 2nd dose for groups 2L and 2H. For groups 3L and 3H (the 3-dose group), the mean age was 13 (±1.6) weeks at the time of 2nd dose and 17.9 (±1.6) at the 3rd dose. After each vaccine dose, the children gained weight and height normally and we found no difference between vaccination groups. The blood cell counts, serum transaminase levels and BUN were normal and no significant increase was observed over the range of normal healthy infants after administration of each vaccine dose. During the entire observation period (90 days after the first dose), no serious adverse events that required hospitalization and no cases of intussusception were recorded.