The expected seroconversion was based on published data with Rotarix vaccine, which showed 58% seroconversion in Indian children given two doses of vaccine at eight and 12 weeks of age [23]. Variables were assessed using descriptive statistics, dispersion for continuous variables, frequency counts and marginal percentages with 95% confidence intervals for categorical variables. Comparisons between the two groups were done using t-tests for normally distributed variables (or non-parametric tests

for non-normally distributed variables) and chi-square tests for categorical variables. All differences Tanespimycin in vitro were considered statistically significant if the two-tailed p-value was <0.05. A total of 118 infants were assessed for enrollment and 28 infants (five did not meet the http://www.selleckchem.com/products/PD-0332991.html inclusion criteria, 17 refused

participation, six were unavailable for the follow up period) were excluded. Of the 90 infants who were enrolled, 45 were randomized into the three dose arm and 45 into the five-dose arm (Fig. 1). Demographic details for infants recruited in both arms of the study were similar (data not shown) and all children received the vaccine by 17 and 26 weeks of age in the three and five dose arms, respectively. Sera at 4 weeks post third and fifth dose were obtained from 88 of 90 infants, with one child lost to follow up in each arm. Of the enrolled infants, 66% (29/44 infants) from the three dose group and 50% (22/44) infants from the five dose group were seropositive at baseline (Fig. 2). Of the 51 infants seropositive prior to immunization, 13 (25.5%) showed a >4 fold and 12 (23.5%) showed a three or two fold increase in RV specific IgA four weeks post last dose of vaccination; 26 (51%) infants did not show any rise or fall in antibody levels. Of the 37 infants

who were seronegative at baseline, 10 (27%) had a >4-fold and seven (19%) had a three or two fold increase in RV specific IgA. second Twenty (54%) infants had no rise or fall in antibody levels and remained seronegative even after three or five doses of vaccination. The GMCs of IgA pre- and post-vaccination are shown in Table 1, stratified by baseline seropositivity in the three and five dose arms. The Wilcoxon signed rank test showed that there was a significant difference (p-value < 0.001) between the pre- and post-vaccination GMCs of the 88 infants taken together and separately as the three dose arm (p = 0.029) and the five dose arm (p < 0.001). However, with three doses, in baseline seropositive children the difference between pre- and post-GMCs did not reach statistical significance (p = 0.086). Of the 88 infants, 42 (47.7%) responded to three or five doses of vaccination. When the proportion of children seroconverting and the GMCs were compared between the three and five dose arms ( Table 2A and Table 2B), there was no significant difference in the post vaccination rotavirus specific serum IgA levels between them (p-value = 0.894, Mann–Whitney 0.