The laboratory assessing the immune responses was blinded to the group allocation. At enrollment, blood and breast milk specimens were obtained from mothers and blood and stool specimens were obtained from the infants. At the time of the second dose of Rotarix®, a breast milk specimen was obtained from the mother.
Four weeks after the second dose of Rotarix®, blood specimen was obtained from each infant. The specimens were tested at the Wellcome Trust Research Laboratory at Christian Medical selleckchem College, Vellore. The IgA and IgG titers were determined by comparing the optical density values form sample wells with the standard curve based on derived units of IgA arbitrarily assigned to pooled human serum samples, as previously described . Statistical analyses were carried out in Stata 11.0 (StataCorp LP, TX, USA). Descriptive measures of
continuous variables were presented as means and standard deviations for symmetrical data, and as medians and interquartile ranges for skewed data. The Spearman rank-order correlation test was used for comparing median values. Seroconversion was defined as infant serum anti-VP6 IgA antibody level of ≥20 IU/mL 4 weeks after the second vaccine dose and a ≥4-fold rise from baseline. We measured the effect of the interventions and other Afatinib exposures on the proportion who seroconverted and on the log-transformed end study antibody levels of until the infants. The relationship between maternal and child antibodies and these outcomes were examined in crude and multivariate logistic and linear regression models. In these models, we initially included variables
that were significant on a 0.05 level (from the crude models), we kept those that remained significant and added the other exposure variables one at a time and retained significant variables for the final model. The ratio between proportions and its corresponding confidence interval was calculated using the binreg command in stata. Ethical clearance was obtained from Society for Applied Studies, Ethics Review Committee, Christian Medical College, Institutional Ethics Committee and South-East Regional Ethical Committee of Norway. This study was conducted in compliance with the protocol, Good Clinical Practices and other relevant regulatory guidelines. Of the 533 infants screened for eligibility, 400 were enrolled and randomized into two equal groups. All infants received the first dose of Rotarix® and 391 received both doses; four families moved out of the study area and five refused the second dose (Fig. 1). Both baseline and end study blood specimen were available for 388 infants. The baseline characteristics were comparable between the groups (Table 1).