This was followed by a randomized, double-blind, placebo controlled Phase IIa study which assessed the formulation of 105.2 FFU/serotype in 60 healthy infants. SII BRV-PV/placebo was administered in 1:1 ratio as three doses with at least four weeks interval between doses. The study assessed the safety, GSK-3 cancer immunogenicity and shedding of the vaccine. Close post-vaccination follow-up showed the vaccine to be safe and well tolerated. A summary of the solicited vaccine

reactogenicity is summarized in Table 2. Almost all the events were mild and transient. Two SAEs (urinary tract infections and septicemia) unrelated to study vaccines were reported and both recovered uneventfully. We saw no effect on laboratory parameters. Three doses of the vaccine were found immunogenic. The seroconversion post dose 2 was 36% and 7.14%, in vaccine and placebo arms respectively (p = 0.0160). The corresponding post dose 3 seroconversion were 48% and 21.43% (p = 0.0492) ( Table 3). The post dose 3 GMTs in vaccine and placebo arms were 18.55 U/ml; and 7.31 U/ml. Following these satisfactory results, a randomized, double-blind, placebo controlled Phase IIb study was conducted which assessed the formulation of 105.6 FFU/serotype in 60 healthy infants. SII BRV-PV/placebo was administered in 1:1 ratio as three doses with at least four weeks interval. This formulation of the vaccine was also found safe and

well tolerated. A summary of the solicited vaccine reactogenicity is summarized in Table 2. click here Almost all the events were mild and transient. No SAE was reported and there all was no effect on laboratory parameters. Three doses of the 105.6 FFU/serotype formulation induced a significant immune response (Table 3). The seroconversion post dose 2 was 56.67% and 11.54%, in vaccine and placebo arms respectively (p value <0.05). The corresponding post dose 3 figures were 60% and 7.69% (p < 0.05). The seroconversion rates indicated that the 105.6 FFU/serotype formulation

is immunogenic in infants. These results are similar to those reported for the Rotarix (GSK) in an Indian study where the seroconversion rates were 58.3% [95% CI: 48.7; 67.4] in the Rotarix group and 6.3%; [95% CI: 2.5; 12.5] in the placebo group [20]. Another Indian study on the 116E vaccine showed 89.7% seroconversion in the vaccine arm and 28.1% in the placebo arm [21]. Another Indian study on Rotateq showed 83% 3-fold rise (seroconversion) in serum IgA antibodies; however the study had no placebo arm [22]. In developed countries, the seroresponses to rotavirus vaccines are high. The examples include a Korean study on Rotarix (88.1%) [23], a Korean study on Rotateq (94.7%) [24], a Japanese study on Rotarix (85.3%) [25], an European study on Rotarix (85.5–89.2%) [26], and a Finnish study on Rotarix (83.7–90.5%) [27]. However, for reasons not completely understood, the seroresponses are lower in developing countries. The examples include an African study on Rotateq (73.8–82.