The human rotavirus vaccine Rotarix™ in infants: an integrated analysis of safety and reactogenicity.

摘要: An integrated analysis of safety and reactogenicity data was undertaken for 28 randomized, placebo-controlled, double-blind Phase II III trials (DBRCTs) the oral live-attenuated human rotavirus vaccine, Rotarix™ (GlaxoSmithKline Vaccines). Healthy infants aged 6–20 wk received 2 or 3 doses vaccine (n = 56562) placebo 45512) at 4- to 8-wk intervals. Solicited adverse events (AEs) were recorded 8 d after each dose placebo. Unsolicited AEs, serious AEs (SAEs), deaths evaluated over 31-d post-vaccination follow-up periods. 95% confidence intervals (CIs) relative risk (RR) across studies excluding “1.0” signified potential imbalances between groups. The incidence solicited AE any Grade severity similar all unsolicited (RR 0.99 [95% CI: 0.94–1.04]; P 0.72) 0.91 0.77–1.08]; 0.31) A significantly higher proportion SAEs reported in group compared with 0.9 0.82–0.98]; 0.01). death low groups (0.13% 0.11% group; RR 1.14 0.78–1.68]; 0.54). Very few cases intussusception (11 7 groups, respectively; 1.39 0.49–4.27]; 0.66). In conclusion, results this DBRCTs show that has a profile