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

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