title: The human rotavirus vaccine Rotarix™ in infants: an integrated analysis of safety and reactogenicity.
abstract: 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.
authors.affiliation: GlaxoSmithKline Vaccines; Wavre, Belgium.
authors.forename: Hubert
authors.initials: H
authors.lastname: Buyse
authors.affiliation: GlaxoSmithKline Vaccines; Wavre, Belgium.
authors.forename: Carlota
authors.initials: C
authors.lastname: Vinals
authors.affiliation: GlaxoSmithKline Vaccines; Bangalore, India.
authors.forename: Naveen
authors.initials: N
authors.lastname: Karkada
authors.affiliation: GlaxoSmithKline Vaccines; King of Prussia, PA USA.
authors.forename: Htay Htay
authors.initials: HH
authors.lastname: Han
mesh_terms: D004311:Double-Blind Method; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology / Q000473:pathology; D005260:Female; D006801:Humans; D015994:Incidence; D007223:Infant; D008297:Male; D012400:Rotavirus Infections / Q000517:prevention & control*; D022243:Rotavirus Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D016019:Survival Analysis; D014611:Vaccination / Q000009:adverse effects* / Q000379:methods*; D014613:Vaccines, Attenuated / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology
chemical_list: C492457:RIX4414 vaccine; D022243:Rotavirus Vaccines; D014613:Vaccines, Attenuated
keywords: Rotarix™; human rotavirus vaccine; intussusceptions; reactogenicity; rotavirus gastroenteritis; vaccine safety
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