Vaccines for preventing rotavirus diarrhoea: Vaccines in use

Background Rotavirus results in more diarrhoea-related deaths in children under five years than any other single agent in countries with high childhood mortality. It is also a common cause of diarrhoea-related hospital admissions in countries with low childhood mortality. Rotavirus vaccines that have been prequalified by theWorldHealthOrganization (WHO) include amonovalent vaccine (RV1; Rotarix, GlaxoSmithKline), a pentavalent vaccine (RV5; RotaTeq, Merck), and, more recently, another monovalent vaccine (Rotavac, Bharat Biotech). Objectives To evaluate rotavirus vaccines prequalified by the WHO (RV1, RV5, and Rotavac) for their efficacy and safety in children. Search methods On 4 April 2018 we searched MEDLINE (via PubMed), the Cochrane Infectious Diseases Group Specialized Register, CENTRAL (published in the Cochrane Library), Embase, LILACS, and BIOSIS. We also searched the WHO ICTRP, ClinicalTrials.gov, clinical trial reports from manufacturers' websites, and reference lists of included studies and relevant systematic reviews. Selection criteria We selected randomized controlled trials (RCTs) in children comparing rotavirus vaccines prequalified for use by the WHO versus placebo or no intervention. Data collection and analysis Two review authors independently assessed trial eligibility and assessed risks of bias. One review author extracted data and a second author cross-checked them.We combined dichotomous data using the risk ratio (RR) and 95% confidence interval (CI).We stratified the analysis by country mortality rate and used GRADE to evaluate evidence certainty. Main results Fifty-five trials met the inclusion criteria and enrolled a total of 216, 480 participants. Thirty-six trials (119, 114 participants) assessed RV1, 15 trials (88, 934 participants) RV5, and four trials (8432 participants) Rotavac.