OBJECTIVES: Systematically review all randomized trials evaluating licensed rotavirus vaccines for efficacy and safety on diarrhoea, hospital admission, death and serious adverse events. METHODS: Electronic searches strategies were performed until October 2011. Trial eligibility, data extraction and quality assessment were performed independently by two reviewers. Dichotomous data were pooled using the risk ratio (RR) and 95% CI. GRADE was used to evaluate evidence quality. RESULTS: Forty-three RCTs including 190,551 participants were identified; 31 trials assessed RV1, and 12 RV5. In children ≤ 1 year, RV1 (RR=0.20, 95%CI0.11 to 0.35; 7 trials, 35,004 participants) and RV5 (RR=0.23, 95%CI 0.08 to 0.71; 3 trials, 6953 participants) are highly efficacious against severe rotavirus diarrhoea cases and/or rotavirus diarrhea requiring hospitalization. For all-cause diarrhea, RV1 reduces severe cases by 42% (RR=0.58, 95% CI 0.40 - 0.84; 8291 participants), and RV5 by 72% (RR=0.28, 95%CI 0.16 - 0.48). Both vaccines were also efficacious during the second year of life (RV1: RR=0.16, 95%CI 0.12 - 0.21; 8 trials, 32,854 participants; RV5:RR=0.44, 95%CI 0.22 - 0.88; 4 trials, 9783 participants). For all-cause diarrhoea, RV1 reduces severe cases by 51% (RR=0.49, 95%CI 0.40 - 0.60; 2 trials, 6269 participants). Both vaccines had no impact on mortality, but serious adverse events following vaccination, including intussusception, were not more common than following placebo. CONCLUSIONS: RV1 and RV5 vaccines are efficacious and relatively safe. These data support the WHO's global vaccine recommendation. Potential reduced vaccine efficacy in low income countries needs to be addressed. Ongoing safety monitoring should be continued in countries that have introduced rotavirus vaccination.