ObjectiveTo systematically review the safety and immunogenicity of quadrivalent HPV vaccine among healthy population. MethodsDatabases including PubMed, EMbase, CBM, The Cochrane Library (Issue 9, 2013), CNKI, Web of Science and WanFang Data were searched for randomized controlled trials (RCTs) about safety and immunogenicity of quadrivalent HPV vaccine from inception to October 2013. Meanwhile handwork retrieval was also conducted and references of included literature were retrieved. Two reviewers independently screened literature according to the inclusion and exclusion criteria, extracted data, and assessed methodological quality of included studies. Meta-analysis was then conducted using RevMan 5.2 software. ResultsA total of 9 studies were finally included consisting of 8 RCTs and involving 39 688 patients. The result of meta-analysis showed that:a) for safety, the incidence of injection adverse reaction (swelling and red spots) in vaccine group was higher than that in placebo group (RR=1.22, 95%CI 1.13 to 1.32, P<0.000 01); while the incidences of systemic adverse reaction (RR=1.03, 95%CI 0.99 to 1.07, P=0.1) and serious adverse reaction (RR=1.06, 95%CI 0.75 to 1.50, P=0.74) were alike between the two groups; and b) for immunogenicity, the serum antibody seroconversion rates in the vaccine group (including subtypes of HPV6, HPV11 HPV16 and HPV18) were all higher than those in the placebo group, with significant differences. ConclusionCompared with placebo, quadrivalent HPV vaccine has relatively high incidences of adverse reaction and high-degree immunogenicity, which can be widely used in the prevention of relevant diseases of human papillomavirus infection among adolescents. The main adverse reaction is local dysfunction, which is well tolerated, so the vaccine can be safely used. Due to limited quantity and quality of the included studies, the above conclusion should be verified by further conducting more large-scale, multicentre, high quality RCTs.