Objective To systematically evaluate the effectiveness and safety of nirsevimab in preventing respiratory syncytial virus (RSV) infection in infants. Methods Clinical trials related to the prevention of RSV infection by using nirsevimab in infants were systematically retrieved from database such as PubMed, Embase, Cochrane Library, China National Knowledge Infrastructure (CNKI), and Wanfang, as well as Chinese and American Clinical Trial Registry platforms, the search period was from the establishment of the databases to December 31, 2024. Literatures were screened based on inclusion and exclusion criteria, the included information of literatures were extracted, and the quality of included studies was evaluated by Cochrane risk of bias assessment tool. Results A total of 5 randomized controlled studies were included in analysis. Data analysis showed that compared with placebo/blank control group, vaccination of nirsevimab before the RSV epidemic season could reduce the risk of RSV-related lower respiratory tract infection (RR=0.24, 95%CI: 0.17-0.34, P<0.01) and RSV infection-related hospitalization risk (RR=0.20, 95%CI: 0.13-0.30, P<0.01) in infants. In addition, compared with placebo/blank control group, there were no statistically significant differences in the incidences of all adverse events (RR=1.04, 95%CI: 0.96-1.12, P=0.37), drug-related adverse events (RR=0.93, 95%CI: 0.52-1.67, P=0.82), death-leading adverse events (RR=0.95, 95%CI: 0.07-12.88, P=0.97), severe adverse events (RR=0.91, 95%CI: 0.63-1.30, P=0.59), and special concerned adverse events (RR=1.29, 95%CI: 0.43-3.82, P=0.65) in infants in niresvimab treatment group. Compared with palivizumab, nirsevimab showed no significant differences in terms of efficacy (RR=0.83, 95%CI: 0.20-3.43, P=0.79) and safety (mortality: RR=2.48, 95%CI［0.29-21.10］, P=0.41; serious adverse events: RR=1.04, 95%CI［0.73-1.50］, P=0.82). Conclusion Nirsevimab has good safety in preventing RSV infection and reducing hospitalization rates, demonstrating promising application prospects.