Background: Live attenuated influenza vaccine (LAIV) is effective in children but contraindicated in children <2 years of age. Methods: We searched Medline, EMBASE, the Cochrane Library, Web of Science, Scopus, PsycInfo and CINA HL through February 2013 for existing systematic reviews, randomized controlled trials (RCTs) and observational studies (for safety). We included studies enrolling healthy children <2 years of age who received LAIV, compared with placebo or inactivated influenza vaccine (IIV). Data were extracted independently by 2 investigators. The relative risk (RR) was pooled across studies using the random effects model. Results: We found 7 eligible randomized controlled trials and 2 observational studies. Randomized controlled trials included 6281 children and were at low to moderate risk of bias. LAIV reduced the incidence of influenza compared with placebo (relative risk = 0.36, 95% confidence interval: 0.23-0.58, P < 0.05) with a number needed to vaccinate of 17. LAIV increased the incidence of minor side effects (fever and rhinorrhea). LAIV had a similar effect in preventing influenza (relative risk = 0.76, 95% confidence interval: 0.45-1.30, P > 0.05) compared with inactivated influenza vaccine. There was an increase of hospitalization rate (post hoc analysis) and medical attended wheezing with LAIV. Conclusions: LAIV is highly effective in children <2 years of age compared with placebo and is as effective to inactivated influenza vaccine. The safety profile of LAIV is reasonable although evidence is sparse. LAIV may be considered as an option in this age group particularly during seasons with vaccine shortage. © 2013 by Lippincott Williams & Wilkins.