Two RCTs were included (n=2,789 infants and children). Both RCTs were of high quality with a maximum Jadad score of 5 points. Both RCTs were randomised, had adequate allocation concealment, were double-blinded, used an intention-to-treat analysis, and had high levels of patients completing full follow-up.
In one trial (which included infants up to 24 months old, with some premature), prophylaxis with palivizumab produced a 55% reduction in respiratory syncytial virus hospitalisation of children compared with placebo treatment (p=0.0004). Subgroup analysis investigating the effect in infants with chronic lung disease (p=0.038) and in pre-term infants without chronic lung disease (p=0.001) also showed significant reductions in those needing hospitalisation.
In the second trial (which recruited infants under one year old with congenital heart disease), prophylaxis with palivizumab was associated with a 45% reduction in respiratory syncytial virus hospitalisation of infants (p=0.003) compared with placebo.
Both trials reported significant reductions in the number of days hospitalised (per 100 children) following treatment with palivizumab.
There were no statistically significant differences between groups in either trial for adverse events.