Prevention of respiratory syncytial virus infections in high-risk infants by monoclonal antibody (palivizumab).

Respiratory syncytial virus (RSV) is a major viral pathogen which causes serious respiratory illness in infants and children worldwide. Palivizumab (Synagis) is an anti-RSV monoclonal antibody administered intramuscularly for the prevention of severe RSV respiratory disease in high-risk infants and young children. The IMpact-RSV trial, the pivotal multicenter, randomized, placebo-controlled trial performed in the USA, Canada and the United Kingdom demonstrated an overall 55% reduction in hospitalization rate due to RSV infection in preterm infants (< or = 35 weeks gestation) with and without chronic lung disease (CLD). Subgroup analysis in premature infants without CLD revealed an even greater reduction in RSV hospitalization rates (78%). Adverse events were infrequent and did not differ between placebo and palivizumab groups. Injection site reactions were infrequent and mild; no differences were observed between palivizumab and placebo subjects. Palivizumab does not interfere with administration of other pediatric vaccines. Comprehensive parent education programs regarding prevention of infection, avoidance of risk factors for infection, careful adherence to infection control policies, and recognition of early symptoms of RSV infection remain important components of RSV prevention strategies. In light of the lack of effective vaccines for this serious health risk, palivizumab offers the only option for prophylaxis against RSV disease in high-risk infants.

RCT Entities:   Population Interventions Outcomes