Safety Study of Palivizumab Injection in Children Under 2 Years at High Risk for Severe Respiratory Syncytial Virus RSV Infection

What this Trial Is About

This research aims to evaluate the safety of palivizumab injections in Indian infants and children under 24 months old who are at high risk of severe respiratory syncytial virus RSV disease. The study is a Phase IV, open-label, multicenter trial focusing on preventing serious lower respiratory tract disease caused by RSV in this vulnerable population. Participants will receive intramuscular injections of palivizumab at a dose of 15 mgkg once a month for up to five doses, administered on Days 1, 31, 61, 91, and 121. Children undergoing cardiac surgery with cardiopulmonary bypass during the study will receive an additional dose after surgery when medically stable for injection. Safety assessments are performed before each dose. During the study, participants will have safety evaluations before each injection, and a follow-up phone call will be made to parents or guardians 30 days after the last dose to monitor safety. Researchers will assess the safety of palivizumab prophylaxis specifically in preterm infants, children with bronchopulmonary dysplasia, and children with significant congenital heart disease. The study lasts until 30 days after the final injection, with careful monitoring throughout.

Study of Palivizumab in Children With High Risk of Severe Respiratory Syncytial Virus (RSV) Disease