This study is an industry sponsored Phase IV safety study of Synagis (Palivizumab) in children with congenital heart disease. Synagis is a monoclonal antibody vaccine for RSV whose safety and efficacy has been already proven in premature infants and infants with bronchopulmonary dysplasia. This study is a multicenter trial in 250 children under two years of age with significant heart disease. The goal of the trial is to assess the safety of Synagis in the population. Each subject receives monthly IM injections of Synagis or placebo over the 5 month RSV season in 1998-99.
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