Respiratory Syncytial Virus Infection Clinical Trial
Official title:
A One-Year Observational Study of Palivizumab in Infants at Risk for Respiratory Syncytial Virus Infection in Latin America
The study was designed to gather information regarding the use of palivizumab for the prophylaxis for respiratory syncytial virus (RSV) infection in high-risk infants in selected countries within Latin America.
RSV causes significant disease. There is a paucity of data from developing countries even
though existing data clearly indicate that RSV accounts for a high proportion of acute
respiratory illnesses (ARIs) in children.
This is a multi-center study in a cohort of infants at risk for RSV infection in Latin
America who have received palivizumab in the usual manner in accordance with the terms of
marketing authorization with regard to dose, population and indication. Enrolled
participants were followed for one year after their first dose of palivizumab.
Epidemiological and clinical data as well as information about compliance, hospitalizations
and safety was collected.
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Observational Model: Cohort, Time Perspective: Prospective
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