NCT01297504

A One-Year Observation of Palivizumab in Infants at Risk for Respiratory Syncytial Virus Infection in Latin America

A One-Year Observational Study of Palivizumab in Infants at Risk for Respiratory Syncytial Virus Infection in Latin America

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 464 (actual)
• Sponsor: AbbVie (prior sponsor, Abbott) · Industry
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Respiratory Syncytial Virus Infection

Timeline

• Start date: 2011-02-01
• Primary completion: 2013-08-01
• Completion: 2013-08-01
• First posted: 2011-02-16
• Last updated: 2014-10-01
• Results posted: 2014-09-03

Locations

24 sites across 7 countries: Argentina, Chile, Colombia, Ecuador, Mexico, Peru, Uruguay