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

AbbVie

Status: Completed

Conditions: Respiratory Syncytial Virus Infection

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT01297504

P10-129

Details and patient eligibility

About

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.

Full 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.

Enrollment: 464 patients

Sex: All

Ages: Under 2 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Children with a history of bronchopulmonary dysplasia, infants with a history of prematurity (less than or equal to 35 weeks gestational age), or children with hemodynamically significant congenital heart disease who received the first dose of palivizumab within the 2 weeks prior to the signature of the Informed Consent Form.
• Parent or legal guardian of child provides written Informed Consent

Exclusion criteria

• Children excluded from receiving palivizumab as per local guidelines

Trial design

464 participants in 1 patient group

Palivizumab

Description:

Infants at risk for respiratory syncytial virus infection received palivizumab prescribed in accordance with the terms of the local marketing authorization.