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Palivizumab for Prevention of Severe Respiratory Syncytial Virus Infection in Russian Children

2014-07-23 21:11:54 | BioPortfolio

Summary

100 Russian children of 2 years of age and less with risk factors (preterm, and/or with heart and lung problems) will receive palivizumab (Synagis) 15 mg/kg intramuscularly as a prophylaxis in order to study the safety and efficacy of the drug in Russian subjects.

Description

A prospective, multicenter, open-label, non-comparative study of safety and efficacy of palivizumab (Synagis) 15 mg/kg intramuscularly as a prophylaxis of severe lower respiratory tract respiratory syncytial virus infection in 100 Russian Children of 2 years of age and less with risk factors (preterm infants (<=35 wGA), infants with bronchopulmonary dysplasia and infants with hemodynamically significant congenital heart disease).

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Conditions

Respiratory Syncytial Infection

Intervention

palivizumab

Location

Ivanovo
Russian Federation
153731

Status

Active, not recruiting

Source

Abbott

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:11:54-0400

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