NCT01006629

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

A Prospective, Multicenter, Open-label, Non-comparative Study of Safety and Efficacy of Synagis in Children at High Risk of Severe Respiratory Syncytial Virus Infection in the Russian Federation

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Abbott · Industry
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

Summary

100 Russian children of 2 years of age and less in high-risk populations (preterm, and/or with heart and lung problems) will receive palivizumab (Synagis) 15 mg/kg intramuscularly as prophylaxis to severe respiratory syncytial virus (RSV) infection in order to study the safety and efficacy of the drug in Russian subjects.

Detailed description

A prospective, multicenter, open-label, non-comparative study of safety and efficacy of palivizumab (Synagis) 15 mg/kg intramuscularly as prophylaxis to severe lower respiratory tract respiratory syncytial virus infection in 100 Russian children of 2 years of age and less in high-risk populations (preterm infants \[less than or equal to 35 weeks gestational age\], infants with bronchopulmonary dysplasia \[BPD\], and infants with hemodynamically significant congenital heart disease \[HSCHD\]).

Conditions

• Respiratory Syncytial Virus Infection
• Premature Birth
• Bronchopulmonary Dysplasia
• Congenital Heart Disease

Interventions

Type	Name	Description
BIOLOGICAL	palivizumab	palivizumab 15 mg/kg intramuscularly

Timeline

• Start date: 2009-11-01
• Primary completion: 2010-04-01
• Completion: 2010-07-01
• First posted: 2009-11-03
• Last updated: 2011-07-19
• Results posted: 2011-07-19

Locations

19 sites across 1 country: Russia