NCT02968173

A Study to Assess the Safety and Effectiveness of Palivizumab Administered to Children at High Risk of Severe Respiratory Syncytial Virus (RSV) Infection in the Russian Federation and the Republic of Belarus

A Prospective, International, Multicenter, Open-Label, Non-Controlled Study of Safety and Effectiveness of Palivizumab, in Children at High Risk of Severe Respiratory Syncytial Virus (RSV) Infection in the Russian Federation and the Republic of Belarus

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 24 Months
• Healthy volunteers: Not accepted

Summary

This is a Phase 3b, prospective, multicenter, open-label, non-controlled study to assess the safety and effectiveness of immunoprophylaxis with the intramuscular (IM) administration of the liquid formulation of palivizumab for the prevention of RSV hospitalizations in infants at high risk (infants born at less than or equal to 35 weeks gestational age and less than or equal to 6 months of age at enrollment; or infants less than or equal to 24 months of age with a diagnosis of chronic lung disease \[CLD\] of prematurity requiring on-going medical treatment within the previous 6 months or infants less than or equal to 24 months of age with hemodynamically significant congenital heart disease \[CHD\]).

Detailed description

Participants will receive palivizumab solution for injection at 15 mg/kg by IM injection every 30 days for a minimum of 3 and a maximum of 5 injections given during anticipated periods of RSV risk in the community; the number of doses will depend on the time of enrollment during the RSV season.

Conditions

• Respiratory Syncytial Virus (RSV)

Interventions

Type	Name	Description
DRUG	Palivizumab	Palivizumab is a humanized immunoglobulin G1 (IgG1) monoclonal antibody directed to an epitope in the A antigenic site of the F (fusion) protein of RSV.

Timeline

• Start date: 2016-11-09
• Primary completion: 2017-07-13
• Completion: 2017-07-13
• First posted: 2016-11-18
• Last updated: 2018-03-13
• Results posted: 2018-03-13