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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Respiratory Syncytial Virus (RSV)

Intervention / Treatment
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* Drug: Palivizumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infants at high risk of severe RSV infection defined as fulfilling at least one of the following: Infants born ≤ 35 weeks gestational age AND are ≤ 6 months of age at enrollment Infants ≤ 24 months of age at enrollment AND with a diagnosis of bronchopulmonary dysplasia (BPD) (defined as oxygen requirement at a corrected gestational age of 36 weeks) requiring intervention/management (i.e., oxygen, diuretics, bronchodilators, corticosteroids, etc.) anytime within 6 months prior to enrollment Infants ≤ 24 months of age at enrollment with hemodynamically significant CHD, either cyanotic or acyanotic, unoperated or partially corrected. Children with acyanotic cardiac lesions must have pulmonary hypertension (≥ 40 mmHg measured pressure in the pulmonary artery [ultrasound acceptable]) or the need for daily medication to manage hemodynamically significant CHD Exclusion Criteria (main exclusion criteria): Hospitalization at the time of enrollment (unless discharge is anticipated within 14 days) Mechanical ventilation (including continuous positive airway pressure, CPAP) at the time of enrollment Life expectancy less than 6 months Unstable cardiac or respiratory status, including cardiac defects so severe that survival is not expected or for which cardiac transplantation is planned or anticipated Active respiratory illness, or other acute infection

Ages Eligible for Study
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Maximum Age: 24 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Children at High Risk of severe RSV Infection<br>A single IM injection every 30 days beginning at Day 0 for a total of 3-5 injections determined by when in the RSV season a participant was enrolled. | Drug: Palivizumab<br>* 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.<br>* Other names: Synagis;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With RSV Hospitalization | An RSV hospitalization is defined as either 1) a respiratory/cardiac hospitalization with a positive RSV test, 2) new onset of respiratory/cardiac symptoms in an already hospitalized child, with an objective measure of worsening respiratory/cardiac status and a positive RSV test, or 3) deaths, which can be demonstrated as caused by RSV (by autopsy or clinical history and virologic evidence). | Approximately 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Number of RSV-Hospitalization Days |  | Approximately 6 months | 
| Percentage of Participants Who Received Supplemental Oxygen While Hospitalized | Increased supplemental oxygen is defined as a new requirement or an increase in supplemental oxygen from prior to the onset of cardiac/respiratory symptoms. | Approximately 6 months | 
| Total RSV-hospitalization Days With Increased Supplemental Oxygen Requirement | Increased supplemental oxygen is defined as a new requirement or an increase in supplemental oxygen from prior to the onset of cardiac/respiratory symptoms. | Approximately 6 months | 
| Number of Intensive Care Unit (ICU) Admissions During RSV-hospitalization |  | Approximately 6 months | 
| Total Days of RSV-ICU Stay |  | Approximately 6 months | 
| Percentage of Participants Who Received Mechanical Ventilation |  | Approximately 6 months | 
| Total Days of Mechanical Ventilation During RSV-hospitalization |  | Approximately 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bronchopulmonary dysplasia (BPD), RSV hospitalization, Palivizumab, Immunoprophylaxis, Chronic lung disease (CLD) of prematurity