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

Study Overview
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Brief Summary
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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
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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]).

Official Title
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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

Conditions
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Respiratory Syncytial Virus Infection, Premature Birth, Bronchopulmonary Dysplasia, Congenital Heart Disease

Intervention / Treatment
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* Biological: palivizumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must meet all of the following criteria to be enrolled into the study: Infants at high risk of severe RSV infection defined as fulfilling at least one of the following: Infants born at less than or equal to 35 weeks gestational age AND are less than or equal to 6 months of age at enrollment Infants less than or equal to 24 months of age at enrollment AND with a diagnosis of bronchopulmonary dysplasia (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 less than or equal to 24 months of age at enrollment with hemodynamically significant congenital heart disease, either cyanotic or acyanotic, unoperated or partially corrected. Children with acyanotic cardiac lesions must have pulmonary hypertension (greater than or equal to 40 mmHg measured pressure in the pulmonary artery [ultrasound acceptable]) or the need for daily medication to manage congenital heart disease. Children with the following conditions are not eligible: hemodynamically insignificant small atrial or ventricular septal defects, patent ductus arteriosis, children with aortic stenosis, pulmonic stenosis, or coarctation of the aorta alone. Informed Consent Form signed by parent(s). Exclusion Criteria: Subjects meeting any of the following criteria are not eligible for the study: 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. Active respiratory illness, or other acute infection. Known renal impairment, as determined by the investigator. Known hepatic impairment, as determined by the investigator. History of seizures (except neonatal seizures). Unstable neurological disorder (includes, but is not restricted to, epilepsy and decompensated hydrocephaly). Known immunodeficiency, as determined by the investigator. Allergy to immunoglobulin products. Prior receipt of RSV vaccine or prophylaxis (e.g., palivizumab or motavizumab), or administration of a product possibly containing RSV-neutralizing antibody within 100 days prior to enrollment (includes, but is not restricted to, the following: RSV hyperimmunoglobulin, polyclonal intravenous immunoglobulin, cytomegalovirus hyperimmunoglobulin, varicella zoster hyperimmunoglobulin). Participation in another clinical trial within 30 days prior to enrollment. Previous enrollment in this trial. For any reason, subject is considered by the investigator to be an unsuitable candidate for this study.

Ages Eligible for Study
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Maximum Age: 2 Years

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: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: palivizumab<br>palivizumab 15 mg/kg intramuscularly every 30 days for 3 to 5 injections | Biological: palivizumab<br>* palivizumab 15 mg/kg intramuscularly<br>* Other names: Synagis 15 mg/kg intramuscularly;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of Adverse Events | Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 and 100 days after the last dose of study drug. The number of subjects experiencing a serious or nonserious treatment-emergent adverse event within 30 days after the last dose of study drug is summarized. See the Reported Adverse Events section for details. | Through 30 days following the last injection of palivizumab | 
| Number of Hospitalizations Due to Respiratory Syncytial Virus (RSV) | Number of subjects experiencing an RSV hospitalization | Through 30 days following the last injection of palivizumab | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Number of RSV Hospitalization Days | All secondary outcome measures were related to hospitalization due to RSV infection. No RSV hospitalizations occurred during the study; therefore, evaluation of the secondary outcome measures was not possible. | Through 30 days following the last injection of palivizumab | 
| Total RSV Hospitalization Days With Increased Supplemental Oxygen Requirement | All secondary outcome measures were related to hospitalization due to RSV infection. No RSV hospitalizations occurred during the study; therefore, evaluation of the secondary outcome measures was not possible. | Through 30 days following the last injection of palivizumab | 
| Number of Intensive Care Unit (ICU) Admissions During RSV Hospitalization | Outcome measure refers to the number of subjects admitted to the ICU during RSV hospitalization. No RSV hospitalizations occurred during the study; therefore, evaluation of the secondary outcome measures was not possible. | Through 30 days following the last injection of palivizumab | 
| Total Days of RSV ICU Stay | All secondary outcome measures were related to hospitalization due to RSV infection. No RSV hospitalizations occurred during the study; therefore, evaluation of the secondary outcome measures was not possible. | Through 30 days following the last injection of palivizumab | 
| Number of Subjects Who Received Mechanical Ventilation During RSV Hospitalization | All secondary outcome measures were related to hospitalization due to RSV infection. No RSV hospitalizations occurred during the study; therefore, evaluation of the secondary outcome measures was not possible. | Through 30 days following the last injection of palivizumab | 
| Total Days of Mechanical Ventilation During RSV Hospitalization | All secondary outcome measures were related to hospitalization due to RSV infection. No RSV hospitalizations occurred during the study; therefore, evaluation of the secondary outcome measures was not possible. | Through 30 days following the last injection of palivizumab | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Efficacy of palivizumab, Respiratory syncytial virus (RSV) infection, Prevention of severe RSV infection, Preterm infants, Infants with bronchopulmonary dysplasia, Infants with hemodynamically significant congenital heart disease