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
Condition: Respiratory Syncytial Virus (RSV)
MeSH terms: Infections; Virus Diseases
Intervention: Palivizumab
Intervention description: 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.
Intervention MeSH terms: Palivizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Maximum age: 24 Months
Healthy volunteers: No
Keywords: Bronchopulmonary dysplasia (BPD); RSV hospitalization; Palivizumab; Immunoprophylaxis; Chronic lung disease (CLD) of prematurity

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]).
    

Eligibility criteria:

        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