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 \[CHD\]).
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
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.
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).
Time frame: Approximately 6 months
Total Number of RSV-Hospitalization Days
Time frame: 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.
Time frame: 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.
Time frame: Approximately 6 months
Number of Intensive Care Unit (ICU) Admissions During RSV-hospitalization
Time frame: Approximately 6 months
Total Days of RSV-ICU Stay
Time frame: Approximately 6 months
Percentage of Participants Who Received Mechanical Ventilation
Time frame: Approximately 6 months
Total Days of Mechanical Ventilation During RSV-hospitalization
Time frame: Approximately 6 months
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