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 Identifier
M15-539
CT.gov Identifier
NCT02968173
EudraCT Identifier
2016-000221-39
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Statistical Analysis Plan
Available Language(s): English
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Protocol
Available Language(s): English
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Study Details

Medical Condition
  • Respiratory Syncytial Virus (RSV)
    • Study Drug
  • Palivizumab
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    N/A - 24 Months
    Inclusion and Exclusion Criteria
    Inclusion 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

    Protocol 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 \[CHD\]).

    Study Locations

    No locations found.