Prospective Study for the Use of Palivizumab (Synagis®) in High-risk Children in Germany

Study Identifier
P10-410
CT.gov Identifier
NCT01155193
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Study Details

Medical Condition
  • Infections & Vaccines - Other
    • Study Drug
    N/A
    Phase
    N/A
    Sex
    Female & Male
    Age
    N/A - 24 Months
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Children born at 35 weeks of gestation or less and less than 6 months of age at the onset of the Respiratory syncytial virus season * Children less than 2 years of age and requiring treatment for bronchopulmonary dysplasia within the last 6 months. * Children less than 2 years of age and with hemodynamically significant congenital heart disease.
    Exclusion Criteria:
    * Children with known hypersensitivity to palivizumab or any component of the formulation, or other humanized monoclonal antibodies

    Protocol Summary

    The SYNAGIS Registry was carried out in order to gather comprehensive real-world data on the use of palivizumab in children at high risk for serious respiratory syncytial virus (RSV) disease. This registry was designed as a post-marketing observational study, and conducted with the aim of collecting data on palivizumab administration, the risk factors for complicated RSV disease, frequency of hospitalizations, and drug adherence.

    Study Locations

    No locations found.