Surveillance of Synagis in Korean Pediatric Patients

Study Identifier
P13-203
CT.gov Identifier
NCT01537198
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
  • Respiratory Syncytial Virus (RSV)
    • Study Drug
    N/A
    Phase
    N/A
    Sex
    Female & Male
    Age
    1 Day - 24 Months
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Pediatric patients at high risk of RSV disease, who need the prevention of serious lower respiratory tract disease caused by RSV, and meet any of the following criteria: * Preterm newborn infants or infants born at 35 weeks of gestation or less, and less than 6 months of age at the onset of RSV season (RSV season defined as Oct. 1 to the following Mar. 31). * Newborn infants, infants, or children under 2 years of age and requiring treatment for bronchopulmonary dysplasia (BPD) within the last 6 months preceding RSV season (RSV season defined as Oct. 1 to the following Mar. 31). * Newborn infants, infants, or children under 2 years of age with hemodynamically significant congenital heart disease (CHD). * Obtained authorization form to use personal and/or health data from legal representative prior to the entry into the study.
    Exclusion Criteria:
    * Contraindications according to the approved label.

    Protocol Summary

    Approximately 600 pediatric patients prescribed palivizumab (Synagis) prophylaxis in usual practice according to the approved Korean product label will be registered into this observational study. Baseline data will be obtained at enrollment including demographics, gestational age, birth weight and underlying diseases and complications especially in regard to respiratory disease and cardiovascular disease. At routine visits for Synagis administration, which will occur according to usual medical practice, information on Synagis prophylaxis, concomitant medication, and adverse events will be collected for up to 30 days after the last administration of Synagis.

    Study Locations

    No locations found.