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Clinical Trial Summary

This is a post marketing observational study (PMOS) conducted in Japan in patients receiving palivizumab for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract infection at the age of 24 months and under, who have immunocompromised medical condition (e.g., combined immunodeficiency disease, antibody deficiency, or other types of immunodeficiency; HIV infection; recovering from organ or bone marrow transplantation; on chemotherapy; on high-dose corticosteroid therapy; on immunosuppressants) or who have Downs syndrome.


Clinical Trial Description

Palivizumab will be prescribed according to the local label and independently of the decision to enroll the subject in the study. Palivizumab will be administered monthly (30 days) throughout the Respiratory Syncytial Virus (RSV) infection season. Survey forms will be collected after the observation period. The number of adverse events and the frequency of hospitalizations due to RSV infections in surveyed patients will be counted to evaluate the safety and efficacy of palivizumab. ;


Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms

  • Respiratory Syncytial Virus Infection
  • Respiratory Syncytial Virus Infections
  • Virus Diseases

NCT number NCT02016690
Study type Observational
Source AbbVie
Contact
Status Completed
Phase N/A
Start date September 2013
Completion date December 2015

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