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Surveillance of Synagis in Korean Pediatric Patients

NCT01537198 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 618

Last updated 2015-07-10

Study results available
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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.

Conditions

  • Respiratory Syncytial Virus Infection

Sponsors & Collaborators

  • AbbVie (prior sponsor, Abbott)

    lead INDUSTRY

Principal Investigators

  • SoRa Lee, MD · AbbVie

Eligibility

Min Age
1 Day
Max Age
24 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2014-06-30
Completion
2014-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01537198 on ClinicalTrials.gov