- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01537198
Surveillance of Synagis in Korean Pediatric Patients
June 18, 2015 updated by: AbbVie (prior sponsor, Abbott)
Post-Marketing Surveillance of Synagis in Korean Pediatric Patients Under the "New Drug Re-Examination"
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 Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
618
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 day to 2 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
General hospital
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Pediatric Participants at High Risk of RSV
Pediatric participants at high risk of respiratory syncytial virus (RSV) in need of the prevention of serious lower respiratory tract disease caused by RSV were prescribed Synagis prophylaxis in usual practice according to the approved Korean product label.
The decision to prescribe or not to prescribe Synagis was taken prior to a participant's enrollment in the study.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Subjects With Adverse Events (AEs), Serious AEs (SAEs), and Adverse Drug Reactions (ADRs)
Time Frame: From the time of informed consent until 30 days after the final administration of Synagis, an expected average of 6 months from the start of Synagis
|
An AE was defined as any untoward medical occurrence that did not necessarily have a causal relationship with treatment.
An SAE was an event that resulted in death, was life-threatening, required or prolonged hospitalization, resulted in congenital anomaly or persistent or significant disability, important medical event requiring medical or surgical intervention to prevent serious outcome, or a spontaneous or elective abortion.
AEs considered to be related to Synagis were classified as ADRs.
The causality of ADRs were assessed by the investigator as 'Probable,' 'Possible' and 'others (unknown).
'Unexpected' AEs are those that are unlabeled.
|
From the time of informed consent until 30 days after the final administration of Synagis, an expected average of 6 months from the start of Synagis
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: SoRa Lee, MD, AbbVie
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2012
Primary Completion (Actual)
June 1, 2014
Study Completion (Actual)
June 1, 2014
Study Registration Dates
First Submitted
December 15, 2011
First Submitted That Met QC Criteria
February 17, 2012
First Posted (Estimate)
February 23, 2012
Study Record Updates
Last Update Posted (Estimate)
July 10, 2015
Last Update Submitted That Met QC Criteria
June 18, 2015
Last Verified
June 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P13-203
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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