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Surveillance of Synagis in Korean Pediatric Patients

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01537198
First received: December 15, 2011
Last updated: March 18, 2013
Last verified: March 2013
History of Changes

December 15, 2011
March 18, 2013
January 2012
February 2017   (final data collection date for primary outcome measure)
  • Number of Subjects with Adverse Events [ Time Frame: Participants will be observed to 30 days after the final administration of Synagis, an expected average of 6 months ] [ Designated as safety issue: Yes ]
  • Body Weight [ Time Frame: Participants will be observed to 30 days after the final administration of Synagis, an expected average of 6 months ] [ Designated as safety issue: Yes ]
  • Vital Signs [ Time Frame: Participants will be observed to 30 days after the final administration of Synagis, an expected average of 6 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01537198 on ClinicalTrials.gov Archive Site
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Surveillance of Synagis in Korean Pediatric Patients
Post-Marketing Surveillance of Synagis in Korean Pediatric Patients Under the New Drug Re-Examination

Approximately 600 pediatric patients prescribed 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, the information on Synagis prophylaxis, concomitant medication information and adverse events information will be collected for up to 30 days after the last administration of Synagis.
Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Probability Sample

General hospital
Respiratory Syncytial Virus Infection
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Pediatric patients at high risk of Respiratory Syncytial Virus
Pediatric patients at high risk of RSV, who need the prevention of serious lower respiratory tract disease caused by RSV
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
600
February 2017
February 2017   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Pediatric patients at high risk of respiratory syncytial virus (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.
Both
up to 24 Months
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01537198
P13-203
No
AbbVie ( AbbVie (prior sponsor, Abbott) )
AbbVie (prior sponsor, Abbott)
Not Provided
Study Director: Deborah Chee, MD AbbVie
AbbVie
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP