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: May 2, 2014
Last verified: May 2014
  Purpose

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.


Condition
Respiratory Syncytial Virus Infection

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Post-Marketing Surveillance of Synagis in Korean Pediatric Patients Under the New Drug Re-Examination

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 600
Study Start Date: January 2012
Estimated Study Completion Date: February 2017
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Ages Eligible for Study:   up to 24 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

General hospital

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01537198

Locations
Korea, Republic of
Site Reference ID/Investigator# 64867
Ansan-si, Korea, Republic of
Site Reference ID/Investigator# 64856
Bucheon-si, Korea, Republic of
Site Reference ID/Investigator# 64858
Busan, Korea, Republic of
Site Reference ID/Investigator# 64860
Busan, Korea, Republic of, 602-702
Site Reference ID/Investigator# 64859
Busan, Korea, Republic of
Site Reference ID/Investigator# 64861
Busan, Korea, Republic of
Site Reference ID/Investigator# 64862
Busan, Korea, Republic of, 612-030
Site Reference ID/Investigator# 64886
Busan, Korea, Republic of, 614-735
Site Reference ID/Investigator# 64888
Busan, Korea, Republic of
Site Reference ID/Investigator# 64874
Chungju-si, Korea, Republic of, 361-711
Site Reference ID/Investigator# 64875
Daegu, Korea, Republic of
Site Reference ID/Investigator# 64846
Daegu, Korea, Republic of, 700-712
Site Reference ID/Investigator# 64868
Daegu, Korea, Republic of, 705-718
Site Reference ID/Investigator# 64845
Daegu, Korea, Republic of, 700-721
Site Reference ID/Investigator# 64844
Daegu, Korea, Republic of
Site Reference ID/Investigator# 64873
Daejeon, Korea, Republic of
Site Reference ID/Investigator# 64878
Goyang-si, Korea, Republic of
Site Reference ID/Investigator# 64871
Gwangju, Korea, Republic of
Site Reference ID/Investigator# 64852
Gwangju, Korea, Republic of
Site Reference ID/Investigator# 64857
Incheon, Korea, Republic of, 405-760
Site Reference ID/Investigator# 119455
Jeonju, Korea, Republic of, 561-712
Site Reference ID/Investigator# 64849
Seoul, Korea, Republic of, 110-744
Site Reference ID/Investigator# 64850
Seoul, Korea, Republic of
Site Reference ID/Investigator# 64872
Seoul, Korea, Republic of
Site Reference ID/Investigator# 64882
Seoul, Korea, Republic of, 133-792
Site Reference ID/Investigator# 64851
Seoul, Korea, Republic of
Site Reference ID/Investigator# 64863
Seoul, Korea, Republic of, 135-710
Site Reference ID/Investigator# 64864
Seoul, Korea, Republic of, 135-710
Site Reference ID/Investigator# 64853
Seoul, Korea, Republic of
Site Reference ID/Investigator# 64887
Seoul, Korea, Republic of
Site Reference ID/Investigator# 64842
Seoul, Korea, Republic of
Site Reference ID/Investigator# 64870
Seoul, Korea, Republic of
Site Reference ID/Investigator# 64884
Seoul, Korea, Republic of, 138-736
Site Reference ID/Investigator# 64883
Seoul, Korea, Republic of, 138-736
Site Reference ID/Investigator# 64855
Seoul, Korea, Republic of
Site Reference ID/Investigator# 64854
Seoul, Korea, Republic of
Site Reference ID/Investigator# 64847
Seoul, Korea, Republic of, 110-744
Site Reference ID/Investigator# 64877
Sungnam-si, Korea, Republic of
Site Reference ID/Investigator# 64865
Suwon, Korea, Republic of, 443-721
Site Reference ID/Investigator# 64866
Suwon, Korea, Republic of, 443-721
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Deborah Chee, MD AbbVie
  More Information

Additional Information:
No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01537198     History of Changes
Other Study ID Numbers: P13-203
Study First Received: December 15, 2011
Last Updated: May 2, 2014
Health Authority: Korea: Food and Drug Administration

Keywords provided by AbbVie:
Postmarketing Drug Surveillance

Additional relevant MeSH terms:
Respiratory Syncytial Virus Infections
Virus Diseases
Pneumovirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections

ClinicalTrials.gov processed this record on July 24, 2014