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Surveillance of Synagis in Korean Pediatric Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01537198
First received: December 15, 2011
Last updated: June 18, 2015
Last verified: June 2015
Results First Received: June 18, 2015  
Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Prospective
Condition: Respiratory Syncytial Virus Infection

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 618 participants were enrolled; 1 participant was a duplicate enrollment and the duplicate data was excluded from the analysis.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Pediatric Participants at High Risk of RSV  
STARTED     617  
COMPLETED     463  
NOT COMPLETED     154  
RSV infection                 2  
Adverse Event                 4  
No Further Visits to the Clinic                 37  
Not Specified                 111  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Pediatric Participants at High Risk of RSV Pediatric participants at high risk of 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.

Baseline Measures
    Pediatric Participants at High Risk of RSV  
Number of Participants  
[units: participants]
  617  
Age  
[units: months]
Mean (Standard Deviation)
  3.38  (3.39)  
Age, Customized  
[units: participants]
 
Newborn infants (0 to 27 days)     166  
Infants and toddlers (28 days to 23 months)     451  
Gender  
[units: participants]
 
Female     281  
Male     336  



  Outcome Measures

1.  Primary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Global Medical Information
Organization: AbbVie (prior sponsor, Abbott)
phone: 800-633-9110



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
Results First Received: June 18, 2015
Last Updated: June 18, 2015
Health Authority: Korea: Food and Drug Administration