A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Motavizumab (MEDI-524) After Dosing for a Second Season in Children

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT00113490
First received: June 8, 2005
Last updated: April 3, 2013
Last verified: April 2013
Results First Received: April 3, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Motavizumab Administration for a Second Season for RSV Prophylaxis
Interventions: Biological: motavizumab (MEDI-524)
Biological: palivizumab 15 mg/kg

  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
Children who received at least 3 doses of motavizumab in Study MI-CP104 during the 2004-2005 RSV season were eligible for enrollment in this study. It was anticipated that approximately 150 children would be enrolled.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Motavizumab or palivizumab was administered to children, using a 1:1 randomization, at 15 mg/kg of study drug by IM injection every 30 days, for a total of 4-5 doses (determined by when in the RSV season a child was enrolled) during the 2005-2006 RSV season.

Reporting Groups
  Description
Motavizumab (MEDI-524) 15 mg/kg A single intramuscular injection every 30 days for a total of 4-5 injections determined by when in the RSV season a child was enrolled.
Palivizumab 15 mg/kg A single intramuscular injection every 30 days for a total of 4-5 injections determined by when in the RSV season a child was enrolled.

Participant Flow:   Overall Study
    Motavizumab (MEDI-524) 15 mg/kg     Palivizumab 15 mg/kg  
STARTED     66     70  
COMPLETED     64     67  
NOT COMPLETED     2     3  
Withdrawal by Subject                 1                 3  
Lost to Follow-up                 1                 0  



  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
Motavizumab (MEDI-524) 15 mg/kg A single intramuscular injection every 30 days for a total of 4-5 injections determined by when in the RSV season a child was enrolled.
Palivizumab 15 mg/kg A single intramuscular injection every 30 days for a total of 4-5 injections determined by when in the RSV season a child was enrolled.
Total Total of all reporting groups

Baseline Measures
    Motavizumab (MEDI-524) 15 mg/kg     Palivizumab 15 mg/kg     Total  
Number of Participants  
[units: participants]
  66     70     136  
Age  
[units: Months]
Mean ± Standard Deviation
  13.25  ± 3.13     13.59  ± 2.89     13.43  ± 3.00  
Gender  
[units: participants]
     
Female     23     32     55  
Male     43     38     81  
Race/Ethnicity, Customized  
[units: participants]
     
Hispanic     61     62     123  
White/Non-Hispanic     5     6     11  
Other     0     2     2  



  Outcome Measures
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1.  Primary:   Number of Subjects Exhibiting Anti-motavizumab Antibodies   [ Time Frame: Day 0 through 120 days post final dose ]

2.  Secondary:   Number of Subjects Reporting Adverse Events (AEs)   [ Time Frame: Day 0 through 30 days post final dose ]

3.  Secondary:   Number of Subjects Reporting Serious Adverse Events (SAEs)   [ Time Frame: Day 0 through 30 days post final dose ]

4.  Secondary:   Number of Subjects With Increased Toxicity Grade From Baseline as Determined by Laboratory Evaluations   [ Time Frame: Day 0 through 30 days post final dose ]

5.  Secondary:   Motavizumab Serum Concentrations at Each Data Collection Visit   [ Time Frame: Prior to dosing on Day 0, Day 30, Day 120, and at 30 and 90-120 days post final dose ]


  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: M. Pamela Griffin, MD/ Clinical Development
Organization: MedImmune
phone: 301-398-0000
e-mail: clinicaltrialenquiries@medimmune.com


Publications of Results:

Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT00113490     History of Changes
Other Study ID Numbers: MI-CP118
Study First Received: June 8, 2005
Results First Received: April 3, 2013
Last Updated: April 3, 2013
Health Authority: United States: Food and Drug Administration