Status:
COMPLETED
Study of Motavizumab (MEDI-524) and Palivizumab Administered Sequentially in the Same Respiratory Syncytial Virus (RSV) Season
Lead Sponsor:
MedImmune LLC
Conditions:
Respiratory Syncytial Virus Infections
Chronic Lung Disease and <= 24 Months of Age or
Eligibility:
All Genders
Up to 24 years
Phase:
PHASE2
Brief Summary
This is a Phase 2, randomized, double-blind study in which motavizumab (MEDI-524) and palivizumab were administered sequentially to high-risk children during the same respiratory syncytial virus (RSV)...
Detailed Description
This is a Phase 2, randomized, double-blind study in which motavizumab and palivizumab were administered sequentially to high-risk children during the same RSV season. It was anticipated that approxim...
Eligibility Criteria
Inclusion
- The child must have been born at less than or equal to 35 weeks gestation and be less than or equal to 6 months of age at the time of entry into the study (child must be entered on or before his/her 6-month birthday); or the child must be less than or equal to 24 months of age at the time of entry into the study (child must be entered on or before his/her 24-month birthday) and diagnosed with chronic lung disease (CLD) of prematurity with stable or decreasing doses of diuretics, steroids, or bronchodilators, or treatment with supplemental oxygen, within the previous 6 months.
- The child must be in general good health at the time of study entry.
- The child's parent(s)/legal guardian must provide written informed consent.
- The child must be able to complete the follow-up visits through 120-150 days from last injection of study drug.
- Parent(s)/legal guardian of patient must have available telephone access.
Exclusion
- Hospitalized at the time of study entry (unless discharge is expected within 10 days after entry into the study)
- Receiving chronic oxygen therapy or mechanical ventilation at the time of study entry (including continuous positive airway pressure \[CPAP\])
- Congenital heart disease (CHD) (children with medically or surgically corrected \[closed\] patent ductus arteriosus and no other CHD may be enrolled)
- Evidence of infection with hepatitis A, B, or C virus
- Known renal impairment, hepatic dysfunction, chronic seizure disorder, or immunodeficiency or HIV infection (a child of a mother with known HIV infection must be proven to be uninfected at the time of enrollment)
- Suspected serious allergic or immune-mediated events with prior receipt of palivizumab
- Acute illness or progressive clinical disorder
- Active infection, including acute RSV infection, at the time of enrollment
- Previous reaction to intravenous immunoglobulin (IGIV), blood products, or other foreign proteins
- Received within the past 120 days or currently receiving immunoglobulin products (such as RSV-IGIV \[RespiGam\], IVIG, or palivizumab) or any investigational agents
- Previous participation in a clinical trial of motavizumab
- Currently participating in any investigational study
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2007
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT00316264
Start Date
April 1 2006
End Date
February 1 2007
Last Update
December 11 2012
Active Locations (19)
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1
Department of Paediatrics and Child Health, The Canberra Hospital
Garran, Australian Capital Territory, Australia, 2605
2
Neonatalogy John Hunter Hospital
New Lambton Heights, New South Wales, Australia, 2305
3
Caboolture Clinical Research
Caboolture, Queensland, Australia, 4510
4
University of Queensland, Royal Children's Hospital
Herston, Queensland, Australia, 4029