Status:
COMPLETED
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Motavizumab (MEDI-524) After Dosing for a Second Season in Children
Lead Sponsor:
MedImmune LLC
Conditions:
Motavizumab Administration for a Second Season for RSV Prophylaxis
Eligibility:
All Genders
Up to 24 years
Phase:
PHASE1
PHASE2
Brief Summary
The primary objective of this study was to determine the effect on immune reactivity to motavizumab (MEDI-524) of monthly intramuscular (IM) doses of motavizumab (MEDI-524) administered for a second s...
Detailed Description
This was a Phase 1/2, randomized, double-blind study in which motavizumab (MEDI-524) or palivizumab was administered to children who previously participated in MI-CP104. Children who received at least...
Eligibility Criteria
Inclusion
- Previous participation in MI-CP104 and received at least 3 injections of MEDI-524 in MI-CP104
- The child must be less than or equal to 24 months of age at time of entry into the study (child must be entered on or before their 24-month birthday)
- The child must be able to complete the follow-up visits through 3-4 months after last dose (total length of participation of 6-8 months)
- Written informed consent obtained from the patient's parent(s) or legal guardian
Exclusion
- Currently hospitalized
- Receiving chronic oxygen therapy or mechanical ventilation at the time of study entry (including continuous positive airway pressure \[CPAP\])
- Evidence of infection with hepatitis A, B, or C virus
- Known renal impairment, hepatic dysfunction, chronic seizure disorder, or immunodeficiency or HIV infection
- Suspected serious allergic or immune mediated events with prior receipt of MEDI-524
- Acute illness or progressive clinical disorder
- Active infection, including acute respiratory syncytial virus (RSV) infection at the time of enrollment
- Previous reaction to IGIV, blood products, or other foreign proteins
- Have ever received palivizumab
- Received within the past 120 days or currently receiving immunoglobulin products (such as RSV-IGIV \[RespiGam(R)\], IVIG), or any investigational agents (except MEDI-524)
- Currently participating in any investigational study
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2006
Estimated Enrollment :
136 Patients enrolled
Trial Details
Trial ID
NCT00113490
Start Date
May 1 2005
End Date
February 1 2006
Last Update
May 22 2013
Active Locations (6)
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1
Pontificia Universidade Catolica Do Rio Grande
Porto Alegre, Brazil, 90610-000
2
Hospital Das Clinicas Da Faculdade
Ribeirão Preto, Brazil, 14049-900
3
Hospital Clinico De La Pointificia Universidad
Santiago, Chile
4
Hospital Clinico de la Universidad de Chile
Santiago, Chile