Trials / Completed
CompletedNCT00113490
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Motavizumab (MEDI-524) After Dosing for a Second Season in Children
A Phase 1/2 Study to Evaluate the Safety, Tolerability, and Immunogenicity of MEDI-524, a Humanized Enhanced Potency Monoclonal Antibody Against Respiratory Syncytial Virus (RSV), After Dosing for a Second Season in Children Who Previously Received MEDI-524 in Protocol MI-CP104
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 136 (actual)
- Sponsor
- MedImmune LLC · Industry
- Sex
- All
- Age
- 24 Months
- Healthy volunteers
- Not accepted
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 season in children.
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 3 doses of motavizumab in MI-CP104 were eligible for enrollment. Subjects were randomized 1:1 to receive motavizumab or palivizumab at 15 mg/kg by IM injection every 30 days for a total of 4-5 injections during the 2004-05 RSV season subsequent to the season in which they were participants of MI-CP104. All subjects were evaluated prior to and 30 minutes after each injection of study drug with 2 follow-up evaluations, one at 30 days and the other at 90-120 days after the last dose.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | motavizumab (MEDI-524) | Patients will receive 15 mg/kg MEDI-524 administered IM every 30 days for a total of 4-5 injections. |
| BIOLOGICAL | palivizumab 15 mg/kg | Patients will receive 15 mg/kg palivizumab administered IM every 30 days for a total of 4-5 injections. |
Timeline
- Start date
- 2005-05-01
- Primary completion
- 2006-02-01
- Completion
- 2006-02-01
- First posted
- 2005-06-09
- Last updated
- 2013-05-22
- Results posted
- 2013-05-22
Locations
6 sites across 2 countries: Brazil, Chile
Source: ClinicalTrials.gov record NCT00113490. Inclusion in this directory is not an endorsement.