Phase 2
Completed N=136
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Motavizumab (MEDI-524) After Dosing for a Second Season in Children
Motavizumab Administration for a Second Season for RSV Prophylaxis
Source: ClinicalTrials.gov NCT00113490 ↗
Enrolled (actual)
136
Serious AEs
3.7%
Results posted
May 2013
Primary outcomePrimary: Number of Subjects Exhibiting Anti-motavizumab Antibodies — 2; 3; 0; 3 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Exhibiting Anti-motavizumab Antibodies |
2; 3; 0; 3; 0; 6 | — |
| SECONDARY Number of Subjects Reporting Adverse Events (AEs) |
56; 62 | — |
| SECONDARY Number of Subjects Reporting Serious Adverse Events (SAEs) |
4; 1 | — |
| SECONDARY Number of Subjects With Increased Toxicity Grade From Baseline as Determined by Laboratory Evaluations |
1; 0; 0; 4; 3; 3 | — |
| SECONDARY Motavizumab Serum Concentrations at Each Data Collection Visit |
1.536; 54.59; 86.21; 76.03; 12.2 | — |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00113490). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.