Motavizumab Administration for a Second Season for RSV Prophylaxis Clinical Trial
Official title:
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
| Verified date | April 2013 |
| Source | MedImmune LLC |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 136 |
| Est. completion date | February 2006 |
| Est. primary completion date | February 2006 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A to 24 Months |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| Brazil | Pontificia Universidade Catolica Do Rio Grande | Porto Alegre | |
| Brazil | Hospital Das Clinicas Da Faculdade | Ribeirao Preto | |
| Chile | Hospital Clinico De La Pointificia Universidad | Santiago | |
| Chile | Hospital Clinico de la Universidad de Chile | Santiago | |
| Chile | Hospital Dr. Sotero Del Rio | Santiago | |
| Chile | Hospital San Jose | Santiago |
| Lead Sponsor | Collaborator |
|---|---|
| MedImmune LLC |
Brazil, Chile,
Abarca K, Jung E, Fernández P, Zhao L, Harris B, Connor EM, Losonsky GA; Motavizumab Study Group. Safety, tolerability, pharmacokinetics, and immunogenicity of motavizumab, a humanized, enhanced-potency monoclonal antibody for the prevention of respirator — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Subjects Exhibiting Anti-motavizumab Antibodies | Serum for measurement of anti-motavizumab antibodies was collected prior to the first, second and, if applicable, fifth doses of study drug, and at the 2 follow-up visits 30 and 90-120 days post final dose. | Day 0 through 120 days post final dose | Yes |
| Secondary | Number of Subjects Reporting Adverse Events (AEs) | Assessments of adverse events (including SAEs) were made by clinical investigators according to the protocol. | Day 0 through 30 days post final dose | Yes |
| Secondary | Number of Subjects Reporting Serious Adverse Events (SAEs) | Assessments of SAEs were made by clinical investigators according to the protocol. | Day 0 through 30 days post final dose | Yes |
| Secondary | Number of Subjects With Increased Toxicity Grade From Baseline as Determined by Laboratory Evaluations | Serum chemistry and hematology parameters were measured at baseline, on Days 25-30 and 120, 30 days post the final dose, and at premature discontinuation. | Day 0 through 30 days post final dose | Yes |
| Secondary | Motavizumab Serum Concentrations at Each Data Collection Visit | Mean serum concentration. | Prior to dosing on Day 0, Day 30, Day 120, and at 30 and 90-120 days post final dose | No |