| June 8, 2005 |
| December 27, 2007 |
| October 2006 |
| March 2007 (final data collection date for primary outcome measure) |
| Immunogenicity of MEDI-524 [ Time Frame: · Serum ELISA binding activity at each data collection visit will be summarized ] [ Designated as safety issue: No ] |
| - Immunogenicity of MEDI-524 |
| Complete list of historical versions of study NCT00113490 on ClinicalTrials.gov Archive Site |
- Safety and tolerability of MEDI-524 and palivizumab as measured by [ Time Frame: through Study Day 120 for patients who receive 4 doses and Study Day 150 for patients who receive 5 doses of study drug ] [ Designated as safety issue: Yes ]
- Pharmacokinetics of MEDI-524 [ Time Frame: · Serum concentrations at each data collection visit will be summarized ] [ Designated as safety issue: Yes ]
|
- - Safety and tolerability of MEDI-524 and palivizumab as measured by:
- - Adverse events through Study Day 120 for patients who receive 4 doses and Study Day 150 for patients who receive 5 doses of study drug (including the occurrence of increased toxicity grade from baseline as determined by laboratory evaluations)
- - Serious adverse events through Study Day 120 for patients who receive 4 doses and Study Day 150 for patients who receive 5 doses of study drug
- - Pharmacokinetics of MEDI-524-Serum concentrations at each data collection visit will be summarized
|
| |
| A Study to Evaluate the Safety, Tolerability, and Immunogenicity of 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 |
The primary objective of this study is to determine the effect on immune reactivity to MEDI-524. |
The primary objective of this study is to determine the effect on immune reactivity to MEDI-524 of monthly intramuscular (IM) doses of MEDI-524 of monthly intramuscular (IM) doses of MEDI-524 administered for a second season, in children who previously received MEDI-524 in protocol MI-CP104. The secondary objectives are to 1) describe the safety and tolerability of MEDI-524 administered for a second season; 2) describe the serum concentration of MEDI-524 administered for a second season. |
| Phase I, Phase II |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety Study |
| Healthy |
| Biological: MEDI-524 |
| Active Comparator: Patients will receive 15 mg/kg MEDI-524 or palivizumab administered IM every 30 days for a total of 4-5 injections. |
| |
| |
| Completed |
| 150 |
| June 2007 |
| March 2007 (final data collection date for primary outcome measure) |
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:
- Be 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
|
| Both |
| up to 24 Months |
| Yes |
| Contact information is only displayed when the study is recruiting subjects |
| Brazil, Chile |
| |
| NCT00113490 |
| Pam Lupien, M.D., MedImmune Inc. |
| MI-CP118 |
| MedImmune LLC |
|
| Study Director: |
Pam Lupien, M.D. |
MedImmune LLC |
|
|
| MedImmune LLC |
| December 2007 |