Phase 2
N=260
Study of Motavizumab (MEDI-524) and Palivizumab Administered Sequentially in the Same Respiratory Syncytial Virus (RSV) Season
Respiratory Syncytial Virus Infections · Chronic Lung Disease and <= 24 Months of Age or · Premature With Gestational Age <=35 Weeks and <=6 Months of Age
Bottom Line
View on ClinicalTrials.gov: NCT00316264 ↗Enrolled (actual)
260
Serious AEs
14.3%
Results posted
Dec 2012
Primary outcome: Primary: Number of Subjects Reporting Serious Adverse Events (SAEs) — 19; 7; 11 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Motavizumab, palivizumab (Biological); Palivizumab, motavizumab (Biological); Motavizumab (Biological)
- Age
- Pediatric
- Sex
- All
- Sponsor
- MedImmune LLC
- Primary completion
- Feb 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Reporting Serious Adverse Events (SAEs) |
19; 7; 11 | — |
| PRIMARY Number of Subjects Reporting Adverse Events (AEs) |
77; 75; 83 | — |
| PRIMARY Number of Subjects With Changes in Laboratory Chemistry Values Reported as AEs. |
1; 1; 5; 1; 0; 0 | — |
| SECONDARY The Serum Concentrations of Motavizumab at Day 0 |
NA; NA; NA | — |
| SECONDARY The Trough Serum Concentrations of Motavizumab at Day 60 |
74.74; 0.9417; 78.02 | — |
| SECONDARY The Trough Serum Concentrations of Motavizumab at Day 150 |
8.801; 93.05; 105.8 | — |
| SECONDARY The Trough Serum Concentrations of Motavizumab 120-150 Days Post Final Dose |
0.5078; 7.586; 10.01 | — |
| SECONDARY The Serum Concentrations of Palivizumab at Day 0 |
NA; NA; NA | — |
| SECONDARY The Trough Serum Concentrations of Palivizumab at Day 60 |
8.103; 87.37; 8.795 | — |
| SECONDARY The Trough Serum Concentrations of Palivizumab at Day 150 |
107.4; 22.89; 12.99 | — |
| SECONDARY The Trough Serum Concentrations of Palivizumab at 120-150 Days Post Final Dose |
7.667; NA; NA | — |
| SECONDARY The Immunogenicity of Motavizumab at Day 0 |
0; 1; 0 | — |
| SECONDARY The Immunogenicity of Motavizumab at Day 60 |
0; 0; 0 | — |
| SECONDARY The Immunogenicity of Motavizumab at Day 150 |
1; 1; 0 | — |
| SECONDARY The Immunogenicity of Motavizumab at 120 to 150 Days Post Final Dose |
3; 1; 0 | — |
| SECONDARY The Immunogenicity of Motavizumab at Any Time |
4; 2; 0 | — |
| SECONDARY The Immunogenicity of Palivizumab at Day 0 |
0; 0; 0 | — |
| SECONDARY The Immunogenicity of Palivizumab at Day 60 |
1; 1; 1 | — |
| SECONDARY The Immunogenicity of Palivizumab at Day 150 |
2; 1; 0 | — |
| SECONDARY The Immunogenicity of Palivizumab at 120 to 150 Days Post Final Dose |
3; 0; 0 | — |
| SECONDARY The Immunogenicity of Palivizumab at Any Time |
4; 2; 1 | — |
Summary
This is a Phase 2, randomized, double-blind study in which motavizumab (MEDI-524) and palivizumab were administered sequentially to high-risk children during the same respiratory syncytial virus (RSV) season. A control group was administered only motavizumab.
Eligibility Criteria
Inclusion Criteria
- The child must have been born at less than or equal to 35 weeks gestation and be less than or equal to 6 months of age at the time of entry into the study (child must be entered on or before his/her 6-month birthday); or the child must be less than or equal to 24 months of age at the time of entry into the study (child must be entered on or before his/her 24-month birthday) and diagnosed with chronic lung disease (CLD) of prematurity with stable or decreasing doses of diuretics, steroids, or bronchodilators, or treatment with supplemental oxygen, within the previous 6 months.
- The child must be in general good health at the time of study entry.
- The child's parent(s)/legal guardian must provide written informed consent.
- The child must be able to complete the follow-up visits through 120-150 days from last injection of study drug.
- Parent(s)/legal guardian of patient must have available telephone access.
Exclusion Criteria
- Hospitalized at the time of study entry (unless discharge is expected within 10 days after entry into the study)
- Receiving chronic oxygen therapy or mechanical ventilation at the time of study entry (including continuous positive airway pressure [CPAP])
- Congenital heart disease (CHD) (children with medically or surgically corrected [closed] patent ductus arteriosus and no other CHD may be enrolled)
- Evidence of infection with hepatitis A, B, or C virus
- Known renal impairment, hepatic dysfunction, chronic seizure disorder, or immunodeficiency or HIV infection (a child of a mother with known HIV infection must be proven to be uninfected at the time of enrollment)
- Suspected serious allergic or immune-mediated events with prior receipt of palivizumab
- Acute illness or progressive clinical disorder
- Active infection, including acute RSV infection, at the time of enrollment
- Previous reaction to intravenous immunoglobulin (IGIV), blood products, or other foreign proteins
- Received within the past 120 days or currently receiving immunoglobulin products (such as RSV-IGIV [RespiGam], IVIG, or palivizumab) or any investigational agents
- Previous participation in a clinical trial of motavizumab
- Currently participating in any investigational study
Data sourced from ClinicalTrials.gov (NCT00316264). 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.