Phase 3
N=6,635
Study of MEDI-524 (Motavizumab) for the Prophylaxis of Serious Respiratory Syncytial Virus (RSV) Disease in High-Risk Children
Respiratory Syncytial Virus Infections
Bottom Line
View on ClinicalTrials.gov: NCT00129766 ↗Enrolled (actual)
6,635
Serious AEs
15.0%
Results posted
Aug 2013
Primary outcome: Primary: Incidence of RSV Hospitalization (Includes Deaths by RSV) — 62; 46 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- motavizumab (MEDI-524) (Biological); palivizumab (Biological)
- Age
- Pediatric
- Sex
- All
- Sponsor
- MedImmune LLC
- Primary completion
- May 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of RSV Hospitalization (Includes Deaths by RSV) |
62; 46 | — |
| PRIMARY Number of Participants Reporting Any Adverse Events (AEs) |
2837; 2839 | — |
| PRIMARY Number of Participants Reporting Any Related AEs |
258; 298 | — |
| PRIMARY Number of Participants Reporting Any Serious Adverse Events (SAEs) |
506; 485 | — |
| PRIMARY Number of Participants Reporting Any Related SAEs |
8; 9 | — |
| PRIMARY Number of Participants Reporting AEs by Highest Severity Grade |
1478; 1538; 1006; 976; 292; 271 | — |
| PRIMARY Number of Participants Who Discontinued Study Drug Due to AEs |
10; 13 | — |
| PRIMARY Number of Participants Who Died |
4; 8 | — |
| PRIMARY Number of Participants Reporting Changes in Vital Signs From Baseline |
0; 2; 0; 1; 3; 3 | — |
| SECONDARY The Incidence of Outpatient Medically-attended Lower Respiratory Illness (LRI) |
696; 648 | 0.110 |
| SECONDARY The Incidence of RSV-specific Medically-attended Outpatient Lower Respiratory Illnesses (LRIs) Between Treatment Groups |
46; 24 | 0.005 sig |
| SECONDARY The Incidence of Medically-attended Otitis Media (OM) Infections |
461; 484; 2845; 2845; 329; 360 | 0.476 |
| SECONDARY The Frequency of Prescribed Antibiotics for Medically-attended LRI |
0.32; 0.30 | 0.493 |
| SECONDARY The Frequency of Prescribed Antibiotics for Medically-attended OM Infections |
1.08; 1.10 | 0.652 |
| SECONDARY The Number of Participants With Anti-motavizumab Antibodies |
7; 1; 1; 7; 18; 22 | — |
| SECONDARY The Serum Concentrations of Motavizumab at Day 0 |
0.01193 | — |
| SECONDARY The Trough Serum Concentrations of Motavizumab at 30 Days Post Dose 1 |
45.95 | — |
| SECONDARY The Trough Serum Concentrations of Motavizumab at 30 Days Post Dose 2 |
64.59 | — |
| SECONDARY The Trough Serum Concentrations of Motavizumab at 30 Days Post Dose 3 |
80.24 | — |
| SECONDARY The Trough Serum Concentrations of Motavizumab at 30 Days Post Dose 4 |
88.52 | — |
Summary
The primary objective of this study was to compare the safety and efficacy of motavizumab to palivizumab when administered monthly by intramuscular (IM) injection for the reduction of the incidence of RSV hospitalization among children at high risk for serious RSV disease. A secondary objective was to compare the incidence of medically-attended lower respiratory infections (LRIs) between treatment groups.
Eligibility Criteria
Inclusion Criteria
- 24 months of age or younger at randomization (child must be randomized on or before his/her 24-month birthday) with a diagnosis of chronic lung disease (CLD) of prematurity requiring medical intervention/management (i.e., supplemental oxygen, bronchodilators, or diuretics) within 6 months before randomization
OR:
- 35 weeks gestational age or less at birth and 6 months of age or younger at randomization (children were to be randomized on or before his/her 6-month birthday)
Exclusion Criteria
- Hospitalization at the time of randomization (unless discharge was anticipated within 10 days)
- Mechanical ventilation or other mechanical support (including continuous positive airways pressure [CPAP])
- Life expectancy < 6 months
- Active RSV infection (a child with signs/symptoms of respiratory infection must have had negative RSV testing)
- Known renal impairment
- Known hepatic dysfunction
- Chronic seizure or evolving or unstable neurologic disorder
- Congenital heart disease [CHD] (children with uncomplicated CHD [e.g., patent ductus arterious (PDA), small septal defect] and children with complicated CHD that were currently anatomically and hemodynamically normal could be enrolled)
- Known immunodeficiency
- Mother with HIV infection (unless the child has been proven to be not infected)
- Known allergy to Ig products
- Receipt of palivizumab, RSV-IGIV, or other RSV-specific monoclonal antibody, or any other polyclonal antibody (for example, hepatitis B IG, IVIG, VZIG) within 3 months prior to randomization
- Anticipated use of palivizumab or IVIG during the study (blood transfusions permitted)
- Previous receipt of RSV vaccines
- Participation in other investigational drug product studies
Data sourced from ClinicalTrials.gov (NCT00129766). 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.