Phase 1
N=31
Safety Study of a Monoclonal Antibody to Respiratory Syncytial Virus (RSV) in Children Hospitalized With RSV Infection
Respiratory Syncytial Virus Prophylaxis
Bottom Line
View on ClinicalTrials.gov: NCT00192504 ↗Enrolled (actual)
31
Serious AEs
6.7%
Results posted
Oct 2021
Primary outcome: Primary: Number of Subjects Reporting Adverse Events Through 30 Days After Dosing — 3; 5; 3; 6 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Motavizumab (Biological); Placebo (Other)
- Age
- Pediatric
- Sex
- All
- Sponsor
- MedImmune LLC
- Primary completion
- Jan 2005
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Reporting Adverse Events Through 30 Days After Dosing |
3; 5; 3; 6 | — |
| PRIMARY Number of Subjects Reporting Serious Adverse Events Through 30 Days After Dosing |
0; 0; 1; 1 | — |
| PRIMARY The Occurrence of Increased Toxixity Grade From Baseline as Determined by Laboratory Evaluations |
0; 1; 1; 1 | — |
| PRIMARY To Describe the Mean Trough Serum Concentrations of Motavizumab (MEDI-524) Administered as a Single Intravenous Dose at Day 2 and Day 30 |
61.78; 170.8; 333.2; 0; 16.63; 59.18 | — |
| SECONDARY To Describe the Immunogenicity of Motavizumab (MEDI-524) Following a Single IV Dose at Day 0 |
0; 0; 0; 0 | — |
| SECONDARY To Describe the Immunogenicity of Motavizumab (MEDI-524) Following a Single IV Dose at Day 30 |
0; 0; 0; 0 | — |
Summary
The purpose of this study is to determine the safety of motavizumab (MEDI-524) following a single intravenous dose in children hospitalized with respiratory syncytial virus (RSV).
Eligibility Criteria
Inclusion Criteria
- Previously healthy
- Age 24 months and younger at the time of randomization
- Gestational age of 36 weeks gestation and older
- Randomization within 24 hours after hospitalization
- Hospitalized for lower respiratory tract illness (ie, respiratory syncytial virus (RSV) bronchiolitis and/or pneumonia) documented by positive RSV antigen detection or culture in respiratory secretions within 72 hours before randomization
Exclusion Criteria
- Already received or would receive ribavirin or other anti-viral treatment for the current episode of RSV infection prior to randomization
- Required intubation for ventilatory support
- Any medically significant underlying ongoing chronic illness or organ system dysfunction or other known acute illness, other than RSV infection
- Known renal impairment, hepatic dysfunction, hematologic abnormalities, seizure or other neurologic disorder or immunodeficiency
- Requirement for supplemental oxygen at any time prior to the current RSV infection (brief use of oxygen in the immediate postnatal period to treat a transient condition was allowed)
- Mechanical ventilation at any time prior to the onset of the current RSV infection
- Congenital heart disease (children with medically or surgically corrected patent ductus arteriosus [PDA], small atrial septal defect [ASD] or ventricular septal defect [VSD] were allowed)
- Previous reaction to intravneous immunoglobulin (IVIG), blood products, or other foreign proteins
- Prior use of IVIG, RSV-IGIV (RespiGam), palivizumab (Synagis), or other immunoglobulin products within the past 2 months
- Currently receiving other investigational agents or have received any other investigational agents within the last 3 months
- Prior or current participation in any investigational study with a therapeutic agent or vaccine for RSV
Data sourced from ClinicalTrials.gov (NCT00192504). 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.