Safety Study of a Monoclonal Antibody to Respiratory Syncytial Virus (RSV) in Children Hospitalized With RSV Infection

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-31

Study Completion Date

2005-01-31

Brief Summary

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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).

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Detailed Description

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This study was designed as a Phase 1, randomized, double-blind, placebo-controlled, dose-escalation, multicenter clinical study to evaluate the safety, tolerability, serum concentrations, and immunogenicity of a single intravenous dose of motavizumab (MEDI-524) and the effect on the amount of respirtory syncytial virus (RSV) in the respiratory tract (nasopharynx) of otherwise healthy children hospitalized with RSV infection.

Conditions

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Respiratory Syncytial Virus Prophylaxis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Motavizumab, 3 mg/kg as a single intravenous dose

Motavizumab, 3 mg/kg as a single intravenous dose administered on Day 0

Group Type EXPERIMENTAL

Motavizumab

Intervention Type BIOLOGICAL

Single dose of Motavizumab at a dose of 3 mg/kg administered intravenously (in the vein) on Day 0

Motavizumab, 15 mg/kg as a single intravenous dose

Motavizumab, 15 mg/kg as a single intravenous dose administered on Day 0

Group Type EXPERIMENTAL

Motavizumab

Intervention Type BIOLOGICAL

Single dose of Motavizumab at a dose of 15 mg/kg administered intravenously (in the vein) on Day 0

Motavizumab, 30 mg/kg as a single intravenous dose

Motavizumab, 30 mg/kg as a single intravenous dose administered on Day 0

Group Type EXPERIMENTAL

Motavizumab

Intervention Type BIOLOGICAL

Single dose of Motavizumab at a dose of 30 mg/kg administered intravenously (in the vein) on Day 0

Placebo, as a single intravenous dose

Placebo, as a single intravenous dose administered on Day 0

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Single dose of placebo administered intravenously (in the vein) on Day 0

Interventions

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Motavizumab

Single dose of Motavizumab at a dose of 3 mg/kg administered intravenously (in the vein) on Day 0

Intervention Type BIOLOGICAL

Motavizumab

Single dose of Motavizumab at a dose of 15 mg/kg administered intravenously (in the vein) on Day 0

Intervention Type BIOLOGICAL

Motavizumab

Single dose of Motavizumab at a dose of 30 mg/kg administered intravenously (in the vein) on Day 0

Intervention Type BIOLOGICAL

Placebo

Single dose of placebo administered intravenously (in the vein) on Day 0

Intervention Type OTHER

Other Intervention Names

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MEDI-524 MEDI-524 MEDI-524

Eligibility Criteria

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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

Maximum Eligible Age

24 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No