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A Study to Evaluate a Single Intramuscular Dose of Motavizumab to Treat Children With Respiratory Syncytial Virus (RSV) Illness

NCT ID: NCT00435227

Last Updated: 2021-08-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-20

Study Completion Date

2008-05-31

Brief Summary

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This was a Phase 2, randomized, double-blind, placebo-controlled, multicenter study to determine the effect of a single 30 mg/kg intramuscular (IM) dose of motavizumab on viral load and motavizumab levels in the upper respiratory tract of children who present with RSV illness but who do not require hospitalization. Using 1:1 randomization, 30 mg/kg motavizumab or placebo will be administered as soon as possible after a child's diagnosis of RSV and his/her eligibility for the study has been confirmed.

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Detailed Description

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This was a Phase 2, randomized, double-blind, placebo-controlled, multicenter study to determine the effect of a single 30 mg/kg IM dose of motavizumab on viral load in the upper respiratory tract of children who present with RSV illness but who do not require hospitalization. Participants were randomly assigned in a 1:1 ratio to 30 mg/kg motavizumab or placebo as soon as possible after a child's diagnosis of RSV and his/her eligibility for the study had been confirmed. Randomization was stratified by age (\<6 months and greater than or equal to 6 to less than or equal to 12 months of age) and by site. Enrollment of an initial 100 children (50 per treatment group) will take place at multiple sites beginning in the 2006-2007 RSV season. The study was terminated early due to inability to enroll the planned number of participants.

Conditions

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Participants Less Than 12 Months of Age With RSV Illness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Motavizumab

Participants will receive a single IM dose of 30 mg/kg of motavizumab on Day 0 of the study.

Group Type EXPERIMENTAL

Motavizumab

Intervention Type BIOLOGICAL

A single IM dose of 30 mg/kg will be administered on Day 0 of the study.

Placebo

Participants will receive a single IM dose of placebo matched to motavizumab on Day 0 of the study.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

A single IM dose of placebo matched to motavizumab will be administered on Day 0 of the study.

Interventions

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Motavizumab

A single IM dose of 30 mg/kg will be administered on Day 0 of the study.

Intervention Type BIOLOGICAL

Placebo

A single IM dose of placebo matched to motavizumab will be administered on Day 0 of the study.

Intervention Type OTHER

Other Intervention Names

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MEDI-524

Eligibility Criteria

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Inclusion Criteria

* Previously healthy
* Age ≤12 months at the time of randomization
* Weight ≤10 kg at the time of randomization
* Gestational age ≥36 weeks
* RSV illness (must have coryza) documented by a positive RSV test at the time of evaluation
* Documented stable clinical condition that does not require hospitalization (oxygen saturation ≥ 95%; respiratory rate \< 60 breaths/minute in children \< 2 months and \< 50 breaths/minute in children 2-12 months)
* Respiratory Distress Assessment Instrument (RDAI) score of ≤ 6 (there can be no more than 1 point assigned for each of the 6 assessment categories) at baseline evaluation
* Randomization within 4 hours of being evaluated with a positive Binax® RSV test
* Written informed consent obtained from the participant's parent(s) or legal guardian

Exclusion Criteria

* Prior receipt of or receiving treatment with steroids (except topical steroids) prior to randomization
* Prior medically diagnosed RSV infection
* Prior receipt of or receiving anti-viral treatment for the current episode of RSV infection prior to randomization
* Any medically significant underlying ongoing chronic illness or organ system dysfunction or other known acute illness, other than the acute RSV infection
* Known renal impairment, hepatic dysfunction, hematologic abnormalities, seizure or other neurologic disorder or immunodeficiency
* Requirement for supplemental oxygen (brief use of oxygen in the immediate postnatal period to treat a transient condition is allowed)
* Mechanical ventilation at any time prior to the onset of the current RSV infection
* Congenital heart disease \[children with medically or surgically closed patent ductus arteriosus (PDA), small atrial septal defect (ASD) or small ventricular septal defect (VSD) will be allowed\]
* Previous reaction to intravenous immunoglobulin (IVIG), blood products, or other foreign proteins
* Prior use of IVIG, RSV-IGIV (RespiGam®), motavizumab or other immunoglobulin products within the past 2 months
* Prior use of palivizumab (Synagis®) 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
Minimum Eligible Age

0 Months

Maximum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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MedImmune LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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M. Pamela Griffin, M.D.

Role: STUDY_DIRECTOR

MedImmune LLC

Locations

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Research Site

Tucson, Arizona, United States

Site Status

Research Site

Jonesboro, Arkansas, United States

Site Status

Research Site

Jonesboro, Arkansas, United States

Site Status

Research Site

Little Rock, Arkansas, United States

Site Status

Research Site

Little Rock, Arkansas, United States

Site Status

Research Site

Orange, California, United States

Site Status

Research Site

San Diego, California, United States

Site Status

Research Site

Miami, Florida, United States

Site Status

Research Site

Tampa, Florida, United States

Site Status

Research Site

Atlanta, Georgia, United States

Site Status

Research Site

Augusta, Georgia, United States

Site Status

Research Site

Chicago, Illinois, United States

Site Status

Research Site

Baltimore, Maryland, United States

Site Status

Research Site

Boston, Massachusetts, United States

Site Status

Research Site

Detroit, Michigan, United States

Site Status

Research Site

Las Vegas, Nevada, United States

Site Status

Research Site

Paterson, New Jersey, United States

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Research Site

Brooklyn, New York, United States

Site Status

Research Site

Buffalo, New York, United States

Site Status

Research Site

The Bronx, New York, United States

Site Status

Research Site

Youngstown, Ohio, United States

Site Status

Research Site

Oklahoma City, Oklahoma, United States

Site Status

Research Site

Nashville, Tennessee, United States

Site Status

Research Site

Dallas, Texas, United States

Site Status

Research Site

Dallas, Texas, United States

Site Status

Research Site

Houston, Texas, United States

Site Status

Research Site

Richmond, Virginia, United States

Site Status

West Virginia University Pediactric Center

Charleston, West Virginia, United States

Site Status

Research Site

Charleston, West Virginia, United States

Site Status

Research Site

Huntington, West Virginia, United States

Site Status

Research Site

Morgantown, West Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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MI-CP146

Identifier Type: -

Identifier Source: org_study_id

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