A Study to Evaluate a Single Intravenous Dose of Motavizumab for the Treatment of Children Hospitalized with Respiratory Syncytial Virus (RSV) Illness

Study identifier:MI-CP141

ClinicalTrials.gov identifier:NCT00421304

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate a Single Intravenous Dose of Motavizumab (MEDI-524), a Humanized Enhanced Potency Monoclonal Antibody Against Respiratory Syncytial Virus (RSV), for the Treatment of Children Hospitalized with RSV Illness

Medical condition

RSV illness in ≤12 months of participants

Phase

N/A

Healthy volunteers

Study drug

Sex

All

Actual Enrollment

118

Study type

Interventional

Age

0 Months - 12 Months

Date

Study Start Date: 10 Jan 2007

Primary Completion Date: 17 Sept 2009

Study Completion Date: 17 Sept 2009

Study design

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Jul 2021 by MedImmune, LLC

Collaborators

Inclusion and exclusion criteria

Inclusion Criteria

Children must meet all of the following criteria:
-Previously healthy
-Age less or equal to 12 months at the time of randomization
-Gestational age more or equal to 36 weeks
-Hospitalized for lower respiratory tract illness (i.e., RSV bronchiolitis and/or pneumonia)
-Documented positive RSV test within 48 hours prior to randomization
-Randomization within 12 hours of the decision to hospitalize a child for RSV illness
-Written informed consent obtained from the participant's parent(s)/legal guardian

Exclusion Criteria

Children must have none of the following:
-Prior receipt of or receiving ribavirin or other anti-viral treatment for the current episode of RSV infection prior to randomization
-Any use of systemic or inhaled steroids within the past 30 days prior to randomization
-Intubation for ventilatory support at randomization
-Any medically significant underlying ongoing chronic illness or organ system dysfunction, or other known acute illness except for 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 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 arteriosis (PDA), small atrial septal defect (ASD) or small ventricular septal defect (VSD) will be allowed]
-Previous reaction to IVIG, blood products, or other foreign proteins
-Prior use of intravenous immunoglobulin (IVIG), palivizumab (SynagisÒ), or other immunoglobulin products within the past 2 months
-Currently receiving other investigational agents or have received any other investigational agents within the 3 months prior to randomization
-Prior or current participation in any investigational study with a therapeutic agent or vaccine for RSV

No locations available

Arms	Assigned Interventions
Placebo Comparator: Placebo Participants will receive a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.	Other: Placebo A single IV dose of placebo matched to motavizumab will be administered on Day 0 of the study.
Experimental: Motavizumab 30 mg/kg Participants will receive a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.	Biological/Vaccine: Motavizumab A single IV dose of motavizumab 30 mg/kg or 100 mg/kg will be administered on Day 0 of the study. Other Name: MEDI-524
Experimental: Motavizumab 100 mg/kg Participants will receive a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.	Biological/Vaccine: Motavizumab A single IV dose of motavizumab 30 mg/kg or 100 mg/kg will be administered on Day 0 of the study. Other Name: MEDI-524

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Trial Results Summaries
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Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]

Contact Backup

Joe Coffie

301-398-4723