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

Study identifier:MI-CP146

ClinicalTrials.gov identifier:NCT00435227

EudraCT identifier:N/A

CTIS identifier:N/A

Terminated/Withdrawn

Official Title

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

Medical condition

Participants less than 12 months of age with RSV illness

Phase

Phase 2

Healthy volunteers

Study drug

Sex

All

Actual Enrollment

Study type

Interventional

Age

0 Months - 12 Months

Date

Study Start Date: 20 Mar 2007

Primary Completion Date: 31 May 2008

Study Completion Date: 31 May 2008

Study design

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

Verification:

Verified 01 Jul 2021 by MedImmune, LLC

Collaborators

Inclusion and exclusion criteria

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

No locations available

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

Documents available

Trial Results Summaries
Available here

Contacts

Contact

Kristin Kopasz

301-398-0000

[email protected]

Contact Backup

Joseph Coffie