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

NCT00192504 | Completed Phase 1 Results

• 1 other identifier: MI-CP106
• Study Type: interventional
• Target: 31
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Respiratory Syncytial Virus Prophylaxis

Keywords

MEDI-524; Motavizumab; respiratory syncytial virus; children; intravenous; Rezield

Outcome Measures

Primary Outcomes (4)

• Number of Subjects Reporting Adverse Events Through 30 Days After Dosing

  Safety and tolerability of motavizumab (MEDI-524) was measured by adverse events through 30 days after dosing

  From the start of treatment to 30 days after dosing

• Number of Subjects Reporting Serious Adverse Events Through 30 Days After Dosing

  Safety and tolerability of motavizumab (MEDI-524) was measured by serious adverse events through 30 days after dosing

  From the start of treatment to 30 days after dosing

• The Occurrence of Increased Toxixity Grade From Baseline as Determined by Laboratory Evaluations

  Safety and tolerability of motavizumab (MEDI-524) was measured by the occurrence of increased toxicity grade from baseline as determined by laboratory evaluations (complete blood count, aspartate aminotransferase (AST), alanine aminotransferase (ALT), blood urea nitrogen (BUN), creatinine, and urinalysis) at baseline and at each study collection time point following dosing

  From the start of treatment to 30 days after dosing

• To Describe the Mean Trough Serum Concentrations of Motavizumab (MEDI-524) Administered as a Single Intravenous Dose at Day 2 and Day 30

  Mean trough serum concentrations of motavizumab (MEDI-524) were collected on Day 2 and on Day 30. Serum concentrations of MEDI-524 were analysed using a qualified enzyme-linked immunosorbent assay (ELISA).

  Day 2 and Day 30

Secondary Outcomes (2)

• To Describe the Immunogenicity of Motavizumab (MEDI-524) Following a Single IV Dose at Day 0

  Immediately before dosing on Day 0

• To Describe the Immunogenicity of Motavizumab (MEDI-524) Following a Single IV Dose at Day 30

  Day 30

Study Arms (4)

Motavizumab, 3 mg/kg as a single intravenous dose

EXPERIMENTAL

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

Biological: Motavizumab

Motavizumab, 15 mg/kg as a single intravenous dose

EXPERIMENTAL

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

Biological: Motavizumab

Motavizumab, 30 mg/kg as a single intravenous dose

EXPERIMENTAL

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

Biological: Motavizumab

Placebo, as a single intravenous dose

PLACEBO COMPARATOR

Placebo, as a single intravenous dose administered on Day 0

Other: Placebo

Interventions

Motavizumab BIOLOGICAL

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

Also known as: MEDI-524

Motavizumab, 3 mg/kg as a single intravenous dose

Placebo OTHER

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

Placebo, as a single intravenous dose

Eligibility Criteria

• Age: Up to 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MedImmune LLC: lead

MeSH Terms

Interventions

motavizumab

Results Point of Contact

• Title: Genevieve A. Losonsky, MD/VP Clinical Development
• Organization: MedImmune, LLC

losonskyG@medimmune.com

301-398-0000

Study Officials

• Genevieve A Losonsky, MD

  MedImmune LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 19, 2005
• Study Start: March 1, 2004
• Primary Completion: January 1, 2005
• Study Completion: January 1, 2005
• Last Updated: October 8, 2021
• Results First Posted: October 8, 2021

Record last verified: 2006-10