A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Motavizumab (MEDI-524) After Dosing for a Second Season in Children

NCT00113490 | Completed Phase 1 Results

• 1 other identifier: MI-CP118
• Study Type: interventional
• Target: 136
• Locations: 2 countries
• Sites: 6

Brief Summary

The primary objective of this study was to determine the effect on immune reactivity to motavizumab (MEDI-524) of monthly intramuscular (IM) doses of motavizumab (MEDI-524) administered for a second season in children.

Conditions

Motavizumab Administration for a Second Season for RSV Prophylaxis

Keywords

motavizumab, palivizumab, synagis; Rezield, MEDI-524

Outcome Measures

Primary Outcomes (1)

• Number of Subjects Exhibiting Anti-motavizumab Antibodies

  Serum for measurement of anti-motavizumab antibodies was collected prior to the first, second and, if applicable, fifth doses of study drug, and at the 2 follow-up visits 30 and 90-120 days post final dose.

  Day 0 through 120 days post final dose

Secondary Outcomes (4)

• Number of Subjects Reporting Adverse Events (AEs)

  Day 0 through 30 days post final dose

• Number of Subjects Reporting Serious Adverse Events (SAEs)

  Day 0 through 30 days post final dose

• Number of Subjects With Increased Toxicity Grade From Baseline as Determined by Laboratory Evaluations

  Day 0 through 30 days post final dose

• Motavizumab Serum Concentrations at Each Data Collection Visit

  Prior to dosing on Day 0, Day 30, Day 120, and at 30 and 90-120 days post final dose

Study Arms (2)

motavizumab (MEDI-524) 15 mg/kg

EXPERIMENTAL

A single IM injection every 30 days beginning at Day 0 for a total of 4-5 injections determined by when in the RSV season a child was enrolled.

Biological: motavizumab (MEDI-524)

palivizumab 15 mg/kg

ACTIVE COMPARATOR

A single IM injection every 30 days beginning at Day 0 for a total of 4-5 injections determined by when in the RSV season a child was enrolled.

Biological: palivizumab 15 mg/kg

Interventions

motavizumab (MEDI-524) BIOLOGICAL

Patients will receive 15 mg/kg MEDI-524 administered IM every 30 days for a total of 4-5 injections.

Also known as: motavizumab, Rezield

motavizumab (MEDI-524) 15 mg/kg

palivizumab 15 mg/kg BIOLOGICAL

Patients will receive 15 mg/kg palivizumab administered IM every 30 days for a total of 4-5 injections.

Also known as: synagis

palivizumab 15 mg/kg

Eligibility Criteria

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

You may qualify if:

• Previous participation in MI-CP104 and received at least 3 injections of MEDI-524 in MI-CP104
• The child must be less than or equal to 24 months of age at time of entry into the study (child must be entered on or before their 24-month birthday)
• The child must be able to complete the follow-up visits through 3-4 months after last dose (total length of participation of 6-8 months)
• Written informed consent obtained from the patient's parent(s) or legal guardian

You may not qualify if:

• Currently hospitalized
• Receiving chronic oxygen therapy or mechanical ventilation at the time of study entry (including continuous positive airway pressure \[CPAP\])
• Evidence of infection with hepatitis A, B, or C virus
• Known renal impairment, hepatic dysfunction, chronic seizure disorder, or immunodeficiency or HIV infection
• Suspected serious allergic or immune mediated events with prior receipt of MEDI-524
• Acute illness or progressive clinical disorder
• Active infection, including acute respiratory syncytial virus (RSV) infection at the time of enrollment
• Previous reaction to IGIV, blood products, or other foreign proteins
• Have ever received palivizumab
• Received within the past 120 days or currently receiving immunoglobulin products (such as RSV-IGIV \[RespiGam(R)\], IVIG), or any investigational agents (except MEDI-524)
• Currently participating in any investigational study

Sponsors & Collaborators

• MedImmune LLC: lead

Study Sites (6)

Pontificia Universidade Catolica Do Rio Grande

Porto Alegre, 90610-000, Brazil

Location

Hospital Das Clinicas Da Faculdade

Ribeirão Preto, 14049-900, Brazil

Location

Hospital Clinico De La Pointificia Universidad

Santiago, Chile

Location

Hospital Clinico de la Universidad de Chile

Santiago, Chile

Location

Hospital Dr. Sotero Del Rio

Santiago, Chile

Location

Hospital San Jose

Santiago, Chile

Location

Related Publications (1)

• Abarca K, Jung E, Fernandez P, Zhao L, Harris B, Connor EM, Losonsky GA; Motavizumab Study Group. Safety, tolerability, pharmacokinetics, and immunogenicity of motavizumab, a humanized, enhanced-potency monoclonal antibody for the prevention of respiratory syncytial virus infection in at-risk children. Pediatr Infect Dis J. 2009 Apr;28(4):267-72. doi: 10.1097/INF.0b013e31818ffd03.

  PMID: 19258920 RESULT

MeSH Terms

Interventions

motavizumab; Palivizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: M. Pamela Griffin, MD/ Clinical Development
• Organization: MedImmune

clinicaltrialenquiries@medimmune.com

301-398-0000

Study Officials

• M Pamela Griffin, M.D.

  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: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2005
• First Posted: June 9, 2005
• Study Start: May 1, 2005
• Primary Completion: February 1, 2006
• Study Completion: February 1, 2006
• Last Updated: May 22, 2013
• Results First Posted: May 22, 2013

Record last verified: 2013-04

Locations

CL (4); BR (2)