MedTrace Logo

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

NCT00113490 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2013-05-22

Study results available
· View outcomes & findings →

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

Interventions

BIOLOGICAL

motavizumab (MEDI-524)

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

BIOLOGICAL

palivizumab 15 mg/kg

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

Sponsors & Collaborators

  • MedImmune LLC

    lead INDUSTRY

Principal Investigators

  • M Pamela Griffin, M.D. · MedImmune LLC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
24 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-05-31
Primary Completion
2006-02-28
Completion
2006-02-28

Countries

  • Brazil
  • Chile

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00113490 on ClinicalTrials.gov