CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 136 enrolled
Drug / intervention
motavizumab (MEDI-524) +1 morebiological
Likely dose
15 mg/kg motavizumab (MEDI-524) intramuscularly every 30 days for 4-5 injectionsAI-extracted
Key inclusion· 4
  • ✓Previous participation in MI-CP104 with at least 3 prior injections of MEDI-524
  • ✓Age ≤24 months at study entry
  • ✓Able to complete follow-up through 3-4 months after last dose (6-8 months total participation)
  • ✓Written informed consent from parent(s) or legal guardian
Key exclusion· 11
  • ✕Currently hospitalized
  • ✕Chronic oxygen therapy or mechanical ventilation (including CPAP)
  • ✕Hepatitis A, B, or C infection
  • ✕Renal impairment, hepatic dysfunction, chronic seizure disorder, immunodeficiency, or HIV infection

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00113490
NCT00113490Phase 2Completed
CompareCT.gov

A Phase 1/2 Study to Evaluate the Safety, Tolerability, and Immunogenicity of MEDI-524, a Humanized Enhanced Potency Monoclonal Antibody Against Respiratory Syncytial Virus (RSV), After Dosing for a Second Season in Children Who Previously Received MEDI-524 in Protocol MI-CP104

MedImmune LLC·interventional·Posted Jun 9, 2005·Updated May 22, 2013

In Brief

A Phase 2 clinical trial evaluating motavizumab (MEDI-524) and palivizumab 15 mg/kg for Motavizumab Administration for a Second Season for RSV Prophylaxis. Completed, enrolled 136 participants across 6 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMotavizumab Administration for a Second Season for RSV Prophylaxis
CountriesBrazil, Chile
Collaborators--

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 9, 2005
Enrollment StartMay 1, 2005
Primary CompletionFeb 1, 2006
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 21.1 years ago

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.

palivizumab 15 mg/kgbiological

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