NCT00121108

MEDI-524 (Motavizumab) for the Prevention of Respiratory Sycytial Virus (RSV) Disease Among Native American Indian Infants in the Southwestern United States

A Phase 3 Study of MEDI-524 (Motavizumab), an Enhanced Potency Humanized Respiratory Syncytial Virus (RSV) Monoclonal Antibody, for the Prevention of RSV Disease Among Native American Infants in the Southwestern United States

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,127 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 0 Months – 6 Months
• Healthy volunteers: Accepted

Summary

MI-CP117 was a Phase 3, randomized, double-blind, placebo-controlled trial designed to determine if motavizumab is more effective than placebo in reducing RSV hospitalization in otherwise healthy Native American Infants in the Southwestern United States during their first RSV season.

Detailed description

MI-CP117 was a Phase 3, randomized, double-blind, placebo-controlled trial designed to determine if motavizumab is more effective than placebo in reducing RSV hospitalization in otherwise healthy Native American infants during their first RSV season. Participants were randomized in a 2:1 ratio to receive either 15 mg/kg motavizumab or placebo by intramuscular (IM) injection every 30 days during the RSV season for a maximum of 5 injections. During their first RSV season, participants were evaluated monthly just prior to each injection of study drug for adverse events (AEs) (including medically attended otitis media), with a final post-dosing follow up evaluation at Study Day 150. During Seasons 1, 2, and 3, blood was to be collected prior to the first and last dose of study drug for serum chemistry evaluations, motavizumab serum concentrations, and anti-motavizumab antibodies. Efficacy and safety outcomes were examined through Study Day 150 and wheezing outcomes were evaluated from the time of randomization until the third birthday.

Conditions

• Healthy

Interventions

Type	Name	Description
BIOLOGICAL	Motavizumab	Intramuscular dose of motavizumab 15 mg/kg will be administered every 30 Days for a maximum of 5 injections (on Days 0, 30, 60, 90, and 120) during the RSV season.
OTHER	Placebo	Intramuscular dose of placebo matched to motavizumab will be administered every 30 days for a maximum of 5 injections (on Days 0, 30, 60, 90, and 120) during the the RSV season.

Timeline

• Start date: 2004-11-15
• Primary completion: 2010-12-27
• Completion: 2010-12-27
• First posted: 2005-07-21
• Last updated: 2022-01-05
• Results posted: 2022-01-05

Locations

12 sites across 1 country: United States