Status:
COMPLETED
MEDI-524 (Motavizumab) for the Prevention of Respiratory Sycytial Virus (RSV) Disease Among Native American Indian Infants in the Southwestern United States
Lead Sponsor:
MedImmune LLC
Conditions:
Healthy
Eligibility:
All Genders
Up to 6 years
Phase:
PHASE3
Brief 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 Nati...
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 Nati...
Eligibility Criteria
Inclusion
- 6 months of age or younger at randomization (child must be randomized on or before their 6-month birthday)
- Male or female Native American
- General state of good health
- Written informed consent obtained from the participant's parent(s) or legal guardian
Exclusion
- Gestational age less than or equal to 35 weeks
- Chronic lung disease of prematurity
- A bleeding diathesis that would preclude IM injections
- Hospitalization at the time of randomization (unless discharge is anticipated within 10 days)
- Active RSV infection (a child with signs/symptoms of respiratory infection must have negative RSV testing) or known prior history of RSV infection
- A documented wheezing episode before enrollment
- Known renal impairment
- Known hepatic dysfunction
- Clinically significant congenital anomaly of the respiratory tract
- Chronic seizure or evolving or unstable neurologic disorder
- Congenital heart disease (CHD) (children with uncomplicated CHD \[e.g., Patent ductus arteriosus, small septal defect\] and children with complicated CHD who are currently anatomically and hemodynamically)
- Known immunodeficiency
- Mother with human immunodeficiency virus infection (unless the child has been proven to be not infected)
- Known allergy to Ig products
- Receipt of palivizumab, Respiratory syncytial virus immunoglobulin, intravenous (RSV-IGIV), or other RSV-specific monoclonal antibody, or any other polyclonal antibody (for example, hepatitis B immunoglobulin, IVIG) within 3 months prior to randomization
- Anticipated use of palivizumab or IVIG during the study (blood transfusions permitted)
- Previous receipt of RSV vaccines
- Participation in other investigational drug product studies
- Any medical or social condition which, in the opinion of the investigator, would adversely affect monitoring the infant
- Inability to complete the study follow-up period through up to 5 years of age
Key Trial Info
Start Date :
November 15 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 27 2010
Estimated Enrollment :
2127 Patients enrolled
Trial Details
Trial ID
NCT00121108
Start Date
November 15 2004
End Date
December 27 2010
Last Update
January 5 2022
Active Locations (12)
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1
Research Site
Chinle, Arizona, United States
2
Research Site
Cibecue, Arizona, United States
3
Research Site
Fort Definace, Arizona, United States
4
Research Site
San Carlos, Arizona, United States