MEDI-524 (Motavizumab) for the Prevention of Respiratory Sycytial Virus (RSV) Disease Among Native American Indian Infants in the Southwestern United States
NCT ID: NCT00121108
Last Updated: 2022-01-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
2127 participants
INTERVENTIONAL
2004-11-15
2010-12-27
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Placebo
Participants will receive IM dose of placebo matched to motavizumab every 30 days for a maximum of 5 injections (on Days 0, 30, 60, 90, and 120) during the the RSV season.
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.
Motavizumab
Participants will receive IM dose of motavizumab 15 milligram/Kilogram (mg/kg) every 30 Days for a maximum of 5 injections (on Days 0, 30, 60, 90, and 120) during the RSV season.
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.
Interventions
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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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Male or female Native American
* General state of good health
* Written informed consent obtained from the participant's parent(s) or legal guardian
Exclusion Criteria
* 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
0 Months
6 Months
ALL
Yes
Sponsors
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MedImmune LLC
INDUSTRY
Responsible Party
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Principal Investigators
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MedImmune, LLC MedImmune, LLC
Role: STUDY_DIRECTOR
MedImmune LLC
Locations
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Research Site
Chinle, Arizona, United States
Research Site
Cibecue, Arizona, United States
Research Site
Fort Definace, Arizona, United States
Research Site
San Carlos, Arizona, United States
Research Site
Tuba City, Arizona, United States
Research Site
Whiteriver, Arizona, United States
Research Site
Winslow, Arizona, United States
Research Site
Baltimore, Maryland, United States
Research Site
Bloomfield, New Mexico, United States
Research Site
Crownpoint, New Mexico, United States
Research Site
Gallup, New Mexico, United States
Research Site
Shiprock, New Mexico, United States
Countries
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References
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O'Brien KL, Chandran A, Weatherholtz R, Jafri HS, Griffin MP, Bellamy T, Millar EV, Jensen KM, Harris BS, Reid R, Moulton LH, Losonsky GA, Karron RA, Santosham M; Respiratory Syncytial Virus (RSV) Prevention study group. Efficacy of motavizumab for the prevention of respiratory syncytial virus disease in healthy Native American infants: a phase 3 randomised double-blind placebo-controlled trial. Lancet Infect Dis. 2015 Dec;15(12):1398-408. doi: 10.1016/S1473-3099(15)00247-9. Epub 2015 Nov 4.
Other Identifiers
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MI-CP117
Identifier Type: -
Identifier Source: org_study_id
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