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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00121108
Recruitment Status : Completed
First Posted : July 21, 2005
Last Update Posted : July 2, 2012
Sponsor:
Information provided by:
MedImmune LLC

Tracking Information
First Submitted Date  ICMJE July 13, 2005
First Posted Date  ICMJE July 21, 2005
Last Update Posted Date July 2, 2012
Study Start Date  ICMJE November 2004
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 17, 2007)
The incidence of RSV hospitalization from Study Day 0 through Study Day 150 of the 1st RSV season will be the primary endpoint. [ Time Frame: Through Day 150 ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 19, 2005)
The incidence of RSV hospitalization from Study Day 0 through Study Day 150 of the 1st RSV season will be the primary endpoint.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 17, 2007)
Safety and tolerability of MEDI-524 will be assessed primarily by summarizing adverse events and serious adverse events occurring through Study Day 150. [ Time Frame: Through Day 150 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 19, 2005)
Safety and tolerability of MEDI-524 will be assessed primarily by summarizing adverse events and serious adverse events occurring through Study Day 150.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE MEDI-524 (Motavizumab) for the Prevention of Respiratory Syncytial Virus (RSV) Disease Among Native American Indian Infants in the Southwestern United States
Official Title  ICMJE A Phase 3 Study of MEDI-524 (Motavizumab) for the Prevention of RSV Disease Among Native American Infants in the Southwestern United States
Brief Summary This study (MI-CP117) is a Phase 3, randomized, double-blind, placebo-controlled trial designed to determine if MEDI-524 compared to placebo will result in clinical efficacy in the reduction of RSV hospitalization in otherwise healthy Native American Indian Infants in the Southwestern United States during their first RSV season.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • Biological: MEDI-524
    15 mg/kg motavizumab administered intramuscularly every 30 days for a maximum of 5 injections during the RSV season
  • Other: Placebo
    15 mg/kg placebo administered intramuscularly every 30 days for a maximum of 5 injections during the RSV season.
Study Arms  ICMJE
  • Placebo Comparator: 2
    Placebo
    Intervention: Other: Placebo
  • Active Comparator: 1
    MEDI-524
    Intervention: Biological: MEDI-524
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 4, 2011)
2127
Original Enrollment  ICMJE
 (submitted: July 19, 2005)
3000
Actual Study Completion Date  ICMJE March 2011
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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 patient's parent(s) or legal guardian

Exclusion Criteria:

  • 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 (children with uncomplicated CHD [e.g., PDA, small septal defect] and children with complicated CHD who are currently anatomically and hemodynamically)
  • Known immunodeficiency
  • Mother with HIV infection (unless the child has been proven to be not infected)
  • Known allergy to Ig products
  • Receipt of palivizumab, RSV-IGIV, or other RSV-specific monoclonal antibody, or any other polyclonal antibody (for example, hepatitis B IG, 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Month to 6 Months   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00121108
Other Study ID Numbers  ICMJE MI-CP117
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hasan Jafri, M.D., MedImmune Inc.
Study Sponsor  ICMJE MedImmune LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Hason Jafri, M.D. MedImmune LLC
PRS Account MedImmune LLC
Verification Date June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP