Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Healthy Biological: MEDI-524 Other: Placebo Phase 3

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2127 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3 Study of MEDI-524 (Motavizumab) for the Prevention of RSV Disease Among Native American Infants in the Southwestern United States
Study Start Date : November 2004
Actual Primary Completion Date : December 2010
Actual Study Completion Date : March 2011
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Placebo Comparator: 2
Placebo
 Other: Placebo
15 mg/kg placebo administered intramuscularly every 30 days for a maximum of 5 injections during the RSV season.
Active Comparator: 1
MEDI-524
 Biological: MEDI-524
15 mg/kg motavizumab administered intramuscularly every 30 days for a maximum of 5 injections during the RSV season


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   1 Month to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00121108


Locations
Layout table for location information
United States, Maryland
Johns Hopkins University Bloomberg School of Public Health
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
MedImmune LLC
Investigators
Layout table for investigator information
Study Director: Hason Jafri, M.D. MedImmune LLC
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Hasan Jafri, M.D., MedImmune Inc.
ClinicalTrials.gov Identifier: NCT00121108    
Other Study ID Numbers: MI-CP117
First Posted: July 21, 2005    Key Record Dates
Last Update Posted: July 2, 2012
Last Verified: June 2012