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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

This study has been completed.
Sponsor:
Information provided by:
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT00121108
First received: July 13, 2005
Last updated: June 27, 2012
Last verified: June 2012
History of Changes
  Purpose

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 Intervention Phase
Healthy
 Biological: MEDI-524
Other: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, 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

Further study details as provided by MedImmune LLC:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 2127
Study Start Date: November 2004
Study Completion Date: March 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   1 Month to 6 Months
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00121108

Locations
United States, Maryland
Johns Hopkins University Bloomberg School of Public Health
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
MedImmune LLC
Investigators
Study Director: Hason Jafri, M.D. MedImmune LLC
  More Information

Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Hasan Jafri, M.D., MedImmune Inc.
ClinicalTrials.gov Identifier: NCT00121108     History of Changes
Other Study ID Numbers: MI-CP117
Study First Received: July 13, 2005
Last Updated: June 27, 2012
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on June 17, 2013