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	Drug: MEDI-524	Phase III

Further Study Details: 

Primary Outcomes: The incidence of RSV hospitalization from Study Day 0 through Study Day 150 of the 1st RSV season will be the primary endpoint.
Secondary Outcomes: Safety and tolerability of MEDI-524 will be assessed primarily by summarizing adverse events and serious adverse events occurring through Study Day 150.
Expected Total Enrollment:  2100

Ages Eligible for Study:  1 Month   -   6 Months,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00121108

Kate O''''Brien, M.D.      410-955-6931 

Maryland
      Johns Hopkins University Bloomberg School of Public Health, Baltimore,  Maryland,  21205,  United States; Recruiting

Study chairs or principal investigators

Kate O''''Brien, M.D.,  Principal Investigator,  Johns Hopkins University   

Study ID Numbers:  MI-CP117
Record last reviewed:  July 2005
Last Updated:  July 25, 2005
Record first received:  July 20, 2005
ClinicalTrials.gov Identifier:  NCT00121108
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-07-26