Expired Study
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Baltimore, Maryland 21205


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.


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


NCT ID:

NCT00121108


Primary Contact:

Study Director
Hason Jafri, M.D.
MedImmune LLC


Backup Contact:

N/A


Location Contact:

Baltimore, Maryland 21205
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 14, 2017

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