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

A Phase 3 Study of MEDI-524 (Motavizumab), an Enhanced Potency Humanized Respiratory Syncytial Virus (RSV) Monoclonal Antibody, for the Prevention of RSV Disease Among Native American Infants in the Southwestern United States

MI-CP117 was a Phase 3, randomized, double-blind, placebo-controlled trial designed to determine if motavizumab is more effective than placebo in reducing RSV hospitalization in otherwise healthy Native American Infants in the Southwestern United States during their first RSV season.

MI-CP117 was a Phase 3, randomized, double-blind, placebo-controlled trial designed to determine if motavizumab is more effective than placebo in reducing RSV hospitalization in otherwise healthy Native American infants during their first RSV season.

Participants were randomized in a 2:1 ratio to receive either 15 mg/kg motavizumab or placebo by intramuscular (IM) injection every 30 days during the RSV season for a maximum of 5 injections.

During their first RSV season, participants were evaluated monthly just prior to each injection of study drug for adverse events (AEs) (including medically attended otitis media), with a final post-dosing follow up evaluation at Study Day 150. During Seasons 1, 2, and 3, blood was to be collected prior to the first and last dose of study drug for serum chemistry evaluations, motavizumab serum concentrations, and anti-motavizumab antibodies. Efficacy and safety outcomes were examined through Study Day 150 and wheezing outcomes were evaluated from the time of randomization until the third birthday.

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 participant'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 (CHD) (children with uncomplicated CHD [e.g., Patent ductus arteriosus, small septal defect] and children with complicated CHD who are currently anatomically and hemodynamically)
• Known immunodeficiency
• Mother with human immunodeficiency virus infection (unless the child has been proven to be not infected)
• Known allergy to Ig products
• Receipt of palivizumab, Respiratory syncytial virus immunoglobulin, intravenous (RSV-IGIV), or other RSV-specific monoclonal antibody, or any other polyclonal antibody (for example, hepatitis B immunoglobulin, 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