Study of MEDI-524 (Motavizumab) for the Prophylaxis of Serious Respiratory Syncytial Virus (RSV) Disease in High-Risk Children

MedImmune

Status and phase: Completed; Phase 3

Conditions: Respiratory Syncytial Virus Infections

Treatments: Biological: motavizumab (MEDI-524); Biological: palivizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00129766

MI-CP110

Details and patient eligibility

About

The primary objective of this study was to compare the safety and efficacy of motavizumab to palivizumab when administered monthly by intramuscular (IM) injection for the reduction of the incidence of RSV hospitalization among children at high risk for serious RSV disease. A secondary objective was to compare the incidence of medically-attended lower respiratory infections (LRIs) between treatment groups.

Full description

A randomized, double-blind, palivizumab-controlled, multi-center, multi-national trial conducted during 2 Northern Hemisphere RSV seasons with an intervening season in the Southern Hemisphere. Each child only participated during a single RSV season. Approximately 6,600 children at risk for serious RSV disease were to be randomized in a 1:1 ratio to receive either 15 mg/kg of palivizumab or motavizumab by IM injection every 30 days for a total of 5 doses.

Enrollment: 6,635 patients

Sex: All

Ages: Under 24 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 24 months of age or younger at randomization (child must be randomized on or before his/her 24-month birthday) with a diagnosis of chronic lung disease (CLD) of prematurity requiring medical intervention/management (i.e., supplemental oxygen, bronchodilators, or diuretics) within 6 months before randomization

OR:

• 35 weeks gestational age or less at birth and 6 months of age or younger at randomization (children were to be randomized on or before his/her 6-month birthday)

Exclusion criteria

• Hospitalization at the time of randomization (unless discharge was anticipated within 10 days)
• Mechanical ventilation or other mechanical support (including continuous positive airways pressure [CPAP])
• Life expectancy < 6 months
• Active RSV infection (a child with signs/symptoms of respiratory infection must have had negative RSV testing)
• Known renal impairment
• Known hepatic dysfunction
• Chronic seizure or evolving or unstable neurologic disorder
• Congenital heart disease [CHD] (children with uncomplicated CHD [e.g., patent ductus arterious (PDA), small septal defect] and children with complicated CHD that were currently anatomically and hemodynamically normal could be enrolled)
• 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, VZIG) 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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6,635 participants in 2 patient groups

palivizumab

Active Comparator group

Description:

15 mg/kg administered intramuscularly for 5 monthly doses

Treatment:

Biological: palivizumab

motavizumab (MEDI-524)

Experimental group

Description:

15 mg/kg of motavizumab was administered intramuscularly for 5 monthly doses

Treatment:

Biological: motavizumab (MEDI-524)