A Pivotal Phase 3 Study of MEDI-524 (Numax; Motavizumab), an Enhanced Potency Humanized RSV Monoclonal Antibody, for the Prophylaxis of Serious RSV Disease in High-Risk Children

CompletadoFase 3ClinicalTrials.gov

ID: NCT00129766Tipo: INTERVENTIONALInicio: 1 de nov de 2004Fin estimado: 1 de may de 2006

Traducción no disponible, mostrando original

Resumen

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.

Descripción detallada

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.

Elegibilidad

Edad máxima: 24 MonthsSexo: ALL

Criterios de inclusión

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:
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)

Criterios de exclusión

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

Intervenciones

biological

motavizumab (MEDI-524)

Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses

biological

palivizumab

Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses

Ubicaciones

Hospital Peiade Interzonal General de Augodos

Buenos Aires, Argentina

Hospital General De Ninos Pedro De Elizalde

Buenos Aires, Argentina

Sanatorio Trinidad

Capital Federal, Argentina

Hospital Materno Neonatal

Córdoba, Argentina

Patrocinadores

PrincipalMedImmune LLC

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