A Phase 2b Randomized, Double-Blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in Healthy Preterm Infants

CompletadoFase 2ClinicalTrials.gov

ID: NCT02878330Tipo: INTERVENTIONALInicio: 3 de nov de 2016Fin estimado: 6 de dic de 2018

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), and antidrug antibody (ADA) response for MEDI8897 in healthy preterm infants who are between 29 and 35 weeks gestational age (GA) and entering their first Respiratory Syncytial Virus (RSV) season.

Descripción detallada

This pivotal Phase 2b study will determine if MEDI8897 will be efficacious in reducing medically attended RSV-confirmed lower respiratory tract infections (LRTI) in healthy preterm infants entering their first RSV season. The population to be enrolled is healthy preterm infants born between 29 weeks 0 days and 34 weeks 6 days GA who would not receive RSV prophylaxis. A total of 1500 infants will be randomized 2:1 to receive either MEDI8897 or placebo. Participants will be followed for 360 days after dosing. Enrollment is planned at approximately 197 sites across the USA, Canada, Europe, and the Southern Hemisphere.

Elegibilidad

Edad máxima: 365 DaysSexo: ALL

Criterios de inclusión

Healthy infants born between 29 weeks 0 days and 34 weeks 6 days GA.
Infants who are entering their first full RSV season at the time of screening.

Criterios de exclusión

Meets American Academy of Pediatrics (AAP) or other local criteria to receive commercial palivizumab.
Any fever (\>= 100.4°F \[\>= 38.0°C\], regardless of route) or lower respiratory illness within 7 days prior to randomization.
Acute illness (defined as the presence of moderate or severe signs and symptoms) at the time of randomization.
Active RSV infection (a child with signs/symptoms of respiratory infection must have negative RSV testing) or known prior history of RSV infection.
Receipt of palivizumab or other RSV monoclonal antibody or any RSV vaccine, including maternal RSV vaccination.

Intervenciones

drug

MEDI8897

A single IM dose of 50 mg on Day 1 of the study.

drug

Placebo

A single IM dose of placebo matched to MEDI8897 on Day 1 of the study.

Ubicaciones

Research Site

Bahía Blanca, Argentina

Research Site

Guaymallen Mendoza, Argentina

Patrocinadores

PrincipalMedImmune LLC

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