A Phase 2b/3 Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-1654 in Healthy Pre-Term and Full-Term Infants

CompletadoFase 3ClinicalTrials.gov

ID: NCT04767373Tipo: INTERVENTIONALInicio: 7 de abr de 2021Fin estimado: 9 de jul de 2024

Traducción no disponible, mostrando original

Resumen

The primary objectives of this phase 2b/3 double-blind, randomized, placebo-controlled study are to evaluate the efficacy and safety of clesrovimab in healthy pre-term and full-term infants. It is hypothesized that clesrovimab will reduce the incidence of respiratory syncytial virus (RSV)-associated medically attended lower respiratory infection (MALRI) from Days 1 through 150 postdose compared to placebo.

Elegibilidad

Edad máxima: 1 YearSexo: ALL

Criterios de inclusión

Is a healthy male or female who is an early or moderate pre-term infant (≥29 to 34 weeks and 6 days gestational age) or a late pre-term or full-term infant (≥35 weeks gestational age)
For the phase 2b cohort only: Has a chronological age \>2 weeks of age up to 1 year and is entering their first respiratory syncytial virus (RSV) season at the time of obtaining documented informed consent.
For the phase 3 cohort only: Has a chronological age from birth up to 1 year and is entering their first RSV season at the time of obtaining documented informed consent.
For participants in South Korea only: Weighs ≥2 kg

Criterios de exclusión

Is recommended to receive palivizumab per local guidelines or professional society recommendations.
Has known hypersensitivity to any component of clesrovimab
Has a bleeding disorder contraindicating IM administration
Has had a recent illness with rectal temperature ≥100.5°F (≥38.1°C) or axillary temperature ≥100.0°F (≥37.8°C) within 72 hours predose
Has received any vaccine or monoclonal antibody for the prevention of RSV
Is currently participating in or has participated in an interventional clinical study with an investigational compound or device at any time before first dose administration or while participating in this study

Intervenciones

biological

Clesrovimab

Clesrovimab solution

drug

Placebo

Placebo (0.9% sodium chloride \[NaCL\]) solution

Ubicaciones

Hospital Militar Central Cir Mayor Cosme Argerich ( Site 1001)

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Clinica del Nino y la Madre ( Site 1005)

Mar de La Plata, Buenos Aires, Argentina

SANATORIO DEL SALVADOR-Pediatria ( Site 1008)

Córdoba, Córdoba Province, Argentina

SANATORIO MATER DEI ( Site 1010)

Buenos Aires, Argentina

Clinica Privada del Sol S.A ( Site 1013)

Córdoba, Argentina

Patrocinadores

PrincipalMerck Sharp & Dohme LLC

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