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RSV+HMPV vaccine
Phase 1/2 Study of Respiratory Syncytial Virus and Human Metapneumovirus (RSV+HMPV) Vaccine Candidate in Adults 60 Years of Age and Older
Ensayo de Sanofi en Respiratory Syncytial Virus Immunization · Human Metapneumovirus Immunization · Healthy Volunteers (del registro, en inglés).
- Fase
- Fase 1/2
- Estado
- Reclutando pacientes
- Participantes
- 2.400
- Centros
- 50
- Fin del objetivo primario
- may 2028
previstos
estimado por el promotor
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, triple ciego. Comenzó en jul 2026.
Qué mide
RSV A serum nAb (neutralizing antibodies) titers (At Day 1 and Day 29) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThis study is a Phase 1/2, randomized, observer-blind, active and placebo-controlled, multi-center study to be conducted in approximately 2400 adults 60 years of age and older. The aim of the study is to evaluate the immunogenicity and safety of an RSV+HMPV vaccine candidate for the prevention of RSV and HMPV disease among adults 60 years of age and older. While there are 3 FDA approved/licensed RSV vaccines currently available to the public, no vaccine is available for the prevention of HMPV in older adults. This study is intended to provide data in support of further clinical development of the RSV+HMPV vaccine candidate. The study will consist of 4 cohorts and 11 vaccine groups (RSV+HMPV \[6 dose levels\], placebo and 4 control groups). The duration of the study will be approximately 12 months for each participant.
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Todos los de SNY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT07734649), actualizada en sep 2026.