Calendario›SNY›Yellow fever vaccine

Yellow fever vaccine

Study on an Investigational Yellow Fever Vaccine Compared With Stamaril in Adults in Europe and Asia

Ensayo de Sanofi en Yellow Fever (del registro, en inglés).

Fase

Fase 2

Estado

En marcha, sin reclutar

Participantes

690

previstos

Centros

23

Fin del objetivo primario

may 2022

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en oct 2021.

Qué mide

Percentage of Yellow Fever-naive Participants Who Achieved Seroconversion 28 Days Post Dose 1 Enrolled in European Union (28 days post dose 1 (Day 29)) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroVYF03 is a phase II, randomized, parallel-group prevention study with 2 arms, active-controlled (Stamaril), observer-blind, multi-center study to assess the non-inferiority of the immune response, in terms of seroconversion rates of the investigational vaccine candidate vYF to the licensed Stamaril, in adults aged 18 years up to 60 years in Europe (EU). The safety and immunogenicity profile of vYF in a cohort of Asian population of Chinese origin outside of China will also be described. The study will also assess the immunogenicity profiles and the safety profiles of vYF and Stamaril. Participants will be randomized in a 2:1 ratio to receive a single subcutaneous injection of either the vYF vaccine (380 participants in EU and 80 participants of Chinese origin in Asia) or Stamaril (190 participants in EU and 40 participants of Chinese origin in Asia), on Day 01. The duration of each participant's participation will be approximately 5 years.

Más ensayos de SNY

Todos los de SNY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT05011123), actualizada en may 2026.