Calendario›NVAX›NanoFlu

NanoFlu

Phase 3 Pivotal Trial of NanoFlu™ in Older Adults

Ensayo de NOVAVAX INC en Gripe humana.

Fase

Fase 3

Estado

Completado

Participantes

2.654

previstos

Centros

19

Fin del objetivo primario

oct 2020

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en oct 2019.

Qué mide

Respuestas de anticuerpos HAI para cepas de gripe homologas de la vacuna expresadas como razon de la ratio geometrica de la media (GMFR) (dia 28)

Cómo lo describe el promotor

En el documentoEn inglés, del registroA Phase 3, randomized, observer-blinded, active-controlled trial to evaluate the immunogenicity and safety of a recombinant quadrivalent nanoparticle influenza vaccine with Matrix-M1 adjuvant (NanoFlu) compared with a licensed quadrivalent inactivated influenza vaccine in adults ≥ 65 years of age. Both vaccines were formulated with the 4 influenza strains recommended for the 2019-20 Northern hemisphere influenza season. 2654 subjects were enrolled and randomized into 1 of 2 treatment groups to receive either NanoFlu or active comparator. Subjects were followed for approximately 1 year following injection; with primary immunogenicity analyses based on Day 28 sera. This trial was conducted in the United States at approximately 19 clinical sites.

Más ensayos de NVAX

Todos los de NVAX, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT04120194), actualizada en abr 2023.