Calendario›NVAX›SARS-CoV-2 rS

SARS-CoV-2 rS

A Study Looking at the Effectiveness, Immune Response, and Safety of a COVID-19 Vaccine in Adults in the United Kingdom

Ensayo de NOVAVAX INC en infeccion por SARS-CoV-2 · COVID-19.

Más ensayos de: COVID-19.

Fase

Fase 3

Estado

Completado

Participantes

15.185

previstos

Centros

33

Fin del objetivo primario

mar 2022

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en sep 2020.

Qué mide

Participantes con enfermedad por coronavirus 2019 (COVID-19) sintomatica leve, moderada o grave (From Day 28 to Day 386) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis is a study to evaluate the efficacy, immune response, and safety of a coronavirus disease 2019 (COVID-19) vaccine called SARS-CoV-2 rS with Matrix-M1 adjuvant in adults aged 18-84 years in the United Kingdom. A vaccine causes the body to have an immune response that may help prevent the infection or reduce the severity of symptoms. An adjuvant is something that can make a vaccine work better. This study will look at the protective effect, body's immune response, and safety of SARS-CoV-2 rS with Matrix-M1 adjuvant in the study population. Participants in the study will randomly be assigned to receive SARS-CoV-2 rS with Matrix-M1 adjuvant or placebo. Each participant in the study will receive a total of 2 intramuscular injections over the course of the study. Approximately 15,000 participants will take part in the study. The first approximately 400 participants who meet additional criteria will receive a flu vaccine, in addition to the SARS-CoV-2 rS vaccine or placebo, as part of a sub-study. An effort will be made to enroll a target of at least 25% of participants who are ≥ 65 years of age, as well as prioritizing other groups that are most affected by COVID-19, including racial and ethnic minorities. Unblinding of treatment assignment may occur in order to allow a participant to make an informed decision regarding receipt of an already approved or deployed SARS-CoV-2 vaccine. Participants who choose to receive an approved or deployed SARS-CoV-2 vaccine as per UK government guidance will be encouraged to remain in the study for scheduled safety assessments.

Más ensayos de NVAX

Todos los de NVAX, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT04583995), actualizada en may 2025.