Immunogenicity and Safety Study of Self-amplifying mRNA COVID-19 Vaccine Administered With Influenza Vaccines in Adults

PHASE3CompletedINTERVENTIONAL
Enrollment

1,514

Participants

Timeline

Start Date

March 27, 2024

Primary Completion Date

October 9, 2024

Study Completion Date

November 21, 2024

Conditions
COVID-19
Interventions
BIOLOGICAL

ARCT-2303

Self-Amplifying RNA COVID-19 vaccine (Omicron XBB.1.5)

BIOLOGICAL

Influenza vaccine

Licensed cell-based influenza vaccine

BIOLOGICAL

Influenza vaccine, adjuvanted

Licensed influenza vaccine, adjuvanted

OTHER

Placebo

0.9% saline

Trial Locations (29)

Unknown

Paratus Clinical Canberra, Canberra

Paratus Clinical Central Coast, Central Coast

Sutherland Shire Clinical Research - Walski, Miranda

Australian Clinical Research Network (ACRN), Sydney

Austrials - St. Leonards, Sydney

Emeritus Research Sydney, Sydney

Griffith University Clinical Trials Unit, Sydney

Northern Beaches Clinical Research - Walski, Sydney

Paratus Clinical Blacktown, Sydney

Wollongong Clinical Research, Wollongong

Nucleus Network Brisbane Clinic, Brisbane

Paratus Clinical Brisbane, Brisbane

USC Southbank, Brisbane

USC Morayfield, Morayfield

USC Sippy Down, Sunshine Coast

CMAX Clinical Research, Adelaide

Austrials -Sunshine, Melbourne

Emeritus Research Melbourne, Melbourne

Nucleus Network - Melbourne Clinic, Melbourne

The Peter Doherty Institute for Infection and Immunity, Melbourne

Veritus Research, Melbourne

Clinitrials - Mount Site, Perth

Clínica San Agustín, San José

IICIMED, San José

Organización y centro de investigación clínica Ochoa (OCINCO), Comayagua

Deposito de Medicamentos de Investigación Cousin Agustín (DEMEDICA), San Pedro Sula

Inversiones en Investigación Médica S.A (INVERIME), Tegucigalpa

Tropical Disease Foundation - Putatan Health Center, City of Muntinlupa

Far Eastern University - Nicanor R. M Foundation, Quezon City

Sponsors
All Listed Sponsors
collaborator

Seqirus

INDUSTRY

collaborator

Novotech (Australia) Pty Limited

INDUSTRY

lead

Arcturus Therapeutics, Inc.

INDUSTRY

NCT06279871 - Immunogenicity and Safety Study of Self-amplifying mRNA COVID-19 Vaccine Administered With Influenza Vaccines in Adults | Biotech Hunter | Biotech Hunter