Study of a Combination Vaccine Comprised of Different Recombinant Spike Antigen Levels of a Matrix-M Adjuvanted Recombinant COVID-19 Vaccine and Recombinant Influenza Vaccine in Adult Participants 50 Years of Age and Older

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

980

Participants

Timeline

Start Date

November 18, 2024

Primary Completion Date

April 3, 2026

Study Completion Date

April 3, 2026

Conditions
COVID-19 ImmunizationInfluenza Immunization
Interventions
BIOLOGICAL

RIV (recombinant influenza vaccine)

Influenza, inactivated, split virus or surface antigen

BIOLOGICAL

rC19 (dose 1)

Protein subunit

BIOLOGICAL

RIV + rC19 (dose 1)

RIV component: Influenza, inactivated, split virus or surface antigen NVXC19 component: Protein subunit

BIOLOGICAL

RIV + rC19 (dose 2)

RIV component: Influenza, inactivated, split virus or surface antigen NVXC19 component: Protein subunit

BIOLOGICAL

RIV + rC19 (dose 3)

RIV component: Influenza, inactivated, split virus or surface antigen NVXC19 component: Protein subunit

BIOLOGICAL

RIV + rC19 (dose 4)

RIV component: Influenza, inactivated, split virus or surface antigen NVXC19 component: Protein subunit

OTHER

Placebo (0.9% NaCl)

Normal saline

Trial Locations (12)

29621

Synexus Clinical Research US - Anderson- Site Number : 8400001, Anderson

32806

Synexus Clinical Research US - Orlando- Site Number : 8400007, Orlando

32934

Optimal Research - Florida- Site Number : 8400006, Melbourne

45236

Synexus Clinical Research US - Cincinnati- Site Number : 8400003, Cincinnati

47714

Synexus Clinical Research US - Evansville- Site Number : 8400004, Evansville

55423

Synexus Clinical Research US - Minneapolis- Site Number : 8400011, Richfield

61614

Optimal Research - Illinois- Site Number : 8400008, Peoria

85020

Central Phoenix Medical Clinic- Site Number : 8400009, Phoenix

89113

Synexus-Las Vegas- Site Number : 8400005, Las Vegas

90704

Synexus Clinical Research US, Inc. - Cerritos- Site Number : 8400002, Cerritos

92083

Synexus Clinical Research US - Vista- Site Number : 8400010, Vista

02148

Walgreens Clinical Trials-Malden- Site Number : 8400012, Malden

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Sanofi

INDUSTRY