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

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

980

Participants

Timeline

Start Date

November 19, 2024

Primary Completion Date

April 1, 2026

Study Completion Date

April 1, 2026

Conditions
COVID-19 ImmunizationInfluenza Immunization
Interventions
BIOLOGICAL

IIV-HD

Inactivated, split-virion

BIOLOGICAL

rC19 (dose 1)

Protein subunit

BIOLOGICAL

IIV-HD + rC19 (dose 1)

IIV-HD component: Inactivated, split-virion rC19 component: Protein subunit

BIOLOGICAL

IIV-HD + rC19 (dose 2)

IIV-HD component: Inactivated, split-virion rC19 component: Protein subunit

BIOLOGICAL

IIV-HD + rC19 (dose 3)

IIV-HD component: Inactivated, split-virion rC19 component: Protein subunit

BIOLOGICAL

IIV-HD + rC19 (dose 4)

IIV-HD component: Inactivated, split-virion rC19 component: Protein subunit

OTHER

Placebo (0.9% NaCl)

Normal saline

Trial Locations (12)

10017

Synexus New York Site Number : 8400007, New York

30328

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

32162

Synexus Clinical Research US, Inc. - The Villages Site Number : 8400011, The Villages

35211

Simon Williamson Clinic - Birmingham- Site Number : 8400003, Birmingham

60602

Synexus Clinical Research- Site Number : 8400004, Chicago

63141

Synexus Clinical Research - St. Louis- Site Number : 8400010, Creve Coeur

75234

Synexus Clinical Research US - Dallas- Site Number : 8400005, Dallas

78229

Synexus Clinical Research US - San Antonio- Site Number : 8400009, San Antonio

78705

Optimal Research, LLC Site Number : 8400002, Austin

84106

Synexus Salt Lake City Site Number : 8400008, Salt Lake City

85741

Orange Grove Family Practice- Site Number : 8400012, Tucson

35802-2568

AES - DRS - Optimal Research Alabama - Huntsville Site Number : 8400006, Huntsville

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Sanofi

INDUSTRY