Evaluation of the Safety and Immunogenicity of Influenza and COVID-19 Combination Vaccine

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

637

Participants

Timeline

Start Date

September 8, 2021

Primary Completion Date

December 22, 2021

Study Completion Date

April 22, 2022

Conditions
SARS-CoV InfectionCovid19
Interventions
BIOLOGICAL

ICC Vaccine

Intramuscular (deltoid) injections of in-clinic mix of various doses of quadrivalent hemagglutinin nanoparticle influenza vaccine(qNIV2), SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.

BIOLOGICAL

qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant

Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.

BIOLOGICAL

SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant

Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56.

Trial Locations (10)

2100

Northern Beaches Clinical Research, Brookvale

2148

Paratus Clinical Research - Western Sydney, Blacktown

2259

Paratus Clinical Research - Central Coast, Kanwal

2291

Hunter Diabetes Centre, Merewether

2617

Paratus Clinical Research - Canberra, Bruce

3214

Emeritus Research, Camberwell

4068

Austrials Pty Ltd - Taringa, Taringa

4101

University of the Sunshine Coast,Southbank, Brisbane

4506

University of the Sunshine Coast, Health Hub Morayfield, Morayfield

4556

University of the Sunshine Coast, Sippy Downs

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novavax

INDUSTRY