A Study to Evaluate the Safety and Immunogenicity of COVID-19 Vaccine and Influenza Combination Vaccine

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

9,320

Participants

Timeline

Start Date

December 9, 2024

Primary Completion Date

July 26, 2026

Study Completion Date

September 30, 2026

Conditions
COVID-19
Interventions
BIOLOGICAL

CIC Vaccine Co-formulated tNIV2 , SARSCoV-2 rS and Matrix-M Adjuvant

CIC will contain SARs-CoV-2 antigen (35 μg), tNIV antigens (2 influenza A \[H1N1 and H3N2\] and 1 influenza B-Victoria lineage strains; 60 μg/strain

BIOLOGICAL

Novavax COVID-19 Vaccine

Each 0.5 mL dose comprises 5 µg SARS-CoV-2 S protein and 50 µg Matrix-M adjuvant

BIOLOGICAL

tNIV Vaccine

2 influenza A \[H1N1 and H3N2\] and 1 influenza B-Victoria lineage strains (60 μg/strain), and Matrix-M adjuvant (75 μg)

BIOLOGICAL

Fluzone High Dose

Fluzone High-Dose is supplied as a suspension for IM injection 0.5 mL with 60 µg per strain

Trial Locations (58)

1010

Optimal Clinical Trials Ltd - PPDS, Auckland

2010

East Sydney Doctors, Darlinghurst

Momentum Darlinghurst, Darlinghurst

Taylor Square Private Clinic, Surry Hills

2019

Emeritus Research - Sydney - PPDS, Botany

2022

Key Health- Bondi Junction, Bondi Junction

2035

Australian Clinical Research Network, Maroubra

2047

Oztrials Clinical Research, Drummoyne

2060

Pioneer Clinical Research - North Sydney, North Sydney

2065

Momentum St Leonards, Sydney

2077

Innovate Clinical Research Pty Ltd, Sydney

2100

Northern Beaches Clinical Research - PPDS, Brookvale

2120

Momentum Pukekohe - PPDS, Auckland

2148

Paratus Clinical Research - Western Sydney - PPDS, Blacktown

2228

Sutherland Shire Clinical Research - PPDS, Miranda

2259

Paratus Clinical Research - Central Coast - PPDS, Kanwal

2289

Novatrials, Kotara

2291

Hunter Diabetes Centre, Merewether

2292

Genesis Research Services, Broadmeadow

2450

Northside Health, Coffs Harbour

2500

Wollongong Clinical Research - PPDS, Wollongong

2617

Paratus Clinical Research - Canberra - PPDS, Bruce

3000

Doherty Clinical Trials Limited, Melbourne

3004

Nucleus Network Limited, Melbourne

3010

Pacific Clinic Research Network - Rotorua - PCRN - PPDS, Rotorua

3021

Momentum Sunshine, Melbourne

3051

University of Melbourne - Melbourne, Melbourne N.

3110

Momentum Tauranga - PPDS, Tauranga

3124

Emeritus Research -PPDS, Camberwell

3153

Veritus Research - Emeritus - PPDS, Bayswater

3220

Ryrie St, Geelong, VIC 3220, Australia, Geelong

3243

Lakeland Clinical Trials - Waikato - PCRN-PPDS, Hamilton

4006

Nucleus Network Pty Ltd, Herston

Paratus Clinical Research - Brisbane Clinic - PPDS, Herston

4068

Momentum Taringa, Brisbane

4101

Mater Hospital Brisbane, South Brisbane

4121

Momentum Wellers, Wellers Hill

4122

Momentum Hawke's Bay - PPDS, Hastings

4222

Griffith University Clinical Trials Unit, Griffith

4414

Momentum Palmerston North - PPDS, Palmerston North

4575

University of the Sunshine Coast, Vitality Village - UniSC Clinical Trials - PPDS, Birtinya

5000

Cmax - Ppds, Adelaide

5018

Lakeland Clinical Trials - Wellington - PCRN - PPDS, Wellington

5036

Momentum Kapiti - PPDS, Waikanae

6000

CliniTrials, Perth

6009

Telethon Kids Institute, Nedlands

6021

Momentum Wellington - PPDS, Wellington

6056

Institute for Respiratory Health - Midland, Midland

7011

Southern Clinical Trials - Tasman - PCRN - PPDS, Nelson

8011

New Zealand Clinical Research - Christchurch - PPDS, Christchurch

8013

Pacific Clinical Research Network - Christchurch - PCRN - PPDS, Christchurch

9016

Momentum Dunedin - PPDS, Dunedin

0810

Menzies School of Health Research, Casuarina

0600

Southern Clinical Trials - Totara - PCRN - PPDS, Auckland

0622

Pacific Clinical Research Network - Auckland - PCRN - PPDS, Auckland

0632

Optimal Clinical Trials Ltd - North Shore - PPDS, Auckland

Unknown

Momentum Lower Hutt - PPDS, Lower Hutt

Aotearoa Clinical Trials Trust, Wellington

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novavax

INDUSTRY