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

PHASE2CompletedINTERVENTIONAL
Enrollment

1,579

Participants

Timeline

Start Date

December 30, 2022

Primary Completion Date

July 25, 2023

Study Completion Date

December 24, 2023

Conditions
COVID-19Influenza
Interventions
DRUG

qNIV Vaccine with Matrix-M Adjuvant

Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV vaccine given on Day 0 and Day 70 .

DRUG

Influenza Vaccine

Intramuscular (deltoid) injections of Comparator influenza vaccine given on Day 0 and Day 70 (if applicable).

DRUG

CIC Vaccine with Matrix-M Adjuvant

Intramuscular (deltoid) injections of co-formulated mix of various doses and formulations of CIC Vaccine given on Day 0 and Day 70

OTHER

Placebo Comparator

Intramuscular (deltoid) injection of placebo given on Day 70.

DRUG

SARS-CoV-2 rS Vaccine with Matrix-M Adjuvant

Intramuscular (deltoid) injections of in-clinic mix of various doses of SARS-CoV-2 rS vaccine given on Day 0 and Day 70 .

Trial Locations (35)

2148

Paratus Clinical Research - Western Sydney, Blacktown

2289

Novatrials, Kotara

2450

Northside Health, Coffs Harbour

4414

P3 Research - Palmerston North, Palmerston North

Unknown

Paratus Clinical Research - Canberra, Bruce

Emeritus Research - Sydney, Botany

Genesis Central Coast, Broadmeadow

Northern Beaches Clinical Research, Brookvale

East Sydney Doctors, Darlinghurst

Holdsworth House Medical Brisbane, Darlinghurst

Oztrials Clinical Research, Drummoyne

Paratus Clinical Research - Central Coast, Kanwal

Australian Clinical Research Network, Maroubra

Hunter Diabetes Centre, Merewether

Sutherland Clinical Trials, Miranda

Illawarra Health and Medical Research Institute, Wollongong

Menzies Darwin, Tiwi

Paratus Clinical Research - Brisbane Clinic, Albion

Mater Adult Hospital, Brisbane

Nucleus Network Pty Ltd, Herston

Core Research Group, Milton

Austrials Pty Ltd - Taringa, Taringa

AusTrials (Wellers Hill), Tarragindi

CMAX, Adelaide

Emeritus Research, Camberwell

Nucleus Network Limited, Melbourne

P3 Reseach - Hawkes Bay, Havelock North

P3 Research - Lower Hutt, Palmerston

P3 Research Kapiti, Paraparaumu

Middlemore Clinical Trials, Auckland

Optimal Clinical Trials Ltd, Auckland

New Zealand Clinical Research - Christchurch, Christchurch

P3 Research - Dunedin, Dunedin

P3 Research - Tauranga, Tauranga

P3 Research - Wellington, Wellington

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novavax

INDUSTRY