Phase 3 Boosting Study for the SARS-CoV-2 rS Variant Vaccines

PHASE3CompletedINTERVENTIONAL
Enrollment

1,340

Participants

Timeline

Start Date

May 25, 2022

Primary Completion Date

July 17, 2022

Study Completion Date

April 7, 2024

Conditions
COVID-19SARS CoV 2 Infection
Interventions
DRUG

NVX-CoV2515

Intramuscular (deltoid) injection of co-formulated Omicron BA.1 SARS-CoV-2 rS vaccine with Matrix-M adjuvant (0.5 mL).

DRUG

NVX-Cov2373

Intramuscular (deltoid) injection of co-formulated prototype SARS-CoV-2 rS vaccine with Matrix-M adjuvant(0.5 mL).

DRUG

NVX-CoV2373 + NVX-CoV2515

Intramuscular (deltoid) injection of 5 µg total (2.5 µg NVX-CoV2373 + 2.5 µg NVX-CoV2515) with 50 µg Matrix-M adjuvant.

DRUG

NVX-CoV2540

Intramuscular (deltoid) injection of co-formulated prototype SARS-CoV-2 rS vaccine with Matrix-M adjuvant(0.5 mL).

DRUG

NVX-CoV2373 + NVX-CoV2540

Intramuscular (deltoid) injection of 5 µg total (2.5 µg NVX-CoV2373 + 2.5 µg NVX-CoV2515) with 50 µg Matrix-M adjuvant.

Trial Locations (19)

2010

Holdsworth House Medical Practice, Sydney

2019

Emeritus Research, Botany

2035

Australian Clinical Research Network (ACRN), Maroubra

2100

Northern Beaches Clinical Research, Brookvale

2148

Paratus Clinical Research Western Sydney, Blacktown

2289

Novatrials, Newcastle

2291

Paratus Clinical Research Central Coast, Kanwal

AIM Centre (Hunter Diabetes Centre), Merewether

2617

Paratus Clinical Research Canberra, Bruce

3124

Emeritus Research, Camberwell

3128

Eastern Health-Box Hill Hospital, Box Hill

3168

Monash Health -Monash Medical Centre, Melbourne

3220

University Hospital Geelong-Barwon Health, Geelong

4010

Paratus Clinical Research Brisbane, Albion

4064

Core Research Group Pty Ltd, Milton

4068

Data Health Australia PTY Ltd t/a Austrials, Taringa

4121

AusTrials Wellers Hill, Wellers Hill

4222

Griffith University Clinical Trial Unit, Southport

5000

Clinical Medical and Analytical Excellence (CMAX), Adelaide

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novavax

INDUSTRY

NCT05372588 - Phase 3 Boosting Study for the SARS-CoV-2 rS Variant Vaccines | Biotech Hunter | Biotech Hunter