A Study Looking at the Effectiveness, Immune Response, and Safety of a COVID-19 Vaccine in Adults in the United Kingdom

PHASE3CompletedINTERVENTIONAL
Enrollment

15,185

Participants

Timeline

Start Date

September 28, 2020

Primary Completion Date

March 29, 2022

Study Completion Date

March 29, 2022

Conditions
SARS-CoV-2 InfectionCOVID-19
Interventions
BIOLOGICAL

SARS-CoV-2 rS/Matrix M1-Adjuvant

Alternating intramuscular (deltoid) injections of SARS-CoV-2 rS co-formulated with Matrix-M1 adjuvant (0.5 mL) on Days 0 and 21.

OTHER

Placebo

Alternating intramuscular (deltoid) injections of placebo (0.5 mL) on Days 0 and 21.

BIOLOGICAL

Licensed seasonal influenza vaccine

Single intramuscular injection of licensed seasonal flu vaccine, administered ideally in opposite deltoid to SARS-CoV-2 rS with Matrix-M1 adjuvant or placebo injection on Day 0.

Trial Locations (33)

BT9 7AB

Belfast Health and Social Care Trust (BHSCT) (Site UK011), Belfast

B15 2 SQ

Synexus Midlands Clinical Research Centre (Site UK024), Edgbaston

TR1 3LJ

The Royal Cornwall Hospitals NHS Trust (Site UK036), Truro

EX2 5DW

Royal Devon and Exeter Hospital (Site UK013), Exeter

ME16 9QQ

"Maidstone Hospital - Central Research and Development Office Above Breast Care Centre - 1st Floor (Site UK028)", Maidstone

G51 4TF

Queen Elizabeth University Hospital (Site UK008), Glasgow

FY3 8NR

Blackpool Teaching Hospitals (Site UK010), Blackpool

OL1 2JH

Salford Hospital (Site UK030), Oldham

L22 0LG

Synexus Merseyside Clinical Research Centre (Site UK026), Waterloo

NW3 2QG

Royal Free (Site UK012), Hampstead

SW17 0QT

St. George's University Hospitals NHS Foundation Trust Clinical Research Facility (Site UK001), Tooting

LL13 7YP

North Wales Clinical Research Centre (NWCRC) (Site UK027), Wrexham

NN17 2UR

Lakeside Healthcare, Lakeside Surgery (Site UK005), Corby

OX3 7JX

Warneford Hospital (Site UK016), Oxford

AB25 2ZN

Aberdeen Royal Infirmary (Site UK007), Foresterhill, Aberdeen

BD9 6RJ

Bradford Teaching Hospitals NHS Trust (Site UK018), Bradford

CF15 9SS

Synexus Wales Clinical Research Centre (Site UK025), Cardiff

PR7 7 NA

Synexus Lancashire Clinical Research Centre (Site UK022), Chorley

CO4 5JL

Colchester Hospital (Site UK034), Colchester

G20 0SP

AES - Glasgow (Site UK033), Glasgow

TS24 9AH

University Hartlepool Hospital (Site UK021), Hartlepool

NE46 1QJ

Synexus Hexham Clinical Research Centre (Site UK023), Hexham

LA1 4RP

Royal Lancaster Infirmary (Site UK029), Lancaster

LS9 7TF

Research & Innovation Centre, St. James's University Hospital (Site UK019), Leeds

SE1 7EH

St. Thomas' Hospital (Site UK020), London

SW10 9NH

Chelsea & Westminster NHS Foundation Trust (Site UK006), London

M15 6SE

AES - Synexus Manchester (Site UK032), Manchester

NR4 7UY

Norfolk and Norwich University Hospital NHS Foundation Trust, Norfolk and Norwich University Hospital (Site UK015), Norwich

PE8 6PL

Wansford and Kingscliffe Practice (Site UK035), Peterborough

RG2 0TG

AES - Synexus Thames Valley (Site UK031), Reading

SO16 6YD

University Hospital Southampton NHS Foundation Trust (UHS) (Site UK014), Southampton

ST16 3SR

Midlands Partnership NHS Foundation Trust Headquarters (Site UK017), Stafford

SK2 7JE

Stockport NHS Foundation Trust (Site UK009), Stockport

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novavax

INDUSTRY

NCT04583995 - A Study Looking at the Effectiveness, Immune Response, and Safety of a COVID-19 Vaccine in Adults in the United Kingdom | Biotech Hunter | Biotech Hunter