A Study Looking at the Effectiveness, Immune Response, and Safety of a COVID-19 Vaccine in Adults in the United Kingdom
A Phase 3, Randomised, Observer-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine (SARS-CoV-2 rS) With Matrix-M1™ Adjuvant in Adult Participants 18-84 Years of Age in the United Kingdom
1 other identifier
interventional
15,185
1 country
33
Brief Summary
This is a study to evaluate the efficacy, immune response, and safety of a coronavirus disease 2019 (COVID-19) vaccine called SARS-CoV-2 rS with Matrix-M1 adjuvant in adults aged 18-84 years in the United Kingdom. A vaccine causes the body to have an immune response that may help prevent the infection or reduce the severity of symptoms. An adjuvant is something that can make a vaccine work better. This study will look at the protective effect, body's immune response, and safety of SARS-CoV-2 rS with Matrix-M1 adjuvant in the study population. Participants in the study will randomly be assigned to receive SARS-CoV-2 rS with Matrix-M1 adjuvant or placebo. Each participant in the study will receive a total of 2 intramuscular injections over the course of the study. Approximately 15,000 participants will take part in the study. The first approximately 400 participants who meet additional criteria will receive a flu vaccine, in addition to the SARS-CoV-2 rS vaccine or placebo, as part of a sub-study. An effort will be made to enroll a target of at least 25% of participants who are ≥ 65 years of age, as well as prioritizing other groups that are most affected by COVID-19, including racial and ethnic minorities. Unblinding of treatment assignment may occur in order to allow a participant to make an informed decision regarding receipt of an already approved or deployed SARS-CoV-2 vaccine. Participants who choose to receive an approved or deployed SARS-CoV-2 vaccine as per UK government guidance will be encouraged to remain in the study for scheduled safety assessments.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2020
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 28, 2020
CompletedFirst Submitted
Initial submission to the registry
October 9, 2020
CompletedFirst Posted
Study publicly available on registry
October 12, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 29, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 29, 2022
CompletedMay 8, 2025
May 1, 2025
1.5 years
October 9, 2020
May 5, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Participants with Symptomatic Mild, Moderate, or Severe Coronavirus Disease 2019 (COVID-19)
Number of participants, testing serologically negative for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at baseline, with first occurrence of positive (+) polymerase chain reaction (PCR)-confirmed SARS-CoV-2 illness with symptomatic mild, moderate, or severe COVID-19 with onset from Day 28 through the length of the study.
From Day 28 to Day 386
Secondary Outcomes (13)
Participants with Symptomatic Moderate or Severe COVID-19
From Day 28 to Day 386
Participants with Symptomatic Severe COVID-19
From Day 28 to Day 386
Participants with Symptomatic Mild, Moderate, or Severe COVID-19 Regardless of Baseline Serostatus
From Day 28 to Day 386
Participants with Asymptomatic or Symptomatic COVID-19
From Day 28 to Day 386
Participants with COVID-19 requiring Hospitalization, Intensive Care Unit (ICU), or Mechanical Ventilation
From Day 28 to Day 386
- +8 more secondary outcomes
Study Arms (4)
Cohort 1: SARS-CoV-2 rS/Matrix-M1 Adjuvant
EXPERIMENTAL2 doses of 5 µg SARS-CoV-2 rS + 50 µg Matrix-M1 adjuvant (co-formulated), 1 dose each on Days 0 and 21.
Cohort 1: Placebo
PLACEBO COMPARATOR2 doses of Placebo (Saline), 1 dose each on Days 0 and 21.
Cohort 2: SARS-CoV-2 rS/Matrix-M1 Adjuvant Plus Licensed Seasonal Flu Vaccine
EXPERIMENTAL2 doses of 5 µg SARS-CoV-2 rS + 50 µg Matrix-M1 adjuvant (co-formulated), 1 dose each on Days 0 and 21. 1 dose of licensed seasonal flu vaccine on Day 0.
Cohort 2: Placebo Plus Licensed Seasonal Flu Vaccine
PLACEBO COMPARATOR2 doses of Placebo (Saline), 1 dose each on Days 0 and 21. 1 dose of licensed seasonal flu vaccine on Day 0.
Interventions
Alternating intramuscular (deltoid) injections of SARS-CoV-2 rS co-formulated with Matrix-M1 adjuvant (0.5 mL) on Days 0 and 21.
Alternating intramuscular (deltoid) injections of placebo (0.5 mL) on Days 0 and 21.
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.
Eligibility Criteria
You may qualify if:
- Able and willing to comply with all study requirements.
- Willing to allow investigators to discuss medical history with their General Practitioner and access all relevant medical records.
- Willing and able to give informed consent.
- Women of child-bearing potential must agree not to have sexual intercourse with men, or must consistently use an agreed method of contraception, from at least 28 days prior to enrolment in the study, through 3 months after the last vaccination.
- Room air oxygen saturation \> 95% at Screening/Day 0.
- Seasonal Flu Vaccine Co-Administration Sub-Study only: Participant should not have received a current season flu vaccine, should have no reason why the specific sub-study flu vaccine cannot be administered, and should not have any prior history of allergy or severe reaction to seasonal flu vaccines.
You may not qualify if:
- Participation in other COVID-19 vaccine or preventative drug trials for the duration of the study.
- Future participation in any blood tests for the duration of the study where participants are informed of their levels of COVID-19 antibodies or antigens.
- Participation in any trial involving an investigational drug, biologic or device within 45 days prior to the first study vaccination.
- History of laboratory-confirmed COVID-19 infection any time prior to first study vaccination.
- Receipt of any immunoglobulins and/or any blood products within 3 months prior to planned administration of study vaccine.
- Any confirmed or suspected immunosuppressive or immunodeficient state. Chronic administration (defined as more than 14 continuous days) of immunosuppressant medication within the past 3 months, except topical steroids or short-term oral steroids (course lasting ≤ 14 days). Note: An immunosuppressant dose of glucocorticoid is defined as a systemic dose ≥ 10 mg of prednisone per day or equivalent. The use of topical, inhaled, and nasal glucocorticoids will be permitted if other chronic disease conditions do not exclude a participant from the study.
- History of allergic disease or reactions likely to be made worse by any component of the study vaccines.
- History of anaphylaxis to any prior vaccine.
- Pregnancy, breast-feeding or willingness/intention to become pregnant within 3 months following the last study vaccination.
- Current diagnosis of or treatment for cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ.
- Bleeding disorder, or prior history of significant bleeding or bruising following intramuscular injections or venepuncture (e.g. to draw blood for tests).
- Continuous use of anticoagulants or anti-platelet agents. Note: The preventative use of ≤ 325 mg of aspirin per day is permitted.
- Suspected or known current alcohol or drug dependency.
- Study team member or first-degree relative of any study team member (inclusive of sponsor, contract research organization (CRO), and site personnel involved in the study).
- Participants having any current workup of undiagnosed illness within 8 weeks prior to start of study which could lead to new condition or diagnosis.
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novavaxlead
Study Sites (33)
Belfast Health and Social Care Trust (BHSCT) (Site UK011)
Belfast, Antrim, BT9 7AB, United Kingdom
Synexus Midlands Clinical Research Centre (Site UK024)
Edgbaston, Birmingham, B15 2 SQ, United Kingdom
The Royal Cornwall Hospitals NHS Trust (Site UK036)
Truro, Cornwall, TR1 3LJ, United Kingdom
Royal Devon and Exeter Hospital (Site UK013)
Exeter, Devon, EX2 5DW, United Kingdom
"Maidstone Hospital - Central Research and Development Office Above Breast Care Centre - 1st Floor" (Site UK028)
Maidstone, Kent, ME16 9QQ, United Kingdom
Queen Elizabeth University Hospital (Site UK008)
Glasgow, Lanarkshire, G51 4TF, United Kingdom
Blackpool Teaching Hospitals (Site UK010)
Blackpool, Lancashire, FY3 8NR, United Kingdom
Salford Hospital (Site UK030)
Oldham, Lancashire, OL1 2JH, United Kingdom
Synexus Merseyside Clinical Research Centre (Site UK026)
Waterloo, Liverpool, L22 0LG, United Kingdom
Royal Free (Site UK012)
Hampstead, London, NW3 2QG, United Kingdom
St. George's University Hospitals NHS Foundation Trust Clinical Research Facility (Site UK001)
Tooting, London, SW17 0QT, United Kingdom
North Wales Clinical Research Centre (NWCRC) (Site UK027)
Wrexham, North Wales, LL13 7YP, United Kingdom
Lakeside Healthcare, Lakeside Surgery (Site UK005)
Corby, Northants, NN17 2UR, United Kingdom
Warneford Hospital (Site UK016)
Oxford, Oxfordshire, OX3 7JX, United Kingdom
Aberdeen Royal Infirmary (Site UK007), Foresterhill
Aberdeen, AB25 2ZN, United Kingdom
Bradford Teaching Hospitals NHS Trust (Site UK018)
Bradford, BD9 6RJ, United Kingdom
Synexus Wales Clinical Research Centre (Site UK025)
Cardiff, CF15 9SS, United Kingdom
Synexus Lancashire Clinical Research Centre (Site UK022)
Chorley, PR7 7 NA, United Kingdom
Colchester Hospital (Site UK034)
Colchester, CO4 5JL, United Kingdom
AES - Glasgow (Site UK033)
Glasgow, G20 0SP, United Kingdom
University Hartlepool Hospital (Site UK021)
Hartlepool, TS24 9AH, United Kingdom
Synexus Hexham Clinical Research Centre (Site UK023)
Hexham, NE46 1QJ, United Kingdom
Royal Lancaster Infirmary (Site UK029)
Lancaster, LA1 4RP, United Kingdom
Research & Innovation Centre, St. James's University Hospital (Site UK019)
Leeds, LS9 7TF, United Kingdom
St. Thomas' Hospital (Site UK020)
London, SE1 7EH, United Kingdom
Chelsea & Westminster NHS Foundation Trust (Site UK006)
London, SW10 9NH, United Kingdom
AES - Synexus Manchester (Site UK032)
Manchester, M15 6SE, United Kingdom
Norfolk and Norwich University Hospital NHS Foundation Trust, Norfolk and Norwich University Hospital (Site UK015)
Norwich, NR4 7UY, United Kingdom
Wansford and Kingscliffe Practice (Site UK035)
Peterborough, PE8 6PL, United Kingdom
AES - Synexus Thames Valley (Site UK031)
Reading, RG2 0TG, United Kingdom
University Hospital Southampton NHS Foundation Trust (UHS) (Site UK014)
Southampton, SO16 6YD, United Kingdom
Midlands Partnership NHS Foundation Trust Headquarters (Site UK017)
Stafford, ST16 3SR, United Kingdom
Stockport NHS Foundation Trust (Site UK009)
Stockport, SK2 7JE, United Kingdom
Related Publications (1)
Toback S, Galiza E, Cosgrove C, Galloway J, Goodman AL, Swift PA, Rajaram S, Graves-Jones A, Edelman J, Burns F, Minassian AM, Cho I, Kumar L, Plested JS, Rivers EJ, Robertson A, Dubovsky F, Glenn G, Heath PT; 2019nCoV-302 Study Group. Safety, immunogenicity, and efficacy of a COVID-19 vaccine (NVX-CoV2373) co-administered with seasonal influenza vaccines: an exploratory substudy of a randomised, observer-blinded, placebo-controlled, phase 3 trial. Lancet Respir Med. 2022 Feb;10(2):167-179. doi: 10.1016/S2213-2600(21)00409-4. Epub 2021 Nov 17.
PMID: 34800364DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Development
Novavax, Inc.
- PRINCIPAL INVESTIGATOR
Paul T Heath, MB BS FRACP FRCPCH
Vaccine Institute, St Georges, University of London
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 9, 2020
First Posted
October 12, 2020
Study Start
September 28, 2020
Primary Completion
March 29, 2022
Study Completion
March 29, 2022
Last Updated
May 8, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share