A Study Looking at the Effectiveness, Immune Response, and Safety of a COVID-19 Vaccine in Adults in the United Kingdom
NCT ID: NCT04583995
Last Updated: 2025-05-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
15185 participants
INTERVENTIONAL
2020-09-28
2022-03-29
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Cohort 1: SARS-CoV-2 rS/Matrix-M1 Adjuvant
2 doses of 5 µg SARS-CoV-2 rS + 50 µg Matrix-M1 adjuvant (co-formulated), 1 dose each on Days 0 and 21.
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.
Cohort 1: Placebo
2 doses of Placebo (Saline), 1 dose each on Days 0 and 21.
Placebo
Alternating intramuscular (deltoid) injections of placebo (0.5 mL) on Days 0 and 21.
Cohort 2: SARS-CoV-2 rS/Matrix-M1 Adjuvant Plus Licensed Seasonal Flu Vaccine
2 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.
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.
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.
Cohort 2: Placebo Plus Licensed Seasonal Flu Vaccine
2 doses of Placebo (Saline), 1 dose each on Days 0 and 21. 1 dose of licensed seasonal flu vaccine on Day 0.
Placebo
Alternating intramuscular (deltoid) injections of placebo (0.5 mL) on Days 0 and 21.
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.
Interventions
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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.
Placebo
Alternating intramuscular (deltoid) injections of placebo (0.5 mL) on Days 0 and 21.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
* Received any live vaccine within 4 weeks or any vaccine (excluding flu) within 2 weeks prior to first study vaccination; or any licensed flu vaccine within 1 week prior to first study vaccination or plans to receive any vaccine from these time periods until 28 days after the second study vaccination.
* History of chronic neurological disorders that have required prior specialist physician review for diagnosis and management (such as multiple sclerosis, dementia, transient ischemic attacks, Parkinson's disease, degenerative neurological conditions, and neuropathy) or a history of stroke or previous neurological disorder within 12 months with residual symptoms. Participants with a history of migraine or chronic headaches or nerve root compression that have been stable on treatment for the last 4 weeks are not excluded.
* Any autoimmune disease/condition (iatrogenic or congenital).
* Any other significant disease, disorder or finding that, in the opinion of the investigator, may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study, or impair interpretation of the study data.
* Participant requires the use of continuous oxygen therapy or any oxygen therapy while awake or is anticipated to require daytime oxygen therapy during the course of the study.
18 Years
84 Years
ALL
Yes
Sponsors
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Novavax
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Development
Role: STUDY_DIRECTOR
Novavax, Inc.
Paul T Heath, MB BS FRACP FRCPCH
Role: PRINCIPAL_INVESTIGATOR
Vaccine Institute, St Georges, University of London
Locations
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Belfast Health and Social Care Trust (BHSCT) (Site UK011)
Belfast, Antrim, United Kingdom
Synexus Midlands Clinical Research Centre (Site UK024)
Edgbaston, Birmingham, United Kingdom
The Royal Cornwall Hospitals NHS Trust (Site UK036)
Truro, Cornwall, United Kingdom
Royal Devon and Exeter Hospital (Site UK013)
Exeter, Devon, United Kingdom
"Maidstone Hospital - Central Research and Development Office Above Breast Care Centre - 1st Floor" (Site UK028)
Maidstone, Kent, United Kingdom
Queen Elizabeth University Hospital (Site UK008)
Glasgow, Lanarkshire, United Kingdom
Blackpool Teaching Hospitals (Site UK010)
Blackpool, Lancashire, United Kingdom
Salford Hospital (Site UK030)
Oldham, Lancashire, United Kingdom
Synexus Merseyside Clinical Research Centre (Site UK026)
Waterloo, Liverpool, United Kingdom
Royal Free (Site UK012)
Hampstead, London, United Kingdom
St. George's University Hospitals NHS Foundation Trust Clinical Research Facility (Site UK001)
Tooting, London, United Kingdom
North Wales Clinical Research Centre (NWCRC) (Site UK027)
Wrexham, North Wales, United Kingdom
Lakeside Healthcare, Lakeside Surgery (Site UK005)
Corby, Northants, United Kingdom
Warneford Hospital (Site UK016)
Oxford, Oxfordshire, United Kingdom
Aberdeen Royal Infirmary (Site UK007), Foresterhill
Aberdeen, , United Kingdom
Bradford Teaching Hospitals NHS Trust (Site UK018)
Bradford, , United Kingdom
Synexus Wales Clinical Research Centre (Site UK025)
Cardiff, , United Kingdom
Synexus Lancashire Clinical Research Centre (Site UK022)
Chorley, , United Kingdom
Colchester Hospital (Site UK034)
Colchester, , United Kingdom
AES - Glasgow (Site UK033)
Glasgow, , United Kingdom
University Hartlepool Hospital (Site UK021)
Hartlepool, , United Kingdom
Synexus Hexham Clinical Research Centre (Site UK023)
Hexham, , United Kingdom
Royal Lancaster Infirmary (Site UK029)
Lancaster, , United Kingdom
Research & Innovation Centre, St. James's University Hospital (Site UK019)
Leeds, , United Kingdom
St. Thomas' Hospital (Site UK020)
London, , United Kingdom
Chelsea & Westminster NHS Foundation Trust (Site UK006)
London, , United Kingdom
AES - Synexus Manchester (Site UK032)
Manchester, , United Kingdom
Norfolk and Norwich University Hospital NHS Foundation Trust, Norfolk and Norwich University Hospital (Site UK015)
Norwich, , United Kingdom
Wansford and Kingscliffe Practice (Site UK035)
Peterborough, , United Kingdom
AES - Synexus Thames Valley (Site UK031)
Reading, , United Kingdom
University Hospital Southampton NHS Foundation Trust (UHS) (Site UK014)
Southampton, , United Kingdom
Midlands Partnership NHS Foundation Trust Headquarters (Site UK017)
Stafford, , United Kingdom
Stockport NHS Foundation Trust (Site UK009)
Stockport, , United Kingdom
Countries
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References
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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.
Related Links
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FDA Safety Alerts and Recalls
CDC (Centers for Disease Control and Prevention): Coronavirus (COVID-19) website
WHO COVID-19 treatment guidelines
NHS Health Research Authority: COVID-19 Research
Other Identifiers
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2019nCoV-302
Identifier Type: -
Identifier Source: org_study_id
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