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    The EU Clinical Trials Register currently displays   38178   clinical trials with a EudraCT protocol, of which   6271   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2020-004123-16
    Sponsor's Protocol Code Number:2019nCoV-302
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-09-11
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2020-004123-16
    A.3Full title of the trial
    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
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to evaluate the efficacy and safety of a SARS-CoV-2 rS vaccine with Matrix-M1™ Adjuvant in Adult Participants 18-84 Years of Age in the United Kingdom
    A.4.1Sponsor's protocol code number2019nCoV-302
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorNovavax, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNovavax, Inc.
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportVaccine TaskForce
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovavax, Inc.
    B.5.2Functional name of contact pointLakshmi Kumar
    B.5.3 Address:
    B.5.3.1Street Address21 Firstfield Road
    B.5.3.2Town/ cityGaithersburg, MD
    B.5.3.3Post code20878
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1540326 5856
    B.5.6E-mailLKumar@Novavax.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameSARS-CoV-2 rS with Matrix-M1™ Adjuvant
    D.3.2Product code NVX-CoV2373
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSARS-CoV-2 recombinant spike protein (SARS-CoV-2 rS) Drug Substance
    D.3.9.3Other descriptive nameNVX-CoV2373
    D.3.9.4EV Substance CodeSUB208321
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Prevention of COVID-19 caused by SARS-CoV-2
    E.1.1.1Medical condition in easily understood language
    Coronavirus Disease
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level LLT
    E.1.2Classification code 10084465
    E.1.2Term COVID-19 vaccination
    E.1.2System Organ Class 100000004865
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate the efficacy of SARS-CoV-2 rS with Matrix-M1 adjuvant in the prevention of virologically confirmed (by polymerase chain reaction [PCR]) to SARS-CoV-2, symptomatic COVID-19, when given as a 2-dose vaccination regimen, as compared to placebo, in serologically negative (to SARS-CoV-2) adult participants.
    E.2.2Secondary objectives of the trial
    To demonstrate efficacy of SARS-CoV-2 rS with Matrix-M1 adjuvant in prevention of virologically confirmed, symptomatic COVID-19, versus placebo, regardless of serostatus at baseline.
    To assess efficacy of SARS-CoV-2 rS with Matrix-M1 adjuvant on:
    - SARS-CoV-2 seropositive participants requiring specific medical interventions.
    - mild COVID-19 symptoms.
    - occurrence of asymptomatic or undetected infections with SARS-CoV-2.
    In a subset of participants, evaluate the immunogenicity of SARS-CoV-2 rS with Matrix-M1 adjuvant.
    To evaluate safety in terms of:
    - SAEs and MAAEs during entire study.
    - AESI, which encompasses PIMMCs and AESIs relevant to COVID-19 including possible vaccine-enhanced disease, at any time after the first dose.
    In a subset, to evaluate safety and reactogenicity in terms of solicited local and systemic AEs for 7 days after each vaccination, and in terms of unsolicited AEs for 21 days after first vaccination and 28 days after second vaccination.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    A licensed seasonal influenza co-administration sub-study will be conducted in the first 400 participants who meet the additional inclusion criteria for this study.

    After being randomised to receive IM injections of SARS-CoV-2 rS with Matrix-M1 adjuvant or placebo, sub-study participants will receive a licensed seasonal influenza vaccine on Day 0 in the opposite deltoid. These participants will be part of the solicited AE safety subset analysis.

    This sub-group will undergo the same safety and efficacy evaluations as the entire study population. In addition, the entire sub-study will have reactogenicity assessed. This group must not have had a current season licensed influenza vaccine and have no prior history of allergy or severe reaction to seasonal influenza vaccine. To assess the possible impact of the study vaccine on the immunogenicity of the influenza vaccine, this group will also have a hemagglutination inhibition assay (HAI) performed.

    Objective: In a subset of adult participants, to evaluate the safety and immunogenicity of SARS-CoV-2 rS with Matrix-M1 adjuvant when co-administered with a licensed seasonal influenza vaccine.
    E.3Principal inclusion criteria
    1. Adult males or females aged 18 to 84 years (inclusive) at screening.
    2. Able and willing (in the investigator’s opinion) to comply with all study requirements.
    3. Willing to allow the investigators to discuss the volunteer’s medical history with their General Practitioner and access all medical records when relevant to study procedures.
    4. Willing and able to give informed consent prior to study enrolment.
    5. Female participants of childbearing potential (defined as any female who has experienced menarche and who is NOT surgically sterile [i.e., hysterectomy, bilateral tubal ligation, or bilateral oophorectomy] or postmenopausal [defined as amenorrhea at least 12 consecutive months or > 1 documented plasma follicle-stimulating hormone level ≥ 40 mIU/mL]) must agree to be heterosexually inactive from at least 28 days prior to enrolment and through 3 months after the last study vaccination OR agree to consistently use any of the following methods of contraception from at least 28 days prior to enrolment and through 3 months after the last study vaccination:
    a. Condoms (male or female) with spermicide
    b. Diaphragm with spermicide
    c. Cervical cap with spermicide
    d. Intrauterine device
    e. Oral or patch contraceptives
    f. Norplant®, Depo-Provera®, or other in country regulatory-approved contraceptive method that is designed to protect against pregnancy
    g. Abstinence, as a form of contraception, is acceptable if in line with the participant’s lifestyle
    NOTE: Periodic abstinence (e.g., calendar, ovulation, symptothermal, postovulation methods) and withdrawal are not acceptable methods of contraception.

    Seasonal Influenza Vaccine Co-Administration Sub-Study Only
    6. Participant should not have received a current season influenza vaccine, have no contraindication to the specific vaccine to be administered in the study, and no prior history of allergy or severe reaction to seasonal influenza vaccines.
    E.4Principal exclusion criteria
    1. Participation in COVID-19 prophylactic drug trials for the duration of the study.
    2. Participation in SARS-CoV-2 serological surveys where participants are informed of their serostatus for the duration of the study.
    3. Participation in research involving an investigational product (drug/biologic/device) within 45 days prior to first study vaccination.
    4. History of laboratory-confirmed (by PCR or serology to SARS-CoV-2) COVID-19 infection at any time prior to randomisation.
    5. Administration of immunoglobulins and/or any blood products within the 3 months preceding the planned administration of the study vaccine candidate.
    6. 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 are not exclusionary.
    7. History of allergic disease or reactions likely to be exacerbated by any component of the study vaccines.
    8. Any history of anaphylaxis to any prior vaccine.
    9. Pregnancy, lactation or willingness/intention to become pregnant during the study.
    10. Current diagnosis of or treatment for cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ, at the discretion of the investigator).
    11. Bleeding disorder (e.g., factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venepuncture.
    12. Continuous use of anticoagulants, such as coumarins and related anticoagulants (i.e., warfarin) or novel oral anticoagulants/anti-platelet agents.
    NOTE: The use of ≤ 325 mg of aspirin per day as prophylaxis is permitted.
    13. Suspected or known current alcohol or drug dependency.
    14. Study team member or first-degree relative of any study team member (inclusive of sponsor, contract research organisation (CRO), and site personnel involved in the study).
    15. Participants who are having any current workup of undiagnosed illness within the last 8 weeks that is either participant-reported or has been clinician-assessed, which could lead to a new condition or diagnosis.
    16. Received any live vaccine within 4 weeks or any vaccine (excluding influenza) within 2 weeks prior to first study vaccination or any licensed influenza vaccine within 1 week prior to first study vaccination. Plans to receive any vaccine from these time periods until 28 days after second study vaccination (with the exception of participants in the seasonal influenza co-administration sub-study; a licensed seasonal influenza vaccine may be received as soon as 7 days after second study vaccination).
    NOTE: An influenza co-administration sub-study will occur in which 400 participants will receive a single dose of seasonal influenza vaccine at the same time as first study vaccination.
    17. Have clinically significant chronic cardiovascular, endocrine, gastrointestinal, hepatic, renal, neurological, respiratory, psychiatric or other medical disorders not excluded by other exclusion criteria, that are assessed by the investigator as being clinically unstable within the prior 4 weeks as evidenced by:
    a. Hospitalisation for the condition, including day surgical interventions.
    b. New significant organ function deterioration.
    c. Needing addition of new treatments or major dose adjustments of current treatments (mild or moderate well-controlled comorbidities are allowed).
    18. 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, neuropathy, and epilepsy) 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.
    19. Any autoimmune or immunodeficiency disease/condition (iatrogenic or congenital).
    NOTE: Stable endocrine disorders that have a confirmed autoimmune etiology (e.g., thyroid, pancreatic) are allowed.
    20. 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.
    E.5 End points
    E.5.1Primary end point(s)
    • FIRST PRIMARY ENDPOINT: First occurrence of virologically confirmed (by PCR to SARS-CoV-2), symptomatic COVID-19 with onset at least 7 days after second study vaccination (e.g., Day 28) in serologically negative (to SARS-CoV-2) adult participants at baseline until the endpoint-driven efficacy analysis is triggered by the occurrence of a prespecified number of blinded endpoints.

    • SECOND PRIMARY ENDPOINT: First occurrence of virologically confirmed (by PCR to SARS-CoV-2), symptomatic moderate or severe COVID-19 with onset at least 7 days after second study vaccination (e.g., Day 28) in serologically negative (to SARS-CoV-2) adult participants at baseline until the endpoint-driven efficacy analysis is triggered by the occurrence of a prespecified number of blinded endpoints.
    E.5.1.1Timepoint(s) of evaluation of this end point
    This will be an event-driven study for the assessment of vaccine efficacy (VE) and will end when a sufficient number of events have been observed, yet all participants will be followed for the entire study duration for safety endpoints.
    E.5.2Secondary end point(s)
    − First occurrence of virologically confirmed (by PCR to SARS-CoV-2), symptomatic COVID-19, with onset at least 7 days after second study vaccination (e.g., Day 28) in adult participants regardless of their serostatus at baseline.

    − First occurrence of laboratory-confirmed (by PCR or serology to SARS-CoV-2) symptomatic or asymptomatic COVID-19 with onset at least 7 days after second study vaccination (e.g., Day 28) in adult participants regardless of their serostatus
    at baseline.

    − First occurrence of COVID-19 requiring hospitalisation, intensive care unit (ICU) admission or mechanical ventilation linked to any virologically confirmed (by PCR to SARS-CoV-2) COVID-19 with onset at least 7 days after second study
    vaccination (e.g., Day 28) in adult participants regardless of their serostatus at baseline.

    − First occurrence of virologically confirmed (by PCR to SARS-CoV-2), mild COVID-19 (with no progression to moderate or severe COVID-19 during the course of the COVID-19 episode) with onset at least 7 days after second study vaccination (e.g., Day 28) in adult participants, regardless of their serostatus at baseline.

    − Analysis of antibodies binding to the SARS-CoV-2 spike (S) protein by enzyme-linked immunosorbent assay (ELISA) at Day 0 (baseline), Day 21 (21 days after first study vaccination), and Day 35 (14 days after second study vaccination).

    − The occurrence and relationship to study vaccination of SAEs and MAAEs (in all adult participants) during the entire study period.
    E.5.2.1Timepoint(s) of evaluation of this end point
    This will be an event-driven study for the assessment of vaccine efficacy (VE) and will end when a sufficient number of events have been observed, yet all participants will be followed for the entire study duration for safety endpoints.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Observer-Blinded
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned14
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of the study is defined as the date on which the last participant completes the last study visit (including the EOS visit and any additional long-term follow-up).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 6750
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2250
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    An effort will be made to enrol subjects aged ≥65 years and other groups most affected by COVID-19
    F.4 Planned number of subjects to be included
    F.4.1In the member state9000
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 9000
    F.4.2.2In the whole clinical trial 9000
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-09-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-09-21
    P. End of Trial
    P.End of Trial StatusOngoing
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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