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    The EU Clinical Trials Register currently displays   43862   clinical trials with a EudraCT protocol, of which   7285   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2020-004272-17
    Sponsor's Protocol Code Number:CLO-SCB-2019-003
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-01-06
    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 ConcernedGermany - PEI
    A.2EudraCT number2020-004272-17
    A.3Full title of the trial
    A Double-Blind, Randomized, Controlled, Phase 2/3 Study to Evaluate the Efficacy, Immunogenicity, and Safety of CpG 1018/Alum-Adjuvanted Recombinant SARS-CoV-2 Trimeric S-protein Subunit Vaccine (SCB-2019) for the Prevention of SARS-CoV-2-mediated COVID-19 in Participants Aged 18 years and Older
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A controlled Phase 2/3 study of adjuvanted recombinant SARS-CoV-2 trimeric S-protein vaccine (SCB-2019) for the prevention of COVID-19
    A.3.2Name or abbreviated title of the trial where available
    SPECTRA
    A.4.1Sponsor's protocol code numberCLO-SCB-2019-003
    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 SponsorClover Biopharmaceuticals AUS Pty Ltd
    B.1.3.4CountryAustralia
    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 supportClover Biopharmaceuticals AUS Pty Ltd
    B.4.2CountryAustralia
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationClover Biopharmaceuticals AUS Pty Ltd
    B.5.2Functional name of contact pointHtay Htay Han
    B.5.3 Address:
    B.5.3.1Street AddressLevel 17, HWT Tower, 40 City Road
    B.5.3.2Town/ citySouthbank VIC
    B.5.3.3Post code3006
    B.5.3.4CountryAustralia
    B.5.6E-mailhtayhtay.han@cloverbiopharma.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 nameSCB-2019 (CpG 1018/Alum-djuvanted SCB-2019)
    D.3.2Product code SCB-2019
    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 INNNot available
    D.3.9.2Current sponsor codeSCB-2019
    D.3.9.3Other descriptive nameSARS-CoV-2 spike trimer fusion protein, recombinant
    D.3.9.4EV Substance CodeSUB216571
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number720
    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 No
    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
    SARS-CoV-2-mediated COVID-19
    E.1.1.1Medical condition in easily understood language
    COVID-19 and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    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
    1. Primary Efficacy Objective: Vaccine Efficacy Against RT-PCR-Confirmed COVID-19 of Any Severity: To demonstrate the efficacy of CpG 1018/Alum-adjuvanted SCB-2019 vaccine for the prevention of any RT-PCR-confirmed COVID-19 of any severity in subjects without evidence of prior SARS-CoV-2 infection.
    2. Primary Safety and Reactogenicity Objective: To assess the safety and reactogenicity of CpG 1018/Alum-adjuvanted SCB-2019 vaccine compared to placebo.
    E.2.2Secondary objectives of the trial
    Secondary Efficacy Objectives:
    - Vaccine Efficacy Against Any RT-PCR Confirmed Moderate-to-Severe COVID-19
    - Vaccine Efficacy Against Any Laboratory-Confirmed SARS-CoV-2 Infection
    - Vaccine Efficacy Against Any RT-PCR-Confirmed Severe COVID-19
    - Vaccine Efficacy Against Any Laboratory-Confirmed Asymptomatic SARS-CoV-2 Infection
    - Vaccine Efficacy Against Burden of Disease (BOD)
    - Vaccine Efficacy Against Any RT-PCR-Confirmed COVID-19 of Any Severity, Associated with Hospitalization
    - Vaccine Efficacy by Evidence of Prior SARS-CoV-2 Infection and Risk of Severe COVID-19
    - Vaccine Efficacy After the First Dose

    Secondary Immunogenicity Objectives: To assess the immunogenicity of CpG 1018/Alum-adjuvanted SCB 2019 vaccine in Phase 2 subjects
    To assess the immune response against Trimer Tag domain of SCB 2019 in Phase 2 subjects

    Secondary Safety Objective: To assess the immune response against Trimer Tag domain of SCB 2019 in Phase 2 subjects



    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Immunogenicity sub study
    Study will be conducted in sub set of the participating countries and patients.
    Objective:
    To assess the immunogenicity of CpG 1018/Alum-adjuvanted SCB-2019 vaccine in Phase 2 subjects
    To assess the immune response against Trimer Tag domain of SCB-2019 in Phase 2 subjects
    E.3Principal inclusion criteria
    1. Male or females ≥18 years of age, inclusive.
    2. Participants who are willing and able to comply with study requirements, including all scheduled visits, vaccinations, laboratory tests, the electronic completion of the COVID-19 ePRO and other study procedures.
    3. Healthy adults or adults with pre-existing medical conditions who are in stable condition.
    A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 3 months before enrollment.
    Note: The first 200 individuals enrolled in the Phase 2 part of the study should be healthy subjects 18 to 64 years or age without comorbidities associated with a high risk of severe COVID-19.
    4. Female subjects are eligible to participate in the study if not pregnant, not breastfeeding, and at least 1 of the following criteria apply:
    • Women of childbearing potential (WOCBP) must have a negative urine pregnancy test prior to each vaccination. A confirmatory serum pregnancy test may be conducted at the Investigator’s discretion. They must be using a highly effective licensed method of birth control for 30 days prior to the first vaccination and must agree to continue such precautions during the study until 90 days after the second vaccination.
    5. Male subjects must agree to employ acceptable contraception from the day of first dose of the study vaccine/placebo until 6 months after the last dose of the study vaccine/placebo and also refrain from donating sperm during this period.
    6. Individuals (or their legally acceptable representative based on local regulations) willing and able to give an informed consent, prior to screening.
    E.4Principal exclusion criteria
    1. Individuals with laboratory-confirmed SARS-CoV-2 infection (e.g., a positive RT-PCR or Rapid COVID-19 antigen test).
    2. Individuals with behavioral or cognitive impairment (including drug and alcohol abuse) in the opinion of the Investigator.
    3. Individuals with any progressive or severe neurologic disorder, seizure disorder, or history of Guillian-Barré syndrome.
    4. Individuals who receive treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, e.g., for cancer or an autoimmune disease, or planned receipt during the study period. If a short-term course of systemic corticosteroids have been administered for treatment of an acute illness, participants should not be enrolled into the study until corticosteroid therapy has been discontinued for at least 30 days before the first study vaccination. A unique dose of systemic steroids on a single day would be allowed, as well as inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted.
    5. Individuals who are pregnant, or breastfeeding, or planning to become pregnant during the study period.
    6. Individuals who have a history of severe adverse reaction associated with a vaccine or severe allergic reaction (e.g., anaphylaxis) to any component of the study vaccine (SCB-2019, CpG 1018 Adjuvant and Aluminum hydroxide/SCB-2019 components as outlined in the latest IB).
    7. Individuals who have a history of malignancy within 1 year before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix which have been cured, or other malignancies with minimal risk of recurrence).
    8. Individuals who have received any other investigational product within 30 days prior to Day 1 or intent to participate in another clinical study at any time during the conduct of this study.
    9. Individuals who have received previous vaccination with any coronavirus vaccine.
    10. Individuals who have received any other licensed vaccines within 14 days prior to enrollment in this study or who are planning to receive any vaccine up to 14 days after the second vaccination.
    11. Individuals with known bleeding disorder that would, in the opinion of the investigator, contraindicate intramuscular injection.
    12. Individuals who received any blood/plasma products or immunoglobulins within 60 days prior to Day 1 or plan to receive it during the study period.
    13. Individuals with any condition that, in the opinion of the Investigator, may increase the risk of study participation or interfere with the assessment of the primary study objectives
    14. Individuals with fever >37.8°C (≥100.04°F; irrespective of method), or any acute illness at baseline (Day 1) or within 3 days of randomization. Participants meeting this criterion may be rescheduled within the relevant window. Afebrile participants with minor illnesses can be enrolled at the discretion of the investigator.
    E.5 End points
    E.5.1Primary end point(s)
    First occurrence of any RT-PCR-confirmed COVID-19 of any severity with onset at least 14 days after the second study vaccination in subjects without evidence of prior SARS-CoV-2 infection.
    Local and systemic solicited AEs reported within 7 days after each study vaccination (in Phase 2 subjects)
    Unsolicited AEs reported from Visit 1 (Day 1) through Safety Call Day 43 (in Phase 2 subjects)
    SAEs, AEs leading to early termination from the study, MAAEs, and AESIs during the entire study period (in all subjects).
    E.5.1.1Timepoint(s) of evaluation of this end point
    For efficacy endpoint: First occurrence of any RT-PCR-confirmed COVID-19 with onset at least 14 days after the second study vaccination

    For safety and reactogenecity endpoints: For SAEs, AEs leading to early termination from the study: during the entire study period
    E.5.2Secondary end point(s)
    First occurrence of RT-PCR confirmed moderate-to-severe COVID 19 (Refer to Case Definition) with onset at least 14 days after the second vaccination in subjects without evidence of prior SARS-CoV-2 infection
    Occurrence of any laboratory-confirmed SARS-CoV-2 infection (Refer to Case Definition) with onset at least 14 days after the second study vaccination in subjects without evidence of prior SARS-CoV-2 infection
    First occurrence of RT-PCR confirmed severe COVID 19 with onset at least 14 days after the second vaccination in subjects without evidence of prior SARS-CoV-2 infection
    Occurrence of laboratory-confirmed asymptomatic SARS-CoV-2 infection (Refer to Case Definition), with onset at least 14 days after the second vaccination in subjects without evidence of prior SARS-CoV-2 infection.
    Occurrence of any SARS-CoV-2 infection, any confirmed RT-PCR COVID-19 and any RT-PCR-confirmed severe COVID-19 with onset at least 14 days after the second vaccination in subjects without evidence of prior SARS-CoV-2 infection
    First occurrence of RT-PCR confirmed COVID 19 of any severity, associated with hospitalization, with onset at least 14 days after the second vaccination in subjects without evidence of prior SARS-CoV-2 infection.
    - First occurrence of RT-PCR confirmed COVID 19 of any severity,
    - First occurrence of RT-PCR-confirmed moderate-to-severe COVID-19,
    - First occurrence of RT-PCR confirmed severe COVID-19,
    - First occurrence of RT-PCR confirmed COVID 19 of any severity, associated with hospitalization,
    - Occurrence of any laboratory-confirmed SARS-CoV-2 infection, and
    - Occurrence of laboratory-confirmed asymptomatic SARS-CoV-2 infection, with onset at least 14 days after the second vaccination
    For Immunogenicity - VNA, ACE2-competitive ELISA, SCB-2019 binding antibody ELISA,
    For Safety- Trimer-Tag binding antibody as measured by ELISA assay
    E.5.2.1Timepoint(s) of evaluation of this end point
    For Efficacy - First occurrence of any RT-PCR-confirmed COVID-19 with onset at least 14 days after the second study vaccination
    For Immunogenicity and safety - Visits 1, 2, 3, 4 and 5


    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    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) Yes
    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 No
    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 concerned7
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA15
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Brazil
    Colombia
    Dominican Republic
    Guatemala
    Nepal
    Panama
    Philippines
    South Africa
    Belgium
    Germany
    Poland
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    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: 16500
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5500
    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
    Subjects with stable and well-controlled comorbidities
    F.4 Planned number of subjects to be included
    F.4.1In the member state800
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 2000
    F.4.2.2In the whole clinical trial 22000
    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)
    If the safety and efficacy of the study vaccine are demonstrated in CLOSCB-2019-003 study and the vaccine will be approved for use in general population, all study participants who were assigned to the placebo group will be offered SCB-2019 vaccination by Clover.
    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 Decision2021-05-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-04-15
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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