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    The EU Clinical Trials Register currently displays   43974   clinical trials with a EudraCT protocol, of which   7312   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:2021-002530-17
    Sponsor's Protocol Code Number:D7220C00001
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-06-28
    Trial results View 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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2021-002530-17
    A.3Full title of the trial
    A Phase II/III Partially Double-Blinded, Randomised, Multinational, Active-Controlled Study in Both Previously Vaccinated and Unvaccinated Adults to Determine the Safety and Immunogenicity of AZD2816, a Vaccine for the Prevention of COVID-19 Caused by Variant Strains of SARS-CoV-2
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 3 study, blinded in vaccinated and unvaccinated adults to determine the safety and immune response of AZD2816, a vaccine for the prevention of COVID-19 caused by variant strains
    A.4.1Sponsor's protocol code numberD7220C00001
    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 SponsorAstraZeneca AB
    B.1.3.4CountrySweden
    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 supportAstraZeneca AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca AB
    B.5.2Functional name of contact pointInformation Center
    B.5.3 Address:
    B.5.3.1Street AddressN/A
    B.5.3.2Town/ cityN/A
    B.5.3.3Post codeN/A
    B.5.3.4CountrySweden
    B.5.6E-mailinformation.center@astrazeneca.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 Yes
    D.2.1.1.1Trade name Vaxzevria
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca AB
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.2Product code AZD1222
    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.3.9.1CAS number 2420395-83-9
    D.3.9.2Current sponsor codeAZD1222
    D.3.9.3Other descriptive nameChAdOx1 nCoV-19
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1 x E11
    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) No
    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.IMP: 2
    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.3.2Product code AZD2816
    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.3.9.2Current sponsor codeAZD2816
    D.3.9.3Other descriptive nameChAdOx-nCoV19
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number1 x E11
    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) No
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    SARS-COV-2 infection (COVID-19)
    E.1.1.1Medical condition in easily understood language
    COVID-19
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level PT
    E.1.2Classification code 10051905
    E.1.2Term Coronavirus infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Previously Unvaccinated Participants Receiving a 2-Dose Primary Vaccination
    To characterize the safety and tolerability of a 2-dose primary vaccination with AZD2816 with a 4-week dosing interval in previously unvaccinated seronegative participants.
    Previously Vaccinated Participants Receiving a 1-Dose Booster
    To characterize the safety and tolerability of 1 booster dose of AZD2816 in participants previously vaccinated with AZD1222.

    Immunogenicity objectives: see protocol
    E.2.2Secondary objectives of the trial
    Previously Unvaccinated Participants Receiving a 2-Dose Primary Vaccination
    - To characterize the safety and tolerability of a heterologous primary vaccination with 1 dose of AZD1222 followed by 1 dose of AZD2816 administered with a 4-week dosing interval in
    previously unvaccinated seronegative participants
    - To characterize the safety and tolerability of a 2-dose primary vaccination with AZD2816 with a 12-week dosing interval in previously unvaccinated seronegative participants
    - To characterize the extended safety of a 2-dose primary vaccination with AZD2816 with a 4-week dosing interval in previously unvaccinated
    seronegative participants (see more in protocol)
    Previously Vaccinated Participants Receiving a 1-Dose Booster
    - To characterize the safety and tolerability of 1 booster dose of AZD1222 in seronegative participants previously vaccinated with AZD1222 (see more in protocol)

    Immunogenicity objectives: see protocol
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1 Adult, ≥ 18 years of age at the time of consent

    For inclusion in the SARS-CoV-2 seronegative population:

    2 No history of laboratory-confirmed SARS-CoV-2 infection (ie, no positive nucleic acid
    amplification test and no positive antibody test).
    3 Seronegative for SARS-CoV-2 at screening (lateral flow test to detect reactivity to the
    nucleoprotein).
    4 Medically stable such that, according to the judgment of the investigator, hospitalization
    within the study period is not anticipated and the participant appears likely to be able to
    remain on study through the end of protocol-specified follow-up
    5 Able to understand and comply with study requirements/procedures (if applicable, with
    assistance by caregiver, surrogate, or legally authorized representative) based on the
    assessment of the investigator
    6 Signed informed consent obtained before conducting any study-related procedures
    7 Contraceptive use by women should be consistent with local regulations regarding the
    methods of contraception for those participating in clinical studies.

    Previously COVID-19 Vaccinated Participants
    8 Prior completion of a 2-dose primary homologous vaccination regimen against the original SARSCoV-2 Wuhan-hu-1 strain with either AZD1222 (2 standard doses as authorized vaccine or as investigational
    product in a clinical trial with a 4 to 12-week dosing interval) or with an mRNA vaccine
    approved for emergency or conditional use (eg, BNT162b2 vaccine [Pfizer-BioNTech]
    with a 3- to 12-week dosing interval or mRNA-1273 vaccine [Moderna] with a 4- to 12- week dosing interval). The second dose in all cases should have been administered at least 90 days prior to first administration of study intervention.
    E.4Principal exclusion criteria
    1 History of allergy to any component of AZD1222/AZD2816.
    2 History of Guillain-Barré syndrome, any demyelinating disease, or any other neuroimmunologic condition
    3 Significant infection or other acute illness, including fever > 100 °F (> 37.8 °C) on the day prior to or day of randomization
    4 Any confirmed or suspected immunosuppressive or immunodeficient state, including asplenia or HIV/AIDS.
    5 Recurrent severe infections and use of immunosuppressant medication within the past 6 months (≥ 20 mg per day of prednisone or its equivalent, given daily or on alternate
    days for ≥ 15 days within 30 days prior to administration of study intervention). The following exceptions are permitted: Topical/inhaled steroids or short-term oral steroids (course lasting ≤ 14 days)
    6 History of primary malignancy (see protocol)
    7 History of thrombocytopenia and/or thrombosis, including participants who have experienced major venous and/or arterial thrombosis in combination with thrombocytopenia following vaccination with any COVID-19 vaccine
    8 History of heparin-induced thrombocytopenia, congenital thrombophilia (ie, factor V Leiden, prothrombin G20210A, antithrombin III deficiency, protein C deficiency and protein S deficiency, factor XIII mutation, familial dysfibrinogenemia), auto-immune thrombophilia (antiphospholipid syndrome, anti-cardiolipin antibodies, anti-β2- glycoprotein 1 antibodies), or paroxysmal nocturnal haemoglobinuria.
    9 Clinically significant bleeding (eg, factor deficiency, coagulopathy, or platelet disorder),
    or prior history of significant bleeding or bruising following intramuscular injections or venepuncture
    10 Severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal
    disease, liver disease, renal disease, endocrine disorder, or neurological illness, as judged
    by the Investigator (note, mild/moderate well-controlled comorbidities are allowed)
    11 Any other significant disease, disorder, or finding that may significantly increase the risk to the participant because of participation in the study, affect the ability of the participant to participate in the study, or impair interpretation of the study data
    12 Any autoimmune conditions, except mild psoriasis and vitiligo
    E.5 End points
    E.5.1Primary end point(s)
    Naďve unvaccinated cohort receiving a 2-dose primary vaccination and
    Previously vaccinated cohort receiving a 1-dose booster vaccination
    -Incidence of local and systemic solicited AEs for 7 days post-dose
    - Incidence of unsolicited AEs, including MAAEs, SAEs, and AESIs, for 28
    days post-dose
    -The change from baseline for safety laboratory measures for 28 days
    post-dose
    Immunogenicity endpoints:
    for Naďve unvaccinated cohort receiving a 2-dose primary vaccination
    -GMT ratio of pseudoneutralizing antibodies for AZD2816
    vaccination/AZD1222 Vaccination
    For Previously vaccinated cohort receiving a 1-dose booster vaccination:
    - GMT ratio of pseudoneutralizing antibodies for AZD2816
    booster/AZD1222 vaccination
    E.5.1.1Timepoint(s) of evaluation of this end point
    for 7 and 28 days post-dose
    for immunogenicity endpoints – 56 days post second dose or 28 days post booster
    E.5.2Secondary end point(s)
    - Incidence of local and systemic solicited AEs for 7 days post-dose
    - Incidence of unsolicited AEs, including MAAEs, SAEs, and AESIs for 28 days post-dose
    - Incidence of MAAEs, SAEs, and AESIs from Day 1 through 6 months post-vaccination

    Secondary immunogenicity endpoints:
    Both cohorts:
    - GMT ratio of pseudoneutralizing antibodies for B.1.351/Wuhan-hu-1
    - Difference in seroresponse (>4-fold increase from baseline in
    pseudoneutralizing antibodies) against B.1.351 versus Wuhan-hu-1
    Naďve unvaccinated cohort receiving a 2-dose primary vaccination
    - GMT ratio of pseudoneutralizing antibodies for AZD2816
    vaccination/AZD1222 vaccination
    -Difference in seroresponse (>4-fold increase from baseline in
    pseudoneutralizing antibodies) for AZD2816 vaccination - AZD1222
    vaccination
    - GMT ratio of pseudoneutralizing antibodies for AZD1222+AZD2816
    vaccination/AZD1222 vaccination
    -Difference in seroresponse (>4-fold increase from baseline in
    pseudoneutralizing
    antibodies) for AZD1222+AZD2816 vaccination - AZD1222 vaccination
    Previously vaccinated cohort receiving a 1-dose booster vaccination
    - GMT ratio of pseudoneutralizing antibodies for AZD2816
    booster/AZD1222 booster
    - GMT ratio of pseudoneutralizing antibodies for AZD1222
    booster/AZD1222 vaccination
    - GMT ratio of pseudoneutralizing antibodies for AZD2816
    booster/AZD1222 vaccination
    - Difference in seroresponse (>4-fold increase from baseline in
    pseudoneutralizing antibodies) for AZD2816 booster versus AZD1222
    primary vaccination
    -Difference in seroresponse (>4-fold increase from baseline in
    pseudoneutralizing antibodies) for AZD2816 booster versus AZD1222 booster
    E.5.2.1Timepoint(s) of evaluation of this end point
    for 7 and 28 days post-dose until 6 months post vaccination
    for immunogenicity objectives - 56 days post-dose (2nd dose), 28 days post booster
    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 No
    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 No
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial8
    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 EEA7
    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
    South Africa
    Brazil
    Poland
    United Kingdom
    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 of the last scheduled procedure shown in the Schedule of Activities (Section 1.3) for the last participant in the study globally.
    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 months7
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months11
    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: 2137
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 712
    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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state450
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1440
    F.4.2.2In the whole clinical trial 2849
    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 Decision2021-07-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-07-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-08-02
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