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    The EU Clinical Trials Register currently displays   40666   clinical trials with a EudraCT protocol, of which   6638   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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    EudraCT Number:2020-005801-14
    Sponsor's Protocol Code Number:VAC31518COV3003
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-12-30
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2020-005801-14
    A.3Full title of the trial
    A Randomized, Double-blind, Placebo-Controlled Phase 3 Study to Evaluate 3 Dose Levels of Ad26.COV2.S Administered As Single-Dose And Two-Dose Schedules in Healthy Adults
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 3 Study to Evaluate 3 Dose Levels of Ad26.COV2.S Administered As Single-Dose And Two-Dose Schedules in Healthy Adults
    A.4.1Sponsor's protocol code numberVAC31518COV3003
    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 SponsorJanssen Vaccines & Prevention B.V.
    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 supportJanssen Vaccines & Prevention B.V.
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen Research & Development
    B.5.2Functional name of contact pointClinical Registry Group
    B.5.3 Address:
    B.5.3.1Street AddressArchimedesweg 20
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333 CM
    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 nameAd26.COV2.S
    D.3.2Product code VAC31518
    D.3.4Pharmaceutical form Suspension 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 codeVAC31518
    D.3.9.3Other descriptive nameAd26.COV2.S
    D.3.9.4EV Substance CodeSUB208328
    D.3.10 Strength
    D.3.10.1Concentration unit billion organisms/ml billion organisms/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 Yes
    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
    Healthy Volunteers (Prevention of SARS-CoV-2-mediated COVID-19)
    E.1.1.1Medical condition in easily understood language
    Healthy Volunteers (Prevention of COVID-19)
    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
    To demonstrate non-inferiority (NI) in the following sequential order:
    •NI after 1-dose of Ad26.COV2.S 2.5x10^10 vp vs 1-dose of Ad26.COV2.S 5x10^10 vp (release titer)
    •NI after 1 dose of Ad26.COV2.S 1.25x10^10 vp vs 1-dose of Ad26.COV2.S 5x10^10 vp (release titer)
    To demonstrate the following in sequential order:
    •NI after 2-doses of Ad26.COV2.S 2.5x10^10 vp vs 1 dose of Ad26.COV2.S 5x10^10 vp (release titer)
    •NI after 2-doses of Ad26.COV2.S 2.5x10^10 vp vs 2-doses of Ad26.COV2.S 5x10^10 vp (release titer)
    •NI after 2-doses of Ad26.COV2.S 1.25x10^10 vp vs 1-dose of Ad26.COV2.S 5x10^10 vp (release titer)
    •NI after 2-doses of Ad26.COV2.S 1.25x10^10 vp vs 2-doses of Ad26.COV2.S 5x10^10 vp (release titer)
    E.2.2Secondary objectives of the trial
    1.To assess the humoral immune response to Ad26.COV2.S across all groups, at all blood collection timepoints.
    2.To assess the seroconversion rate to 1 dose or 2 doses of Ad26.COV2.S across all groups, at all blood collection timepoints.
    3.To assess the safety and reactogenicity of Ad26.COV2.S administered at several dose levels, as a 2-dose or a 1-dose regimen.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Participant is 18 to 55 years of age, inclusive, on the day of signing the ICF.
    2.Participant must have a BMI <30.0 kg/m2.
    3.Participant must be healthy, in the investigator’s clinical judgment, as confirmed by medical history, physical examination, and vital signs performed at screening, and must not have comorbidities related to an increased risk of severe COVID-19, except for smoking, which is allowed.Participant may have underlying illnesses, as long as the symptoms and signs are medically controlled and not considered to be comorbidities related to an increased risk of severe COVID-19 , except for smoking, which is allowed. If on medication for a condition, the medication dose must have been stable for at least 12 weeks preceding vaccination and expected to remain stable for the duration of the study. Participant will be included on the basis of physical examination, medical history, and vital signs.
    4.Contraceptive (birth control) use should be consistent with local regulations regarding the acceptable methods of contraception for those participating in clinical studies.
    5.Participant agrees to not donate bone marrow, blood, and blood products from the first study vaccine administration until 3 months after receiving the last dose of study vaccine.
    E.4Principal exclusion criteria
    1.Participant has a clinically significant acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection) or temperature ≥38.0ºC (100.4°F) within 24 hours prior to the planned first dose of study vaccine; randomization at a later date is permitted at the discretion of the investigator and after consultation with the sponsor.
    2.Participant has a history of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which is considered cured with minimal risk of recurrence).
    3.Participant has a known or suspected allergy or history of anaphylaxis or other serious adverse reactions to vaccines or their excipients (including specifically the excipients of the study vaccine).
    4.Participant has abnormal function of the immune system resulting from:
    a.Clinical conditions (eg, autoimmune disease, potential immune mediated disease or known or suspected immunodeficiency, chronic kidney disease [with dialysis]) expected to have an impact on the immune response of the study vaccine. Participants with clinical conditions stable under non-immunomodulator treatment eg, autoimmune thyroiditis, autoimmune inflammatory rheumatic disease such as rheumatoid arthritis) may be enrolled at the discretion of the investigator. Non-immunomodulator treatment is allowed as well as steroids at a non-immunosuppressive dose or route of administration.
    b.Chronic (>10 days) or recurrent use of systemic corticosteroids within 6 months before administration of study vaccine and during the study.
    Note: Ocular, topical or inhaled steroids are allowed.
    c.Administration of antineoplastic and immunomodulating agents or radiotherapy within 6 months before administration of study vaccine and during the study.
    5.Participant has a history of any neurological disorders or seizures including Guillain-Barré syndrome, with the exception of febrile seizures during childhood.
    6.Participant has a history of chronic urticaria (recurrent hives), eczema or adult atopic dermatitis.
    7.Participant received treatment with immunoglobulins in the 3 months or blood products in the 4 months before the planned administration of the first dose of study vaccine or has any plans to receive such treatment during the study.
    8.Participant received or plans to receive:
    c.Licensed live attenuated vaccines – within 28 days before or after planned administration of the first or subsequent study vaccinations
    d.Other licensed (not live) vaccines – within 14 days before or after planned administration of the first or subsequent study vaccinations.
    9.Participant received an investigational drug or used an invasive investigational medical device within 30 days or received an investigational vaccine within 6 months before the planned administration of the first dose of study vaccine or is currently enrolled or plans to participate in another investigational study during the course of this study, including receipt of any investigational agent for prophylaxis of COVID-19.
    10.Participant is a woman who is pregnant or planning to become pregnant within 3 months after the last dose of study vaccine.
    11.Participant has a history of an underlying clinically significant acute or chronic medical condition or physical examination findings for which, in the opinion of the investigator, participation would not be in the best interest of the participant (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.
    12.Participant had surgery requiring hospitalization (defined as inpatient stay for longer than 24 hours or overnight stay), within 12 weeks before vaccination, or will not have fully recovered from surgery requiring hospitalization, or has surgery requiring hospitalization planned during the time the participant is expected to participate in the study or within 6 months after the last dose of study vaccine administration.
    13.Participant has a contraindication to IM injections and blood draws eg, bleeding disorders.
    15.Participant has chronic active hepatitis B or hepatitis C infection per medical history.
    E.5 End points
    E.5.1Primary end point(s)
    •Binding antibody concentrations to SARS CoV-2 S protein as measured by ELISA 28 days after vaccination
    •NI will be demonstrated in terms of humoral immune response expressed by the GMCs of S-ELISA, 28 days post-dose 1, using a NI margin of 2/3 for the GMC ratio (GMC 2.5x1010 [or 1.25x1010 vp]/GMC 5x1010 vp)
    •Binding antibody concentrations to SARS CoV-2 S protein as measured by ELISA 28 days after vaccination 2
    •NI will be demonstrated in terms of humoral immune response expressed by the GMCs of S-ELISA, 28 days post-dose 2 (2.5x1010 vp or 1.25x1010 vp) and 28 days post-dose 1 or 2 (5x1010 vp), using a NI margin of 2/3 for the GMC ratio (GMC 2.5x1010 [or 1.25x1010 vp]/GMC 5x1010 vp)
    E.5.1.1Timepoint(s) of evaluation of this end point
    28 days after vaccination
    E.5.2Secondary end point(s)
    •Binding antibody concentrations to SARS CoV-2 S protein as measured by ELISA
    •Antibody GMCs (S-ELISA)
    •The proportion of subjects achieving seroconversion of serum antibody against the SARS-CoV-2 S protein by S-ELISA
    •Solicited local and systemic AEs for 7 days after each vaccination
    •Unsolicited AEs for 28 days after each vaccination
    •SAEs throughout the study (from first vaccination until end of the study)
    •MAAEs (until 6 months post vaccination)
    •MAAEs leading to study discontinuation (during the entire study) for all participants following vaccination
    E.5.2.1Timepoint(s) of evaluation of this end point
    until 6 months post vaccination
    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 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 and end of shelf life
    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. 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 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 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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA19
    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
    United States
    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
    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 months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    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: 1450
    F.1.3Elderly (>=65 years) No
    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. 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 state570
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 700
    F.4.2.2In the whole clinical trial 1450
    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)
    At the end of the study, participants who received placebo may be offered the Ad26.COV2.S study vaccine at no cost when the vaccine has been shown to be safe and efficacious, and preferably also after the duration of protection has been determined. This will occur in accordance with local and national regulations and in consultation with the responsible national authorities.
    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 Decision2021-02-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-01-12
    P. End of Trial
    P.End of Trial StatusOngoing
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
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