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    Summary
    EudraCT Number:2020-005720-11
    Sponsor's Protocol Code Number:VAC31518COV3006
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2021-04-22
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2020-005720-11
    A.3Full title of the trial
    A Randomized, Double-blind, Placebo-controlled, Phase 2/3 Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Different Dose Levels of Ad26.COV2.S Administered as a Two-dose Regimen Followed by a Booster in Healthy Children From Birth to 17 Years Inclusive When Compared to the Administration of One- and Two-doses of Ad26.COV2.S (in a Two-dose Regimen) in Healthy Adults Aged 18 to 55 Years Inclusive
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2/3 Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Different Dose Levels of Ad26.COV2.S in Healthy Children From Birth to 17 Years Inclusive When Compared to the Administration of One- and Two-doses of Ad26.COV2.S in Healthy Adults Aged 18 to 55 Years Inclusive
    A.3.2Name or abbreviated title of the trial where available
    HORIZON 2
    A.4.1Sponsor's protocol code numberVAC31518COV3006
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/059/2021
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorJanssen Vaccines & Prevention B.V.
    B.1.3.4CountryNetherlands
    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.4.2CountryNetherlands
    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
    B.5.3.4CountryNetherlands
    B.5.6E-mailClinicalTrialsEU@its.jnj.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 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 number100
    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 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
    1. To assess the safety and reactogenicity of 2 dose levels of Ad26.COV2.S (2.5x10^10 vp and 5x10^10 vp) or placebo administered IM as a 2-dose regimen (56-day interval) in children, from the first vaccination until 6 months post-dose 2.
    2. To assess the humoral immune response of 2 dose levels of Ad26.COV2.S (2.5x10^10 vp [children] and 5x10^10 vp [adults and children]) or placebo administered IM as a 2-dose regimen (56 day interval) [children].
    3. To demonstrate NI of immune responses induced by 1 dose (dose 1 of the 2-dose regimen) of Ad26.COV2.S 5x10^10 vp in children (by age group)a vs 1 dose of Ad26.COV2.S 5x10^10 vp in adults.
    4. To demonstrate NI of immune responses induced by 2 doses of Ad26.COV2.S 5x10^10 vp in children (by age group)a vs 1 dose of Ad26.COV2.S 5x10^10 vp in adults
    E.2.2Secondary objectives of the trial
    1. To continue to assess the safety and reactogenicity of 2 dose levels of Ad26.COV2.S (2.5x10^10 vp and 5x10^10 vp) (including a booster dose at 12 months post-dose 2, if applicable) in children, from 6 months post-dose 2 until the end of the study.
    2. To assess the humoral immune response of a booster dose of Ad26.COV2.S at 2 dose levels (2.5x10^10 vp or 5x10^10 vp) or placebo, administered in children who received the active primary vaccine regimen, 12 months after the first vaccination.
    3. To assess the safety and reactogenicity of 1 dose level of Ad26.COV2.S (5x10^10 vp) administered IM as a 2-dose regimen (56-day interval) in adults.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Adults:
    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, as confirmed bymedical history, physical examination, and vital signs performed at screening, and must nothave comorbidities related to an increased risk of severe COVID-19
    4. Contraceptive (birth control) use by a participant of childbearing potential should beconsistent with local regulations regarding the acceptable methods of contraception forthose participating in clinical studies.
    5. Participant agrees to not donate bone marrow, blood, and blood products from the firststudy vaccine administration until 3 months after receiving the last dose of study vaccine.

    Children:
    1. Participant’s age is <18 years of age at the time of first vaccination.
    2. Participant was born at ≥37 weeks gestation with a minimum birth weight of 2.5 kg (only applicable for infants and children <2 years of age).
    3. Participant must be healthy, 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.
    4. Contraceptive (birth control) use by a participant of childbearing potential 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
    Adults:
    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, history of anaphylaxis, or other serious adverse reactions, related to vaccines or their excipients (including specifically the excipients of the study vaccine) (refer to the IB Ad26.COV2.S 2020).
    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) 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. Use of systemic corticosteroids at an immunosuppressive dose (treatment duration more than 14 days for one course or recurrent use) within 6 months before administration of study vaccine and during the study is disallowed.
    b.Administration of antineoplastic and immunomodulating agents or radiotherapy within 6 months before the planned administration of the first dose of study vaccine and during the study.
    5.Participant has a history of seizures, with the exception of febrile seizures during childhood, Guillain-Barré syndrome, or an actively evolving neurological disorder
    6.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
    7.Participant is pregnant, breastfeeding, or planning to become pregnant within 3 months after the last dose of study vaccine.
    8.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.
    9.Participant had surgery requiring hospitalization (defined as inpatient stay for longer than 24 hours or overnight stay), within 12 weeks before planned first study 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.
    10.Participant has a contraindication to IM injections and blood draws eg, bleeding disorders
    11.Participant has chronic active hepatitis B or hepatitis C infection per medical history.
    12.Participant previously received a coronavirus vaccine.
    Children:
    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, bone marrow transplant, or solid organ transplant within 5 years before screening.
    3.Participant has a known or suspected allergy, history of anaphylaxis, or other serious adverse reactions, related to vaccines or their excipients (including specifically the excipients of the study vaccine) (refer to the IB Ad26.COV2.S 2020).
    4.Use of systemic corticosteroids at an immunosuppressive dose (treatment duration more than 14 days for one course or recurrent use) within 6 months before administration of study vaccine and during the study
    5.Any serious, chronic, or progressive disease (eg, diabetes, cardiac disease, hepatic disease, progressive neurological disease or seizure disorder; autoimmune disease, HIV infection or AIDS, blood dyscrasias, bleeding diathesis, signs of cardiac or renal failure, or severe malnutrition, neonates with congenital anomalies)
    6.Participant has extreme obesity (BMI ≥35)
    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

    Please refer to the protocol for more criteria
    E.5 End points
    E.5.1Primary end point(s)
    •Solicited local and systemic AEs for 7 days post-dose 1 and 2.
    •Unsolicited AEs for 28 days post-dose 1 and 2.
    •MAAEs from the first vaccination until 6 months post-dose 2.
    •SAEs (incl. MIS-C) from the first vaccination until 6 months post-dose 2.
    •Serological response to vaccination as measured by enzyme-linked immunosorbent assay (ELISA; [S ELISA, EU/mL]), 28 days post-dose 1 and 2.
    •Antibody geometric mean concentration (GMCs, S-ELISA), 28 days post-dose 1 and 2.
    •Serological response to vaccination as measured by ELISA (S-ELISA, EU/mL), 28 days post dose 1 (children) and 28 days post-dose 1 or 2 (adults).
    •NI will be demonstrated in terms of humoral immune response expressed by the GMCs of ELISA, 28 days post-dose 1 in children and 28 days post-dose 1 or 2 in adults, using an NI margin of 2/3 for the GMC ratio (GMC childrena/GMC adults).
    •Serological response to vaccination as measured by ELISA (S-ELISA, EU/mL), 28 days post-dose 2 (children) and 28 days post-dose 1 or 2 (adults).
    •NI will be demonstrated in terms of humoral immune response expressed by the GMCs of ELISA, 28 days post-dose 2 in children and 28 days post-dose 1 or 2 in adults, using an NI margin of 2/3 for the GMC ratio (GMC childrena/GMC adults).
    E.5.1.1Timepoint(s) of evaluation of this end point
    day 7, day 28 and until 6 months post-dose 2
    SAEs throughout the entire study
    E.5.2Secondary end point(s)
    •Solicited local and systemic AEs for 7 days after the booster vaccination for children in the active vaccine groups and for 7 days after dose 3 and dose 4 for children in the placebo groups.
    •Unsolicited AEs for 28 days after the booster vaccination for children in the active vaccine groups and for 28 days after dose 3 and dose 4 for children in the placebo groups.
    •MAAEs from the booster vaccination until 6 months after the booster vaccination for children in the active vaccine groups and from dose 3 until 6 months after dose 4 for children in the placebo groups
    •MAAEs leading to study discontinuation from 6 months post-dose 2 until the end of study.
    •SAEs (incl. MIS-C) from 6 months post-dose 2 until end of the study.
    •Serological response to vaccination as measured by ELISA (S-ELISA, EU/mL), 28 days after the booster vaccination.
    •Antibody GMCs (S ELISA), 7 and 28 days after the booster vaccination.
    •Solicited local and systemic AEs for 7 days post-dose 1 and 2.
    •Unsolicited AEs for 28 days post-dose 1 and 2.
    •MAAEs from first vaccination until 6 months post-dose 2.
    •MAAEs leading to study discontinuation during the entire study.
    •SAEs during the entire study.
    E.5.2.1Timepoint(s) of evaluation of this end point
    day 7, day 28 and until 6 months post-dose 2
    SAEs throughout the entire study
    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 Yes
    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
    Reactogenicity and 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 trial19
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    Argentina
    Australia
    Brazil
    Canada
    Colombia
    Finland
    Italy
    Mexico
    Poland
    South Africa
    Spain
    Sweden
    Turkey
    United Kingdom
    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
    LSLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months5
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 3425
    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) Yes
    F.1.1.3.1Number of subjects for this age range: 225
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 1200
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 1200
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 800
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 250
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    subjects under 18 years
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 3675
    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)
    NA
    G. Investigator Networks to be involved in the Trial
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: Turkey
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