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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:2021-006754-31
    Sponsor's Protocol Code Number:80101
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-02-10
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2021-006754-31
    A.3Full title of the trial
    Establishing immunogenicity and safety of needle-free intradermal delivery by nanoporous ceramic skin patch of mRNA SARS-CoV-2 vaccine as a revaccination strategy in healthy volunteers
    Onderzoeken van de immunogeniciteit en veiligheid van intradermale vaccinatie met een keramische huid patch waar mRNA SARS-CoV-2 vaccin op geladen is, als revaccinatie-strategie in gezonde vrijwilligers
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and immunological response against SARS-CoV-2 after revaccination with mRNA-1273 with a ceramic skin patch
    Veiligheid en afweerrespons tegen SARS-CoV-2 na revaccinatie met mRNA-1273 met een keramische huid patch
    A.3.2Name or abbreviated title of the trial where available
    MILESTONE: iMmunogenicity IntradermaL cEramic Skin paTch sars-cOv-2 vacciNE
    MILESTONE: Immunogeniciteit van intradermale SARS-CoV-2 vaccin toediening met een keramische huid pa
    A.4.1Sponsor's protocol code number80101
    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 SponsorLeiden University Medical Center
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportLeiden University Medical Center
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportMyLifeTechnologies
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLeiden University Medical Center
    B.5.2Functional name of contact pointLG Visser
    B.5.3 Address:
    B.5.3.1Street AddressAlbinusdreef 2, C5
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333 ZA
    B.5.3.4CountryNetherlands
    B.5.4Telephone number31715262613
    B.5.6E-maill.g.visser@lumc.nl
    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 Spikevax
    D.2.1.1.2Name of the Marketing Authorisation holderMODERNA BIOTECH SPAIN, S.L.
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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.3.4Pharmaceutical form Concentrate for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    Intramuscular use
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Safety and immunogenicity after revaccination with Spikevax in healthy adults who have received Comirnaty as a primary vaccine
    Veiligheid en immunogeniciteit van revaccinatie met Spikevax bij gezonde proefpersonen die de primaire vaccinatie serie met Comirnaty hebben gehad
    E.1.1.1Medical condition in easily understood language
    healthy persons
    gezonde proefpersonen
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Study safety and immunogenicity against SARS-CoV-2 after revaccination with Spikevax in fractional doses and with a skin patch
    Onderzoeken van veiligheid en immunogeniciteit tegen SARS-CoV-2 na revaccinatie met Spikevax in kleine doses en met behulp van een huid patch
    E.2.2Secondary objectives of the trial
    cellular immunity (B-cell and IGRA) after revaccination with Spikevax in fractional doses
    cellulaire immuniteit (B-cel en IGRA) na revaccinatie met Spikevax in kleinere doses
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    age 18-40
    primary vaccination series with Comirnaty
    healthy
    not immunocompromised
    not pregnant
    leeftijd 18-40
    primaire vaccinatie serie met Comirnaty
    gezond
    niet immuungecompromitteerd
    niet zwanger
    E.4Principal exclusion criteria
    having had covid-19 (anti-N and PCR)
    having received a covid-19 booster
    use of corticosteroids (systemic of topical)
    use of other immunesuppressants
    doorgemaakte covid-19 (anti-N en PCR)
    eerder een covid-19 booster gehad
    gebruik van corticosteroïden (systemisch of topical)
    gebruik van ander immuunsuppresiva
    E.5 End points
    E.5.1Primary end point(s)
    - Safety of intradermal vaccination with ceramic skin patch with Spikevax, compared to a similar dose intramuscularly
    - Antibody response after intradermal vaccination with ceramic skin patch with Spikevax, compared to a similar dose intramuscularly
    - veiligheid van intradermale vaccinatie van Spikevax met behulp van een keramische huid patch, vergeleken met dezelfde dosis intramusculair toegediend
    - antistofrespons na intradermale vaccinatie van Spikevax met behulp van een keramische huid patch, vergeleken met dezelfde dosis intramusculair toegediend
    E.5.1.1Timepoint(s) of evaluation of this end point
    Dx = screening for eligibility
    D1 = vaccination
    D15 = adverse event diary, immune response monitoring
    D29 = immune response monitoring
    M6 = final contact for SAE
    Dx = screening voor geschiktheid van deelname
    D1 = vaccinatie
    D15 = einde bijwerking dagboekje, immuunrespons monitoring
    D29 = immuunrespons monitoring
    M6 = laatste contact voor SAE
    E.5.2Secondary end point(s)
    cellular immunity (B-cell and IGRA) after revaccination with Spikevax in fractional doses
    cellulaire immuniteit (B-cel en IGRA) na revaccinatie met Spikevax in kleinere doses
    E.5.2.1Timepoint(s) of evaluation of this end point
    D1 = vaccination
    D29 = immune response monitoring
    D1 = vaccinatie
    D29 = immuunrespons monitoring
    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 Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    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) No
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.3.1Comparator description
    Spikevax - mRNA-1273 vaccine
    Spikevax - mRNA-1273 vaccine
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    LVLS
    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 months9
    E.8.9.1In the Member State concerned days
    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: 20
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state20
    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
    Geen
    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 Decision2022-02-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-03-22
    P. End of Trial
    P.End of Trial StatusOngoing
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