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    The EU Clinical Trials Register currently displays   43843   clinical trials with a EudraCT protocol, of which   7282   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:2021-003547-24
    Sponsor's Protocol Code Number:21CH134
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-06-30
    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 ConcernedFrance - ANSM
    A.2EudraCT number2021-003547-24
    A.3Full title of the trial
    Factors influencing the COVID-19 vaccine immune response (reactogenicity and immunogenicity) according to age and presence or not of a past history of COVID-19. COVIMMUNAGE study
    Etude des facteurs influençant la réponse immunitaire vaccinale COVID-19 (réactogénicité et immunogénicité) en fonction de l’âge et de la présence ou non d’un antécédent de COVID-19. Etude COVIMMUNAGE
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Factors influencing the COVID-19 vaccine immune response (reactogenicity and immunogenicity) according to age and presence or not of a past history of COVID-19. COVIMMUNAGE study
    Etude des facteurs influençant la réponse immunitaire vaccinale COVID-19 (réactogénicité et immunogénicité) en fonction de l’âge et de la présence ou non d’un antécédent de COVID-19. Etude COVIMMUNAGE
    A.3.2Name or abbreviated title of the trial where available
    COVIMMUNAGE
    COVIMMUNAGE
    A.4.1Sponsor's protocol code number21CH134
    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 SponsorCHU de Saint Etienne
    B.1.3.4CountryFrance
    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 supportCHU de Saint Etienne
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU Saint Etienne
    B.5.2Functional name of contact pointproject manager
    B.5.3 Address:
    B.5.3.1Street AddressURCIP - Batiment Recherche - Hôpital Nord
    B.5.3.2Town/ citySAINT ETIENNE CEDEX 2
    B.5.3.3Post code42055
    B.5.3.4CountryFrance
    B.5.4Telephone number147712028633
    B.5.5Fax number147712782033
    B.5.6E-mailarnauld.garcin@chu-st-etienne.fr
    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 COVID-19 mRNA Vaccine (nucleoside modified) - Pfizer BioNTech - Comirnaty
    D.2.1.1.2Name of the Marketing Authorisation holderBioNTech Manufacturing GmbH
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameComirnaty
    D.3.4Pharmaceutical form Concentrate for dispersion for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    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 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.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 Yes
    D.2.1.1.1Trade name COVID-19 Vaccine Moderna
    D.2.1.1.2Name of the Marketing Authorisation holderMODERNA BIOTECH SPAIN, S.L.
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameCOVID-19 Vaccine Moderna
    D.3.4Pharmaceutical form Concentrate for dispersion for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    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 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.IMP: 3
    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 COVID-19 mRNA Vaccine (nucleoside modified) - Pfizer BioNTech - Comirnaty
    D.2.1.1.2Name of the Marketing Authorisation holderBioNTech Manufacturing GmbH
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameComirnaty
    D.3.4Pharmaceutical form Concentrate for dispersion for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    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 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.IMP: 4
    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 COVID-19 Vaccine Moderna
    D.2.1.1.2Name of the Marketing Authorisation holderMODERNA BIOTECH SPAIN, S.L.
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameCOVID-19 Vaccine Moderna
    D.3.4Pharmaceutical form Concentrate for dispersion for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    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 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
    Volunteer
    Volontaire
    E.1.1.1Medical condition in easily understood language
    Volunteer
    Volontaire
    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 evaluate the temporal kinetics of the pre- and post-vaccine neutralizing systemic humoral immune response to SARS-CoV-2 in the convalescent and naïve groups and by type of vaccine used and according to age
    Evaluer la cinétique temporelle de la réponse immunitaire humorale systémique neutralisante pré et post vaccin anti- SARS-CoV-2 en fonction de l’âge dans le groupe des convalescents et dans le groupe des naïfs et selon le type de vaccin utilisé.
    E.2.2Secondary objectives of the trial
    1-Evaluate the temporal kinetics of the total systemic humoral immune response pre and post SARS-CoV-2 vaccine according to factors that may influence these kinetics (COVID-19 history and vaccine type and age)

    2-Evaluate the temporal kinetics of the mucosal humoral immune response before and after SARS-CoV-2 vaccine according to the factors that may influence these kinetics (history of COVID-19 and type of vaccine and age)

    3-Evaluate the temporal kinetics of the cellular immune response before and after the SARS-CoV-2 vaccine according to factors that may influence these kinetics (history of COVID-19 and type of vaccine, age)

    4-Evaluate the post-vaccine SARS-CoV-2 reactogenic inflammatory response according to the factors that may influence these kinetics (history of COVID-19 and type of vaccine, age )
    1-Evaluer la cinétique temporelle de la réponse immunitaire humorale systémique totale pré et post vaccin anti- SARS-CoV-2 en fonction des facteurs pouvant influencer cette cinétique (antécédent de COVID-19, âge et type de vaccin)

    2-Evaluer la cinétique temporelle de la réponse immunitaire humorale mucosale pré et post vaccin anti- SARS-CoV-2 en fonction des facteurs pouvant influencer cette cinétique (antécédent de COVID-19, âge et type de vaccin)

    3-Evaluer la cinétique temporelle de la réponse immunitaire cellulaire T et B pré et post vaccin anti- SARS-CoV-2 en fonction des facteurs pouvant influencer cette cinétique (antécédent de COVID-19, âge et type de vaccin)

    4-Evaluer la réponse inflammatoire réactogène post vaccin anti- SARS-CoV-2 en fonction des facteurs pouvant influencer cette cinétique (antécédent de COVID-19, âge et type de vaccin)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Volunteer aged ≥ 18 years-old
    - For the group WITH a past history of COVID-19 (convalescents) = subject within ≥ 3 months after infection
    - For the NO past history of COVID-19 (naives), subject with no known history of COVID-19
    - Patient affiliated or entitled to a social security plan
    - Patients who have received informed information about the study and who have co-signed a consent to participate in the study with the investigator
    - Volontaire âgé de 18 ans et plus
    - Pour le groupe AVEC antécédent de COVID-19 (convalescents) = sujet ayant été infectés depuis ≥ 3 mois avec diagnostic par PCR spécifique SARS-CoV-2 et épisode symptomatique (=fièvre plus de 48h)
    - Pour le groupe SANS antécédent de COVID-19 (naïfs), sujet sans antécédent de COVID-19 connu
    - Patient affilié ou ayant droit d’un régime de sécurité sociale
    - Patient ayant reçu une information éclairée sur l’étude et ayant co-signé, avec l’investigateur, un consentement de participation à l’étude
    E.4Principal exclusion criteria
    o Immunocompromised or under immunosuppressive treatment or with a pathology (chronic infections, autoimmune) that the investigator considers would impact on the immune response
    o Subject with a history of COVID hospitalized in intensive care
    o Subject allergic to one of the components of the vaccines used in the study
    o subject vaccinated for COVID-19
    o Subject with persistent symptoms of COVID-19 (long COVID)
    o Subjects with unstable chronic pathology
    o Persons deprived of liberty, hospitalized without consent, hospitalized for purposes other than research
    o Under guardianship or curatorship
    o Having received a vaccine in the last 30 days
    - Sujet immunodéprimé ou sous traitement immunosuppresseur ou ayant une pathologie (infections chronique, auto immune) dont l’investigateur considère qu’elle impacterait sur la réponse immunitaire
    - Sujet avec un antécédent de COVID hospitalisé en réanimation
    - Sujet allergique à un des composants des vaccins utilisés dans l’étude
    - sujet vacciné pour la COVID-19
    - sujet présentant des symptômes persistants de COVID-19 (COVID long) : symptômes durant plus de 3 mois après le diagnostic de COVID (anosmie, dysguesie, essoufflement…)
    - Sujet avec une pathologie chronique instable
    - Personnes privées de liberté, hospitalisées sans consentement, hospitalisées à d’autres fins que celles de la recherche
    - Personnes sous tutelle ou curatelle
    - Ayant reçu un vaccin (quelque qu’il soit) dans les 30 derniers jours
    E.5 End points
    E.5.1Primary end point(s)
    Anti-SARS-CoV-2 -specific neutralizing antibody
    Titre d’AC neutralisants anti S
    E.5.1.1Timepoint(s) of evaluation of this end point
    at inclusion, 15 days, 3, 6 and 12 months post last vaccination
    at inclusion, 15 days, 3, 6 and 12 months post last vaccination
    E.5.2Secondary end point(s)
    1- Anti-SARS-CoV-2 antibody - Spike and Nucleocapsid (ELISA test)

    2- Anti-SARS-CoV-2 - IgA antibody in saliva

    3- Cellular response evaluated by SARS-CoV-2 quantiferon value and TruCulture method (Myriad)

    4- Expression kinetics in foldchange

    5- Biophysical (glycosylation, avidity, isotopes) and functional characteristics of antibodies anti-S
    1- Titre d’AC anti-S et anti-N déterminés par ELISA .

    2- Titre d’IgA anti SARS-CoV-2 dans la salive.

    3- La réponse cellulaire sera évaluée par la valeur du quantiferon SARS-CoV-2 et par le méthode Truculture (Myriad).

    4- Cinétique d’expression (à l’inclusion et à 24h et 72h après chaque dose de vaccin) en foldchange (transcriptomique) des signatures de gènes induits par la vaccination dans les cellules mononuclées du sang périphérique et taux de cytokines sériques à l’inclusion, 24h et 72h après chaque dose de vaccin.

    5- Caractéristiques biophysiques (glycosylation, avidité, isotopes) et fonctionnelles (test des activités médiées par la partie Fc des Ac) d’AC anti-S.
    E.5.2.1Timepoint(s) of evaluation of this end point
    at inclusion, 15 days, 3, 6 and 12 months post last vaccination
    at inclusion, 15 days, 3, 6 and 12 months post last 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 No
    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 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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    cohorte
    cohort
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    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 concerned2
    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 No
    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 trial is the end of all immunological analysis.
    Date de la fin des analyses immunologiques.
    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 months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    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: 150
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2021-06-30. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women Yes
    F.3.3.4Nursing women Yes
    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 state200
    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
    Aucun
    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 Decision2021-07-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-08-25
    P. End of Trial
    P.End of Trial StatusOngoing
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