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    Summary
    EudraCT Number:2021-001978-37
    Sponsor's Protocol Code Number:CombiVacS
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-05-06
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2021-001978-37
    A.3Full title of the trial
    A Phase 2, Comparative, Randomised, Adaptive Trial to Evaluate the safety and immunogenicity of one dose of COMIRNATY in subjects that had received one dose of VAXZEVRIA.
    Ensayo clínico de Fase II, comparativo, aleatorizado , adaptativo para evaluar la seguridad e immunogenicidad de una dosis de COMINARTY en sujetos que hayan recibido una dosis de VAXZERIA.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2, Comparative, Randomised, Adaptive Trial to Evaluate the safety and immunogenicity of one dose of COMIRNATY in subjects that had received one dose of VAXZEVRIA.
    Ensayo clínico de Fase II, comparativo, aleatorizado , adaptativo para evaluar la seguridad e immunogenicidad de una dosis de COMINARTY en sujetos que hayan recibido una dosis de VAXZERIA.
    A.3.2Name or abbreviated title of the trial where available
    CombiVacS
    CombiVacS
    A.4.1Sponsor's protocol code numberCombiVacS
    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 SponsorInstituto de Salud Carlos III. ISCIII
    B.1.3.4CountrySpain
    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 supportISCIII
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital Universitario La Paz
    B.5.2Functional name of contact pointAlberto M. Borobia
    B.5.3 Address:
    B.5.3.1Street AddressPaseo de la Castellana 261
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code280046
    B.5.3.4CountrySpain
    B.5.4Telephone number+34912071466
    B.5.5Fax number912071466
    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 COMIRNATY. Concentrado para dispersión inyectable
    D.2.1.1.2Name of the Marketing Authorisation holderBioNTech Manufacturing GmbH
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 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 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 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
    Covid-19 Vaccination
    Vacunación Covid-19
    E.1.1.1Medical condition in easily understood language
    Covid-19 Vaccination
    Vacunación Covid-19
    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
    Primary Immunogenicity Objective: To assess the humoral immune response against SARS-Cov-2, 14 days after a vaccination with COMIRNATY in subjects that received a previous single dose of VAXZEVRIA, as compared with dosing, in SARS-Cov2 seronegative adults.
    Primary Safety Objectives:To evaluate the safety of a dose of COMIRNATY in subjects that received a previous single dose of VAXZEVRIA in subject aged more than 18 years and in good health or stable clinical situation that have received a previous single dose of VAXZEVRIA.
    A stratification will be made taking into account: site of vaccination, sex and age. Subjects will be randomized in a proportion of 2:1. If primary analysis at 14 days confirms the starting hypothesis, subjects randomized to no vaccination will be crossed to receive a dose of COMINARTY. In case the primary analysis does not confirm the starting hypothesis, subjects will be followed without administration of COMINARTY.
    Objetivo primario Inmunogenicidad: Evaluar la respuesta inmune humoral contra el SARS-Cov-2, 14 días después de una vacunación con COMIRNATY en sujetos que recibieron una dosis única previa de VAXZEVRIA, en comparación con la dosificación, en adultos seronegativos al SARS-Cov2.
    Objetivos primarios de seguridad: Evaluar la seguridad de una dosis de COMIRNATY en sujetos que recibieron una dosis única previa de VAXZEVRIA en mayores de 18 años y buen estado de salud o situación clínica estable que han recibido una dosis única previa de VAXZEVRIA.
    Se hará una estratificación teniendo en cuenta: lugar de vacunación, sexo y edad. Los sujetos serán asignados al azar en una proporción de 2: 1. Si el análisis primario a los 14 días confirma la hipótesis inicial, los sujetos asignados al azar a ninguna vacunación se cruzarán para recibir una dosis de COMINARTY. En caso de que el análisis primario no confirme la hipótesis de partida, los sujetos serán seguidos sin la administración de COMINARTY
    E.2.2Secondary objectives of the trial
    Secondary immunogenicity objectives:
    To assess the humoral immune response against SARS-Cov-2, 28 days after a vaccination with COMIRNATY in subjects that received a previous single dose of VAXZEVRIA.
    To assess the long-term (up to 1 year) humoral immune response against SARS-Cov-2 of a dose of COMIRNATY in subjects that received a previous single dose of VAXZEVRIA.
    Exploratory objective:Evaluate the relationship between the immune response measured as NAV (Neutralizing antibodies) and antibodies against SARS-Cov2 spike protein measured by immunoassay.
    To assess the humoral immune response against viral variants of SARS-Cov-2, 14 and 28 days after a dose of COMIRNATY in subjects that received a previous single dose of VAXZEVRIA.
    Secondary efficacy objectives: To assess the occurrence of symptomatic molecularly confirmed COVID-19 and severity of COVID-19 signs and symptoms after the administration of a dose of COMIRNATY in subjects that received a prior single dose of VAXZEVRIA.
    Objetivos secundarios de inmunogenicidad:
    Evaluar la respuesta inmune humoral frente al SARS-Cov-2, 28 días después de una vacunación con COMIRNATY en sujetos que recibieron una dosis única previa de VAXZEVRIA.
    Evaluar la respuesta inmune humoral a largo plazo (hasta 1 año) frente al SARS-Cov-2 de una dosis de COMIRNATY en sujetos que recibieron una dosis única previa de VAXZEVRIA.
    Evaluar la respuesta inmune humoral frente a variantes virales de SARS-Cov-2, 14 y 28 días después de una dosis de COMIRNATY en sujetos que recibieron una dosis única previa de VAXZEVRIA.
    Objetivos secundarios de eficacia: Evaluar la aparición de COVID-19 sintomático confirmado molecularmente y la gravedad de los signos y síntomas de COVID-19 después de la administración de una dosis de COMIRNATY en sujetos que recibieron una dosis única previa de VAXZEVRIA. Objetivo exploratorio: Evaluar relación entre respuesta inmune medida como NAV y los ac contra la spike SARS-Cov2 medida por inmunoensayo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Adult subjects (18 years old) having received a previous single dose of VAXZEVRIA vaccination between 8 and 12 weeks before the screening visit.
    2. Subjects in good health or stable clinical situation.
    3. Subject providing informed consent to participate in the trial.
    1. Sujetos adultos (18 años) que hayan recibido una dosis única previa de la vacuna VAXZEVRIA entre 8 y 12 semanas antes de la visita de selección.
    2. Sujetos en buen estado de salud o situación clínica estable.
    3. Sujeto que proporciona su consentimiento informado para participar en el ensayo.
    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 within 24 hours prior to the planned dose of study vaccine.
    2. Participant has a known or suspected allergy or history of anaphylaxis or other serious adverse reactions to COMINARTY excipients.
    3. Subjects have symptoms or signs compatible with COVID19
    1. El participante tiene una enfermedad aguda clínicamente significativa (esto no incluye enfermedades menores como diarrea o infección leve del tracto respiratorio superior) o temperatura ≥38.0oC dentro de las 24 horas previas a la dosis planificada de la vacuna del estudio.
    2. El participante tiene una alergia conocida o sospechada o antecedentes de anafilaxia u otras reacciones adversas graves a los excipientes de COMINARTY.
    3. Los sujetos tienen síntomas o signos compatibles con COVID19
    E.5 End points
    E.5.1Primary end point(s)
    Primary immunogenicity end-point:
    Serological response to vaccination (antibodies against SARS-Cov2 spike protein) as measured by immunoassay, 14 days after the boost dose.
    Primary safety end-points:
    Solicited local and systemic adverse events (AEs) for 7 days after vaccine
    Unsolicited local and systemic adverse events (AEs) for 28 days after vaccine
    Serious adverse events (SAEs) throughout the study (from randomization until end of the study).
    Medically-attended adverse events (MAAEs) from the day of vaccination until 6 months after the last vaccination.
    Criterio de valoración de la inmunogenicidad primaria:
    Respuesta serológica a la vacunación (anticuerpos contra la proteína de pico SARS-Cov2) medida por inmunoensayo, 14 días después de la dosis de refuerzo.
    Criterios de valoración de seguridad primarios:
    Eventos adversos (EA) locales y sistémicos solicitados durante 7 días después de la vacuna
    Eventos adversos (EA) locales y sistémicos no solicitados durante 28 días después de la vacuna
    Eventos adversos graves (AAG) a lo largo del estudio (desde la aleatorización hasta el final del estudio).
    Eventos adversos atendidos médicamente (MAAE) desde el día de la vacunación hasta los 6 meses después de la última vacunación.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Primary immunogenicity end-point:14 days after the boost dose.
    Primary safety end-points:
    Solicited local and systemic adverse events (AEs) for 7 days after vaccine
    Unsolicited local and systemic adverse events (AEs) for 28 days after vaccine
    Serious adverse events (SAEs) throughout the study (from randomization until end of the study).
    Medically-attended adverse events (MAAEs) from the day of vaccination until 6 months after the last vaccination.
    Criterio de valoración de la inmunogenicidad primaria:14 días después de la dosis de refuerzo.
    Criterios de valoración de seguridad primarios:
    Eventos adversos (EA) locales y sistémicos solicitados durante 7 días después de la vacuna
    Eventos adversos (EA) locales y sistémicos no solicitados durante 28 días después de la vacuna
    Eventos adversos graves (AAG) a lo largo del estudio (desde la aleatorización hasta el final del estudio).
    Eventos adversos atendidos médicamente (MAAE) desde el día de la vacunación hasta los 6 meses después de la última vacunación.:
    E.5.2Secondary end point(s)
    Secondary immunogenicity end-point:
     Serological response to vaccination (antibodies against SARS-Cov2 spike protein) as measured by immunoassay, 28 days after the boost dose.
     SARS-CoV-2 neutralization as measured by virus neutralization assay, 14 and 28 days after the boost dose.
     Serological response to vaccination (antibodies against SARS-Cov2 spike protein) as measured by immunoassay at 3, 6 and 12months after the boost dose.
     Neutralizing antibody titers at 3, 6 and 12 months after the boost dose.
    Secondary efficacy end-points:
     The number of participants with molecularly confirmed COVID-19.
     Presence and severity of COVID-19 signs and symptoms as measured by Symptoms of
    Infection with Coronavirus-19 (SIC).
    Criterio de valoración secundario de la inmunogenicidad:
     Respuesta serológica a la vacunación (anticuerpos contra la proteína de pico del SARS-Cov2) medida por inmunoensayo, 28 días después de la dosis de refuerzo.
     Neutralización del SARS-CoV-2 medida por el ensayo de neutralización del virus, 14 y 28 días después de la dosis de refuerzo.
     Respuesta serológica a la vacunación (anticuerpos contra la proteína de pico del SARS-Cov2) medida por inmunoensayo a los 3, 6 y 12 meses después de la dosis de refuerzo.
     Títulos de anticuerpos neutralizantes a los 3, 6 y 12 meses después de la dosis de refuerzo.
    Criterios de valoración secundarios de la eficacia:
     El número de participantes con COVID-19 confirmado molecularmente.
     Presencia y gravedad de los signos y síntomas de COVID-19 según la medición de Síntomas de
    Infección por Coronavirus-19 (SIC).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary immunogenicity end-point:
    Serological response to vaccination (antibodies against SARS-Cov2 spike protein) as measured by immunoassay, 28 days after the boost dose.
    SARS-CoV-2 neutralization as measured by virus neutralization assay, 14 and 28 days after the boost dose.
    Serological response to vaccination (antibodies against SARS-Cov2 spike protein) as measured by immunoassay at 3, 6 and 12months after the boost dose.
    Neutralizing antibody titers at 3, 6 and 12 months after the boost dose.
    Criterio de valoración secundario de la inmunogenicidad:
    Respuesta serológica a la vacunación (anticuerpos contra la proteína de pico SARS-Cov2) medida por inmunoensayo, 28 días después de la dosis de refuerzo.
    Neutralización del SARS-CoV-2 medida por el ensayo de neutralización del virus, 14 y 28 días después de la dosis de refuerzo.
    Respuesta serológica a la vacunación (anticuerpos contra la proteína de pico del SARS-Cov2) medida por inmunoensayo a los 3, 6 y 12 meses después de la dosis de refuerzo.
    Títulos de anticuerpos neutralizantes a los 3, 6 y 12 meses después de la dosis de refuerzo.
    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 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 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 Yes
    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 Yes
    E.8.2.3.1Comparator description
    No administración de dosis de cominarty
    no administration of COMINARTY dose
    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 concerned5
    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
    LVLS
    LVLS
    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 months
    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: 300
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 300
    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 state600
    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
    Ninguno
    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 Decision2021-04-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-04-16
    P. End of Trial
    P.End of Trial StatusOngoing
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