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    Summary
    EudraCT Number:2020-005444-35
    Sponsor's Protocol Code Number:C4591015
    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:2022-01-25
    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 number2020-005444-35
    A.3Full title of the trial
    A PHASE 2/3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A SARS-COV-2 RNA VACCINE CANDIDATE (BNT162b2) AGAINST COVID-19 IN HEALTHY PREGNANT WOMEN 18 YEARS OF AGE AND OLDER
    ESTUDIO FASE 2/3 CONTROLADO CON PLACEBO, ALEATORIZADO, CEGADO PARA EL OBSERVADOR, PARA EVALUAR LA SEGURIDAD, LA TOLERABILIDAD Y LA INMUNOGENICIDAD DE UNA VACUNA CANDIDATA DE ARN (BNT162B2) DEL SARS-COV-2, CONTRA COVID-19 EN MUJERES EMBARAZADAS SANAS DE 18 AÑOS DE EDAD Y MAYORES
    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, Tolerability, and Immunogenicity of SARS CoV-2 RNA Vaccine Candidate (BNT162b2) Against COVID-19 in Healthy Pregnant Women 18 Years of Age and Older
    Estudio fase 2/3 para evaluar la seguridad, la tolerabilidad y la inmunogenicidad de una vacuna candidata de ARN (BNT162b2) del SARS‑CoV-2, contra COVID-19 en mujeres embarazadas sanas de 18 años de edad y mayores
    A.4.1Sponsor's protocol code numberC4591015
    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 SponsorBioNTech SE
    B.1.3.4CountryGermany
    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 supportPfizer Inc.
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportBioNTech
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBioNTech SE
    B.5.2Functional name of contact pointRegulatory Affairs Strategist
    B.5.3 Address:
    B.5.3.1Street AddressAn der Goldgrube 12
    B.5.3.2Town/ cityMainz
    B.5.3.3Post code55131
    B.5.3.4CountryGermany
    B.5.4Telephone number+49613190847593
    B.5.5Fax number+4961319084390
    B.5.6E-mailRuben.Rizzi@biontech.de
    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
    D.2.1.1.2Name of the Marketing Authorisation holderBiontech SE
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameBNT162b2
    D.3.2Product code RBP020.2 (PF-07302048)
    D.3.4Pharmaceutical form Concentrate for solution 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 INNNAP
    D.3.9.2Current sponsor codeBNT162b2
    D.3.9.3Other descriptive nameTozinameran
    D.3.9.4EV Substance CodeSUB210693
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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
    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
    Protection against COVID-19
    Protección frente a la COVID-19
    E.1.1.1Medical condition in easily understood language
    prevention of infection with the Corona virus
    Prevención de la infección con Coronavirus
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level PT
    E.1.2Classification code 10051905
    E.1.2Term Coronavirus infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary Safety:
    To describe the safety and tolerability of prophylactic BNT162b2 when administered to maternal participants 18 years of age or older vaccinated at 24 to 34 weeks’ gestation.

    Primary Immunogenicity:
    To demonstrate the NI of the immune response to prophylactic BNT162b2 in maternal participants 18 years of age or older vaccinated at 24 to 34 weeks’ gestation compared to nonpregnant women 18 years of age or older from the C4591001 study without evidence of past SARS-CoV-2 infection.

    To demonstrate the NI of the immune response to prophylactic BNT162b2 in maternal participants 18 years of age or older vaccinated at 24 to 34 weeks’ gestation compared to nonpregnant women 18 years of age or older from the C4591001 study with and without evidence of prior SARS-CoV-2 infection.
    Principales de seguridad:
    Describir la seguridad y tolerabilidad de la vacuna preventiva BNT162b2 cuando se administra a madres participantes de 18 años de edad o mayores que recibieron la vacuna entre las semanas 24 y 34 de gestación.

    Principales de inmunogenicidad:
    Demostrar la ausencia de inferioridad (AI) de la respuesta inmunitaria a la vacuna preventiva BNT162b2 en madres participantes de 18 años o mayores que recibieron la vacuna entre las semanas 24 y 34 de gestación en comparación con mujeres no embarazadas de 18 años de edad o mayores del estudio C4591001, sin indicios de infección previa por el SARSCoV-2.

    Demostrar la AI de la respuesta inmunitaria a la vacuna preventiva BNT162b2 en madres participantes de 18 años o mayores que recibieron la vacuna entre las semanas 24 y 34 de gestación en comparación con mujeres no embarazadas de 18 años de edad o mayores del estudio C4591001, sin indicios de infección previa por el SARSCoV-2.
    E.2.2Secondary objectives of the trial
    If at least 12 cases are observed:
    To evaluate the efficacy of prophylactic BNT162b2 against confirmed COVID 19 occurring from 7 days after Dose 2 through 1 month after delivery in maternal participants 18 years of age or older vaccinated at 24 to 34 weeks’ gestation without evidence of prior SARS-CoV-2 infection.
    To evaluate the efficacy of prophylactic BNT162b2 against confirmed COVID 19 occurring from 7 days after Dose 2 through 1 month after delivery in maternal participants 18 years of age or older vaccinated at 24 to 34 weeks’ gestation with and without evidence of prior SARS-CoV-2 infection.

    To describe the efficacy of prophylactic BNT162b2 against asymptomatic SARS CoV-2 infection through 1 month after delivery in maternal participants 18 years of age or older vaccinated at 24 to 34 weeks’ gestation without evidence of prior SARS-CoV-2 infection.

    For further objectives refer to protocol Section 3
    Si se observan 12 casos como mínimo:
    Evaluar la eficacia de la vacuna preventiva BNT162b2 contra la COVID-19 confirmada que se produce entre 7 días después de la dosis 2 y 1 mes después del parto en madres participantes de 18 años de edad o mayores que recibieron la vacuna entre las semanas 24 y 34 de gestación:
    - sin indicios de infección previa por el SARS-CoV-2.
    - con y sin indicios de infección previa por el SARS-CoV-2.

    Describir la eficacia de la vacuna preventiva BNT162b2 contra la infección asintomática por el SARS-CoV-2 hasta 1 mes después del parto en madres participantes de 18 años o mayores que recibieron la vacuna entre las semanas 24 y 34 de gestación, sin indicios de infección previa por el SARSCoV-2.

    Describir la respuesta inmunitaria con el transcurso del tiempo y la persistencia de la vacuna BNT162b2 preventiva cuando se administra a madres participantes de 18 años de edad o mayores entre las semanas 24 y 34 de gestación.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Maternal Participants
    Age and Sex:
    1. Healthy women ≥18 years of age who are between 24 0/7 and 34 0/7 weeks’ gestation on the day of planned first vaccination, with an uncomplicated, singleton pregnancy, who are at no known increased risk for complications.
    a. Phase 2 participants will include healthy women ≥18 years of age who are between 27 0/7 and 34 0/7 weeks’ gestation on the day of planned vaccination, with an uncomplicated, singleton pregnancy, who are at no known increased risk for complications.
    GA will be documented based on one of the following composite criteria based on timing and availability of data on the LMP, ultrasound examination, and physical examination, for natural pregnancies. The earliest ultrasound data available during the current pregnancy should be used to establish GA:
    a. First-Trimester Data Available (data obtained at ≤13 6/7 weeks):
    • The date of the first day of the reported LMP may be used to establish the GA if corroborated by a first-trimester ultrasound.
    • If there is a discrepancy of >7 days between the LMP-determined GA and a first trimester ultrasound OR the LMP is uncertain/unknown, then the GA should be determined using the first-trimester ultrasound.
    b. Second-Trimester Data Available (data obtained at 14 0/7 to 27 6/7 weeks):
    • The date of the first day of the reported LMP may be used to establish the GA if corroborated by a second-trimester ultrasound or a physical examination including fundal height.
    • If there is a discrepancy of >10 days between the LMP-determined GA and the second-trimester ultrasound OR if the LMP is uncertain/unknown, then the GA should be determined using the second-trimester ultrasound.
    c. Third-Trimester Data Available (data obtained at ≥28 weeks):
    • The date of the first day of the reported LMP may be used to establish the GA if corroborated by a second-trimester ultrasound or a physical examination including fundal height.
    • If there is a discrepancy of >10 days between the LMP-determined GA and the second-trimester ultrasound OR if the LMP is uncertain/unknown, then the GA should be determined using the second-trimester ultrasound.
    Type of Participant and Disease Characteristics:
    2. Participants who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
    3. Receiving prenatal standard of care based on country requirements.
    4. Had an ultrasound examination performed at ≥18 weeks of pregnancy with no significant fetal abnormalities observed, based on the investigator’s judgment.
    5. Healthy participants who are determined by medical history, physical examination, and clinical judgment to be appropriate for inclusion in the study. Note: Participants with preexisting stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks before enrollment, can be included.
    6. Documented negative HIV antibody test, syphilis test, and HBV surface antigen test during this pregnancy and prior to randomization (Visit 1).
    7. Intention to deliver at a hospital or birthing facility where study procedures can be conducted.
    8. Expected to be available for the duration of the study and can be contacted by telephone during study participation.
    9. Participant is willing to give informed consent for her infant to participate in the study.
    Weight:
    10. Prepregnancy BMI of ≤40 kg/m2. If prepregnancy BMI is not available, the BMI at the time of the first obstetric visit during the current pregnancy may be used.
    Informed Consent:
    11. Capable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.
    OR
    For certain countries only: If the maternal participant is illiterate, a thumb printed informed consent must be obtained, which must be signed and dated by an impartial witness who was present throughout the entire informed consent process confirming that the maternal participant has been informed of all pertinent aspects of the study.
    Infant Participants
    1. Evidence of a signed and dated ICD signed by the parent(s).
    • The maternal participant must sign an ICD for herself and her fetus/infant before taking part in the study. The father of the fetus/infant must sign an ICD if required by local requirements.
    OR
    • For certain countries only: If the infant participant’s maternal participant is illiterate, a thumb printed informed consent must have been obtained, which must have been signed and dated by an impartial witness who was present throughout the entire informed consent process confirming that the maternal participant has been informed of all pertinent aspects of the study for herself (maternal participant) and her fetus/infant prior to taking part in the study.
    2. Parent(s) willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
    Madres participantes
    Edad y sexo:
    1. Mujeres sanas ≥18 años de edad que estén entre la semana 24 0/7 y 34 0/7 de gestación el día de la primera vacunación planificada, que tengan un embarazo único sin complicaciones y que no corran un mayor riesgo conocido de presentar complicaciones.
    a. En fase 2, se incluirán mujeres sanas ≥18 años de edad que estén entre la semana 27 0/7 y 34 0/7 de gestación el día de la vacunación planificada, que tengan un embarazo único sin complicaciones y que no corran un mayor riesgo conocido de presentar complicaciones.
    En el caso de los embarazos naturales, la edad gestacional (EG) se documentará en función de uno de los siguientes criterios combinados, según el momento y la disponibilidad de datos sobre la FUM, la ecografía y la exploración física. Para establecer la EG, se deben utilizar los primeros datos ecográficos disponibles durante el embarazo en curso:
    a. Datos disponibles del 1ºtrimestre (datos que se obtienen en la semana ≤13 6/7):
    • La fecha del 1ºdía de la última menstruación que se notificó puede utilizarse para establecer la EG, si se corrobora con una ecografía del 1ºtrimestre.
    • Si existe una discrepancia >7 días entre la EG que se determinó con la FUM y una ecografía del 1º trimestre, O BIEN, si la FUM es incierta/ desconocida, la EG debe determinarse mediante la ecografía del primer trimestre.
    b. Datos disponibles del 2º trimestre (datos que se obtienen entre las semanas 14 0/7 y 27 6/7):
    • La fecha del 1ºdía de la última menstruación que se notificó puede utilizarse para establecer la EG, si se corrobora con una ecografía del 2ºtrimestre o una exploración física, incluida la altura uterina.
    • Si existe una discrepancia >10 días entre la EG que se determinó con la FUM y una ecografía del 2º trimestre, O BIEN, si la FUM es incierta/ desconocida, la EG debe determinarse mediante la ecografía del 2ºtrimestre.
    c. Datos disponibles del 3º trimestre (datos que se obtienen en la semana ≥28):
    • La fecha del 1º día de la última menstruación que se notificó puede utilizarse para establecer la EG, si se corrobora con una ecografía del segundo trimestre o una exploración física, incluida la altura uterina.
    • Si existe una discrepancia >10 días entre la EG que se determinó con la FUM y una ecografía del segundo trimestre, O BIEN, si la FUM es incierta/ desconocida, la EG debe determinarse mediante la ecografía del 2º trimestre.
    2. Participantes que estén dispuestas a, y sean capaces de, acudir a todas las visitas programadas, y a cumplir con el plan de tratamiento, las pruebas analíticas y otros procedimientos del estudio.
    3. Participantes que estén recibiendo la asistencia prenatal de referencia según los requisitos del país.
    4. Participantes a las que se le realizó una ecografía a las ≥18 semanas de embarazo en la que no se observaron anomalías fetales de importancia, según el criterio del investigador.
    5. Participantes sanas que, según los antecedentes médicos, la exploración física y el criterio clínico, sean aptas para ingresar en el estudio.
    6. Participantes que cuenten con resultados negativos de la prueba de anticuerpos contra el VIH, la prueba de sífilis y la prueba del antígeno de superficie del VHB que se hayan documentado durante este embarazo y antes de la aleatorización (visita 1).
    7. Participantes con intención de dar a luz en un hospital o centro de maternidad en donde se puedan realizar los procedimientos del estudio.
    8. Participantes disponibles durante el estudio y se las pueda contactar por teléfono durante la participación en el estudio.
    9. Participantes dispuestas a dar su CI para que su lactante participe en el estudio.
    Peso:
    10. IMC antes del embarazo <40 kg/m2. Si no se dispone de IMC antes, se puede utilizar el IMC al momento de la 1º visita obstétrica durante el embarazo en curso.
    Consentimiento informado (CI)
    11. Participantes capaces de dar el CI firmado, tal como se describe en el Apéndice 1, que incluye el cumplimiento de los requisitos y las restricciones que figuran en el DCI y en este protocolo.
    Lactantes participantes
    1. Corroboración de que existe un DCI fechado y firmado por los padres.
    • La madre participante debe firmar un DCI para ella y su feto/lactante antes de participar en el estudio. El padre del feto/lactante debe firmar un DCI, si así lo exigen los requisitos locales. O BIEN
    • Solo para determinados países: si la madre del lactante participante es analfabeta, se debe preparar un documento de CI con huella dactilar de pulgar, el cual debe haber sido firmado y fechado por un testigo imparcial que haya presenciado todo el proceso de CI y que confirme que la madre participante ha sido informada de todos los aspectos pertinentes del estudio para ella (madre participante) y su feto/lactante antes de participar del estudio.
    2. Padres dispuestos a, y ser capaces de, acudir a las visitas programadas, y a cumplir con el plan de tratamiento, las pruebas analíticas y otros procedimientos del estudio.
    E.4Principal exclusion criteria
    Maternal Participants
    Medical Conditions:
    1. Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator’s judgment, make the participant inappropriate for the study.
    2. Previous clinical (based on COVID-19 symptoms/signs alone, if a SARS-CoV-2 NAAT result was not available) or microbiological (based on COVID-19 symptoms/signs and a positive SARS-CoV-2 NAAT result) diagnosis of COVID 19.
    3. History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention or any related vaccine.
    4. Participants with known or suspected immunodeficiency.
    5. Bleeding diathesis or condition associated with prolonged bleeding that would in the opinion of the investigator contraindicate intramuscular injection.
    6. Phase 2 only: A prior or current major illness of the mother or conditions of the fetus that, in the investigator’s judgment, will substantially increase the risk associated with the participant’s participation in, and completion of, the study or could preclude the evaluation of the participant’s response, including but not limited to the following:
    • Gestational hypertension or preeclampsia-eclampsia
    • Placental abnormality
    • Polyhydramnios or oligohydramnios
    • Significant bleeding or blood clotting disorder
    • Gestational diabetes
    • Any signs of premature labor with the current pregnancy or having ongoing intervention (medical/surgical) in the current pregnancy to prevent preterm birth
    • Prior stillbirth or neonatal death, prior low birth weight or preterm delivery, prior history of at least 3 miscarriages, prior pregnancies numbering greater than 5, or previous infant with a known genetic disorder or major congenital anomaly
    7. For Phase 2 only: Maternal participants with a history of stable chronic diseases that are known to be associated with increased risk of obstetrical or neonatal complications (as defined above in exclusion criterion 6) should not be included.
    8. Phase 3: Current major illness of the mother or conditions of the fetus that, in the investigator’s judgment, will substantially increase the risk associated with the participant’s participation in, and completion of, the study or could preclude the evaluation of the participant’s response, including but not limited to the following:
    • Uncontrolled gestational hypertension
    • Preeclampsia eclampsia
    • Placental abnormality
    • Polyhydramnios or oligohydramnios
    • Significant bleeding or blood clotting disorder
    • Uncontrolled gestational diabetes
    • Any signs of premature labor with the current pregnancy or having ongoing intervention (medical/surgical) in the current pregnancy to prevent preterm birth
    • Prior stillbirth or neonatal death, preterm delivery (≤34 weeks), or previous infant with a known genetic disorder or major congenital anomaly.
    Prior/Concomitant Therapy:
    9. Previous vaccination with any coronavirus vaccine.
    10. Receipt of medications intended to prevent COVID 19.
    11. Receipt of blood/plasma products or immunoglobulin, from 60 days before administration of study intervention, or planned receipt through delivery, with 1 exception, anti-D immunoglobulin (eg, RhoGAM), which can be given at any time.
    12. Current alcohol abuse or illicit drug use.
    13. Participants who receive treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease, or planned receipt through the postvaccination blood draw.
    Prior/Concurrent Clinical Study Experience:
    14. Participation in other studies involving study intervention within 28 days prior to study entry and/or during study participation.
    15. Previous participation in other studies involving study intervention containing LNPs.
    Diagnostic Assessments:
    16. Not applicable.
    Other Exclusions:
    17. Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.
    18. Participants whose unborn baby has been fathered by investigational site staff members directly involved in the conduct of the study or their family members, site staff members otherwise supervised by the investigator, or Pfizer employees directly involved in the conduct of the study.
    Infant Participants
    1. Infant who is a direct descendant (eg, child or grandchild) of the study personnel.
    Madres participantes: Afecciones:
    1.Otras afecciones médicas o psiquiátricas, incluidas las ideas o conductas de suicidio recientes (durante el último año) o activas, o resultados anómalos en las pruebas analíticas, que puedan aumentar el riesgo de la participación en el estudio o, según la opinión del investigador, indiquen que la participante no es apta para el estudio.
    2.Diagnóstico clínico anterior de COVID-19 o diagnóstico microbiológico anterior de COVID-19.
    3.Antecedentes de acontecimientos adversos graves asociados a una vacuna o reacción alérgica grave (p. ej., anafilaxia) a cualquier componente del tratamiento del estudio o cualquier vacuna relacionada.
    4.Participantes con una inmunodeficiencia presunta o confirmada.
    5.Diátesis hemorrágica o afección asociada a una hemorragia prolongada que, según criterio del investigador, sería una contraindicación para la inyección intramuscular.
    6.Solo fase 2: enfermedad grave, anterior o en curso, de la madre o afecciones del feto que, según el criterio del investigador, aumentarán considerablemente el riesgo asociado a la participación en el estudio, y la finalización del mismo, o podrían impedir la evaluación de la respuesta del participante; entre estas afecciones se incluyen las siguientes:
    •Hipertensión gestacional o preeclampsia y eclampsia
    •Anomalías placentarias
    •Polihidramnios u oligohidramnios
    •Trastorno hemorrágico o de la coagulación de importancia
    •Diabetes gestacional
    •Cualquier indicio de trabajo de parto prematuro durante el embarazo en curso, o realización de una intervención (médica/quirúrgica) en marcha durante el embarazo en curso, para prevenir el parto prematuro
    •Antecedentes de muerte neonatal o mortinato, nacimiento de bajo peso o parto prematuro, así como antecedentes de al menos 3 abortos espontáneos, de más de 5 embarazos previos, o de hijos con un trastorno genético conocido o una anomalía congénita grave
    7.Solo para fase 2: no se debe incluir a madres participantes con antecedentes de enfermedades crónicas estables que se sepa que estén asociadas a un mayor riesgo de complicaciones obstétricas o neonatales (según criterio exclusión 6).
    8.Fase 3: enfermedad grave en curso de la madre o afecciones del feto que, según el criterio del investigador, aumentarán considerablemente el riesgo asociado a la participación en el estudio, y la finalización del mismo, o podrían impedir la evaluación de la respuesta del participante; entre estas afecciones se incluyen las siguientes:
    • Hipertensión gestacional no controlada
    • Preeclampsia y eclampsia
    • Anomalías placentarias
    •Polihidramnios u oligohidramnios
    •Trastorno hemorrágico o de la coagulación de importancia
    •Diabetes gestacional no controlada
    •Cualquier indicio de trabajo de parto prematuro durante el embarazo en curso, o realización una intervención (médica/quirúrgica) en marcha durante el embarazo en curso, para prevenir el parto prematuro
    •Antecedentes de muerte neonatal o mortinato, de parto prematuro (≤34 semanas) o de hijos con un trastorno genético conocido o una anomalía congénita grave
    Tratamiento anterior/concomitante:
    9.Administración de alguna vacuna anterior contra el coronavirus.
    10.Administración de medicamentos con la intención de prevenir la COVID-19.
    11.Administración de hemoderivados o de productos de Ig, a partir de los 60 días anteriores a la administración del tratamiento del estudio, o administración planificada hasta el parto, con a excepción de la Ig anti-D (p. ej., RhoGAM), que se puede administrar en cualquier momento.
    12.Consumo excesivo actual de alcohol o de drogas ilícitas.
    13.Participantes que reciben inmunodepresores, incluidos los citotóxicos o corticoesteroides sistémicos (p. ej., para el cáncer o una enfermedad autoinmunitaria), o el tratamiento planificado hasta la extracción de sangre después de la vacunación.
    Experiencia anterior/concurrente en estudios clínicos:
    14.Participación en otros estudios con un tratamiento en estudio durante los 28 días anteriores al ingreso en el estudio o durante la participación en el mismo.
    15.Participación anterior en otros estudios con un tratamiento en estudio que contenga nanopartículas de lípidos.
    16.Evaluaciones diagnósticas: No procede.
    Otras exclusiones:
    17.Personal del centro de investigación o empleados de Pfizer involucrados directamente en la realización del estudio, integrantes del personal del centro supervisados por el investigador y sus respectivos familiares.
    18.Participantes cuyo feto ha sido engendrado por integrantes del personal de un centro de investigación implicados directamente en la realización del estudio y sus familiares; integrantes del personal del centro que sean supervisados de algún modo por el investigador o empleados de Pfizer implicados directamente en la realización del estudio.
    Lactantes participantes
    1. Lactantes descendientes directos (p. ej., hijo o nieto) de integrantes del personal del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Safety:
    • Prompted local reactions (redness, swelling, and pain at the injection site)
    • Prompted systemic events (fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain)
    • AEs
    • SAEs

    Primary Immunogenicity:
    • SARS-CoV-2 neutralizing titers
    Principales de seguridad:
    • Reacciones locales provocadas (enrojecimiento, hinchazón y dolor en el lugar de inyección)
    • Reacciones sistémicas provocadas (fiebre, cansancio, cefalea, escalofríos, vómitos, diarrea, dolor muscular de reciente aparición o agravado y dolor articular de reciente aparición o agravado)
    • AA
    • AAG

    Principales de Inmunogenicidad:
    • Títulos neutralizantes del SARSCoV-2
    E.5.1.1Timepoint(s) of evaluation of this end point
    Please see the clinical study protocol Section 3
    Por favor, vea la sección 3 del protocolo.
    E.5.2Secondary end point(s)
    • COVID-19 incidence per 1000 person years of blinded follow-up based on central laboratory or locally confirmed NAAT
    • COVID-19 incidence per 1000 person years of blinded follow-up based on central laboratory or locally confirmed NAAT
    • Incidence of asymptomatic infection of SARS-CoV-2 based on N binding antibody seroconversion
    • Full-length S-binding IgG levels
    • SARS-CoV-2 neutralizing titers
    • Specific birth outcomes
    • AEs from birth through 1 month of age
    • SAEs and AESIs (major congenital anomalies, developmental delay) through 6 months of age
    • Full-length S-binding IgG levels
    • Incidencia de COVID-19 por 1000 años-persona de seguimiento con enmascaramiento según el laboratorio central o prueba de amplificación de ácido nucleico (PAAN) confirmada de manera local
    • Incidencia de COVID-19 por 1000 años-persona de seguimiento con enmascaramiento según el laboratorio central o prueba de amplificación de ácido nucleico (PAAN) confirmada de manera local
    • Incidencia de infección asintomática por el SARS-CoV-2 según la seroconversión de anticuerpos de unión a N.
    • Niveles de IgG de unión a S de longitud completa
    • Títulos neutralizantes del SARSCoV-2
    • Resultados específicos del nacimiento
    • AA desde el nacimiento hasta un mes de edad
    • AAG y AAEI (anomalías congénitas graves, retraso en el desarrollo) hasta 6 meses de edad
    • Niveles de IgG de unión a S de longitud completa
    E.5.2.1Timepoint(s) of evaluation of this end point
    Please see the clinical study protocol Section 3
    Por favor, vea la sección 3 del protocolo.
    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) 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 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
    cegado para el observador
    Observer blind
    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 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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    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
    Brazil
    Canada
    Chile
    Mozambique
    South Africa
    Spain
    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
    The end of the study is defined as the date of last visit of the last participant in the study.
    El fin del estudio se define como la fecha de la última visita del último participante del estudio
    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 days30
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days14
    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: 4000
    F.1.1.1In Utero Yes
    F.1.1.1.1Number of subjects for this age range: 4000
    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: 4000
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 No
    F.3.3.3Pregnant women Yes
    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 state316
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 275
    F.4.2.2In the whole clinical trial 4000
    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)
    No intervention will be provided to study participants at the end of the study.
    No se proporcionará tratamiento a los participantes del estudio al final de este estudio.
    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 Decision2021-04-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-04-13
    P. End of Trial
    P.End of Trial StatusOngoing
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