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Estudio de fase 2 de VLA15, una vacuna candidata contra la borreliosis de Lyme, en una población de estudio pediátrica y adulta sana

19 de agosto de 2026 actualizado por: Pfizer

Estudio de seguridad e inmunogenicidad de VLA15, una vacuna candidata multivalente recombinante basada en OspA contra la borreliosis de Lyme: un estudio de fase 2 aleatorizado, controlado, observador ciego en una población de estudio pediátrica y adulta sana

VLA15-221 es un estudio de Fase 2, que se realizará en dos partes: Fase de estudio principal (Parte A) y Fase de refuerzo (Parte B). El estudio comparará la seguridad y la inmunogenicidad de dos calendarios de inmunización primaria diferentes aplicando tres (meses 0-2-6) o dos (meses 0-6) vacunas. Dentro del estudio, se incluirán 600 sujetos sanos de 5 a 65 años. Se inscribirán sujetos con antecedentes de borreliosis de Lyme (infección previa con Borrelia), así como sujetos sin tratamiento previo con Borrelia. La duración del estudio por asignatura será de un máximo de 19 meses en la Parte A y 37 meses adicionales para las asignaturas inscritas en la Parte B.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

VLA15-221 es un estudio de fase 2 multicéntrico, aleatorizado, observador ciego, controlado con placebo, que se organiza en dos partes: fase de estudio principal (parte A) y fase de refuerzo (parte B). En la Parte A, 600 sujetos de 5 a 65 años se inscribirán 1:1:1 en tres grupos: el grupo 1 se vacunará con VLA15 en los meses 0-2-6, el grupo 2 se vacunará con VLA15 en los meses 0-6 y con placebo en el Mes 2 y el Grupo 3 se vacunará con placebo en el Mes 0-2-6. En la Parte B, un subconjunto de sujetos recibirá una inyección de refuerzo con VLA15 o placebo en el Mes 18.

Tipo de estudio

Intervencionista

Inscripción (Actual)

625

Fase

  • Fase 2

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Estados Unidos
    • Connecticut
      • Bridgeport, Connecticut, Estados Unidos, 06606
        • New England Research Associates
      • Stamford, Connecticut, Estados Unidos, 06905
        • Stamford Therapeutics Consortium
      • Waterbury, Connecticut, Estados Unidos, 06708
        • Chase Medical Research, LLC
      • Waterbury, Connecticut, Estados Unidos, 06708
        • Pediatric Associates of Conn. PC
    • Minnesota
      • Minneapolis, Minnesota, Estados Unidos, 55402
        • Clinical Research Institute, Inc.
    • New Jersey
      • East Orange, New Jersey, Estados Unidos, 07018
        • Foundation Pediatrics
      • Irvington, New Jersey, Estados Unidos, 07111
        • Med Clinical Research Partners, LLC
    • New York
      • Binghamton, New York, Estados Unidos, 13905
        • Meridian Clinical Research LLC
      • Rochester, New York, Estados Unidos, 14609
        • Rochester Clinical Research, Inc.
      • Staten Island, New York, Estados Unidos, 10314
        • Richmond Behavioral Associates
      • The Bronx, New York, Estados Unidos, 10467
        • Advantage Clinical Trials
    • Ohio
      • Cleveland, Ohio, Estados Unidos, 44122
        • Velocity Clinical Research, Inc.
    • Pennsylvania
      • Erie, Pennsylvania, Estados Unidos, 16506
        • Allegheny Health and Wellness Pavilion
      • Erie, Pennsylvania, Estados Unidos, 16508
        • Liberty Family Practice
      • Fort Washington, Pennsylvania, Estados Unidos, 19034
        • Lockman & Lubell Pediatric Associates
    • Rhode Island
      • Providence, Rhode Island, Estados Unidos, 02906
        • The Miriam Hospital
      • Providence, Rhode Island, Estados Unidos, 02903
        • Rhode Island Hospital
      • Providence, Rhode Island, Estados Unidos, 02903
        • Hasbro Children's Hospital
      • Warwick, Rhode Island, Estados Unidos, 02886
        • Velocity Clinical Research Providence

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

5 años a 65 años (Niño, Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Sí

Descripción

Criterios de inclusión:

  • El sujeto tiene entre 5 y 65 años el día de la selección (Visita 0)
  • El sujeto goza de buena salud general.

  • Los padres/representantes legales y el sujeto entienden el estudio y sus procedimientos, aceptan sus disposiciones

    • para sujetos de 18 a 65 años: consentimiento informado por escrito antes de cualquier procedimiento relacionado con el estudio
    • para sujetos de 5 a 17 años: consentimiento informado por escrito del representante legal del sujeto, de acuerdo con los requisitos locales, y consentimiento informado por escrito del sujeto, si corresponde, antes de cualquier procedimiento relacionado con el estudio.

  • Si el sujeto está en edad fértil: el sujeto tiene una prueba de embarazo en suero negativa en la selección (visita 0) y acepta emplear medidas anticonceptivas adecuadas de acuerdo con los siguientes plazos:

    • Fase principal del estudio: duración de todo el estudio
    • Fase de refuerzo: hasta el mes 23 (es decir, 5 meses después de la dosis de refuerzo)
  • El sujeto está dispuesto y es capaz de cumplir con las visitas programadas, el plan de tratamiento y otros procedimientos del estudio.
  • El sujeto está disponible durante la duración del estudio y puede ser contactado por teléfono durante la participación en el estudio

Criterio de exclusión:

  • El sujeto tiene una enfermedad crónica relacionada con la borreliosis de Lyme (LB), un LB sintomático activo o recibió tratamiento para LB en los últimos 3 meses antes del Día 1;
  • El sujeto recibió vacunación previa contra LB;
  • El sujeto tuvo una picadura de garrapata dentro de las 4 semanas anteriores al Día 1;
  • El sujeto tiene antecedentes médicos o actualmente tiene una enfermedad clínicamente relevante;
  • El sujeto tiene antecedentes médicos o tiene actualmente una enfermedad neuroinflamatoria o autoinmune;
  • El sujeto tiene trombocitopenia conocida, trastorno hemorrágico o recibió anticoagulantes en las 3 semanas anteriores al Día 1;
  • El sujeto ha recibido una inmunización activa o pasiva dentro de las 4 semanas anteriores al Día 1;
  • El sujeto ha recibido cualquier otro medicamento registrado o no registrado en otro ensayo clínico dentro de las 4 semanas anteriores a la vacunación en el Día 1;
  • El sujeto tiene un defecto conocido o sospechado del sistema inmunitario o recibió terapia inmunosupresora dentro de las 4 semanas anteriores al Día 1;
  • El sujeto tiene antecedentes de anafilaxia de causa desconocida o reacciones alérgicas graves de causa desconocida o tiene hipersensibilidad conocida o reacciones alérgicas a uno de los componentes de la vacuna;
  • El sujeto tuvo alguna neoplasia maligna en los últimos 5 años;
  • El sujeto está embarazada, tiene planes de quedar embarazada durante el curso del estudio o está amamantando al momento de la inscripción;
  • El sujeto ha donado o planea donar sangre o productos derivados de la sangre 4 semanas antes del Día 1;
  • El sujeto tiene cualquier condición que pueda comprometer su bienestar, podría interferir con la evaluación de los criterios de valoración del estudio o limitaría la capacidad del sujeto para completar el estudio;
  • El sujeto está en una relación de dependencia;

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Prevención
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Cuadruplicar

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Parte A+B - Grupo 1
Parte A: VLA15 en los meses 0, 2 y 6 Parte B: VLA15 en los meses 18, 30 y 42
Biológico: VLA15
un candidato a vacuna recombinante multivalente basado en la proteína A de la superficie externa (OspA)
Experimental: Parte A+B - Grupo 2
Parte A: VLA15 en los meses 0 y 6, placebo en el mes 2 Parte B: VLA15 en los meses 18, 30 y 42
Biológico: VLA15
un candidato a vacuna recombinante multivalente basado en la proteína A de la superficie externa (OspA)
Biológico: Placebo
PBS (solución salina tamponada con fosfato)
Comparador de placebos: Parte A+B - Grupo 3
Parte A: Placebo en los meses 0, 2 y 6 Parte B: Placebo en los meses 18, 30 y 42
Biológico: Placebo
PBS (solución salina tamponada con fosfato)

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percentage of Participants With Solicited Local and Solicited Systemic Adverse Events (AEs) Within 7 Days After Vaccination 1
Periodo de tiempo: From Day 1 to Day 7 after vaccination 1 at Month 0
Participants or their legal guardians were required to record any solicited local and systemic AEs in the electronic diary. Solicited symptoms were pre-defined symptoms which were collected via an electronic diary. Solicited local AEs included pain, tenderness, erythema/redness meeting grading scale (MGS), swelling MGS and induration/hardening MGS. Solicited systemic AEs included headache, muscle pain, joint pain, nausea, vomiting, fatigue and fever.
From Day 1 to Day 7 after vaccination 1 at Month 0
Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 2
Periodo de tiempo: From Day 1 to Day 7 after vaccination 2 at Month 2
Participants or their legal guardians were required to record any solicited local and systemic AEs in the electronic diary. Solicited symptoms were pre-defined symptoms which were collected via an electronic diary. Solicited local AEs included pain, tenderness, erythema/redness MGS, swelling MGS and induration/hardening MGS. Solicited systemic AEs included headache, muscle pain, joint pain, nausea, vomiting, fatigue and fever.
From Day 1 to Day 7 after vaccination 2 at Month 2
Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 3
Periodo de tiempo: From Day 1 to Day 7 after vaccination 3 at Month 6
Participants or their legal guardians were required to record any solicited local and systemic AEs in the electronic diary. Solicited symptoms were pre-defined symptoms which were collected via an electronic diary. Solicited local AEs included pain, tenderness, erythema/redness MGS, swelling MGS and induration/hardening MGS. Solicited systemic AEs included headache, muscle pain, joint pain, nausea, vomiting, fatigue and fever.
From Day 1 to Day 7 after vaccination 3 at Month 6
Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Any Vaccination During the Main Study Phase
Periodo de tiempo: From Day 1 to Day 7 after any vaccination 1, 2 or 3 at Month 0, 2 and 6, respectively
Participants or their legal guardians were required to record any solicited local and systemic AEs in the electronic diary. Solicited symptoms were pre-defined symptoms which were collected via an electronic diary. Solicited local AEs included pain, tenderness, erythema/redness MGS, swelling MGS and induration/hardening MGS. Solicited systemic AEs included headache, muscle pain, joint pain, nausea, vomiting, fatigue and fever.
From Day 1 to Day 7 after any vaccination 1, 2 or 3 at Month 0, 2 and 6, respectively
Geometric Mean Titers (GMTs) for Immunoglobulin G (IgG) Against Each Outer Surface Protein A (OspA) Serotype (ST1 to ST6) at Day 208 During the Main Study Phase
Periodo de tiempo: At Day 208 (Month 7)
GMTs for IgG against each OspA serotype ST1 to ST6, determined by an IgG binding assay at Day 208 was presented in this outcome measure.
At Day 208 (Month 7)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 1 Booster Dose
Periodo de tiempo: From Day 1 to Day 7 after vaccination 1 booster dose at Month 18
Participants or their legal guardians were required to record any solicited local and systemic AEs in the electronic diary. Solicited symptoms were pre-defined symptoms which were collected via an electronic diary. Solicited local AEs included pain, tenderness, erythema/redness MGS, swelling MGS and induration/hardening MGS. Solicited systemic AEs included headache, muscle pain, joint pain, nausea, vomiting, fatigue and fever.
From Day 1 to Day 7 after vaccination 1 booster dose at Month 18
Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 2 Booster Dose
Periodo de tiempo: From Day 1 to Day 7 after vaccination 2 booster dose at Month 30
Participants or their legal guardians were required to record any solicited local and systemic AEs in the electronic diary. Solicited symptoms were pre-defined symptoms which were collected via an electronic diary. Solicited local AEs included pain, tenderness, erythema/redness MGS, swelling MGS and induration/hardening MGS. Solicited systemic AEs included headache, muscle pain, joint pain, nausea, vomiting, fatigue and fever.
From Day 1 to Day 7 after vaccination 2 booster dose at Month 30
Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 3 Booster Dose
Periodo de tiempo: From Day 1 to Day 7 after vaccination 3 booster dose at Month 42
Participants or their legal guardians were required to record any solicited local and systemic AEs in the electronic diary. Solicited symptoms were pre-defined symptoms which were collected via an electronic diary. Solicited local AEs included pain, tenderness, erythema/redness MGS, swelling MGS and induration/hardening MGS. Solicited systemic AEs included headache, muscle pain, joint pain, nausea, vomiting, fatigue and fever.
From Day 1 to Day 7 after vaccination 3 booster dose at Month 42
Percentage of Participants With Serious Adverse Events (SAEs)
Periodo de tiempo: From Day 1 of vaccination 1 up to 6 months following the last booster dose (up to Month 48)
A SAE was any untoward medical occurrence that at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect; was another medically important condition.
From Day 1 of vaccination 1 up to 6 months following the last booster dose (up to Month 48)
Percentage of Participants With Adverse Events of Special Interest (AESIs)
Periodo de tiempo: From Day 1 of vaccination 1 up to 6 months following the last booster dose (up to Month 48)
An AESI (serious or non-serious) was one of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor were appropriate.
From Day 1 of vaccination 1 up to 6 months following the last booster dose (up to Month 48)
Percentage of Participants With Unsolicited AE
Periodo de tiempo: Up to 28 Days after vaccination 1, 2 or 3 at Month 0, 2 and 6, respectively, and up to 28 Days after vaccination 1, 2 or 3 booster dose at Month 18, 30 and 42, respectively
An AE was any untoward medical occurrence in a participant administered an investigational product, whether or not related to this treatment. Unsolicited AEs were defined as any solicited local or systemic AE if it had an onset date more than 6 days after vaccination or any other symptom or untoward medical event.
Up to 28 Days after vaccination 1, 2 or 3 at Month 0, 2 and 6, respectively, and up to 28 Days after vaccination 1, 2 or 3 booster dose at Month 18, 30 and 42, respectively
Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group
Periodo de tiempo: SAEs & AESIs: From Day 1 of vaccination up to Month 48; Solicited AEs: from Day 1 to Day 7 after vaccination 1, 2, 3, 4, 5 and 6; Unsolicited AEs: up to 28 Days after vaccination 1, 2, 3, 4, 5 and 6
Percentage of participants with SAEs, AESIs, solicited and unsolicited AEs stratified by age group 5-11, 12-17 and 18-65 years were reported. SAE: any untoward medical occurrence that at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect; was another medically important condition. AESI: scientific and medical concern specific to the sponsor's product or program. Solicited AE: predefined reactions at injection site or systemic reactions after each vaccination. Unsolicited AEs: any solicited local or systemic AE if it had an onset date more than 6 days after vaccination or any other symptom or untoward medical event.
SAEs & AESIs: From Day 1 of vaccination up to Month 48; Solicited AEs: from Day 1 to Day 7 after vaccination 1, 2, 3, 4, 5 and 6; Unsolicited AEs: up to 28 Days after vaccination 1, 2, 3, 4, 5 and 6
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) at Baseline, Days 85, 180, 365 and Month 18
Periodo de tiempo: Baseline; Days 85, 180 and 365; Month 18
GMTs for IgG against each OspA serotype ST1 to ST6, determined by an IgG binding assay were evaluated.
Baseline; Days 85, 180 and 365; Month 18
Seroconversion Rate (SCR) at Days 85, 180, 208, 365 and Month 18
Periodo de tiempo: Days 85, 180, 208 and 365; Month 18
Seroconversion for enzyme linked immunosorbent assay (ELISA) was defined as a change from seronegative at baseline to seropositive at a measured time point. For participants who were OspA seropositive at baseline, seroconversion was defined as a greater than or equal to (>=) 4-fold rise in IgG antibody titer from baseline. SCR was percentage of participants with seroconversion reported for each OspA serotype specific IgG ST1 to ST6, as determined by ELISA.
Days 85, 180, 208 and 365; Month 18
Geometric Mean of the Fold Rise (GMFR) for IgG When Compared to Baseline Against Each OspA Serotype (ST1 to ST6) at Days 85 and 208
Periodo de tiempo: Days 85 and 208
GMFR for IgG when compared to baseline against each OspA serotype ST1 to ST6, determined by IgG binding assay at Day 85 and Day 208 were evaluated.
Days 85 and 208
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group at Baseline, Days 85, 180, 194, 365 and Month 18
Periodo de tiempo: Baseline; Days 85, 180, 194 (18 to 65 years only) and 365; Month 18
GMTs for IgG against each OspA serotype ST1 to ST6, determined by an IgG binding assay stratified by age group (5-11, 12-17 and 18-65 years) were evaluated. Day 194 data was reported for adult participants only as pre-specified in protocol.
Baseline; Days 85, 180, 194 (18 to 65 years only) and 365; Month 18
SCR Stratified by Age Group at Days 85, 180, 194, 208, 365 and Month 18
Periodo de tiempo: Days 85, 180, 194 (18 to 65 years only), 208 and 365; Month 18
Seroconversion for ELISA was defined as a change from seronegative at baseline to seropositive at a measured time point. For participants who were OspA seropositive at baseline, seroconversion was defined as a >=4-fold rise in IgG antibody titer from baseline. SCR was percentage of participants with seroconversion reported for each OspA serotype specific IgG ST1 to ST6, as determined by ELISA. Day 194 data was reported for adult participants only as pre-specified in protocol.
Days 85, 180, 194 (18 to 65 years only), 208 and 365; Month 18
GMFR for IgG When Compared to Baseline Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group at Days 85 and 208
Periodo de tiempo: Days 85 and 208
GMFR for IgG when compared to baseline against each OspA serotype ST1 to ST6, stratified by age group (5-11, 12-17 and 18-65 years) determined by IgG binding assay at Day 85 and Day 208 were evaluated.
Days 85 and 208
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) at Months 18, 19, 23, 26, 30, 31, 39, 42, 43 and 48
Periodo de tiempo: Months 18, 19, 23, 26, 30, 31, 39, 42, 43 and 48
GMTs for IgG against each OspA serotype ST1 to ST6, determined by an IgG binding assay were evaluated.
Months 18, 19, 23, 26, 30, 31, 39, 42, 43 and 48
SCR at Months 18, 19, 23, 26, 30, 31, 39, 42, 43 and 48
Periodo de tiempo: Months 18, 19, 23, 26, 30, 31, 39, 42, 43 and 48
Seroconversion for ELISA was defined as a change from seronegative at baseline to seropositive at a measured time point. For participants who were OspA seropositive at baseline, seroconversion was defined as a >=4-fold rise in IgG antibody titer from baseline. SCR was percentage of participants with seroconversion reported for each OspA serotype specific IgG ST1 to ST6, as determined by ELISA.
Months 18, 19, 23, 26, 30, 31, 39, 42, 43 and 48
GMFR for IgG Against Each OspA Serotype (ST1 to ST6) at Months 19, 31 and 43 During the Booster Phase
Periodo de tiempo: Months 19, 31 and 43
GMFRs for IgG were determined by IgG binding assay for each OspA serotype (ST1-ST6) at Months 19, 31, and 43 relative to the corresponding pre-booster timepoints Months 18, 30, and 42, respectively.
Months 19, 31 and 43
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group at Months 18, 19, 23, 26, 30, 31, 39, 42, 43 and 48
Periodo de tiempo: Months 18, 19, 23, 26, 30, 31, 39, 42, 43 and 48
GMTs for IgG against each OspA serotype ST1 to ST6, determined by an IgG binding assay stratified by age group (5-11, 12-17 and 18-65 years) were evaluated.
Months 18, 19, 23, 26, 30, 31, 39, 42, 43 and 48
SCR Stratified by Age Group at Months 18, 19, 23, 26, 30, 31, 39, 42, 43 and 48
Periodo de tiempo: Months 18, 19, 23, 26, 30, 31, 39, 42, 43 and 48
Seroconversion for ELISA was defined as a change from seronegative at baseline to seropositive at a measured time point. For participants who were OspA seropositive at baseline, seroconversion was defined as a >=4-fold rise in IgG antibody titer from baseline. SCR was percentage of participants with seroconversion reported for each OspA serotype specific IgG ST1 to ST6, as determined by ELISA.
Months 18, 19, 23, 26, 30, 31, 39, 42, 43 and 48
GMFR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group at Months 19, 31 and 43 During the Booster Phase
Periodo de tiempo: Months 19, 31 and 43
GMFRs for IgG were determined by IgG binding assay for each OspA serotype (ST1-ST6), stratified by age group (5-11, 12-17 and 18-65 years) at Months 19, 31, and 43 relative to the corresponding pre-booster timepoints Months 18, 30, and 42, respectively.
Months 19, 31 and 43

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Pfizer

Colaboradores

Valneva Austria GmbH

Investigadores

  • Director de estudio: Pfizer CT.gov Call Center, Pfizer

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Enlaces Útiles

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

8 de marzo de 2021

Finalización primaria (Actual)

25 de marzo de 2022

Finalización del estudio (Actual)

2 de julio de 2025

Fechas de registro del estudio

Enviado por primera vez

8 de marzo de 2021

Primero enviado que cumplió con los criterios de control de calidad

15 de marzo de 2021

Publicado por primera vez (Actual)

17 de marzo de 2021

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

15 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

19 de agosto de 2026

Última verificación

1 de agosto de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • VLA15-221
  • C4601008 (Otro identificador: Alias Study Number)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

Pfizer brindará acceso a los datos individuales de los participantes anonimizados y a los documentos del estudio relacionados (p. protocolo, Plan de Análisis Estadístico (SAP), Informe de Estudio Clínico (CSR)) a solicitud de investigadores calificados, y sujeto a ciertos criterios, condiciones y excepciones. Se pueden encontrar más detalles sobre los criterios de intercambio de datos de Pfizer y el proceso para solicitar acceso en: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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