Un estudio sobre vacunas de ARN modificado contra la influenza en adultos sanos
9 de junio de 2026 actualizado por: Pfizer
UN ESTUDIO PARA EVALUAR LA SEGURIDAD, TOLERABILIDAD E INMUNOGENICIDAD DE VACUNAS DE ARN MODIFICADAS CONTRA LA INFLUENZA EN ADULTOS SALUDABLES
El propósito de este estudio es saber si las vacunas de ARN modificado (modRNA) para la prevención de la influenza son:
- seguro; y
- cómo estas vacunas producen una respuesta inmune en adultos generalmente sanos. La respuesta inmune es la forma en que el cuerpo se protege contra cosas que considera dañinas o extrañas.
El ARN (también llamado ácido ribonucleico) es uno de los dos tipos de ácido nucleico producido por las células. El ARN contiene información que ha sido copiada del ADN (el otro tipo de ácido nucleico). Las células producen varias formas diferentes de ARN y cada forma tiene una función específica en la célula. Muchas formas de ARN tienen funciones relacionadas con la producción de proteínas. El ARN también es el material genético de algunos virus en lugar de ADN. El ARN se puede producir en el laboratorio y utilizar en estudios de investigación. También llamado ácido ribonucleico.
Influenza es el término utilizado para referirse a la enfermedad gripal. Es una infección causada por un virus que afecta la boca, la nariz y la garganta.
El estudio busca participantes que:
- tener al menos 18 años de edad
- no haber recibido una vacuna contra la influenza en los últimos 6 meses
- son generalmente sanos
Este estudio se dividirá en tres subestudios: subestudio A (SSA), subestudio B (SSB) y subestudio C (SSC).
Todos los participantes, independientemente del subestudio, recibirán 1 dosis de cualquiera de las siguientes vacunas mediante una inyección en el brazo:
- 1 de las vacunas contra la influenza modRNA que se está estudiando; o
- una vacuna contra la influenza aprobada para su uso en su respectivo grupo de edad.
Los participantes participarán en este estudio durante aproximadamente 6 meses. Durante este tiempo, los participantes tendrán al menos 3 visitas a la clínica.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
1202
Fase
- Fase 2
- Fase 1
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
-
-
Alabama
-
Mobile, Alabama, Estados Unidos, 36608
- AMR Clinical
-
-
Arizona
-
Scottsdale, Arizona, Estados Unidos, 85260
- Headlands Research - Scottsdale
-
-
California
-
Anaheim, California, Estados Unidos, 92801
- Anaheim Clinical Trials, LLC
-
Lake Forest, California, Estados Unidos, 92630
- Orange County Research Center
-
San Diego, California, Estados Unidos, 92103
- Artemis Institute for Clinical Research
-
Walnut Creek, California, Estados Unidos, 94598
- Diablo Clinical Research, Inc.
-
-
Connecticut
-
Milford, Connecticut, Estados Unidos, 06460
- Clinical Research Consulting
-
-
Florida
-
Hialeah, Florida, Estados Unidos, 33012
- Indago Research & Health Center, Inc
-
Hollywood, Florida, Estados Unidos, 33024
- Research Centers of America
-
Hollywood, Florida, Estados Unidos, 33024
- Research Centers of America ( Hollywood )
-
Miami Lakes, Florida, Estados Unidos, 33014
- Palm Springs Community Health Center
-
Orlando, Florida, Estados Unidos, 32801
- Clinical Neuroscience Solutions, Inc.
-
Orlando, Florida, Estados Unidos, 32819
- Headlands Research Orlando
-
South Miami, Florida, Estados Unidos, 33143
- Qps-Mra, Llc
-
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Hawaii
-
Honolulu, Hawaii, Estados Unidos, 96814
- East-West Medical Research Institute
-
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Louisiana
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New Orleans, Louisiana, Estados Unidos, 70119
- Alliance for Multispecialty Research, LLC
-
-
Minnesota
-
Saint Paul, Minnesota, Estados Unidos, 55114
- Prism Research LLC dba Nucleus Network
-
-
Missouri
-
Chesterfield, Missouri, Estados Unidos, 63005
- Clinical Research Professionals
-
Kansas City, Missouri, Estados Unidos, 64114
- Alliance for Multispecialty Research, LLC
-
-
New York
-
Rochester, New York, Estados Unidos, 14609
- Rochester Clinical Research, LLC
-
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North Carolina
-
Durham, North Carolina, Estados Unidos, 27703
- Duke Vaccine and Trials Unit
-
Raleigh, North Carolina, Estados Unidos, 27612
- M3 Wake Research, Inc.
-
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19107
- DM Clinical Research - Philadelphia
-
-
Texas
-
Brownsville, Texas, Estados Unidos, 78526
- Headlands Horizons LLC
-
Mesquite, Texas, Estados Unidos, 75149
- SMS Clinical Research
-
San Antonio, Texas, Estados Unidos, 78229
- Clinical Trials of Texas, LLC
-
San Antonio, Texas, Estados Unidos, 78229
- Clinical Trials of Texas, LLC dba Flourish Research
-
Tomball, Texas, Estados Unidos, 77375
- Dynamed Clinical Research, LP d/b/a DM Clinical Research
-
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Utah
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Salt Lake City, Utah, Estados Unidos, 84109
- J. Lewis Research, Inc. / Foothill Family Clinic
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Salt Lake City, Utah, Estados Unidos, 84121
- J. Lewis Research, Inc. / Foothill Family Clinic South
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Virginia
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Charlottesville, Virginia, Estados Unidos, 22911
- Charlottesville Medical Research
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Norfolk, Virginia, Estados Unidos, 23502
- AMR Clinical
-
-
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
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Descripción
Criterios clave de inclusión
Se aplica a los 3 subestudios:
- participantes ≥18 años de edad.
- participantes generalmente sanos.
SOLO subestudio C:
- recibo de la vacuna contra la influenza autorizada para la temporada de influenza 2023-2024 hace al menos 6 meses.
Criterios de exclusión clave
Los 3 subestudios:
- diagnóstico de influenza (mediante pruebas clínicas) en los últimos 6 meses.
- Individuos inmunocomprometidos con inmunodeficiencia conocida o sospechada.
- recepción de cualquier vacuna contra la influenza en investigación o autorizada dentro de los 6 meses.
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: SSA: Vacuna contra la influenza ModRNA 2A
- Dosis única el día 1
|
Inyección intramuscular
|
|
Experimental: SSA: Vacuna contra la influenza ModRNA 3A
- Dosis única el día 1
|
Inyección intramuscular
|
|
Experimental: SSA: Vacuna contra la influenza ModRNA 4A
- Dosis única el día 1
|
Inyección intramuscular
|
|
Experimental: SSA: Vacuna contra la influenza ModRNA 5A
- Dosis única el día 1
|
Inyección intramuscular
|
|
Comparador activo: SSA: QIV1
- Dosis única el día 1
|
Inyección intramuscular
|
|
Experimental: SSB: Vacuna contra la influenza ModRNA 3B
- Dosis única el día 1
|
Inyección intramuscular
|
|
Experimental: SSB: Vacuna contra la influenza ModRNA 4B
- Dosis única el día 1
|
Inyección intramuscular
|
|
Experimental: SSB: Vacuna contra la influenza ModRNA 5B
- Dosis única el día 1
|
Inyección intramuscular
|
|
Comparador activo: SSB: QIV2
- Dosis única el día 1
|
Inyección intramuscular
|
|
Comparador activo: SSB: QIV3
- Dosis única el día 1
|
Inyección intramuscular
|
|
Experimental: SSC: vacuna contra la influenza ModRNA 3C
- Dosis única el día 1
|
Inyección intramuscular
|
|
Experimental: SSC: Vacuna contra la influenza ModRNA 4C
- Dosis única el día 1
|
Inyección intramuscular
|
|
Experimental: SSC: Vacuna contra la influenza ModRNA 5C
- Dosis única el día 1
|
Inyección intramuscular
|
|
Experimental: SSC: Vacuna contra la influenza ModRNA 6C
- Dosis única el día 1
|
Inyección intramuscular
|
|
Experimental: SSC: Vacuna contra la influenza ModRNA 7C
- Dosis única el día 1
|
Inyección intramuscular
|
|
Experimental: SSC: Vacuna contra la influenza ModRNA 8C
- Dosis única el día 1
|
Inyección intramuscular
|
|
Experimental: SSC: Vacuna contra la influenza ModRNA 9C
- Dosis única el día 1
|
Inyección intramuscular
|
|
Comparador activo: SSC: QIV2
- Dosis única el día 1
|
Inyección intramuscular
|
|
Comparador activo: SSC: QIV3
- Dosis única el día 1
|
Inyección intramuscular
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
SSA: Percentage of Participants With Local Reactions for up to 7 Days Following Vaccination
Periodo de tiempo: From Day 1 through Day 7 after study vaccination [Vaccination on Day 1]
|
Local reactions included pain at the injection site, redness and swelling and were recorded by participants in the electronic dairy (e-diary) or by investigators in case report form (CRF) after vaccination.
All local reactions were graded based on center for biologics evaluation and research (CBER) toxicity guidelines as Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe) and Grade 4 (potentially life-threatening).
In this outcome measure, data is reported as percentage of participants with any local reaction of any grade.
|
From Day 1 through Day 7 after study vaccination [Vaccination on Day 1]
|
|
SSB: Percentage of Participants With Local Reactions for up to 7 Days Following Vaccination
Periodo de tiempo: From Day 1 through Day 7 after study vaccination [Vaccination on Day 1]
|
Local reactions included pain at the injection site, redness and swelling and were recorded by participants in the e-diary or by investigators in CRF after vaccination.
All local reactions were graded based on CBER toxicity guidelines as Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe) and Grade 4 (potentially life-threatening).
In this outcome measure, data is reported as percentage of participants with any local reaction of any grade.
|
From Day 1 through Day 7 after study vaccination [Vaccination on Day 1]
|
|
SSC: Percentage of Participants With Local Reactions for up to 7 Days Following Vaccination
Periodo de tiempo: From Day 1 through Day 7 after study vaccination [Vaccination on Day 1]
|
Local reactions included pain at the injection site, redness and swelling and were recorded by participants in the e-diary or by investigators in CRF after vaccination.
All local reactions were graded based on CBER toxicity guidelines as Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe) and Grade 4 (potentially life-threatening).
In this outcome measure, data is reported as percentage of participants with any local reaction of any grade.
|
From Day 1 through Day 7 after study vaccination [Vaccination on Day 1]
|
|
SSA: Percentage of Participants With Systemic Events for up to 7 Days Following Vaccination
Periodo de tiempo: From Day 1 through Day 7 after study vaccination [Vaccination on Day 1]
|
Systemic events (fever, vomiting, diarrhea, headache, fatigue, chills, new or worsened muscle pain and joint pain) were recorded by participants in the e-diary or by investigators in CRF after vaccination.
All systemic events were graded based on CBER toxicity guidelines as Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe) and Grade 4 (potentially life-threatening).
In this outcome measure, data is reported as percentage of participants with any systemic events of any grade.
|
From Day 1 through Day 7 after study vaccination [Vaccination on Day 1]
|
|
SSB: Percentage of Participants With Systemic Events for up to 7 Days Following Vaccination
Periodo de tiempo: From Day 1 through Day 7 after study vaccination [Vaccination on Day 1]
|
Systemic events (fever, vomiting, diarrhea, headache, fatigue, chills, new or worsened muscle pain and joint pain) were recorded by participants in the e-diary or by investigators in CRF after vaccination.
All systemic events were graded based on CBER toxicity guidelines as Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe) and Grade 4 (potentially life-threatening).
In this outcome measure, data is reported as percentage of participants with any systemic events of any grade.
|
From Day 1 through Day 7 after study vaccination [Vaccination on Day 1]
|
|
SSC: Percentage of Participants With Systemic Events for up to 7 Days Following Vaccination
Periodo de tiempo: From Day 1 through Day 7 after study vaccination [Vaccination on Day 1]
|
Systemic events (fever, vomiting, diarrhea, headache, fatigue, chills, new or worsened muscle pain and joint pain) were recorded by participants in the e-diary or by investigators in CRF after vaccination.
All systemic events were graded based on CBER toxicity guidelines as Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe) and Grade 4 (potentially life-threatening).
In this outcome measure, data is reported as percentage of participants with any systemic events of any grade.
|
From Day 1 through Day 7 after study vaccination [Vaccination on Day 1]
|
|
SSA: Percentage of Participants With Adverse Events (AEs) From Vaccination Through 4 Weeks After Vaccination
Periodo de tiempo: From study vaccination on Day 1 through 4 weeks after study vaccination
|
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) were included in this outcome measure.
|
From study vaccination on Day 1 through 4 weeks after study vaccination
|
|
SSB: Percentage of Participants With AEs From Vaccination Through 4 Weeks After Vaccination
Periodo de tiempo: From study vaccination on Day 1 through 4 weeks after study vaccination
|
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) were included in this outcome measure.
|
From study vaccination on Day 1 through 4 weeks after study vaccination
|
|
SSC: Percentage of Participants With AEs From Vaccination Through 4 Weeks After Vaccination
Periodo de tiempo: From study vaccination on Day 1 through 4 weeks after study vaccination
|
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) were included in this outcome measure.
|
From study vaccination on Day 1 through 4 weeks after study vaccination
|
|
SSA: Percentage of Participants With SAEs From Vaccination Through 6 Months After Vaccination
Periodo de tiempo: From study vaccination on Day 1 through 6 months after study vaccination
|
An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, any other pre-specified criteria in protocol of the study or other important medical event judged by the investigator.
|
From study vaccination on Day 1 through 6 months after study vaccination
|
|
SSB: Percentage of Participants With SAEs From Vaccination Through 6 Months After Vaccination
Periodo de tiempo: From study vaccination on Day 1 through 6 months after study vaccination
|
An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, any other pre-specified criteria in protocol of the study or other important medical event judged by the investigator.
|
From study vaccination on Day 1 through 6 months after study vaccination
|
|
SSC: Percentage of Participants With SAEs From Vaccination Through 6 Months After Vaccination
Periodo de tiempo: From study vaccination on Day 1 through 6 months after study vaccination
|
An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, any other pre-specified criteria in protocol of the study or other important medical event judged by the investigator.
|
From study vaccination on Day 1 through 6 months after study vaccination
|
|
SSA: Percentage of Participants With Medically Attended Adverse Events (MAEs) From Vaccination Through 6 Months After Vaccination
Periodo de tiempo: From study vaccination on Day 1 through 6 months after study vaccination
|
An MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility.
|
From study vaccination on Day 1 through 6 months after study vaccination
|
|
SSB: Percentage of Participants With MAEs From Vaccination Through 6 Months After Vaccination
Periodo de tiempo: From study vaccination on Day 1 through 6 months after study vaccination
|
An MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility.
|
From study vaccination on Day 1 through 6 months after study vaccination
|
|
SSC: Percentage of Participants With MAEs From Vaccination Through 6 Months After Vaccination
Periodo de tiempo: From study vaccination on Day 1 through 6 months after study vaccination
|
An MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility.
|
From study vaccination on Day 1 through 6 months after study vaccination
|
|
SSA: Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) From Vaccination Through 6 Months After Vaccination
Periodo de tiempo: From study vaccination on Day 1 through 6 months after study vaccination
|
An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects (e.g., asthma).
|
From study vaccination on Day 1 through 6 months after study vaccination
|
|
SSB: Percentage of Participants With NDCMCs From Vaccination Through 6 Months After Vaccination
Periodo de tiempo: From study vaccination on Day 1 through 6 months after study vaccination
|
An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects (e.g., asthma).
|
From study vaccination on Day 1 through 6 months after study vaccination
|
|
SSC: Percentage of Participants With NDCMCs From Vaccination Through 6 Months After Vaccination
Periodo de tiempo: From study vaccination on Day 1 through 6 months after study vaccination
|
An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects (e.g., asthma).
|
From study vaccination on Day 1 through 6 months after study vaccination
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
SSA: Geometric Mean Titers (GMTs) of Strain-Specific Hemagglutination Inhibition Assay (HAI) Titers at Baseline and 4 Weeks After Vaccination
Periodo de tiempo: Baseline (before study vaccination on Day 1), 4 weeks after study vaccination
|
GMTs and the corresponding 2-sided 95% confidence intervals (CIs) were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution).
|
Baseline (before study vaccination on Day 1), 4 weeks after study vaccination
|
|
SSA: Geometric Mean Fold Rise (GMFR) of Strain-Specific HAI Titers From Before Vaccination to 4 Weeks After Vaccination
Periodo de tiempo: From before study vaccination on Day 1 up to 4 weeks after study vaccination
|
GMFR was defined as the geometric mean of the fold rise in the assay results from before vaccination to a specified time point after vaccination.
|
From before study vaccination on Day 1 up to 4 weeks after study vaccination
|
|
SSA: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination
Periodo de tiempo: 4 weeks after study vaccination
|
Seroconversion was defined as an HAI titer <1:10 prior to vaccination and >=1:40 at the time point of interest, or an HAI titer of >=1:10 prior to vaccination with at least a 4-fold rise at the time point of interest.
|
4 weeks after study vaccination
|
|
SSA: Percentage of Participants With HAI Titers >=1:40 For Each Strain at Baseline and 4 Weeks After Vaccination
Periodo de tiempo: Baseline (before study vaccination on Day 1), 4 weeks after study vaccination
|
This measure is for percentage of participants achieving HAI titers >=1:40 for each strain.
|
Baseline (before study vaccination on Day 1), 4 weeks after study vaccination
|
|
SSB: GMTs of Strain-Specific HAI Titers at Baseline and 4 Weeks After Vaccination
Periodo de tiempo: Baseline (before study vaccination on Day 1), 4 weeks after study vaccination
|
Baseline (before study vaccination on Day 1), 4 weeks after study vaccination
|
|
|
SSB: GMFRs of Strain-Specific HAI Titers From Before Vaccination to 4 Weeks After Vaccination
Periodo de tiempo: From before study vaccination on Day 1 up to 4 weeks after study vaccination
|
From before study vaccination on Day 1 up to 4 weeks after study vaccination
|
|
|
SSB: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination
Periodo de tiempo: 4 weeks after study vaccination
|
4 weeks after study vaccination
|
|
|
SSB: Percentage of Participants With HAI Titers >=1:40 For Each Strain at Baseline and 4 Weeks After Vaccination
Periodo de tiempo: Baseline (before study vaccination on Day 1), 4 weeks after study vaccination
|
This measure is for percentage of participants achieving HAI titers >=1:40 for each strain.
|
Baseline (before study vaccination on Day 1), 4 weeks after study vaccination
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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.
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)
23 de mayo de 2024
Finalización primaria (Actual)
5 de febrero de 2025
Finalización del estudio (Actual)
5 de febrero de 2025
Fechas de registro del estudio
Enviado por primera vez
24 de mayo de 2024
Primero enviado que cumplió con los criterios de control de calidad
30 de mayo de 2024
Publicado por primera vez (Actual)
31 de mayo de 2024
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
12 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
9 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- C4781013
- NCT06436703 (Identificador de registro: ClinicalTrials.gov)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
Pfizer proporcionará acceso a datos individuales no identificados de los participantes y a documentos del estudio relacionados (p. ej.
protocolo, Plan de Análisis Estadístico (SAP), Informe de Estudio Clínico (CSR)) previa solicitud de investigadores calificados, y sujeto a ciertos criterios, condiciones y excepciones.
Puede 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. .