Un estudio para aprender sobre las respuestas de la vacuna contra la gripe y Covid-19 en personas sanas
17 de agosto de 2026 actualizado por: BioNTech SE
Un estudio de fase 1/2, aleatorizado y cegado al observador para evaluar la seguridad, la tolerabilidad y la inmunogenicidad de los candidatos de vacuna combinados contra la influenza y Covid-19 en individuos sanos
Este estudio es aprender sobre las vacunas contra la gripe y covid, ya sea solo o cuando se mezclan.
Las personas sanas de 18 años o más pueden unirse.
Los participantes recibirán un disparo en cada brazo, ya sea una vacuna contra la gripe o covid, solas o mezcladas.
El estudio dura unos 6 meses y los participantes deben visitar el sitio de investigación al menos 3 veces.
Descripción general del estudio
Estado
Terminado
Condiciones
Tipo de estudio
Intervencionista
Inscripción (Actual)
1353
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
-
-
California
-
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
-
Miami, Florida, Estados Unidos, 33176
- Miami Dade Medical Research Institute, LLC
-
Miami Lakes, Florida, Estados Unidos, 33014
- Palm Springs Community Health Center
-
Orlando, Florida, Estados Unidos, 32819
- Headlands Research Orlando
-
-
Georgia
-
Stockbridge, Georgia, Estados Unidos, 30281
- Clinical Research Atlanta
-
-
Hawaii
-
Honolulu, Hawaii, Estados Unidos, 96814
- East-West Medical Research Institute
-
-
Missouri
-
Chesterfield, Missouri, Estados Unidos, 63005
- Clinical Research Professionals
-
Springfield, Missouri, Estados Unidos, 65802
- Bio-Kinetic Clinical Applications, LLC dba QPS-MO
-
Springfield, Missouri, Estados Unidos, 65807
- Bio-Kinetic Clinical Applications, LLC dba QPS-MO-Screening and Recruitment Center
-
-
Nebraska
-
Omaha, Nebraska, Estados Unidos, 68134
- Velocity Clinical Research, Omaha
-
-
Nevada
-
Las Vegas, Nevada, Estados Unidos, 89030
- Las Vegas Clinical Trials
-
-
New Hampshire
-
Portsmouth, New Hampshire, Estados Unidos, 03801
- ActivMed Practices & Research, LLC.
-
-
Texas
-
Houston, Texas, Estados Unidos, 77065
- DM Clinical Research- Cyfair
-
Mesquite, Texas, Estados Unidos, 75149
- SMS Clinical Research
-
Tomball, Texas, Estados Unidos, 77375
- Dynamed Clinical Research, LP d/b/a DM Clinical Research
-
-
Utah
-
Salt Lake City, Utah, Estados Unidos, 84109
- J. Lewis Research, Inc. / Foothill Family Clinic
-
Salt Lake City, Utah, Estados Unidos, 84121
- J. Lewis Research, Inc. / Foothill Family Clinic South
-
-
Virginia
-
Charlottesville, Virginia, Estados Unidos, 22911
- Charlottesville Medical Research
-
-
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 de inclusión:
- Participantes de 18 años de edad o mayores
- Participantes sanos que están determinados por el historial médico, el examen físico (si se requiere clínicamente) y el juicio clínico del investigador para ser elegible para su inclusión en el estudio.
Criterios de exclusión:
- Vacunación con cualquier formulación de la temporada 2024-2025 de investigación o una vacuna contra la vacuna Covid-19.
- Tratado con terapias antivirales para la influenza (p. Ej., Tamiflu) dentro de los 180 días previos al día 1
Consulte el contacto del estudio para obtener más detalles de elegibilidad.
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: Arm A/AA
Low Dose COVID-19 Vaccine and Placebo
|
Salina
Vacuna Pfizer-Biontech Covid-19
|
|
Experimental: Arm B/BB
Medium Dose COVID-19 Vaccine and Placebo
|
Salina
Vacuna Pfizer-Biontech Covid-19
|
|
Comparador activo: Arm C/CC
High Dose COVID-19 Vaccine and Placebo
|
Salina
Vacuna Pfizer-Biontech Covid-19
|
|
Experimental: Arm D/DD
Low Dose Investigational Influenza Vaccine and Placebo
|
Salina
Vacuna contra la influenza en investigación
|
|
Comparador activo: Arm E
Licensed Influenza Vaccine 1 and Licensed COVID-19 Vaccine
|
Vacuna Pfizer-Biontech Covid-19
Vacuna de influenza con licencia 1
|
|
Comparador activo: Arm EE
Licensed Influenza Vaccine 2 and Licensed COVID-19 Vaccine
|
Vacuna Pfizer-Biontech Covid-19
Vacuna de influenza con licencia 2
|
|
Experimental: Arm F/FF
Medium Dose Investigational Influenza Vaccine and Placebo
|
Salina
Vacuna contra la influenza en investigación
|
|
Experimental: Arm G/GG
Low Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine and Placebo
|
Salina
Combined investigational influenza and Pfizer-BioNTech COVID-19 Vaccine
|
|
Experimental: Arm H/HH
Medium Dose Investigational Influenza Vaccine/Low Dose COVID-19 Vaccine and Placebo
|
Salina
Combined investigational influenza and Pfizer-BioNTech COVID-19 Vaccine
|
|
Experimental: Arm I/II
Low Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine and Placebo
|
Salina
Combined investigational influenza and Pfizer-BioNTech COVID-19 Vaccine
|
|
Experimental: Arm J/JJ
High Dose Investigational Influenza Vaccine and Placebo
|
Salina
Vacuna contra la influenza en investigación
|
|
Experimental: Arm K/KK
Medium Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine and Placebo
|
Salina
Combined investigational influenza and Pfizer-BioNTech COVID-19 Vaccine
|
|
Experimental: Arm L/LL
Medium Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine and Placebo
|
Salina
Combined investigational influenza and Pfizer-BioNTech COVID-19 Vaccine
|
|
Experimental: Arm M/MM
High Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine and Placebo
|
Salina
Combined investigational influenza and Pfizer-BioNTech COVID-19 Vaccine
|
|
Experimental: Arm N
High Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine and Placebo
|
Salina
Combined investigational influenza and Pfizer-BioNTech COVID-19 Vaccine
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Cohort 1: Percentage of Participants With Any Local Reactions for up to 7 Days Following Vaccination
Periodo de tiempo: From Day 1 through Day 7 after Vaccination [Vaccination on Day 1]
|
Local reactions included redness, swelling, and pain at the injection site, were recorded in the electronic dairy (e-diary) or case report form (CRF) after vaccination.
Local reactions were graded per the 'Local Reaction Grading Scale' per protocol.
Percentage of participants with at least 1 local reaction of grade 1 and above were reported in this outcome measure.
|
From Day 1 through Day 7 after Vaccination [Vaccination on Day 1]
|
|
Cohort 2: Percentage of Participants With Any Local Reactions for up to 7 Days Following Vaccination
Periodo de tiempo: From Day 1 through Day 7 after Vaccination [Vaccination on Day 1]
|
Local reactions included redness, swelling, and pain at the injection site, were recorded in the e-diary or CRF after vaccination.
Local reactions were graded per the 'Local Reaction Grading Scale' per protocol.
Percentage of participants with at least 1 local reaction of grade 1 and above were reported in this outcome measure.
|
From Day 1 through Day 7 after Vaccination [Vaccination on Day 1]
|
|
Cohort 1: Percentage of Participants With Any Systemic Events for up to 7 Days Following Vaccination
Periodo de tiempo: From Day 1 through Day 7 after Vaccination [Vaccination on Day 1]
|
Systemic Events: fever, diarrhea, vomiting, headache, fatigue/tiredness, chills, new or worsened muscle pain, and new or worsened joint pain, were recorded in the e-diary or CRF after vaccination.
Systemic events were graded per the 'Systemic Events Grading Scale' per protocol.
Percentage of participants with at least 1 systemic event of grade 1 and above were reported in this outcome measure.
|
From Day 1 through Day 7 after Vaccination [Vaccination on Day 1]
|
|
Cohort 2: Percentage of Participants With Any Systemic Events for up to 7 Days Following Vaccination
Periodo de tiempo: From Day 1 through Day 7 after Vaccination [Vaccination on Day 1]
|
Systemic Events: fever, diarrhea, vomiting, headache, fatigue/tiredness, chills, new or worsened muscle pain, and new or worsened joint pain, were recorded in the e-diary or CRF after vaccination.
Systemic events were graded per the 'Systemic Events Grading Scale' per protocol.
Percentage of participants with at least 1 systemic event of grade 1 and above were reported in this outcome measure.
|
From Day 1 through Day 7 after Vaccination [Vaccination on Day 1]
|
|
Cohort 1: Percentage of Participants Reporting Adverse Events (AEs) From Vaccination Through 1 Month After Vaccination
Periodo de tiempo: From Vaccination on Day 1 through 1 month after Vaccination [Vaccination on Day 1]
|
An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention.
AEs included both serious and all non-serious AEs.
Serious AE (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.
Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) were included in this outcome measure.
|
From Vaccination on Day 1 through 1 month after Vaccination [Vaccination on Day 1]
|
|
Cohort 2: Percentage of Participants Reporting AEs From Vaccination Through 1 Month After Vaccination
Periodo de tiempo: From Vaccination on Day 1 through 1 month after Vaccination [Vaccination on Day 1]
|
An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention.
AEs included both serious and all non-serious AEs.
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.
Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) were included in this outcome measure.
|
From Vaccination on Day 1 through 1 month after Vaccination [Vaccination on Day 1]
|
|
Cohort 1: Percentage of Participants Reporting SAEs From Vaccination Through 6 Months After Vaccination
Periodo de tiempo: From Vaccination on Day 1 through 6 Months after Vaccination [Vaccination on Day 1]
|
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, and any other pre-specified criteria in protocol of the study or other important medical event.
Only SAEs collected by non-systematic assessment (excluding local reactions and systematic events [if any]) were included in this outcome measure.
|
From Vaccination on Day 1 through 6 Months after Vaccination [Vaccination on Day 1]
|
|
Cohort 2: Percentage of Participants Reporting SAEs From Vaccination Through 6 Months After Vaccination
Periodo de tiempo: From Vaccination on Day 1 through 6 Months after Vaccination [Vaccination on Day 1]
|
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, and any other pre-specified criteria in protocol of the study or other important medical event.
Only SAEs collected by non-systematic assessment (excluding local reactions and systematic events [if any]) were included in this outcome measure.
|
From Vaccination on Day 1 through 6 Months after Vaccination [Vaccination on Day 1]
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
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)
11 de noviembre de 2024
Finalización primaria (Actual)
15 de julio de 2025
Finalización del estudio (Actual)
15 de julio de 2025
Fechas de registro del estudio
Enviado por primera vez
8 de noviembre de 2024
Primero enviado que cumplió con los criterios de control de calidad
8 de noviembre de 2024
Publicado por primera vez (Actual)
12 de noviembre de 2024
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
19 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
17 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Infecciones del Tracto Respiratorio
- Infecciones
- Infecciones por Orthomyxoviridae
- Infecciones por virus de ARN
- Enfermedades virales
- Enfermedades de las vías respiratorias
- Enfermedades pulmonares
- Neumonía Viral
- Neumonía
- Infecciones por coronavirus
- Infecciones por coronaviridae
- Infecciones por Nidovirales
- COVID-19
- Influenza Humana
- Productos biológicos
- Mezclas complejas
- Vacunas
- Vacunas virales
- Vacunas para COVID-19
Otros números de identificación del estudio
- C5261023
- C5261023-C1; C5261023-C2 (Otro identificador: Alias Study Number)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
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
producto fabricado y exportado desde los 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. .