Un estudio para evaluar la seguridad y la inmunogenicidad de mRNA-1975 y mRNA-1982 contra la enfermedad de Lyme en participantes de 18 a 70 años de edad
6 de julio de 2026 actualizado por: ModernaTX, Inc.
Un estudio de fase 1/2, aleatorizado, observador ciego, controlado con placebo y de rango de dosis para evaluar la seguridad y la inmunogenicidad del ARNm heptavalente-1975 (SR1-7) y el ARNm monovalente-1982 (SR1) en paralelo contra la enfermedad de Lyme en Participantes saludables de 18 a 70 años de edad
El propósito de este estudio es evaluar la seguridad y la inmunogenicidad en paralelo de mRNA-1975 heptavalente y mRNA-1982 monovalente contra la enfermedad de Lyme en participantes adultos sanos.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
807
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
-
-
Connecticut
-
Milford, Connecticut, Estados Unidos, 06460
- Clinical Research Consulting, LLC
-
Stamford, Connecticut, Estados Unidos, 06905
- Stamford Therapeutics Consortium
-
Waterbury, Connecticut, Estados Unidos, 06708
- Chase Medical Research, LLC
-
-
Florida
-
Jacksonville, Florida, Estados Unidos, 32216
- Encore Research Group-Jacksonville Center for Clinical Research
-
Lake Mary, Florida, Estados Unidos, 32746
- University Clinical Research-DeLand, LLC d/b/a Accel Research Sites
-
-
Georgia
-
Stockbridge, Georgia, Estados Unidos, 30281
- Clinical Research Atlanta, headlands LLC
-
-
Kansas
-
Lenexa, Kansas, Estados Unidos, 66219
- Johnson County Clin-Trials, Inc. (JCCT)
-
-
Maryland
-
Columbia, Maryland, Estados Unidos, 21045
- Centennial Medical Group
-
Rockville, Maryland, Estados Unidos, 20850
- Advanced Primary and Geriatric Care
-
-
Massachusetts
-
Brookline, Massachusetts, Estados Unidos, 02445
- DM Clinical Research - Brookline
-
-
Minnesota
-
Minneapolis, Minnesota, Estados Unidos, 55402
- Clinical Research Institute, Inc.
-
-
Nebraska
-
Omaha, Nebraska, Estados Unidos, 68134
- Meridian Clinical Research - Omaha
-
-
New Hampshire
-
Newington, New Hampshire, Estados Unidos, 03801
- ActivMed Research LLC
-
-
New York
-
Rochester, New York, Estados Unidos, 14609
- Rochester Clinical Research, Inc.
-
-
Oklahoma
-
Oklahoma City, Oklahoma, Estados Unidos, 73112
- Lynn Health Science Institute
-
-
Pennsylvania
-
Hatboro, Pennsylvania, Estados Unidos, 19040
- Hatboro Medical Associates/CCT Research
-
-
Rhode Island
-
Providence, Rhode Island, Estados Unidos, 02886
- Velocity Clinical Research Providence
-
-
Texas
-
Fort Worth, Texas, Estados Unidos, 76135
- Benchmark Research
-
Tomball, Texas, Estados Unidos, 77375
- DM Clinical Research
-
-
Virginia
-
Charlottesville, Virginia, Estados Unidos, 22911
- Charlottesville Medical Research Center, LLC
-
-
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:
- Índice de masa corporal de 18 a 39 kilogramos/metro cuadrado (inclusive) en la Visita de Selección.
- Los participantes en edad fértil pueden inscribirse en el estudio.
- Para participantes femeninas en edad fértil: prueba de embarazo negativa, anticoncepción adecuada o se ha abstenido de todas las actividades que podrían resultar en un embarazo durante el período de intervención del estudio, y acuerdo para continuar con la anticoncepción adecuada o la abstinencia durante los 3 meses posteriores a la última inyección del estudio.
Criterio de exclusión:
- Tiene una enfermedad crónica relacionada con la enfermedad de Lyme o una infección sintomática activa de la enfermedad de Lyme según lo sospechado o diagnosticado por un médico.
- Recibió tratamiento para la enfermedad de Lyme en los 3 meses anteriores.
- Se ha vacunado previamente contra la enfermedad de Lyme o ha participado en el pasado en cualquier estudio de vacunas para la enfermedad de Lyme.
- Tuvo una picadura de garrapata dentro de las 4 semanas anteriores a la visita de inyección del estudio.
- Condiciones dermatológicas que podrían afectar las evaluaciones locales de AR solicitadas (por ejemplo, tatuajes, parches de psoriasis que afectan la piel sobre las áreas deltoides).
- Recibió inmunosupresores sistémicos durante >14 días en total dentro de los 180 días anteriores a la visita de selección (para corticosteroides, ≥10 miligramos/día de prednisona o equivalente) o anticipa la necesidad de tratamiento inmunosupresor sistémico en cualquier momento durante la participación en el estudio.
- Antecedentes de miocarditis, pericarditis o miopericarditis independientemente del momento del historial médico anterior.
- Historial de anafilaxia, urticaria u otra reacción adversa significativa que requiera intervención médica después de recibir una vacuna o intervención que incluya uno o más de los mismos componentes contenidos en la inyección del estudio.
- Ha recibido inmunoglobulinas sistémicas, terapias biológicas de acción prolongada que afectan las respuestas inmunitarias (por ejemplo, infliximab) o hemoderivados en los 90 días anteriores a la visita de selección o planea recibirlos durante el estudio.
Nota: Pueden aplicarse otros criterios de inclusión y exclusión.
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: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: ARNm-1975: Dosis 1
Los participantes recibirán 3 inyecciones intramusculares (IM) de la vacuna mRNA-1975 en el nivel de dosis 1 los días 1, 57 y 169.
|
Dispersión entregada IM
Otros nombres:
|
|
Experimental: ARNm-1975: dosis 2
Los participantes recibirán 3 inyecciones IM de la vacuna mRNA-1975 en el nivel de dosis 2 los días 1, 57 y 169.
|
Dispersión entregada IM
Otros nombres:
|
|
Experimental: ARNm-1975: Dosis 3
Los participantes recibirán 3 inyecciones IM de la vacuna mRNA-1975 en el nivel de dosis 3 los días 1, 57 y 169.
|
Dispersión entregada IM
Otros nombres:
|
|
Experimental: ARNm-1975: Dosis 4
Los participantes recibirán 3 inyecciones IM de la vacuna mRNA-1975 en el nivel de dosis 4 los días 1, 57 y 169.
|
Dispersión entregada IM
Otros nombres:
|
|
Experimental: ARNm-1982: Dosis 1
Los participantes recibirán 3 inyecciones IM de la vacuna mRNA-1982 en el nivel de dosis 1 los días 1, 57 y 169.
|
Dispersión entregada IM
Otros nombres:
|
|
Experimental: ARNm-1982: dosis 2
Los participantes recibirán 3 inyecciones IM de la vacuna mRNA-1982 en el nivel de dosis 2 los días 1, 57 y 169.
|
Dispersión entregada IM
Otros nombres:
|
|
Experimental: ARNm-1982: dosis 3
Los participantes recibirán 3 inyecciones IM de la vacuna mRNA-1982 en el nivel de dosis 3 los días 1, 57 y 169.
|
Dispersión entregada IM
Otros nombres:
|
|
Comparador de placebos: Placebo
Los participantes recibirán 3 inyecciones IM de placebo compatible con la vacuna los días 1, 57 y 169.
|
Solución entregada IM
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) Within 7 Days After Day 1 Injection
Periodo de tiempo: Up to 7 days after Day 1 injection
|
Solicited ARs were collected in an electronic diary (eDiary).
Local ARs: injection site pain, erythema (redness), swelling/induration (hardness); and axillary (underarm) swelling or tenderness ipsilateral to the side of injection.
Systemic ARs: fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills.
Note, not all solicited ARs were considered adverse events (AEs).
Investigator reviewed whether the solicited AR was also to be recorded as an AE.
A summary of serious AEs (SAEs) and nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.
|
Up to 7 days after Day 1 injection
|
|
Number of Participants With Solicited Local and Systemic ARs Within 7 Days After Day 57 Injection
Periodo de tiempo: Up to 7 days after Day 57 injection
|
Solicited ARs were collected in an eDiary.
Local ARs: injection site pain, erythema (redness), swelling/induration (hardness); and axillary (underarm) swelling or tenderness ipsilateral to the side of injection.
Systemic ARs: fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills.
Note, not all solicited ARs were considered AEs.
Investigator reviewed whether the solicited AR was also to be recorded as an AE.
A summary of SAEs and nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.
|
Up to 7 days after Day 57 injection
|
|
Number of Participants With Solicited Local and Systemic ARs Within 7 Days After Day 169 Injection
Periodo de tiempo: Up to 7 days after Day 169 injection
|
Solicited ARs were collected in an eDiary.
Local ARs: injection site pain, erythema (redness), swelling/induration (hardness); and axillary (underarm) swelling or tenderness ipsilateral to the side of injection.
Systemic ARs: fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills.
Note, not all solicited ARs were considered AEs.
Investigator reviewed whether the solicited AR was also to be recorded as an AE.
A summary of SAEs and nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.
|
Up to 7 days after Day 169 injection
|
|
Number of Participants With Unsolicited AEs
Periodo de tiempo: Up to 28 days post any injection
|
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.
Any abnormal laboratory test result (hematology, clinical chemistry, or prothrombin time [PT]/partial thromboplastin time [PTT]) or other safety assessment (for example, electrocardiogram, radiological scan, vital sign measurement), including one that worsened from baseline and was considered clinically significant in the medical and scientific judgment of the Investigator was recorded as an AE.
A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.
|
Up to 28 days post any injection
|
|
Number of Participants With Medically Attended AEs (MAAEs), Adverse Events of Special Interest (AESIs), SAEs, and AEs Leading to Study Discontinuation
Periodo de tiempo: Day 1 up to Month 18
|
A MAAE is an AE that led to an unscheduled visit to a healthcare practitioner.
An SAE was defined as any AE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability, was a congenital anomaly/birth defect, or was an important medical event.
An AESI was an AE (serious or nonserious) of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and immediate notification by the Investigator to the Sponsor were required.
A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.
|
Day 1 up to Month 18
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Geometric Mean Concentration (GMC) of Anti-Outer Surface Protein (Anti-OspA) Binding Immunoglobulin (IgG) Antibodies for Serotype (SR-1) Antigen Measured by Enzyme-Linked Immunosorbent Assay (ELISA)
Periodo de tiempo: Days 1, 29, 85 and 197
|
Antibody values reported as below lower limit of quantification (LLOQ) were replaced by 0.5*LLOQ.
Values reported greater than upper limit of quantification (ULOQ) were replaced by the ULOQ.
LLOQ was 41.4 nanograms (ng)/milliliter (mL) and ULOQ was 428000 ng/mL for manual assay; LLOQ was 47.6 ng/mL and 583000 ng/mL for automated assay for SR-1 IgG antibody.
95% confidence interval (CI) for GM value was calculated based on the t-distribution of the log-transformed values , then back transformed to the original scale for presentation.
|
Days 1, 29, 85 and 197
|
|
GMC of Anti-OspA Binding IgG Antibodies for SR-2 Antigen Measured by ELISA
Periodo de tiempo: Days 1, 29, 85, and 197
|
Antibody values reported as below LLOQ were replaced by 0.5*LLOQ.
Values reported greater than ULOQ were replaced by the ULOQ.
LLOQ was 30 ng/mL and ULOQ was 214000 ng/mL for manual assay; LLOQ was 66.6 ng/mL and 215000 ng/mL for automated assay for SR-2 IgG antibody.
95% CI for GM value was calculated based on the t-distribution of the log-transformed values, then back transformed to the original scale for presentation.
Since mRNA-1982 was designed to elicit antibodies against SR-1 antigen only, the data for this outcome measure has been reported for mRNA-1975 and placebo arms only.
|
Days 1, 29, 85, and 197
|
|
GMC of Anti-OspA Binding IgG Antibodies for SR-3 Antigen Measured by ELISA
Periodo de tiempo: Days 1, 29, 85 and 197
|
Antibody values reported as below LLOQ were replaced by 0.5*LLOQ.
Values reported greater than ULOQ were replaced by the ULOQ.
LLOQ was 14.5 ng/mL and ULOQ was 299000 ng/mL for manual assay; LLOQ was 62.5 ng/mL and 296000 ng/mL for automated assay for SR-3 IgG antibody.
95% CI for GM value was calculated based on the t-distribution of the log-transformed values, then back transformed to the original scale for presentation.
Since mRNA-1982 was designed to elicit antibodies against SR-1 antigen only, the data for this outcome measure has been reported for mRNA-1975 and placebo arms only.
|
Days 1, 29, 85 and 197
|
|
GMC of Anti-OspA Binding IgG Antibodies for SR-4 Antigen Measured by ELISA
Periodo de tiempo: Days 1, 29, 85 and 197
|
Antibody values reported as below LLOQ were replaced by 0.5*LLOQ.
Values reported greater than ULOQ were replaced by the ULOQ.
LLOQ was 32.6 ng/mL and ULOQ was 292000 ng/mL for manual assay; LLOQ was 59.7 ng/mL and 264000 ng/mL for automated assay for SR-4 IgG antibody.
95% CI for GM value was calculated based on the t-distribution of the log-transformed values, then back transformed to the original scale for presentation.
Since mRNA-1982 was designed to elicit antibodies against SR-1 antigen only, the data for this outcome measure has been reported for mRNA-1975 and placebo arms only.
|
Days 1, 29, 85 and 197
|
|
GMC of Anti-OspA Binding IgG Antibodies for SR-5 Antigen Measured by ELISA
Periodo de tiempo: Days 1, 29, 85 and 197
|
Antibody values reported as below LLOQ were replaced by 0.5*LLOQ.
Values reported greater than ULOQ were replaced by the ULOQ.
LLOQ was 45.5 ng/mL and ULOQ was 298000 ng/mL for manual assay; LLOQ was 84.2 ng/mL and 319000 ng/mL for automated assay for SR-5 IgG antibody.
95% CI for GM value was calculated based on the t-distribution of the log-transformed values, then back transformed to the original scale for presentation.
Since mRNA-1982 was designed to elicit antibodies against SR-1 antigen only, the data for this outcome measure has been reported for mRNA-1975 and placebo arms only.
|
Days 1, 29, 85 and 197
|
|
GMC of Anti-OspA Binding IgG Antibodies for SR-6 Antigen Measured by ELISA
Periodo de tiempo: Days 1, 29, 85 and 197
|
Antibody values reported as below LLOQ were replaced by 0.5*LLOQ.
Values reported greater than ULOQ were replaced by the ULOQ.
LLOQ was 18.1 ng/mL and ULOQ was 203000 ng/mL for manual assay; LLOQ was 68.7 ng/mL and 248000 ng/mL for automated assay for SR-6 IgG antibody.
95% CI for GM value was calculated based on the t-distribution of the log-transformed values, then back transformed to the original scale for presentation.
Since mRNA-1982 was designed to elicit antibodies against SR-1 antigen only, the data for this outcome measure has been reported for mRNA-1975 and placebo arms only.
|
Days 1, 29, 85 and 197
|
|
GMC of Anti-OspA Binding IgG Antibodies for SR-7 Antigen Measured by ELISA
Periodo de tiempo: Days 1, 29, 85 and 197
|
Antibody values reported as below LLOQ were replaced by 0.5*LLOQ.
Values reported greater than ULOQ were replaced by the ULOQ.
LLOQ was 13 ng/mL and ULOQ was 197000 ng/mL for manual assay; LLOQ was 78.9 ng/mL and 174000 ng/mL for automated assay for SR-7 IgG antibody.
95% CI for GM value was calculated based on the t-distribution of the log-transformed values, then back transformed to the original scale for presentation.
Since mRNA-1982 was designed to elicit antibodies against SR-1 antigen only, the data for this outcome measure has been reported for mRNA-1975 and placebo arms only.
|
Days 1, 29, 85 and 197
|
|
Geometric Mean Fold Rise (GMFR) of Anti-OspA Binding IgG Antibody Concentration for SR-1 Antigen
Periodo de tiempo: Days 29, 85 and 197
|
Antibody values reported as below LLOQ were replaced by 0.5*LLOQ.
Values reported greater than ULOQ were replaced by the ULOQ.
LLOQ was 41.4 ng/mL and ULOQ was 428000 ng/mL for manual assay; LLOQ was 47.6 ng/mL and 583000 ng/mL for automated assay for SR-1 IgG antibody.
95% CI for GMFR value was calculated based on the t-distribution of the difference in the log-transformed values, then back transformed to the original scale for presentation.
|
Days 29, 85 and 197
|
|
GMFR of Anti-OspA Binding IgG Antibody Concentration for SR-2 Antigen
Periodo de tiempo: Days 29, 85 and 197
|
Antibody values reported as below LLOQ were replaced by 0.5*LLOQ.
Values reported greater than ULOQ were replaced by the ULOQ.
LLOQ was 30 ng/mL and ULOQ was 214000 ng/mL for manual assay; LLOQ was 66.6 ng/mL and 215000 ng/mL for automated assay for SR-2 IgG antibody.
95% CI for GMFR value was calculated based on the t-distribution of the difference in the log-transformed values, then back transformed to the original scale for presentation.
Since mRNA-1982 was designed to elicit antibodies against SR-1 antigen only, the data for this outcome measure has been reported for mRNA-1975 and placebo arms only.
|
Days 29, 85 and 197
|
|
GMFR of Anti-OspA Binding IgG Antibody Concentration for SR-3 Antigen
Periodo de tiempo: Days 29, 85 and 197
|
Antibody values reported as below LLOQ were replaced by 0.5*LLOQ.
Values reported greater than ULOQ were replaced by the ULOQ.
LLOQ was 14.5 ng/mL and ULOQ was 299000 ng/mL for manual assay; LLOQ was 62.5 ng/mL and 296000 ng/mL for automated assay for SR-3 IgG antibody.
95% CI for GMFR value was calculated based on the t-distribution of the difference in the log-transformed values, then back transformed to the original scale for presentation.
Since mRNA-1982 was designed to elicit antibodies against SR-1 antigen only, the data for this outcome measure has been reported for mRNA-1975 and placebo arms only.
|
Days 29, 85 and 197
|
|
GMFR of Anti-OspA Binding IgG Antibody Concentration for SR-4 Antigen
Periodo de tiempo: Days 29, 85 and 197
|
Antibody values reported as below LLOQ were replaced by 0.5*LLOQ.
Values reported greater than ULOQ were replaced by the ULOQ.
LLOQ was 32.6 ng/mL and ULOQ was 292000 ng/mL for manual assay; LLOQ was 59.7 ng/mL and 264000 ng/mL for automated assay for SR-4 IgG antibody.
95% CI for GMFR value was calculated based on the t-distribution of the difference in the log-transformed values, then back transformed to the original scale for presentation.
Since mRNA-1982 was designed to elicit antibodies against SR-1 antigen only, the data for this outcome measure has been reported for mRNA-1975 and placebo arms only.
|
Days 29, 85 and 197
|
|
GMFR of Anti-OspA Binding IgG Antibody Concentration for SR-5 Antigen
Periodo de tiempo: Days 29, 85 and 197
|
Antibody values reported as below LLOQ were replaced by 0.5*LLOQ.
Values reported greater than ULOQ were replaced by the ULOQ.
LLOQ was 45.5 ng/mL and ULOQ was 298000 ng/mL for manual assay; LLOQ was 84.2 ng/mL and 319000 ng/mL for automated assay for SR-5 IgG antibody.
95% CI for GMFR value was calculated based on the t-distribution of the difference in the log-transformed values, then back transformed to the original scale for presentation.
Since mRNA-1982 was designed to elicit antibodies against SR-1 antigen only, the data for this outcome measure has been reported for mRNA-1975 and placebo arms only.
|
Days 29, 85 and 197
|
|
GMFR of Anti-OspA Binding IgG Antibody Concentration for SR-6 Antigen
Periodo de tiempo: Days 29, 85 and 197
|
Antibody values reported as below LLOQ were replaced by 0.5*LLOQ.
Values reported greater than ULOQ were replaced by the ULOQ.
LLOQ was 18.1 ng/mL and ULOQ was 203000 ng/mL for manual assay; LLOQ was 68.7 ng/mL and 248000 ng/mL for automated assay for SR-6 IgG antibody.
95% CI for GMFR value was calculated based on the t-distribution of the difference in the log-transformed values, then back transformed to the original scale for presentation.
Since mRNA-1982 was designed to elicit antibodies against SR-1 antigen only, the data for this outcome measure has been reported for mRNA-1975 and placebo arms only.
|
Days 29, 85 and 197
|
|
GMFR of Anti-OspA Binding IgG Antibody Concentration for SR-7 Antigen
Periodo de tiempo: Days 29, 85 and 197
|
Antibody values reported as below LLOQ were replaced by 0.5*LLOQ.
Values reported greater than ULOQ were replaced by the ULOQ.
LLOQ was 13 ng/mL and ULOQ was 197000 ng/mL for manual assay; LLOQ was 78.9 ng/mL and 174000 ng/mL for automated assay for SR-7 IgG antibody.
95% CI for GMFR value was calculated based on the t-distribution of the difference in the log-transformed values, then back transformed to the original scale for presentation.
Since mRNA-1982 was designed to elicit antibodies against SR-1 antigen only, the data for this outcome measure has been reported for mRNA-1975 and placebo arms only.
|
Days 29, 85 and 197
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Number of Deaths Related to Study Drug
Periodo de tiempo: Day 1 up to Month 18
|
A death that occurred during the study or that came to the attention of the investigator during the study was reported to the Sponsor, whether or not it was considered related to study drug.
The investigator assessed causality (that is, whether there is a reasonable possibility that the study drug caused the death).
The relationship was characterized using the following classifications: Not related: There was not a reasonable possibility of a relationship to the study drug.
The temporal sequence of the death relative to administration of the study drug was not reasonable AND/OR the death was more likely explained by a cause other than the study drug.
Related: There was a reasonable possibility of a relationship to the study drug.
There was evidence of exposure to the study drug.
The temporal sequence of the death relative to the administration of the study drug was reasonable.
The death was more likely explained by the study drug than by another cause.
|
Day 1 up to Month 18
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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)
26 de julio de 2023
Finalización primaria (Actual)
30 de mayo de 2025
Finalización del estudio (Actual)
30 de mayo de 2025
Fechas de registro del estudio
Enviado por primera vez
26 de julio de 2023
Primero enviado que cumplió con los criterios de control de calidad
26 de julio de 2023
Publicado por primera vez (Actual)
3 de agosto de 2023
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
30 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
6 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- mRNA-1975/1982-P101
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. .