Un estudio sobre la seguridad, reactogenicidad y respuesta inmune de la vacuna GVGH iNTS-GMMA contra la Salmonella no tifoidea invasiva en adultos, niños y bebés
31 de agosto de 2026 actualizado por: GlaxoSmithKline
Un estudio de intervención de fase IIa, ciego, aleatorizado, controlado, de reducción de edad, de un solo centro, para evaluar la seguridad, la reactogenicidad y la respuesta inmune de la vacuna GVGH iNTS contra S. Typhimurium y S. Enteritidis, en adultos, niños y Lactantes, incluida la búsqueda de dosis en lactantes, en África
El propósito de este estudio es evaluar la seguridad, reactogenicidad y respuesta inmune de los módulos invasivos no tifoideos generalizados de Salmonella para antígenos de membrana (iNTS-GMMA) del Instituto de Vacunas para la Salud Global (GVGH) de GlaxoSmithKline (GSK) contra S. Typhimurium y S. Enteritidis con un enfoque de reducción de la edad y aumento de la dosis en la población africana, comenzando con los adultos (de 18 a 50 años de edad), luego en los niños (de 24 a 59 meses de edad) y finalmente hasta los bebés (de 9 meses y 6 años). semanas de edad).
Los lactantes son el objetivo de la vacunación primaria a partir de las 6 semanas de edad.
Descripción general del estudio
Estado
Terminado
Condiciones
Descripción detallada
El estudio se realizará en dos etapas:
Etapa 1: Reducción de la edad de adultos a niños y bebés
- Los participantes adultos recibirán iNTS-GMMA dosis C (alta) o una vacuna de control por vía intramuscular el día 1 y el día 57.
- Los niños participantes recibirán la dosis B (media) o la dosis C (alta) de la vacuna candidata o el control el día 1 y el día 57.
- Los bebés participantes (9 meses de edad) recibirán la dosis A (baja), la dosis B (media) o la dosis C (alta) de la vacuna candidata o el control el día 1, el día 85 y el día 169.
- Los bebés participantes (6 semanas de edad) recibirán la dosis A (baja), la dosis B (media) o la dosis C (alta) de la vacuna candidata o el control el día 1, el día 85 (fase de preparación) y el día 232. (Fase de refuerzo).
Etapa 2: Búsqueda de dosis en bebés de 6 semanas de edad
-Los bebés (6 semanas de edad) recibirán uno de los tres niveles de dosis (Dosis A [baja], Dosis B [media] o Dosis C [alta]) de la vacuna candidata o el control el día 1, día 85 ( Fase de cebado) y Día 232 (fase de refuerzo).
Tipo de estudio
Intervencionista
Inscripción (Actual)
183
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
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Kumasi, Ghana
- GSK Investigational Site
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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
- Niño
- Adulto
Acepta Voluntarios Saludables
Sí
Descripción
Criterios de inclusión:
Todos los participantes (adultos, niños, bebés de 9 meses de edad y bebés de 6 semanas de edad) se inscribirán en el centro clínico de Ghana y deberán cumplir TODOS los siguientes criterios al ingresar al estudio:
- Los participantes y/o los padres/representantes legalmente aceptables (LAR) de los participantes, quienes, en opinión del investigador, pueden cumplir y cumplirán con los requisitos del protocolo (p. ej., completar las tarjetas del diario, devolver para visitas de seguimiento).
- Consentimiento informado por escrito o presenciado/impreso obtenido del participante/padres/LAR(es) del participante antes de realizar cualquier procedimiento específico del estudio.
- Participantes sanos según lo establecido por el historial médico, el examen clínico y las investigaciones de laboratorio.
- Participantes que cumplan con los requisitos de selección.
- Participantes negativos para el virus de la inmunodeficiencia humana (VIH), hepatitis B y hepatitis C.
Los participantes adultos deben cumplir TODOS los siguientes criterios al ingresar al estudio:
- Un hombre o mujer de entre 18 y 50 años inclusive en el momento de la administración de la primera intervención del estudio.
- Se pueden inscribir en el estudio mujeres participantes en edad no fértil. El potencial no fértil se define como premenarquia, ligadura u oclusión de trompas bilateral actual, histerectomía, ovariectomía bilateral o posmenopausia.
- Las participantes femeninas en edad fértil pueden inscribirse en el estudio si el participante:
ha practicado métodos anticonceptivos adecuados durante 1 mes antes de la administración de la intervención del estudio, y:
- tiene una prueba de embarazo negativa el día de la administración de la intervención del estudio, y
- ha aceptado continuar con la anticoncepción adecuada durante todo el período de tratamiento y durante 1 mes después de completar la serie de administración de intervención del estudio.
La tarjeta de Ghana se utilizará como documento fuente para verificar las edades de los adultos.
Los niños participantes deben cumplir TODOS los siguientes criterios al ingresar al estudio:
- Un hombre o mujer de entre 24 y 59 meses inclusive de edad en el momento de la administración de la primera intervención del estudio.
- Vacunas infantiles de rutina previamente completadas según el mejor conocimiento de los padres/LAR del participante.
- Nacidos después de un período de gestación de ≥37 semanas.
Los bebés participantes deben cumplir TODOS los siguientes criterios al ingresar al estudio:
- Un hombre o mujer de 6 semanas o 9 meses de edad en el momento de la primera administración de la intervención del estudio.
- Nacidos después de un período de gestación de ≥37 semanas.
- Nacido de madre seronegativa para VIH, virus de la hepatitis B y virus de la hepatitis C.
El Cuadro del camino hacia la salud se utilizará como documento fuente para confirmar las edades de los niños y bebés.
Criterio de exclusión:
Condiciones médicas
- Exposición conocida a S. Typhimurium o S. Enteritidis durante el período que comienza en el nacimiento para bebés y niños, y a los 3 años para adultos, según lo documentado en los registros de los pacientes.
- Antecedentes de cualquier reacción o hipersensibilidad que pueda verse exacerbada por cualquier componente de las intervenciones del estudio.
- Hipersensibilidad, incluida alergia, a medicamentos o equipos médicos cuyo uso esté previsto en este estudio.
- Condiciones clínicas progresivas, inestables o incontroladas.
- Cualquier condición inmunosupresora o inmunodeficiente confirmada o sospechada, según el historial médico y el examen físico.
- Defectos congénitos mayores, según la evaluación del investigador.
- Anomalía funcional aguda o crónica clínicamente significativa pulmonar, cardiovascular, hepática o renal, según lo determinado mediante examen físico o pruebas de detección de laboratorio.
- Enfermedad aguda y/o fiebre en el momento de la inscripción (la fiebre se define como temperatura ≥ 38,0°C).
- Historia recurrente o trastornos neurológicos no controlados o convulsiones.
- Cualquier anomalía de laboratorio hematológica y/o bioquímica clínicamente significativa.
- La desnutrición se define como un puntaje Z de la OMS inferior a -2 DE.
- Infección por malaria definida como la presencia de parásitos asexuales en la sangre.
- Condiciones clínicas que representan una contraindicación para la vacunación intramuscular y las extracciones de sangre.
- Cualquier deterioro conductual o cognitivo o enfermedad psiquiátrica que, a juicio del investigador, pueda interferir con la capacidad del participante para participar en el estudio.
- Cualquier otra condición clínica que, a juicio del investigador, pueda suponer un riesgo adicional para el participante por su participación en el estudio.
Terapia previa/concomitante
- Historial de recepción de vacunas iNTS o GMMA en investigación en la vida del participante.
- Uso de cualquier producto en investigación o no registrado distinto de las intervenciones del estudio durante el período que comienza 30 días antes de la primera dosis de las intervenciones del estudio, o su uso planificado durante el período del estudio.
- Administración/administración planificada de una vacuna no prevista en el protocolo del estudio en el período que comienza 14 días antes de cada dosis y finaliza 28 días después de la última dosis de la administración de las intervenciones del estudio, con excepción de las vacunas contra la gripe y las vacunas administradas como parte de un programa de salud pública. campaña de vacunación.
Una vacuna no prevista en el protocolo del estudio administrada durante el período que comienza 14 días antes de la primera dosis y finaliza 14 días después de la última dosis de la administración de las intervenciones del estudio para vacunas vivas o 7 días en el caso de vacunas inactivadas*, con excepción de la gripe. vacunas o la vacuna COVID-19, que pueden considerarse caso por caso.
- Si las autoridades de salud pública organizan una vacunación masiva de emergencia para una amenaza imprevista a la salud pública (por ejemplo, una pandemia) fuera del programa de inmunización de rutina, el período de tiempo descrito anteriormente puede reducirse si, siempre que se utilice de acuerdo con las recomendaciones del gobierno local y el Patrocinador. es notificado.
En tales circunstancias, un participante puede considerarse elegible para la inscripción en el estudio y/o la administración de la intervención del estudio después de que haya pasado el período de demora apropiado y se hayan vuelto a verificar los criterios de inclusión/exclusión, y si se confirma que el participante es elegible.
- Administración de fármacos modificadores del sistema inmunológico de acción prolongada en cualquier momento durante el período del estudio.
- Administración de inmunoglobulinas y/o cualquier producto sanguíneo o derivado plasmático desde el nacimiento (para bebés de 6 semanas de edad) o durante el período que comienza 3 meses antes de la administración de la primera dosis de las intervenciones del estudio o la administración planificada durante el período del estudio.
- Administración crónica (definida como más de 14 días en total) de inmunosupresores u otros medicamentos inmunomodificadores durante el período que comienza 3 meses antes de la primera dosis de intervención del estudio hasta el final del estudio. Para los corticosteroides, esto significará un equivalente de prednisona mayor o igual a (>=) 20 mg/día para participantes adultos/>= 0,5 mg/kg/día con un máximo de 20 mg/día para participantes pediátricos (bebés y niños). Se permiten esteroides inhalados y tópicos.
Experiencia previa/concurrente en estudios clínicos
• Participar simultáneamente en otro estudio clínico, en cualquier momento durante el período del estudio, en el que el participante haya estado o estará expuesto a una intervención en investigación o no en investigación (vacuna, medicamento y dispositivo).
Otras exclusiones
- Mujer gestante o lactante.
- Mujer que planea quedar embarazada o planea suspender las precauciones anticonceptivas.
- Historial de consumo crónico actual de alcohol y/o abuso de drogas. Esto se decidirá a discreción del investigador.
- Cualquier personal del estudio o sus dependientes inmediatos, familiares o miembros del hogar.
- Niño bajo cuidado.
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 Secuencial
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Adults_Dose C Group
Adults, 18-50 years of age, will receive 2 doses of the iNTS-GMMA Dose C (high dose) vaccine at Day 1 and Day 57.
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-2 doses of iNTS-GMMA Dose C vaccine administered intramuscularly, at Day 1 and Day 57 to adults and children in the Adults_Dose C and Children_Dose C groups; -3 doses of iNTS-GMMA Dose C vaccine administered intramuscularly, at Day 1, Day 85 and Day 169 to infants in the Infants_9M_Dose C group, and at Day 1, Day 57 and at Day 232 to infants in the Infants_6W_Dose C group.
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Comparador activo: Adults_Control Group
Adults, 18-50 years of age, will receive 1 dose of the MenACWY vaccine at Day 1 and 1 dose of Placebo at Day 57.
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1 dosis de Placebo administrada por vía intramuscular el día 57 a adultos del grupo Adultos_Control.
-1 dose of MenACWY vaccine administered intramuscularly at Day 1 to adults in the Adults_Control group; -2 doses of MenACWY vaccine administered intramuscularly at Day 1 and Day 57 to children in the Children_Control B and Children_Control C groups, and at Day 1 and Day 85 to infants in the Infants_9M_Control A, Infants_9M_Control B and Infants_9M_Control C groups; -3 doses of MenACWY vaccine administered intramuscularly at Day 1, Day 57 and at Day 232 to infants in the Infants_6W_Control A, Infants_6W_Control B and Infants_6W_Control C groups.
A 4th dose of MenACWY vaccine is administered after the trial ends, to infants in the aforementioned study groups, as per the licensed indication and in private vaccination settings.
Otros nombres:
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Experimental: Children_Dose B Group
Children, 24-59 months of age, will receive 2 doses of the iNTS-GMMA Dose B (medium dose) vaccine at Day 1 and Day 57.
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-2 doses of iNTS-GMMA Dose B vaccine administered intramuscularly, at Day 1 and Day 57 to children in the Children_Dose B group; -3 doses of iNTS-GMMA Dose B vaccine administered intramuscularly, at Day 1, Day 85 and Day 169 to infants in the Infants_9M_Dose B group, and at Day 1, Day 57 and Day at 232 to infants in the Infants_6W_Dose B group.
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Comparador activo: Children_Control B Group
Children, 24-59 months of age, will receive 2 doses of the MenACWY vaccine at Day 1 and Day 57.
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-1 dose of MenACWY vaccine administered intramuscularly at Day 1 to adults in the Adults_Control group; -2 doses of MenACWY vaccine administered intramuscularly at Day 1 and Day 57 to children in the Children_Control B and Children_Control C groups, and at Day 1 and Day 85 to infants in the Infants_9M_Control A, Infants_9M_Control B and Infants_9M_Control C groups; -3 doses of MenACWY vaccine administered intramuscularly at Day 1, Day 57 and at Day 232 to infants in the Infants_6W_Control A, Infants_6W_Control B and Infants_6W_Control C groups.
A 4th dose of MenACWY vaccine is administered after the trial ends, to infants in the aforementioned study groups, as per the licensed indication and in private vaccination settings.
Otros nombres:
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Experimental: Children_Dose C Group
Children, 24-59 months of age, will receive 2 doses of the iNTS-GMMA Dose C (high dose) vaccine at Day 1 and Day 57.
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-2 doses of iNTS-GMMA Dose C vaccine administered intramuscularly, at Day 1 and Day 57 to adults and children in the Adults_Dose C and Children_Dose C groups; -3 doses of iNTS-GMMA Dose C vaccine administered intramuscularly, at Day 1, Day 85 and Day 169 to infants in the Infants_9M_Dose C group, and at Day 1, Day 57 and at Day 232 to infants in the Infants_6W_Dose C group.
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Comparador activo: Children_Control C Group
Children, 24-59 months of age, will receive 2 doses of the MenACWY vaccine at Day 1 and Day 57.
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-1 dose of MenACWY vaccine administered intramuscularly at Day 1 to adults in the Adults_Control group; -2 doses of MenACWY vaccine administered intramuscularly at Day 1 and Day 57 to children in the Children_Control B and Children_Control C groups, and at Day 1 and Day 85 to infants in the Infants_9M_Control A, Infants_9M_Control B and Infants_9M_Control C groups; -3 doses of MenACWY vaccine administered intramuscularly at Day 1, Day 57 and at Day 232 to infants in the Infants_6W_Control A, Infants_6W_Control B and Infants_6W_Control C groups.
A 4th dose of MenACWY vaccine is administered after the trial ends, to infants in the aforementioned study groups, as per the licensed indication and in private vaccination settings.
Otros nombres:
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Experimental: Infants_9M_Dose A Group
Infants, 9 months of age, will receive 3 doses of the iNTS-GMMA Dose A (low dose) vaccine at Day 1, Day 85 and Day 169.
These infants will also receive an Expanded Program on Immunization (EPI) vaccination with Measles and Rubella Vaccine (MR-VAC) and Yellow Fever (YF) vaccine at 28 days after the first study intervention administration occurring at Day 1, at the local EPI vaccination centers, and not part of the current clinical trial.
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3 doses of iNTS-GMMA Dose A vaccine administered intramuscularly, at Day 1, Day 85 and Day 169 to infants in the Infants_9M_Dose A group, and at Day 1, Day 57 and Day at 232 to infants in the Infants_6W_Dose A group.
Measles and Rubella vaccine is administered to study participants, as part of an Expanded Program on Immunization (EPI) vaccination at the local EPI vaccination centers, and not part of the current clinical trial, as follows: - at 28 days after the first study intervention administration (occurring at Day 1) to infants in the Infants_9M_Dose A, Infants_9M_Control A, Infants_9M_Dose B, Infants_9M_Control B, Infants_9M_Dose C and Infants_9M_Control C groups.
- at 28 days after the third study intervention administration (occurring at Day 232) to infants in Infants_6W_Dose A, Infants_6W_Control A, Infants_6W_Dose B, Infants_6W_Control B, Infants_6W_Dose C and Infants_6W_Control C groups.
Otros nombres:
Yellow Fever vaccine is administered to study participants, as part of an Expanded Program on Immunization (EPI) vaccination at the local EPI vaccination centers, and not part of the current clinical trial, as follows: - at 28 days after the first study intervention administration (occurring at Day 1) to infants in the Infants_9M_Dose A, Infants_9M_Control A, Infants_9M_Dose B, Infants_9M_Control B, Infants_9M_Dose C and Infants_9M_Control C groups.
- at 28 days after the third study intervention administration (occurring at Day 232) to infants in Infants_6W_Dose A, Infants_6W_Control A, Infants_6W_Dose B, Infants_6W_Control B, Infants_6W_Dose C and Infants_6W_Control C groups.
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Comparador activo: Infants_9M_Control A Group
Infants, 9 months of age, will receive 2 doses of the MenACWY vaccine at Day 1 and Day 85 and 1 dose of the DTPa-HBV-IPV+Hib vaccine at Day 169.
These infants will also receive an EPI vaccination with MR-VAC and YF vaccine at 28 days after the first study intervention administration occurring at Day 1, at the local EPI vaccination centers, and not part of the current clinical trial.
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1 dosis de la vacuna DTPa-HBV-IPV+Hib administrada por vía intramuscular el día 169 a los bebés de los grupos Infants_9M_Control A, Infants_9M_Control B y Infants_9M_Control C.
Otros nombres:
-1 dose of MenACWY vaccine administered intramuscularly at Day 1 to adults in the Adults_Control group; -2 doses of MenACWY vaccine administered intramuscularly at Day 1 and Day 57 to children in the Children_Control B and Children_Control C groups, and at Day 1 and Day 85 to infants in the Infants_9M_Control A, Infants_9M_Control B and Infants_9M_Control C groups; -3 doses of MenACWY vaccine administered intramuscularly at Day 1, Day 57 and at Day 232 to infants in the Infants_6W_Control A, Infants_6W_Control B and Infants_6W_Control C groups.
A 4th dose of MenACWY vaccine is administered after the trial ends, to infants in the aforementioned study groups, as per the licensed indication and in private vaccination settings.
Otros nombres:
Measles and Rubella vaccine is administered to study participants, as part of an Expanded Program on Immunization (EPI) vaccination at the local EPI vaccination centers, and not part of the current clinical trial, as follows: - at 28 days after the first study intervention administration (occurring at Day 1) to infants in the Infants_9M_Dose A, Infants_9M_Control A, Infants_9M_Dose B, Infants_9M_Control B, Infants_9M_Dose C and Infants_9M_Control C groups.
- at 28 days after the third study intervention administration (occurring at Day 232) to infants in Infants_6W_Dose A, Infants_6W_Control A, Infants_6W_Dose B, Infants_6W_Control B, Infants_6W_Dose C and Infants_6W_Control C groups.
Otros nombres:
Yellow Fever vaccine is administered to study participants, as part of an Expanded Program on Immunization (EPI) vaccination at the local EPI vaccination centers, and not part of the current clinical trial, as follows: - at 28 days after the first study intervention administration (occurring at Day 1) to infants in the Infants_9M_Dose A, Infants_9M_Control A, Infants_9M_Dose B, Infants_9M_Control B, Infants_9M_Dose C and Infants_9M_Control C groups.
- at 28 days after the third study intervention administration (occurring at Day 232) to infants in Infants_6W_Dose A, Infants_6W_Control A, Infants_6W_Dose B, Infants_6W_Control B, Infants_6W_Dose C and Infants_6W_Control C groups.
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Experimental: Infants_9M_Dose B Group
Infants, 9 months of age, will receive 3 doses of the iNTS-GMMA Dose B (medium dose) vaccine at Day 1, Day 85 and Day 169.
These infants will also receive an EPI vaccination withMR-VAC and YF vaccine at 28 days after the first study intervention administration occurring at Day 1, at the local EPI vaccination centers, and not part of the current clinical trial.
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-2 doses of iNTS-GMMA Dose B vaccine administered intramuscularly, at Day 1 and Day 57 to children in the Children_Dose B group; -3 doses of iNTS-GMMA Dose B vaccine administered intramuscularly, at Day 1, Day 85 and Day 169 to infants in the Infants_9M_Dose B group, and at Day 1, Day 57 and Day at 232 to infants in the Infants_6W_Dose B group.
Measles and Rubella vaccine is administered to study participants, as part of an Expanded Program on Immunization (EPI) vaccination at the local EPI vaccination centers, and not part of the current clinical trial, as follows: - at 28 days after the first study intervention administration (occurring at Day 1) to infants in the Infants_9M_Dose A, Infants_9M_Control A, Infants_9M_Dose B, Infants_9M_Control B, Infants_9M_Dose C and Infants_9M_Control C groups.
- at 28 days after the third study intervention administration (occurring at Day 232) to infants in Infants_6W_Dose A, Infants_6W_Control A, Infants_6W_Dose B, Infants_6W_Control B, Infants_6W_Dose C and Infants_6W_Control C groups.
Otros nombres:
Yellow Fever vaccine is administered to study participants, as part of an Expanded Program on Immunization (EPI) vaccination at the local EPI vaccination centers, and not part of the current clinical trial, as follows: - at 28 days after the first study intervention administration (occurring at Day 1) to infants in the Infants_9M_Dose A, Infants_9M_Control A, Infants_9M_Dose B, Infants_9M_Control B, Infants_9M_Dose C and Infants_9M_Control C groups.
- at 28 days after the third study intervention administration (occurring at Day 232) to infants in Infants_6W_Dose A, Infants_6W_Control A, Infants_6W_Dose B, Infants_6W_Control B, Infants_6W_Dose C and Infants_6W_Control C groups.
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Comparador activo: Infants_9M_Control B Group
Infants, 9 months of age, will receive 2 doses of the MenACWY vaccine at Day 1 and Day 85 and 1 dose of the DTPa-HBV-IPV+Hib vaccine at Day 169.
These infants will also receive an EPI vaccination with MR-VAC and YF vaccine at 28 days after the first study intervention administration occurring at Day 1, at the local EPI vaccination centers, and not part of the current clinical trial.
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1 dosis de la vacuna DTPa-HBV-IPV+Hib administrada por vía intramuscular el día 169 a los bebés de los grupos Infants_9M_Control A, Infants_9M_Control B y Infants_9M_Control C.
Otros nombres:
-1 dose of MenACWY vaccine administered intramuscularly at Day 1 to adults in the Adults_Control group; -2 doses of MenACWY vaccine administered intramuscularly at Day 1 and Day 57 to children in the Children_Control B and Children_Control C groups, and at Day 1 and Day 85 to infants in the Infants_9M_Control A, Infants_9M_Control B and Infants_9M_Control C groups; -3 doses of MenACWY vaccine administered intramuscularly at Day 1, Day 57 and at Day 232 to infants in the Infants_6W_Control A, Infants_6W_Control B and Infants_6W_Control C groups.
A 4th dose of MenACWY vaccine is administered after the trial ends, to infants in the aforementioned study groups, as per the licensed indication and in private vaccination settings.
Otros nombres:
Measles and Rubella vaccine is administered to study participants, as part of an Expanded Program on Immunization (EPI) vaccination at the local EPI vaccination centers, and not part of the current clinical trial, as follows: - at 28 days after the first study intervention administration (occurring at Day 1) to infants in the Infants_9M_Dose A, Infants_9M_Control A, Infants_9M_Dose B, Infants_9M_Control B, Infants_9M_Dose C and Infants_9M_Control C groups.
- at 28 days after the third study intervention administration (occurring at Day 232) to infants in Infants_6W_Dose A, Infants_6W_Control A, Infants_6W_Dose B, Infants_6W_Control B, Infants_6W_Dose C and Infants_6W_Control C groups.
Otros nombres:
Yellow Fever vaccine is administered to study participants, as part of an Expanded Program on Immunization (EPI) vaccination at the local EPI vaccination centers, and not part of the current clinical trial, as follows: - at 28 days after the first study intervention administration (occurring at Day 1) to infants in the Infants_9M_Dose A, Infants_9M_Control A, Infants_9M_Dose B, Infants_9M_Control B, Infants_9M_Dose C and Infants_9M_Control C groups.
- at 28 days after the third study intervention administration (occurring at Day 232) to infants in Infants_6W_Dose A, Infants_6W_Control A, Infants_6W_Dose B, Infants_6W_Control B, Infants_6W_Dose C and Infants_6W_Control C groups.
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Experimental: Infants_9M_Dose C Group
Infants, 9 months of age, will receive 3 doses of the iNTS-GMMA Dose C (high dose) vaccine at Day 1, Day 85 and Day 169.
These infants will also receive an EPI vaccination with MR-VAC and YF vaccine at 28 days after the first study intervention administration occurring at Day 1, at the local EPI vaccination centers, and not part of the current clinical trial.
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-2 doses of iNTS-GMMA Dose C vaccine administered intramuscularly, at Day 1 and Day 57 to adults and children in the Adults_Dose C and Children_Dose C groups; -3 doses of iNTS-GMMA Dose C vaccine administered intramuscularly, at Day 1, Day 85 and Day 169 to infants in the Infants_9M_Dose C group, and at Day 1, Day 57 and at Day 232 to infants in the Infants_6W_Dose C group.
Measles and Rubella vaccine is administered to study participants, as part of an Expanded Program on Immunization (EPI) vaccination at the local EPI vaccination centers, and not part of the current clinical trial, as follows: - at 28 days after the first study intervention administration (occurring at Day 1) to infants in the Infants_9M_Dose A, Infants_9M_Control A, Infants_9M_Dose B, Infants_9M_Control B, Infants_9M_Dose C and Infants_9M_Control C groups.
- at 28 days after the third study intervention administration (occurring at Day 232) to infants in Infants_6W_Dose A, Infants_6W_Control A, Infants_6W_Dose B, Infants_6W_Control B, Infants_6W_Dose C and Infants_6W_Control C groups.
Otros nombres:
Yellow Fever vaccine is administered to study participants, as part of an Expanded Program on Immunization (EPI) vaccination at the local EPI vaccination centers, and not part of the current clinical trial, as follows: - at 28 days after the first study intervention administration (occurring at Day 1) to infants in the Infants_9M_Dose A, Infants_9M_Control A, Infants_9M_Dose B, Infants_9M_Control B, Infants_9M_Dose C and Infants_9M_Control C groups.
- at 28 days after the third study intervention administration (occurring at Day 232) to infants in Infants_6W_Dose A, Infants_6W_Control A, Infants_6W_Dose B, Infants_6W_Control B, Infants_6W_Dose C and Infants_6W_Control C groups.
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Comparador activo: Infants_9M_Control C Group
Infants, 9 months of age, will receive 2 doses of the MenACWY vaccine at Day 1 and Day 85 and 1 dose of the DTPa-HBV-IPV+Hib vaccine at Day 169.
These infants will also receive an EPI vaccination with MR-VAC and YF vaccine at 28 days after the first study intervention administration occurring at Day 1, at the local EPI vaccination centers, and not part of the current clinical trial.
|
1 dosis de la vacuna DTPa-HBV-IPV+Hib administrada por vía intramuscular el día 169 a los bebés de los grupos Infants_9M_Control A, Infants_9M_Control B y Infants_9M_Control C.
Otros nombres:
-1 dose of MenACWY vaccine administered intramuscularly at Day 1 to adults in the Adults_Control group; -2 doses of MenACWY vaccine administered intramuscularly at Day 1 and Day 57 to children in the Children_Control B and Children_Control C groups, and at Day 1 and Day 85 to infants in the Infants_9M_Control A, Infants_9M_Control B and Infants_9M_Control C groups; -3 doses of MenACWY vaccine administered intramuscularly at Day 1, Day 57 and at Day 232 to infants in the Infants_6W_Control A, Infants_6W_Control B and Infants_6W_Control C groups.
A 4th dose of MenACWY vaccine is administered after the trial ends, to infants in the aforementioned study groups, as per the licensed indication and in private vaccination settings.
Otros nombres:
Measles and Rubella vaccine is administered to study participants, as part of an Expanded Program on Immunization (EPI) vaccination at the local EPI vaccination centers, and not part of the current clinical trial, as follows: - at 28 days after the first study intervention administration (occurring at Day 1) to infants in the Infants_9M_Dose A, Infants_9M_Control A, Infants_9M_Dose B, Infants_9M_Control B, Infants_9M_Dose C and Infants_9M_Control C groups.
- at 28 days after the third study intervention administration (occurring at Day 232) to infants in Infants_6W_Dose A, Infants_6W_Control A, Infants_6W_Dose B, Infants_6W_Control B, Infants_6W_Dose C and Infants_6W_Control C groups.
Otros nombres:
Yellow Fever vaccine is administered to study participants, as part of an Expanded Program on Immunization (EPI) vaccination at the local EPI vaccination centers, and not part of the current clinical trial, as follows: - at 28 days after the first study intervention administration (occurring at Day 1) to infants in the Infants_9M_Dose A, Infants_9M_Control A, Infants_9M_Dose B, Infants_9M_Control B, Infants_9M_Dose C and Infants_9M_Control C groups.
- at 28 days after the third study intervention administration (occurring at Day 232) to infants in Infants_6W_Dose A, Infants_6W_Control A, Infants_6W_Dose B, Infants_6W_Control B, Infants_6W_Dose C and Infants_6W_Control C groups.
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Experimental: Infants_6W_Dose A Group
Infants, 6 weeks of age, will receive 3 doses of the iNTS-GMMA Dose A (low dose) vaccine at Day 1, Day 57 and at Day 232.
These infants will also receive an EPI vaccination with MR-VAC and YF vaccine at 28 days after the third study intervention administration occurring at Day 232, at the local EPI vaccination centers, and not part of the current clinical trial.
|
3 doses of iNTS-GMMA Dose A vaccine administered intramuscularly, at Day 1, Day 85 and Day 169 to infants in the Infants_9M_Dose A group, and at Day 1, Day 57 and Day at 232 to infants in the Infants_6W_Dose A group.
Measles and Rubella vaccine is administered to study participants, as part of an Expanded Program on Immunization (EPI) vaccination at the local EPI vaccination centers, and not part of the current clinical trial, as follows: - at 28 days after the first study intervention administration (occurring at Day 1) to infants in the Infants_9M_Dose A, Infants_9M_Control A, Infants_9M_Dose B, Infants_9M_Control B, Infants_9M_Dose C and Infants_9M_Control C groups.
- at 28 days after the third study intervention administration (occurring at Day 232) to infants in Infants_6W_Dose A, Infants_6W_Control A, Infants_6W_Dose B, Infants_6W_Control B, Infants_6W_Dose C and Infants_6W_Control C groups.
Otros nombres:
Yellow Fever vaccine is administered to study participants, as part of an Expanded Program on Immunization (EPI) vaccination at the local EPI vaccination centers, and not part of the current clinical trial, as follows: - at 28 days after the first study intervention administration (occurring at Day 1) to infants in the Infants_9M_Dose A, Infants_9M_Control A, Infants_9M_Dose B, Infants_9M_Control B, Infants_9M_Dose C and Infants_9M_Control C groups.
- at 28 days after the third study intervention administration (occurring at Day 232) to infants in Infants_6W_Dose A, Infants_6W_Control A, Infants_6W_Dose B, Infants_6W_Control B, Infants_6W_Dose C and Infants_6W_Control C groups.
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Comparador activo: Infants_6W_Control A Group
Infants, 6 weeks of age, will receive 3 doses of the MenACWY vaccine at Day 1, Day 57 and at Day 232 To allow completion of the vaccination schedule, a fourth dose of the MenACWY vaccine is administered after the trial ends, as per the licensed indication and in private vaccination settings.
These infants also will receive an EPI vaccination with MR-VAC and YF vaccine at 28 days after the third study intervention administration occurring at Day 232, at the local EPI vaccination centers, and not part of the current clinical trial.
|
-1 dose of MenACWY vaccine administered intramuscularly at Day 1 to adults in the Adults_Control group; -2 doses of MenACWY vaccine administered intramuscularly at Day 1 and Day 57 to children in the Children_Control B and Children_Control C groups, and at Day 1 and Day 85 to infants in the Infants_9M_Control A, Infants_9M_Control B and Infants_9M_Control C groups; -3 doses of MenACWY vaccine administered intramuscularly at Day 1, Day 57 and at Day 232 to infants in the Infants_6W_Control A, Infants_6W_Control B and Infants_6W_Control C groups.
A 4th dose of MenACWY vaccine is administered after the trial ends, to infants in the aforementioned study groups, as per the licensed indication and in private vaccination settings.
Otros nombres:
Measles and Rubella vaccine is administered to study participants, as part of an Expanded Program on Immunization (EPI) vaccination at the local EPI vaccination centers, and not part of the current clinical trial, as follows: - at 28 days after the first study intervention administration (occurring at Day 1) to infants in the Infants_9M_Dose A, Infants_9M_Control A, Infants_9M_Dose B, Infants_9M_Control B, Infants_9M_Dose C and Infants_9M_Control C groups.
- at 28 days after the third study intervention administration (occurring at Day 232) to infants in Infants_6W_Dose A, Infants_6W_Control A, Infants_6W_Dose B, Infants_6W_Control B, Infants_6W_Dose C and Infants_6W_Control C groups.
Otros nombres:
Yellow Fever vaccine is administered to study participants, as part of an Expanded Program on Immunization (EPI) vaccination at the local EPI vaccination centers, and not part of the current clinical trial, as follows: - at 28 days after the first study intervention administration (occurring at Day 1) to infants in the Infants_9M_Dose A, Infants_9M_Control A, Infants_9M_Dose B, Infants_9M_Control B, Infants_9M_Dose C and Infants_9M_Control C groups.
- at 28 days after the third study intervention administration (occurring at Day 232) to infants in Infants_6W_Dose A, Infants_6W_Control A, Infants_6W_Dose B, Infants_6W_Control B, Infants_6W_Dose C and Infants_6W_Control C groups.
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Experimental: Infants_6W_Dose B Group
Infants, 6 weeks of age, will receive 3 doses of the iNTS-GMMA Dose B (medium dose) vaccine at Day 1, Day 57 and at Day 232.
These infants will also receive an EPI vaccination with MR-VAC and YF vaccine at 28 days after the third study intervention administration occurring at Day 232, at the local EPI vaccination centers, and not part of the current clinical trial.
|
-2 doses of iNTS-GMMA Dose B vaccine administered intramuscularly, at Day 1 and Day 57 to children in the Children_Dose B group; -3 doses of iNTS-GMMA Dose B vaccine administered intramuscularly, at Day 1, Day 85 and Day 169 to infants in the Infants_9M_Dose B group, and at Day 1, Day 57 and Day at 232 to infants in the Infants_6W_Dose B group.
Measles and Rubella vaccine is administered to study participants, as part of an Expanded Program on Immunization (EPI) vaccination at the local EPI vaccination centers, and not part of the current clinical trial, as follows: - at 28 days after the first study intervention administration (occurring at Day 1) to infants in the Infants_9M_Dose A, Infants_9M_Control A, Infants_9M_Dose B, Infants_9M_Control B, Infants_9M_Dose C and Infants_9M_Control C groups.
- at 28 days after the third study intervention administration (occurring at Day 232) to infants in Infants_6W_Dose A, Infants_6W_Control A, Infants_6W_Dose B, Infants_6W_Control B, Infants_6W_Dose C and Infants_6W_Control C groups.
Otros nombres:
Yellow Fever vaccine is administered to study participants, as part of an Expanded Program on Immunization (EPI) vaccination at the local EPI vaccination centers, and not part of the current clinical trial, as follows: - at 28 days after the first study intervention administration (occurring at Day 1) to infants in the Infants_9M_Dose A, Infants_9M_Control A, Infants_9M_Dose B, Infants_9M_Control B, Infants_9M_Dose C and Infants_9M_Control C groups.
- at 28 days after the third study intervention administration (occurring at Day 232) to infants in Infants_6W_Dose A, Infants_6W_Control A, Infants_6W_Dose B, Infants_6W_Control B, Infants_6W_Dose C and Infants_6W_Control C groups.
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Comparador activo: Infants_6W_Control B Group
Infants ,6 weeks of age, will receive 3 doses of the MenACWY vaccine at Day 1, Day 57 and at Day 232.
To allow completion of the vaccination schedule, a fourth dose of the MenACWY vaccine is administered after the trial ends, as per the licensed indication and in private vaccination settings.
These infants will also receive an EPI vaccination with MR-VAC and YF vaccine at 28 days after the third study intervention administration occurring at Day 232, at the local EPI vaccination centers, and not part of the current clinical trial.
|
-1 dose of MenACWY vaccine administered intramuscularly at Day 1 to adults in the Adults_Control group; -2 doses of MenACWY vaccine administered intramuscularly at Day 1 and Day 57 to children in the Children_Control B and Children_Control C groups, and at Day 1 and Day 85 to infants in the Infants_9M_Control A, Infants_9M_Control B and Infants_9M_Control C groups; -3 doses of MenACWY vaccine administered intramuscularly at Day 1, Day 57 and at Day 232 to infants in the Infants_6W_Control A, Infants_6W_Control B and Infants_6W_Control C groups.
A 4th dose of MenACWY vaccine is administered after the trial ends, to infants in the aforementioned study groups, as per the licensed indication and in private vaccination settings.
Otros nombres:
Measles and Rubella vaccine is administered to study participants, as part of an Expanded Program on Immunization (EPI) vaccination at the local EPI vaccination centers, and not part of the current clinical trial, as follows: - at 28 days after the first study intervention administration (occurring at Day 1) to infants in the Infants_9M_Dose A, Infants_9M_Control A, Infants_9M_Dose B, Infants_9M_Control B, Infants_9M_Dose C and Infants_9M_Control C groups.
- at 28 days after the third study intervention administration (occurring at Day 232) to infants in Infants_6W_Dose A, Infants_6W_Control A, Infants_6W_Dose B, Infants_6W_Control B, Infants_6W_Dose C and Infants_6W_Control C groups.
Otros nombres:
Yellow Fever vaccine is administered to study participants, as part of an Expanded Program on Immunization (EPI) vaccination at the local EPI vaccination centers, and not part of the current clinical trial, as follows: - at 28 days after the first study intervention administration (occurring at Day 1) to infants in the Infants_9M_Dose A, Infants_9M_Control A, Infants_9M_Dose B, Infants_9M_Control B, Infants_9M_Dose C and Infants_9M_Control C groups.
- at 28 days after the third study intervention administration (occurring at Day 232) to infants in Infants_6W_Dose A, Infants_6W_Control A, Infants_6W_Dose B, Infants_6W_Control B, Infants_6W_Dose C and Infants_6W_Control C groups.
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Experimental: Infants_6W_Dose C Group
Infants ,6 weeks of age, will receive 3 doses of the iNTS-GMMA Dose C (high dose) vaccine at Day 1, Day 57 and at Day 232.
These infants will also receive an EPI vaccination with MR-VAC and YF vaccine at 28 days after the third study intervention administration occurring at Day 232, at the local EPI vaccination centers, and not part of the current clinical trial.
|
-2 doses of iNTS-GMMA Dose C vaccine administered intramuscularly, at Day 1 and Day 57 to adults and children in the Adults_Dose C and Children_Dose C groups; -3 doses of iNTS-GMMA Dose C vaccine administered intramuscularly, at Day 1, Day 85 and Day 169 to infants in the Infants_9M_Dose C group, and at Day 1, Day 57 and at Day 232 to infants in the Infants_6W_Dose C group.
Measles and Rubella vaccine is administered to study participants, as part of an Expanded Program on Immunization (EPI) vaccination at the local EPI vaccination centers, and not part of the current clinical trial, as follows: - at 28 days after the first study intervention administration (occurring at Day 1) to infants in the Infants_9M_Dose A, Infants_9M_Control A, Infants_9M_Dose B, Infants_9M_Control B, Infants_9M_Dose C and Infants_9M_Control C groups.
- at 28 days after the third study intervention administration (occurring at Day 232) to infants in Infants_6W_Dose A, Infants_6W_Control A, Infants_6W_Dose B, Infants_6W_Control B, Infants_6W_Dose C and Infants_6W_Control C groups.
Otros nombres:
Yellow Fever vaccine is administered to study participants, as part of an Expanded Program on Immunization (EPI) vaccination at the local EPI vaccination centers, and not part of the current clinical trial, as follows: - at 28 days after the first study intervention administration (occurring at Day 1) to infants in the Infants_9M_Dose A, Infants_9M_Control A, Infants_9M_Dose B, Infants_9M_Control B, Infants_9M_Dose C and Infants_9M_Control C groups.
- at 28 days after the third study intervention administration (occurring at Day 232) to infants in Infants_6W_Dose A, Infants_6W_Control A, Infants_6W_Dose B, Infants_6W_Control B, Infants_6W_Dose C and Infants_6W_Control C groups.
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Comparador activo: Infants_6W_Control C Group
Infants ,6 weeks of age, will receive 3 doses of the MenACWY vaccine at Day 1, Day 57 and at Day 232.
To allow completion of the vaccination schedule, a fourth dose of the MenACWY vaccine is administered after the trial ends, as per the licensed indication and in private vaccination settings.
These infants will also receive an EPI vaccination with MR-VAC and YF vaccine at 28 days after the third study intervention administration occurring at Day 232, at the local EPI vaccination centers, and not part of the current clinical trial.
|
-1 dose of MenACWY vaccine administered intramuscularly at Day 1 to adults in the Adults_Control group; -2 doses of MenACWY vaccine administered intramuscularly at Day 1 and Day 57 to children in the Children_Control B and Children_Control C groups, and at Day 1 and Day 85 to infants in the Infants_9M_Control A, Infants_9M_Control B and Infants_9M_Control C groups; -3 doses of MenACWY vaccine administered intramuscularly at Day 1, Day 57 and at Day 232 to infants in the Infants_6W_Control A, Infants_6W_Control B and Infants_6W_Control C groups.
A 4th dose of MenACWY vaccine is administered after the trial ends, to infants in the aforementioned study groups, as per the licensed indication and in private vaccination settings.
Otros nombres:
Measles and Rubella vaccine is administered to study participants, as part of an Expanded Program on Immunization (EPI) vaccination at the local EPI vaccination centers, and not part of the current clinical trial, as follows: - at 28 days after the first study intervention administration (occurring at Day 1) to infants in the Infants_9M_Dose A, Infants_9M_Control A, Infants_9M_Dose B, Infants_9M_Control B, Infants_9M_Dose C and Infants_9M_Control C groups.
- at 28 days after the third study intervention administration (occurring at Day 232) to infants in Infants_6W_Dose A, Infants_6W_Control A, Infants_6W_Dose B, Infants_6W_Control B, Infants_6W_Dose C and Infants_6W_Control C groups.
Otros nombres:
Yellow Fever vaccine is administered to study participants, as part of an Expanded Program on Immunization (EPI) vaccination at the local EPI vaccination centers, and not part of the current clinical trial, as follows: - at 28 days after the first study intervention administration (occurring at Day 1) to infants in the Infants_9M_Dose A, Infants_9M_Control A, Infants_9M_Dose B, Infants_9M_Control B, Infants_9M_Dose C and Infants_9M_Control C groups.
- at 28 days after the third study intervention administration (occurring at Day 232) to infants in Infants_6W_Dose A, Infants_6W_Control A, Infants_6W_Dose B, Infants_6W_Control B, Infants_6W_Dose C and Infants_6W_Control C groups.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Number of adult participants 18-50 years of age with solicited administration site events
Periodo de tiempo: During 7 days after the first study intervention administration occurring at Day 1
|
The solicited administration site events are pain, redness and swelling.
|
During 7 days after the first study intervention administration occurring at Day 1
|
|
Number of adult participants 18-50 years of age with solicited administration site events
Periodo de tiempo: During 7 days after the second study intervention administration occurring at Day 57
|
The solicited administration site events are pain, redness and swelling.
|
During 7 days after the second study intervention administration occurring at Day 57
|
|
Number of adult participants 18-50 years of age with solicited systemic events
Periodo de tiempo: During 7 days after the first study intervention administration occurring at Day 1
|
The solicited systemic events are fever, headache, myalgia, arthralgia and fatigue.
Fever is defined as axillary temperature higher than or equal to (>=) 38.0 degrees Celsius (°C)/100.4
degrees Fahrenheit (°F).
|
During 7 days after the first study intervention administration occurring at Day 1
|
|
Number of adult participants 18-50 years of age with solicited systemic events
Periodo de tiempo: During 7 days after the second study intervention administration occurring at Day 57
|
The solicited systemic events are fever, headache, myalgia, arthralgia and fatigue.
Fever is defined as axillary temperature >= 38.0 °C/100.4
degrees °F.
|
During 7 days after the second study intervention administration occurring at Day 57
|
|
Number of adult participants 18-50 years of age with unsolicited adverse events (AEs)
Periodo de tiempo: During 28 days after the first study intervention administration occurring at Day 1
|
An unsolicited AE is any AE reported in addition to those solicited during the clinical study.
Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event.
|
During 28 days after the first study intervention administration occurring at Day 1
|
|
Number of adult participants 18-50 years of age with unsolicited adverse events (AEs)
Periodo de tiempo: During 28 days after the second study intervention administration occurring at Day 57
|
An unsolicited AE is any AE reported in addition to those solicited during the clinical study.
Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event.
|
During 28 days after the second study intervention administration occurring at Day 57
|
|
Number of adult participants 18-50 years of age with serious adverse events (SAEs)
Periodo de tiempo: From first study intervention administration (Day 1) up to the end of study participation (Day 85)
|
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, or results in abnormal pregnancy outcomes.
|
From first study intervention administration (Day 1) up to the end of study participation (Day 85)
|
|
Number of adult participants 18-50 years of age with adverse events (AEs) leading to withdrawal from the study or discontinuation of study intervention
Periodo de tiempo: From first study intervention administration (Day 1) up to the end of study participation (Day 85)
|
An AE is any untoward medical occurrence (an unfavorable/unintended sign - including an abnormal laboratory finding), symptom, or disease (new or exacerbated) in a clinical study participant that is temporally associated with the study intervention.
The AE may or may not be considered related to the study intervention.
Any AEs that lead to discontinuation of study intervention and/or the study are considered under this outcome measure.
|
From first study intervention administration (Day 1) up to the end of study participation (Day 85)
|
|
Number of adult participants 18-50 years of age with deviations from reference ranges or baseline values for hematological, renal and hepatic panel test results
Periodo de tiempo: At Day 8 (7 days after the first study intervention administration)
|
Clinically significant abnormal laboratory findings are those which are not associated with an underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.
|
At Day 8 (7 days after the first study intervention administration)
|
|
Number of adult participants 18-50 years of age with deviations from reference ranges or baseline values for hematological, renal and hepatic panel test results
Periodo de tiempo: At Day 64 (7 days after the second study intervention administration)
|
Clinically significant abnormal laboratory findings are those which are not associated with an underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.
|
At Day 64 (7 days after the second study intervention administration)
|
|
Number of child participants 24-59 months of age with solicited administration site events
Periodo de tiempo: During 7 days after the first study intervention administration occurring at Day 1
|
The solicited administration site events are pain, redness and swelling.
|
During 7 days after the first study intervention administration occurring at Day 1
|
|
Number of child participants 24-59 months of age with solicited administration site events
Periodo de tiempo: During 7 days after the second study intervention administration occurring at Day 57
|
The solicited administration site events are pain, redness and swelling.
|
During 7 days after the second study intervention administration occurring at Day 57
|
|
Number of child participants 24-59 months of age with solicited systemic events
Periodo de tiempo: During 7 days after the first study intervention administration occurring at Day 1
|
The solicited systemic events are fever, irritability/fussiness, loss of appetite, drowsiness and vomiting.
Fever is defined as axillary temperature >= 38.0 °C/100.4
degrees °F.
|
During 7 days after the first study intervention administration occurring at Day 1
|
|
Number of child participants 24-59 months of age with solicited systemic events
Periodo de tiempo: During 7 days after the second study intervention administration occurring at Day 57
|
The solicited systemic events are fever, irritability/fussiness, loss of appetite, drowsiness and vomiting.
Fever is defined as axillary temperature >= 38.0 °C/100.4
degrees °F.
|
During 7 days after the second study intervention administration occurring at Day 57
|
|
Number of child participants 24-59 months of age with unsolicited AEs
Periodo de tiempo: During 28 days after the first study intervention administration occurring at Day 1
|
During 28 days after the first study intervention administration occurring at Day 1
|
|
|
Number of child participants 24-59 months of age with unsolicited AEs
Periodo de tiempo: During 28 days after the second study intervention administration occurring at Day 57
|
During 28 days after the second study intervention administration occurring at Day 57
|
|
|
Number of child participants 24-59 months of age with serious adverse events (SAEs)
Periodo de tiempo: From first study intervention administration (Day 1) up to the end of study participation (Day 85)
|
From first study intervention administration (Day 1) up to the end of study participation (Day 85)
|
|
|
Number of child participants 24-59 months of age with AEs leading to withdrawal from the study or discontinuation of study intervention
Periodo de tiempo: From first study intervention administration (Day 1) up to the end of study participation (Day 85)
|
From first study intervention administration (Day 1) up to the end of study participation (Day 85)
|
|
|
Number of child participants 24-59 months of age with deviations from reference ranges or baseline values for hematological, renal and hepatic panel test results
Periodo de tiempo: At Day 8 (7 days after the first study intervention administration)
|
At Day 8 (7 days after the first study intervention administration)
|
|
|
Number of child participants 24-59 months of age with deviations from reference ranges or baseline values for hematological, renal and hepatic panel test results
Periodo de tiempo: At Day 64 (7 days after the second study intervention administration)
|
At Day 64 (7 days after the second study intervention administration)
|
|
|
Number of infant participants 9 months of age with solicited administration site events
Periodo de tiempo: During 7 days after the first study intervention administration occurring at Day 1
|
The solicited administration site events are pain, redness and swelling.
|
During 7 days after the first study intervention administration occurring at Day 1
|
|
Number of infant participants 9 months of age with solicited administration site events
Periodo de tiempo: During 7 days after the second study intervention administration occurring at Day 85
|
The solicited administration site events are pain, redness and swelling.
|
During 7 days after the second study intervention administration occurring at Day 85
|
|
Number of infant participants 9 months of age with solicited administration site events
Periodo de tiempo: During 7 days after the third study intervention administration occurring at Day 169
|
The solicited administration site events are pain, redness and swelling.
|
During 7 days after the third study intervention administration occurring at Day 169
|
|
Number of infant participants 9 months of age with solicited systemic events
Periodo de tiempo: During 7 days after the first study intervention administration occurring at Day 1
|
The solicited systemic events are fever, irritability/fussiness, loss of appetite, drowsiness, and vomiting.
Fever is defined as axillary temperature >= 38.0 °C/100.4
degrees °F.
|
During 7 days after the first study intervention administration occurring at Day 1
|
|
Number of infant participants 9 months of age with solicited systemic events
Periodo de tiempo: During 7 days after the second study intervention administration occurring at Day 85
|
The solicited systemic events are fever, irritability/fussiness, loss of appetite, drowsiness, and vomiting.
Fever is defined as axillary temperature >= 38.0 °C/100.4
degrees °F.
|
During 7 days after the second study intervention administration occurring at Day 85
|
|
Number of infant participants 9 months of age with solicited systemic events
Periodo de tiempo: During 7 days after the third study intervention administration occurring at Day 169
|
The solicited systemic events are fever, irritability/fussiness, loss of appetite, drowsiness, and vomiting.
Fever is defined as axillary temperature >= 38.0 °C/100.4
degrees °F.
|
During 7 days after the third study intervention administration occurring at Day 169
|
|
Number of infant participants 9 months of age with unsolicited adverse events (AEs)
Periodo de tiempo: During 28 days after the first study intervention administration occurring at Day 1
|
During 28 days after the first study intervention administration occurring at Day 1
|
|
|
Number of infant participants 9 months of age with unsolicited adverse events (AEs)
Periodo de tiempo: During 28 days after the second study intervention administration occurring at Day 85
|
During 28 days after the second study intervention administration occurring at Day 85
|
|
|
Number of infant participants 9 months of age with unsolicited adverse events (AEs)
Periodo de tiempo: During 28 days after the third study intervention administration occurring at Day 169
|
During 28 days after the third study intervention administration occurring at Day 169
|
|
|
Number of infant participants 9 months of age with serious adverse events (SAEs)
Periodo de tiempo: From first study intervention administration (Day 1) up to the end of study participation (Day 337)
|
From first study intervention administration (Day 1) up to the end of study participation (Day 337)
|
|
|
Number of infant participants 9 months of age with adverse events (AEs) leading to withdrawal from the study or discontinuation of study intervention
Periodo de tiempo: From first study intervention administration (Day 1) up to the end of study participation (Day 337)
|
From first study intervention administration (Day 1) up to the end of study participation (Day 337)
|
|
|
Number of infant participants 9 months of age with deviations from reference range or baseline values for hematological, renal and hepatic panel test results
Periodo de tiempo: At Day 8 (7 days after the first study intervention administration)
|
At Day 8 (7 days after the first study intervention administration)
|
|
|
Number of infant participants 9 months of age with deviations from reference range or baseline values for hematological, renal and hepatic panel test results
Periodo de tiempo: At Day 92 (7 days after the second study intervention administration)
|
At Day 92 (7 days after the second study intervention administration)
|
|
|
Number of infant participants 9 months of age with deviations from reference range or baseline values for hematological, renal and hepatic panel test results
Periodo de tiempo: At Day 176 (7 days after the third study intervention administration)
|
At Day 176 (7 days after the third study intervention administration)
|
|
|
Number of infant participants 6 weeks of age with solicited administration site events
Periodo de tiempo: During 7 days after the first study intervention administration occurring at Day 1
|
The solicited administration site events are pain, redness and swelling.
|
During 7 days after the first study intervention administration occurring at Day 1
|
|
Number of infant participants 6 weeks of age with solicited administration site events
Periodo de tiempo: During 7 days after the second study intervention administration occurring at Day 57
|
The solicited administration site events are pain, redness and swelling.
|
During 7 days after the second study intervention administration occurring at Day 57
|
|
Number of infant participants 6 weeks of age with solicited systemic events
Periodo de tiempo: During 7 days after the first study intervention administration occurring at Day 1
|
The solicited systemic events are fever, irritability/fussiness, loss of appetite, drowsiness, and vomiting.
Fever is defined as axillary temperature >= 38.0 °C/100.4
degrees °F.
|
During 7 days after the first study intervention administration occurring at Day 1
|
|
Number of infant participants 6 weeks of age with solicited systemic events
Periodo de tiempo: During 7 days after the second study intervention administration occurring at Day 57
|
The solicited systemic events are fever, irritability/fussiness, loss of appetite, drowsiness, and vomiting.
Fever is defined as axillary temperature >= 38.0 °C/100.4
degrees °F.
|
During 7 days after the second study intervention administration occurring at Day 57
|
|
Number of infant participants 6 weeks of age with unsolicited adverse events (AEs)
Periodo de tiempo: During 28 days after the first study intervention administration occurring at Day 1
|
During 28 days after the first study intervention administration occurring at Day 1
|
|
|
Number of infant participants 6 weeks of age with unsolicited adverse events (AEs)
Periodo de tiempo: During 28 days after the second study intervention administration occurring at Day 57
|
During 28 days after the second study intervention administration occurring at Day 57
|
|
|
Number of infant participants 6 weeks of age with SAEs
Periodo de tiempo: From first study intervention administration (Day 1) up to 28 days after second study intervention (Day 85)
|
From first study intervention administration (Day 1) up to 28 days after second study intervention (Day 85)
|
|
|
Number of infant participants 6 weeks of age with adverse events (AEs) leading to MR-VAC administration withdrawal from the study or discontinuation of study intervention
Periodo de tiempo: From first study intervention administration (Day 1) up to 28 days after second study intervention (Day 85)
|
From first study intervention administration (Day 1) up to 28 days after second study intervention (Day 85)
|
|
|
Number of infant participants 6 weeks of age with deviations from reference ranges or baseline values for hematological, renal, and hepatic panel test results
Periodo de tiempo: At Day 8 (7 days after the first study intervention administration)
|
At Day 8 (7 days after the first study intervention administration)
|
|
|
Number of infant participants 6 weeks of age with deviations from reference ranges or baseline values for hematological, renal, and hepatic panel test results at Day 64
Periodo de tiempo: At Day 64 (7 days after the second study intervention administration)
|
At Day 64 (7 days after the second study intervention administration)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Concentraciones medias geométricas (GMC) de inmunoglobulina G (IgG) específicas del serotipo antiinvasivo de Salmonella no tifoidea (iNTS) en participantes adultos de 18 a 50 años de edad
Periodo de tiempo: En los días 1 y 57 (antes de cada administración de intervención del estudio) y en los días 29 y 85 (28 días después de cada administración de intervención del estudio)
|
Anti-S.
Typhimurium OAg IgG total y anti-S.
Se evalúan las GMC de IgG total de Enteritidis OAg.
|
En los días 1 y 57 (antes de cada administración de intervención del estudio) y en los días 29 y 85 (28 días después de cada administración de intervención del estudio)
|
|
Concentraciones medias geométricas (GMC) de inmunoglobulina G (IgG) específicas del serotipo antiinvasivo de Salmonella no tifoidea (iNTS) en niños participantes de 24 a 59 meses de edad
Periodo de tiempo: En los días 1 y 57 (antes de cada administración de intervención del estudio) y en los días 29 y 85 (28 días después de cada administración de intervención del estudio)
|
Anti-S.
Typhimurium OAg IgG total y anti-S.
Se evalúan las GMC de IgG total de Enteritidis OAg.
|
En los días 1 y 57 (antes de cada administración de intervención del estudio) y en los días 29 y 85 (28 días después de cada administración de intervención del estudio)
|
|
Concentraciones medias geométricas (GMC) de inmunoglobulina G (IgG) específicas del serotipo antiinvasivo de Salmonella no tifoidea (iNTS) en bebés participantes de 9 meses de edad
Periodo de tiempo: En los días 1, 85 y 169 (antes de la administración de cada intervención del estudio) y en los días 29, 113 y 197 (28 días después de la administración de cada intervención del estudio)
|
Anti-S.
Typhimurium OAg IgG total y anti-S.
Se evalúan las GMC de IgG total de Enteritidis OAg.
|
En los días 1, 85 y 169 (antes de la administración de cada intervención del estudio) y en los días 29, 113 y 197 (28 días después de la administración de cada intervención del estudio)
|
|
Concentraciones medias geométricas (GMC) de inmunoglobulina G (IgG) específicas del serotipo antiinvasivo de Salmonella no tifoidea (iNTS) en bebés participantes de 6 semanas de edad
Periodo de tiempo: En los días 1, 57 y 232 (antes de la administración de cada intervención del estudio), en los días 29, 85 y 260 (28 días después de la administración de cada intervención del estudio) y en el día 239 (7 días después de la administración de la tercera intervención del estudio)
|
Anti-S.
Typhimurium OAg IgG total y anti-S.
Se evalúan las GMC de IgG total de Enteritidis OAg.
|
En los días 1, 57 y 232 (antes de la administración de cada intervención del estudio), en los días 29, 85 y 260 (28 días después de la administración de cada intervención del estudio) y en el día 239 (7 días después de la administración de la tercera intervención del estudio)
|
|
Number of infant participants 6 weeks of age with solicited administration site events
Periodo de tiempo: During 7 days after the third study intervention administration occurring at Day 232
|
The solicited administration site events are pain, redness and swelling.
|
During 7 days after the third study intervention administration occurring at Day 232
|
|
Number of infant participants 6 weeks of age with solicited systemic events
Periodo de tiempo: During 7 days after the third study intervention administration occurring at Day 232
|
The solicited systemic events are fever, irritability/fussiness, loss of appetite, drowsiness, and vomiting.
Fever is defined as axillary temperature >= 38.0 °C/100.4
degrees °F.
|
During 7 days after the third study intervention administration occurring at Day 232
|
|
Number of infant participants 6 weeks of age with unsolicited AEs
Periodo de tiempo: During 28 days after the third study intervention administration occurring at Day 232
|
During 28 days after the third study intervention administration occurring at Day 232
|
|
|
Number of infant participants 6 weeks of age with SAEs
Periodo de tiempo: From 28 days after the second study intervention administration (Day 85) up to end of study participation (Day 400)
|
From 28 days after the second study intervention administration (Day 85) up to end of study participation (Day 400)
|
|
|
Number of infant participants 6 weeks of age with adverse events (AEs) leading to withdrawal from the study or withholding further study intervention administration
Periodo de tiempo: From 28 days after the second study intervention administration (Day 85) up to end of study participation (Day 400)
|
From 28 days after the second study intervention administration (Day 85) up to end of study participation (Day 400)
|
|
|
Number of infant participants 6 weeks of age with deviations from reference ranges or baseline values for hematological, renal, and hepatic panel test results
Periodo de tiempo: At Day 239 (7 days after the study intervention administration)
|
At Day 239 (7 days after the study intervention administration)
|
|
|
Number of adult participants 18-50 years of age achieving, for each antigen (Ag), at least a 2-fold and 4-fold rise in anti-invasive nontyphoidal Salmonella (iNTS) serotype specific immunoglobulin G (IgG) antibody concentration
Periodo de tiempo: At Days 29 and 85 (28 days after each study intervention administration) compared to Day 1 (baseline, prior to first study intervention administration)
|
Anti-S.
Typhimurium OAg total IgG and anti-S.
Enteritidis OAg total IgG antibody concentrations are assessed.
|
At Days 29 and 85 (28 days after each study intervention administration) compared to Day 1 (baseline, prior to first study intervention administration)
|
|
Number of child participants 24-59 months of age achieving, for each antigen (Ag), at least a 2-fold and 4-fold rise in anti-invasive nontyphoidal Salmonella (iNTS) serotype specific immunoglobulin G (IgG) antibody concentration
Periodo de tiempo: At Days 29 and 85 (28 days after each study intervention administration) compared to Day 1 (baseline, prior to first study intervention administration)
|
Anti-S.
Typhimurium OAg total IgG and anti-S.
Enteritidis OAg total IgG antibody concentrations are assessed.
|
At Days 29 and 85 (28 days after each study intervention administration) compared to Day 1 (baseline, prior to first study intervention administration)
|
|
Number of infant participants 9 months of age achieving, for each antigen (Ag), at least a 2-fold and 4-fold rise in anti-invasive nontyphoidal Salmonella (iNTS) serotype specific immunoglobulin G (IgG) antibody concentration
Periodo de tiempo: At Days 29, 113 and 197 (28 days after each study intervention administration) compared to Day 1 (baseline, prior to first study intervention administration)
|
Anti-S.
Typhimurium OAg total IgG and anti-S.
Enteritidis OAg total IgG antibody concentrations are assessed.
|
At Days 29, 113 and 197 (28 days after each study intervention administration) compared to Day 1 (baseline, prior to first study intervention administration)
|
|
Number of infant participants 6 weeks of age achieving, for each antigen (Ag), at least a 2-fold and 4-fold rise in anti-invasive nontyphoidal Salmonella (iNTS) serotype specific immunoglobulin G (IgG) antibody concentration
Periodo de tiempo: At Days 29, 85 and 260 (28 days after each study intervention administration) and at Day 239 (7 days after the third study intervention administration) compared to Day 1 (baseline, prior to first study intervention administration)
|
Anti-S.
Typhimurium OAg total IgG and anti-S.
Enteritidis OAg total IgG antibody concentrations are assessed.
|
At Days 29, 85 and 260 (28 days after each study intervention administration) and at Day 239 (7 days after the third study intervention administration) compared to Day 1 (baseline, prior to first study intervention administration)
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Director de estudio: GSK Clinical Trials, GlaxoSmithKline
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)
15 de enero de 2024
Finalización primaria (Actual)
6 de agosto de 2026
Finalización del estudio (Actual)
6 de agosto de 2026
Fechas de registro del estudio
Enviado por primera vez
19 de diciembre de 2023
Primero enviado que cumplió con los criterios de control de calidad
18 de enero de 2024
Publicado por primera vez (Actual)
19 de enero de 2024
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
2 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
31 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Infecciones
- Infecciones bacterianas
- Infecciones bacterianas y micosis
- Infecciones por bacterias gramnegativas
- Infecciones por enterobacterias
- Infecciones por salmonela
- Productos biológicos
- Mezclas complejas
- Vacunas bacterianas
- Vacunas
- Vacunas virales
- Vacunas meningocócicas
- Menacwy
- Diphtheria-tétanus-acelular a la tos ferina inactivada con poliovirus-hemophilus influenzae B-Hepatitis B Vacuna
- Vacuna contra la fiebre amarilla
- Vacuna contra la rubéola
Otros números de identificación del estudio
- 217218
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
Los IPD para este estudio estarán disponibles a través del sitio de solicitud de datos de estudios clínicos.
Marco de tiempo para compartir IPD
IPD estará disponible dentro de los 6 meses posteriores a la publicación de los resultados de los criterios de valoración principales, criterios de valoración secundarios clave y datos de seguridad del estudio.
Criterios de acceso compartido de IPD
El acceso se proporciona después de que se envía una propuesta de investigación y ha recibido la aprobación del Panel de Revisión Independiente y después de que esté vigente un Acuerdo de Intercambio de Datos.
El acceso se proporciona por un período inicial de 12 meses, pero se puede conceder una prórroga, cuando esté justificada, por hasta otros 12 meses.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
- RSC
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
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. .