Un estudio sobre la seguridad y las respuestas inmunitarias de la vacuna GVGH altSonflex1-2-3 contra la shigellosis en adultos, niños y bebés
18 de junio de 2026 actualizado por: GlaxoSmithKline
Un estudio de fase I/II con observador ciego, aleatorizado, controlado y en etapas en varios países para evaluar la seguridad, la reactogenicidad y las respuestas inmunitarias de la vacuna GVGH altSonflex1-2-3 contra S. Sonnei y S. Flexneri, serotipos 1b, 2a , y 3a, en adultos en Europa (Etapa 1) Seguido de reducción de la edad de adultos a niños y lactantes, y búsqueda de dosis en lactantes en África (Etapa 2)
El objetivo del estudio clínico actual es evaluar, por primera vez en humanos (FTIH), la seguridad e inmunogenicidad de la vacuna candidata altSonflex1-2-3 contra S. sonnei y S. flexneri serotipos 1b, 2a y 3a.
La vacuna se administrará por primera vez en adultos de 18 a 50 años de edad en Europa.
Posteriormente, la vacuna se administrará a una población endémica de shigellosis en África, primero en adultos de 18 a 50 años de edad, luego en niños de 24 a 59 meses de edad y finalmente en lactantes de 9 meses de edad.
Los bebés también recibirán una tercera vacunación.
Se evaluarán tres dosis diferentes de la vacuna [cantidades de antígeno bajas (Dosis A), medias (Dosis B) y altas (Dosis C)] utilizando un enfoque de reducción de la edad (desde la población adulta menos vulnerable hasta la población pediátrica más vulnerable). ).
Los resultados de este estudio permitirán la selección de la dosis más adecuada para un mayor desarrollo de vacunas en lactantes de 9 meses de edad, que es el principal grupo de edad objetivo de esta vacuna.
Descripción general del estudio
Estado
Terminado
Condiciones
Tipo de estudio
Intervencionista
Inscripción (Actual)
551
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.
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
9 meses a 50 años (Niño, Adulto)
Acepta Voluntarios Saludables
Sí
Descripción
Criterios de inclusión:
Todos los participantes:
• Participantes y/o padres de los participantes/representantes legalmente aceptables LAR(s), quienes, en opinión del investigador, pueden y cumplirán con los requisitos del protocolo (p. cumplimentación de las fichas diarias, regreso para visitas de seguimiento).
- Consentimiento informado por escrito o presenciado/impreso con el pulgar obtenido del participante/padre(s)/LAR(s) del participante antes de la realización de cualquier procedimiento específico del estudio.
- Participantes sanos según lo establecido por el historial médico, el examen clínico y la evaluación de laboratorio.
- Participantes que cumplan con todos los requisitos de selección.
- Participantes seronegativos para hepatitis B y hepatitis C.
- Participantes negativos para el antígeno leucocitario humano B27 (HLA-B27).
Adultos de 18 a 50 años:
- Un hombre o una mujer entre, inclusive, 18 y 50 años de edad en el momento de la administración de la primera intervención del estudio.
- La participante femenina en edad no fértil puede inscribirse en el estudio. La no posibilidad de procrear 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 la participante:
- ha practicado un método anticonceptivo adecuado 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 un método anticonceptivo adecuado durante todo el período de tratamiento y durante 1 mes después de completar la serie de administración de la intervención del estudio.
- Participantes seronegativos para el virus de la inmunodeficiencia humana (VIH).
Niños de 24 a 59 meses de edad:
- Un hombre o una mujer entre, inclusive, 24 y 59 meses de edad en el momento de la primera vacunación.
- Puntuación Z nutricional normal (-2 desviación estándar o mayor).
- Vacunas infantiles de rutina previamente completadas al mejor conocimiento de los padres/LAR(s) del participante.
- Nacido después de un período de gestación de ≥37 semanas.
- Participantes seronegativos para el VIH.
Bebés de 9 meses de edad:
- Un macho o hembra de 9 meses de edad en el momento de la primera vacunación.
- Puntuación Z nutricional normal (-2 desviaciones estándar o más).
- Vacunas infantiles de rutina previamente completadas al mejor conocimiento de los padres/LAR(s) del participante.
- Nacido después de un período de gestación de ≥37 semanas.
- Participantes negativos para el VIH según lo confirmado por la prueba de reacción en cadena de la polimerasa (PCR) del ácido desoxirribonucleico (ADN).
Criterio de exclusión:
Todos los participantes:
• Exposición conocida a Shigella durante la vida del participante según lo confirmado durante la entrevista con el participante o documentado por los registros del paciente (p. ej., antecedentes de infección por Shigella microbiológicamente confirmada), viaje reciente* (dentro de 2 años) a un país donde Shigella u otras enfermedades entéricas las infecciones son endémicas o de ocupación reciente* (dentro de los 3 años) que involucran especies de Shigella.
La exclusión por viaje u ocupación es aplicable solo a Adultos de 18 a 50 años en Europa (Etapa 1).
• Condiciones clínicas progresivas, inestables o descontroladas.
• Antecedentes (conocidos o sospechados) de cualquier reacción o hipersensibilidad que pueda ser exacerbada por cualquier componente de la vacuna del estudio.
• Cualquier condición inmunosupresora o inmunodeficiente confirmada o sospechada, según la historia clínica y el examen físico (no se requieren pruebas de laboratorio).
• Hipersensibilidad, incluida la alergia, a medicamentos o equipos médicos cuyo uso está previsto en este estudio.
- Condiciones clínicas que representan una contraindicación para la vacunación IM y extracciones de sangre.
- Cualquier deterioro conductual o cognitivo o enfermedad psiquiátrica que, en opinión del investigador, pueda interferir con la capacidad del participante para participar en el estudio.
- Enfermedad aguda y/o fiebre (definida como temperatura ≥ 38,0 °C) en el momento de la inscripción*.
El participante todavía puede inscribirse en el estudio en un momento en que la enfermedad aguda y/o la fiebre se hayan resuelto.
• Cualquier anomalía de laboratorio hematológica y/o bioquímica clínicamente significativa.
- Prueba COVID-19 positiva confirmada durante el período que comienza 30 días antes de la primera administración de las vacunas del estudio (Día -30 al Día 1).
- Cualquier otra condición clínica que, a juicio del investigador, pueda suponer un riesgo adicional para el participante por su participación en el estudio.
- Administración de fármacos modificadores del sistema inmunitario de acción prolongada en cualquier momento durante el período de estudio (p. infliximab).
- Recepción previa de una vacuna experimental contra Shigella o desafío con Shigella viva.
- Uso de cualquier producto en investigación o no registrado (fármaco, vacuna o dispositivo médico)* que no sea la vacuna del estudio durante el período que comienza 30 días antes de la primera dosis de la intervención del estudio (Día -30 al Día 1), o uso planificado durante el periodo de estudio.
El uso de hierbas y tratamientos tradicionales no se considera un criterio de exclusión.
• Una vacuna no prevista* por el Protocolo del Estudio administrada durante el período que comienza a los -21 días antes de la primera dosis (-28 días en el caso de las vacunas vivas) y finaliza después de la última dosis de administración de la intervención del estudio**.
Las vacunas permitidas por el Protocolo incluyen vacunas contra la gripe y COVID-19 en todos los participantes y vacunas EPI en niños y bebés.
En caso de vacunación masiva de emergencia, el período de tiempo anterior puede reducirse.
- Participar simultáneamente en otro estudio clínico, en cualquier momento durante el período del estudio, en el que el participante ha estado o estará expuesto a una intervención en investigación o no en investigación (medicamento o dispositivo médico invasivo).
- Cualquier miembro del personal del estudio o dependientes inmediatos, familiares o miembros del hogar.
Adultos de 18 a 50 años:
- Enfermedad aguda o crónica, anomalía funcional pulmonar, cardiovascular, hepática o renal clínicamente significativa, según lo determine el examen físico o las pruebas de detección de laboratorio.
- 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 intervención del estudio de vacunas. Para los corticosteroides, esto significará el equivalente de prednisona ≥20 mg/día para los participantes adultos. Se permiten esteroides inhalados y tópicos.
- Hembra gestante o lactante.
- Mujer que planea quedarse embarazada o planea suspender las precauciones anticonceptivas.
- Historial o actual de consumo crónico de alcohol y/o abuso de drogas.
Adultos de 18 a 50 años y Niños de 24 a 59 meses:
• Administración de inmunoglobulinas y/o cualquier hemoderivado o derivados del plasma, o trasplante de médula ósea, durante el período que comienza 3 meses antes de la primera dosis de la vacuna del estudio o administración planificada durante el período del estudio.
Niños de 24 a 59 meses de edad y bebés de 9 meses de edad:
- Anomalía funcional pulmonar, cardiovascular, hepática o renal clínicamente significativa, aguda o crónica, según lo determine el examen físico o las pruebas de detección de laboratorio.
- 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 la vacuna. Para los corticosteroides, esto significará prednisona ≥0,5 mg/kg/día o 20 mg/día, cualquiera que sea la dosis máxima para participantes pediátricos. Se permiten esteroides inhalados y tópicos.
- Niño en cuidado.
Bebés de 9 meses de edad:
• Administración de inmunoglobulinas y/o cualquier hemoderivado o derivado del plasma, o trasplante de médula ósea, desde el nacimiento o administración planificada durante el período de estudio.
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 |
|---|---|
|
Experimental: Stage 1 Adults: altSonflex1-2-3 High Dose Group 1
European participants 18-50 years of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1 and Day 85. High dose of altSonflex1-2-3 contained 15 micrograms (µg) of O-antigen (OAg) each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
|
2 doses in adults 18-50 years of age and children 24-59 months of age, 3 doses in infants 9 months of age
|
|
Experimental: Stage 1 Adults: altSonflex1-2-3 High Dose Group 2
European participants 18-50 years of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1 and Day 169.
High dose of altSonflex1-2-3 contained 15 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
|
2 doses in adults 18-50 years of age and children 24-59 months of age, 3 doses in infants 9 months of age
|
|
Comparador de placebos: Stage 1 Adults: Placebo Group
European participants 18-50 years of age were randomized to receive 1 dose of Placebo on Day 1 and on Day 85 or 169.
All participants in Step 1 that received placebo were pooled, as pre-specified in Statistical Analysis Plan.
|
2 doses in adults 18-50 years of age (stage 1)
|
|
Experimental: Stage 2 Adults: altSonflex1-2-3 High Dose
African participants 18-50 years of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1 and Day 85. High dose of altSonflex1-2-3 contained of 15 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
|
2 doses in adults 18-50 years of age and children 24-59 months of age, 3 doses in infants 9 months of age
|
|
Comparador activo: Stage 2 Adults: Control
African participants 18-50 years of age were randomized to receive 1 dose of MENVEO as comparator on Day 1 and 1 dose of BOOSTRIX as comparator Day 85.
|
1 dose in adults 18-50 years of age (stage 2) and children 24-59 months of age and 2 doses in infants 9 months of age
1 dose in adults 18-50 years of age (stage 2)
|
|
Experimental: Stage 2 Children: altSonflex1-2-3 Medium Dose
African participants 24-59 months of age were randomized to receive a medium dose of altSonflex1-2-3 on Day 1 and Day 85. Medium dose of altSonflex1-2-3 contained 7.5 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
|
2 doses in children 24-59 months of age, 3 doses in infants 9 months of age
|
|
Experimental: Stage 2 Children: altSonflex1-2-3 High Dose
African participants 24-59 months of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1 and Day 85. High dose of altSonflex1-2-3 contained 15 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
|
2 doses in adults 18-50 years of age and children 24-59 months of age, 3 doses in infants 9 months of age
|
|
Comparador activo: Stage 2 Children: Control
African participants 24-59 months of age were randomized to receive 1 dose of MENVEO as comparator on Day 1 and 1 dose of TYPHIM VI as comparator on Day 85.
|
1 dose in adults 18-50 years of age (stage 2) and children 24-59 months of age and 2 doses in infants 9 months of age
1 dose in children 24-59 months of age
|
|
Experimental: Stage 2 Infants safety cohort: altSonflex1-2-3 Low Dose
African participants 9 months of age were randomized to receive a low dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253.
The measles-rubella vaccine (MR-VAC) was administered on Day 29 and Day 281.
Low dose of altSonflex1-2-3 contained 3.75 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
|
3 doses in infants 9 months of age
2 doses in children 24-59 months of age
|
|
Experimental: Stage 2 Infants safety cohort: altSonflex1-2-3 Medium Dose
African participants 9 months of age were randomized to receive a medium dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253.
MR-VAC was administered on Day 29 and Day 281.
Medium dose of altSonflex1-2-3 contained 7.5 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
|
2 doses in children 24-59 months of age, 3 doses in infants 9 months of age
2 doses in children 24-59 months of age
|
|
Experimental: Stage 2 Infants safety cohort: altSonflex1-2-3 High Dose
African participants 9 months of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253.
MR-VAC was administered on Day 29 and Day 281.
High dose of altSonflex1-2-3 contained 15 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
|
2 doses in adults 18-50 years of age and children 24-59 months of age, 3 doses in infants 9 months of age
2 doses in children 24-59 months of age
|
|
Comparador activo: Stage 2 Infants safety cohort: Control
African participants 9 months of age were randomized to receive a dose of MENVEO as comparator on Day 1 and Day 85 and INFRANRIX HEXA as comparator on Day 253.
MR-VAC was administered on Day 29 and Day 281.
|
1 dose in adults 18-50 years of age (stage 2) and children 24-59 months of age and 2 doses in infants 9 months of age
2 doses in children 24-59 months of age
1 dose in infants 9 months of age
|
|
Experimental: Stage 2 Infants dose-finding cohort: altSonflex1-2-3 Low Dose
African participants 9 months of age were randomized to receive a low dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253.
MR-VAC was co-administered on Day 1 and Day 253.
This cohort was created to identify the preferred dose among low, medium and high doses.
Low dose of altSonflex1-2-3 contained 3.75 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
|
3 doses in infants 9 months of age
2 doses in children 24-59 months of age
|
|
Experimental: Stage 2 Infants dose-finding cohort: altSonflex1-2-3 Medium Dose
African participants 9 months of age were randomized to receive a medium dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253.
MR-VAC was co-administered on Day 1 and Day 253.
This cohort was created to identify the preferred dose among low, medium and high doses.
Medium dose of altSonflex1-2-3 contained 7.5 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
|
2 doses in children 24-59 months of age, 3 doses in infants 9 months of age
2 doses in children 24-59 months of age
|
|
Experimental: Stage 2 Infants dose-finding cohort: altSonflex1-2-3 High Dose
African participants 9 months of age were randomized to receive a high dose of altSonflex1-2-3 on Day 1, Day 85 and Day 253.
MR-VAC was co-administered on Day 1 and Day 253.
This cohort was created to identify the preferred dose among low, medium and high doses.
High dose of altSonflex1-2-3 contained 15 µg OAg of each Shigella serotype (S. sonnei, S. flexneri 1b, S. flexneri 2a, S. flexneri 3a).
|
2 doses in adults 18-50 years of age and children 24-59 months of age, 3 doses in infants 9 months of age
2 doses in children 24-59 months of age
|
|
Comparador activo: Stage 2 Infants dose-finding cohort: Control
African participants 9 months of age were randomized to receive a dose of MENVEO as comparator on Day 1 and Day 85 and INFRANRIX HEXA as comparator on Day 253.
MR-VAC was co-administered on Day 1 and Day 253.
This cohort was created to identify the preferred dose among low, medium and high doses.
|
1 dose in adults 18-50 years of age (stage 2) and children 24-59 months of age and 2 doses in infants 9 months of age
2 doses in children 24-59 months of age
1 dose in infants 9 months of age
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Stage 2: Geometric Mean Concentrations (GMCs) of Anti-serotype Specific Shigella Lipopolysaccharide (LPS)/O-Antigen (OAg) Serum Immunoglobulin G (IgG) in Participants 9 Months of Age in Africa
Periodo de tiempo: At Day 281 (28 days after the third study intervention)
|
Anti-serotype specific Shigella LPS/OAg serum IgG GMCs were measured by enzyme-linked immunosorbent assay (ELISA) and expressed in ELISA units per milliliter (EU/mL) of serum.
Four serotypes were tested.
Due to the fact, that the Per protocol set (PPS) for Stage 2 Infants - dose finding cohort had less than the 72 participants per group defined in the protocol as a minimum number of participants to ensure power of the analysis, the Stage 2 Infants Safety cohort and Dose-finding cohort were pooled for the statistical analysis as per the Statistical Analysis Plan.
As per protocol, statistical analysis was performed only for the S. sonnei serotype, comparing Stage 2 Infants: Pooled groups (medium vs low dose); and Stage 2 Infants Dose-finding groups (high vs low dose).
The objective of this outcome measure is to identify the preferred dose of each component of the altSonflex1-2-3 vaccine for infants 9 months of age in Africa, therefore control groups were not analyzed.
|
At Day 281 (28 days after the third study intervention)
|
|
Stage 1: Number of Participants 18 to 50 Years of Age in Europe With Solicited Administration Site Events
Periodo de tiempo: Within 7 days after each study intervention (administered at Day 1, Day 85 and Day 169 [depending on the vaccination schedule])
|
The solicited administration site events assessed were erythema, pain, and swelling.
|
Within 7 days after each study intervention (administered at Day 1, Day 85 and Day 169 [depending on the vaccination schedule])
|
|
Stage 1: Number of Adults 18 to 50 Years of Age in Europe With Solicited Systemic Events
Periodo de tiempo: Within 7 days after each study intervention (administered at Day 1, Day 85 and Day 169 [depending on the vaccination schedule])
|
The solicited systemic event assessed was fever.
Fever is defined as temperature equal to or above (=>) 38.0°C.
|
Within 7 days after each study intervention (administered at Day 1, Day 85 and Day 169 [depending on the vaccination schedule])
|
|
Stage 1: Number of Participants 18 to 50 Years of Age in Europe With Unsolicited Adverse Events (AEs)
Periodo de tiempo: Within 28 days after each study intervention (administered at at Day 1, Day 85 and Day 169 [depending on the vaccination schedule])
|
An unsolicited AE is defined as an 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 is reported as an unsolicited adverse event.
|
Within 28 days after each study intervention (administered at at Day 1, Day 85 and Day 169 [depending on the vaccination schedule])
|
|
Stage 1: Number of Participants 18 to 50 Years of Age in Europe With Serious Adverse Events (SAEs)
Periodo de tiempo: From Day 1 to Day 113 and/or Day 197
|
An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, results in abnormal pregnancy outcomes or any other situation based on appropriate medical or scientific judgement.
|
From Day 1 to Day 113 and/or Day 197
|
|
Stage 1: Number of Participants 18 to 50 Years of Age in Europe With Deviations From Normal Values of Haematological, Renal, and Hepatic Panel Test Results After First Study Intervention
Periodo de tiempo: At Day 8
|
Panel tests include measures of alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine, basophils, eosinophils, erythrocytes, haematocrit, haemoglobin, lymphocytes, monocytes, neutrophils, platelets and white blood cells (WBC).
Categories reported when comparing Day 1 (baseline) and normal range hematological, renal and hepatic laboratory results are defined as follows: <parameter>,<range at baseline>,<range at timing>, where range is being classified as Below = value below; Within = value within; and Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
|
At Day 8
|
|
Stage 1: Number of Participants 18 to 50 Years of Age in Europe With Deviations From Normal Values of Haematological, Renal, and Hepatic Panel Test Results After Second Study Intervention
Periodo de tiempo: At Day 92 (Stage 1 Adults: altSonflex1-2-3 High Dose Group 1), at Day 176 (Stage 1 Adults: altSonflex1-2-3 High Dose Group 2) and at Day 92/Day 176 (Stage 1 Adults: Placebo Group)
|
Panel tests include measures of ALT, AST, creatinine, basophils, eosinophils, erythrocytes, haematocrit, haemoglobin, lymphocytes, monocytes, neutrophils, platelets and WBC.
Categories reported when comparing Day 85/Day 169 (baseline) and normal range hematological, renal and hepatic laboratory results are defined as follows: <parameter>,<range at baseline>,<range at timing>, where range is being classified as Below = value below; Within = value within; and Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
|
At Day 92 (Stage 1 Adults: altSonflex1-2-3 High Dose Group 1), at Day 176 (Stage 1 Adults: altSonflex1-2-3 High Dose Group 2) and at Day 92/Day 176 (Stage 1 Adults: Placebo Group)
|
|
Stage 2: Number of Participants 18 to 50 Years of Age in Africa With Solicited Administration Site Events
Periodo de tiempo: Within 7 days after each study intervention (administered at Day 1 and Day 85)
|
The solicited administration site events assessed were pain, erythema, and swelling.
|
Within 7 days after each study intervention (administered at Day 1 and Day 85)
|
|
Stage 2: Number of Participants 18 to 50 Years of Age in Africa With Solicited Systemic Events
Periodo de tiempo: Within 7 days after each study intervention (administered at Day 1 and Day 85)
|
The solicited systemic event assessed was fever.
Fever is defined as temperature equal to or above (=>) 38.0°C.
|
Within 7 days after each study intervention (administered at Day 1 and Day 85)
|
|
Stage 2: Number of Participants 18 to 50 Years of Age in Africa With Unsolicited Adverse Events (AEs)
Periodo de tiempo: Within 28 days after each study intervention (administered at Day 1 and Day 85)
|
An unsolicited AE is defined as an 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 is reported as an unsolicited adverse event.
|
Within 28 days after each study intervention (administered at Day 1 and Day 85)
|
|
Stage 2: Number of Participants 18 to 50 Years of Age in Africa With Serious Adverse Events (SAEs)
Periodo de tiempo: From Day 1 to Day 113
|
An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, results in abnormal pregnancy outcomes or any other situation based on appropriate medical or scientific judgement.
|
From Day 1 to Day 113
|
|
Stage 2: Number of Participants 18 to 50 Years of Age in Africa With Deviations From Normal Values of Haematological, Renal, and Hepatic Panel Test Results After First Study Intervention
Periodo de tiempo: At Day 8
|
Panel tests include measures of ALT, AST, creatinine, basophils, eosinophils, erythrocytes, haematocrit, haemoglobin, lymphocytes, monocytes, neutrophils, platelets and WBC.
Categories reported when comparing Day 1 (baseline) and normal range hematological, renal and hepatic laboratory results are defined as follows: <parameter>,<range at baseline>,<range at timing>, where range is being classified as Below = value below; Within = value within; and Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
|
At Day 8
|
|
Stage 2: Number of Participants 18 to 50 Years of Age in Africa With Deviations From Normal Values of Haematological, Renal, and Hepatic Panel Test Results After Second Study Intervention
Periodo de tiempo: At Day 92
|
Panel tests include measures of ALT, AST, creatinine, basophils, eosinophils, erythrocytes, haematocrit, haemoglobin, lymphocytes, monocytes, neutrophils, platelets and WBC.
Categories reported when comparing Day 85 (baseline) and normal range hematological, renal and hepatic laboratory results are defined as follows: <parameter>,<range at baseline>,<range at timing>, where range is being classified as Below = value below; Within = value within; and Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
|
At Day 92
|
|
Stage 2: Number of Participants 24 to 59 Months of Age in Africa With Solicited Administration Site Events
Periodo de tiempo: Within 7 days after each study intervention (administered at Day 1 and Day 85)
|
The solicited administration site events assessed were erythema, pain, and swelling.
|
Within 7 days after each study intervention (administered at Day 1 and Day 85)
|
|
Stage 2: Number of Participants 24 to 59 Months of Age in Africa With Solicited Systemic Events
Periodo de tiempo: Within 7 days after each study intervention (administered at Day 1 and Day 85)
|
The solicited systemic event assessed was fever.
Fever is defined as temperature equal to or above (=>) 38.0°C.
|
Within 7 days after each study intervention (administered at Day 1 and Day 85)
|
|
Stage 2: Number of Participants 24 to 59 Months of Age in Africa With Unsolicited Adverse Events (AEs)
Periodo de tiempo: Within 28 days after each study intervention (administered at Day 1 and Day 85)
|
An unsolicited AE is defined as an 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 is reported as an unsolicited adverse event.
|
Within 28 days after each study intervention (administered at Day 1 and Day 85)
|
|
Stage 2: Number of Participants 24 to 59 Months of Age in Africa With Serious Adverse Events (SAEs)
Periodo de tiempo: From Day 1 to Day 113
|
An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, results in abnormal pregnancy outcomes or any other situation based on appropriate medical or scientific judgement.
|
From Day 1 to Day 113
|
|
Stage 2: Number of Participants 24 to 59 Months of Age in Africa With Deviations From Normal Values of Haematological, Renal, and Hepatic Panel Test Results After First Study Intervention
Periodo de tiempo: At Day 8
|
Panel tests include measures of ALT, AST, creatinine, basophils, eosinophils, erythrocytes, haematocrit, haemoglobin, lymphocytes, monocytes, neutrophils, platelets and WBC.
Categories reported when comparing Day 1 (baseline) and normal range hematological, renal and hepatic laboratory results are defined as follows: <parameter>,<range at baseline>,<range at timing>, where range is being classified as Below = value below; Within = value within; and Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
|
At Day 8
|
|
Stage 2: Number of Participants 24 to 59 Months of Age in Africa With Deviations From Normal Values of Haematological, Renal, and Hepatic Panel Test Results After Second Study Intervention
Periodo de tiempo: At Day 92
|
Panel tests include measures of ALT, AST, creatinine, basophils, eosinophils, erythrocytes, haematocrit, haemoglobin, lymphocytes, monocytes, neutrophils, platelets and WBC.
Categories reported when comparing Day 85 (baseline) and normal range hematological, renal and hepatic laboratory results are defined as follows: <parameter>,<range at baseline>,<range at timing>, where range is being classified as Below = value below; Within = value within; and Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
|
At Day 92
|
|
Stage 2: Number of Participants 9 Months of Age in Africa With Solicited Administration Site Events - Infants Safety Cohort
Periodo de tiempo: Within 7 days after each study intervention (administered at Day 1, Day 85 and Day 253)
|
The solicited administration site events assessed were erythema, pain, and swelling.
|
Within 7 days after each study intervention (administered at Day 1, Day 85 and Day 253)
|
|
Stage 2: Number of Participants 9 Months of Age in Africa With Solicited Administration Site Events - Infants Dose-finding Cohort
Periodo de tiempo: Within 7 days after each study intervention (administered at Day 1, Day 85 and Day 253)
|
The solicited administration site events assessed were erythema, pain, and swelling.
|
Within 7 days after each study intervention (administered at Day 1, Day 85 and Day 253)
|
|
Stage 2: Number of Participants 9 Months of Age in Africa With Solicited Systemic Events - Infants Safety Cohort
Periodo de tiempo: Within 7 days after each study intervention (administered at Day 1, Day 85 and Day 253)
|
The solicited systemic event is fever.
Fever is defined as temperature equal to or above (=>) 38.0°C.
|
Within 7 days after each study intervention (administered at Day 1, Day 85 and Day 253)
|
|
Stage 2: Number of Participants 9 Months of Age in Africa With Solicited Systemic Events - Infants Dose-finding Cohort
Periodo de tiempo: Within 7 days after each study intervention (administered at Day 1, Day 85 and Day 253)
|
The solicited systemic event is fever.
Fever is defined as temperature equal to or above (=>) 38.0°C.
|
Within 7 days after each study intervention (administered at Day 1, Day 85 and Day 253)
|
|
Stage 2: Number of Participants 9 Months of Age in Africa With Unsolicited Adverse Events (AEs) - Infants Safety Cohort
Periodo de tiempo: Within 28 days after each study intervention (administered at Day 1, Day 85 and Day 253)
|
An unsolicited AE is defined as an 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 is reported as an unsolicited adverse event.
|
Within 28 days after each study intervention (administered at Day 1, Day 85 and Day 253)
|
|
Stage 2: Number of Participants 9 Months of Age in Africa With Unsolicited Adverse Events (AEs) - Infants Dose-finding Cohort
Periodo de tiempo: Within 28 days after each study intervention (administered at Day 1, Day 85 and Day 253)
|
An unsolicited AE is defined as an 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 is reported as an unsolicited adverse event.
|
Within 28 days after each study intervention (administered at Day 1, Day 85 and Day 253)
|
|
Stage 2: Number of Participants 9 Months of Age in Africa With Serious Adverse Events (SAEs) - Infants Safety Cohort
Periodo de tiempo: From Day 1 to Day 281
|
An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, results in abnormal pregnancy outcomes or any other situation based on appropriate medical or scientific judgement.
|
From Day 1 to Day 281
|
|
Stage 2: Number of Participants 9 Months of Age in Africa With Serious Adverse Events (SAEs) - Infants Dose-finding Cohort
Periodo de tiempo: From Day 1 to Day 281
|
An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, results in abnormal pregnancy outcomes or any other situation based on appropriate medical or scientific judgement.
|
From Day 1 to Day 281
|
|
Stage 2: Number of Participants 9 Months of Age in Africa With Deviations From Normal Values of Haematological, Renal, and Hepatic Panel Test Results After First Study Intervention - Infants Safety Cohort
Periodo de tiempo: At Day 8
|
Panel tests include measures of alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine, potassium, sodium, urea, basophils, eosinophils, erythrocytes, haematocrit, haemoglobin, lymphocytes, monocytes, neutrophils, platelets and white blood cells (WBC).
Categories reported when comparing Day 1 (baseline) and normal range hematological, renal and hepatic laboratory results are defined as follows: <parameter>,<range at baseline>,<range at timing>, where range is being classified as Below = value below; Within = value within; and Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
|
At Day 8
|
|
Stage 2: Number of Participants 9 Months of Age in Africa With Deviations From Normal Values of Haematological, Renal, and Hepatic Panel Test Results After First Study Intervention - Infants Dose-finding Cohort
Periodo de tiempo: At Day 8
|
Panel tests include measures of ALT, AST, creatinine, basophils, eosinophils, erythrocytes, haematocrit, haemoglobin, lymphocytes, monocytes, neutrophils, platelets and WBC.
Categories reported when comparing Day 1 (baseline) and normal range hematological, renal and hepatic laboratory results are defined as follows: <parameter>,<range at baseline>,<range at timing>, where range is being classified as Below = value below; Within = value within; and Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
|
At Day 8
|
|
Stage 2: Number of Participants 9 Months of Age in Africa With Deviations From Normal Values of Haematological, Renal, and Hepatic Panel Test Results After Second Study Intervention - Infants Safety Cohort
Periodo de tiempo: At Day 92
|
Panel tests include measures of ALT, AST, creatinine, potassium, sodium, urea, basophils, eosinophils, erythrocytes, haematocrit, haemoglobin, lymphocytes, monocytes, neutrophils, platelets and WBC.
Categories reported when comparing Day 1 (baseline) and normal range hematological, renal and hepatic laboratory results are defined as follows: <parameter>,<range at baseline>,<range at timing>, where range is being classified as Below = value below; Within = value within; and Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
|
At Day 92
|
|
Stage 2: Number of Participants 9 Months of Age in Africa With Deviations From Normal Values of Haematological, Renal, and Hepatic Panel Test Results After Second Study Intervention - Infants Dose-finding Cohort
Periodo de tiempo: At Day 92
|
Panel tests include measures of alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine, potassium, sodium, urea, basophils, eosinophils, erythrocytes, haematocrit, haemoglobin, lymphocytes, monocytes, neutrophils, platelets and white blood cells (WBC).
Categories reported when comparing Day 1 (baseline) and normal range hematological, renal and hepatic laboratory results are defined as follows: <parameter>,<range at baseline>,<range at timing>, where range is being classified as Below = value below; Within = value within; and Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
|
At Day 92
|
|
Stage 2: Number of Participants 9 Months of Age in Africa With Deviations From Normal Values of Haematological, Renal, and Hepatic Panel Test Results After Third Study Intervention - Infants Safety Cohort
Periodo de tiempo: At Day 260
|
Panel tests include measures of ALT, AST, creatinine, basophils, eosinophils, erythrocytes, haematocrit, haemoglobin, lymphocytes, monocytes, neutrophils, platelets and WBC.
Categories reported when comparing Day 1 (baseline) and normal range hematological, renal and hepatic laboratory results are defined as follows: <parameter>,<range at baseline>,<range at timing>, where range is being classified as Below = value below; Within = value within; and Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
|
At Day 260
|
|
Stage 2: Number of Participants 9 Months of Age in Africa With Deviations From Normal Values of Haematological, Renal, and Hepatic Panel Test Results After Third Study Intervention - Infants Dose-finding Cohort
Periodo de tiempo: At Day 260
|
Panel tests include measures of alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine, potassium, sodium, urea, basophils, eosinophils, erythrocytes, haematocrit, haemoglobin, lymphocytes, monocytes, neutrophils, platelets and white blood cells (WBC).
Categories reported when comparing Day 1 (baseline) and normal range hematological, renal and hepatic laboratory results are defined as follows: <parameter>,<range at baseline>,<range at timing>, where range is being classified as Below = value below; Within = value within; and Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
|
At Day 260
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Stage 1: Anti-serotype Specific Shigella LPS/OAg Serum IgG GMCs in Participants 18 to 50 Years of Age in Europe
Periodo de tiempo: At Day 1 and Day 85/Day 169(before each study intervention); at Day 15 (14 days after the first study intervention); at Day 29 and Day 113/Day 197 (28 days after each study intervention)
|
Anti-serotype specific Shigella LPS/OAg serum IgG GMCs were measured by ELISA and expressed in EU/mL of serum.
S. sonnei, S. flexneri 1b, S. flexneri 2a, and S. flexneri 3a serotypes were tested.
|
At Day 1 and Day 85/Day 169(before each study intervention); at Day 15 (14 days after the first study intervention); at Day 29 and Day 113/Day 197 (28 days after each study intervention)
|
|
Stage 2: Anti-serotype Specific Shigella LPS/OAg Serum IgG GMCs in Participants 18 to 50 Years of Age in Africa
Periodo de tiempo: At Day 1 and Day 85 (before each study intervention administration) and Day 29 and Day 113 (28 days after each study intervention administration)
|
At Day 1 and Day 85 (before each study intervention administration) and Day 29 and Day 113 (28 days after each study intervention administration)
|
|
|
Stage 2: Anti-serotype Specific Shigella LPS/OAg Serum IgG GMCs in Participants 24 to 59 Months of Age in Africa
Periodo de tiempo: At Day 1 and Day 85 (before each study intervention) and Day 29 and Day 113 (28 days after each study intervention)
|
At Day 1 and Day 85 (before each study intervention) and Day 29 and Day 113 (28 days after each study intervention)
|
|
|
Stage 2: Anti-serotype Specific Shigella LPS/OAg Serum IgG GMCs in Participants 9 Months of Age in Africa - Infants Safety Cohort
Periodo de tiempo: At Day 1, Day 85 and Day 253 (before each study intervention administration) and Day 29, Day 113 and Day 281 (28 days after each study intervention administration)
|
At Day 1, Day 85 and Day 253 (before each study intervention administration) and Day 29, Day 113 and Day 281 (28 days after each study intervention administration)
|
|
|
Stage 2: Anti-serotype Specific Shigella LPS/OAg Serum IgG GMCs in Participants 9 Months of Age in Africa - Dose-finding Cohort
Periodo de tiempo: At Day 1, Day 85 and Day 253 (before each study intervention administration) and Day 29, Day 113 and Day 281 (28 days after each study intervention administration)
|
At Day 1, Day 85 and Day 253 (before each study intervention administration) and Day 29, Day 113 and Day 281 (28 days after each study intervention administration)
|
|
|
Stage 1: Number of Participants 18 to 50 Years of Age Achieving a GVGH ELISA Level Equivalent to ≥1:800 Titer Against S. Sonnei LPS/OAg
Periodo de tiempo: At Day 1 and Day 85/Day 169 (before each study intervention); at Day 15 (14 days after the first study intervention); at Day 29 and Day 113/Day 197 (28 days after each study intervention)
|
At Day 1 and Day 85/Day 169 (before each study intervention); at Day 15 (14 days after the first study intervention); at Day 29 and Day 113/Day 197 (28 days after each study intervention)
|
|
|
Stage 2: Number of Participants 18 to 50 Years of Age Achieving a GVGH ELISA Level Equivalent to ≥1:800 Titer Against S. Sonnei LPS/OAg
Periodo de tiempo: At Day 1 and Day 85 (before each study intervention) and Day 29 and Day 113 (28 days after each study intervention)
|
At Day 1 and Day 85 (before each study intervention) and Day 29 and Day 113 (28 days after each study intervention)
|
|
|
Stage 2: Number of Participants 24 to 59 Months of Age Achieving a GVGH ELISA Level Equivalent to ≥1:800 Titer Against S. Sonnei LPS/OAg
Periodo de tiempo: At Day 1 and Day 85 (before each study intervention) and Day 29 and Day 113 (28 days after each study intervention)
|
At Day 1 and Day 85 (before each study intervention) and Day 29 and Day 113 (28 days after each study intervention)
|
|
|
Stage 2: Number of Participants 9 Months of Age Achieving a GVGH ELISA Level Equivalent to ≥1:800 Titer Against S. Sonnei LPS/Oag - Safety Cohort
Periodo de tiempo: At Day 1, Day 85 and Day 253 (before each study intervention) and Day 29, Day 113 and Day 281 (28 days after each study intervention)
|
At Day 1, Day 85 and Day 253 (before each study intervention) and Day 29, Day 113 and Day 281 (28 days after each study intervention)
|
|
|
Stage 2: Number of Participants 9 Months of Age Achieving a GVGH ELISA Level Equivalent to ≥1:800 Titer Against S. Sonnei LPS/Oag - Dose-finding Cohort
Periodo de tiempo: At Day 1, Day 85 and Day 253 (before each study intervention) and Day 29, Day 113 and Day 281 (28 days after each study intervention)
|
At Day 1, Day 85 and Day 253 (before each study intervention) and Day 29, Day 113 and Day 281 (28 days after each study intervention)
|
|
|
Stage 1: Number of Participants 18 to 50 Years of Age Achieving a GVGH ELISA Level Equivalent to ≥1:1600 Titer Against S. Sonnei LPS/OAg
Periodo de tiempo: At Day 1 and Day 85/Day 169 (before each study intervention); at Day 15 (14 days after the first study intervention); at Day 29 and Day 113/Day 197 (28 days after each study intervention)
|
At Day 1 and Day 85/Day 169 (before each study intervention); at Day 15 (14 days after the first study intervention); at Day 29 and Day 113/Day 197 (28 days after each study intervention)
|
|
|
Stage 2: Number of Participants 18 to 50 Years of Age Achieving a GVGH ELISA Level Equivalent to ≥1:1600 Titer Against S. Sonnei LPS/OAg
Periodo de tiempo: At Day 1 and Day 85 (before each study intervention) and Day 29 and Day 113 (28 days after each study intervention)
|
At Day 1 and Day 85 (before each study intervention) and Day 29 and Day 113 (28 days after each study intervention)
|
|
|
Stage 2: Number of Participants 24 to 59 Months of Age Achieving a GVGH ELISA Level Equivalent to ≥1:1600 Titer Against S. Sonnei LPS/OAg
Periodo de tiempo: At Day 1 and Day 85 (before each study intervention) and Day 29 and Day 113 (28 days after each study intervention)
|
At Day 1 and Day 85 (before each study intervention) and Day 29 and Day 113 (28 days after each study intervention)
|
|
|
Stage 2: Number of Participants 9 Months of Age Achieving a GVGH ELISA Level Equivalent to ≥1:1600 Titer Against S. Sonnei LPS/OAg - Safety Cohort
Periodo de tiempo: At Day 1, Day 85 and Day 253 (before each study intervention) and Day 29, Day 113 and Day 281 (28 days after each study intervention)
|
At Day 1, Day 85 and Day 253 (before each study intervention) and Day 29, Day 113 and Day 281 (28 days after each study intervention)
|
|
|
Stage 2: Number of Participants 9 Months of Age Achieving a GVGH ELISA Level Equivalent to ≥1:1600 Titer Against S. Sonnei LPS/OAg - Dose-finding Cohort
Periodo de tiempo: At Day 1, Day 85 and Day 253 (before each study intervention) and Day 29, Day 113 and Day 281 (28 days after each study intervention)
|
At Day 1, Day 85 and Day 253 (before each study intervention) and Day 29, Day 113 and Day 281 (28 days after each study intervention)
|
|
|
Stage 1: Number of Participants 18 to 50 Years of Age Showing at Least a 4-fold Increase in Anti-serotype Specific Shigella LPS/OAg Serum IgG Concentrations, as Measured by GVGH ELISA
Periodo de tiempo: At Day 15 (14 days after the first study intervention) and at Day 29 and Day 113/Day 197 (28 days after each study intervention) compared to baseline (Day 1 and Day 85/Day 169)
|
At Day 15 (14 days after the first study intervention) and at Day 29 and Day 113/Day 197 (28 days after each study intervention) compared to baseline (Day 1 and Day 85/Day 169)
|
|
|
Stage 2: Number of Participants 18 to 50 Years of Age Showing at Least a 4-fold Increase in Anti-serotype Specific Shigella LPS/OAg Serum IgG Concentrations, as Measured by GVGH ELISA
Periodo de tiempo: At Day 29 and Day 113 (28 days after each study intervention) compared to baseline (Day 1 and Day 85)
|
At Day 29 and Day 113 (28 days after each study intervention) compared to baseline (Day 1 and Day 85)
|
|
|
Stage 2: Number of Participants 24 to 59 Months of Age Showing at Least a 4-fold Increase in Anti-serotype Specific Shigella LPS/OAg Serum IgG Concentrations, as Measured by GVGH ELISA
Periodo de tiempo: At Day 29 and Day 113 (28 days after each study intervention) compared to baseline (Day 1 and Day 85)
|
At Day 29 and Day 113 (28 days after each study intervention) compared to baseline (Day 1 and Day 85)
|
|
|
Stage 2: Number of Participants 9 Months of Age Showing at Least a 4-fold Increase in Anti-serotype Specific Shigella LPS/OAg Serum IgG Concentrations, as Measured by GVGH ELISA - Safety Cohort
Periodo de tiempo: At Day 29, Day 113 and Day 281 (28 days after each study intervention) compared to baseline (Day 1, Day 85 and Day 253)
|
At Day 29, Day 113 and Day 281 (28 days after each study intervention) compared to baseline (Day 1, Day 85 and Day 253)
|
|
|
Stage 2: Number of Participants 9 Months of Age Showing at Least a 4-fold Increase in Anti-serotype Specific Shigella LPS/OAg Serum IgG Concentrations, as Measured by GVGH ELISA - Dose-finding Cohort
Periodo de tiempo: At Day 29, Day 113 and Day 281 (28 days after each study intervention) compared to baseline (Day 1, Day 85 and Day 253)
|
At Day 29, Day 113 and Day 281 (28 days after each study intervention) compared to baseline (Day 1, Day 85 and Day 253)
|
|
|
Stage 2: Anti-measles IgG Concentrations in Participants 9 Months of Age in the Dose-finding Cohort
Periodo de tiempo: At Day 1 (before first measles and rubella vaccine (MR-VAC)) and at Day 281 (28 days after the second MR-VAC administration)
|
At Day 1 (before first measles and rubella vaccine (MR-VAC)) and at Day 281 (28 days after the second MR-VAC administration)
|
|
|
Stage 2: Anti-rubella IgG Concentrations in Participants 9 Months of Age in the Dose-finding Groups
Periodo de tiempo: At Day 1 (before first measles and rubella vaccine (MR-VAC)) and at Day 281 (28 days after the second MR-VAC administration)
|
At Day 1 (before first measles and rubella vaccine (MR-VAC)) and at Day 281 (28 days after the second MR-VAC administration)
|
|
|
Stage 2: Number of Participants 9 Months of Age in the Dose-finding Groups Achieving Anti-measles IgG Concentrations of ≥150 Milli International Units Per Milliliter (mIU/mL) and ≥200 mIU/mL
Periodo de tiempo: Day 281 (28 days after the second MR-VAC administration)
|
Day 281 (28 days after the second MR-VAC administration)
|
|
|
Stage 2: Number of Participants 9 Months of Age in the Dose-finding Groups Achieving Anti-rubella IgG Concentrations of ≥4 mIU/mL and ≥10 mIU/mL
Periodo de tiempo: Day 281 (28 days after the second MR-VAC administration)
|
Day 281 (28 days after the second MR-VAC administration)
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: GSK Clinical Trials, GlaxoSmithKline
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)
6 de octubre de 2021
Finalización primaria (Actual)
24 de junio de 2025
Finalización del estudio (Actual)
24 de junio de 2025
Fechas de registro del estudio
Enviado por primera vez
29 de septiembre de 2021
Primero enviado que cumplió con los criterios de control de calidad
29 de septiembre de 2021
Publicado por primera vez (Actual)
11 de octubre de 2021
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
22 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
18 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Signos y Síntomas Digestivos
- Enfermedades intestinales
- Infecciones
- Enfermedades del Sistema Digestivo
- Enfermedades Gastrointestinales
- Gastroenteritis
- Infecciones bacterianas
- Infecciones bacterianas y micosis
- Infecciones por bacterias gramnegativas
- Infecciones por enterobacterias
- Disentería
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Diarrea
- Disentería Bacilar
- Productos biológicos
- Mezclas complejas
- Vacunas bacterianas
- Vacunas
- Vacunas meningocócicas
- Boostrix
- Diphtheria-tétanus-acelular a la tos ferina inactivada con poliovirus-hemophilus influenzae B-Hepatitis B Vacuna
- Vacuna de polisacáridos Vi, tifoidea
Otros números de identificación del estudio
- 212149
- 2021-000891-12 (Número EudraCT)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
La IPD para este estudio estará disponible 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, los criterios de valoración secundarios clave y los 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 se establezca un Acuerdo de intercambio de datos.
El acceso se brinda por un período inicial de 12 meses, pero se puede otorgar una extensión, cuando se justifique, 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. .