Safety and Immunogenicity Study of GSK Biologicals' Pandemic Influenza Candidate Vaccine (H1N1) (GSK2340272A)
31 de julio de 2017 actualizado por: GlaxoSmithKline
Safety and Immunogenicity Study of GSK Biologicals' Pandemic Influenza Candidate Vaccine (GSK2340272A) in Children Aged 3 to 17 Years
This trial is designed to assess the safety and immunogenicity of a prime-boost schedule of GSK Biologicals' investigational vaccine GSK2340272A in children aged between 3 and 17 years.
Descripción general del estudio
Estado
Estado
Terminado
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Tipo de estudio
Tipo de estudio
Intervencionista
Inscripción (Actual)
Inscripción
210
Fase
Fase
- Fase 3
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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Bilbao, España, 48013
- GSK Investigational Site
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Burgos, España, 09005
- GSK Investigational Site
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Madrid, España, 28046
- GSK Investigational Site
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Móstoles/Madrid, España, 28935
- GSK Investigational Site
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Sevilla, España, 41013
- 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
Criterio de elegibilidad
Edades elegibles para estudiar
3 años a 17 años (Niño)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol.
- Children, male or female, aged between 3 and 17 years at the time of the first study vaccination.
- Written informed consent obtained from the subject parent(s) or LAR(s) of the subject. Assent obtained from the subject when applicable.
- Healthy children as established by medical history and clinical examination when entering into the study.
- Parent/LAR with access to a consistent means of telephone contact, land line or mobile, but NOT a pay phone or other multiple-user.
Exclusion Criteria:
- Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of the study vaccine or planned use during the study period.
- Clinically or virologically confirmed influenza infection within six months preceding the study start.
- Planned administration of any vaccine 30 days prior and 30 days after any study vaccine administration.
- Chronic administration of immunosuppressants or other immune-modifying drugs within three months prior to enrolment in this study or planned administration during the study period.
- Acute disease and/or fever at the time of enrolment
- Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
- Acute or chronic, clinically-significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history and physical examination.
- Previous administration of any H1N1 A/California-like vaccine.
- Administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned during the study.
- If the subject is female and if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for two months after completion of the vaccination series.
- Any known or suspected allergy to any constituent of influenza vaccines;a history of anaphylactic-type reaction to any constituent of influenza vaccines; or a history of severe adverse reaction to a previous influenza vaccine.
- Known use of an analgesic or antipyretic medication within 12 hours prior to first vaccination.
- Child in Care.
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: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Número de brazos
1
Armas e Intervenciones
Grupo de participantes/brazoGrupo de participantes/brazo |
Intervención / TratamientoIntervención / Tratamiento |
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Experimental: Grupo A
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Two primary intramuscular (IM) injections and a booster IM injection
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¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Number of Subjects With Haemagglutination-inhibition (HI) Antibody Concentrations Above the Cut-off Value
Periodo de tiempo: At Day 0
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The seropositivity cut-off value of the assay was equal to or above (≥) 1:10 in the sera of subjects seronegative before vaccination.
The flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09).
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At Day 0
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Number of Subjects With HI Antibody Concentrations Above the Cut-off Value
Periodo de tiempo: At Day 42
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The seropositivity cut-off value of the assay was ≥ 1:10 in the sera of subjects seronegative before vaccination.
The flu strain assesssed was Flu A/CAL/7/09.
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At Day 42
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Titers for Serum HI Antibodies
Periodo de tiempo: At Day 0
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Antibody titers were presented as geometric mean titers (GMTs).
The reference seropositivity cut-off value was ≥ 1:10.
The flu strain assessed was Flu A/CAL/7/09.
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At Day 0
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Titers for Serum HI Antibodies
Periodo de tiempo: At Day 42
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Antibody titers were presented as geometric mean titers (GMTs).
The reference seropositivity cut-off value was ≥ 1:10.
The flu strain assessed was Flu A/CAL/7/09.
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At Day 42
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Number of Seroconverted (SCR) Subjects in Terms of HI Antibodies
Periodo de tiempo: At Day 42
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A seroconverted subject was defined as: For initially seronegative subjects [antibody titer below (<) 1:10 prior to vaccination], antibody titer ≥ 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:10 prior to vaccination), at least a 4-fold increase in post-vaccination titer.
The flu strain assessed was Flu A/CAL/7/09.
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At Day 42
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Number of Seroprotected (SPR) Subjects in Terms of HI Antibodies
Periodo de tiempo: At Day 42
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Seroprotection was defined as the percentage of subjects with a serum HI titer ≥ 1:40, that usually is accepted as indicating protection.
The flu strain assessed was Flu A/CAL/7/09.
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At Day 42
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Seroconversion Factor (SCF) for HI Antibody Titers
Periodo de tiempo: At Day 42
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Seroconversion factor was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination.
The flu strain assessed was Flu A/CAL/7/09.
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At Day 42
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Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Número de sujetos con cualquier síntoma local solicitado y grado 3
Periodo de tiempo: Durante el período posterior a la vacunación de 7 días (días 0 a 6) después de cada dosis y entre dosis
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Los síntomas locales solicitados evaluados fueron dolor, enrojecimiento e hinchazón.
Cualquiera = aparición del síntoma independientemente del grado de intensidad.
Dolor de grado 3 = dolor que impidió la actividad normal.
Enrojecimiento/hinchazón de grado 3 = enrojecimiento/hinchazón que se extiende más allá de los 50 milímetros (mm) del lugar de la inyección.
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Durante el período posterior a la vacunación de 7 días (días 0 a 6) después de cada dosis y entre dosis
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Number of Subjects With HI Antibody Concentrations Above the Cut-off Value
Periodo de tiempo: At Days 0, 21, 42 and at Month 12
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The seropositivity cut-off value of the assay was ≥ 1:10 in the sera of subjects seronegative before vaccination.
The flu strain assesssed was Flu A/CAL/7/09.
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At Days 0, 21, 42 and at Month 12
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Titers for Serum HI Antibodies
Periodo de tiempo: At Days 0, 21, 42 and at Month 12
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Antibody titers were presented as geometric mean titers (GMTs).
The reference seropositivity cut-off value was ≥ 1:10.
The flu strain assessed was Flu A/CAL/7/09.
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At Days 0, 21, 42 and at Month 12
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Number of Seroconverted (SCR) Subjects in Terms of HI Antibodies
Periodo de tiempo: At Days 21, 42 and at Month 12
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A seroconverted subject was defined as: For initially seronegative subjects [antibody titer below (<) 1:10 prior to vaccination], antibody titer ≥ 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:10 prior to vaccination), at least a 4-fold increase in post-vaccination antibody titer.
The flu strain assessed was Flu A/CAL/7/09.
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At Days 21, 42 and at Month 12
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Number of Seroprotected Subjects in Terms of HI Antibodies
Periodo de tiempo: At Days 0, 21, 42 and at Month 12
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Seroprotection was defined as the percentage of subjects with a serum HI titer ≥ 1:40, that usually is accepted as indicating protection.
The flu strain assessed was Flu A/CAL/7/09.
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At Days 0, 21, 42 and at Month 12
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Seroconversion Factor (SCF) for HI Antibody Titers
Periodo de tiempo: At Days 21, 42 and at Month 12
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Seroconversion factor was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination.
The flu strain assessed was Flu A/CAL/7/09.
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At Days 21, 42 and at Month 12
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Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value
Periodo de tiempo: At Days 0, 21 and 42
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The seropositivity cut-off value of the assay was ≥ 1:8 in the sera of subjects seronegative before vaccination.
The flu strain assesssed was Flu A/Neth/602/09.
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At Days 0, 21 and 42
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Titers for Serum Neutralizing Antibodies
Periodo de tiempo: At Days 0, 21 and 42
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Antibody titers were presented as geometric mean titers (GMTs).
The reference seropositivity cut-off value was ≥ 1:8.
The flu strain assessed was A/Netherlands/602/2009 (H1N1)v-like (Flu A/Neth/602/09).
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At Days 0, 21 and 42
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Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value
Periodo de tiempo: At Month 12
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The seropositivity cut-off value of the assay was ≥ 1:8 in the sera of subjects seronegative before vaccination.
The flu strain assesssed was Flu A/Neth/602/09.
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At Month 12
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Titers for Serum Neutralizing Antibodies
Periodo de tiempo: At Month 12
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Antibody titers were presented as geometric mean titers (GMTs).
The reference seropositivity cut-off value was ≥ 1:8.
The flu strain assessed was Flu A/Neth/602/09.
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At Month 12
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Number of Seroconverted (SCR) Subjects in Terms of H1N1 Neutralizing Antibodies
Periodo de tiempo: At Days 21 and 42
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A seroconverted subject was defined as: For initially seronegative subjects, antibody titer ≥ 1:32 after vaccination; For initially seropositive subjects, at least a 4-fold increase in post-vaccination titer.
The flu strain assessed was Flu A/Neth/602/09.
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At Days 21 and 42
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Number of Seroconverted (SCR) Subjects in Terms of H1N1 Neutralizing Antibodies
Periodo de tiempo: At Month 12
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A seroconverted subject was defined as: For initially seronegative subjects, antibody titer ≥ 1:32 after vaccination; For initially seropositive subjects, at least a 4-fold increase in post-vaccination titer.
The flu strain assessed was Flu A/Neth/602/09.
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At Month 12
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Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Periodo de tiempo: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
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Assessed solicited general symptoms were diarrhea, drowsiness, irritability, loss of appetite, shivering, sweating and fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)].
Any = occurrence of the symptom regardless of intensity grade.
Grade 3 symptom = symptom that prevented normal activity.
Grade 3 fever = fever > 39.0 °C.
Related = symptom assessed by the investigator as related to the vaccination.
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During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
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Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Periodo de tiempo: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
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Assessed solicited general symptoms were arthralgia, fatigue, gastrointestinal, headache, myalgia, shivering and fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)].
Any = occurrence of the symptom regardless of intensity grade.
Grade 3 symptom = symptom that prevented normal activity.
Grade 3 fever = fever > 39.0 °C.
Related = symptom assessed by the investigator as related to the vaccination.
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During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
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Number of Subjects With Any Medically-attended Events (MAEs)
Periodo de tiempo: During the entire study period (from Day 0 up to Month 12)
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MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason.
Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.
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During the entire study period (from Day 0 up to Month 12)
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Number of Subjects With Any Adverse Events of Specific Interest (AESIs), Including Potential Immune-mediated Disease (pIMDs)
Periodo de tiempo: During the entire study period (from Day 0 up to Month 12)
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An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.
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During the entire study period (from Day 0 up to Month 12)
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Number of Subjects With Normal or Abnormal Biochemical Levels
Periodo de tiempo: At Days 0, 21 and 42
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Among biochemical parameters assessed were alanine aminotransferase [ALAT], aspartate aminotransferase [ASAT], bilirubin [BILI], creatinine [CREA] and blood urea nitrogen [BUN].
Levels of biochemical parameters assessed in terms of normal laboratory values were - unknown, below, within and above.
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At Days 0, 21 and 42
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Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Periodo de tiempo: During the 21-day (Days 0-20) follow-up period after the first vaccination
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An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Grade 3 AE = an AE which prevented normal, everyday activities.
Related = AE assessed by the investigator as related to the vaccination.
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During the 21-day (Days 0-20) follow-up period after the first vaccination
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Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Periodo de tiempo: During the 83-day (Days 0-82) follow-up period after the first vaccination and the 62-day (Days 0-61) follow-up period after the second vaccination
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An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Grade 3 AE = an AE which prevented normal, everyday activities.
Related = AE assessed by the investigator as related to the vaccination.
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During the 83-day (Days 0-82) follow-up period after the first vaccination and the 62-day (Days 0-61) follow-up period after the second vaccination
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Number of Subjects With Serious Adverse Events (SAEs)
Periodo de tiempo: During the entire study period (from Day 0 up to Month 12)
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Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
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During the entire study period (from Day 0 up to Month 12)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Garcia-Sicilia J, Aristegui J, Omenaca F, Carmona A, Tejedor JC, Merino JM, Garcia-Corbeira P, Walravens K, Bambure V, Moris P, Caplanusi A, Gillard P, Dieussaert I. Safety and persistence of the humoral and cellular immune responses induced by 2 doses of an AS03-adjuvanted A(H1N1)pdm09 pandemic influenza vaccine administered to infants, children and adolescents: Two open, uncontrolled studies. Hum Vaccin Immunother. 2015;11(10):2359-69. doi: 10.1080/21645515.2015.1063754.
- Garcia-Sicilia J, Gillard P, Carmona A, Tejedor JC, Aristegui J, Merino JM, Behre U, Caplanusi A, Vaman T, Dieussaert I. Immunogenicity and safety of AS03-adjuvanted H1N1 pandemic vaccines in children and adolescents. Vaccine. 2011 Jun 10;29(26):4353-61. doi: 10.1016/j.vaccine.2011.04.011. Epub 2011 Apr 17.
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
Inicio del estudio
10 de septiembre de 2009
Finalización primaria (Actual)
Finalización primaria
27 de noviembre de 2010
Finalización del estudio (Actual)
Finalización del estudio
27 de noviembre de 2010
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
20 de agosto de 2009
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
20 de agosto de 2009
Publicado por primera vez (Estimar)
Publicado por primera vez
24 de agosto de 2009
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
19 de febrero de 2018
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
31 de julio de 2017
Última verificación
Última verificación
1 de octubre de 2016
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
Otros números de identificación del estudio
- 113528
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Datos del estudio/Documentos
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Plan de Análisis Estadístico
Identificador de información: 113528Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
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Formulario de informe de caso anotado
Identificador de información: 113528Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
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Formulario de consentimiento informado
Identificador de información: 113528Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
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Informe de estudio clínico
Identificador de información: 113528Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
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Conjunto de datos de participantes individuales
Identificador de información: 113528Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
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Protocolo de estudio
Identificador de información: 113528Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
-
Especificación del conjunto de datos
Identificador de información: 113528Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
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. .