Immunogenicity & Safety of GSK's Influenza Vaccine 1557484A Given to Adults Aged ≥18 Years
9 de mayo de 2018 actualizado por: GlaxoSmithKline
A Trial to Evaluate the Safety and Immunogenicity of an Investigational Vaccination Regimen in Adults Aged ≥18 Years
The purpose of this Phase 3, observer-blind, placebo-controlled, multi-center study is to characterize the immunogenicity & safety of the investigation vaccination regimen of GSK 1557484A vaccine given to adults aged ≥18 years.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
4561
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
-
-
Nova Scotia
-
Halifax, Nova Scotia, Canadá, B3K 6R8
- GSK Investigational Site
-
Truro, Nova Scotia, Canadá, B2N 1L2
- GSK Investigational Site
-
-
Ontario
-
London, Ontario, Canadá, N5W 6A2
- GSK Investigational Site
-
Sarnia, Ontario, Canadá, N7T 4X3
- GSK Investigational Site
-
Sudbury, Ontario, Canadá, P3E 6C3
- GSK Investigational Site
-
Woodstock, Ontario, Canadá, N4S 4G3
- GSK Investigational Site
-
-
Quebec
-
Pointe-Claire, Quebec, Canadá, H9R 4S3
- GSK Investigational Site
-
Quebec City, Quebec, Canadá, G1E 7G9
- GSK Investigational Site
-
Sherbrooke, Quebec, Canadá, J1H 4J6
- GSK Investigational Site
-
St-Romuald, Quebec, Canadá, G6W 5M6
- GSK Investigational Site
-
-
-
-
Alabama
-
Huntsville, Alabama, Estados Unidos, 35802
- GSK Investigational Site
-
-
Arizona
-
Phoenix, Arizona, Estados Unidos, 85020
- GSK Investigational Site
-
-
California
-
Anaheim, California, Estados Unidos, 92801
- GSK Investigational Site
-
-
Florida
-
Jacksonville, Florida, Estados Unidos, 32216
- GSK Investigational Site
-
Melbourne, Florida, Estados Unidos, 32935
- GSK Investigational Site
-
Miami, Florida, Estados Unidos, 33143
- GSK Investigational Site
-
Pembroke Pines, Florida, Estados Unidos, 33024
- GSK Investigational Site
-
-
Georgia
-
Stockbridge, Georgia, Estados Unidos, 30281
- GSK Investigational Site
-
-
Illinois
-
Chicago, Illinois, Estados Unidos, 60610
- GSK Investigational Site
-
Peoria, Illinois, Estados Unidos, 61602
- GSK Investigational Site
-
-
Indiana
-
South Bend, Indiana, Estados Unidos, 46601
- GSK Investigational Site
-
-
Kansas
-
Lenexa, Kansas, Estados Unidos, 66219
- GSK Investigational Site
-
Wichita, Kansas, Estados Unidos, 67207
- GSK Investigational Site
-
-
Louisiana
-
Metairie, Louisiana, Estados Unidos, 70006
- GSK Investigational Site
-
-
Maryland
-
Rockville, Maryland, Estados Unidos, 20850
- GSK Investigational Site
-
-
Missouri
-
Saint Louis, Missouri, Estados Unidos, 63141
- GSK Investigational Site
-
-
Montana
-
Missoula, Montana, Estados Unidos, 59801
- GSK Investigational Site
-
-
Nevada
-
Las Vegas, Nevada, Estados Unidos, 89104
- GSK Investigational Site
-
-
New Jersey
-
Edison, New Jersey, Estados Unidos, 08817
- GSK Investigational Site
-
-
New York
-
Poughkeepsie, New York, Estados Unidos, 12601
- GSK Investigational Site
-
Rochester, New York, Estados Unidos, 14609
- GSK Investigational Site
-
-
North Carolina
-
Raleigh, North Carolina, Estados Unidos, 27612
- GSK Investigational Site
-
-
Ohio
-
Cleveland, Ohio, Estados Unidos, 44122
- GSK Investigational Site
-
-
Pennsylvania
-
Erie, Pennsylvania, Estados Unidos, 16506
- GSK Investigational Site
-
Pittsburgh, Pennsylvania, Estados Unidos, 15236
- GSK Investigational Site
-
-
South Carolina
-
Spartanburg, South Carolina, Estados Unidos, 29303
- GSK Investigational Site
-
-
Tennessee
-
Nashville, Tennessee, Estados Unidos, 37203
- GSK Investigational Site
-
-
Texas
-
Austin, Texas, Estados Unidos, 78705
- GSK Investigational Site
-
Fort Worth, Texas, Estados Unidos, 76135
- GSK Investigational Site
-
San Angelo, Texas, Estados Unidos, 76904
- GSK Investigational Site
-
-
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
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- A male or female 18 years of age or greater at the time of the first vaccination.
- Written informed consent obtained from the subject.
- Among 18 to 49 year old subjects, good general health as established by medical history and clinical examination before entering into the study.
- Among subjects > 49 years of age, stable health status within 1 month prior to enrollment.
- Access to a consistent means of telephone contact.
- Comprehension of the study requirements, ability to comprehend and comply with procedures for collection of short- and long-term safety data, expressed availability for the required study period, and ability and willingness to attend scheduled visits.
Exclusion Criteria:
- Evidence of substance abuse or of neurological or psychiatric diagnoses which, even if clinically stable, are deemed by the investigator to render the potential subjectunable/unlikely to provide accurate safety reports.
- Diagnosed with cancer, or treatment for cancer, within 3 years.
- An oral temperature ≥37.8º C, or acute symptoms greater than "mild" severity on the scheduled date of first vaccination.
- Any confirmed or suspected immunosuppressive or immunodeficient condition including history of human immunodeficiency virus infection.
- Receipt of systemic glucocorticoids within 1 month of study enrollment, or any other cytotoxic or immunosuppressive drug within 6 months of study enrollment.
- Any significant disorder of coagulation or treatment with Coumadin derivatives or heparin.
- Administration of any vaccines within 30 days before study enrollment.
- Previous administration of any H5N1 vaccine.
- Use of any investigational or non-registered product or planned participation in another investigational study within 30 days prior to study enrollment, or during the 364 days following the first test article dose. Use of any investigational or non-registered product with immunosuppressive properties is exclusionary at any time during the trial.
- Receipt of any immunoglobulins and/or any blood products within 3 months of study enrollment or planned administration of any of these products during the study period.
- Any known or suspected allergy to any constituent of influenza vaccines; a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine.
- Known pregnancy or a positive urine beta-human chorionic gonadotropin test result prior to either vaccination.
- Lactating or nursing.
- Women of child bearing potential who lack a history of reliable contraceptive practices. The provision of this history does NOT replace the requirement to perform, and obtain negative results in pregnancy urine tests prior to treatments.
- Known use of an analgesic or antipyretic medication within 12 hours prior to first treatment.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Influenza A (H5N1) 18-64Y Group
Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted vaccine formulations A. B, or C in approximately equal proportions, at Days 0 and 21.
The first dose was administered in the deltoid region of the non-dominant arm.
The second dose was administered in the deltoid region of the dominant arm.
|
Two intramuscular injections at Days 0 and 21.
|
|
Comparador de placebos: Placebo 18-64Y Group
Subjects aged 18-64 years, who received 2 doses of placebo at Days 0 and 21.
The first dose was administered in the deltoid region of the non-dominant arm.
The second dose was administered in the deltoid region of the dominant arm.
|
Two intramuscular injections at Days 0 and 21.
|
|
Experimental: Influenza A (H5N1) >64Y Group
Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted vaccine formulations A. B, or C in approximately equal proportions, at Days 0 and 21.
The first dose was administered in the deltoid region of the non-dominant arm.
The second dose was administered in the deltoid region of the dominant arm.
|
Two intramuscular injections at Days 0 and 21.
|
|
Comparador de placebos: Placebo >64Y Group
Subjects aged > 64 years, who received 2 doses of placebo at Days 0 and 21.
The first dose was administered in the deltoid region of the non-dominant arm.
The second dose was administered in the deltoid region of the dominant arm.
|
Two intramuscular injections at Days 0 and 21.
|
|
Experimental: Influenza A (H5N1) Group
Pooled group of subjects aged >18 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted vaccine formulations A. B, or C in approximately equal proportions, at Days 0 and 21.
The first dose was administered in the deltoid region of the non-dominant arm.
The second dose was administered in the deltoid region of the dominant arm.
|
Two intramuscular injections at Days 0 and 21.
|
|
Comparador de placebos: Placebo Group
Pooled group of subjects aged >18 years, who received 2 doses of placebo at Days 0 and 21.
The first dose was administered in the deltoid region of the non-dominant arm.
The second dose was administered in the deltoid region of the dominant arm.
|
Two intramuscular injections at Days 0 and 21.
|
|
Experimental: Influenza A (H5N1) 18-60Y Group
Subjects aged 18-60 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted vaccine formulations A. B, or C in approximately equal proportions, at Days 0 and 21.
The first dose was administered in the deltoid region of the non-dominant arm.
The second dose was administered in the deltoid region of the dominant arm.
|
Two intramuscular injections at Days 0 and 21.
|
|
Comparador de placebos: Placebo 18-60Y Group
Subjects aged 18-60 years, who received 2 doses of placebo at Days 0 and 21.
The first dose was administered in the deltoid region of the non-dominant arm.
The second dose was administered in the deltoid region of the dominant arm.
|
Two intramuscular injections at Days 0 and 21.
|
|
Experimental: Influenza A (H5N1) >60Y Group
Subjects aged >60 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted vaccine formulations A. B, or C in approximately equal proportions, at Days 0 and 21.
The first dose was administered in the deltoid region of the non-dominant arm.
The second dose was administered in the deltoid region of the dominant arm.
|
Two intramuscular injections at Days 0 and 21.
|
|
Comparador de placebos: Placebo >60Y Group
Subjects aged > 60 years, who received 2 doses of placebo at Days 0 and 21.
The first dose was administered in the deltoid region of the non-dominant arm.
The second dose was administered in the deltoid region of the dominant arm.
|
Two intramuscular injections at Days 0 and 21.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Number of Seroconverted Subjects Against A/Indonesia/5/2005 (H5N1)
Periodo de tiempo: At Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)
|
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination (Day 0) reciprocal HI titer < 1:10 and a post-vaccination (Day 42) reciprocal titer ≥ 1:40, or a pre-vaccination reciprocal HI titer ≥ 1:10 and at least a 4-fold increase in post-vaccination reciprocal titer against A/Indonesia/5/05 virus 21 days after the second dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted.
|
At Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)
|
|
Number of Seroprotected Subjects Against A/Indonesia/5/2005 (H5N1)
Periodo de tiempo: At Day 0 and Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)
|
A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40.
|
At Day 0 and Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)
|
|
Number of Subjects With Any Solicited Local Symptoms.
Periodo de tiempo: During a 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after each vaccine administration
|
Assessed solicited local symptoms were pain, redness and swelling.
Any = occurrence of the symptom regardless of intensity grade.
|
During a 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after each vaccine administration
|
|
Number of Subjects With Any Solicited General Symptoms.
Periodo de tiempo: During a 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after each vaccine administration
|
Assessed solicited general symptoms were fatigue, headache, joint pain at other locations, muscle aches, shivering, sweating and temperature[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)].
Any = occurrence of the symptom regardless of intensity grade.
|
During a 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after each vaccine administration
|
|
Number of Subjects With Any Unsolicited Adverse Events (AEs).
Periodo de tiempo: During a 21-day follow-up period for each vaccine administration, as well as overall (Day 0 through Day 84)
|
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.
|
During a 21-day follow-up period for each vaccine administration, as well as overall (Day 0 through Day 84)
|
|
Number of Subjects With Serious Adverse Events (SAEs)
Periodo de tiempo: From Day 0 through Day 182 and through Day 379.
|
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.
|
From Day 0 through Day 182 and through Day 379.
|
|
Number of Subjects With Medically Attended Events (MAEs)
Periodo de tiempo: From Day 0 through Day 182 and through Day 364.
|
From Day 0 through Day 182 and through Day 364.
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Number of Subjects With Serum Reciprocal HI Antibodies Against A/Indonesia/5/2005 Equal to or Above (≥) 1:10
Periodo de tiempo: At Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)
|
At Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)
|
|
|
Number of Subjects With A/Indonesia/5/05 Antibody Titers ≥ 1:10
Periodo de tiempo: At Month 6 (Day 182) post Dose 1
|
At Month 6 (Day 182) post Dose 1
|
|
|
Number of Seroconverted Subjects Against A/Indonesia/5/2005 (H5N1)
Periodo de tiempo: At Month 6 (Day 182) after Dose 1
|
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination (Day 0) reciprocal HI titer < 1:10 and a post-vaccination (Day 42) reciprocal titer ≥ 1:40, or a pre-vaccination reciprocal HI titer ≥ 1:10 and at least a 4-fold increase in post-vaccination reciprocal titer against A/Indonesia/5/05 virus 21 days after the second dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted.
|
At Month 6 (Day 182) after Dose 1
|
|
Number of Seroprotected Subjects Against A/Indonesia/5/2005 (H5N1)
Periodo de tiempo: At Month 6 (Day 182) after Dose 1
|
At Month 6 (Day 182) after Dose 1
|
|
|
Titers for Serum HI Antibodies Against A/Indonesia/5/05 (H5N1)
Periodo de tiempo: At Month 6 (Day 182) after Dose 1
|
Titers are presented as geometric mean titers (GMTs).
The reference seropositivity cut-off value was ≥ 1:10.
|
At Month 6 (Day 182) after Dose 1
|
|
Number of Subjects With a Vaccine Response to the Vaccine-homologous Virus and Drift Variant H5N1 Virus, as Assessed by Microneutralization Assays.
Periodo de tiempo: At Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)
|
Virus antibody response rates were defined as the number of subjects with antibody titers at Day 42 ≥ 4-fold the pre-vaccination antibody titers.
The 2 strains assessed were Flu A/Indonesia/5/05 and Flu A/Vietnam/1194/04.
|
At Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1) as Assessed by Microneutralization Assays
Periodo de tiempo: At Day 0 and Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)
|
Titers were expressed as Geometric Mean Titers (GMTs).
|
At Day 0 and Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
23 de enero de 2008
Finalización primaria (Actual)
15 de octubre de 2008
Finalización del estudio (Actual)
19 de marzo de 2009
Fechas de registro del estudio
Enviado por primera vez
28 de enero de 2008
Primero enviado que cumplió con los criterios de control de calidad
5 de febrero de 2008
Publicado por primera vez (Estimar)
15 de febrero de 2008
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
8 de junio de 2018
Última actualización enviada que cumplió con los criterios de control de calidad
9 de mayo de 2018
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
- 110464
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
-
Plan de Análisis Estadístico
Identificador de información: 110464Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
-
Informe de estudio clínico
Identificador de información: 110464Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
-
Formulario de informe de caso anotado
Identificador de información: 110464Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
-
Conjunto de datos de participantes individuales
Identificador de información: 110464Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
-
Especificación del conjunto de datos
Identificador de información: 110464Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
-
Formulario de consentimiento informado
Identificador de información: 110464Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
-
Protocolo de estudio
Identificador de información: 110464Comentarios 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. .