Safety, Immunogenicity, and Relative Efficacy of H1N1 Vaccines in Adults Aged 18 Years and Older
19 de marzo de 2018 actualizado por: GlaxoSmithKline
A Study to Evaluate the Safety, Immunogenicity, and Relative Efficacy of A/California/7/2009 (H1N1)V-like Vaccines GSK2340274A and GSK2340273A in Adults Aged 18 Years and Older
The purpose of this study is to characterize the safety, immunogenicity, and relative efficacy of the H1N1 (swine) flu vaccines GSK2340273A and GSK2340274A in adults 18 years of age or older.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
Collaborators: United States Department of Health and Human Services, Office of Biomedical Advanced Research and Development Authority
Tipo de estudio
Intervencionista
Inscripción (Actual)
4048
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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Quebec, Canadá, G1W 4R4
- GSK Investigational Site
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British Columbia
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Coquitlam, British Columbia, Canadá, V3K 3P4
- GSK Investigational Site
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Newfoundland and Labrador
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Bay Roberts, Newfoundland and Labrador, Canadá, A0A 1G0
- GSK Investigational Site
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Saint John's, Newfoundland and Labrador, Canadá, A1A 3R5
- GSK Investigational Site
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Ontario
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Brampton, Ontario, Canadá, L6T 3T1
- GSK Investigational Site
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London, Ontario, Canadá, N5W 6A2
- GSK Investigational Site
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Ottawa, Ontario, Canadá, K1Y 4G2
- GSK Investigational Site
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Sudbury, Ontario, Canadá, P3E 1H5
- GSK Investigational Site
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Toronto, Ontario, Canadá, M3H 5S4
- GSK Investigational Site
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Quebec
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Gatineau, Quebec, Canadá, J8Y 6S8
- GSK Investigational Site
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Quebec City, Quebec, Canadá, G1E 7G9
- GSK Investigational Site
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Sherbrooke, Quebec, Canadá, J1H 1Z1
- GSK Investigational Site
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St-Romulad, Quebec, Canadá, G6W 5M6
- GSK Investigational Site
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Arizona
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Mesa, Arizona, Estados Unidos, 85213
- GSK Investigational Site
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Phoenix, Arizona, Estados Unidos, 85020
- GSK Investigational Site
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Phoenix, Arizona, Estados Unidos, 85028
- GSK Investigational Site
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California
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Los Angeles, California, Estados Unidos, 90057
- GSK Investigational Site
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Florida
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Clearwater, Florida, Estados Unidos, 33761
- GSK Investigational Site
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DeLand, Florida, Estados Unidos, 32720
- GSK Investigational Site
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Delray Beach, Florida, Estados Unidos, 33484
- GSK Investigational Site
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Jacksonville, Florida, Estados Unidos, 32205
- GSK Investigational Site
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Illinois
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Chicago, Illinois, Estados Unidos, 60610
- GSK Investigational Site
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Kansas
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Wichita, Kansas, Estados Unidos, 67207
- GSK Investigational Site
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Kentucky
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Lexington, Kentucky, Estados Unidos, 40509
- GSK Investigational Site
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Maryland
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Columbia, Maryland, Estados Unidos, 21045
- GSK Investigational Site
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Rockville, Maryland, Estados Unidos, 20850
- GSK Investigational Site
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Massachusetts
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Milford, Massachusetts, Estados Unidos, 01757
- GSK Investigational Site
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Missouri
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Kansas City, Missouri, Estados Unidos, 64114
- GSK Investigational Site
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New Jersey
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Somers Point, New Jersey, Estados Unidos, 08244
- GSK Investigational Site
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New York
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Binghamton, New York, Estados Unidos, 13901
- GSK Investigational Site
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Camillus, New York, Estados Unidos, 13031
- GSK Investigational Site
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North Carolina
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Winston-Salem, North Carolina, Estados Unidos, 27103
- GSK Investigational Site
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Ohio
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Willoughby Hills, Ohio, Estados Unidos, 44094
- GSK Investigational Site
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Pennsylvania
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Erie, Pennsylvania, Estados Unidos, 16506
- GSK Investigational Site
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Rhode Island
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Warwick, Rhode Island, Estados Unidos, 02886
- GSK Investigational Site
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South Carolina
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Spartanburg, South Carolina, Estados Unidos, 29303
- GSK Investigational Site
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Tennessee
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Nashville, Tennessee, Estados Unidos, 37203
- GSK Investigational Site
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Washington
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Wenatchee, Washington, Estados Unidos, 98801
- GSK Investigational Site
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Subjects who the investigator believes can and will comply with the requirements of the protocol.
- Written informed consent obtained from the subject.
- Male and female adults, >= 18 years of age at the time of the first vaccination.
- Satisfactory baseline medical assessment by history and physical examination.
- Safety laboratory test results within the parameters specified in the protocol.
- Comprehension of the study requirements, ability to comprehend and comply with procedures for collection of safety data, expressed availability for the required study period, and ability and willingness to attend scheduled visits as demonstrated by signature on the informed consent document.
- Access to a consistent means of telephone contact, which may be either in the home or at the workplace, land line, or mobile, but NOT a pay phone or other multiple-user device.
- Female subjects of non-childbearing potential may be enrolled in the study.
- Female subjects of childbearing potential may be enrolled in the study, if the subject:
- has practiced adequate contraception for 30 days prior to vaccination; and
- has a negative pregnancy test on the day of first vaccination; and
- has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.
Exclusion Criteria:
- Medical history of physician-confirmed infection with an A/California/7/2009 (H1N1)v-like virus.
- Previous vaccination at any time with an A/California/7/2009 (H1N1)v-like virus vaccine.
- With the exception of seasonal influenza vaccination, administration of any vaccine(s) within 30 days before study vaccination on Day 0. Seasonal influenza vaccine may be administered up to 14 days prior to study vaccination on Day 0.
- Planned administration of any vaccine other than the study vaccines between Day 0 and the phlebotomy 21 days after vaccination.
- Planned administration of any monovalent pandemic (H1N1)v-like vaccine other than the study vaccines during the whole study (Day 0 - Day 385).
- Previous vaccination with an H1N1v-like virus vaccine or a medical history of physician-confirmed infection with an H1N1v-like virus.
- Presence of evidence of substance abuse or of neurological or psychiatric diagnoses which, although stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.
- Presence of a temperature >= 38.0ºC (>= 100.4 ºF), oral temperature assessment preferred, or acute symptoms greater than "mild" severity on the scheduled date of first vaccination.
- Diagnosed with cancer, or treatment for cancer, within 3 years.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- Receipt of systemic glucocorticoids within 1month prior to study enrollment, or any other cytotoxic or immunosuppressive drug within 6 months of study enrollment. Topical, intra-articularly injected, or inhaled glucocorticoids, topical calcineurin inhibitors, or imiquimod are allowed.
- 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 significant disorder of coagulation or treatment with warfarin derivatives or heparin. Persons receiving individual doses of low molecular weight heparin are eligible if no such doses are given in the 24 hours before a study vaccination. Persons receiving prophylactic antiplatelet medications, e.g., low-dose acetylsalicylic acid, and without a clinically-apparent bleeding tendency, are eligible.
- History of an acute evolving neurological disorder or history of Guillain-Barré syndrome within 6 weeks of receipt of seasonal influenza vaccine.
- With the exception of seasonal influenza vaccination, administration of any vaccines within 30 days before study vaccination on Day 0. Seasonal influenza vaccine may be administered up to 14 days prior to study vaccination on Day 0.
- Planned administration of any vaccine other than the study vaccine between Day 0 and the phlebotomy 21 days after the second study vaccine dose.
- Use of any investigational or non-registered product within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- 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 pregnancy or a positive urine beta-human chorionic gonadotropin test result prior to vaccination.
- Lactating or nursing women.
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 |
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Experimental: GSK2340274A Group
Healthy male or female subjects between and including 18 to 60 years of age and older (>60 years) and between 18 to 64 years of age and older (>64 years), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
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One intramuscular injection
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Experimental: GSK2340273A Group
Healthy male or female subjects between and including 18 to 60 years of age and older (>60 years) and between 18 to 64 years of age and older (>64 years), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.
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One intramuscular injection
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Number of Seroconverted (SCR) Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain
Periodo de tiempo: At Day 21
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A seroconverted subject was defined as a vaccinated subject who had a post-vaccination titer higher than or equal to (≥)1:40 or at least a 4-fold increase of the pre-vaccination titer of ≥ 1:10.
The Flu strain assessed was A/California/7/09 (H1N1)v-like (Flu A/CAL/7/09) in subjects of 18-60 years and older and 18-64 years and older, following the Committee for Medicinal Products for Human Use (CHMP) and the Center for Biologics Evaluation and Research (CBER) guidance.
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At Day 21
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Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain
Periodo de tiempo: At Day 0
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A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) antibody titer ≥ 1:40 against the tested virus.
The Flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.
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At Day 0
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Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain
Periodo de tiempo: At Day 21
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A seroprotected subject was defined as a vaccinated subject with serum HI antibody titer ≥ 1:40.
The Flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.
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At Day 21
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Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain
Periodo de tiempo: At Day 21
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SCF was defined as the fold increase in serum HI geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus, in subjects 18-60 years and older and 18-64 years and older, following the CHMP guidance.
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At Day 21
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Number of A/California/7/2009 (H1N1)V-like Illness (ILI) Cases
Periodo de tiempo: From Day 14 post-vaccination up to study end (at Day 385)
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The analysis focused on Quantitative Reverse Transcription Polymerase Chain Reaction Assay (RT-qPCR)-confirmed A/California/7/2009 (H1N1)v-like illness (ILI) cases.
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From Day 14 post-vaccination up to study end (at Day 385)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Number of Seropositive Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain
Periodo de tiempo: At Days 0 and 21
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Cut-off values assessed were greater than or equal to (≥) 1:10 in the sera of subjects seronegative before vaccination. The Flu strains assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance. |
At Days 0 and 21
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Titers for Serum HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain
Periodo de tiempo: At Days 0 and 21
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Titers were presented as geometric mean titers (GMTs).
The flu strain assessed was /California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.
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At Days 0 and 21
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Number of Seropositive Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain
Periodo de tiempo: At Day 42
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Cut-off values assessed were greater than or equal to (≥) 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) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.
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At Day 42
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Titers for Serum HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain
Periodo de tiempo: At Day 42
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Titers were presented as geometric mean titers (GMTs).
The flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.
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At Day 42
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Number of Seropositive Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain
Periodo de tiempo: At Day 182
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Cut-off values assessed were greater than or equal to ≥ 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) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.
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At Day 182
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Titers for Serum HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain
Periodo de tiempo: At Day 182
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Titers were presented as geometric mean titers (GMTs).
The flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.
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At Day 182
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Number of Seroconverted (SCR) Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain
Periodo de tiempo: At Day 42
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A seroconverted subject was defined as a vaccinated subject who had a post-vaccination titer ≥1:40 and at least a 4-fold increase of the pre-vaccination titer.
The Flu strain assessed was A/California/7/09 (H1N1)v-like) (Flu A/CAL/7/09) in subjects of 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.
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At Day 42
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Number of Seroconverted (SCR) Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain
Periodo de tiempo: At Day 182
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A seroconverted subject was defined as a vaccinated subject who had a post-vaccination titer ≥1:40 and at least a 4-fold increase of the pre-vaccination titer.
The Flu strain assessed was A/California/7/09 (H1N1)v-like) (Flu A/CAL/7/09) in subjects of 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.
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At Day 182
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Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain
Periodo de tiempo: At Day 42
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A seroprotected subject was defined as a vaccinated subject with serum HI antibody titer ≥ 1:40.
The Flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.
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At Day 42
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Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain
Periodo de tiempo: At Day 182
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A seroprotected subject was defined as a vaccinated subject with serum HI antibody titer ≥ 1:40.
The Flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.
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At Day 182
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Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain
Periodo de tiempo: At Day 42
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SCF was defined as the fold increase in serum HI geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus, in subjects 18-60 years and older and 18-64 years and older, following the CHMP.
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At Day 42
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Seroconversion Factor (SCF) for HI Antibodies Against A/CAL/7/09 H1N1 Virus Strain
Periodo de tiempo: At Day 182
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SCF was defined as the fold increase in serum HI geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus, in subjects 18-60 years and older and 18-64 years and older, following the CHMP.
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At Day 182
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Number of A/California Influenza Related Cases
Periodo de tiempo: From Day 0 up to the end of ILI surveillance (Day 385)
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Influenza related cases included: A/California/7/2009 (H1N1)v-like influenza illness (ILI) cases, pneumonia cases, RT-qPCR confirmed influenza, culture confirmed influenza and RT-qPCR confirmed influenza with pneumonia.
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From Day 0 up to the end of ILI surveillance (Day 385)
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Number of ILI Symptoms in All Reported ILI Cases
Periodo de tiempo: From Day 0 up to the end of ILI surveillance (Day 385)
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Assessed ILI symptoms were fever [defined as oral temperature equal to or above (≥) 38.5 degrees Celsius (°C)], myalgia (muscle aches all over the body), cough, sore throat, runny/stuffy nose, short of breath, headache, vomiting, diarrhea, chills, fatigue.
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From Day 0 up to the end of ILI surveillance (Day 385)
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Number of ILI Symptoms in All Reported ILI Cases
Periodo de tiempo: From Day 14 post-vaccination through the end of ILI surveillance (Day 385)
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Assessed ILI symptoms were fever [defined as oral temperature equal to or above (≥) 38.5 degrees Celsius (°C)], myalgia (muscle aches all over the body), cough, sore throat, runny/stuffy nose, short of breath, headache, vomiting, diarrhea, chills, fatigue.
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From Day 14 post-vaccination through the end of ILI surveillance (Day 385)
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Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Periodo de tiempo: During the 7-day (Days 0-6) post-vaccination period
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Assessed solicited local symptoms were pain, redness and swelling.
Any = occurrence of the symptom regardless of intensity grade.
Grade 3 pain = pain that prevented normal activity.
Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.
Safety results were tabulated according to age stratification: adults aged 18-64 years and older (>64y).
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During the 7-day (Days 0-6) post-vaccination period
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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
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Assessed solicited general symptoms were fatigue, fever [defined as axillary temperature equal to or above (≥) 38.0 degrees Celsius (°C)], headache, joint pain at other location, muscle aches, shivering and sweating.
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.
Safety results were tabulated according to age stratification: adults aged 18-64 years and older (>64y).
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During the 7-day (Days 0-6) post-vaccination period
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Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels
Periodo de tiempo: At Days 7 and 21
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Among biochemical and haematological parameters assessed were alanine aminotransferase [ALT], alkaline phosphatase [AP], aspartate aminotransferase [AST], basophils [BAS], total bilirubin [T/BIL], bilirubin direct [BIL/D], creatinine [CREA], eosinophils [EOS], hematocrit [HEM], haemoglobin [Hgb], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelets [PLA], red blood cells [RBC], blood urea nitrogen [BUN] and white blood cells [WBC].
Levels of haematological/biochemical parameters assessed with respect to normal laboratory values were - unknown, below, within and above for subjects aged 18-64 years (18-64y) and >64 years old (>64y).
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At Days 7 and 21
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Number of Subjects With Any Medically-attended Adverse Events (MAEs)
Periodo de tiempo: Throughout the entire study period (Day 0 - Day 385)
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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.
Safety results were tabulated according to age stratification: adults aged 18-64 years and older (>64y).
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Throughout the entire study period (Day 0 - Day 385)
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Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs)
Periodo de tiempo: Throughout the entire study period (Day 0 - Day 385)
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Potential immune-mediated diseases (pIMDs) represent a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
Safety results were tabulated according to age stratification: adults aged 18-64 years and older (>64y).
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Throughout the entire study period (Day 0 - Day 385)
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Number of Subjects With Any Unsolicited Adverse Events (AEs)
Periodo de tiempo: Within the 42-day (Days 0-41) post-vaccination period
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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.
Safety results were tabulated according to age stratification: adults aged 18-64 years and older (>64y).
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Within the 42-day (Days 0-41) post-vaccination period
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Number of Subjects With Serious Adverse Events (SAEs)
Periodo de tiempo: Throughout the entire study period (Day 0 - Day 385)
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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.
Safety results were tabulated according to age stratification: adults aged 18-64 years and older (>64y).
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Throughout the entire study period (Day 0 - Day 385)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
9 de noviembre de 2009
Finalización primaria (Actual)
10 de enero de 2011
Finalización del estudio (Actual)
1 de febrero de 2011
Fechas de registro del estudio
Enviado por primera vez
17 de septiembre de 2009
Primero enviado que cumplió con los criterios de control de calidad
17 de septiembre de 2009
Publicado por primera vez (Estimar)
18 de septiembre de 2009
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
21 de marzo de 2018
Última actualización enviada que cumplió con los criterios de control de calidad
19 de marzo de 2018
Última verificación
1 de marzo de 2018
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 113480
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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Formulario de consentimiento informado
Identificador de información: 113480Comentarios 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: 113480Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
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Especificación del conjunto de datos
Identificador de información: 113480Comentarios 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: 113480Comentarios 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: 113480Comentarios 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: 113480Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
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Plan de Análisis Estadístico
Identificador de información: 113480Comentarios 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. .