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Study to Evaluate the Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Influenza Vaccines GSK2654911A and GSK2654909A Administered to Adults 18 to 64 Years of Age

14 de junio de 2018 actualizado por: GlaxoSmithKline

An Observer-blind Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' Influenza Vaccines GSK2654911A and GSK2654909A Administered to Adults 18 to 64 Years of Age

The purpose of this study is to evaluate the safety, reactogenicity, and immunogenicity of different formulations of a two-dose primary series and booster vaccination of monovalent Influenza H9N2 vaccine manufactured in Quebec, Canada with and without adjuvant, in adults 18 to 64 years of age.

Descripción general del estudio

Tipo de estudio

Intervencionista

Inscripción (Actual)

422

Fase

  • 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.

Ubicaciones de estudio

    • Quebec
      • Sherbrooke, Quebec, Canadá, J1H 2G2
        • GSK Investigational Site
    • Florida
      • Miami, Florida, Estados Unidos, 33143
        • GSK Investigational Site
    • New Jersey
      • Edison, New Jersey, Estados Unidos, 08817
        • GSK Investigational Site
    • Texas
      • Austin, Texas, Estados Unidos, 78705
        • 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 a 64 años (Adulto)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Male or female adults from 18 to 64 years of age (inclusive) at time of first study vaccination.
  • Written informed consent obtained from the subject.
  • Subjects who the investigator believes can and will comply with the requirements of the protocol.
  • Healthy subjects as established by medical history and physical examination.
  • Body weight of at least 110 lbs (49.9 kg).
  • 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 (i.e., a common-use phone serving multiple rooms or apartments).
  • Female subjects of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as current tubal ligation, hysterectomy, ovariectomy or post-menopause.
  • Female subjects of childbearing potential may be enrolled in the study, if they have practiced adequate contraception for 30 days prior to vaccination, and have a negative pregnancy test on the day of vaccination, and agree to continue to practice adequate contraception until 2 months after booster dose administration.

Exclusion Criteria:

  • Presence or evidence 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 or evidence of substance abuse.
  • Diagnosed with cancer, or treatment for cancer within three years.

    • Persons with a history of cancer who are disease-free without treatment for three years or more are eligible.
    • Persons with a history of histologically-confirmed basal cell carcinoma of the skin successfully treated with local excision only are excepted and may enroll, but other histologic types of skin cancer are exclusionary.
    • Women who are disease-free three years or more after treatment for breast cancer and receiving long-term prophylaxis may enroll.
  • Presence of a temperature ≥ 38.0ºC (≥100.4ºF), 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 (HIV) infection (no laboratory testing required).
  • Receipt of systemic glucocorticoids (e.g., prednisone ≥ 10 mg/day for more than 14 consecutive days) within 30 days prior to the first dose of study vaccine, or any other cytotoxic, immunosuppressive or immune-modifying drugs within 365 days of study enrollment. Topical, intra-articularly injected, or inhaled glucocorticoids, topical calcineurin inhibitors or imiquimod are allowed.
  • Any significant disorder of coagulation or treatment with warfarin derivatives or heparin. Persons receiving individual doses of low molecular weight heparin outside of 24 hours prior to vaccination are eligible. Persons receiving prophylactic antiplatelet medications, e.g., low-dose aspirin, and without a clinically-apparent bleeding tendency, are eligible.
  • An acute evolving neurological disorder or Guillain Barré Syndrome within 42 days of receipt of prior seasonal or pandemic influenza vaccine.
  • Administration of an inactive vaccine within 14 days or of a live attenuated vaccine within 30 days before the first dose of study vaccine/product.
  • Planned administration of any vaccine other than the study vaccine/product before blood sampling at the Day 42 visit.
  • Previous administration of any H9 vaccine or physician-confirmed H9 disease.
  • Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • Receipt of any immunoglobulins and/or any blood products within 90 days before study enrolment or planned administration of any of these products during the study period.
  • Any known or suspected allergy to any constituent of influenza vaccines or component used in the manufacturing process of the study vaccine including 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 (β-hCG) test result before the first vaccination.
  • Lactating or nursing women.
  • Any condition which, in the opinion of the investigator, prevents the subject from participating in the study.

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: Group A
Subjects will receive the investigational vaccine GSK2654911A formulation 1 and placebo
2 or 3 doses of GSK2654911A (different formulations) followed by 1 or 0 dose of saline placebo respectively, depending in the treatment group. All doses to be administered intramuscularly (IM) in deltoid region of arm.
1 dose of saline placebo administered intramuscularly (IM) in deltoid region of arm.
Experimental: Group B
Subjects will receive the investigational vaccine GSK2654911A formulation 2 and placebo
2 or 3 doses of GSK2654911A (different formulations) followed by 1 or 0 dose of saline placebo respectively, depending in the treatment group. All doses to be administered intramuscularly (IM) in deltoid region of arm.
1 dose of saline placebo administered intramuscularly (IM) in deltoid region of arm.
Experimental: Group C
Subjects will receive the investigational vaccine GSK2654911A formulation 3 and placebo
2 or 3 doses of GSK2654911A (different formulations) followed by 1 or 0 dose of saline placebo respectively, depending in the treatment group. All doses to be administered intramuscularly (IM) in deltoid region of arm.
1 dose of saline placebo administered intramuscularly (IM) in deltoid region of arm.
Experimental: Group D
Subjects will receive the investigational vaccine GSK2654911A formulation 4 and placebo
2 or 3 doses of GSK2654911A (different formulations) followed by 1 or 0 dose of saline placebo respectively, depending in the treatment group. All doses to be administered intramuscularly (IM) in deltoid region of arm.
1 dose of saline placebo administered intramuscularly (IM) in deltoid region of arm.
Experimental: Group E
Subjects will receive the investigational vaccine GSK2654909A and placebo
1 dose of saline placebo administered intramuscularly (IM) in deltoid region of arm.
2 or 3 doses of GSK2654909A followed by 1 or 0 dose of saline placebo, respectively (treatment 5). All doses to be administered IM in deltoid region of arm.
Experimental: Group F
Subjects will receive the investigational vaccine GSK2654911A formulation 5
2 or 3 doses of GSK2654911A (different formulations) followed by 1 or 0 dose of saline placebo respectively, depending in the treatment group. All doses to be administered intramuscularly (IM) in deltoid region of arm.
Experimental: Group G
Subjects will receive the investigational vaccine GSK2654911A formulation 6
2 or 3 doses of GSK2654911A (different formulations) followed by 1 or 0 dose of saline placebo respectively, depending in the treatment group. All doses to be administered intramuscularly (IM) in deltoid region of arm.
Experimental: Group H
Subjects will receive the investigational vaccine GSK2654911A formulation 7
2 or 3 doses of GSK2654911A (different formulations) followed by 1 or 0 dose of saline placebo respectively, depending in the treatment group. All doses to be administered intramuscularly (IM) in deltoid region of arm.
Experimental: Group I
Subjects will receive the investigational vaccine GSK2654911A formulation 8
2 or 3 doses of GSK2654911A (different formulations) followed by 1 or 0 dose of saline placebo respectively, depending in the treatment group. All doses to be administered intramuscularly (IM) in deltoid region of arm.
Experimental: Group J
Subjects will receive the investigational vaccine GSK2654909A
2 or 3 doses of GSK2654909A followed by 1 or 0 dose of saline placebo, respectively (treatment 5). All doses to be administered IM in deltoid region of arm.
Comparador de placebos: Placebo Group
Subjects will receive Placebo
1 dose of saline placebo administered intramuscularly (IM) in deltoid region of arm.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
Humoral immune response in terms of HI antibodies against H9N2 v-like antigen
Periodo de tiempo: Day 21
Day 21
Humoral immune response in terms of HI antibodies against H9N2 v-like antigen
Periodo de tiempo: Day 42
Day 42

Medidas de resultado secundarias

Medida de resultado
Periodo de tiempo
Humoral immune response in terms of HI antibodies against H9N2 antigen
Periodo de tiempo: GMTs and seropositivity rates, SPR on Days 0, 7, 21, 28, 42, 182, 191, 385 and 546. SCR and MGI on Days 7, 21, 28, 42, 182, 191, 385 and 546. B-SCR and BF on Days 191, 385 and 546.
GMTs and seropositivity rates, SPR on Days 0, 7, 21, 28, 42, 182, 191, 385 and 546. SCR and MGI on Days 7, 21, 28, 42, 182, 191, 385 and 546. B-SCR and BF on Days 191, 385 and 546.
Humoral immune response in terms of HI antibodies against H9N2 antigen for each vaccine group and for age strata (18-40 years; 41-64 years)
Periodo de tiempo: GMTs and seropositivity rates, SPR on Days 0, 7, 21, 28, 42, 182, 191, 385 and 546. SCR and MGI on Days 7, 21, 28, 42, 182, 191, 385 and 546. B-SCR and BF on Days 191, 385 and 546.
GMTs and seropositivity rates, SPR on Days 0, 7, 21, 28, 42, 182, 191, 385 and 546. SCR and MGI on Days 7, 21, 28, 42, 182, 191, 385 and 546. B-SCR and BF on Days 191, 385 and 546.
Humoral immune response in terms of HI antibodies against any drift strain from H9N2 antigen or against any other H9 subtype antigen
Periodo de tiempo: GMTs and seropositivity rates on Days 0, 7, 21, 28, 42, 182 , 191, 385 and 546. SCR and MGI on Days 21, 42, 182, 191, 385, 546. SPR on Days 0, 21, 42, 182, 191, 385 and 546. B-SCR and BF on Days 191, 385 and 546.
GMTs and seropositivity rates on Days 0, 7, 21, 28, 42, 182 , 191, 385 and 546. SCR and MGI on Days 21, 42, 182, 191, 385, 546. SPR on Days 0, 21, 42, 182, 191, 385 and 546. B-SCR and BF on Days 191, 385 and 546.
Humoral immune response in terms of neutralizing (MN) antibodies against H9N2 and against any drift strain (or other H9 subtype)
Periodo de tiempo: GMTs and seropositivity rate on Days 0, 21, 42, 182, 191, 385 and 546. VRR on Days 21, 42, 182, 191, 385, 546. Booster-VRR on Day 191, 385 and 546.
GMTs and seropositivity rate on Days 0, 21, 42, 182, 191, 385 and 546. VRR on Days 21, 42, 182, 191, 385, 546. Booster-VRR on Day 191, 385 and 546.
Occurrence of local and general symptoms
Periodo de tiempo: During the 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after any vaccination
During the 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after any vaccination
Occurrence and relationship to vaccination of unsolicited adverse events
Periodo de tiempo: Within 21 days (Day 0 to Day 20, 21 to 41, 182 to 202) after any vaccination
Within 21 days (Day 0 to Day 20, 21 to 41, 182 to 202) after any vaccination
Occurrence and relationship to vaccination of adverse events with medically attended visits
Periodo de tiempo: During the entire study period (Day 0 - Day 546)
During the entire study period (Day 0 - Day 546)
Occurrence and relationship to vaccination of Adverse events of special interest (AESIs), potential Immune-Mediated Diseases (pIMDs), Serious Adverse Events (SAEs) and adverse pregnancy outcome
Periodo de tiempo: During the entire study period (Day 0 - Day 546)
During the entire study period (Day 0 - Day 546)
Number of subjects with clinical safety laboratory abnormalities
Periodo de tiempo: Days 0, 7, 21, 28, 42, 182, 191, and 385.
Days 0, 7, 21, 28, 42, 182, 191, and 385.

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)

22 de agosto de 2012

Finalización primaria (Actual)

26 de octubre de 2012

Finalización del estudio (Actual)

19 de marzo de 2014

Fechas de registro del estudio

Enviado por primera vez

3 de agosto de 2012

Primero enviado que cumplió con los criterios de control de calidad

6 de agosto de 2012

Publicado por primera vez (Estimar)

7 de agosto de 2012

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

18 de junio de 2018

Última actualización enviada que cumplió con los criterios de control de calidad

14 de junio de 2018

Última verificación

1 de junio de 2018

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

IPD for this study will be made available via the Clinical Study Data Request site.

Marco de tiempo para compartir IPD

IPD is available via the Clinical Study Data Request site (click on the link provided below)

Criterios de acceso compartido de IPD

Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • SAVIA
  • CIF
  • RSC

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. .

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