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Evaluation of Safety and Immunogenicity of Co-administering Human Papillomavirus Vaccine With Another Vaccine in Healthy Female Subjects

28 de junio de 2018 actualizado por: GlaxoSmithKline

Immunogenicity and Safety Study of GSK Biologicals' HPV Vaccine (GSK-580299) Co-administered With a Commercially Available Vaccine in Healthy Female Adolescents

Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. Vaccination of pre-teens and adolescents, ideally before sexual debut and thus before exposure to oncogenic HPV, is a rational strategy for prevention of cervical cancer, and so HPV vaccination could complement the existing pre-adolescent/adolescent vaccination programs. Therefore, this Phase IIIb study is designed to evaluate the safety and immunogenicity of co-administering a commercially available vaccine with GSK Biologicals' HPV-16/18 L1 AS04 (Cervarix ®) vaccine as compared to the administration of either vaccine alone. This Protocol Posting has been updated in order to comply with the FDA AA, Sept 2007.

Descripción general del estudio

Tipo de estudio

Intervencionista

Inscripción (Actual)

814

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

    • British Columbia
      • Surrey, British Columbia, Canadá, V3R 8P8
        • GSK Investigational Site
    • Ontario
      • Brampton, Ontario, Canadá, L6T 3T1
        • GSK Investigational Site
      • Newmarket, Ontario, Canadá, L3Y 5G8
        • GSK Investigational Site
      • Sarnia, Ontario, Canadá, N7T 4X3
        • GSK Investigational Site
      • Sudbury, Ontario, Canadá, P3E 1H5
        • GSK Investigational Site
      • Hoersholm, Dinamarca, 2970
        • GSK Investigational Site
      • Odense C, Dinamarca, 5000
        • GSK Investigational Site
      • Bordány, Hungría, 6795
        • GSK Investigational Site
      • Budapest, Hungría, 1032
        • GSK Investigational Site
      • Budapest, Hungría, 1033
        • GSK Investigational Site
      • Budapest, Hungría, 1039
        • GSK Investigational Site
      • Budapest, Hungría, 1089
        • GSK Investigational Site
      • Győr, Hungría, 9024
        • GSK Investigational Site
      • Hódmezővásárhely, Hungría, 6800
        • GSK Investigational Site
      • Szeged, Hungría, 6723
        • GSK Investigational Site
      • Szombathely, Hungría, 9700
        • GSK Investigational Site
      • Karlskrona, Suecia, SE-371 41
        • GSK Investigational Site
      • Linköping, Suecia, SE-581 85
        • GSK Investigational Site
      • Lycksele, Suecia, SE-921 82
        • GSK Investigational Site
      • Umeå, Suecia, SE-901 85
        • GSK Investigational Site
      • Örebro, Suecia, SE-702 11
        • 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

9 años a 15 años (Niño)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Femenino

Descripción

Inclusion Criteria:

  • Subjects who the investigator believes that they and/or their legally acceptable representatives (LARs) can and will comply with the requirements of the protocol should be enrolled in the study.
  • A female between, and including, 9 and 15 years of age (has not attained her 16th birthday) at the time of the first vaccination.
  • Written informed consent obtained from the subject prior to enrolment. For subjects below the legal age of consent, written informed consent must be obtained from the subject's LAR, and written informed assent must be obtained from the subject.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.
  • Subjects must not be pregnant.
  • Subjects must be of non-childbearing potential, or if the subject is of childbearing potential, she must be abstinent or use adequate contraception for 30 days prior to vaccination and must agree to continue such precautions for two months after completion of the vaccination series.

Exclusion Criteria:

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period (up to Month 12).
  • Concurrently participating in another clinical study, at any time during the study period (up to the Month 12 telephone contact), in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
  • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
  • Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before and 30 days after each dose of vaccine(s). Administration of routine vaccines may be allowed up to 8 days before the first dose
  • A subject planning to become pregnant, likely to become pregnant or planning to discontinue contraceptive precautions during the study period and up to two months after the last vaccine dose.
  • Pregnant or breastfeeding women.
  • Previous vaccination against HPV or planned administration of any HPV vaccine other than that foreseen by the study protocol during the study period.
  • Previous administration of components of the investigational vaccine.
  • Previous vaccination against hepatitis A or B planned administration of any hepatitis A or B vaccine other than that foreseen by the study protocol during the study period.
  • History of hepatitis A or B infection.
  • Known exposure to hepatitis A or B within the previous 6 weeks.
  • Known acute or chronic, clinically significant neurologic, hepatic or renal functional abnormality, as determined by previous physical examination or laboratory tests.
  • Cancer or autoimmune disease under treatment.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccines
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
  • Acute disease at the time of enrolment.
  • Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.

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: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Cervarix™ & Twinrix™ Group
Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
Three doses of vaccine administered intramuscularly with the second and third dose given one month and six months after the first dose
Otros nombres:
  • Vacuna contra el VPH
  • GSK Biologicals' HPV-16/18 L1 AS04
Three doses of vaccine administered intramuscularly with the second and third dose given one month and six months after the first dose
Experimental: Cervarix™ Group
Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
Three doses of vaccine administered intramuscularly with the second and third dose given one month and six months after the first dose
Otros nombres:
  • Vacuna contra el VPH
  • GSK Biologicals' HPV-16/18 L1 AS04
Comparador activo: Twinrix™ Group
Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
Three doses of vaccine administered intramuscularly with the second and third dose given one month and six months after the first dose

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of Subjects Seroconverted for Anti-hepatitis A (Anti-HAV) Antibodies
Periodo de tiempo: At Month 7
Seroconversion is defined as the appearance of anti-HAV antibodies [i.e., antibody titer greater than or equal to 15 milli-international units/milliliter (mIU/mL)] in the sera of subjects seronegative (antibody titer below 15 mIU/mL) before vaccination.
At Month 7
Anti-Heptatis A (HAV) Antibody Titers.
Periodo de tiempo: At Month 7
Titers are given as Geometric Mean Titers (GMTs) expressed as mIU/mL.
At Month 7
Number of Subjects Seroprotected for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibodies
Periodo de tiempo: At Month 7
A subject seroprotected against HBs is a subject with antibody titers greater than or equal to 10 mIU/mL.
At Month 7
Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies
Periodo de tiempo: At Month 7
Seroconversion is defined as the appearance of antibodies with titers greater than or equal to the predefined cut-off value in the serum of subject seronegative before vaccination. Cut-off values = 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.
At Month 7
Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibody Titers
Periodo de tiempo: At Month 7
Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).
At Month 7

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Anti-HBs Antibody Titers
Periodo de tiempo: At Month 7
Titers are given as Geometric Mean Titers (GMTs)expressed as mIU/mL.
At Month 7
Number of Subjects Seroconverted for Anti-HBs Antibodies
Periodo de tiempo: At month 7
Seroconversion is defined as the appearance of anti-HBs antibodies (i.e., antibody titer greater than or equal to 3.3 mIU/mL) in the sera of subjects seronegative (with antibody titers below 3.3 mIU/mL) before vaccination.
At month 7
Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies in Vaccine Recipients Aged 9 Years
Periodo de tiempo: At Month 7
Seroconversion is defined as the appearance of antibodies with titers greater than or equal to the predefined cut-off value in the serum of subject seronegative before vaccination. Cut-off values = 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.
At Month 7
Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibody Titers in Vaccine Recipients Aged 9 Years
Periodo de tiempo: At Month 7
Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).
At Month 7
Number of Subjects Seroconverted for Anti-HAV Antibodies
Periodo de tiempo: One month after the second dose of vaccine
Seroconversion is defined as the appearance of anti-HAV antibodies (i.e., antibody titer greater than or equal to 15 mIU/mL) in the sera of subjects seronegative (antibody titer below 15 mIU/mL) before vaccination.
One month after the second dose of vaccine
Anti-HAV Antibody Titers
Periodo de tiempo: One month after the second dose of vaccine
Titers are given as geometric mean titers (GMTs) expressed as mIU/mL.
One month after the second dose of vaccine
Number of Subjects Seroconverted and Number of Subjects Seroprotected for Anti-HBs Antibodies
Periodo de tiempo: One month after the second dose of vaccine

Seroconversion is defined as the appearance of anti-HBs antibodies (i.e., antibody titer greater than or equal to 3.3 mIU/mL) in the sera of subjects seronegative (with antibody titers below 3.3 mIU/mL) before vaccination.

A seroprotected subject against HBs is a subject with antibody titers greater than or equal to 10 mIU/mL.

One month after the second dose of vaccine
Anti-HBs Antibody Titers
Periodo de tiempo: One month after the second dose of vaccine
Titers are given as geometric mean titers (GMTs) expressed as mIU/mL.
One month after the second dose of vaccine
Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies
Periodo de tiempo: One month after the second dose of vaccine
Seroconversion is defined as the appearance of antibodies with titers greater than or equal to the predefined cut-off value in the serum of subject seronegative before vaccination. Cut-off values assessed include 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.
One month after the second dose of vaccine
Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibody Titers
Periodo de tiempo: One month after the second dose of vaccine
Titers are given as Geometric Mean Titers (GMTs) expressed as EL.U/mL.
One month after the second dose of vaccine
Number of Subjects Reporting Solicited Local Symptoms
Periodo de tiempo: During the 7-day period (Day 0-6) following vaccination
Solicited local symptoms assessed include injection site pain, redness and swelling. Data are presented across doses.
During the 7-day period (Day 0-6) following vaccination
Number of Subjects Reporting Solicited General Symptoms
Periodo de tiempo: During the 7-day period following vaccination
Solicited general symptoms assessed include arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, rash, temperature [axillary route, greater than or equal to 37.5 degree Celsius (°C)] and urticaria.
During the 7-day period following vaccination
Number of Subjects Reporting Medically Significant Conditions
Periodo de tiempo: Throughout the active phase of the study (up to Month 7)
Medically significant conditions include adverse events (AEs) prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.
Throughout the active phase of the study (up to Month 7)
Number of Subjects Reporting Medically Significant Conditions
Periodo de tiempo: Throughout the safety follow-up (from Month 7 up to Month 12)
Medically significant conditions include adverse events (AEs) prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.
Throughout the safety follow-up (from Month 7 up to Month 12)
Number of Subjects Reporting Unsolicited Adverse Events
Periodo de tiempo: During the 30-day period following any vaccination
Unsolicited adverse events include any adverse event 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.
During the 30-day period following any vaccination
Number of Subjects Reporting Serious Adverse Events (SAE)
Periodo de tiempo: Throughout the study (up to Month 12)
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Throughout the study (up to Month 12)

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.

Publicaciones Generales

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

15 de diciembre de 2007

Finalización primaria (Actual)

1 de diciembre de 2008

Finalización del estudio (Actual)

28 de abril de 2009

Fechas de registro del estudio

Enviado por primera vez

20 de diciembre de 2007

Primero enviado que cumplió con los criterios de control de calidad

20 de diciembre de 2007

Publicado por primera vez (Estimar)

21 de diciembre de 2007

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

17 de agosto de 2018

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

28 de junio de 2018

Última verificación

1 de octubre de 2016

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 110886

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

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

  1. Formulario de informe de caso anotado
    Identificador de información: 110886
    Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
  2. Formulario de consentimiento informado
    Identificador de información: 110886
    Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
  3. Plan de Análisis Estadístico
    Identificador de información: 110886
    Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
  4. Especificación del conjunto de datos
    Identificador de información: 110886
    Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
  5. Protocolo de estudio
    Identificador de información: 110886
    Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
  6. Conjunto de datos de participantes individuales
    Identificador de información: 110886
    Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
  7. Informe de estudio clínico
    Identificador de información: 110886
    Comentarios 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. .

Ensayos clínicos sobre Cervarix™

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