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Evaluation of Immunogenicity and Safety of Two 2-dose Human Papillomavirus (HPV) Vaccine Schedules in 9-14 Year Old Girls

19 de mayo de 2020 actualizado por: GlaxoSmithKline

Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' HPV-16/18 L1 AS04 Vaccine When Administered According to Alternative 2-dose Schedules in 9 - 14 Year Old Females

This study has been designed to evaluate the immunogenicity and safety of GSK Biologicals' HPV-16/18 vaccine when administered according to alternative 2-dose schedules (0,6 months and 0,12 months) in healthy 9-14 year old females as compared to the standard 3-dose schedule (0,1,6 months) in 15-25 year old females.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

1447

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

  • Alemania
      • Berlin, Alemania, 13055
        • GSK Investigational Site
      • Hamburg, Alemania, 22159
        • GSK Investigational Site
    • Baden-Wuerttemberg
      • Freiburg, Baden-Wuerttemberg, Alemania, 79106
        • GSK Investigational Site
      • Kehl, Baden-Wuerttemberg, Alemania, 77694
        • GSK Investigational Site
    • Bayern
      • Schoenau Am Koenigssee, Bayern, Alemania, 83471
        • GSK Investigational Site
      • Wuerzburg, Bayern, Alemania, 97070
        • GSK Investigational Site
    • Niedersachsen
      • Hannover, Niedersachsen, Alemania, 30625
        • GSK Investigational Site
      • Hannover, Niedersachsen, Alemania, 30657
        • GSK Investigational Site
      • Wolfenbuettel, Niedersachsen, Alemania, 38302
        • GSK Investigational Site
      • Wolfsburg, Niedersachsen, Alemania, 38440
        • GSK Investigational Site
    • Nordrhein-Westfalen
      • Kleve-Materborn, Nordrhein-Westfalen, Alemania, 47533
        • GSK Investigational Site
    • Rheinland-Pfalz
      • Mainz, Rheinland-Pfalz, Alemania, 55116
        • GSK Investigational Site
      • Mainz, Rheinland-Pfalz, Alemania, 55131
        • GSK Investigational Site
      • Trier, Rheinland-Pfalz, Alemania, 54290
        • GSK Investigational Site
    • Schleswig-Holstein
      • Flensburg, Schleswig-Holstein, Alemania, 24937
        • GSK Investigational Site
    • Thueringen
      • Weimar, Thueringen, Alemania, 99423
        • GSK Investigational Site
  • Canadá
    • British Columbia
      • Coquitlam, British Columbia, Canadá, V3K 3P4
        • GSK Investigational Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canadá, B3K 6R8
        • GSK Investigational Site
    • Ontario
      • Sudbury, Ontario, Canadá, P3E 1H5
        • GSK Investigational Site
      • Toronto, Ontario, Canadá, M9W 4L6
        • GSK Investigational Site
      • Woodstock, Ontario, Canadá, N4S 5P5
        • GSK Investigational Site
    • Quebec
      • Sherbrooke, Quebec, Canadá, J1H 2G2
        • GSK Investigational Site
  • Italia
    • Liguria
      • Genova, Liguria, Italia, 16132
        • GSK Investigational Site
    • Lombardia
      • Milano, Lombardia, Italia, 20122
        • GSK Investigational Site
    • Piemonte
      • Cuneo, Piemonte, Italia, 12100
        • GSK Investigational Site
    • Sardegna
      • Cagliari, Sardegna, Italia, 09127
        • GSK Investigational Site
    • Sicilia
      • Ragusa, Sicilia, Italia, 97100
        • GSK Investigational Site
    • Veneto
      • Padova, Veneto, Italia, 35128
        • GSK Investigational Site
  • Tailandia
      • Bangkok, Tailandia, 10330
        • GSK Investigational Site
      • Chiangmai, Tailandia, 50200
        • GSK Investigational Site
  • Taiwán
      • Taipei, Taiwán, 100
        • GSK Investigational Site
      • Taipei, Taiwán
        • GSK Investigational Site
      • Taoyuan, Taiwán, 333
        • 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 25 años (Niño, Adulto)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Femenino

Descripción

Inclusion Criteria:

  • Subjects who the investigator believes can and will comply with the requirements of the protocol or/ and subjects who the investigator believes their parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol
  • A female between, and including, 9 and 25 years of age at the time of the first vaccination
  • Written informed consent obtained from the subject/from the parent(s)/LAR(s) of the subject prior to enrolment in the study. In addition, subjects below the legal age of consent should sign and personally date a written informed assent form
  • Healthy subjects
  • 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 vaccination, and
    • has agreed to continue adequate contraception during the entire vaccination period and up to two months after the last study vaccine dose

Exclusion Criteria:

  • Pregnant or breastfeeding
  • A female planning to become pregnant, likely to become pregnant or planning to discontinue contraceptive precautions during the entire vaccination period and up to two months after the last study vaccine dose
  • Previous vaccination against HPV or planned administration of another HPV vaccine during the study
  • Child in care. A child in care is a child who has been placed under the control or protection of an agency, organisation, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation. The definition of a child in care does not include a child who is adopted or has an appointed legal guardian.
  • 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
  • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. History of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the study vaccines
  • Cancer or autoimmune disease under treatment
  • Planned administration/administration of a vaccine/product not foreseen by the study protocol within 30 days before each dose of vaccine. Administration of routine meningococcal, hepatitis B, hepatitis A, inactivated influenza, diphtheria/tetanus and/or diphtheria/tetanus-containing vaccine up to 8 days before each dose of study vaccine is allowed. Enrolment will be deferred until the subject is outside of specified window
  • Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product
  • Previous administration of MPL or AS04 adjuvant.
  • Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period
  • Any confirmed or suspected immunosuppressive or immunodeficient condition
  • Family history of congenital or hereditary immunodeficiency
  • Major congenital defects or serious chronic illness
  • Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests, which in the opinion of the investigator precludes administration of the study vaccine
  • Acute disease and/or fever at the time of enrolment

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 1 Group
Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Day 0 and at Month 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
Biológico: GSK Biologicals' HPV vaccine 580299
Subjects received 2 or 3 doses of HPV vaccine administered intramuscularly.
Otros nombres:
  • Cervarix
Comparador activo: Cervarix 2 Group
Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Day 0, at Month 1 and at Month 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
Biológico: GSK Biologicals' HPV vaccine 580299
Subjects received 2 or 3 doses of HPV vaccine administered intramuscularly.
Otros nombres:
  • Cervarix
Experimental: Cervarix 3 Group
Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Day 0 and at Month 12, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
Biológico: GSK Biologicals' HPV vaccine 580299
Subjects received 2 or 3 doses of HPV vaccine administered intramuscularly.
Otros nombres:
  • Cervarix

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of Seroconverted Subjects for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies in Cervarix 1 Group and Cervarix 2 Group at Month 7
Periodo de tiempo: At Month 7 (i.e. one month after the last dose of study vaccine)
Seroconversion was defined as the appearance of antibodies (anti-HPV-16 concentrations greater than or equal to (≥) 8 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL) and anti-HPV-18 concentrations ≥ 7 EL.U/mL) in the serum of subjects seronegative before vaccination. A seronegative subject was a subject with anti-HPV-16/18 antibody concentration lower than (<) 8/7 EL.U/mL, respectively.
At Month 7 (i.e. one month after the last dose of study vaccine)
Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA) in Cervarix 1 Group and Cervarix 2 Group at Month 7
Periodo de tiempo: At Month 7 (i.e. one month after the last dose of study vaccine)
Antibody concentrations were assessed by ELISA and expressed as geometric mean concentrations (GMCs) in EL.U/mL.
At Month 7 (i.e. one month after the last dose of study vaccine)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies in Cervarix 1 Group and Cervarix 2 Group at Day 0 and at Months 7, 12, 18, 24 and 36
Periodo de tiempo: At Day 0 and at Months 7, 12, 18, 24 and 36

Seroconversion was defined as the appearance of antibodies (anti-HPV-16 concentrations ≥ 8 EL.U/mL and anti-HPV-18 concentrations ≥ 7 EL.U/mL [applicable for Day 0, Month 7 and Month 12 time points] and anti-HPV-16 concentrations ≥ 19 EL.U/mL and anti-HPV-18 concentrations ≥ 18 EL.U/mL [applicable for Month 18, Month 24 and Month 36 time points]) in the serum of subjects seronegative before vaccination.

A seronegative subject was a subject with an anti-HPV-16/18 antibody concentration below (<) the aforementioned cut-offs.

Note: In order to increase the ELISA precision, the assay cut-off value was changed from 8 EL.U/mL to 19 EL.U/mL for HPV-16 and from 7 EL.U/mL to 18 EL.U/mL for HPV-18 from Month 18 onwards.
At Day 0 and at Months 7, 12, 18, 24 and 36
Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA) in Cervarix 1 Group and Cervarix 2 Group at Day 0 and at Months 7, 12, 18, 24 and 36
Periodo de tiempo: At Day 0 and at Months 7, 12, 18, 24 and 36
Antibody concentrations were assessed by ELISA and expressed as geometric mean concentrations (GMCs) in EL.U/mL.
At Day 0 and at Months 7, 12, 18, 24 and 36
Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies in Cervarix 3 Group
Periodo de tiempo: At Day 0 and at Months 13, 18, 24 and 36

Seroconversion was defined as the appearance of antibodies (anti-HPV-16 concentrations ≥ 8 EL.U/mL and anti-HPV-18 concentrations ≥ 7 EL.U/mL [applicable for Day 0 and Month 13 time points] and anti-HPV-16 concentrations ≥ 19 EL.U/mL and anti-HPV-18 concentrations ≥ 18 EL.U/mL [applicable for Month 18, Month 24 and Month 36 time points]) in the serum of subjects seronegative before vaccination.

A seronegative subject was a subject with an anti-HPV-16/18 antibody concentration below (<) the aforementioned cut-offs.

Note: In order to increase the ELISA precision, the assay cut-off value was changed from 8 EL.U/mL to 19 EL.U/mL for HPV-16 and from 7 EL.U/mL to 18 EL.U/mL for HPV-18 from Month 18 onwards.
At Day 0 and at Months 13, 18, 24 and 36
Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA) in Cervarix 3 Group
Periodo de tiempo: At Day 0 and at Months 13, 18, 24 and 36
Antibody concentrations were assessed by ELISA and expressed as geometric mean concentrations (GMCs) in EL.U/mL.
At Day 0 and at Months 13, 18, 24 and 36
Anti-HPV-16 and Anti-HPV-18 Antibody Titers [by Pseudovirion-Based Neutralisation Assay (PBNA)] in a Subset of Subjects From Cervarix 3 Group
Periodo de tiempo: At Day 0 and at Months 13, 18, 24 and 36
Antibody titers were expressed as geometric mean titers (GMTs). The cut-off of the assay was 40 ED50 for both anti-HPV-16 and anti-HPV-18. The assay was performed on a subset of 100 subjects from Cervarix 3 Group.
At Day 0 and at Months 13, 18, 24 and 36
Anti-HPV-16 and Anti-HPV-18 Antibody Titers (by PBNA) in a Subset of Subjects From Cervarix 1 Group and Cervarix 2 Group
Periodo de tiempo: At Day 0 and at Months 7, 12, 18, 24 and 36
Antibody titers were expressed as GMTs. The cut-off of the assay was 40 ED50 for both anti-HPV-16 and anti-HPV-18. The assay was performed on a subset of 100 subjects per study group.
At Day 0 and at Months 7, 12, 18, 24 and 36
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects
Periodo de tiempo: At Day 0 and at Months 7, 12, 24 and 36
The CMI response represents the measure of the cytokines production [i.e. interleukin-2 (IL-2), interferon gamma (IFN-γ), tumor necrosis factor alpha (TNF-α) and the cluster of differentiation 40 Ligand (CD40L)] by HPV-antigen specific T lymphocytes and measured by intracellular cytokine staining (ICS) assay for HPV-16. The frequency was presented as number of cytokine-positive cluster of differentiation (CD)4 i.e. CD4+/CD8+ cells per million CD4+/CD8+ cells. All doubles = T cell expressing at least 2 cytokines. Results were tabulated by the pre-vaccination status of the subjects, where S- = seronegative subjects (antibody concentration < cut-off value) prior to vaccination. S+ = seropositive subjects (antibody concentration ≥ cut-off value) prior to vaccination. The assay was performed on a subset of 100 subjects per study group.
At Day 0 and at Months 7, 12, 24 and 36
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects
Periodo de tiempo: At Day 0 and at Months 7, 12, 24 and 36
The CMI response represents the measure of the cytokines production [IL-2, IFN-γ, TNF-α, and CD40L] by HPV-antigen specific T lymphocytes and measured by ICS assay for HPV-18. The frequency was presented as a number of cytokine-producing CD4+/CD8+ cells per million CD4+/CD8+ cells. All doubles = T cell expressing at least 2 cytokines. Results were tabulated by the pre-vaccination status of the subjects, where S- = seronegative subjects (antibody concentration < the cut-off value) prior to vaccination. S+ = seropositive subjects (antibody concentration ≥ cut-off value) prior to vaccination. The assay was performed on a subset of 100 subjects per study group.
At Day 0 and at Months 7, 12, 24 and 36
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects
Periodo de tiempo: At Day 0 and at Months 13, 18 and 36
The CMI response represents the measure of the cytokines production (IL-2, IFN-γ, TNF-α, and CD40L) by HPV-antigen specific T lymphocytes and measured by ICS assay for HPV-16. The frequency was presented as a number of cytokine-positive cluster of differentiation (CD)4 i.e.CD4+/CD8+ cells per million CD4+/CD8+ cells. All doubles= T cell expressing at least 2 cytokines. Results were tabulated by the pre-vaccination status of the subjects, where S- = seronegative subjects (antibody concentration < cut-off value) prior to vaccination. S+ = seropositive subjects (antibody concentration ≥ cut-off value) prior to vaccination. The assay was performed on a subset of 100 subjects from Cervarix 3 Group.
At Day 0 and at Months 13, 18 and 36
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects
Periodo de tiempo: At Day 0 and at Months 13, 18 and 36
The CMI response represents the measure of the cytokines production (i.e. IL-2, IFN-γ, TNF-α, and CD40L) by HPV-antigen specific T lymphocytes and measured by ICS assay for HPV-18. The frequency was presented as a number of cytokine-producing CD4+/CD8+ cells per million CD4+/CD8+ cells. All doubles = T cell expressing at least 2 cytokines. Results were tabulated by the pre-vaccination status of the subjects, where S- = seronegative subjects (antibody concentration < cut-off value) prior to vaccination. S+ = seropositive subjects (antibody concentration ≥ cut-off value) prior to vaccination. The assay was performed on a subset of 100 subjects from Cervarix 3 Group.
At Day 0 and at Months 13, 18 and 36
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific B CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects
Periodo de tiempo: At Day 0 and at Months 7, 12, 24 and 36
The CMI response was assessed as being the frequency of B-cell memory of HPV-16 antigen-specific memory B-cells per million memory B-cells in subjects with detectable B-cells. The results are presented by pre-vaccination status, where S- = seronegative subjects (antibody concentration < cut-off value) prior to vaccination and S+ = seropositive subjects (antibody concentration ≥ cut-off value) prior to vaccination. The assay was performed on a subset of 100 subjects per study group.
At Day 0 and at Months 7, 12, 24 and 36
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific B CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects
Periodo de tiempo: At Day 0 and at Months 7, 12, 24 and 36
The cell-mediated immune response was assessed as being the frequency of B-cell memory of HPV-18 antigen-specific memory B-cells per million memory B-cells in subjects with detectable B-cells. The results are presented by pre-vaccination status, where S- = seronegative subjects (antibody concentration < cut-off value) prior to vaccination and S+ = seropositive subjects (antibody concentration ≥ cut-off value) prior to vaccination. The assay was performed on a subset of 100 subjects per study group.
At Day 0 and at Months 7, 12, 24 and 36
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific B CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects
Periodo de tiempo: At Day 0 and at Months 13, 18 and 36
The cell-mediated immune response was assessed as being the frequency of B-cell memory of HPV-16 antigen-specific memory B-cells per million memory B-cells in subjects with detectable B-cells. The results are presented by pre-vaccination status, where S- = seronegative subjects (antibody concentration < cut-off value) prior to vaccination and S+ = seropositive subjects (antibody concentration ≥ cut-off value) prior to vaccination. The assay was performed on a subset of 100 subjects from Cervarix 3 Group.
At Day 0 and at Months 13, 18 and 36
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific B CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects
Periodo de tiempo: At Day 0 and at Months 13, 18 and 36
The cell-mediated immune response was assessed as being the frequency of B-cell memory of HPV-18 antigen-specific memory B-cells per million memory B-cells in subjects with detectable B-cells. The results are presented by pre-vaccination status, where S- = seronegative subjects (antibody concentration < cut-off value) prior to vaccination and S+ = seropositive subjects (antibody concentration ≥ cut off value) prior to vaccination. The assay was performed on a subset of 100 subjects from Cervarix 3 Group.
At Day 0 and at Months 13, 18 and 36
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Periodo de tiempo: During the 7-day period (Days 0-6) after each vaccine dose and across doses
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any solicited local symptom regardless of their intensity grade. Grade 3 pain = significant pain at rest, that prevented normal every day activity. Grade 3 redness/swelling = redness/swelling above 50 millimeters (mm).
During the 7-day period (Days 0-6) after each vaccine dose and across doses
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Periodo de tiempo: During the 7-day period (Days 0-6) after each vaccine dose and across doses
Assessed solicited general symptoms were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, rash, fever and urticaria. Any = occurrence of any solicited general symptom regardless of intensity grade or relationship to vaccination. Any fever = axillary temperature ≥ 37.5 degrees Celsius (°C). Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever greater than (>) 39.0 °C. Related = general symptom assessed by the investigator as causally related to the vaccination.
During the 7-day period (Days 0-6) after each vaccine dose and across doses
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Periodo de tiempo: During the 30 day (Days 0-29) post-vaccination period
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 = any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 = unsolicited AE preventing normal activity. Related = unsolicited AE assessed by the investigator as causally related to the study vaccination.
During the 30 day (Days 0-29) post-vaccination period
Number of Subjects With Any Potential Immune-Mediated Diseases (pIMDs)
Periodo de tiempo: From Day 0 up to Month 13 (for Cervarix 1 Group and Cervarix 2 Group) and from Day 0 up to Month 18 (for Cervarix 3 Group)
pIMDs are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology.
From Day 0 up to Month 13 (for Cervarix 1 Group and Cervarix 2 Group) and from Day 0 up to Month 18 (for Cervarix 3 Group)
Number of Subjects With Medically Significant Conditions (MSCs)
Periodo de tiempo: From Day 0 up to Month 36 (throughout the study period)
MSCs include 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.
From Day 0 up to Month 36 (throughout the study period)
Number of Subjects With Any, Related and Fatal Serious Adverse Events (SAEs)
Periodo de tiempo: From Day 0 up to Month 36 (throughout the study period)

SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject. Any = any SAE regardless of intensity grade or relation to vaccination.

Related = SAE assessed by the investigator as causally related to the study vaccination.
From Day 0 up to Month 36 (throughout the study period)
Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies
Periodo de tiempo: From Day 0 up to Month 36 (throughout the study period)
Outcomes of reported pregnancies were: Ectopic pregnancy, Elective termination NO apparent congenital anomaly (ACA), Live Infant NO ACA, Stillbirth NO ACA.
From Day 0 up to Month 36 (throughout the study period)
Number of Subjects Completing the Vaccination Course
Periodo de tiempo: From Day 0 up to Month 13
The number of subjects completing the vaccination course was assessed as the number of subjects with at least one dose received during the study.
From Day 0 up to Month 13

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

GlaxoSmithKline

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

Enlaces Útiles

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)

29 de junio de 2011

Finalización primaria (Actual)

28 de junio de 2012

Finalización del estudio (Actual)

13 de noviembre de 2014

Fechas de registro del estudio

Enviado por primera vez

17 de junio de 2011

Primero enviado que cumplió con los criterios de control de calidad

23 de junio de 2011

Publicado por primera vez (Estimar)

27 de junio de 2011

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

9 de junio de 2020

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

19 de mayo de 2020

Última verificación

1 de mayo de 2020

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 114700
  • 2011-000757-22 (Número EudraCT)

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

Datos del estudio/Documentos

  1. Formulario de consentimiento informado
    Identificador de información: 114700
    Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
  2. Protocolo de estudio
    Identificador de información: 114700
    Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
  3. Informe de estudio clínico
    Identificador de información: 114700
    Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
  4. Plan de Análisis Estadístico
    Identificador de información: 114700
    Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
  5. Conjunto de datos de participantes individuales
    Identificador de información: 114700
    Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
  6. Especificación del conjunto de datos
    Identificador de información: 114700
    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. .

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