Evaluation of the Immunogenicity and Safety of GlaxoSmithKline Biologicals' HPV Vaccine in Young Males.
5 de febrero de 2018 actualizado por: GlaxoSmithKline
An Observer-blind, Randomized, Controlled Study to Assess the Immunogenicity and Safety of GlaxoSmithKline Biologicals' HPV Vaccine Administered Intramuscularly According to a 0, 1, 6 Month Schedule in Healthy Male Subjects Aged 10-18 Years
The main aim of this vaccine is to prevent cervical cancer in women.
However, it could also be relevant to vaccinate selected groups of males.
Therefore, this study is designed to evaluate the safety and immunogenicity of the HPV vaccine in pre-teen and adolescent male subjects aged 10-18 years.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
270
Fase
- Fase 2
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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Kotka, Finlandia, 48100
- GSK Investigational Site
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Kouvola, Finlandia, 45100
- GSK Investigational Site
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Mikkeli, Finlandia, 50100
- GSK Investigational Site
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Rauma, Finlandia, 26100
- GSK Investigational Site
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Tampere, Finlandia, 33200
- 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
10 años a 18 años (Niño, Adulto)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Masculino
Descripción
Inclusion criteria:
- A male between, and including, 10 and 18 years of age 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, a written informed consent must be obtained from the subject's parent/guardian. In addition, a written informed assent must be obtained from the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
Exclusion criteria:
- Previous vaccination against Human Papillomavirus (HPV).
- Previous vaccination against Hepatitis B, known clinical history of Hepatitis B infection.
- Cancer or autoimmune disease under treatment.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Cervarix Group
Healthy male subjects between and including 10 to 18 years of age at the time of the first vaccination, who were administered 3 doses of Cervarix™ (HPV-16/18 L1 VLP AS04) vaccine, intramuscularly into the deltoid region of the non-dominant arm, according to a 0, 1 and 6-month schedule.
The subjects were followed up for 7 months after the first dose and an additional telephone contact was foreseen at Month 12.
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All subjects received an intramuscular injection into the deltoid of the non-dominant arm according to a 0, 1 and 6-month schedule.
Otros nombres:
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Comparador activo: Engerix-B Group
Healthy male subjects between and including 10 to 18 years of age at the time of the first vaccination, who were administered 3 doses of Engerix-B™ (HBV) vaccine, intramuscularly into the deltoid region of the non-dominant arm, according to a 0, 1 and 6-month schedule.
The subjects were followed up for 7 months after the first dose and an additional telephone contact was foreseen at Month 12.
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All subjects received an intramuscular injection into the deltoid of the non-dominant arm according to a 0, 1 and 6-month schedule
Otros nombres:
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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 Subjects for Anti-HPV-16 and Anti-HPV-18
Periodo de tiempo: At Month 7
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Seroconversion was defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies [anti-HPV-16 titers greater than or equal to (≥) 8 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL) and anti-HPV-18 titres ≥7 EL.U/mL] in the serum of subjects seronegative before vaccination.
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At Month 7
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Antibody Titers Against HPV-16 (Anti-HPV-16) and HPV-18 (Anti-HPV-18)
Periodo de tiempo: At Month 7
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Titers were presented as geometric mean titers (GMT).
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At Month 7
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18
Periodo de tiempo: At Month 2
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Seroconversion was defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies (anti-HPV-16 titres ≥ 8 EL.U/mL and anti-HPV-18 titres ≥ 7 EL.U/mL) in the serum of subjects seronegative before vaccination.
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At Month 2
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Antibody Titers Against HPV-16 (Anti-HPV-16) and HPV-18 (Anti-HPV-18)
Periodo de tiempo: At Month 2
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Titers were presented as GMTs.
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At Month 2
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Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Periodo de tiempo: Within 7 days (Days 0-6) after each dose and across doses, up to 7 months
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Solicited local symptoms assessed were pain, redness and swelling.
Any = any solicited local symptom irrespective of intensity grade; Grade 3 pain = pain that prevented normal activity; Grade 3 redness/swelling = redness/swelling spreading beyond (>) 50 mm.
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Within 7 days (Days 0-6) after each dose and across doses, up to 7 months
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Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Periodo de tiempo: Within 7 days (Days 0-6) after each dose and across doses, up to 7 months
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Solicited general symptoms assessed were arthralgia, fatigue, fever (defined as axillary temperature ≥37.5 °C), gastrointestinal, headache, myalgia, rash and urticaria.
Any = any solicited general symptom irrespective of intensity grade or relationship to vaccination; Grade 3 = symptom that prevented normal activity; Grade 3 fever = temperature > 39.0 °C; Related = symptoms considered by the investigator to have a causal relationship to vaccination.
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Within 7 days (Days 0-6) after each dose and across doses, up to 7 months
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Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Periodo de tiempo: Within 30 days (Day 0-29) after any vaccination, up to 7 months
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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.
Grade 3 AE = an AE which prevented normal, everyday activities.
Related = AE assessed by the investigator as related to the vaccination.
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Within 30 days (Day 0-29) after any vaccination, up to 7 months
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Number of Subjects With New Onset of Chronic Diseases (NOCDs) and Other Medically Significant Conditions
Periodo de tiempo: Throughout the active phase of the study (up to Month 7) and the extended safety follow-up (from Month 7 up to Month 12)
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NOCDs include asthma, Chron's disease, dermatitis atopic.
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 and injury.
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Throughout the active phase of the study (up to Month 7) and the extended safety follow-up (from Month 7 up to Month 12)
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Number of Subjects With Serious Adverse Events (SAEs)
Periodo de tiempo: Throughout the active phase of the study (up to Month 7) and the extended safety follow-up (from Month 7 up to Month 12)
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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.
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Throughout the active phase of the study (up to Month 7) and the extended safety follow-up (from Month 7 up to Month 12)
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Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
Periodo de tiempo: At Month 2 and Month 7, post-vaccination
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The occurence of clinically relevant abnormalities was assessed in the following biochemical and haematological parameters: alanine aminotransferase [ALT], basophils [BAS], creatinine [CREA], eosinophils [EOS] and hematocrit [Hem].
Levels of haematological/biochemical parameters assessed in terms of normal, below and above laboratory values were - normal, below, above and missing.
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At Month 2 and Month 7, post-vaccination
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Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
Periodo de tiempo: At Month 2 and at Month 7, post-vaccination
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The occurence of clinically relevant abnormalities was assessed in the following biochemical and haematological parameters: lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelets [PLA], red blood cells [RBC] and white blood cells [WBC].
Levels of haematological/biochemical parameters assessed in terms of normal, below and above laboratory values were - normal, below, above and missing.
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At Month 2 and at Month 7, post-vaccination
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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.
Publicaciones Generales
- Verstraeten T, Descamps D, David MP, Zahaf T, Hardt K, Izurieta P, Dubin G, Breuer T. Analysis of adverse events of potential autoimmune aetiology in a large integrated safety database of AS04 adjuvanted vaccines. Vaccine. 2008 Dec 2;26(51):6630-8. doi: 10.1016/j.vaccine.2008.09.049.
- Petaja T, Keranen H, Karppa T, Kawa A, Lantela S, Siitari-Mattila M, Levanen H, Tocklin T, Godeaux O, Lehtinen M, Dubin G. Immunogenicity and safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine in healthy boys aged 10-18 years. J Adolesc Health. 2009 Jan;44(1):33-40. doi: 10.1016/j.jadohealth.2008.10.002.
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)
5 de abril de 2006
Finalización primaria (Actual)
1 de junio de 2007
Finalización del estudio (Actual)
19 de junio de 2007
Fechas de registro del estudio
Enviado por primera vez
28 de marzo de 2006
Primero enviado que cumplió con los criterios de control de calidad
28 de marzo de 2006
Publicado por primera vez (Estimar)
31 de marzo de 2006
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
17 de septiembre de 2018
Última actualización enviada que cumplió con los criterios de control de calidad
5 de febrero de 2018
Última verificación
1 de febrero de 2018
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 580299/011
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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Informe de estudio clínico
Identificador de información: 580299/011Comentarios 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: 580299/011Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
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Formulario de consentimiento informado
Identificador de información: 580299/011Comentarios 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: 580299/011Comentarios 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: 580299/011Comentarios 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: 580299/011Comentarios 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. .