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Evaluation of the Immunogenicity and Safety of GlaxoSmithKline Biologicals' HPV Vaccine in Young Males.

5 de fevereiro de 2018 atualizado 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.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

270

Estágio

  • Fase 2

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Finlândia
      • Kotka, Finlândia, 48100
        • GSK Investigational Site
      • Kouvola, Finlândia, 45100
        • GSK Investigational Site
      • Mikkeli, Finlândia, 50100
        • GSK Investigational Site
      • Rauma, Finlândia, 26100
        • GSK Investigational Site
      • Tampere, Finlândia, 33200
        • GSK Investigational Site

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

10 anos a 18 anos (Filho, Adulto)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Macho

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Prevenção
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
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.
Biológico: Cervarix vaccine
All subjects received an intramuscular injection into the deltoid of the non-dominant arm according to a 0, 1 and 6-month schedule.
Outros nomes:
  • Vacina contra o HPV
Comparador Ativo: 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.
Biológico: Engerix-B vaccine
All subjects received an intramuscular injection into the deltoid of the non-dominant arm according to a 0, 1 and 6-month schedule
Outros nomes:
  • Vacina HBV

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18
Prazo: At Month 7
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.
At Month 7
Antibody Titers Against HPV-16 (Anti-HPV-16) and HPV-18 (Anti-HPV-18)
Prazo: At Month 7
Titers were presented as geometric mean titers (GMT).
At Month 7

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18
Prazo: At Month 2
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.
At Month 2
Antibody Titers Against HPV-16 (Anti-HPV-16) and HPV-18 (Anti-HPV-18)
Prazo: At Month 2
Titers were presented as GMTs.
At Month 2
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Prazo: Within 7 days (Days 0-6) after each dose and across doses, up to 7 months
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.
Within 7 days (Days 0-6) after each dose and across doses, up to 7 months
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Prazo: Within 7 days (Days 0-6) after each dose and across doses, up to 7 months
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.
Within 7 days (Days 0-6) after each dose and across doses, up to 7 months
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Prazo: Within 30 days (Day 0-29) after any vaccination, up to 7 months
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.
Within 30 days (Day 0-29) after any vaccination, up to 7 months
Number of Subjects With New Onset of Chronic Diseases (NOCDs) and Other Medically Significant Conditions
Prazo: Throughout the active phase of the study (up to Month 7) and the extended safety follow-up (from Month 7 up to Month 12)
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.
Throughout the active phase of the study (up to Month 7) and the extended safety follow-up (from Month 7 up to Month 12)
Number of Subjects With Serious Adverse Events (SAEs)
Prazo: Throughout the active phase of the study (up to Month 7) and the extended safety follow-up (from Month 7 up to Month 12)
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.
Throughout the active phase of the study (up to Month 7) and the extended safety follow-up (from Month 7 up to Month 12)
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
Prazo: At Month 2 and Month 7, post-vaccination
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.
At Month 2 and Month 7, post-vaccination
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
Prazo: At Month 2 and at Month 7, post-vaccination
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.
At Month 2 and at Month 7, post-vaccination

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

GlaxoSmithKline

Publicações e links úteis

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Publicações Gerais

Links úteis

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

5 de abril de 2006

Conclusão Primária (Real)

1 de junho de 2007

Conclusão do estudo (Real)

19 de junho de 2007

Datas de inscrição no estudo

Enviado pela primeira vez

28 de março de 2006

Enviado pela primeira vez que atendeu aos critérios de CQ

28 de março de 2006

Primeira postagem (Estimativa)

31 de março de 2006

Atualizações de registro de estudo

Última Atualização Postada (Real)

17 de setembro de 2018

Última atualização enviada que atendeu aos critérios de controle de qualidade

5 de fevereiro de 2018

Última verificação

1 de fevereiro de 2018

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 580299/011

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Dados/documentos do estudo

  1. Relatório de Estudo Clínico
    Identificador de informação: 580299/011
    Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
  2. Conjunto de dados de participantes individuais
    Identificador de informação: 580299/011
    Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
  3. Formulário de Consentimento Informado
    Identificador de informação: 580299/011
    Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
  4. Especificação do conjunto de dados
    Identificador de informação: 580299/011
    Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
  5. Plano de Análise Estatística
    Identificador de informação: 580299/011
    Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
  6. Protocolo de estudo
    Identificador de informação: 580299/011
    Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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