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Long-Term Immune Persistence of GlaxoSmithKline Biologicals' Inactivated Hepatitis A Vaccine Injected According to a 0, 12-month Schedule

23 de outubro de 2017 atualizado por: GlaxoSmithKline

Double-blind Randomized Study to Evaluate the Immunogenicity and Reactogenicity of Two Different Lots of GlaxoSmithKline Biologicals' Inactivated Hepatitis A Vaccine Containing 1440 EL.U of Antigen Per mL and Injected According to a 0, 12 Month Schedule in Healthy Adult Volunteers

The aim of this study is to evaluate the persistence of hepatitis A antibodies at 138, 150, 162, 174,186, 198, 210, 222, 234 and 246 months after subjects received their first dose of a 2 dose vaccination schedule of hepatitis A vaccine.

This protocol posting deals with objectives & outcome measures of the extension phase at year 11 to 20.

No additional subjects will be recruited during this long-term follow-up.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

This is a long-term follow-up study at Years 11, 12, 13, 14, 15, 16, 17, 18, 19 and 20 after primary vaccination with GSK Biologicals' hepatitis A vaccine (two-dose schedule). To evaluate the long-term antibody persistence, volunteers will donate a blood sample at Years 11, 12, 13, 14, 15, 16, 17, 18, 19 and 20 after the first vaccine dose of the primary vaccination course to determine their anti-hepatitis A (anti-HAV) antibody concentrations.

If a subject has become seronegative for anti-HAV antibodies during any of the long-term blood sampling time point (i.e. Months 138, 150, 162, 174,186, 198, 210, 222, 234 and 246), he/ she will be offered an additional vaccine dose. A blood sample will be taken on the day of the additional vaccination 14 days and one month after additional vaccination to evaluate the immune response following this vaccination.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007 and to extend the follow up until Year 20.

The study has 10 phases: 100571, 100572, 100573, 100574, 100575, 110677, 110678, 110679, 110680, 110681.

Tipo de estudo

Intervencional

Inscrição (Real)

135

Estágio

  • Fase 4

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

  • Bélgica
      • Wilrijk, Bélgica, 2610
        • 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

29 anos a 60 anos (Adulto)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • Subjects who had received at least one dose of the study vaccine in the primary study
  • Written informed consent will have been obtained from the subjects before the blood sampling visit of each year.

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: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Havrix Group
Subjects who received during the primary study 2 doses of Havrix™ at Day 0 and at Month 12.
Biológico: Havrix™
2 doses at 12 months interval

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration
Prazo: At Months 138, 150, 162, 174, 186, 198, 210, 222, 234 and 246
Concentrations given as geometric mean concentration (GMC) expressed as milli-international unit per millilitre (mIU/mL). ** = Regarding Month 234 data, please note that there were 5 subjects for whom serum sample tube was broken and thus due to risk of contamination the test were not performed. Hence these subjects were not included in the LT-ATP cohort for immunogenicity analysis at Month 234. $ = Regarding Month 246 data, please note there was 1 subject for whom serum sample tube was broken and hence scrapped by laboratory. Hence this subject was not included in the LT-ATP cohort for immunogenicity analysis at Month 246.
At Months 138, 150, 162, 174, 186, 198, 210, 222, 234 and 246
Number of Seropositive Subjects Against Hepatitis A Virus
Prazo: At Months 138, 150, 162, 174, 186, 198, 210, 222, 234 and 246
A seropositive subject was a vaccinated subject whose concentrations for antibodies against hepatitis A virus (anti-HAV) were equal or above (>=) the assay cut-off for seropositivity of 15 milli-international units per milliliter (mIU/mL). ** = Regarding Month 234 data, please note that there were 5 subjects for whom serum sample tube was broken and thus due to risk of contamination the test were not performed. Hence these subjects were not included in the LT-ATP cohort for immunogenicity analysis at Month 234. $ = Regarding Month 246 data, please note there was 1 subject for whom serum sample tube was broken and hence scrapped by laboratory. Hence this subject was not included in the LT-ATP cohort for immunogenicity analysis at Month 246.
At Months 138, 150, 162, 174, 186, 198, 210, 222, 234 and 246

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration
Prazo: Before additional vaccination, 14 days after additional vaccination and 30 days after additional vaccination

Concentrations given as GMC expressed as mIU/mL. 4 subjects received additional vaccination at Month 186 and 1 subject at Month 198.

Please note that value 14.9 means <15.
Before additional vaccination, 14 days after additional vaccination and 30 days after additional vaccination
Number of Subjects Reporting Solicited Local Symptoms
Prazo: During the 4-day (Days 0-3) follow-up period after additional vaccination
Solicited local symptoms assessed include pain, redness and swelling. Additional vaccination was given to 4 subjects at the Month 186 timepoint and to 1 subject at the Month 198 timepoint.
During the 4-day (Days 0-3) follow-up period after additional vaccination
Number of Subjects Reporting Solicited General Symptoms
Prazo: During the 4-day (Days 0-3) follow-up period after additional vaccination

Solicited general symptoms assessed include fatigue, fever, gastrointestinal symptoms and headache.

4 subjects received additional vaccination at Month 186 and 1 subject at Month 198.
During the 4-day (Days 0-3) follow-up period after additional vaccination
Number of Subjects Reporting Unsolicited Adverse Events (AE)
Prazo: During the 30-day follow-up period after additional vaccination

An AE is 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.

4 subjects received additional vaccination at Month 186 and 1 at Month 198.
During the 30-day follow-up period after additional vaccination
Number of Subjects Reporting Serious Adverse Events (SAE) Assessed by the Investigator as Related to Primary Study Vaccination, Procedures or Lack of Vaccine Efficacy
Prazo: At Months 138, 150, 162, 174, 186, 198, 210, 222, 234 and 246
An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above
At Months 138, 150, 162, 174, 186, 198, 210, 222, 234 and 246
Number of Subjects Reporting Serious Adverse Events (SAE) After Additional Vaccination
Prazo: During the 30-day follow-up period after additional vaccination

An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.

4 subjects received additional vaccination at Month 186 and 1 at Month 198.
During the 30-day follow-up period after additional vaccination
Number of Subjects Reporting Pregnancies After Additional Vaccination
Prazo: At Months 186 and 198
The number of subjects with outcome of pregnancies reported among subjects who had received the additional vaccination was tabulated. 4 subjects received additional vaccination at Month 186 and 1 subject at Month 198.
At Months 186 and 198

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

1 de janeiro de 2004

Conclusão Primária (Real)

1 de março de 2013

Conclusão do estudo (Real)

1 de março de 2013

Datas de inscrição no estudo

Enviado pela primeira vez

14 de fevereiro de 2006

Enviado pela primeira vez que atendeu aos critérios de CQ

14 de fevereiro de 2006

Primeira postagem (Estimativa)

15 de fevereiro de 2006

Atualizações de registro de estudo

Última Atualização Postada (Real)

29 de novembro de 2017

Última atualização enviada que atendeu aos critérios de controle de qualidade

23 de outubro de 2017

Última verificação

1 de janeiro de 2017

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 100571 (M138)
  • 100572 (M150) (Outro identificador: GSK)
  • 100573 (M162) (Outro identificador: GSK)
  • 100574 (M174) (Outro identificador: GSK)
  • 100575 (M186) (Outro identificador: GSK)
  • 110677 (M198) (Outro identificador: GSK)
  • 110678 (M210) (Outro identificador: GSK)
  • 110679 (Outro identificador: GSK)
  • 110680 (Outro identificador: GSK)
  • 110681 (Outro identificador: GSK)

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. Conjunto de dados de participantes individuais
    Identificador de informação: 100571 (M138)
    Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register. The results of this study 100571 are summarised with studies 100572, 100573, 100574, 100575, 110677, 110678, 110679, 110680, and 110681 on the GSK Clinical Study
  2. Formulário de Consentimento Informado
    Identificador de informação: 100571 (M138)
    Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
  3. Protocolo de estudo
    Identificador de informação: 100571 (M138)
    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: 100571 (M138)
    Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
  5. Relatório de Estudo Clínico
    Identificador de informação: 100571 (M138)
    Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
  6. Plano de Análise Estatística
    Identificador de informação: 100571 (M138)
    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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