Study to Evaluate Persistence of Antibodies After Vaccination With Meningococcal Vaccine GSK 134612
1 de março de 2017 atualizado por: GlaxoSmithKline
Persistence of Antibodies After Vaccination With GSK Biologicals' Meningococcal Vaccine GSK134612 in Adolescents and Young Adults
Subjects were previously vaccinated at 11 to 17 years of age.
This extension phase starts 24 months after vaccination and the subjects who were vaccinated in the primary study will be enrolled in this extension phase.
No new subjects will be enrolled.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
Subjects were previously vaccinated at 11 to 17 months of age with GSK Biologicals' meningococcal vaccine 134612 or with Mencevax™.
This extension phase starts 24 months after vaccination and the subjects who were vaccinated in the primary study will be enrolled in this extension phase.
No new studies will be enrolled.
The subjects will have 4 blood samples taken: at 24, 36, 48 and 60 months after vaccination.
Tipo de estudo
Intervencional
Inscrição (Real)
697
Estágio
- Fase 3
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.
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
11 anos a 17 anos (Filho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Subjects who the investigator believes that they and/or their parent(s)/guardian(s) can and will comply with the requirements of the protocol should be enrolled in the study.
- A male or female having been vaccinated with a meningococcal vaccine in the primary study 109069.
- Written informed consent obtained from parent(s)/guardian(s) of the subject and written informed assent obtained from the subject if the subject is less than 18 years of age, or written informed consent obtained from the subject if the subject has achieved the 18th birthday.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
Exclusion Criteria:
- Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the subject's first visit.
- History of meningococcal disease; such cases will be documented.
- Administration of a meningococcal polysaccharide or a meningococcal polysaccharide conjugate vaccine since previous vaccination in study 109069.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history.
- Administration of immunoglobulins and/or any blood products within the three months preceding the subject's first visit.
- Bleeding disorders, such as thrombocytopenia, or subjects on anti-coagulant therapy
- Subjects who withdrew consent to be contacted for follow-up studies.
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: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Group A
Subjects who received GSK Biologicals' meningococcal vaccine 134612 in the primary vaccination study 109069.
|
A blood sample will be taken yearly at each long-term follow-up visit (i.e.
Year 2 through Year 5) after vaccination during the primary study.
No vaccines are administered in the long-term follow-up study
|
|
Comparador Ativo: Group B
Subjects who received MencevaxTM ACWY in the primary vaccination study 109069.
|
A blood sample will be taken yearly at each long-term follow-up visit (i.e.
Year 2 through Year 5) after vaccination during the primary study.
No vaccines are administered in the long-term follow-up study
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Number of Seroprotected Subjects Against the Vaccine Meningococcal Serogroups
Prazo: At Month 24 post primary dose
|
A seroprotected subject was defined as a subject who had anti-meningococcal serogroups A (MenA), C (MenC), W-135 (MenW-135) and Y (MenY) antibody titers equal to or above (≥) the cut-off value of 1:8.
The persistence of serum bactericidal antibodies was evaluated using baby rabbit complement (rSBA) titers.
The blood analyses were performed at the GSK Biologicals' laboratory.
|
At Month 24 post primary dose
|
|
Number of Seroprotected Subjects Against the Vaccine Meningococcal Serogroups
Prazo: At Month 36 post primary dose
|
A seroprotected subject was defined as a subject who had anti-meningococcal serogroups A (MenA), C (MenC), W-135 (MenW-135) and Y (MenY) antibody titers equal to or above (≥) the cut-off value of 1:8.
The persistence of serum bactericidal antibodies was evaluated using baby rabbit complement (rSBA) titers.
The blood analyses for this timepoint were performed solely at the Public Health of England's (PHE) laboratory.
|
At Month 36 post primary dose
|
|
Number of Seroprotected Subjects Against the Vaccine Meningococcal Serogroups
Prazo: At Month 48 post primary dose
|
A seroprotected subject was defined as a subject who had anti-meningococcal serogroups A (MenA), C (MenC), W-135 (MenW-135) and Y (MenY) antibody titers equal to or above (≥) the cut-off value of 1:8.
The persistence of serum bactericidal antibodies was evaluated using baby rabbit complement (rSBA) titers.
The blood analyses for this timepoint were performed solely at the Public Health of England's (PHE) laboratory.
|
At Month 48 post primary dose
|
|
Number of Seroprotected Subjects Against the Vaccine Meningococcal Serogroups
Prazo: At Month 60 post primary dose
|
A seroprotected subject was defined as a subject who had anti-meningococcal serogroups A (MenA), C (MenC), W-135 (MenW-135) and Y (MenY) antibody titers equal to or above (≥) the cut-off value of 1:8.
The persistence of serum bactericidal antibodies was evaluated using baby rabbit complement (rSBA) titers.
The blood analyses for this timepoint were performed solely at the Public Health of England's (PHE) laboratory.
|
At Month 60 post primary dose
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Number of Seropositive Subjects Against the Vaccine Meningococcal Serogroups
Prazo: At Months 24, 36, 48 and 60 post primary dose
|
A seropositive subject was defined as a subject who had the anti-meningococcal serogroups A (MenA), C (MenC), W-135 (MenW-135) and Y (MenY) antibody titers equal to or above (≥) the cut-off value of 1:128.
The persistence of serum bactericidal antibodies was evaluated using baby rabbit complement (rSBA) titers.
The blood analyses were performed at the Public Health of England's (PHE) laboratory and at GSK Biologicals' laboratory.
|
At Months 24, 36, 48 and 60 post primary dose
|
|
Antibody Titers Against the Vaccine Meningococcal Serogroups
Prazo: At Months 24, 36, 48 and 60 post primary dose
|
Seropositivity status was defined as the anti-meningococcal serogroups A (MenA), C (MenC), W-135 (MenW-135) and Y (MenY) titers equal to or above the cut-off value of 1:128.
Antibody titers were presented as geometric mean titers (GMTs).
The blood analyses were performed at the Public Health of England's (PHE) laboratory and at GSK Biologicals' laboratory.
|
At Months 24, 36, 48 and 60 post primary dose
|
|
Number of Subjects With Antibody Concentrations Against the Vaccine Polysaccharides
Prazo: At Month 24 post primary dose
|
Antibody concentrations against polysaccharide A (anti-PSA), polysaccharide C (anti-PSC), polysaccharide W-135 (anti-PSW-135) and polysaccharide Y (anti-PSY) assessed were equal to or above (≥) the cut-off values of 0.3 micrograms/milliliter (µg/mL ) and 2.0 micrograms/milliliter (µg/mL).
Concentration of antibodies was determined by enzyme-linked immunosorbent assay (ELISA).
|
At Month 24 post primary dose
|
|
Antibody Concentrations Against the Vaccine Polysaccharides
Prazo: At Month 24 post primary dose
|
Antibody concentrations against polysaccharide A (anti-PSA), polysaccharide C (anti-PSC), polysaccharide W-135 (anti-PSW-135) and polysaccharide Y (anti-PSY) assessed were equal to or above (≥) the cut-off values of 0.3 micrograms/milliliter (µg/mL ) and 2.0 micrograms/milliliter (µg/mL).
Concentration of antibodies was determined by enzyme-linked immunosorbent assay (ELISA).
|
At Month 24 post primary dose
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
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 setembro de 2009
Conclusão Primária (Real)
1 de maio de 2013
Conclusão do estudo (Real)
1 de maio de 2013
Datas de inscrição no estudo
Enviado pela primeira vez
7 de setembro de 2009
Enviado pela primeira vez que atendeu aos critérios de CQ
9 de setembro de 2009
Primeira postagem (Estimativa)
10 de setembro de 2009
Atualizações de registro de estudo
Última Atualização Postada (Real)
12 de abril de 2017
Última atualização enviada que atendeu aos critérios de controle de qualidade
1 de março de 2017
Última verificação
1 de dezembro de 2016
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 112148
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