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Study to Asses DTPw-HBV/Hib at 15-18 Months (m) and Mencevax™ ACW at 24 to 30 m in Primed Subjects

26 de abril de 2018 atualizado por: GlaxoSmithKline

Booster Vaccination Study to Assess Safety & Reactogenicity of a Dose of DTPw-HBV/Hib Vaccine and to Assess the Immunogenicity, Safety & Reactogenicity of a Dose of Mencevax™ ACW in Subjects Primed in Study 759346/007

The purpose of this study is to assess the safety and reactogenicity of a booster dose of diphtheria-tetanus-whole cell pertussis-hepatitis B virus/Haemophilus influenzae type b vaccine (DTPw-HBV/Hib) at 15-18 m and to assess the immunogenicity, safety, and reactogenicity of a dose of Mencevax™ Group A, C and W135 polysaccharide meningococcal vaccine (ACW) at 24 to 30 m in primed subjects.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Visão geral do estudo

Descrição detalhada

This open study will have two parallel groups based on the vaccination received in the primary study: AC primed Group: primed with Tritanrix™-HepB/Hib-MenAC vaccine and AC unprimed Group (control): primed with Tritanrix™-HepB/Hiberix™ vaccine. All subjects will receive a booster dose of Tritanrix™-HepB/Hiberix™ vaccine at 15 to 18 months of age with GSK Biological's OPV vaccine given concomitantly and a dose of Mencevax™ ACW vaccine at 24 to 30 months of age. Blood sampling will be done prior to (pre) and one month after (post) the Mencevax™ ACW vaccine administration for immunogenicity analyses. The study will last minimum 7 to maximum 16 months per subject.

Mencevax™ ACWY was changed to Mencevax™ ACW throughout the posting to correct an inconsistency in the earlier version of the protocol posting and to reflect the actual situation.

Tipo de estudo

Intervencional

Inscrição (Real)

168

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.

Locais de estudo

      • Brits, África do Sul, 0250
        • GSK Investigational Site
      • Ga-Rankuwa, África do Sul, 0208
        • GSK Investigational Site
      • Rooihuiskraal, África do Sul, 0145
        • 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

1 ano a 1 ano (Filho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
  • A male or female between, and including, 15 and 18 months of age at the time of vaccination.
  • Written informed consent obtained from the parent or guardian of the subject.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.
  • Having participated in the primary vaccination study (CPMS N° 759346/007).

Exclusion criteria:

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the vaccination, or planned use during the study period.
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to vaccination.
  • Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of vaccination.
  • Booster vaccination against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b (Hib) and/or meningococcal serogroups A, C or W disease, after the date of the study conclusion visit of the primary vaccination study (CPMS N° 759346/007).
  • History of diphtheria, tetanus, pertussis, hepatitis B, Hib and/or meningococcal serogroup A, C or W disease.
  • Known exposure to diphtheria, tetanus, pertussis, hepatitis B, Hib and/or meningococcal serogroup A, C or W disease.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • A family history of congenital or hereditary immunodeficiency.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccines administered in the study.
  • Major congenital defects or serious chronic illness.
  • History of any neurologic disorders or seizures including febrile seizures in infancy.
  • Acute disease at the time of enrolment.
  • Axillary temperature ≥ 37.5°C at the time of vaccination.
  • Administration of immunoglobulins and/or any blood products within the three months preceding the vaccination or planned administration during the study period.
  • Anaphylactic reaction following the administration of vaccine in the primary vaccination study.
  • Known hypersensitivity to any component of the vaccine, or subjects having shown signs of hypersensitivity after previous administration of diphtheria, tetanus, pertussis, hepatitis B, Hib or meningococcal vaccines.

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: AC primed Group
One intramuscular dose during the booster vaccination study in subjects aged 15 to 18 months
One intramuscular dose during the booster vaccination study in subjects aged 15 to 18 months
One subcutaneous dose during the booster vaccination study in subjects aged 24 to 30 months
Comparador Ativo: AC unprimed Group
One intramuscular dose during the booster vaccination study in subjects aged 15 to 18 months
One intramuscular dose during the booster vaccination study in subjects aged 15 to 18 months
One subcutaneous dose during the booster vaccination study in subjects aged 24 to 30 months

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Number of Subjects With Serum Bactericidal Assay Against N. Meningitidis Serogroups A, C Using Rabbit Complement (rSBA-MenA,C) Antibodies
Prazo: At one month post vaccination with Mencevax™ ACW vaccine (Month 25-31)
Pre-defined assay cut-off values for assessed titers were greater than or equal to (≥) 1:128.
At one month post vaccination with Mencevax™ ACW vaccine (Month 25-31)

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Number of Subjects With rSBA-MenA,C, W-135 Antibody Titers ≥ Predefined Cut-offs
Prazo: Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31)
Antibody titer cut-offs were ≥ 1:8 and ≥ 1:128.
Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31)
Anti-rSBA-MenA, C, W-135 Antibody Titers
Prazo: Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31)
Antibody titers were expressed as geometric mean titers (GMTs).
Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31)
Number of Subjects With Anti-polysaccharide A (Anti-PSA) and C (Anti-PSC) Antibody Concentrations Above Predefined Cut-off Values
Prazo: Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31)
Antibody concentrations cut-off were ≥ 0.3 and ≥2 micrograms per millilitre (µg/mL).
Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31)
Anti-PSA and Anti-PSC Antibody Concentrations
Prazo: Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31
Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs).
Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31
Number of Subjects With Anti- Polysaccharide W (Anti-PSW) Antibody Concentrations ≥ Predefined Cut-off Values
Prazo: Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31)
Antibody concentrations were ≥ 0.3 µg/mL.
Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31)
Anti-PSW Antibody Concentrations
Prazo: Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31)
Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs).
Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31)
Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentrations ≥ Predefined Cut-off Values
Prazo: Prior to (Months 24-30) the administration of the Mencevax™ ACW vaccine
Antibody concentrations cut-off were ≥ 10 milli international units per milliliter (mIU/mL).
Prior to (Months 24-30) the administration of the Mencevax™ ACW vaccine
Anti-HBs Antibody Concentrations
Prazo: Prior to (Months 24-30) the administration of the Mencevax™ ACW vaccine
Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs).
Prior to (Months 24-30) the administration of the Mencevax™ ACW vaccine
Number of Subjects With Vaccine Response for rSBA-Men A, C and W-135
Prazo: At one month after the administration of the Mencevax™ ACW vaccine (Months 25-31)
Vaccine response was defined as follows: for initially seronegative subjects (i.e. with rSBA titre < 1:8 pre-vaccination), rSBA titre ≥ 1:32 post-vaccination (seroconversion), and for initially seropositive subjects (i.e. with rSBA titre ≥ 1:8 pre-vaccination), at least a 4-fold increase in rSBA titre from pre to post-vaccination.
At one month after the administration of the Mencevax™ ACW vaccine (Months 25-31)
Number of Subjects With Fever
Prazo: During the 4-day (Days 0-3) after the administration of the Tritanrix™-HepB/Hiberix™ vaccine
Any Fever (measured rectally) = subjects with symptom, regardless of the intensity grade.
During the 4-day (Days 0-3) after the administration of the Tritanrix™-HepB/Hiberix™ vaccine
Number of Subjects With Solicited Local Symtoms
Prazo: During the 4-Day (Days 0-3) after the administration of the Mencevax™ ACW vaccine
Assessed solicited local symptoms were: pain, redness and swelling at the injection site. Any = subjects with symptom, regardless of the intensity grade.
During the 4-Day (Days 0-3) after the administration of the Mencevax™ ACW vaccine
Number of Subjects With Solicited General Symptoms
Prazo: During the 4-Day (Days 0-3) after the administration of the Mencevax™ ACW vaccine
Assessed solicited general symptoms were: drowsiness, fever, irritability and loss of appetite. Any = subjects with symptoms, regardless of intensity grade and casual relationship to study vaccination.
During the 4-Day (Days 0-3) after the administration of the Mencevax™ ACW vaccine
Number of Subjects With Unsolicited Adverse Events (AEs)
Prazo: During the 31-Day (Days 0-30) after the administration of the Mencevax™ ACW vaccine
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.
During the 31-Day (Days 0-30) after the administration of the Mencevax™ ACW vaccine
Number of Subjects With Serious Adverse Events (SAEs)
Prazo: From Months 15-18 and up to Months 25-31 post vaccination
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.
From Months 15-18 and up to Months 25-31 post vaccination

Colaboradores e Investigadores

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Patrocinador

Publicações e links úteis

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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

19 de abril de 2006

Conclusão Primária (Real)

1 de maio de 2007

Conclusão do estudo (Real)

17 de maio de 2007

Datas de inscrição no estudo

Enviado pela primeira vez

3 de fevereiro de 2006

Enviado pela primeira vez que atendeu aos critérios de CQ

20 de abril de 2006

Primeira postagem (Estimativa)

24 de abril de 2006

Atualizações de registro de estudo

Última Atualização Postada (Real)

6 de junho de 2018

Última atualização enviada que atendeu aos critérios de controle de qualidade

26 de abril de 2018

Última verificação

1 de janeiro de 2017

Mais Informações

Termos relacionados a este estudo

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. Protocolo de estudo
    Identificador de informação: 104756
    Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
  2. Especificação do conjunto de dados
    Identificador de informação: 104756
    Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
  3. Plano de Análise Estatística
    Identificador de informação: 104756
    Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
  4. Formulário de Consentimento Informado
    Identificador de informação: 104756
    Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
  5. Conjunto de dados de participantes individuais
    Identificador de informação: 104756
    Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
  6. Relatório de Estudo Clínico
    Identificador de informação: 104756
    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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