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Primary Vaccination Study With a Pneumococcal Conjugate Vaccine in Healthy Children 6 to 10 Weeks of Age

31 de dezembro de 2019 atualizado por: GlaxoSmithKline

Primary Vaccination Course in Healthy Children Receiving the Pneumococcal Vaccine GSK 1024850A Co-administered With Tritanrix™-HepB/Hib at 6, 10 and 14 Weeks of Age

The purpose of this study is to assess the immunogenicity in terms of antibody response and the safety/reactogenicity in terms of solicited and unsolicited symptoms and serious adverse events following primary vaccination of Indian infants with pneumococcal conjugate vaccine GSK1024850A co-administered with a diphtheria, tetanus, whole cell pertussis (DTPw)-combined vaccine during the first 4 months of life. The study will be conducted in India.

Visão geral do estudo

Tipo de estudo

Intervencional

Inscrição (Real)

360

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

      • Kolkata, Índia, 700073
        • GSK Investigational Site
      • Ludhiana, Índia, 141 008
        • GSK Investigational Site
      • Pune, Índia
        • GSK Investigational Site
      • Vellore, Índia, 632004
        • 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 mês a 2 meses (Filho)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • Male or female subjects between, and including 6-10 weeks of age at the time of the first vaccination.
  • Subjects for whom the investigator believes that their parent(s)/guardian(s) can and will comply with the requirements of the protocol.
  • Written or oral, signed or thumb-printed informed consent obtained from the parent(s)/guardian(s) of the child/ward. Where parent(s)/guardian(s) are illiterate, the consent form will be countersigned by a witness.
  • Free of any known or suspected health problems (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) other than the study vaccines within 30 days preceding the first dose of the study vaccines, or planned use during the study period.
  • Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
  • A family history of congenital or hereditary immunodeficiency.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
  • Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period (with the exception of hepatitis B immunoglobulins at birth).
  • Previous vaccination against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b and/or Streptococcus pneumoniae (with the exception of hepatitis B vaccination at birth or at least 30 days before the subject's first study visit).
  • History of, or intercurrent, diphtheria, tetanus, pertussis, hepatitis B, Streptococcus and Haemophilus influenzae type b disease.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
  • History of any neurological disorders or seizures.
  • Major congenital defects or serious chronic illness.
  • Acute disease at the time of enrolment.
  • Babies for which birth weight is < 2 kilogram.

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: Synflorix & Tritanrix-HebB/Hib Group
Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
Injeção intramuscular, 3 doses
Intramuscular injection, 3 doses
Outros nomes:
  • DTPw-HBV/Hib
Comparador Ativo: Hiberix group & Tritanrix-HebB Group
Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
Intramuscular injection, 3 doses
Outros nomes:
  • Hib
Intramuscular injection, 3 doses
Outros nomes:
  • DTPw-HBV

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes
Prazo: One month after primary immunization (month 3)

Concentrations were expressed as Geometric Mean Concentrations (GMCs) in microgram per milliliter (µg/mL).

Pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.

One month after primary immunization (month 3)
Concentration of Antibody Against Protein D (PD)
Prazo: One month after primary immunization (month 3)
Concentrations were expressed as GMCs GSK's 22F-inhibition in enzyme-linked-immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
One month after primary immunization (month 3)

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Number of Subjects With Opsonophagocytic Activity Against Pneumococcal Serotypes
Prazo: One month after primary immunization (month 3)

Vaccine pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.

Cross-reactive pneumococcal serotypes included 6A and 19A.

Opsonophagocytic activity was defined as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. The cut-off of the assay was an opsonic titer equal to or greater than 8.

One month after primary immunization (month 3)
Number of Subjects With Antibody Concentrations Against Pneumococcal Serotypes Equal to or Above Cut-off Value
Prazo: One month after primary immunization

Vaccine pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Cross-reactive pneumococcal serotypes included 6A and 19A.

The cut-off was defined as 0.20 microgram per milliliter (µg/mL).

One month after primary immunization
Concentrations of Antibodies Against Pneumococcal Cross-reactive Serotypes
Prazo: One month after primary immunization (month 3)
Concentrations were expressed as GMCs in µg/mL. Pneumococcal cross-reactive serotypes included 6A and 19A.
One month after primary immunization (month 3)
Number of Subjects Seropositive for Pneumococcal Serotypes
Prazo: One month after primary immunization (month 3)

Vaccine pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Cross-reactive pneumococcal serotypes included 6A and 19A.

Seropositivity was defined as a titer equal to or greater than 0.05 µg/mL

One month after primary immunization (month 3)
Number of Subjects Seropositive for Protein D (PD)
Prazo: One month after primary immunization (month 3)
Seropositivity for PD was defined greater than or equal to 100 EL.U/mL.
One month after primary immunization (month 3)
Concentration of Antibody Against Polyribosyl-ribitol Phosphate (PRP)
Prazo: One month after primary immunization (month 3)
Concentration is expressed as GMC in µg/mL.
One month after primary immunization (month 3)
Concentration of Antibodies Against Diphteria (Anti-DT) and Tetanus (Anti-TT)
Prazo: One month after primary immunization (month 3)
Concentrations were expressed as GMCs in international units per milliliter (IU/mL).
One month after primary immunization (month 3)
Concentration of Antibody Against Bordetella Pertussis (B. Pertussis)
Prazo: One month after primary immunization (month 3)
Concentration was expressed as GMC in EL.U/mL.
One month after primary immunization (month 3)
Concentration of Antibody Against Hepatitis B (Anti-HBs) by Enzyme-Linked ImmunoSorbent Assay (ELISA).
Prazo: One month after primary immunization (month 3)
Concentration was expressed as GMC in milli international units per milliliter (mIU/mL). As a decrease in the specificity of the anti-HBs ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL), the table shows results following partial or complete retesting/reanalysis.
One month after primary immunization (month 3)
Number of Subjects Seropostive for B. Pertussis
Prazo: One month after primary immunization (month 3)
Seropositivity was defined as and antibody concentration equal to or greater than 15 EL.U/mL.
One month after primary immunization (month 3)
Number of Seroprotected Subjects (Anti-DT, Anti-TT, Anti-PRP, Anti-HBs)
Prazo: One month after primary immunization (month 3)

Seroprotection was defined as:

Anti-DT antibody concentration equal to or greater than 0.1 IU/mL. Anti-TT antibody concentration equal to or greater than 0.1 IU/mL. Anti-PRP antibody concentration equal to or greater than 0.15 µg/mL Anti-HBs antibody concentration greater than or equal to 10 mIU/mL.

One month after primary immunization (month 3)
Number of Seroprotected Subjects (Anti-PRP Above the Cut-off of 1.0 µg/mL)
Prazo: One month after primary immunization (month 3)
Anti-PRP antibody concentration equal to or greater than 1.0 µg/mL.
One month after primary immunization (month 3)
Number of Subjects With Solicited Local and General Symptoms
Prazo: Within 4 days (day 0-3) after vaccination
Solicited local symptoms included pain, redness and swelling. Solicited general symptoms included drowsiness, fever (equal to or above 38 degrees Celsius and above 39 degrees Celsius), irritability and loss of appetite.
Within 4 days (day 0-3) after vaccination
Number of Subjects With Unsolicited Adverse Events (AEs)
Prazo: Within 31 days (day 0-30) after 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.

Unsolicited AE covers any AE 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

Within 31 days (day 0-30) after vaccination
Number of Subjects With Serious Adverse Events (SAEs)
Prazo: Following first vaccination (Month 0) throughout the entire study period (month 3)
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Following first vaccination (Month 0) throughout the entire study period (month 3)

Colaboradores e Investigadores

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

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 (Real)

7 de março de 2009

Conclusão Primária (Real)

13 de novembro de 2009

Conclusão do estudo (Real)

13 de novembro de 2009

Datas de inscrição no estudo

Enviado pela primeira vez

23 de dezembro de 2008

Enviado pela primeira vez que atendeu aos critérios de CQ

23 de dezembro de 2008

Primeira postagem (Estimativa)

25 de dezembro de 2008

Atualizações de registro de estudo

Última Atualização Postada (Real)

3 de janeiro de 2020

Última atualização enviada que atendeu aos critérios de controle de qualidade

31 de dezembro de 2019

Última verificação

1 de dezembro de 2019

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

IPD is available via the Clinical Study Data Request site (click on the link provided below)

Prazo de Compartilhamento de IPD

IPD is available via the Clinical Study Data Request site (click on the link provided below)

Critérios de acesso de compartilhamento IPD

Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Tipo de informação de suporte de compartilhamento de IPD

  • PROTOCOLO DE ESTUDO
  • SEIVA
  • CIF
  • CSR

Dados/documentos do estudo

  1. Protocolo de estudo
    Identificador de informação: 111188
    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: 111188
    Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
  3. Formulário de Relato de Caso Anotado
    Identificador de informação: 111188
    Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
  4. Relatório de Estudo Clínico
    Identificador de informação: 111188
    Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
  5. Formulário de Consentimento Informado
    Identificador de informação: 111188
    Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
  6. Especificação do conjunto de dados
    Identificador de informação: 111188
    Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
  7. Plano de Análise Estatística
    Identificador de informação: 111188
    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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