- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01061541
Immunogenicity, Safety & Reactogenicity of GSK Vaccine Tritanrix™-HepB/Hib2.5 Compared to GSK Vaccine Tritanrix™-HepB/Hiberix™
A Phase II, Double-blind, Randomized Study to Compare the Immunogenicity, Safety and Reactogenicity of GlaxoSmithKline (GSK) Biologicals' Tritanrix™-HepB/Hib2.5 to GSK Biologicals' Tritanrix™-HepB/Hiberix™ When Administered as a Three-dose Primary Vaccination Course to Healthy Infants at 6, 10 and 14 Weeks of Age. A Dose of Unconjugated Hib Vaccine (Plain PRP Booster) Will be Administered at the Age of 10 Months to 50% of the Subjects
In order to reduce the amount of thiomersal in its vaccines, GSK Biologicals has developed a DTPw-HBV vaccine with low thiomersal content (Tritanrix™- HepB low thio). This vaccine is to be used in combination with a Hib low dose vaccine containing 2.5µg of PRP antigen (Hib 2.5). The purpose of this study is to generate clinical data with Tritanrix™-HepB low thio vaccine when extemporaneously mixed with Hib 2.5 vaccine. The control group will receive Tritanrix™-HepB/Hiberix™.
Subjects received primary vaccination in study 208108/091 (double blind). Of these subjects 50% were randomised to participate in the PRP challenge study (208108/092) (open), and all subjects will be invited to participate in a booster study DTPWHBV=HIB2.5-093 (101477).
Visão geral do estudo
Status
Condições
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 2
Contactos e Locais
Locais de estudo
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Muntinlupa, Filipinas, 1781
- GSK Investigational Site
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
- A male or female between, and including, 6 and 8 weeks of age at the time of the first vaccination.
- Written informed consent obtained from the parent or guardian of the subject.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- Born after a gestation period of 36 to 42 weeks.
- Born to a mother proven seronegative for HBsAg.
Exclusion Criteria:
- Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days before each dose of vaccine, with the exception of oral polio vaccine (OPV).
- Bacille Calmette-Guérin (BCG) vaccine received after the first 2 weeks of life.
- Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
- Previous vaccination against diphtheria, tetanus, pertussis, hepatitis B and/or Hib.
- History of, or intercurrent, diphtheria, tetanus, pertussis, hepatitis B and/or Hib disease.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
- A family history of congenital or hereditary immunodeficiency.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Major congenital defects or serious chronic illness.
- History of any neurologic disorders or seizures.
- Acute disease at the time of enrolment.
- Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or history.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- Other conditions which in the opinion of the investigator may potentially interfere with interpretation of study outcomes.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: Grupo A
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One dose as intramuscular injection at 6, 10 and 14 weeks of age.
One dose as intramuscular injection at 6, 10 and 14 weeks of age.
One dose as intramuscular injection at 10 months of age
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Comparador Ativo: Grupo B
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One dose as intramuscular injection at 10 months of age
One dose as intramuscular injection at 6, 10 and 14 weeks of age.
One dose as intramuscular injection at 6, 10 and 14 weeks of age.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
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anti-PRP antibody concentration above a protocol defined cut-off value.
Prazo: One month after the third dose of the primary vaccination course.
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One month after the third dose of the primary vaccination course.
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Medidas de resultados secundários
Medida de resultado |
Prazo |
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Ocorrência de sintomas solicitados
Prazo: Durante o período de acompanhamento de 4 dias após cada dose
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Durante o período de acompanhamento de 4 dias após cada dose
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anti-HBs antibody concentration
Prazo: One month after the third dose of the primary vaccination course
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One month after the third dose of the primary vaccination course
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anti-PRP antibody concentration
Prazo: One month after the third dose of the primary vaccination course
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One month after the third dose of the primary vaccination course
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anti-tetanus antibody concentration
Prazo: One month after the third dose of the primary vaccination course
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One month after the third dose of the primary vaccination course
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anti-diphtheria antibody concentration
Prazo: One month after the third dose of the primary vaccination course
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One month after the third dose of the primary vaccination course
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anti-Bordetella pertussis (BPT) antibody concentration
Prazo: One month after the third dose of the primary vaccination course
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One month after the third dose of the primary vaccination course
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Vaccine response to Bordetella pertussis antigen.
Prazo: One month after the third dose of the primary vaccination course
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One month after the third dose of the primary vaccination course
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Seropositivity/seroprotection rates and GMCs for antibodies against all vaccine antigens
Prazo: Before the first dose of the primary vaccination course
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Before the first dose of the primary vaccination course
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anti-PRP antibody concentration
Prazo: Before and one month after the plain PRP challenge dose.
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Before and one month after the plain PRP challenge dose.
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Occurrence of unsolicited symptoms
Prazo: During the 31-day follow-up period after each dose
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During the 31-day follow-up period after each dose
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Occurrence of serious adverse events
Prazo: Over the full course of the study
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Over the full course of the study
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Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- 208108/091
- 208108/092 (Outro identificador: GSK)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Dados/documentos do estudo
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Especificação do conjunto de dados
Identificador de informação: 208108/091Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
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Conjunto de dados de participantes individuais
Identificador de informação: 208108/091Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register. The results of this study 208108/091 are summarised with study 208108/092 on the GSK Clinical Study Register.
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Plano de Análise Estatística
Identificador de informação: 208108/091Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
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Formulário de Consentimento Informado
Identificador de informação: 208108/091Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
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Relatório de Estudo Clínico
Identificador de informação: 208108/091Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
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Protocolo de estudo
Identificador de informação: 208108/091Comentários 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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