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Study of Two Doses of GSK Biologicals' Live Attenuated HRV Vaccine (Two Different Formulations) in Healthy Infants.

15 de setembro de 2016 atualizado por: GlaxoSmithKline

Phase II, Double-blind, Randomized, Placebo-controlled Study of 2 Doses of GSK Biologicals' Live Attenuated Human Rotavirus Vaccine at Different Virus Concentrations (10 5.2 and 10 6.4 Ffu) in Healthy Infants Following a 0, 2 Month Schedule and Previously Uninfected With Human Rotavirus.

This is a dose exploration study to assess the safety and immunogenicity of two doses of the candidate HRV vaccine at different virus concentrations in the target age group (infants approximately 2 months of age and previously uninfected with human rotavirus) and receiving concomitant administration of routine vaccinations. The study also aims at exploring the effect of unrestricted feeding on the immunogenicity of the vaccine.

Visão geral do estudo

Descrição detalhada

All subjects enrolled from Eastern United States and Eastern Canada will continue their participation in the pilot efficacy follow-up (pilot efficacy subset).

The third dose of IPV vaccine (IPOL) may be given at visit 3, 4 or another time, at the investigator's discretion.

Comvax may be given in place of OmniHIB/ActHIB at Visit 1 and Visit 2 and the third dose of Comvax administered according to the prescribing information.

Tipo de estudo

Intervencional

Inscrição (Real)

529

Estágio

  • Fase 2

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:

  • A male or female child between, and including 6 and 12 weeks (42-90 days) of age at the time of the first vaccination.
  • Free of obvious health problems as established by medical history and clinical examination before entering into the study.
  • Written informed consent obtained from the parents or guardians of the subject.
  • Born after a normal gestation period (between 36 and 42 weeks).

Exclusion Criteria:

  • Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the study vaccine or placebo or planned use during the study period.
  • Planned administration of a vaccine (including routine pediatric vaccines) not foreseen by the study protocol during the period starting from 14 days before each dose of vaccine(s) and ending 14 days after. Hepatitis B vaccine given concomitantly or within 14 days before and after vaccination is not an exclusion criteria.
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
  • History of diphtheria, tetanus, pertussis, polio, Hib disease and/or invasive pneumococcal infection. History of invasive pneumococcal infection is not an exclusion criteria for Canadian subjects.
  • Previous vaccination against diphtheria, tetanus, pertussis, polio, Haemophilus influenzae type b, and/or Streptococcus pneumoniae. Previous vaccination against Streptococcus pneumoniae is not an exclusion criteria for Canadian subjects.
  • Use of antibiotics within 7 days preceding dose 1.
  • Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the GI tract or other serious medical condition as determined by the investigator.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
  • History of allergic disease or reaction likely to be exacerbated by any component of the vaccine.
  • Acute disease at time of enrollment.
  • Gastroenteritis within 7 days preceding the study vaccine administration.
  • Household contact with an immunosuppressed individual or pregnant women.
  • Administration of immunoglobulins and/or blood products since birth or planned administration during the study period.
  • Previous confirmed occurrence of rotavirus gastroenteritis.
  • Inability to contact parents/guardians of the subject by telephone.

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: Triplo

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador de Placebo: Grupo C
Three-dose intramuscular injection (US subjects only)
Two-dose intramuscular injection (US subjects only)
Three-dose intramuscular injection (US subjects only)
Three-dose intramuscular injection (US subjects only)
Outros nomes:
  • ActHIB
Three-dose intramuscular injection (Canada only)
Experimental: Group A
Human Rotavirus Vaccine - Formulation 1
Two oral doses
Three-dose intramuscular injection (US subjects only)
Two-dose intramuscular injection (US subjects only)
Three-dose intramuscular injection (US subjects only)
Three-dose intramuscular injection (US subjects only)
Outros nomes:
  • ActHIB
Three-dose intramuscular injection (Canada only)
Experimental: Group B
Human Rotavirus Vaccine - Formulation 2
Two oral doses
Three-dose intramuscular injection (US subjects only)
Two-dose intramuscular injection (US subjects only)
Three-dose intramuscular injection (US subjects only)
Three-dose intramuscular injection (US subjects only)
Outros nomes:
  • ActHIB
Three-dose intramuscular injection (Canada only)

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Prazo
Proportion of subjects with vaccine take
Prazo: Two months after the second dose
Two months after the second dose
Occurrence of any grade 2 or 3 fever, vomiting or diarrhea
Prazo: Within the 15-day solicited follow-up period after any dose of study vaccine.
Within the 15-day solicited follow-up period after any dose of study vaccine.

Medidas de resultados secundários

Medida de resultado
Prazo
Occurrence of each type of solicited symptoms
Prazo: Within the 15-day solicited follow-up period after any dose of study vaccine
Within the 15-day solicited follow-up period after any dose of study vaccine
Occurrence of unsolicited symptoms according to WHO classification.
Prazo: Within 42 days after dose 1 and dose 2
Within 42 days after dose 1 and dose 2
Occurrence of serious adverse events
Prazo: Throughout the entire study period
Throughout the entire study period
Serum rotavirus immunoglobulin A (IgA) antibody titers
Prazo: At visits 1, 3 and 4 and at all Visits for pilot efficacy subset
At visits 1, 3 and 4 and at all Visits for pilot efficacy subset
Rotavirus seropositivity status
Prazo: Before dose 1 and at the end of the study
Before dose 1 and at the end of the study
Vaccine take (for pilot efficacy subset only)
Prazo: 2 months after dose 1
2 months after dose 1
Anti- polyribosyl-ribitol phosphate (PRP), anti-diphtheria and anti-tetanus toxoids, anti- pertussis toxoid (PT), anti- filamentous haemagglutinin (FHA), anti- pertactin (PRN), anti-polio type 1, 2 and 3 antibody concentrations
Prazo: Two months after dose 2 and at the end of the study.
Two months after dose 2 and at the end of the study.
Antibody concentrations to pneumococcal serotypes 4, 6B, 9V, 14, 18C, 19F and 23F
Prazo: Two months after dose 2 and at the end of the study (only in a subset of U.S. subjects)
Two months after dose 2 and at the end of the study (only in a subset of U.S. subjects)
Anti-PRP, anti-diphtheria, anti-tetanus, anti-polio type 1, 2 and 3 seroprotection status.
Prazo: Two months after dose 2 and at the end of the study.
Two months after dose 2 and at the end of the study.
Anti-PT, anti-FHA, anti-PRN, pneumococcal serotypes 4, 6B, 9V, 14, 18C, 19F and 23F (only in US subjects) seropositivity status.
Prazo: Two months after dose 2 and at the end of the study.
Two months after dose 2 and at the end of the study.
Seropositivity status and Geometric mean titres (GMTs) of rotavirus IgA for breast fed infants compared with formula fed infants
Prazo: Two months after dose 2.
Two months after dose 2.
Occurrence of rotavirus gastroenteritis (in a pilot efficacy subset of subjects)
Prazo: Two weeks after dose 2 until the end of the rotavirus season following vaccination.
Two weeks after dose 2 until the end of the rotavirus season following vaccination.

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

1 de novembro de 2000

Conclusão Primária (Real)

1 de setembro de 2002

Conclusão do estudo (Real)

1 de setembro de 2002

Datas de inscrição no estudo

Enviado pela primeira vez

4 de agosto de 2008

Enviado pela primeira vez que atendeu aos critérios de CQ

5 de agosto de 2008

Primeira postagem (Estimativa)

6 de agosto de 2008

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

16 de setembro de 2016

Última atualização enviada que atendeu aos critérios de controle de qualidade

15 de setembro de 2016

Última verificação

1 de setembro de 2016

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. Especificação do conjunto de dados
    Identificador de informação: 444563/005
    Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
  2. Protocolo de estudo
    Identificador de informação: 444563/005
    Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
  3. Conjunto de dados de participantes individuais
    Identificador de informação: 444563/005
    Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
  4. Relatório de Estudo Clínico
    Identificador de informação: 444563/005
    Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
  5. Formulário de Consentimento Informado
    Identificador de informação: 444563/005
    Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
  6. Plano de Análise Estatística
    Identificador de informação: 444563/005
    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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