- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00729001
Study of Two Doses of GSK Biologicals' Live Attenuated HRV Vaccine (Two Different Formulations) in Healthy Infants.
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.
Visão geral do estudo
Status
Condições
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
Inscrição (Real)
Estágio
- Fase 2
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
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
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:
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:
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:
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
Patrocinador
Publicações e links úteis
Publicações Gerais
- Dennehy PH; North American Human Rotavirus Vaccine Study Group. A short report on the highlights of world-wide development of RIX4414: a North American experience comparative evaluation of safety and immunogenicity of two dosages of an oral live attenuated human rotavirus vaccine (RIX4414) in infants in the United States and Canada. Vaccine. 2006 May 1;24(18):3780-1. doi: 10.1016/j.vaccine.2005.07.030. Epub 2005 Aug 1.
- Dennehy PH, Brady RC, Halperin SA, Ward RL, Alvey JC, Fischer FH Jr, Innis BL, Rathfon H, Schuind A, De Vos B; North American Human Rotavirus Vaccine Study Group. Comparative evaluation of safety and immunogenicity of two dosages of an oral live attenuated human rotavirus vaccine. Pediatr Infect Dis J. 2005 Jun;24(6):481-8. doi: 10.1097/01.inf.0000164763.55558.71.
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
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 444563/005
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Dados/documentos do estudo
-
Especificação do conjunto de dados
Identificador de informação: 444563/005Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
-
Protocolo de estudo
Identificador de informação: 444563/005Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
-
Conjunto de dados de participantes individuais
Identificador de informação: 444563/005Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
-
Relatório de Estudo Clínico
Identificador de informação: 444563/005Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
-
Formulário de Consentimento Informado
Identificador de informação: 444563/005Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
-
Plano de Análise Estatística
Identificador de informação: 444563/005Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
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