- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00385840
Study to Evaluate the Immunogenicity and Safety of a Second Vaccination With the Adjuvanted Influenza Vaccine Candidate
9 de maio de 2018 atualizado por: GlaxoSmithKline
A Study to Evaluate the Immunogenicity, Safety and Reactogenicity of a Second Vaccination With the Adjuvanted Influenza Vaccine Candidate Compared to Fluarix™ Administered Intramuscularly in Elderly Aged 60 Years and Above.
The purpose of this study is to evaluate the immunogenicity and the safety of a second vaccination with candidate vaccine compared to Fluarix™ administered intramuscularly in elderly aged 60 years and above
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Tipo de estudo
Intervencional
Inscrição (Real)
678
Estágio
- Fase 2
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
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Elverum, Noruega, 2408
- GSK Investigational Site
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Hamar, Noruega, 2301
- GSK Investigational Site
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Paradis, Noruega, 5231
- GSK Investigational Site
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Stavanger, Noruega, 4010
- GSK Investigational Site
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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
60 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- A male or female age 60 years or older at the time of the revaccination, who previously participated in 107192 & 107214 clinical trials.
- Subjects who the investigator believes can and will comply with the requirements of the protocol
- Written informed consent obtained from the subject.
- Free of an acute aggravation of the health status as established by clinical examination before entering into the study.
Exclusion Criteria:
- Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the administration of the study vaccine, or planned use during the study period.
- Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 3 months prior to the first vaccine dose.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
- Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
- Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study. Planned administration of a vaccine not foreseen by the study protocol up to 30 days after vaccination.
- History of hypersensitivity to a previous dose of influenza vaccine.
- History of confirmed influenza infection within the last 12 months.
- History of allergy or reactions likely to be exacerbated by any component of the vaccine(s)
- Acute disease at the time of enrolment.
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 |
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Comparador Ativo: Fluarix Group
Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the Fluarix™ vaccine in study NCT00321763, received 1 dose of Fluarix™ vaccine in this study.
The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
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Single dose, intramuscular injection
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Experimental: GSK1247446A Group
Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the GSK1247446A vaccine in study NCT00321763, received 1 dose of adjuvanted GSK1247446A vaccine in this study.
The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
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Single dose, intramuscular injection
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
Prazo: During the 7-day (Days 0-6) post-vaccination period
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Assessed solicited local symptoms were ecchymosis, pain, redness and swelling.
Any = Incidence of a particular solicited local symptom regardless of intensity grade.
Grade 3 pain = Pain that prevented normal everyday activity.
Grade 3 redness/swelling/ecchymosis = Redness/swelling/ecchymosis above 50 millimeters (mm).
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During the 7-day (Days 0-6) post-vaccination period
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Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Prazo: During the 7-day (Days 0-6) post-vaccination period
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Assessed solicited general symptoms were arthralgia, fatigue, fever, headache, muscle aches and shivering.
Any = Incidence of a particular solicited general symptom regardless of intensity grade or relationship with the study vaccination.
Any Fever = Axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C).
Grade 3 symptom = Symptom that prevented normal activity.
Grade 3 fever = Axillary temperature > 39.0°C.
Related = Symptom considered by the investigator to have a causal relationship to study vaccination.
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During the 7-day (Days 0-6) post-vaccination period
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Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
Prazo: During the 30-day (Days 0-29) post vaccination period
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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.
Any = Any unsolicited AE regardless of intensity or relationship to vaccination.
Grade 3 = Unsolicited AE that prevented normal activity.
Related = Unsolicited AE assessed by the investigator as causally related to the vaccination.
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During the 30-day (Days 0-29) post vaccination period
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Number of Subjects With Any and Related Serious Adverse Events (SAEs).
Prazo: During the entire study period (from Day 0 to Day 29)
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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.
Any SAE = Occurrence of any SAE regardless of intensity grade or relation to vaccination Related = SAE considered by the investigator to have a causal relationship to study vaccination.
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During the entire study period (from Day 0 to Day 29)
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Number of Seroconverted Subjects Against 3 Strains of Influenza Disease.
Prazo: At Day 21
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A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer.
The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia.
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At Day 21
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Number of Seroprotected Subjects Against 3 Strains of Influenza Disease.
Prazo: At Day 0 and Day 21
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A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40.
The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia.
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At Day 0 and Day 21
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Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.
Prazo: At Day 21
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The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia.
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At Day 21
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Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.
Prazo: At Day 0 and Day 21
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Titers are presented as geometric mean titers (GMTs).
The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia.
The seropositivity cut-off assay was 1:10.
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At Day 0 and Day 21
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
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
20 de outubro de 2006
Conclusão Primária (Real)
1 de fevereiro de 2007
Conclusão do estudo (Real)
5 de fevereiro de 2007
Datas de inscrição no estudo
Enviado pela primeira vez
10 de outubro de 2006
Enviado pela primeira vez que atendeu aos critérios de CQ
10 de outubro de 2006
Primeira postagem (Estimativa)
11 de outubro de 2006
Atualizações de registro de estudo
Última Atualização Postada (Real)
8 de junho de 2018
Última atualização enviada que atendeu aos critérios de controle de qualidade
9 de maio de 2018
Última verificação
1 de outubro de 2016
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 108708
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
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Conjunto de dados de participantes individuais
Identificador de informação: 108708Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
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Plano de Análise Estatística
Identificador de informação: 108708Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
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Especificação do conjunto de dados
Identificador de informação: 108708Comentários 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: 108708Comentários 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: 108708Comentários 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: 108708Comentários 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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