Non-Inferiority of Various GSK Bio's Influenza Vaccine Presentations in Adults Aged 65 Years and Over
9 de maio de 2018 atualizado por: GlaxoSmithKline
Non-Inferiority of GlaxoSmithKline Biologicals' Influenza Vaccine (GSK576389A) 1 Container Over 2 Container Presentation in Adults Aged 65 Years and Over
This observer blind study is designed to compare the immune response of GSK Biologicals' influenza vaccine GSK576389A when administered using various presentations in adults aged 65 years and older.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Visão geral do estudo
Status
Concluído
Condições
Descrição detalhada
The study contains 6 parallel groups, stratified by two age groups: 65-74 years and ≥ 75 years and by two influenza vaccination histories: no influenza vaccination in the last 3 seasons and at least one influenza vaccination in the last 3 seasons.
Tipo de estudo
Intervencional
Inscrição (Real)
1596
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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Soeborg, Dinamarca, 2860
- GSK Investigational Site
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Tartu, Estônia, 50417
- GSK Investigational Site
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Bergen, Noruega, 5094
- GSK Investigational Site
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Elverum, Noruega, 2408
- GSK Investigational Site
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Hamar, Noruega, 2317
- 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
65 anos e mais velhos (Adulto mais velho)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
- A male or female aged 65 years or older at the time of the vaccination.
- Written informed consent obtained from the subject.
- Free of an acute aggravation of the health status as established by clinical evaluation before entering into the study.
Exclusion Criteria:
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days prior to vaccination, or planned use 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 Visit 2 after vaccination.
- Planned administration of an influenza vaccine other than the study vaccines during the entire study period.
- Vaccination against influenza since January 2007 (including the Northern Hemisphere NH 2006/2007 or NH 2007/08 influenza vaccine).
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the administration of the study vaccine.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- History of hypersensivity to a previous dose of influenza vaccine.
- History of allergy or reactions likely to be exacerbated by any component of the vaccine(s)
- Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by clinical evaluation or pre-existing laboratory screening tests.
- Acute disease at the time of enrolment.
- Administration of immunoglobulins and/or any blood products within the three months preceding the first administration of the study vaccine or planned administration during the study.
- Any medical conditions in which intramuscular injections are contraindicated.
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: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: GSK576389A- 2006/2007 Season - 1 container Group
Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 1 container.
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Single dose, intramuscular injection, GSK Bio's influenza vaccine GSK576389A formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
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Experimental: GSK576389A - 2006/2007 Season - 2 containers Group
Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 2 containers.
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Single dose, intramuscular injection, GSK Bio's influenza vaccine GSK576389A formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
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Comparador Ativo: Fluarix 2006/2007 Season Group
Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
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Single dose, intramuscular injection, Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
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Experimental: GSK576389A - 2007/2008 Season - 1 container Group
Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 1 container.
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Single dose, intramuscular injection, GSK Bio's influenza vaccine GSK576389A formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
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Experimental: GSK576389A - 2007/2008 Season - 2 containers Group
Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 2 containers.
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Single dose, intramuscular injection, GSK Bio's influenza vaccine GSK576389A formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
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Comparador Ativo: Fluarix 2007/2008 Season Group
Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
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Single dose, intramuscular injection, Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
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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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Haemagglutination Inhibition (HI) Antibody Titers for the H1N1 Vaccine Strain
Prazo: At Days 0 and 21
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Antibody titers were expressed as Geometric mean titers (GMTs).
The H1N1 vaccine strains included A/New Caledonia and A/Solomon Islands antigens.
A/New Caledonia vaccine strain was administered to both groups receiving the adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season.
A/Solomon Islands vaccine strain was administered to both groups receiving the adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season.
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At Days 0 and 21
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Duração dos AEs Locais Solicitados
Prazo: Durante um período de acompanhamento de 7 dias (dia 0-6) após a vacinação
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A duração foi definida como o número de dias com qualquer grau de sintomas locais.
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Durante um período de acompanhamento de 7 dias (dia 0-6) após a vacinação
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Duração dos EAs gerais solicitados
Prazo: Durante um período de acompanhamento de 7 dias (dia 0-6) após a vacinação
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A duração foi definida como o número de dias com qualquer grau de sintomas gerais.
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Durante um período de acompanhamento de 7 dias (dia 0-6) após a vacinação
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Número de Indivíduos Relatando Qualquer, Grau 3 e EAs Não Solicitados Relacionados
Prazo: Durante um período de acompanhamento de 21 dias (dia 0-20) após a vacinação
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EA não solicitado cobre qualquer EA relatado além daqueles solicitados durante o estudo clínico e qualquer sintoma solicitado com início fora do período especificado de acompanhamento para sintomas solicitados.
Qualquer foi definido como a ocorrência de qualquer sintoma não solicitado independentemente do grau de intensidade ou relação com a vacinação.
Grau 3 foi um evento que impediu atividades normais e relacionado foi definido como um EA não solicitado avaliado pelo investigador como sendo causalmente relacionado à vacinação do estudo.
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Durante um período de acompanhamento de 21 dias (dia 0-20) após a vacinação
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HI Antibody Titers Against Each of the Three Vaccine Strains for the Two Season Formulations
Prazo: At Days 0 and 21
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Antibody titers were expressed as GMTs.
The vaccine strains included A/New Caledonia or A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.
A/New Caledonia vaccine strain was administered to all groups receiving the Northern Hemisphere 2006/2007 influenza season vaccine formulations.
A/Solomon Islands vaccine strain was administered to all groups receiving the Northern Hemisphere 2007/2008 influenza season vaccine formulations.
A/Wisconsin and B/Malaysia vaccine strains were administered to all groups.
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At Days 0 and 21
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The Number of Subjects Seroconverted for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations
Prazo: At Day 21
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A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer.
The vaccine strains included A/New Caledonia (for all groups receiving vaccine formulations for the Northern Hemisphere [NH] 2006/2007 influenza season) or A/Solomon Islands (for all groups receiving vaccine formulations for the NH 2007/2008 influenza season), A/Wisconsin and B/Malaysia antigens.
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At Day 21
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HI Antibody Seroconversion Factors
Prazo: At Day 21
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Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The vaccine strains included A/New Caledonia (for all groups receiving vaccine formulations for the Northern Hemisphere [NH] 2006/2007 influenza season) or A/Solomon Islands (for all groups receiving vaccine formulations for the NH 2007/2008 influenza season), A/Wisconsin and B/Malaysia antigens.
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At Day 21
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The Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations
Prazo: At Days 0 and 21
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A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection.
The vaccine strains included A/New Caledonia (for all groups receiving vaccine formulations for the Northern Hemisphere [NH] 2006/2007 influenza season) or A/Solomon Islands (for all groups receiving vaccine formulations for the NH 2007/2008 influenza season), A/Wisconsin and B/Malaysia antigens.
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At Days 0 and 21
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Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)
Prazo: During a 7-day follow-up period (Day 0-6) after vaccination
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Grade 3 ecchymosis, redness and swelling was greater than 100 millimeter (mm) i.e. >100mm and grade 3 pain was considerable pain at rest that prevented normal everyday activities.
Any was occurrence of any local symptom regardless of their intensity grade.
Any for ecchymosis, redness and swelling was >20mm.
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During a 7-day follow-up period (Day 0-6) after vaccination
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Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Prazo: During a 7-day follow-up period (Day 0-6) after vaccination
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Any temperature was defined as oral temperature greater than or equal to 38.0 degree centigrade i.e ≥38.0°C, grade 3 temperature was oral temperature ≥39.0°C.
For other symptoms, any was defined as occurrence of any general symptom regardless of intensity grade or relation to vaccination and grade 3 was defined as a general symptom that prevented normal activity.
Related was a general symptom assessed by the investigator as causally related to the study vaccination.
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During a 7-day follow-up period (Day 0-6) after vaccination
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Number of Subjects Reporting Any, Grade 3 and Related Medically Significant Conditions (MSCs)
Prazo: During a 21-day follow-up period (Day 0-20) after vaccination
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MSCs were defined as an AEs with a medically-attended visit (MAE) i.e. prompting emergency room (ER) visits, hospitalizations or physician visits and that were not routine visits for physical examination or vaccination.
Any MSC was defined as at least one MSC experienced.
Grade 3 was a MSC that prevented normal activities and related was defined as a MSC assessed by the investigator to be causally related to the study vaccination.
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During a 21-day follow-up period (Day 0-20) after vaccination
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Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
Prazo: During a 21-day follow-up period (Day 0-20) after vaccination
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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 was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.
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During a 21-day follow-up period (Day 0-20) after vaccination
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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 setembro de 2007
Conclusão Primária (Real)
1 de novembro de 2007
Conclusão do estudo (Real)
2 de novembro de 2007
Datas de inscrição no estudo
Enviado pela primeira vez
19 de setembro de 2007
Enviado pela primeira vez que atendeu aos critérios de CQ
19 de setembro de 2007
Primeira postagem (Estimativa)
20 de setembro de 2007
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 novembro de 2016
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 110620
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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Formulário de Relato de Caso Anotado
Identificador de informação: 110620Comentários 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: 110620Comentários 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: 110620Comentários 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: 110620Comentários 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: 110620Comentários 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: 110620Comentários 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: 110620Comentários 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 .