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Immunogenicity and Safety Study of a GSK Influenza Vaccine Candidate in Adults.

9 de maio de 2018 atualizado por: GlaxoSmithKline

Immunogenicity and Safety Study of a GSK Influenza Vaccine Candidate GSK 2115160A in Adults.

The purpose of this study is to evaluate the safety and immunogenicity of GSK influenza vaccine candidate compared to a licensed trivalent influenza vaccine in adults.

Visão geral do estudo

Tipo de estudo

Intervencional

Inscrição (Real)

420

Estágio

  • Fase 1

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

      • Hradec Kralove, Tcheca, 500 03
        • GSK Investigational Site

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

18 anos a 60 anos (Adulto)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • Healthy subjects as established by medical history and clinical examination before entering into the study.
  • Subjects who the investigator believes can and will comply with the requirements of the protocol should be enrolled in the study.
  • A male or female between, and including, 18 and 60 years of age at the time of the vaccination.
  • Written informed consent obtained from the subject.
  • If the subject is female, she must be of non-childbearing potential, if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series.

Exclusion Criteria:

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the administration of study vaccine, or planned use during the study period.
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 3 months prior to administration of the vaccine.
  • Administration of a vaccine not foreseen in the study protocol from 30 days before vaccination up to 21 days post vaccination.
  • Confirmed influenza infection within a year preceding the study start.
  • Administration of an influenza vaccine during Northern Hemisphere season 2007-2008.
  • Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
  • History of hypersensitivity to a previous dose of influenza vaccine
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).
  • 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 laboratory screening tests.
  • Administration of immunoglobulins and/or any blood products within the three months preceding the administration of study vaccine or planned administration during the study period.
  • Pregnant or lactating female.
  • Female planning to become pregnant or planning to discontinue contraceptive precautions.
  • History of chronic alcohol consumption and/or drug abuse.
  • Any condition which, in the opinion of the investigator, prevents the subject from participating in the study.
  • History of administration of experimental/licensed vaccine.

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: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Quadrivalent influenza vaccine GSK 2115160A Group 1
Subjects in this group received 1 full dose of GSK Biologicals' quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
Single intramuscular dose on Day 0.
Experimental: Quadrivalent influenza vaccine GSK 2115160A Group 2
Subjects in this group received 1 low dose of GSK Biologicals' quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
Single intramuscular dose on Day 0.
Comparador Ativo: Trivalent influenza vaccine GSK 2115160A Group 1
Subjects in this group received 1 low dose of GSK Biologicals' trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
Single intramuscular dose on Day 0.
Comparador Ativo: Trivalent influenza vaccine GSK 2115160A Group 2
Subjects in this group received 1 full dose of GSK Biologicals' trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
Single intramuscular dose on Day 0.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Serum Haemagglutination-inhibition (HI) Antibody Titers, Against Each of the Vaccine Influenza Virus Strains.
Prazo: At Day 0 and Day 21
Antibody titers were expressed as Geometric mean titers (GMTs).The vaccine influenza strains included A/Solomon Islands,A/Wisconsin,B/Malaysia and B/Jiangsu antigens.
At Day 0 and Day 21

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Number of Subjects Seroconverted for HI Antibodies Against the Vaccine Influenza Strains.
Prazo: At Day 21
A seroconverted subject was defined as a subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer. The vaccine influenza strains included A/Solomon Islands, A/Wisconsin, B/Malaysia and B/Jiangsu antigens.
At Day 21
HI Antibody Seroconversion Factors Against the Vaccine Influenza Strains
Prazo: Day 21
Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The Influenza vaccine strains included A/Solomon Islands, A/Wisconsin, B/Malaysia and B/Jiangsu antigens.
Day 21
Number of Subjects Seroprotected for HI Antibodies Against the Vaccine Influenza Strains.
Prazo: At Days 0 and 21
A seroprotected subject was defined as a subject with a serum HI titer ≥1:40 that usually is accepted as indicating protection. The Influenza vaccine strains included A/Solomon Islands, A/Wisconsin, B/Malaysia and B/Jiangsu antigens.
At Days 0 and 21
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.
Prazo: During a 7 day (Days 0-6) follow-up period after vaccination
Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of any specified solicited local symptoms reported irrespective of intensity grade. Grade 3 pain was defined as considerable pain that prevented normal activity. Grade 3 redness and swelling were defined as redness/swelling above 100 millimeters (mm).
During a 7 day (Days 0-6) follow-up period after vaccination
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Reported by the Former GSK Rules of Grading.
Prazo: During a 7-day follow-up period (Days 0-6) after vaccination
Solicited local symptoms assessed by the former GSK rules of grading were pain, redness and swelling. Any was defined as occurrence of any specified solicited local symptoms reported irrespective of intensity grade. Grade 3 pain was defined as pain that prevented normal activity. Grade 3 redness and swelling were defined as redness/swelling above 50 millimeters (mm).
During a 7-day follow-up period (Days 0-6) after vaccination
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Prazo: During a 7-day follow-up period (Days 0-6) after vaccination
Solicited general symptoms assessed were arthralgia, fatigue, headache, myalgia, nausea, shivering and fever. Any =occurrence of any specified solicited general symptoms reported irrespective of intensity grade or relationship to vaccination. Any fever = oral temperature ≥ 38.0 degrees Celsius (°C).. Grade 3 symptoms = symptoms that prevented normal activities. Grade 3 fever = oral temperature ≥39.0°C. Related = symptoms considered by the investigator to have a causal relationship to vaccination
During a 7-day follow-up period (Days 0-6) after vaccination
Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading.
Prazo: During a 7-day follow-up period (Days 0-6) after vaccination
Solicited general symptoms assessed by the former GSK rules of grading were arthralgia, fatigue, headache, myalgia, nausea, shivering and fever. Any = occurrence of any specified solicited general symptoms reported irrespective of intensity grade or relationship to vaccination. Any fever = oral temperature ≥ 37.5 °C. Grade 3 symptoms = symptoms that prevented normal activities. Grade 3 fever = oral temperature above 39.0°C. . Related = symptoms considered by the investigator to have a causal relationship to vaccination.
During a 7-day follow-up period (Days 0-6) after vaccination
Number of Subjects Reporting Any Medically Significant Conditions (MSCs) and Auto-immune Diseases (AIDs).
Prazo: During the entire study period (Days 0-180)
MSCs were defined as those adverse events (AEs) prompting emergency room visits, hospitalizations or physician visits and that were not routine visits for physical examination or vaccination. AIDs include a large group of diseases characterized by abnormal functioning of the immune system that causes immune system to produce antibodies against own tissues.
During the entire study period (Days 0-180)
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AE(s).
Prazo: During a 21 day (Days 0-20) follow-up period after vaccination-
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 was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination
During a 21 day (Days 0-20) follow-up period after vaccination-
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
Prazo: During the entire study period (Days 0-180)
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.
During the entire study period (Days 0-180)

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

14 de julho de 2008

Conclusão Primária (Real)

28 de janeiro de 2009

Conclusão do estudo (Real)

28 de janeiro de 2009

Datas de inscrição no estudo

Enviado pela primeira vez

11 de julho de 2008

Enviado pela primeira vez que atendeu aos critérios de CQ

11 de julho de 2008

Primeira postagem (Estimativa)

14 de julho de 2008

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 março de 2017

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. Formulário de Consentimento Informado
    Identificador de informação: 111295
    Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
  2. Relatório de Estudo Clínico
    Identificador de informação: 111295
    Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
  3. Formulário de Relato de Caso Anotado
    Identificador de informação: 111295
    Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
  4. Protocolo de estudo
    Identificador de informação: 111295
    Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
  5. Conjunto de dados de participantes individuais
    Identificador de informação: 111295
    Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
  6. Especificação do conjunto de dados
    Identificador de informação: 111295
    Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
  7. Plano de Análise Estatística
    Identificador de informação: 111295
    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 .

Ensaios clínicos em GSK Biologicals' quadrivalent influenza vaccine

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