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Safety and Immunogenicity of 3 Lots of Cell-derived Subunit Influenza Vaccine as Compared to 1 Lot to Egg-derived Subunit Influenza Vaccine in Healthy Adults (>=18 to <=60)

2 de agosto de 2019 atualizado por: Novartis Vaccines

A Phase III, Randomized, Controlled, Observer-Blind, Multi-Center Study to Evaluate Safety, Tolerability and Immunogenicity of a Single Intramuscular Dose of Three Lots of a Trivalent Subunit Influenza Vaccine Produced in Mammalian Cell Culture Or of a Trivalent Subunit Influenza Vaccine Produced in Embryonated Hen Eggs, in Healthy Adult Subjects Aged >=18 to <=60

The present study aims to evaluate safety, tolerability and immunogenicity of three lots of Chiron's cell-derived subunit influenza vaccine in healthy adult subjects as compared to a conventional egg-derived control vaccine licensed in Europe.

Visão geral do estudo

Tipo de estudo

Intervencional

Inscrição (Real)

1200

Estágio

  • Fase 3

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

      • Panevezys, Lituânia
        • 2nd Department of Internal Diseases, Panevezys Hospital,
      • Vilnius, Lituânia
        • Dept. Infectious Diseases and Microbiology of Vilnius University

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

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  1. 18 to <61 years of age
  2. mentally competent to understand the nature, the scope and the consequences of the study
  3. able and willing to give written informed consent prior to study entry
  4. in good health as determined by:

    1. medical history,
    2. physical examination,
    3. clinical judgment of the Investigator.

Exclusion Criteria:

  1. unwilling or unable to give written informed consent to participate in the study
  2. participation in another clinical trial of an investigational agent within 90 days prior to Visit 1 and throughout the entire study
  3. currently experiencing an acute infectious disease
  4. any serious disease, such as, for example:

    1. cancer,
    2. autoimmune disease (including rheumatoid arthritis),
    3. advanced arteriosclerotic disease or complicated diabetes mellitus,
    4. chronic obstructive pulmonary disease (COPD) requiring oxygen therapy,
    5. acute or progressive hepatic disease,
    6. acute or progressive renal disease,
    7. congestive heart failure
  5. surgery planned during the study period
  6. bleeding diathesis
  7. history of hypersensitivity to any component of the study medication or chemically related substances
  8. history of any anaphylaxis, serious vaccine reactions, or allergy to any of the vaccine component
  9. known or suspected impairment/alteration of immune function, for example resulting from:

    1. receipt of immunosuppressive therapy (any corticosteroid therapy or cancer chemotherapy),
    2. receipt of immunostimulants,
    3. receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivates within 3 months prior to Visit 1 or planned during the full length of the study,
    4. high risk for developing an immunocompromising disease
  10. history of drug or alcohol abuse
  11. laboratory-confirmed influenza disease within 6 months prior to Visit 1
  12. receipt of influenza vaccine within 6 months prior to Visit 1
  13. receipt of another vaccine within 60 days prior to Visit 1, or planned vaccination within 3 weeks following study vaccination
  14. any acute respiratory disease or infections requiring systemic antibiotic or antiviral therapy (chronic antibiotic therapy for urinary tract prophylaxis is acceptable) or experienced fever (i.e., axillary temperature ≥ 38 degree C) within 5 days prior to Visit 1
  15. if female, pregnant or breastfeeding
  16. if female, refusal to use a reliable contraceptive method during the three weeks following vaccination
  17. planned relocation abroad during the study period
  18. any condition that, in the opinion of the Investigator, might interfere with the evaluation of the study objectives.

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: cTIV_lot 1
One single 0.5ml intramuscular injection of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 1
Experimental: cTIV_lot 2
One single 0.5ml intramuscular injection of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 2
Experimental: cTIV_lot 3
One single 0.5ml intramuscular injection of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 3
Comparador Ativo: TIV group
One single 0.5ml intramuscular injection of Egg Derived Trivalent Subunit Influenza Vaccine (TIV).

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Geometric Mean Titers After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult Subjects
Prazo: Day 22 postvaccination

The haemagglutinin Inhibition (HI) antibody titer response following

  1. one dose of cTIV for each of the three lots separately and
  2. one dose of cTIV (combined) compared to TIV is reported as Geometric mean titers (GMTs).

The HI GMTs were evaluated using egg-derived antigen assay.

Day 22 postvaccination
Geometric Mean Ratios After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult Subjects
Prazo: Day 22 postvaccination

Immunogenicity was assessed in terms of Geometric Mean Ratio (GMR) following

  1. one dose of cTIV for each of the three vaccine lots separately and
  2. for one dose of cTIV (combined) compared to TIV, according to the CHMP criterion.

The European licensure (CHMP) criterion is met if the mean geometric increase (GMR, day 22/day 1) in HI antibody titer is >2.5.

Day 22 postvaccination
Percentage of Subjects With HI Titers ≥40
Prazo: Day 22 postvaccination

Immunogenicity was assessed in terms of percentage of adult subjects achieving HI titers ≥40, after

  1. one dose of cTIV for each of the three vaccine lots separately and
  2. for one dose of cTIV (combined) compared to TIV, according to the CHMP criterion.

European Licensure (CHMP) criterion is met if the percentage of subjects achieving HI titers ≥40 is >70%.

Day 22 postvaccination
Percentage of Subjects With Seroconversion or Significant Increase in HI Antibody Titers After One Dose of Either Cell-derived or Egg-derived Subunit Trivalent Influenza Vaccine
Prazo: Day 22 postvaccination

Immunogenicity was assessed in terms of percentage of adult subjects showing seroconversion or significant increase in HI antibody titers after

  1. one dose of cTIV for each of the three vaccine lots separately and
  2. one dose of cTIV (combined) compared to TIV, according to the CHMP criterion.

European Licensure (CHMP) criterion is met if the percentage of subjects achieving seroconversion or significant increase is >40%.

As per European Licensure (CHMP) criterion seroconversion is defined as percentage of subjects with a prevaccination HI titer <10 to a postvaccination titer ≥40; whereas, significant increase is defined as HI titer ≥10 prevaccination and ≥4-fold Hi titer increase post-vaccination.

Day 22 postvaccination

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine.
Prazo: Day 1 to Day 7 postvaccination

To assess the safety and tolerability in terms of number of subjects reporting solicited adverse events following one injection of

  1. one dose of cTIV for each of the three vaccine lots separately and
  2. for one dose of cTIV (combined) compared to TIV.
Day 1 to Day 7 postvaccination
Safety Data of Subjects Upto Six Months After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine
Prazo: Day 1 - Day 181 postvaccination
Additional safety data from day 1 through day 181 after one dose of cTIV (combined) or TIV in terms of serious adverse events (SAEs), adverse events (AEs) necessitating a physician's visit and/or resulting in premature subject's withdrawal from study is reported.
Day 1 - Day 181 postvaccination

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Investigadores

  • Cadeira de estudo: Novartis Vaccines, Novartis Vaccines & Diagnostics

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 setembro de 2005

Conclusão Primária (Real)

1 de outubro de 2005

Conclusão do estudo (Real)

1 de abril de 2006

Datas de inscrição no estudo

Enviado pela primeira vez

3 de abril de 2006

Enviado pela primeira vez que atendeu aos critérios de CQ

3 de abril de 2006

Primeira postagem (Estimativa)

5 de abril de 2006

Atualizações de registro de estudo

Última Atualização Postada (Real)

15 de agosto de 2019

Última atualização enviada que atendeu aos critérios de controle de qualidade

2 de agosto de 2019

Última verificação

1 de agosto de 2019

Mais Informações

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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