- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00492063
Safety and Immunogenicity of a Cell Culture-derived Influenza Vaccine in Healthy Adults and Elderly
A Phase III, Observer-Blind, Randomized, Multi-Center Study to Evaluate Safety, Tolerability and Immunogenicity of a Single Intramuscular Dose of a Trivalent Subunit Influenza Vaccine Produced in Mammalian Cell Culture and of a Trivalent Subunit Influenza Vaccine Produced in Embryonated Hen Eggs, in Healthy Adult and Elderly Subjects
Visão geral do estudo
Status
Condições
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 3
Contactos e Locais
Locais de estudo
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Krakow, Polônia, 30-969
- Centrum Farmakologii Klinicznej
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Kielce
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ul. Langiewicza 2, Kielce, Polônia, 25-381
- Wojewódzki Szpital Dzieciecy
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Kraków
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Pl. Sikorskiego 6a, Kraków, Polônia, 31-115
- Praktyka Grupowa Lekarzy POZ "Familia"
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os. Jagiellonskie 1, Kraków, Polônia, 31-832
- N ZOZ Jagiellonskie, Centrum Medyczne Sp. z o.o.
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ul. Pradnicka 80, Kraków, Polônia, 31-202
- Szpital Jana Pawła II
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- 18 to 60 years of age (first age group) OR over 60 years of age (second age group)
- mentally competent to understand the nature, the scope and the consequences of the study
- able and willing to give written informed consent prior to study entry
- available for all the visits scheduled in the study
- residence in the study area
in good health as determined by:
- medical history,
- physical examination,
- clinical judgment of the investigator.
Exclusion Criteria:
- unable or unwilling to give written informed consent to participate in the study
- suffering from an acute infectious disease
any serious disease such as:
- cancer (except for benign or localized skin cancer and non metastatic prostate cancer not currently treated with chemotherapy),_
- autoimmune disease (including rheumatoid arthritis),
- advanced arteriosclerotic disease or complicated diabetes mellitus,
- chronic obstructive pulmonary disease (COPD) requiring oxygen therapy,
- acute or progressive hepatic disease,
- acute or progressive renal disease,
- congestive heart failure
- surgery planned during the study period
- bleeding diathesis
- history of hypersensitivity to any component of the study medication or chemically related substances, such as allergy to eggs or egg products
known or suspected impairment/alteration of immune function resulting from:
- receipt of immunosuppressive therapy (any cortical steroid or cancer chemotherapy),
- receipt of immunostimulants,
- receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within the past 3 months and for the full length of the study,
- high risk for developing an immunocompromising disease within the past 6 months
- history of drug or alcohol abuse
- laboratory confirmed influenza disease in the past 6 months
- received influenza vaccine within the past 6 months
- received another vaccine or any investigational agent within the past 60 days, or planned vaccination within 3 weeks following the study vaccination
- any acute respiratory disease or infections requiring systemic antibiotic or antiviral therapy (chronic antibiotic therapy for urinary tract prophylaxis was acceptable) or experienced fever ≥ 38°C within the past 3 days
- pregnant women or women who refused to use a reliable contraceptive method throughout the study (180 days)
- any condition which, in the opinion of the investigator, might have interfered with the evaluation of the study objectives.
Plano de estudo
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 |
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Experimental: Cell culture-derived influenza vaccine (cTIV)
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One vaccination (0.5 mL) of cell culture-derived influenza vaccine (cTIV) was administered in the deltoid muscle
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Comparador Ativo: Egg-derived influenza virus vaccine (TIV)
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One vaccination (0.5 mL) of egg-derived influenza virus vaccine (TIV) was administered in the deltoid muscle
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Percentages Of Subjects Who Achieved HI Titer ≥40 After One Vaccination of Cell Culture-derived (cTIV) or Egg-derived (TIV) Influenza Subunit Vaccines
Prazo: Before vaccination (day 1) and three weeks after vaccination (day 22)
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Immunogenicity was measured as the percentage of adults (≥18 to ≤60 years) and elderly (≥61 years) achieving HI titers ≥40 at baseline (day 1) and three weeks (day 22) after one vaccination of cTIV or TIV vaccine for each of three vaccine strains, evaluated using the hemagglutination inhibition (HI) egg-derived antigen assay. In compliance with the requirements of the EMEA recommendations (CPMP/BWP/2490/00, CPMP/BWP/214/96), this criterion is met if the percentage of subjects achieving HI titers ≥40 is >70% in the ≥18 to ≤60 years of age group or >60% in the ≥61 years of age group. |
Before vaccination (day 1) and three weeks after vaccination (day 22)
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Percentages Of Subjects Who Achieved Seroconversion Or Significant Increase In HI Titer After One Vaccination of cTIV or TIV
Prazo: Three weeks after vaccination (day 22)
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Seroconversion or significant in HI titer is defined as the percentage of subjects with a prevaccination HI titer <10 (negative) to a postvaccination titer ≥40; or in subjects with prevaccination HI titer ≥10, at least a 4-fold increase in postvaccination HI titer.
In compliance with the requirements of the EMEA recommendations (CPMP/BWP/2490/00, CPMP/BWP/214/96), the criterion is met if the percentage of subjects achieving seroconversion/significant increase is >40% in the ≥18 to ≤60 years of age group or >30% in the ≥61 years of age group.
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Three weeks after vaccination (day 22)
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Geometric Mean Ratio of Subjects After One Vaccination of cTIV or TIV
Prazo: Three weeks after vaccination (day 22)
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Immunogenicity was measured as the geometric mean ratio (GMR), calculated as the ratio of postvaccination to prevaccination HI Geometric Mean Titers (GMTs), three weeks after (day 22) one vaccination of cTIV or TIV.
In compliance with the requirements of the EMEA recommendations (CPMP/BWP/2490/00, CPMP/BWP/214/96), this criterion is met if the GMR (day 22/day 1) in HI antibody titer is >2.5 in the ≥18 to ≤60 years of age group or >2.0 in the ≥61 years of age group.
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Three weeks after vaccination (day 22)
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Number of Subjects Who Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination
Prazo: Up to 7 days postvaccination
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The solicited local and systemic reactions were collected from day 1 up to and including day 7 after vaccination for both the vaccine groups.
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Up to 7 days postvaccination
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Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
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
- V58P4
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