Safety, and Immunogenicity of Two Influenza Vaccines in Healthy Subjects 3 to 64 Years Old
16 de setembro de 2015 atualizado por: Novartis
A Phase III, Observer-Blind, Randomized, Controlled, Multicenter Study to Evaluate Safety, Tolerability, and Immunogenicity of Two Trivalent Subunit Inactivated Influenza Vaccines in Healthy Children Aged 3 to 8 Years, in Healthy Children/Adolescents Aged 9 to 17 Years,and in Healthy Adults Aged 18 to 64 Years
This protocol is designed to evaluate safety, clinical tolerability and immunogenicity of the 2007 southern hemisphere formulation of a Novartis conventional influenza vaccine licensed in the EU and many other worldwide countries, according to the US FDA Draft Guidance for Industry "Clinical data needed to support the licensure of trivalent inactivated influenza vaccine", issued in March 2006, and to evaluate safety, clinical tolerability and immunogenicity of the 2007 southern hemisphere formulation of a Novartis conventional influenza vaccine already licensed in US.
The purpose of the control arm is primarily to provide a comparative assessment for safety, not immunogenicity or effectiveness.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
1893
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
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Buenos Aires, Argentina
- Site 2: C1425AWK
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Cordoba, Argentina
- Site 1: X5000BJH
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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
3 anos a 64 anos (Filho, Adulto)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Healthy subjects 3 to 64 years of age
Exclusion Criteria:
- Receipt of other investigational products within 3 months or other vacine within 1 month;
- Allergy to eggs, egg products, or any other vaccine component;
- Laboratory confirmed influenza disease within 6 months;
- Have previously received an influenza vaccination (3 to 8 years only);
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: Influenza virus vaccine
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Two intramuscular injections of the investigational influenza virus vaccine administered 4 weeks part to group 3 to 8 years of age while one injection was administered to groups 9 to 17 years of age and 18 to 64 years of age.
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Comparador Ativo: Comparator influenza vaccine
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Two intramuscular injections were administered 4 weeks apart to group 3 to 8 years of age while one injection was administered to groups 9 to 17 years of age and 18 to 64 years of age.
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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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Percentage of Subjects With Seroprotection, in Healthy Adults 18 to 64 Years of Age
Prazo: 21 days after vaccination
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To evaluate immunogenicity, measured by seroprotection (percentage of subjects achieving a hemagglutination inhibition [HI] titer ≥40) after one injection of the investigational influenza virus vaccine, administered to healthy adults 18 to 64 years of age.
The CBER Guidance states that the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroprotection meet or exceed 70%.
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21 days after vaccination
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Percentage of Subjects Achieving a Seroconversion Rate, in Adults 18 to 64 Years of Age
Prazo: 21 days after vaccination
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Seroconversion rate is defined as percentage of subjects achieving seroconversion (defined as negative pre-vaccination serum [HI<10]/ post-vaccination HI titer ≥40) or significant increase defined as at least a 4-fold increase).
According to the CBER Guidance, the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroconverion/significant increase meet or exceed 40%.
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21 days after vaccination
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Number of Subjects Reporting Solicited Local and Systemic Symptoms in Adults 18 to 64 Years of Age
Prazo: 7 days after vaccination
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Solicited local and systemic reactions were assessed after vaccination in adults 18 to 64 years of age.
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7 days after vaccination
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Percentage of Subjects With Seroprotection, in Healthy Children/Adolescents 9 to 17 Years of Age
Prazo: 21 days after vaccination
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To descriptively evaluate immunogenicity, measured by seroprotection rate (percentage of subjects achieving a hemagglutination inhibition [HI] titer ≥40) after one injection of investigational influenza virus vaccine, administered to healthy children/adolescents 9 to 17 years of age.
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21 days after vaccination
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Percentage of Subjects Achieving Seroconversion Rate, in Healthy Children/Adolescents 9 to 17 Years of Age
Prazo: 21 days after vaccination
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Seroconversion rate is defined as percentage of subjects achieving seroconversion (defined as negative pre-vaccination serum [HI<10]/ post-vaccination HI titer ≥40) or significant increase (defined as at least a 4-fold increase) after one injection of the investigational influenza virus vaccine, administered to healthy children/adolescents 9 to 17 years of age.
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21 days after vaccination
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Geometric Mean Titers (GMTs), in Healthy Children/Adolescents 9 to 17 Years of Age
Prazo: 21 days after vaccination
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To evaluate immunogenicity measured by GMTs after one injection of investigational influenza virus vaccine, administered to healthy children/adolescents 9 to 17 years of age.
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21 days after vaccination
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Number of Subjects Reporting Solicited Local and Systemic Symptoms in Children/Adolescents 9 to 17 Years of Age
Prazo: 7 days after vaccination
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Solicited local and systemic reactions were assessed after vaccination in children/adolescents 9 to 17 years of age.
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7 days after vaccination
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Percentage of Subjects With Seroprotection, in Healthy Children 3 to 8 Years of Age
Prazo: 50 days after last vaccination
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To descriptively evaluate immunogenicity, measured by seroprotection rate (percentage of subjects achieving a hemagglutination inhibition [HI] titer ≥40) after two injections of the investigational influenza virus vaccine, in healthy children 3 to 8 years of age.
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50 days after last vaccination
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Percentage of Subjects Achieving Seroconversion Rate, in Healthy Children 3 to 8 Years of Age
Prazo: 50 days after last vaccination
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Seroconversion rate is defined as percentage of subjects achieving seroconversion (defined as negative pre-vaccination serum [HI<10]/ post-vaccination HI titer ≥40) or significant increase (defined as at least a 4-fold increase) after two injections of the investigational influenza virus vaccine, in healthy children 3 to 8 years of age.
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50 days after last vaccination
|
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Geometric Mean Titers (GMTs), in Healthy Children 3 to 8 Years of Age
Prazo: 50 days after last vaccination
|
To evaluate immunogenicity measured by GMTs after two injections of the investigational influenza virus vaccine, in healthy children 3 to 8 years of age.
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50 days after last vaccination
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Number or Subjects Reporting Solicited Local and Systemic Symptoms, in Healthy Children 3 to 8 Years of Age.
Prazo: 7 days after each vaccination
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Solicited local and systemic reactions were assessed after each vaccination, in healthy children 3 to 8 years of age.
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7 days after each vaccination
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Geometric Mean Titers (GMTs), in Healthy Adults 18 to 64 Years of Age
Prazo: 21 days after vaccination
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Immunogenicity measured by GMTs after one injection of the investigational influenza virus vaccine, in healthy adults 18 to 64 years of age.
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21 days after vaccination
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
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 abril de 2007
Conclusão Primária (Real)
1 de julho de 2007
Conclusão do estudo (Real)
1 de dezembro de 2007
Datas de inscrição no estudo
Enviado pela primeira vez
23 de abril de 2007
Enviado pela primeira vez que atendeu aos critérios de CQ
23 de abril de 2007
Primeira postagem (Estimativa)
24 de abril de 2007
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
1 de outubro de 2015
Última atualização enviada que atendeu aos critérios de controle de qualidade
16 de setembro de 2015
Última verificação
1 de setembro de 2015
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- V71P5
- IND: 13299
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