Safety, Tolerability and Immunogenicity of an Trivalent Inactivated Cell-Culture Influenza Vaccine in Healthy Adults
25 de março de 2019 atualizado por: SK Chemicals Co., Ltd.
Randomized, Double-blinded, Controlled, Phase I Trial to Assess Safety, Tolerability and Immunogenicity of 'NBP607(Trivalent Inactivated Cell-Culture Influenza Vaccine)' Compared to Egg-based Influenza Vaccine in Healthy Adult
A randomized, double-blinded, controlled, Phase I clinical trial to assess the safety, tolerability and immunogenicity of 'NBP607(trivalent inactivated cell-culture influenza vaccine)' compared to egg-based influenza vaccine in healthy adult volunteers
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
- Assessment of Safety
- Assessment of Immunogenicity
- Estimated Enrollment: 100
Tipo de estudo
Intervencional
Inscrição (Real)
100
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
-
-
Guro-gu
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Seoul, Guro-gu, Republica da Coréia, 153-703
- Korea University Guro Hospital
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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
20 anos a 59 anos (Adulto)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- 20 to <60 years of age
- able and willing to give written informed consent prior to study entry
- if female, at least 2 years after post- menopausal and negative result of urine-human chorionic gonadotropin (HCG) test at screening
Exclusion Criteria:
- hypersensitivity to any component of the study medication or chemically related substances, such as allergy to eggs or egg products
- Immunodeficiency disease
- history of hypersensitivity when vaccination, such as Guillain-Barre syndrome
- thrombocytopenia or Coagulation disorders
- experienced fever (>37.5°C) within the past 24 hours or any acute respiratory infection
- receipt of Immunosuppressants or Immunomodulators within the past 3 months
- receipt of blood products or immunoglobulin within the past 3 months
- received influenza vaccine within the past 6 months
- received another vaccine within the past 1 month or plans vaccination within 1 months following the study vaccination
- participation on another clinical trial within 1 month prior to the study vaccination
- history of blood donation within 1 week prior to the study vaccination for plan of blood donation within 7 days following the study vaccination
- any chronic diseases that interfere with the clinical trial or Malignant tumors
- pregnant or breastfeeding
- any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives or might interfere with the safety of the study subject.
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: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Group 1
NBP607 0.5ml
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1 dose, 0.5ml, Intramuscular (IM) injection
|
|
Comparador Ativo: Group 2
Agrippal 0.5ml
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1 dose, 0.5ml, Intramuscular (IM) injection
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Incidence rate of solicited local adverse events (AEs)
Prazo: Within 21 days after vaccination
|
All AEs were classified and analyzed according to its severity and causality.
The number and percentage of subjects with AEs were analyzed.
Incidence rate, 95% confidence interval as well as number of occurrences were calculated.
|
Within 21 days after vaccination
|
|
Incidence rate of solicited systemic AEs
Prazo: Within 21 days after vaccination
|
All AEs were classified and analyzed according to its severity and causality.
The number and percentage of subjects with AEs were analyzed.
Incidence rate, 95% confidence interval as well as number of occurrences were calculated.
|
Within 21 days after vaccination
|
|
Incidence rate of unsolicited AEs
Prazo: Within 21 days after vaccination
|
All AEs were classified and analyzed according to its severity and causality.
The number and percentage of subjects with AEs were analyzed.
Incidence rate, 95% confidence interval as well as number of occurrences were calculated.
|
Within 21 days after vaccination
|
|
Pulse rate at each visit
Prazo: 0-14 days prior to vaccination/day of vaccination/3-7 days after vaccination/21-28 days after vaccination
|
Comparisons within each group between pre-/post- vaccination were summarized and presented.
|
0-14 days prior to vaccination/day of vaccination/3-7 days after vaccination/21-28 days after vaccination
|
|
Blood pressure(systolic/diastolic) at each visit
Prazo: 0-14 days prior to vaccination/day of vaccination/3-7 days after vaccination/21-28 days after vaccination
|
Comparisons within each group between pre-/post- vaccination were summarized and presented.
|
0-14 days prior to vaccination/day of vaccination/3-7 days after vaccination/21-28 days after vaccination
|
|
Body temperature at each visit
Prazo: 0-14 days prior to vaccination/day of vaccination/3-7 days after vaccination/21-28 days after vaccination
|
Comparisons within each group between pre-/post- vaccination were summarized and presented.
|
0-14 days prior to vaccination/day of vaccination/3-7 days after vaccination/21-28 days after vaccination
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|
Rate of normal/abnormal results in Electrocardiogram (ECG) (ventricular rate, PR interval, QRS, QT, and QTc) collected during screening visit and close-out visit
Prazo: Screening visit(0-14 days prior to vaccination)/close-out visit(21-28 days after vaccination)
|
Comparisons within each group between pre-/post- vaccination were summarized and presented.
|
Screening visit(0-14 days prior to vaccination)/close-out visit(21-28 days after vaccination)
|
|
Rate of normal/abnormal results in physical examination at each visit
Prazo: 0-14 days prior to vaccination/day of vaccination/3-7 days after vaccination/21-28 days after vaccination
|
Comparisons within each group between pre-/post- vaccination were summarized and presented.
|
0-14 days prior to vaccination/day of vaccination/3-7 days after vaccination/21-28 days after vaccination
|
|
Rate of normal/abnormal results in clinical laboratory tests(Platelet, Cl, etc.) during screening visit and close-out visit
Prazo: Screening visit(0-14 days prior to vaccination)/close-out visit(21-28 days after vaccination)
|
Comparisons within each group between pre-/post- vaccination were summarized and presented.
|
Screening visit(0-14 days prior to vaccination)/close-out visit(21-28 days after vaccination)
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Seroconversion rate measured by pre-/post-vaccination Haemagglutination Inhibition (HI) titer[Immunogenicity]
Prazo: 21-28 days after vaccination
|
The proportion of subjects achieving one of the following conditions; i)If the pre-vaccination HI titer were <1:10, subjects achieving an HI titer ≥1:40 after vaccination ii)If the pre-vaccination HI titers were ≥1:10, subjects with a minimum 4-fold rise in HI titer
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21-28 days after vaccination
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Geometric Mean Ratio (GMR) measured by pre-/post-vaccination HI titer[Immunogenicity]
Prazo: 21-28 days after vaccination
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The mean increase in geometric mean HI titer
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21-28 days after vaccination
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Seroprotection rate measured by post-vaccination HI titer[Immunogenicity]
Prazo: 21-28 days after vaccination
|
The proportion of subjects with post-vaccination HI titers of ≥1:40
|
21-28 days after vaccination
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Woo Joo Kim, Ph.D., Korea University Guro Hospital
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 2012
Conclusão Primária (Real)
1 de outubro de 2012
Conclusão do estudo (Real)
1 de novembro de 2012
Datas de inscrição no estudo
Enviado pela primeira vez
12 de dezembro de 2012
Enviado pela primeira vez que atendeu aos critérios de CQ
25 de março de 2019
Primeira postagem (Real)
28 de março de 2019
Atualizações de registro de estudo
Última Atualização Postada (Real)
28 de março de 2019
Última atualização enviada que atendeu aos critérios de controle de qualidade
25 de março de 2019
Última verificação
1 de outubro de 2012
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- NBP607_Flu_I_2012
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