- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT03826719
Safety, Tolerability and Immunogenicity of NBP607QIV in Healthy Adult Volunteers
A Randomized, Double-blinded, Controlled, Phase I/II Clinical Trial to Assess the Safety, Tolerability and Immunogenicity of NBP607QIV Compared to Trivalent Egg-based Influenza Vaccine in Healty Adult Volunteers
Visão geral do estudo
Descrição detalhada
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 2
- Fase 1
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Healthy adults aged 19 to 59 years
- Those who are able and willing to give written informed consent to study participation and compliance with study instructions after being informed of and understand details of the study
- If female, at least 2 years after post- menopausal and negative result of urine-human chorionic gonadotropin (HCG) test at screening
Exclusion Criteria:
- Those with hypersensitivity to any component of the study medication or chemically related substances, such as allergy to eggs or egg products
- Those with Immunodeficiency disease
- Those with history of hypersensitivity when vaccination, such as Guillain-Barre syndrome
- Those who are contraindicated for intramuscular injection due to thrombocytopenia or coagulopathy
- Those who experienced fever (>38°C) within the past 24 hours or any acute respiratory infection
- Those with history of treatment with any of Immunosuppressants or Immunomodulators within the past 3 months
- Those with history of receiving blood products or immunoglobulin within the past 3 months
- Those with history of influenza vaccination within the past 6 months
- Those who received another vaccine within the past 1 month or have plan to receive another vaccine within 1 months following the study vaccination
- Those with history of participation on another clinical trial within 1 month prior to the study vaccination
- Those with history of blood donation within 1 week prior to the study vaccination or plan of blood donation within 7 days following the study vaccination
- Those with any chronic diseases that interfere with the clinical trial or malignant tumors
- Pregnant or breastfeeding
- Those with 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
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: NBP607QIV
1 dose of 0.5mL by Intramuscular injection
|
Purified inactivated influenza virus surface antigens of four strains(quadrivalent)
|
Comparador Ativo: Agrippal
1 dose of 0.5mL by Intramuscular injection
|
Influenza virus surface antigens of three strains(trivalent)
|
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: 7 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. Comparisons within each group between pre-/post- vaccination were summarized and presented. The number and percentage of subjects with AEs were analyzed. Incidence rate, 95% confidence interval as well as number of occurrences were calculated. |
7 days after vaccination
|
Incidence rate of solicited systemic AEs
Prazo: 7 days after vaccination
|
The number and percentage of subjects with AEs were analyzed.
Incidence rate, 95% confidence interval as well as number of occurrences were calculated.
|
7 days after vaccination
|
Incidence rate of unsolicited AEs
Prazo: 21 days after vaccination
|
The number and percentage of subjects with AEs were analyzed.
Incidence rate, 95% confidence interval as well as number of occurrences were calculated.
|
21 days after vaccination
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Seroprotection rate measured by post-vaccination Haemagglutination Inhibition(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
|
Seroconversion rate measured by pre-/post-vaccination HI titerImmunogenicity]
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
|
21-28 days after vaccination
|
9. Geometric Mean Ratio (GMR) measured by pre-/post-vaccination HI titer[Immunogenicity]
Prazo: 21-28 days after vaccination
|
The mean increase in geometric mean HI titer
|
21-28 days after vaccination
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
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 (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- NBP607QIV_Flu_I_2013
Plano para dados de participantes individuais (IPD)
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