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- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02592486
The Immunogenicity of Simultaneous Administration of Quadrivalent Influenza Vaccine and 23-valent Pneumococcal Vaccine
A Randomized, Open-label, Parallel Design Study to Compare the Immunogenicity of Simultaneous Administration Versus Sequential Administration of Quadrivalent Influenza Vaccine and 23-valent Pneumococcal Vaccine
Visão geral do estudo
Status
Condições
Descrição detalhada
The immunogenicity of simultaneous administration of quadrivalent influenza vaccine and pneumococcal vaccine was unknown. We compare the immunogenicity of simultaneous administration of quadrivalent influenza vaccine and pneumococcal vaccine with that of separate administration.
162 Participants are randomly assigned to one of the two study groups; Simultaneous administration group: receive injections of pneumococcal vaccine and influenza vaccine simultaneously.
Sequential administration group: receive injections of pneumococcal vaccine 2 weeks after the injection of the influenza vaccine.
We compare the immunogenicity of the two groups.
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 4
Contactos e Locais
Locais de estudo
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Chiba
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Kamogawa, Chiba, Japão, 2968602
- Department of Pulmonary Medicine, Kameda Medical Center
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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:
- adults aged ≧65 years who had never received pneumococcal vaccine and quadrivalent influenza vaccine of 2015/2016 season
Exclusion Criteria:
- a sensitivity to pneumococcal and influenza vaccine
- received other inactivated vaccine within 14 days
- received other live vaccine within 28 days
- the presence of conditions known to impair pneumococcal vaccine response
- having malignant disease
- taking oral corticosteroids or immunosuppressive agent
- history of splenectomy
- history of an acute febrile illness or signs of severe acute illness at the time of vaccination
- other inappropriate condition to receive vaccination
- suffering an acute illness requiring antibiotics or steroids within the past month
- not expected to survive 12 months were also excluded
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Comparador Ativo: Simultaneous administration group
The subjects receive injections of pneumococcal vaccine and influenza vaccine simultaneously.
We use commercially available PPV23 (Pneumovax NP®, MSDKK, Tokyo, Japan) containing 25 μg each of 23 capsular polysaccharide types.
We use Fluvic HA syringe® (Handai Biken Ltd, Osaka, Japan), quadrivalent influenza vaccine (0.5ml) of 2015/2016 season.
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Injections of pneumococcal vaccine and influenza vaccine simultaneously.
Outros nomes:
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Comparador Ativo: Sequential administration group
The subjects receive injections of pneumococcal vaccine 2 weeks after the injection of the influenza vaccine.
We use commercially available PPV23 (Pneumovax NP®, MSDKK, Tokyo, Japan) containing 25 μg each of 23 capsular polysaccharide types.
We use Fluvic HA syringe® (Handai Biken Ltd, Osaka, Japan), quadrivalent influenza vaccine (0.5ml) of 2015/2016.
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Injections of pneumococcal vaccine 2 weeks after the injection of the influenza vaccine.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
The Number of Patients With Positive Antibody Response in Serotype 23F of Pneumococcal Antibody.
Prazo: 1month after the dose of PPV23
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The primary endpoint was the number of patients with positive antibody responses (≥2-fold increase in IgG concentrations 4-6 weeks after PPSV23 vaccination) in serotype 23F of the pneumococcal antibody.
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1month after the dose of PPV23
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
The Number of Patients With Positive Antibody Response in Serotype 3, 4, 6B, 1 4 and 19A of Pneumococcal Antibody.
Prazo: 4 to 6 weeks after vaccination (P1), 24 weeks to 27 weeks after vaccination (P2)
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Positive antibody response was defined as ≥2-fold increase in IgG concentrations 4-6 weeks after PPSV23 vaccination in respective serotypes of the pneumococcal antibody.
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4 to 6 weeks after vaccination (P1), 24 weeks to 27 weeks after vaccination (P2)
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The Geometric Mean Concentrations of Specific Antibodies to the 6 Serotypes (23F, 3, 4, 6B 14 and 19A)
Prazo: Before vaccination (at baseline; in designated P0), 4 to 6 weeks after vaccination (P1), 24 weeks to 27 weeks after vaccination (P2)
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Pneumococcal IgG concentrations were converted using natural log transformations and presented as a geometric mean concentration.
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Before vaccination (at baseline; in designated P0), 4 to 6 weeks after vaccination (P1), 24 weeks to 27 weeks after vaccination (P2)
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The Number of Patients With Seroprotection Rate in Quadrivalent Influenza Vaccine.
Prazo: 4 to 6 weeks after vaccination (I1) and 24 weeks to 27 weeks after vaccination (I2)
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Seroprotection rates (post-vaccination titer ≥1:40) were calculated to assess the immunogenicity of influenza vaccination.
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4 to 6 weeks after vaccination (I1) and 24 weeks to 27 weeks after vaccination (I2)
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Kei Nakashima, MD, Department of Pulmonary Medicine, Kameda Medical Center
Publicações e links úteis
Publicações Gerais
- Walter ND, Taylor TH, Shay DK, Thompson WW, Brammer L, Dowell SF, Moore MR; Active Bacterial Core Surveillance Team. Influenza circulation and the burden of invasive pneumococcal pneumonia during a non-pandemic period in the United States. Clin Infect Dis. 2010 Jan 15;50(2):175-83. doi: 10.1086/649208.
- Oishi K, Yoshimine H, Watanabe H, Watanabe K, Tanimura S, Kawakami K, Iwagaki A, Nagai H, Goto H, Kudoh S, Kuriyama T, Fukuchi Y, Matsushima T, Shimada K, Matsumoto K, Nagatake T. Drug-resistant genes and serotypes of pneumococcal strains of community-acquired pneumonia among adults in Japan. Respirology. 2006 Jul;11(4):429-36. doi: 10.1111/j.1440-1843.2006.00867.x.
- Hirst GK. THE QUANTITATIVE DETERMINATION OF INFLUENZA VIRUS AND ANTIBODIES BY MEANS OF RED CELL AGGLUTINATION. J Exp Med. 1942 Jan 1;75(1):49-64. doi: 10.1084/jem.75.1.49.
- Dransfield MT, Nahm MH, Han MK, Harnden S, Criner GJ, Martinez FJ, Scanlon PD, Woodruff PG, Washko GR, Connett JE, Anthonisen NR, Bailey WC; COPD Clinical Research Network. Superior immune response to protein-conjugate versus free pneumococcal polysaccharide vaccine in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2009 Sep 15;180(6):499-505. doi: 10.1164/rccm.200903-0488OC. Epub 2009 Jun 25.
- Grabowska K, Hogberg L, Penttinen P, Svensson A, Ekdahl K. Occurrence of invasive pneumococcal disease and number of excess cases due to influenza. BMC Infect Dis. 2006 Mar 20;6:58. doi: 10.1186/1471-2334-6-58.
- Nakashima K, Aoshima M, Ohfuji S, Yamawaki S, Nemoto M, Hasegawa S, Noma S, Misawa M, Hosokawa N, Yaegashi M, Otsuka Y. Immunogenicity of simultaneous versus sequential administration of a 23-valent pneumococcal polysaccharide vaccine and a quadrivalent influenza vaccine in older individuals: A randomized, open-label, non-inferiority trial. Hum Vaccin Immunother. 2018;14(8):1923-1930. doi: 10.1080/21645515.2018.1455476. Epub 2018 May 14.
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 (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
- Infecções por vírus de RNA
- Doenças Virais
- Infecções
- Infecções do Trato Respiratório
- Doenças Respiratórias
- Pneumonia
- Doenças pulmonares
- Infecções bacterianas
- Infecções Bacterianas e Micoses
- Infecções estreptocócicas
- Infecções por Bactérias Gram-Positivas
- Pneumonia Bacteriana
- Infecções por Orthomyxoviridae
- Infecções Pneumocócicas
- Pneumonia Pneumocócica
- Gripe Humana
- Efeitos Fisiológicos das Drogas
- Fatores imunológicos
- Vacina Pneumocócica Heptavalente Conjugada
Outros números de identificação do estudo
- 15-041-160127
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