The Immunogenicity of Simultaneous Administration of Quadrivalent Influenza Vaccine and 23-valent Pneumococcal Vaccine
2018年8月21日 更新者：Kei Nakashima、Kameda Medical Center
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
The immunogenicity of simultaneous administration of quadrivalent influenza vaccine and pneumococcal vaccine was unknown.
The purpose of present study is to compare the immunogenicity of simultaneous administration of influenza vaccine and pneumococcal vaccine with that of separate administration.
研究概览
地位
完全的
详细说明
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.
研究类型
介入性
注册 (实际的)
162
阶段
- 第四阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Chiba
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Kamogawa、Chiba、日本、2968602
- Department of Pulmonary Medicine, Kameda Medical Center
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
65年 及以上 (年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：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.
其他名称：
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有源比较器：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.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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The Number of Patients With Positive Antibody Response in Serotype 23F of Pneumococcal Antibody.
大体时间：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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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The Number of Patients With Positive Antibody Response in Serotype 3, 4, 6B, 1 4 and 19A of Pneumococcal Antibody.
大体时间：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)
大体时间：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.
大体时间：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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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Kei Nakashima, MD、Department of Pulmonary Medicine, Kameda Medical Center
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- 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.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2015年11月1日
初级完成 (实际的)
2016年3月1日
研究完成 (实际的)
2016年8月1日
研究注册日期
首次提交
2015年10月28日
首先提交符合 QC 标准的
2015年10月29日
首次发布 (估计)
2015年10月30日
研究记录更新
最后更新发布 (实际的)
2019年1月31日
上次提交的符合 QC 标准的更新
2018年8月21日
最后验证
2018年8月1日
更多信息
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