Health Economic Evaluation of Influenza and Pneumococcal Vaccination in COPD Patients
Health Economic Evaluation of Influenza and Pneumococcal Vaccination in COPD Patients Aged 45-80 Years: A Multicenter, Open-Label, Blank-Controlled Clinical Trial
This is a multicenter, open-label, blank-controlled clinical trial to evaluate the impact of influenza vaccination and pneumococcal vaccination on disease progression and medical burden in COPD patients aged 45-80 years, as well as the safety and immunogenicity of vaccination. COPD patients aged 45-80 years are recruited. On the basis of informed consent and voluntary participation, influenza and pneumococcal vaccination are carried out. At each site, towns/subdistricts will be randomly assigned as clusters to one of four groups in a 2:2:2:1 ratio: influenza vaccine group, pneumonia vaccine group, combined vaccination group, and blank control group. Follow-up lasts 12 months from informed consent.
For the immunogenicity subgroup, during the period from September 1, 2026 to October 31, 2026, the first 50 participants enrolled for influenza vaccination at each site (Dongtai City and Wujin District) are included in the influenza vaccine immunogenicity subgroup, and the first 50 participants enrolled for pneumococcal vaccination at each site are included in the pneumococcal vaccine immunogenicity subgroup, with the two subgroups serving as mutual controls. Blood samples (5ml each time) are collected before vaccination and at 1 month, 6 months, and 12 months after vaccination.
研究概览
研究类型
介入性
注册 (估计的)
7000
阶段
- 第四阶段
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
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Meet the GOLD diagnostic criteria for chronic obstructive pulmonary disease: presence of risk factors and/or clinical symptoms and pulmonary function test showing persistent airflow limitation (i.e., post-bronchodilator FEV1/FVC < 70%), after excluding other diagnoses.
- Aged between 45 and 80 years.
- Provide informed consent and sign the informed consent form.
Exclusion Criteria:
- Combined with structural lung disease (including: bronchiectasis, interstitial lung disease, old tuberculosis, diffuse panbronchiolitis, obliterative bronchiolitis, atelectasis, destroyed lung, congenital lung dysplasia, post-lung resection).
- Combined with lung malignancy.
- Combined with acute phase or unstable cardiovascular, liver, kidney, neurological or psychiatric diseases.
- Pregnant, lactating women, or those planning pregnancy within 1 year.
- History of 23-valent pneumococcal polysaccharide vaccination within 5 years.
- Other conditions that, in the investigator's judgment, make the subject unsuitable for participation in this study.
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：非随机化
- 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 |
|---|---|
|
实验性的：Influenza Vaccine Group
Trivalent Influenza Vaccine (Split Virion), inactivated, produced by Sinovac Biotech Co., Ltd. or Chengdu Institute of Biological Products Co., Ltd.
One dose, intramuscular.
|
Trivalent Influenza Vaccine (Split Virion), inactivated, produced by Sinovac Biotech Co., Ltd.
One dose, intramuscular.
|
|
实验性的：Pneumococcal Vaccine Group
23-valent Pneumococcal Polysaccharide Vaccine, produced by Sinovac Biotech Co., Ltd. or Chengdu Institute of Biological Products Co., Ltd.
One dose, intramuscular.
|
23-valent Pneumococcal Polysaccharide Vaccine, produced by Chengdu Institute of Biological Products Co., Ltd.
One dose, intramuscular.
|
|
实验性的：Combined Vaccination Group
Both Trivalent Influenza Vaccine (Split Virion) and 23-valent Pneumococcal Polysaccharide Vaccine.
One dose per vaccine, intramuscular.
|
Trivalent Influenza Vaccine (Split Virion), inactivated, produced by Sinovac Biotech Co., Ltd.
One dose, intramuscular.
23-valent Pneumococcal Polysaccharide Vaccine, produced by Chengdu Institute of Biological Products Co., Ltd.
One dose, intramuscular.
|
|
无干预：Blank Control Group
No vaccine.
Participants receive usual care and follow-up.
|
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 |
|---|---|---|
|
Number of COPD acute exacerbation events within 12 months after vaccination.
大体时间：12 months after vaccination
|
Number of COPD acute exacerbation events within 12 months after vaccination.
|
12 months after vaccination
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in lung function (FEV₁ absolute value) from baseline to 12 months after vaccination.
大体时间：From baseline to 12 months after vaccination
|
Change in lung function (FEV₁ absolute value) from baseline to 12 months after vaccination.
|
From baseline to 12 months after vaccination
|
|
Change in lung function (FEV₁/FVC) from baseline to 12 months after vaccination.
大体时间：From baseline to 12 months after vaccination
|
Change in lung function (FEV₁/FVC) from baseline to 12 months after vaccination.
|
From baseline to 12 months after vaccination
|
|
Change in lung function (FEV₁% predicted) from baseline to 12 months after vaccination.
大体时间：From baseline to 12 months after vaccination
|
Change in lung function (FEV₁% predicted) from baseline to 12 months after vaccination.
|
From baseline to 12 months after vaccination
|
|
Change in lung function (annual decline rate) from baseline to 12 months after vaccination.
大体时间：From baseline to 12 months after vaccination
|
Change in lung function (annual decline rate) from baseline to 12 months after vaccination.
|
From baseline to 12 months after vaccination
|
|
Change in CAT score from baseline to 12 months after vaccination.
大体时间：From baseline to 12 months after vaccination
|
The COPD Assessment Test (CAT) is a questionnaire with total scores ranging from 0 to 40.
Higher scores indicate worse health status.
The outcome is the change from baseline to 12 months post-vaccination.
|
From baseline to 12 months after vaccination
|
|
Incidence of serious adverse events (SAEs) within 12 months after vaccination.
大体时间：12 months after vaccination
|
Incidence of serious adverse events (SAEs) within 12 months after vaccination.
|
12 months after vaccination
|
|
Serum hemagglutinin antibody titers against influenza virus at 1, 6, and 12 months after vaccination (immunogenicity subgroup).
大体时间：1, 6, and 12 months after vaccination
|
Serum hemagglutinin antibody titers against influenza virus at 1, 6, and 12 months after vaccination (immunogenicity subgroup).
|
1, 6, and 12 months after vaccination
|
|
Serum neutralizing/killing antibody titers against pneumococcus at 1, 6, and 12 months after vaccination (immunogenicity subgroup).
大体时间：1, 6, and 12 months after vaccination
|
Serum neutralizing/killing antibody titers against pneumococcus at 1, 6, and 12 months after vaccination (immunogenicity subgroup).
|
1, 6, and 12 months after vaccination
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of COPD acute exacerbation events within 12 months after vaccination in participants aged 60 years and above.
大体时间：12 months after vaccination
|
Number of COPD acute exacerbation events within 12 months after vaccination in participants aged 60 years and above.
|
12 months after vaccination
|
|
Change in lung function (FEV₁ absolute value) from baseline to 12 months after vaccination in participants aged 60 years and above.
大体时间：From baseline to 12 months after vaccination
|
Change in lung function (FEV₁ absolute value) from baseline to 12 months after vaccination in participants aged 60 years and above.
|
From baseline to 12 months after vaccination
|
|
Change in lung function (FEV₁/FVC) from baseline to 12 months after vaccination in participants aged 60 years and above.
大体时间：From baseline to 12 months after vaccination
|
Change in lung function (FEV₁/FVC) from baseline to 12 months after vaccination in participants aged 60 years and above.
|
From baseline to 12 months after vaccination
|
|
Change in lung function (FEV₁% predicted) from baseline to 12 months after vaccination in participants aged 60 years and above.
大体时间：From baseline to 12 months after vaccination
|
Change in lung function (FEV₁% predicted) from baseline to 12 months after vaccination in participants aged 60 years and above.
|
From baseline to 12 months after vaccination
|
|
Change in lung function (annual decline rate) from baseline to 12 months after vaccination in participants aged 60 years and above.
大体时间：From baseline to 12 months after vaccination
|
Change in lung function (annual decline rate) from baseline to 12 months after vaccination in participants aged 60 years and above.
|
From baseline to 12 months after vaccination
|
|
Change in CAT score from baseline to 12 months after vaccination in participants aged 60 years and above.
大体时间：From baseline to 12 months after vaccination
|
The COPD Assessment Test (CAT) is a questionnaire with total scores ranging from 0 to 40.
Higher scores indicate worse health status.
The outcome is the change from baseline to 12 months post-vaccination.
|
From baseline to 12 months after vaccination
|
|
Incidence of serious adverse events (SAEs) within 12 months after vaccination in participants aged 60 years and above.
大体时间：12 months after vaccination
|
Incidence of serious adverse events (SAEs) within 12 months after vaccination in participants aged 60 years and above.
|
12 months after vaccination
|
|
Serum hemagglutinin antibody titers against influenza virus at 1, 6, and 12 months after vaccination (immunogenicity subgroup) in participants aged 60 years and above.
大体时间：1, 6, and 12 months after vaccination
|
Serum hemagglutinin antibody titers against influenza virus at 1, 6, and 12 months after vaccination (immunogenicity subgroup) in participants aged 60 years and above.
|
1, 6, and 12 months after vaccination
|
|
Serum neutralizing/killing antibody titers against pneumococcus at 1, 6, and 12 months after vaccination (immunogenicity subgroup) in participants aged 60 years and above.
大体时间：1, 6, and 12 months after vaccination
|
Serum neutralizing/killing antibody titers against pneumococcus at 1, 6, and 12 months after vaccination (immunogenicity subgroup) in participants aged 60 years and above.
|
1, 6, and 12 months after vaccination
|
|
Incidence of influenza within 12 months post-vaccination in COPD patients.
大体时间：12 months after vaccination
|
Incidence of influenza within 12 months post-vaccination in COPD patients.
|
12 months after vaccination
|
|
Incidence of pneumonia within 12 months post-vaccination in COPD patients.
大体时间：12 months after vaccination
|
Incidence of pneumonia within 12 months post-vaccination in COPD patients.
|
12 months after vaccination
|
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。
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 (估计的)
2026年6月15日
初级完成 (估计的)
2027年6月30日
研究完成 (估计的)
2027年12月31日
研究注册日期
首次提交
2026年5月29日
首先提交符合 QC 标准的
2026年6月5日
首次发布 (实际的)
2026年6月11日
研究记录更新
最后更新发布 (实际的)
2026年6月11日
上次提交的符合 QC 标准的更新
2026年6月5日
最后验证
2026年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.