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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Influenza Vaccine Group | Experimental | Trivalent Influenza Vaccine (Split Virion), inactivated, produced by Sinovac Biotech Co., Ltd. or Chengdu Institute of Biological Products Co., Ltd. One dose, intramuscular. |
|
| Pneumococcal Vaccine Group | Experimental | 23-valent Pneumococcal Polysaccharide Vaccine, produced by Sinovac Biotech Co., Ltd. or Chengdu Institute of Biological Products Co., Ltd. One dose, intramuscular. |
|
| Combined Vaccination Group | Experimental | Both Trivalent Influenza Vaccine (Split Virion) and 23-valent Pneumococcal Polysaccharide Vaccine. One dose per vaccine, intramuscular. |
|
| Blank Control Group | No Intervention | No vaccine. Participants receive usual care and follow-up. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Influenza Vaccine Group | Biological | Trivalent Influenza Vaccine (Split Virion), inactivated, produced by Sinovac Biotech Co., Ltd. One dose, intramuscular. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of COPD acute exacerbation events within 12 months after vaccination. | Number of COPD acute exacerbation events within 12 months after vaccination. | 12 months after vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Change in lung function (FEV₁ absolute value) 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of COPD acute exacerbation events within 12 months after vaccination in participants aged 60 years and above. | 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. |
Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| D011014 | Pneumonia |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| Pneumococcal Vaccine Group | Biological | 23-valent Pneumococcal Polysaccharide Vaccine, produced by Chengdu Institute of Biological Products Co., Ltd. One dose, intramuscular. |
|
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. | 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. | 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. | 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. | 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). | 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). | Serum neutralizing/killing antibody titers against pneumococcus at 1, 6, and 12 months after vaccination (immunogenicity subgroup). | 1, 6, and 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Incidence of pneumonia within 12 months post-vaccination in COPD patients. | 12 months after vaccination |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D008171 | Lung Diseases |