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.
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.
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.
Parallel
Influenza Vaccine Group
Biological/VaccineTrivalent Influenza Vaccine (Split Virion), inactivated, produced by Sinovac Biotech Co., Ltd. One dose, intramuscular.
Pneumococcal Vaccine Group
Biological/Vaccine23-valent Pneumococcal Polysaccharide Vaccine, produced by Chengdu Institute of Biological Products Co., Ltd. One dose, intramuscular.
Number of COPD acute exacerbation events within 12 months after vaccination.
Number of COPD acute exacerbation events within 12 months after vaccination.
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.
Change in lung function (FEV₁/FVC) from baseline to 12 months after vaccination.
Change in lung function (FEV₁/FVC) 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.
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.
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.
Change in lung function (FEV₁ absolute value) from baseline to 12 months after vaccination in participants aged 60 years and above.
Change in lung function (FEV₁ absolute value) 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.
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% 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.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
