Influenza and Pneumonia
Conditions
Brief summary
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.
Interventions
BIOLOGICALInfluenza Vaccine Group
Trivalent Influenza Vaccine (Split Virion), inactivated, produced by Sinovac Biotech Co., Ltd. One dose, intramuscular.
BIOLOGICALPneumococcal Vaccine Group
23-valent Pneumococcal Polysaccharide Vaccine, produced by Chengdu Institute of Biological Products Co., Ltd. One dose, intramuscular.
Sponsors
Jiangsu Province Centers for Disease Control and Prevention
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of COPD acute exacerbation events within 12 months after vaccination. | 12 months after vaccination | Number of COPD acute exacerbation events within 12 months after vaccination. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 absolute value) 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/FVC) 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 (FEV₁% predicted) 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 lung function (annual decline rate) from baseline to 12 months after vaccination. |
| Change in CAT score from baseline to 12 months after vaccination. | 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. |
| Incidence of serious adverse events (SAEs) within 12 months after vaccination. | 12 months after vaccination | Incidence of serious adverse events (SAEs) within 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 hemagglutinin antibody titers against influenza virus 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 | Serum neutralizing/killing antibody titers against pneumococcus at 1, 6, and 12 months after vaccination (immunogenicity subgroup). |
Outcome results
None listed