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.

Study Overview

• Status: Not yet recruiting
• Conditions: Influenza and Pneumonia
• Intervention / Treatment: Biological: Influenza Vaccine Group; Biological: Pneumococcal Vaccine Group

• Study Type: Interventional
• Enrollment (Estimated): 7000
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Biological: Influenza Vaccine Group; Trivalent Influenza Vaccine (Split Virion), inactivated, produced by Sinovac Biotech Co., Ltd. One dose, intramuscular.
Experimental: 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.	Biological: Pneumococcal Vaccine Group; 23-valent Pneumococcal Polysaccharide Vaccine, produced by Chengdu Institute of Biological Products Co., Ltd. One dose, intramuscular.
Experimental: Combined Vaccination Group; Both Trivalent Influenza Vaccine (Split Virion) and 23-valent Pneumococcal Polysaccharide Vaccine. One dose per vaccine, intramuscular.	Biological: Influenza Vaccine Group; Trivalent Influenza Vaccine (Split Virion), inactivated, produced by Sinovac Biotech Co., Ltd. One dose, intramuscular.; Biological: Pneumococcal Vaccine Group; 23-valent Pneumococcal Polysaccharide Vaccine, produced by Chengdu Institute of Biological Products Co., Ltd. One dose, intramuscular.
No Intervention: Blank Control Group; No vaccine. Participants receive usual care and follow-up.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Other Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Jiangsu Province Centers for Disease Control and Prevention

Study record dates

Study Major Dates

• Study Start (Estimated): June 15, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: May 29, 2026
• First Submitted That Met QC Criteria: June 5, 2026
• First Posted (Actual): June 11, 2026

Study Record Updates

• Last Update Posted (Actual): June 11, 2026
• Last Update Submitted That Met QC Criteria: June 5, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Influenza, Human; Pneumonia
• Other Study ID Numbers: 002003421HT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No