Health Economic Evaluation of Influenza and Pneumococcal Vaccination in COPD Patients

Phase 4Not Yet RecruitingNCT07640841

Jiangsu Province Centers for Disease Control and Prevention7,000 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

7,000

Conditions

Influenza and Pneumonia

Eligibility

Sex: ALLMin age: 45 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Number of COPD acute exacerbation events within 12 months after vaccination.

Time frame: 12 months after vaccination