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Not yet recruiting NCT07640841

Health Economic Evaluation of Influenza and Pneumococcal Vaccination in COPD Patients

Phase IV Interventional Influenza and Pneumonia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Influenza Vaccine Group, Pneumococcal Vaccine Group.
Who it may be relevant to
Registry conditions: Influenza and Pneumonia. Basic parameters: 45 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Health Economic Evaluation of Influenza and Pneumococcal Vaccination in COPD Patients Aged 45-80 Years: A Multicenter, Open-Label, Blank-Controlled Clinical Trial

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.

Interventions

  • 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.

Primary outcome measures

  • Number of COPD acute exacerbation events within 12 months after vaccination. [Time frame: 12 months after vaccination]
Secondary outcome measures (8)
  • Change in lung function (FEV₁ absolute value) from baseline to 12 months after vaccination. [Time frame: From baseline to 12 months after vaccination]
  • Change in lung function (FEV₁/FVC) from baseline to 12 months after vaccination. [Time frame: From baseline to 12 months after vaccination]
  • Change in lung function (FEV₁% predicted) from baseline to 12 months after vaccination. [Time frame: From baseline to 12 months after vaccination]
  • Change in lung function (annual decline rate) from baseline to 12 months after vaccination. [Time frame: From baseline to 12 months after vaccination]
  • Change in CAT score from baseline to 12 months after vaccination. [Time frame: From baseline to 12 months after vaccination]
  • Incidence of serious adverse events (SAEs) within 12 months after vaccination. [Time frame: 12 months after vaccination]
  • Serum hemagglutinin antibody titers against influenza virus at 1, 6, and 12 months after vaccination (immunogenicity subgroup). [Time frame: 1, 6, and 12 months after vaccination]
  • Serum neutralizing/killing antibody titers against pneumococcus at 1, 6, and 12 months after vaccination (immunogenicity subgroup). [Time frame: 1, 6, and 12 months after vaccination]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07640841 · 002003421HT

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗