Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07640841

Health Economic Evaluation of Influenza and Pneumococcal Vaccination in COPD Patients

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Influenza and Pneumonia Infections Influenza, Human Lung Diseases Orthomyxoviridae Infections Pneumonia RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

45 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Influenza Vaccine Group

Biological

Trivalent Influenza Vaccine (Split Virion), inactivated, produced by Sinovac Biotech Co., Ltd. One dose, intramuscular.

Pneumococcal Vaccine Group

Biological

23-valent Pneumococcal Polysaccharide Vaccine, produced by Chengdu Institute of Biological Products Co., Ltd. One dose, intramuscular.

Primary outcomes

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

    Time frame: 12 months after vaccination

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

Secondary outcomes

  1. 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 absolute value) from baseline to 12 months after vaccination.

  2. 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/FVC) from baseline to 12 months after vaccination.

  3. 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 (FEV₁% predicted) from baseline to 12 months after vaccination.

  4. 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 lung function (annual decline rate) from baseline to 12 months after vaccination.

  5. Change in CAT score from baseline to 12 months after vaccination.

    Time frame: 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.

  6. Incidence of serious adverse events (SAEs) within 12 months after vaccination.

    Time frame: 12 months after vaccination

    Incidence of serious adverse events (SAEs) within 12 months after vaccination.

  7. 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 hemagglutinin antibody titers against influenza virus at 1, 6, and 12 months after vaccination (immunogenicity subgroup).

  8. 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

    Serum neutralizing/killing antibody titers against pneumococcus at 1, 6, and 12 months after vaccination (immunogenicity subgroup).

Other outcomes

  1. Number of COPD acute exacerbation events within 12 months after vaccination in participants aged 60 years and above.

    Time frame: 12 months after vaccination

    Number of COPD acute exacerbation events within 12 months after vaccination in participants aged 60 years and above.

  2. Change in lung function (FEV₁ absolute value) from baseline to 12 months after vaccination in participants aged 60 years and above.

    Time frame: From baseline to 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.

  3. Change in lung function (FEV₁/FVC) from baseline to 12 months after vaccination in participants aged 60 years and above.

    Time frame: 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.

  4. Change in lung function (FEV₁% predicted) from baseline to 12 months after vaccination in participants aged 60 years and above.

    Time frame: 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.

  5. Change in lung function (annual decline rate) from baseline to 12 months after vaccination in participants aged 60 years and above.

    Time frame: 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.

  6. Change in CAT score from baseline to 12 months after vaccination in participants aged 60 years and above.

    Time frame: 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.

  7. Incidence of serious adverse events (SAEs) within 12 months after vaccination in participants aged 60 years and above.

    Time frame: 12 months after vaccination

    Incidence of serious adverse events (SAEs) within 12 months after vaccination in participants aged 60 years and above.

  8. Serum hemagglutinin antibody titers against influenza virus at 1, 6, and 12 months after vaccination (immunogenicity subgroup) in participants aged 60 years and above.

    Time frame: 1, 6, and 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.

  9. Serum neutralizing/killing antibody titers against pneumococcus at 1, 6, and 12 months after vaccination (immunogenicity subgroup) in participants aged 60 years and above.

    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) in participants aged 60 years and above.

  10. Incidence of influenza within 12 months post-vaccination in COPD patients.

    Time frame: 12 months after vaccination

    Incidence of influenza within 12 months post-vaccination in COPD patients.

  11. Incidence of pneumonia within 12 months post-vaccination in COPD patients.

    Time frame: 12 months after vaccination

    Incidence of pneumonia within 12 months post-vaccination in COPD patients.

Sponsors and collaborators

Lead sponsor

Jiangsu Province Centers for Disease Control and Prevention

Network

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 11, 2026
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.