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Influenza and PneumoniaPhase 4NCT07640841

Health Economic Evaluation of Influenza and Pneumococcal Vaccination in COPD Patients

A Phase 4 study testing Influenza Vaccine Group and Pneumococcal Vaccine Group in people with Influenza and Pneumonia, run by Jiangsu Province Centers for Disease Control and Prevention.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 45 to 80 years
Conditions the study is for
Influenza and Pneumonia
What is being tested?
Influenza Vaccine Group and Pneumococcal Vaccine Group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7,000 participants
Where
No sites listed yet
Study dates
15 Jun 2026to 31 Dec 2027
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

About this study

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

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.

Being tested
Influenza Vaccine Group, Pneumococcal Vaccine Group
Medical subject headings
Influenza, Human, Pneumonia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Influenza Vaccine GroupBiological

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

  • Pneumococcal Vaccine GroupBiological

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

Study groups in NCT07640841
Study groupRoleWhat they receive
Influenza Vaccine GroupExperimentalTrivalent Influenza Vaccine (Split Virion), inactivated, produced by Sinovac Biotech Co., Ltd. or Chengdu Institute of Biological Products Co., Ltd. One dose, intramuscular.
Receives: Biological: Influenza Vaccine Group
Pneumococcal Vaccine GroupExperimental23-valent Pneumococcal Polysaccharide Vaccine, produced by Sinovac Biotech Co., Ltd. or Chengdu Institute of Biological Products Co., Ltd. One dose, intramuscular.
Receives: Biological: Pneumococcal Vaccine Group
Combined Vaccination GroupExperimentalBoth Trivalent Influenza Vaccine (Split Virion) and 23-valent Pneumococcal Polysaccharide Vaccine. One dose per vaccine, intramuscular.
Receives: Biological: Influenza Vaccine Group; Biological: Pneumococcal Vaccine Group
Blank Control GroupNo interventionNo vaccine. Participants receive usual care and follow-up.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: 12 months after vaccination

Secondary outcomes (8)

  1. 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.

    Measured: From baseline to 12 months after vaccination

  2. 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.

    Measured: From baseline to 12 months after vaccination

  3. 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.

    Measured: From baseline to 12 months after vaccination

  4. 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.

    Measured: From baseline to 12 months after vaccination

  5. 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.

    Measured: From baseline to 12 months after vaccination

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

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

    Measured: 12 months after vaccination

  7. 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).

    Measured: 1, 6, and 12 months after vaccination

  8. 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).

    Measured: 1, 6, and 12 months after vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2026
  2. Study start15 Jun 2026 (estimated)
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
7,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07640841
Sponsor's protocol ID
002003421HT
Status last verified
May 2026
First submitted
29 May 2026
Last updated
11 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Influenza Vaccine Group and Pneumococcal Vaccine Group in people with Influenza and Pneumonia, run by Jiangsu Province Centers for Disease Control and Prevention.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of COPD acute exacerbation events within 12 months after vaccination. (time frame: 12 months after vaccination). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07640841.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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