Not Yet RecruitingPhase 4

Health Economic Evaluation of Influenza and Pneumococcal Vaccination in COPD Patients

7,000 participantsStarted 2026-06-15

Plain-language 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. 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.

Who can participate

Age range

45 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is specifically looking at influenza and pneumococcal vaccinations in COPD patients — does my current COPD management plan already include both of these vaccines, and would joining this study change anything about how or when I receive them?
2Since the trial is measuring COPD flare-ups over 12 months after vaccination, what does my doctor think my personal risk of acute exacerbations looks like right now, and how might that affect whether this trial is worth discussing as an option?
3This is a Phase 4 trial, which I understand means these vaccines are already approved — so what new information is this study trying to add, and how does that differ from what my doctor already knows about using these vaccines for COPD?
4The trial isn't recruiting yet — if my doctor thinks it might be a good fit for me, how long might we need to wait before I could even apply, and should I be doing anything differently in the meantime to manage my COPD?
5Given that this study has a health economics focus alongside the clinical outcomes, could participating affect my costs or insurance in any way, and is there anything I should understand about what's being tracked beyond just my medical results?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 12 months after vaccination

Trial details

NCT IDNCT07640841

SponsorJiangsu Province Centers for Disease Control and Prevention

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2027-06-30

View on ClinicalTrials.gov More Influenza and Pneumonia trials