Health Economic Evaluation of Influenza and Pneumococcal Vaccination in COPD Patients
5 juni 2026 uppdaterad av: Jiangsu Province Centers for Disease Control and Prevention
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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
7000
Fas
- Fas 4
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Influenza Vaccine Group
Trivalent Influenza Vaccine (Split Virion), inactivated, produced by Sinovac Biotech Co., Ltd. or Chengdu Institute of Biological Products Co., Ltd.
One dose, intramuscular.
|
Trivalent Influenza Vaccine (Split Virion), inactivated, produced by Sinovac Biotech Co., Ltd.
One dose, intramuscular.
|
|
Experimentell: Pneumococcal Vaccine Group
23-valent Pneumococcal Polysaccharide Vaccine, produced by Sinovac Biotech Co., Ltd. or Chengdu Institute of Biological Products Co., Ltd.
One dose, intramuscular.
|
23-valent Pneumococcal Polysaccharide Vaccine, produced by Chengdu Institute of Biological Products Co., Ltd.
One dose, intramuscular.
|
|
Experimentell: Combined Vaccination Group
Both Trivalent Influenza Vaccine (Split Virion) and 23-valent Pneumococcal Polysaccharide Vaccine.
One dose per vaccine, intramuscular.
|
Trivalent Influenza Vaccine (Split Virion), inactivated, produced by Sinovac Biotech Co., Ltd.
One dose, intramuscular.
23-valent Pneumococcal Polysaccharide Vaccine, produced by Chengdu Institute of Biological Products Co., Ltd.
One dose, intramuscular.
|
|
Inget ingripande: Blank Control Group
No vaccine.
Participants receive usual care and follow-up.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Number of COPD acute exacerbation events within 12 months after vaccination.
Tidsram: 12 months after vaccination
|
Number of COPD acute exacerbation events within 12 months after vaccination.
|
12 months after vaccination
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in lung function (FEV₁ absolute value) from baseline to 12 months after vaccination.
Tidsram: From baseline to 12 months after vaccination
|
Change in lung function (FEV₁ absolute value) from baseline to 12 months after vaccination.
|
From baseline to 12 months after vaccination
|
|
Change in lung function (FEV₁/FVC) from baseline to 12 months after vaccination.
Tidsram: From baseline to 12 months after vaccination
|
Change in lung function (FEV₁/FVC) from baseline to 12 months after vaccination.
|
From baseline to 12 months after vaccination
|
|
Change in lung function (FEV₁% predicted) from baseline to 12 months after vaccination.
Tidsram: From baseline to 12 months after vaccination
|
Change in lung function (FEV₁% predicted) from baseline to 12 months after vaccination.
|
From baseline to 12 months after vaccination
|
|
Change in lung function (annual decline rate) from baseline to 12 months after vaccination.
Tidsram: From baseline to 12 months after vaccination
|
Change in lung function (annual decline rate) from baseline to 12 months after vaccination.
|
From baseline to 12 months after vaccination
|
|
Change in CAT score from baseline to 12 months after vaccination.
Tidsram: 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.
|
From baseline to 12 months after vaccination
|
|
Incidence of serious adverse events (SAEs) within 12 months after vaccination.
Tidsram: 12 months after vaccination
|
Incidence of serious adverse events (SAEs) within 12 months after vaccination.
|
12 months after vaccination
|
|
Serum hemagglutinin antibody titers against influenza virus at 1, 6, and 12 months after vaccination (immunogenicity subgroup).
Tidsram: 1, 6, and 12 months after vaccination
|
Serum hemagglutinin antibody titers against influenza virus at 1, 6, and 12 months after vaccination (immunogenicity subgroup).
|
1, 6, and 12 months after vaccination
|
|
Serum neutralizing/killing antibody titers against pneumococcus at 1, 6, and 12 months after vaccination (immunogenicity subgroup).
Tidsram: 1, 6, and 12 months after vaccination
|
Serum neutralizing/killing antibody titers against pneumococcus at 1, 6, and 12 months after vaccination (immunogenicity subgroup).
|
1, 6, and 12 months after vaccination
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Number of COPD acute exacerbation events within 12 months after vaccination in participants aged 60 years and above.
Tidsram: 12 months after vaccination
|
Number of COPD acute exacerbation events within 12 months after vaccination in participants aged 60 years and above.
|
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.
Tidsram: 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.
|
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.
Tidsram: 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.
|
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.
Tidsram: 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.
|
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.
Tidsram: 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.
|
From baseline to 12 months after vaccination
|
|
Change in CAT score from baseline to 12 months after vaccination in participants aged 60 years and above.
Tidsram: 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.
|
From baseline to 12 months after vaccination
|
|
Incidence of serious adverse events (SAEs) within 12 months after vaccination in participants aged 60 years and above.
Tidsram: 12 months after vaccination
|
Incidence of serious adverse events (SAEs) within 12 months after vaccination in participants aged 60 years and above.
|
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.
Tidsram: 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.
|
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.
Tidsram: 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.
|
1, 6, and 12 months after vaccination
|
|
Incidence of influenza within 12 months post-vaccination in COPD patients.
Tidsram: 12 months after vaccination
|
Incidence of influenza within 12 months post-vaccination in COPD patients.
|
12 months after vaccination
|
|
Incidence of pneumonia within 12 months post-vaccination in COPD patients.
Tidsram: 12 months after vaccination
|
Incidence of pneumonia within 12 months post-vaccination in COPD patients.
|
12 months after vaccination
|
Samarbetspartners och utredare
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Studieavstämningsdatum
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Studera stora datum
Studiestart (Beräknad)
15 juni 2026
Primärt slutförande (Beräknad)
30 juni 2027
Avslutad studie (Beräknad)
31 december 2027
Studieregistreringsdatum
Först inskickad
29 maj 2026
Först inskickad som uppfyllde QC-kriterierna
5 juni 2026
Första postat (Faktisk)
11 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
11 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
5 juni 2026
Senast verifierad
1 maj 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 002003421HT
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