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Health Economic Evaluation of Influenza and Pneumococcal Vaccination in COPD Patients

5 czerwca 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Szacowany)

7000

Faza

  • Faza 4

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Zapobieganie
  • Przydział: Nielosowe
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Biologiczny: Influenza Vaccine Group
Trivalent Influenza Vaccine (Split Virion), inactivated, produced by Sinovac Biotech Co., Ltd. One dose, intramuscular.
Eksperymentalny: 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.
Biologiczny: Pneumococcal Vaccine Group
23-valent Pneumococcal Polysaccharide Vaccine, produced by Chengdu Institute of Biological Products Co., Ltd. One dose, intramuscular.
Eksperymentalny: Combined Vaccination Group
Both Trivalent Influenza Vaccine (Split Virion) and 23-valent Pneumococcal Polysaccharide Vaccine. One dose per vaccine, intramuscular.
Biologiczny: Influenza Vaccine Group
Trivalent Influenza Vaccine (Split Virion), inactivated, produced by Sinovac Biotech Co., Ltd. One dose, intramuscular.
Biologiczny: Pneumococcal Vaccine Group
23-valent Pneumococcal Polysaccharide Vaccine, produced by Chengdu Institute of Biological Products Co., Ltd. One dose, intramuscular.
Brak interwencji: Blank Control Group
No vaccine. Participants receive usual care and follow-up.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Number of COPD acute exacerbation events within 12 months after vaccination.
Ramy czasowe: 12 months after vaccination
Number of COPD acute exacerbation events within 12 months after vaccination.
12 months after vaccination

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change in lung function (FEV₁ absolute value) from baseline to 12 months after vaccination.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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).
Ramy czasowe: 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).
Ramy czasowe: 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

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Number of COPD acute exacerbation events within 12 months after vaccination in participants aged 60 years and above.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 12 months after vaccination
Incidence of pneumonia within 12 months post-vaccination in COPD patients.
12 months after vaccination

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Jiangsu Province Centers for Disease Control and Prevention

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

15 czerwca 2026

Zakończenie podstawowe (Szacowany)

30 czerwca 2027

Ukończenie studiów (Szacowany)

31 grudnia 2027

Daty rejestracji na studia

Pierwszy przesłany

29 maja 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

5 czerwca 2026

Pierwszy wysłany (Rzeczywisty)

11 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

11 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

5 czerwca 2026

Ostatnia weryfikacja

1 maja 2026

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 002003421HT

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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