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Health Economic Evaluation of Influenza and Pneumococcal Vaccination in COPD Patients

5. Juni 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

7000

Phase

  • Phase 4

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Verhütung
  • Zuteilung: Nicht randomisiert
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Biologisch: Influenza Vaccine Group
Trivalent Influenza Vaccine (Split Virion), inactivated, produced by Sinovac Biotech Co., Ltd. One dose, intramuscular.
Experimental: 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.
Biologisch: Pneumococcal Vaccine Group
23-valent Pneumococcal Polysaccharide Vaccine, produced by Chengdu Institute of Biological Products Co., Ltd. One dose, intramuscular.
Experimental: Combined Vaccination Group
Both Trivalent Influenza Vaccine (Split Virion) and 23-valent Pneumococcal Polysaccharide Vaccine. One dose per vaccine, intramuscular.
Biologisch: Influenza Vaccine Group
Trivalent Influenza Vaccine (Split Virion), inactivated, produced by Sinovac Biotech Co., Ltd. One dose, intramuscular.
Biologisch: Pneumococcal Vaccine Group
23-valent Pneumococcal Polysaccharide Vaccine, produced by Chengdu Institute of Biological Products Co., Ltd. One dose, intramuscular.
Kein Eingriff: Blank Control Group
No vaccine. Participants receive usual care and follow-up.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Number of COPD acute exacerbation events within 12 months after vaccination.
Zeitfenster: 12 months after vaccination
Number of COPD acute exacerbation events within 12 months after vaccination.
12 months after vaccination

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in lung function (FEV₁ absolute value) from baseline to 12 months after vaccination.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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).
Zeitfenster: 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).
Zeitfenster: 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

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Number of COPD acute exacerbation events within 12 months after vaccination in participants aged 60 years and above.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 12 months after vaccination
Incidence of pneumonia within 12 months post-vaccination in COPD patients.
12 months after vaccination

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Jiangsu Province Centers for Disease Control and Prevention

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

15. Juni 2026

Primärer Abschluss (Geschätzt)

30. Juni 2027

Studienabschluss (Geschätzt)

31. Dezember 2027

Studienanmeldedaten

Zuerst eingereicht

29. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

5. Juni 2026

Zuerst gepostet (Tatsächlich)

11. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

11. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

5. Juni 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 002003421HT

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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