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Health Economic Evaluation of Influenza and Pneumococcal Vaccination in COPD Patients

5 giugno 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

7000

Fase

  • Fase 4

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Biologico: Influenza Vaccine Group
Trivalent Influenza Vaccine (Split Virion), inactivated, produced by Sinovac Biotech Co., Ltd. One dose, intramuscular.
Sperimentale: 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.
Biologico: Pneumococcal Vaccine Group
23-valent Pneumococcal Polysaccharide Vaccine, produced by Chengdu Institute of Biological Products Co., Ltd. One dose, intramuscular.
Sperimentale: Combined Vaccination Group
Both Trivalent Influenza Vaccine (Split Virion) and 23-valent Pneumococcal Polysaccharide Vaccine. One dose per vaccine, intramuscular.
Biologico: Influenza Vaccine Group
Trivalent Influenza Vaccine (Split Virion), inactivated, produced by Sinovac Biotech Co., Ltd. One dose, intramuscular.
Biologico: Pneumococcal Vaccine Group
23-valent Pneumococcal Polysaccharide Vaccine, produced by Chengdu Institute of Biological Products Co., Ltd. One dose, intramuscular.
Nessun intervento: Blank Control Group
No vaccine. Participants receive usual care and follow-up.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of COPD acute exacerbation events within 12 months after vaccination.
Lasso di tempo: 12 months after vaccination
Number of COPD acute exacerbation events within 12 months after vaccination.
12 months after vaccination

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in lung function (FEV₁ absolute value) from baseline to 12 months after vaccination.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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).
Lasso di tempo: 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).
Lasso di tempo: 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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of COPD acute exacerbation events within 12 months after vaccination in participants aged 60 years and above.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 12 months after vaccination
Incidence of pneumonia within 12 months post-vaccination in COPD patients.
12 months after vaccination

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Jiangsu Province Centers for Disease Control and Prevention

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

15 giugno 2026

Completamento primario (Stimato)

30 giugno 2027

Completamento dello studio (Stimato)

31 dicembre 2027

Date di iscrizione allo studio

Primo inviato

29 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

5 giugno 2026

Primo Inserito (Effettivo)

11 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

11 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

5 giugno 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 002003421HT

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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