Health Economic Evaluation of Influenza and Pneumococcal Vaccination in COPD Patients
5 de junio de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
7000
Fase
- Fase 4
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
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.
|
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.
|
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.
|
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.
|
|
Sin intervención: Blank Control Group
No vaccine.
Participants receive usual care and follow-up.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Number of COPD acute exacerbation events within 12 months after vaccination.
Periodo de tiempo: 12 months after vaccination
|
Number of COPD acute exacerbation events within 12 months after vaccination.
|
12 months after vaccination
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in lung function (FEV₁ absolute value) from baseline to 12 months after vaccination.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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).
Periodo de tiempo: 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).
Periodo de tiempo: 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
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Number of COPD acute exacerbation events within 12 months after vaccination in participants aged 60 years and above.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 12 months after vaccination
|
Incidence of pneumonia within 12 months post-vaccination in COPD patients.
|
12 months after vaccination
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
15 de junio de 2026
Finalización primaria (Estimado)
30 de junio de 2027
Finalización del estudio (Estimado)
31 de diciembre de 2027
Fechas de registro del estudio
Enviado por primera vez
29 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
5 de junio de 2026
Publicado por primera vez (Actual)
11 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
11 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
5 de junio de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 002003421HT
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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