Health Economic Evaluation of Influenza and Pneumococcal Vaccination in COPD Patients
5 juin 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
7000
Phase
- Phase 4
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
|
Expérimental: 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.
|
|
Expérimental: 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.
|
|
Aucune intervention: Blank Control Group
No vaccine.
Participants receive usual care and follow-up.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Number of COPD acute exacerbation events within 12 months after vaccination.
Délai: 12 months after vaccination
|
Number of COPD acute exacerbation events within 12 months after vaccination.
|
12 months after vaccination
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in lung function (FEV₁ absolute value) from baseline to 12 months after vaccination.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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).
Délai: 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).
Délai: 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
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Number of COPD acute exacerbation events within 12 months after vaccination in participants aged 60 years and above.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 12 months after vaccination
|
Incidence of pneumonia within 12 months post-vaccination in COPD patients.
|
12 months after vaccination
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
15 juin 2026
Achèvement primaire (Estimé)
30 juin 2027
Achèvement de l'étude (Estimé)
31 décembre 2027
Dates d'inscription aux études
Première soumission
29 mai 2026
Première soumission répondant aux critères de contrôle qualité
5 juin 2026
Première publication (Réel)
11 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
11 juin 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
5 juin 2026
Dernière vérification
1 mai 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 002003421HT
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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