Health Economic Evaluation of Influenza and Pneumococcal Vaccination in COPD Patients
5 июня 2026 г. обновлено: 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.
Обзор исследования
Статус
Еще не набирают
Условия
Вмешательство/лечение
Тип исследования
Интервенционный
Регистрация (Оцененный)
7000
Фаза
- Фаза 4
Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Нет
Описание
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.
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Профилактика
- Распределение: Нерандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: 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.
|
|
Экспериментальный: 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.
|
|
Экспериментальный: 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.
|
|
Без вмешательства: Blank Control Group
No vaccine.
Participants receive usual care and follow-up.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Number of COPD acute exacerbation events within 12 months after vaccination.
Временное ограничение: 12 months after vaccination
|
Number of COPD acute exacerbation events within 12 months after vaccination.
|
12 months after vaccination
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change in lung function (FEV₁ absolute value) from baseline to 12 months after vaccination.
Временное ограничение: 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.
Временное ограничение: 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.
Временное ограничение: 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.
Временное ограничение: 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.
Временное ограничение: 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.
Временное ограничение: 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).
Временное ограничение: 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).
Временное ограничение: 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
|
Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Number of COPD acute exacerbation events within 12 months after vaccination in participants aged 60 years and above.
Временное ограничение: 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.
Временное ограничение: 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.
Временное ограничение: 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.
Временное ограничение: 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.
Временное ограничение: 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.
Временное ограничение: 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.
Временное ограничение: 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.
Временное ограничение: 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.
Временное ограничение: 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.
Временное ограничение: 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.
Временное ограничение: 12 months after vaccination
|
Incidence of pneumonia within 12 months post-vaccination in COPD patients.
|
12 months after vaccination
|
Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Оцененный)
15 июня 2026 г.
Первичное завершение (Оцененный)
30 июня 2027 г.
Завершение исследования (Оцененный)
31 декабря 2027 г.
Даты регистрации исследования
Первый отправленный
29 мая 2026 г.
Впервые представлено, что соответствует критериям контроля качества
5 июня 2026 г.
Первый опубликованный (Действительный)
11 июня 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
11 июня 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
5 июня 2026 г.
Последняя проверка
1 мая 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 002003421HT
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .