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Набор скоро начнётся NCT07640841

Health Economic Evaluation of Influenza and Pneumococcal Vaccination in COPD Patients

Фаза IV С лечением Influenza and Pneumonia

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Influenza Vaccine Group, Pneumococcal Vaccine Group.
Кому может быть актуально
Состояния в реестре: Influenza and Pneumonia. Базовые параметры: 45 лет — 80 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Health Economic Evaluation of Influenza and Pneumococcal Vaccination in COPD Patients Aged 45-80 Years: A Multicenter, Open-Label, Blank-Controlled Clinical Trial

Обзор

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.

Вмешательства

  • Биопрепарат Influenza Vaccine Group
    Trivalent Influenza Vaccine (Split Virion), inactivated, produced by Sinovac Biotech Co., Ltd. One dose, intramuscular.
  • Биопрепарат Pneumococcal Vaccine Group
    23-valent Pneumococcal Polysaccharide Vaccine, produced by Chengdu Institute of Biological Products Co., Ltd. One dose, intramuscular.

Первичные конечные точки

  • Number of COPD acute exacerbation events within 12 months after vaccination. [Срок оценки: 12 months after vaccination]
Вторичные конечные точки (8)
  • Change in lung function (FEV₁ absolute value) from baseline to 12 months after vaccination. [Срок оценки: From baseline to 12 months after vaccination]
  • Change in lung function (FEV₁/FVC) from baseline to 12 months after vaccination. [Срок оценки: From baseline to 12 months after vaccination]
  • Change in lung function (FEV₁% predicted) from baseline to 12 months after vaccination. [Срок оценки: From baseline to 12 months after vaccination]
  • Change in lung function (annual decline rate) from baseline to 12 months after vaccination. [Срок оценки: From baseline to 12 months after vaccination]
  • Change in CAT score from baseline to 12 months after vaccination. [Срок оценки: From baseline to 12 months after vaccination]
  • Incidence of serious adverse events (SAEs) within 12 months after vaccination. [Срок оценки: 12 months after vaccination]
  • Serum hemagglutinin antibody titers against influenza virus at 1, 6, and 12 months after vaccination (immunogenicity subgroup). [Срок оценки: 1, 6, and 12 months after vaccination]
  • Serum neutralizing/killing antibody titers against pneumococcus at 1, 6, and 12 months after vaccination (immunogenicity subgroup). [Срок оценки: 1, 6, and 12 months after vaccination]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07640841 · 002003421HT

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗