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Идёт набор NCT06676644

Estimate the Safety and Effectiveness of Adjuvanted Influenza Vaccine Among Asian Elderly People When Compared to Non-adjuvanted Vaccines

Без фазы С лечением Influenza Vaccines Elderly

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: adjuvanted, non-adjuvanted.
Кому может быть актуально
Состояния в реестре: Influenza Vaccines, Elderly. Базовые параметры: от 65 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
Тайвань
Следующий шаг
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Официальное название

A Comparative Study on the Immunogenicity and Safety of Adjuvanted Versus Non-Adjuvanted Influenza Vaccines in the Elderly

Обзор

To compare the immunogenicity, cellular immune response, and safety between adjuvanted (aIIV4) and non-adjuvanted (IIV4) seasonal influenza vaccines in the Taiwanese elderly population with chronic medical conditions.

Подробное описание

Annual influenza vaccination is the most important and cost-effective intervention in reducing the impact of influenza, and a key component of the WHO response and preparedness efforts for influenza of pandemic potential. Reduced effectiveness of conventional egg-based vaccination was observed among risk group, such as elderly and people on with chronic medical conditions, which may result from their impaired immunogenicity. WHO, as well as ACIP of the USA, Europe, and Australia suggested adjuvanted influenza vaccines as one of alternatives for those people, which could decrease the disease burden significantly in several analyses. An adjuvanted commercial vaccine has been approved in Taiwan recently, but the local data of safety and effectiveness analysis is limited. This 1-year randomized control trial is designed to estimate the safety and effectiveness of adjuvanted influenza vaccine among Asian elderly people when compared to non-adjuvanted vaccines.

Вмешательства

  • Препарат adjuvanted
    adjuvanted (aIIV4) influenza vaccine in the Taiwanses elderly with chronic medical conditions
  • Препарат non-adjuvanted
    non-adjuvanted (IIV4) influenza vaccine in the Taiwanses elderly with chronic medical conditions

Первичные конечные точки

  • The seroconversion rate (SCR) measured by the change in hemagglutination inhibition (HI) titer against the vaccine strains in serum between Day 1 (pre-vaccination) and Day 29. [Срок оценки: Measured through Day 29]
Вторичные конечные точки (4)
  • The geometric mean titer (GMT), seroprotection rate (SPR), cellular immune responses on Day1, Day 29 (±3), Day 181 (±7), and Day 361 (±7) [Срок оценки: Measured through Day 361]
  • Incidence of severe adverse reactions within 28 days after immunization. [Срок оценки: Measured through Day 28]
  • Incidence of laboratory-confirmed influenza during the study period. [Срок оценки: Measured through Day 361]
  • Incidence of emergency department visits and hospitalizations related to respiratory illness, all-cause mortality during the study period. [Срок оценки: Measured through Day 361]

Критерии участия

Критерии включения

  • Adults aged 65 years or above
  • Presence of at least 1 chronic medical condition associated with increased risk of complicated influenza, including hypertension, chronic obstructive pulmonary disease (group A, B, E), asthma, congestive heart failure (ACC/AHA stage A, B, C, D), coronary arterial disease, diabetes mellitus, chronic liver disease (Child-Pugh score A, B, C) or chronic kidney disease (stage 1\~4), neuromuscular disorders, hematological or solid organ malignancies, recipient of hematopoietic stem cell transplantation or solid organ transplantation.

Критерии исключения

  • Contraindications to influenza vaccination including history of severe adverse event after vaccination, such as anaphylaxis or Guillain-Barré Syndrome, or a severe bleeding tendency
  • Prior receipt of influenza vaccination during the current flu season.
  • Determination by the Principal Investigator (PI) that the participant is ineligible for enrollment based on clinical assessment.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Четверное слепое
Основная цель
Профилактика

Центры проведения

Тайвань · 1 центр
  • National Taiwan University Hospital — Taipei

Идентификаторы

NCT: NCT06676644 · 202409030MIND

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗