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Идёт набор NCT06029933

Fluad vs. Fluzone High-Dose Vaccine Effectiveness Among Adults ≥65 Years

— Наблюдательное Influenza Community-acquired Pneumonia Cardiovascular Events

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 Quadrivalent Inactivated Influenza Vaccine (aIIV4), High-Dose Quadrivalent Inactivated Influenza Vaccine (HD-IIV4).
Кому может быть актуально
Состояния в реестре: Influenza, Community-acquired Pneumonia, Cardiovascular Events. 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
США
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

Relative Vaccine Effectiveness of Adjuvanted Inactivated Influenza Vaccine (aIIV) vs High-Dose Inactivated Influenza Vaccine (HD-IIV) for Prevention of Lab-Confirmed Influenza Among Adults ≥65 Years of Age in the United States

Обзор

This study will evaluate the relative vaccine effectiveness of quadrivalent adjuvanted inactivated influenza vaccine (aIIV4) versus quadrivalent high-dose inactivated influenza vaccine (HD-IIV4) in preventing polymerase chain reaction (PCR)-confirmed influenza and influenza-related outcomes in adults ≥65 years of age during the 2023/24, 2024/25, and 2026/27 influenza seasons. The study is an observational study conducted at Kaiser Permanente Northern California (KPNC), an integrated health care system in the United States.

Вмешательства

  • Биопрепарат Adjuvanted Quadrivalent Inactivated Influenza Vaccine (aIIV4)
    Fluad Quadrivalent vaccine is an inactivated influenza vaccine formulated to contain 60 mcg of hemagglutinin (HA) total, with 15 mcg from each of the four recommended influenza strains and the MF59 adjuvant in single-dose prefilled 0.5 mL syringes. Kaiser Permanente Northern California members ≥65 years may receive Fluad as part of routine clinical care during the influenza season.
  • Биопрепарат High-Dose Quadrivalent Inactivated Influenza Vaccine (HD-IIV4)
    Fluzone High-Dose Quadrivalent vaccine is an inactivated split virion influenza vaccine formulated to contain 240 mcg of HA total, with 60 mcg from each of the four recommended influenza strains in single-dose prefilled 0.7 mL syringes. Kaiser Permanente Northern California members ≥65 years may receive Fluzone High-Dose as part of routine clinical care during the influenza season.

Первичные конечные точки

  • PCR-confirmed influenza [Срок оценки: ≥14 days after vaccination until date of outcome, death, loss-to-follow-up, or end of each season (estimated May 2024, May 2025, or May 2027)]
Вторичные конечные точки (3)
  • Emergency department visit or hospitalization for PCR-confirmed influenza [Срок оценки: ≥14 days after vaccination until date of outcome, death, loss-to-follow-up, or end of each season (estimated May 2024, May 2025, or May 2027)]
  • Hospitalization for PCR-confirmed influenza [Срок оценки: ≥14 days after vaccination until date of outcome, death, loss-to-follow-up, or end of each season (estimated May 2024, May 2025, or May 2027)]
  • Hospitalization for all-cause community-acquired pneumonia [Срок оценки: ≥14 days after vaccination until date of outcome, death, loss-to-follow-up, or end of each season (estimated May 2024, May 2025, or May 2027)]

Критерии участия

Критерии включения

  • Age ≥65 years at the time of influenza vaccination
  • KPNC member at the time of vaccination
  • Receive either aIIV4 or HD-IIV4 at a KPNC facility during the 2023/24 and/or 2024/25 influenza seasons

Критерии исключения

  • Age <65 years at the time of influenza vaccination
  • Received either aIIV4 or HD-IIV4 in the inpatient setting
  • Receive more than one influenza vaccination during a single season period (i.e., 2023/24 or 2024/25 influenza seasons)
  • Receive an influenza vaccination outside of KPNC

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 1 центр
  • Kaiser Permanente Northern California (entire region) — Oakland

Публикации

  • Hsiao A, Leong T, Fireman B, Hansen J, Zerbo O, Jacobson KB, Liao LD, Haag MDM, McGovern I, Zhang B, Dang J, Klein NP. Adjuvanted vs High-Dose Influenza Vaccines in Older US Adults: A Cluster Randomized Crossover Study. JAMA Netw Open. 2026 May 1;9(5):e2610120. doi: 10.1001/jamanetworkopen.2026.10120. PMID 42081247

Идентификаторы

NCT: NCT06029933 · 2033496

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗