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Набор скоро начнётся NCT07739719

SAFE (Self-Administration of Flumist to ImprovE Uptake: A Household-Based Cluster Randomized Trial)

Фаза IV С лечением Influenza (Healthy Volunteers)

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: LAIV FLUMIST.
Кому может быть актуально
Состояния в реестре: Influenza (Healthy Volunteers). Базовые параметры: 2 лет — 59 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
Канада
Следующий шаг
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Обзор

The flu is a health risk for Canadians. It causes up to 15,000 hospitalizations every year and is one of the top 10 causes of death. Getting a flu vaccine is the best way to prevent the flu and any severe complications. Unfortunately, many Canadians do not get the flu vaccine. A recent survey found that less than a quarter of healthy adults got the flu vaccine. In Canada, current standard access to influenza vaccination is at physician offices, public health clinics, or pharmacy. Therefore, this study is testing a novel access route to influenza vaccine. This study will answer the question: "Will self-administration at home of FLUMIST through a pharmacy pick up model increase uptake of influenza vaccination compared to usual care?" FLUMIST is a needle-free vaccine given as a nasal spray. Households will be randomly chosen to either be offered the FLUMIST vaccine that can be given at home or to make their own choice for the flu season, which may or may not include vaccination.

Подробное описание

SAFE is a pragmatic cluster randomized trial where households are randomized to either LAIV self-administration or to usual care and where the primary outcome is self-reported influenza vaccination in the current season. Randomization is the most rigorous design for comparative study. The intervention is aimed at the household level because it is an efficient method to increase uptake (as opposed to an induvial level randomized trial). The study will be conducted in Burlington Ontario (pop.187,000 living in 73,000 households) and will take place between September 2026 and January 2027. Demographic data (age, gender, comorbidity) will be obtained at baseline. Households randomized to the intervention (self- or caregiver administration) will obtain their vaccine from their local pharmacy and will self-administer the vaccine at home). Both households in the intervention group and in the usual care group will receive an information sheet about influenza vaccination. After baseline data collection, follow up data will be collected during the first seven days post vaccination and at 30 days.

Вмешательства

  • Биопрепарат LAIV FLUMIST
    Children, adolescents, adults 9 to 59 years - 1 dose (0.2 ml).

Первичные конечные точки

  • Vaccine uptake [Срок оценки: 30 days from last influenza vaccination]
Вторичные конечные точки (1)
  • Independent factors predictive of influenza uptake [Срок оценки: 30 days from last vaccination]

Критерии участия

Критерии включения

Household: Households with at least one child aged 2 to 17 years, living in Burlington, Ontario Individual: 1) Residence in an eligible household 2) Age 2 years to 59 years

Критерии исключения

Household: Households where all members have received influenza vaccine in 2 years prior to the study.

Individual:

  • Pregnancy
  • Breast feeding
  • Past serious allergic reaction to study vaccine components (including gentamicin, gelatin, or arginine) or to previous influenza vaccination
  • Severe asthma or active wheezing
  • History of Guillain-Barre syndrome within 6 weeks of receiving a previous influenza vaccine
  • Children 2 to 17 receiving aspirin or salicylate -containing medications. Children who are not receiving aspirin should not receive aspirin for at least 4 weeks after receiving Flumist unless medically indicated.
  • Severely immunocompromised person
  • People who will provide care to severely immunocompromised persons for at least 2 weeks following vaccination or who share a household with an immunocompromised person.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

Канада · 1 центр
  • McMaster University — Hamilton

Идентификаторы

NCT: NCT07739719 · SAFE RCT

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗