SAFE (Self-Administration of Flumist to ImprovE Uptake: A Household-Based Cluster Randomized Trial) (NCT07739719) | Clinical Trial Compass
Not Yet RecruitingPhase 4
SAFE (Self-Administration of Flumist to ImprovE Uptake: A Household-Based Cluster Randomized Trial)
Canada966 participantsStarted 2026-10-15
Plain-language summary
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.
Who can participate
Age range
2 Years – 59 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Exclusion criteria
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Vaccine uptake
Timeframe: 30 days from last influenza vaccination
. 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.