SAFE (Self-Administration of Flumist to ImprovE Uptake: A Household-Based Cluster Randomized Trial)
Starting soon · Phase 4
Conditions studied: Influenza (Healthy Volunteers)
In brief
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.
Key facts
- Study ID
- NCT07739719
- Run by
- McMaster University
- People needed
- 966
- Starts
- 2026-10-15
- Expected to finish
- 2027-02-15
- Last updated by the study team
- 2026-07-31
Who can join
Age: 2 and older, up to 59. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- McMaster University — Hamilton, Ontario, Canada
Full record on ClinicalTrials.gov
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