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

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.

Inclusion criteria

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

Exclusion criteria

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.