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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Influenza (Healthy Volunteers)
• Intervention / Treatment: Biological: LAIV FLUMIST

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 966
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Dr. Mark Loeb Professor, MD; Phone Number: 26066 905-525-9140; Email: loebm@mcmaster.ca

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8S 4K1
      • McMaster University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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:

1. Pregnancy
2. Breast feeding
3. Past serious allergic reaction to study vaccine components (including gentamicin, gelatin, or arginine) or to previous influenza vaccination
4. Severe asthma or active wheezing
5. History of Guillain-Barre syndrome within 6 weeks of receiving a previous influenza vaccine
6. 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.
7. Severely immunocompromised person
8. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Usual Care
Experimental: LAIV: FLUMIST; Children, adolescents, adults 9 to 59 years - 1 dose (0.2 ml). Children 2 to 8 years not previously vaccinated with seasonal influenza vaccine - 2 doses (0.2ml each, at least 4 weeks apart)	Biological: LAIV FLUMIST; Children, adolescents, adults 9 to 59 years - 1 dose (0.2 ml).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vaccine uptake	To assess whether self-administration at home of FLUMIST through a pharmacy pick up model can increase uptake of influenza vaccination compared to usual care.	30 days from last influenza vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Independent factors predictive of influenza uptake	Secondary objectives will be to determine independent factors predictive of influenza uptake.	30 days from last vaccination

Collaborators and Investigators

• Sponsor: McMaster University

Study record dates

Study Major Dates

• Study Start (Estimated): October 15, 2026
• Primary Completion (Estimated): February 15, 2027
• Study Completion (Estimated): February 15, 2027

Study Registration Dates

• First Submitted: July 28, 2026
• First Submitted That Met QC Criteria: July 28, 2026
• First Posted (Actual): July 31, 2026

Study Record Updates

• Last Update Posted (Actual): July 31, 2026
• Last Update Submitted That Met QC Criteria: July 28, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Influenza, Human
• Other Study ID Numbers: SAFE RCT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes