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

NCT07739719 | Not Yet Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: SAFE RCT
• Study Type: interventional
• Target: 966
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Influenza (Healthy Volunteers)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Independent factors predictive of influenza uptake

  30 days from last vaccination

Study Arms (2)

LAIV: FLUMIST

EXPERIMENTAL

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

Control

NO INTERVENTION

Usual Care

Interventions

LAIV FLUMIST BIOLOGICAL

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

LAIV: FLUMIST

Eligibility Criteria

• Age: 2 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

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.

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

McMaster University

Hamilton, Ontario, L8S 4K1, Canada

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Central Study Contacts

Dr. Mark Loeb Professor, MD

CONTACT

905-525-9140; loebm@mcmaster.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: July 28, 2026
• First Posted: July 31, 2026
• Study Start (Estimated): October 15, 2026
• Primary Completion (Estimated): February 15, 2027
• Study Completion (Estimated): February 15, 2027
• Last Updated: July 31, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)