SAFE (Self-Administration of Flumist to ImprovE Uptake: A Household-Based Cluster Randomized Trial) | NCT07739719

NCT07739719

Overview

NCT ID: NCT07739719
Lead Sponsor: McMaster UniversityOTHER
Official Title: SAFE (Self-Administration of Flumist to ImprovE Uptake: A Household-Based Cluster Randomized Trial)
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.

Ages Eligible for Study: Child (0-17)Adult (18-64)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: Yes
Eligibility Criteria: 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.

Central Contacts: Dr. Mark Loeb Professor, MDContact
loebm@mcmaster.ca905-525-9140 ext. 26066