FLUMIST for Flu

(SAFE Trial)

DM
Overseen ByDr. Mark Loeb Professor, MD
Age: < 65
Sex: Any
Trial Phase: Phase 4
Sponsor: McMaster University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

This trial is for households in Canada with people eligible to receive the FLUMIST nasal spray flu vaccine. Participants should not have conditions that prevent them from safely using this type of vaccine, such as certain immune problems or allergies.

Inclusion Criteria

My household has a child aged 2 to 17 and we live in Burlington, Ontario.
I am between 2 and 59 years old.
Individual residence in an eligible household

Exclusion Criteria

Individual severely immunocompromised person
I have severe asthma or am currently experiencing wheezing.
Households where all members have received influenza vaccine in 2 years prior to the study
See 6 more

What Are the Treatments Tested in This Trial?

Interventions

  • LAIV FLUMIST

Trial Overview

The study compares two groups: one can pick up and use the FLUMIST nasal spray flu vaccine at home, while the other follows usual care (getting vaccinated through clinics or pharmacies if they choose). Households are randomly assigned to each group.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: LAIV: FLUMISTExperimental Treatment1 Intervention
Group II: ControlActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

McMaster University

Lead Sponsor

Trials
936
Recruited
2,630,000+