Influenza (Healthy Volunteers)Phase 4SAFENCT07739719
SAFE (Self-Administration of Flumist to ImprovE Uptake: A Household-Based Cluster Randomized Trial)
A Phase 4 study testing LAIV FLUMIST in people with Influenza (Healthy Volunteers), run by McMaster University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza (Healthy Volunteers)
- What is being tested?
- LAIV FLUMIST
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 966 participants
- Where
- 1 siteCanada
- Study dates
- 15 Oct 2026to 15 Feb 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 59 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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.
- Conditions
- Influenza (Healthy Volunteers)
- Being tested
- LAIV FLUMIST
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LAIV FLUMISTBiological
Children, adolescents, adults 9 to 59 years - 1 dose (0.2 ml).
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Biological: LAIV FLUMIST |
| Control | No intervention | Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days from last influenza vaccination
Secondary outcomes (1)
Independent factors predictive of influenza uptake
Secondary objectives will be to determine independent factors predictive of influenza uptake.
Measured: 30 days from last vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study start15 Oct 2026 (estimated)
- Primary completion15 Feb 2027 (estimated)
- Study completion15 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza (Healthy Volunteers)Studies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model 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
- Masking
- None (open label)
- Enrolment
- 966 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07739719
- Sponsor's protocol ID
- SAFE RCT
- Acronym
- SAFE
- Status last verified
- Jul 2026
- First submitted
- 28 Jul 2026
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SAFE (Self-Administration of Flumist to ImprovE Uptake: A Household-Based Cluster Randomized Trial)
- ClinicalTrials.gov ID
- NCT07739719
- Acronym / sponsor ID
- SAFE / SAFE RCT
- Conditions
- Influenza (Healthy Volunteers)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 966 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 15 Feb 2027 (estimated)
- Study completion
- 15 Feb 2027 (estimated)
- First posted
- 31 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model 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
| Arm | Type | Receives |
|---|---|---|
| LAIV: FLUMIST | Experimental | Biological: LAIV FLUMISTChildren, 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) |
| Control | No intervention | –Usual Care |
Who may qualify
- Ages
- 2 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (10 listed)
- Household: Households where all members have received influenza vaccine in 2 years prior to the study.
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LAIV FLUMISTChildren, adolescents, adults 9 to 59 years - 1 dose (0.2 ml). | Biological | LAIV: FLUMIST |
Primary outcome
Vaccine uptake
Time frame: 30 days from last influenza vaccination
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.
1 secondary outcome
Independent factors predictive of influenza uptake
Time frame: 30 days from last vaccination
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Influenza (Healthy Volunteers)
RecruitingObservational study
Screening for LID Clinical Studies Unit Healthy Volunteer Protocols
Zika, Influenza
RecruitingPhase 1
A Trial to Evaluate the Effect of CD388/MK1406 on the Immunogenicity of Fluzone® HD Vaccine (CD388.SQ.1.08/MK-1406-007)
Healthy Participants
Active, not recruitingPhase 3
A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 With Influenza Vaccine in Adults ≥ 50 Years of Age
Pneumococcal Disease
Not yet recruitingPhase 3
Study of a Combination SARS-CoV-2 Recombinant Spike and High-Dose Inactivated Influenza Vaccine With Matrix-M Adjuvant in Adult Participants 60 Years of Age and Older
Immunization, Healthy Volunteers
RecruitingObservational study
Post-marketing Surveillance Study for the Safety of Efluelda® Pre-filled Syringe
Influenza Immunization, Healthy Volunteers
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing LAIV FLUMIST in people with Influenza (Healthy Volunteers), run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Mark Loeb Professor, MD (905-525-9140 ext. 26066, loebm@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vaccine uptake (time frame: 30 days from last influenza vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.