FluSNIFF-toddler is a Phase 2, randomised, single-blind, placebo-controlled crossover trial evaluating the safety of the live attenuated influenza vaccine (LAIV) in children aged 12–23 months. It is sponsored by University Hospital Southampton NHS Foundation Trust, funded by the National Institute for Health Research (NIHR) and the UK Vaccine Task Force, and supported by the Royal College of General Practitioners' Research and Surveillance Centre (Oxford-RCGP RSC), University of Oxford.

Participation is designed to be low-burden. uMed, a digital health platform, manages participant identification, eConsent, electronic follow-up, and adverse event reporting on your practice's behalf. Sites are only responsible for two short in-person visits per participant.

Depending on your site's set up status. First vaccinations are hoping to begin 7 September, however many sites will begin in the following weeks. Join the daily site drop-in call at 10am (Link to Meeting) to discuss what is outstanding for your practice.

Patient approvals will be sent to GPs via the uMed platform as soon as the required set up procedures have taken place. You will receive an email asking for your practice to approve patients in uMed platform. If you have not received this email, your practice has not completed the required set up procedures. Join the daily site drop-in call at 10am (Link to Meeting) to discuss what is outstanding for your practice.

If you have specific questions about your site's outstanding actions, join the daily site drop-in call at 10am: Link to Meeting.

https://mystudy.umed.io/

uMed identifies and contacts eligible participants using coded clinical data from NHS GP records (EMIS/TPP).

uMed obtains eConsent from the parent through the uMed platform before the first site visit. The site then countersigns at the first visit.

Two in-person visits, including booking appointments, randomisation within the uMed platform, vaccine/placebo administration, updating the platform with visit data (e.g. batch numbers, expiry dates), and recording of SAEs as required. Data requirements for each visit have been kept to a minimum to reduce site burden.

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Recruitment runs through the uMed-managed pathway (screening survey, eConsent, and platform approval). If a parent approaches your practice directly and is interested, uMed can add them to the outreach list rather than the practice consenting them separately.

Yes. Each site attends a one-hour Site Initiation Visit (SIV) including Targeted GCP Training, covering study overview and schedule of events, a GCP refresher, IMP management and documentation, safety and SAE reporting on the uMed platform, and eISF/delegation log completion.

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No -Targeted GCP training is provided to all sites at the SIV.

FluSNIFF - Season 2 - Site Initiation Visit (SIV) | Meeting-Join | Microsoft Teams 

7th September at 10am

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FluSNIFF - Season 2 - Site Initiation Visit (SIV) 

11th September at 10am

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All required documents and training materials can be found further down this page under ‘Key Documents and Resources for GPs’

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Fluenz (LAIV) is ordered directly from UKHSA via the usual ImmForm system, under your practice's existing account, free of charge as part of standard NHS seasonal flu vaccine supply arrangements. Please ensure stock is reserved specifically for FluSNIFF-toddler participants.

No. The vaccine is stored under normal NHS cold-chain procedures until administration. Placebo (0.9% saline) is stored at room temperature and prepared from existing NHS stock.

All GPs will be sent atomisers, posters, and patient cards as standard. If you need more atomisers, email sitesupport@umed.io with the subject line “More atomisers needed – ODS code: [your ODS code]”.

All administration of Fluenz and placebo takes place under a Patient Specific Direction (PSD), prescribed individually by an authorised prescriber and signed on the FluSNIFF PSD Proforma. Only staff listed on the site Delegation Log, appropriately trained and authorised under the PSD, may administer either product.

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Serious Adverse Events (SAEs) must be submitted via the uMed platform within 24 hours of the site becoming aware, which automatically alerts the Chief Investigator and Sponsor. Protocol deviations are recorded using the Protocol Deviation Form and uploaded once signed by the Investigator.

A one-off payment of £279.50 per site (covering administration and SIV attendance), plus £78.34 per patient (covering appointment scheduling, randomisation, and administration of the second study intervention), plus an additional £30 per patient randomised — a total of £108.34 per patient. An additional £32 per patient applies where an SAE is reported. Sites can either sign a Self-Billing Agreement (uMed pays directly, no invoice required) or invoice uMed directly, as set out in the Site Agreement.