FluSNIFF
Research type
Research Study
Full title
A Phase 2 randomised, single blinded, placebo controlled, cross-over trial of a single dose of live attenuated influenza vaccine in 12-23 month old children (FluSNIFF-toddler)
IRAS ID
1012411
Contact name
Saul Faust
Contact email
Sponsor organisation
University Hospital Southampton NHS Foundation Trust
ISRCTN Number
ISRCTN28027532
Research summary
Influenza (known as flu) causes substantial illness every winter, especially among older-people, those with weakened immune systems, and young children. The NHS currently offers a nasal flu vaccine to children over 2 years, which also helps protect others by reducing transmission. Although children under 2 years are highest risk from flu, they haven’t yet been offered the vaccine as sufficient safety data was not available for this age.
What we’re doing:
● We will recruit 12- to 23-month-old children at their GP practice and randomly assign them to receive the nasal flu vaccine or a placebo nasal spray at their first visit. The parents will not know which one the child receives.
● Over the next four weeks, we will record/monitor the number of children in each group return to their GP with a wheezing diagnosis.
● At the second visit, each child will receive whichever nasal spray they did not get at the first visit. Rates of wheezing will then again be compared after the second visit.
● Every child will receive both the vaccine and a placebo.
If the rate of wheezing after the vaccine is the same (or lower) than after the placebo, the UK’s vaccination advisory committee may decide to offer the nasal flu vaccine to all children from 12 months of age next winter.
This trial will be conducted with a company called uMed, a clinical research technology platform, who partners with UK Healthcare Providers to access NHS Electronic Health Record data and invite patients to participate in research. The uMed system was used in the HARMONIE study of nirsevimab (preventing RSV in infants) performed in general practice and hospitals in autumn 2022. uMed will be involved in aspects including digital screening & invitations, remote eConsent and electronic monitoring, ensuring it runs efficiently.REC name
London - Hampstead Research Ethics Committee
REC reference
25/LO/0534
Date of REC Opinion
21 Aug 2025
REC opinion
Further Information Favourable Opinion