SNIFFLE-4 Study
Research type
Research Study
Full title
Safety of Nasal Influenza Immunisation in Children with Asthma: The SNIFFLE 4 study
IRAS ID
207822
Contact name
Paul Turner
Contact email
Sponsor organisation
Imperial College Healthcare NHS Trust
Eudract number
2016-002352-24
Duration of Study in the UK
0 years, 7 months, 20 days
Research summary
Since 2013, the UK government has begun to phase in the introduction of Fluenz, an influenza (‘flu) vaccine given as a nasal spray, to all children aged 2-18 years. Fluenz has been available in the United States since 2003, and has been given to over a million children. Previous studies have shown the vaccine to be highly effective and against influenza infection, with an excellent safety profile.
Like most 'flu vaccines, Fluenz is grown in hen’s eggs and contains egg protein, and until recently there were no data on its use in egg-allergic children. For this reason, we conducted the SNIFFLE-1 and -2 studies, which demonstrated the safety of the vaccine in children with egg allergy. The studies also provided reassuring data that Fluenz can be given the children with asthma/recurrent wheezing without causing acute respiratory symptoms. This is important, due to some data which demonstrated infants under 12 months of age might be at increased risk of wheezing post vaccination with Fluenz. However, only a limited number of children with "severe" asthma - requiring high dose inhaled corticosteroid therapy or more (BTS 4+ treatment) were included in this cohort, which limited the conclusions which could be drawn regarding this group of children.
We now wish to assess the safety of Fluenz in children attending two specialist asthma clinics to obtain data which can be used to inform national UK guidance on Fluenz administration. The study will run during the winter ‘flu vaccination season (autumn 2016 to early 2017).
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
16/WM/0276
Date of REC Opinion
2 Aug 2016
REC opinion
Favourable Opinion