SNIFFLE-3 Study
Research type
Research Study
Full title
Efficacy & Safety of Nasal Influenza Immunisation in Children - The SNIFFLE-3 study
IRAS ID
184277
Contact name
Paul Turner
Contact email
Eudract number
2015-003019-39
Duration of Study in the UK
0 years, 6 months, 18 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 2-17 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. However, in 2014, Fluenz was not as effective as the injected vaccine in USA, for reasons that are unclear.
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.
Given the vaccine efficacy data from the USA in 2014, we now want to see how effective Fluenz is at protecting against the ‘flu, in children with and without allergies. At the same time, we plan to add to the safety data generated by the original SNIFFLE studies, confirming the vaccine is safe in children with asthma and recurrent wheezing. The study will run during the winter ‘flu vaccination season (autumn 2015 to early 2016).
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
15/WM/0256
Date of REC Opinion
1 Sep 2015
REC opinion
Further Information Favourable Opinion