SNIFFLE 2 Study
Research type
Research Study
Full title
Safety of Nasal Influenza Immunisation in Egg Allergic Children - The SNIFFLE 2 study
IRAS ID
154310
Contact name
Mich Erlewyn-Lajeunesse
Contact email
Sponsor organisation
University Hospital Southampton NHS Foundation Trust
Eudract number
2014-002031-26
Clinicaltrials.gov Identifier
Research summary
Egg allergy is very common in early childhood, affecting at least one in 50 preschool children. Influenza ('flu') vaccines contain egg protein, as the vaccine is cultured in hen's eggs. While individuals with egg allergy may be at risk of allergic reactions to influenza vaccines, there is now robust data to support the safety of many influenza vaccines (containing low or negligible amounts of egg protein) in patients with egg allergy. These vaccines, given by intramuscular injection, have previously been administered only to 'high risk' children (e.g. those with severe asthma).
From the 2013/14 influenza season, influenza vaccination for all children age 2-3 years was introduced into the UK immunisation schedule, to reduce the morbidity and mortality associated with this disease. This new vaccine, known as LAIV (Live Attenuated Intranasal Vaccine, marked as Fluenz) is given by a spray into the nose.
The intranasal LAIV has been available in the United States for several years and is highly effective and against influenza infection, with an excellent safety profile in children. However, LAIV is also grown in hen's eggs and contains egg protein, and until recently there were no data on the safety of LAIV in egg-allergic children. For this reason, we conducted the SNIFFLE study to obtain the required safety data. In a cohort of 282 children with egg allergy (40% of whom had a history of anaphylaxis) there were no systemic or significant allergic reactions.
The objective of this multicentre study is to increase the statistical power of this data through a larger cohort, and test the feasibility of a more pragmatic approach to the use of intranasal LAIV in egg-allergic children, in order to demonstrate that these children can safely be given the new LAIV within the primary care setting proposed in the UK immunisation programme.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
14/WM/0159
Date of REC Opinion
2 Jul 2014
REC opinion
Further Information Favourable Opinion